JP6691347B2 - Intracardiac defibrillation catheter - Google Patents

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, cardioversion must be performed. The present applicant has, as a catheter for performing such defibrillation in a heart chamber, an insulating tube member having a multi-lumen structure, a handle connected to the proximal end of the tube member, and the tube member. A second DC electrode composed of a plurality of ring-shaped electrodes mounted on the tip region of the first DC electrode group, and a plurality of ring-shaped electrodes mounted on the tube member so as to be spaced from the first DC electrode group toward the base end side. Group, a first lead wire group formed of lead wires connected to each of the electrodes forming the first DC electrode group, and a second lead wire formed of lead wires connected to each of the electrodes forming the second DC electrode group A lead wire group, wherein the first lead wire group and the second lead wire group extend in 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 having such a configuration into the right atrium through the superior vena cava, and further into the coronary sinus opening (the coronary sinus ostium) in the posterior inferior wall of the right atrium. , The first DC electrode group is located in the coronary sinus, and the second DC electrode group is located in the right atrium, and then voltages of different polarities are applied to the first DC electrode group and the second DC electrode group. To do. As a result, it is possible to provide the heart, which is undergoing atrial fibrillation, with electric energy necessary and sufficient for defibrillation.

JP, 2010-63708, A

Recently, a procedure for inserting an intracardiac defibrillation catheter into the right atrium from the inferior vena cava and inserting it into the coronary sinus ostium has been performed.
Such a procedure (approach from the inferior vena cava) is a conventional procedure in which an intracardiac defibrillation catheter is inserted from the superior vena cava into the right atrium and then into the coronary sinus ostium (approach from the superior vena cava). It is less invasive as compared with, and is preferable from the viewpoint of postoperative beauty.

  However, in the approach from the inferior vena cava, it is difficult to insert the intracardiac defibrillation catheter into the coronary sinus ostium, and even after the coronary sinus ostium is inserted, torque is applied to untwist the tube member. Such operations are necessary.

Therefore, when performing an approach from the inferior vena cava, it is conceivable to insert the intracardiac defibrillation catheter along the guide wire that was previously inserted into the coronary sinus ostium.
Here, in order to insert the intracardiac defibrillation catheter along the guidewire into the target site, a lumen (guidewire lumen) through which the guidewire can be inserted into the tube member of the intracardiac defibrillation catheter Need to be formed.

  However, in the approach from the inferior vena cava, the intracardiac defibrillation catheter (tube member) is moved so as to go around the right atrium once before being inserted into the ostium of the coronary vein, so that it is attached to the tip of the catheter. If the tip member is made of a hard material such as metal, the tip (tip member) of the tip member may damage the inner wall of the right atrium.

In order to avoid such a problem, it is possible to attach a resin tip member to the tip of the defibrillation catheter.
Specifically, a resin-made chip member having a through hole (lumen) is produced by molding, and the chip member is formed so that the through hole of this chip member and the central lumen of the tube member serving as the guide wire lumen communicate with each other. It is conceivable to fix the base end of the above and the tip end of the tube member by fusion or the like.

  However, since the resin-made tip member has a low adhesion strength to the tube member, the tip member comes into contact with the inner wall of the heart or the like and, for example, with respect to the tip end portion (portion not fused with the tube member) When a radial force is applied to the tip member, the tip member may fall off the tip portion of the tube member.

  The lumen tube that defines the central lumen of the tube member is usually made of a material having good lubricity and chemical resistance (fluorine resin or polyolefin resin), but in the through hole of the chip member, , Unable to exert such lubricity and chemical resistance.

The present invention has been made based on the above circumstances.
The object of the present invention is to damage the inner wall of the right atrium by its tip even when it is used in the procedure of inserting it from the inferior vena cava into the right atrium and inserting it into the coronary sinus ostium (approach from the inferior vena cava). Another object of the present invention is to provide an intracardiac defibrillation catheter in which the tip member does not fall off during the procedure.
Another object of the present invention is to provide an intracardiac defibrillation catheter capable of exhibiting good lubricity and chemical resistance in the insertion path of the guide wire from the proximal end of the tube member to the distal end of the defibrillation catheter. To provide.

(1) An intracardiac defibrillation catheter according to the present invention is a catheter that is inserted into a heart chamber for defibrillation,
An insulating tube member,
A tip member attached to the tip of the tube member,
A handle attached to the proximal end of the tube member,
A first electrode group (first DC electrode group) including a plurality of ring-shaped electrodes attached to the tip region of the tube member;
A second electrode group (second DC electrode group) composed of a plurality of ring-shaped electrodes that are mounted on the distal end region of the tube member and are separated from the first DC electrode group toward the base end side;
A first lead wire group composed of a plurality of lead wires each having a tip connected to the plurality of electrodes forming the first DC electrode group;
A second lead wire group composed of a plurality of lead wires each having a tip connected to the plurality of electrodes forming the second DC electrode group ;
A distal end of the tube member, the distal end of which is fixed, and the proximal end of which includes at least one operation wire capable of being pulled ,
In the heart chamber, defibrillation is performed by applying voltages of different polarities to the first DC electrode group and the second DC electrode group,
The tube member has a multi-lumen structure in which a central lumen through which a guide wire can be inserted and a plurality of sub-lumens arranged around the central lumen are formed.
The lead wire forming the first lead wire group and the lead wire forming the second lead wire group extend in different sub-lumens of the tube member,
The operation wire extends in a sub-lumen different from a sub-lumen in which the lead wire configuring the first lead wire group or the second lead wire group extends,
A sub-lumen in which the central lumen and the operation wire extend is formed at the tip end portion of the tube member (the outer periphery of the tube member is cut so that the sub-lumen remains) . A cylindrical second reduced diameter portion that defines and forms the central lumen (formed by further cutting the outer periphery of the tube member so that the central lumen remains) at the diameter portion and the tip side of the first reduced diameter portion. Has and
The tip end side of the first reduced diameter portion has an outer diameter substantially the same as the outer diameter of the first reduced diameter portion and an inner diameter substantially the same as the outer diameter of the second reduced diameter portion, A cylindrical member shorter than the axial length of the second reduced diameter portion, wherein an anchor member for fixing the distal end of the operation wire is attached to the distal end portion of the tube member,
The tip member is made of a resin whose hardness does not exceed the hardness of the material forming the tube member, a through hole is formed along the axial direction, and has an outer diameter substantially the same as the outer diameter of the tube member. Have,
The axial length of the tip member is substantially the same as the combined length of the first reduced diameter portion and the second reduced diameter portion,
The tip member includes a base end portion having an inner diameter substantially the same as the outer diameter of the first reduced diameter portion and a distal end portion having an inner diameter substantially the same as the outer diameter of the second reduced diameter portion. The second reduced diameter projecting from the tip end of the anchor member at the tip end portion of the tip member, and covering the outer periphery of the first reduced diameter portion and the anchor member at the base end portion of the tip member. Is attached to the distal end of the tube member so as to cover the outer periphery of the section,
The tip end of the tip member and the tip end of the second reduced diameter portion are substantially aligned with each other.

  According to the intracardiac defibrillation catheter having such a configuration, since the tip member located at the tip thereof is made of resin having a hardness not exceeding the hardness of the constituent material of the tube member, Even when used in the approach technique, the tip member does not damage the inner wall of the right atrium.

Further, in a state in which the anchor member is surrounded by the distal end surface of the first reduced diameter portion of the tube member, the outer peripheral surface of the second reduced diameter portion, the proximal end surface of the distal end portion of the tip member and the inner peripheral surface of the proximal end portion, The anchor member can be attached to the tip of the tube member.

(2) In the intracardiac defibrillation catheter of the present invention, the central lumen is formed by a lumen tube made of a fluororesin or a polyolefin resin having a hardness of 50D or more, and the tip member is made of a heat having a hardness of 35D to 40D. It is preferably made of a plastic resin.

According to the intracardiac defibrillation catheter of the present invention, even when it is used for a procedure by the approach from the inferior vena cava, the tip member constituting the catheter does not damage the inner wall of the right atrium, and the procedure can be performed during the procedure. The tip member does not fall off.
Further, since a step is not formed in the insertion path of the guide wire from the proximal end of the tube member to the distal end of the defibrillation catheter, the guide wire can be inserted easily.
In addition, in the insertion path of the guide wire from the proximal end of the tube member to the distal end of the defibrillation catheter, good lubricity and chemical resistance can be exhibited by the inner wall material of the central lumen of the tube member.

It is a top view showing a defibrillation catheter concerning one embodiment of the present invention. FIG. 2 is a transverse cross-sectional view (cross-sectional view taken along the line II-II of FIG. 1) of a tube member that constitutes the defibrillation catheter shown in FIG. 1. It is a perspective view which shows the front-end | tip part of the defibrillation catheter shown in FIG. It is a longitudinal cross-sectional view which shows the front-end | tip part of the defibrillation catheter shown in FIG. FIG. 5 is a transverse cross-sectional view (VA-VA cross-sectional view of FIG. 4) showing the distal end portion of the defibrillation catheter shown in FIG. 1. FIG. 5 is a transverse cross-sectional view (VB-VB cross-sectional view of FIG. 4) showing the distal end portion of the defibrillation catheter shown in FIG. 1. FIG. 5 is a transverse cross-sectional view (VC-VC cross-sectional view of FIG. 4) showing the distal end portion of the defibrillation catheter shown in FIG. 1. FIG. 3 is a perspective view showing an anchor member and an operating wire that form the defibrillation catheter shown in FIG. 1. It is a perspective view which shows the tip member which comprises the defibrillation catheter shown in FIG. It is a top view which shows the inside of the handle which comprises the defibrillation catheter shown in FIG. FIG. 9 is a partially enlarged view showing the inside of the handle shown in FIG. 8 (detailed view of IX portion in FIG. 8). FIG. 9 is a partial enlarged view (perspective view) showing the inside of the handle shown in FIG. 8. FIG. 9 is a partially enlarged view showing the inside of the handle shown in FIG. 8 (detailed view of X part in FIG. 8). FIG. 11 is a transverse cross-sectional view (XI-XI cross-sectional view of FIG. 10) of a tube member that constitutes the defibrillation catheter shown in FIG. 1.

Hereinafter, embodiments of the present invention will be described with reference to the drawings, but the present invention is not limited thereto.
In addition, in this invention, a "base end part" means a part including a base end and having a certain length, and a "tip part" means a part including a tip and having a certain length.

The defibrillation catheter 100 of the present embodiment shown in FIGS. 1 to 11 includes a central lumen 10L that serves as a guide wire lumen, and eight sub-lumens 11L to 18L arranged around the central lumen 10L at equal angular intervals. Insulating tube member 10 having a multi-lumen structure in which is formed, handle 20 attached to the proximal end portion 102 of this tube member 10, and eight ring-shaped electrodes attached to the distal end region of tube member 10. A first DC electrode group 31G made up of 31 and a second DC electrode group 32G made up of eight ring-shaped electrodes 32 that are attached to the distal end region of the tube member 10 so as to be separated from the first DC electrode group 31G on the proximal side. Four ring-shaped electrodes 3 for potential measurement, which are attached to the tip region of the tube member 10 between the first DC electrode group 31G and the second DC electrode group 32G. And a first lead wire group 41G composed of eight lead wires 41 each having its tip connected to the electrode 31 forming the first DC electrode group 31G, and an electrode 32 forming the second DC electrode group 32G A second lead wire group 42G composed of eight lead wires 42 connected to each other, and a third lead wire group 43G composed of four lead wires 43 each of which has its tip connected to the electrode 33 for potential measurement. An electrode connector 50 arranged on the proximal end side of the handle 20 and having a plurality of terminals (not shown), a guide wire connector 60 arranged on the proximal end side of the handle 20 and having a guide wire port 61 at the proximal end, and the tube member 10. Each of the distal ends of the tube member 10 is fixed to the distal end portion of the tube member 10, and each of the proximal ends of the operation wires 71 and 72 can be pulled, and the tip member 80 mounted on the distal end portion of the tube member 10. The operation wires 71 and 72 extend to the sub-lumens 11L and 15L of the tube member 10, the first lead wire group 41G extends to the sub-lumen 14L, and the second lead to the sub-lumen 17L. The line group 42G extends, the third lead wire group 43G extends in the sub-lumen 12L, and voltages of different polarities are applied between the first DC electrode group 31G and the second DC electrode group 32G. A catheter for defibrillation in a heart chamber by
The distal end portion 101 of the tube member 10 is formed with a central lumen 10L and sub-lumens 11L to 18L (formed by cutting the outer periphery of the tube member 10 so that the sub-lumens 11L to 18L remain). 1011 and a second cylindrical reduced diameter portion that defines and forms the central lumen 10L (formed by further cutting the outer periphery of the tube member 10 so that the central lumen 10L remains) on the tip side of the first reduced diameter portion 1011. 1012 and
At the tip side of the first reduced diameter portion 1011 has an outer diameter substantially the same as the outer diameter of the first reduced diameter portion 1011 and an inner diameter substantially the same as the outer diameter of the second reduced diameter portion 1012. An anchor member 75 for fixing the distal ends of the operation wires 71 and 72 to the distal end portion 101 of the tube member 10, which is a cylindrical member shorter than the axial length of the portion 1012,
The outer diameter of the tip member 80 is substantially the same as the outer diameter of the tube member 10, and the length of the tip member 80 is the same as the combined length of the first reduced diameter portion 1011 and the second reduced diameter portion 1012. ,
The tip member 80 is made of a resin having a hardness not exceeding the hardness of the material forming the tube member 10, and has a base end portion 81 having an inner diameter substantially the same as the outer diameter of the first reduced diameter portion 1011 and a second reduced diameter portion. The tip end portion 82 has an inner diameter substantially the same as the outer diameter of the portion 1012, the base end portion 81 covers the outer circumference of the first reduced diameter portion 1011 and the anchor member 75, and the tip end portion 82 of the anchor member 75. The second reduced diameter portion 1012 protruding from the tip is attached to the distal end portion of the tube member 10 so as to cover the outer periphery thereof, and the tip of the tip member 80 and the tip of the second reduced diameter portion 1012 are aligned. It is a fibrillation catheter.

  The intracardiac defibrillation catheter 100 of the present embodiment includes a tube member 10, a handle 20, a first DC electrode group 31G, a second DC electrode group 32G, a potential measuring electrode 33, and a first lead wire group. 41G, a second lead wire group 42G, a third lead wire group 43G, an electrode connector 50, a guide wire connector 60, operation wires 71 and 72, and a tip member 80.

As shown in FIG. 2, the tube member 10 that constitutes the intracardiac defibrillation catheter 100 of the present embodiment is a multi-lumen tube. The tube member 10 includes a central lumen 10L that is open at the distal end and the proximal end. , And eight sub-lumens 11L to 18L arranged at equal angular intervals (45 ° intervals) are formed around it.
In FIG. 2, 191 is an inner (core) part made of a low hardness nylon elastomer, and 192 is an outer (shell) part made of a high hardness nylon elastomer.

  The central lumen 10L and the sub-lumens 11L to 18L are each defined by a lumen tube made of fluororesin or the like. Examples of the fluororesin constituting such a lumen tube include perfluoroalkyl vinyl ether copolymer (PFA) and polytetrafluoroethylene (PTFE).

The nylon elastomer forming the outer portion 17 of the tube member 10 has different hardness depending on the axial direction. Thereby, the tube member 10 is configured so that the hardness gradually increases from the distal end side toward the proximal end side.
Further, a braid may be formed between the inner portion 191 and the outer portion 192 on the base end side of the tube member 10.
The outer diameter of the tube member 10 is, for example, 1.2 to 3.3 mm.

  The handle 20 constituting the intracardiac defibrillation catheter 100 of the present embodiment is attached to the proximal end portion 102 of the tube member 10. The handle 20 includes a handle body 21 and wire fasteners 231 and 232. It has a rotation operation part 23 provided and a strain relief 24. By rotating the rotating operation part 23 (pulling the operating wire 71 or the operating wire 72), the tip of the tube member 10 can be deflected (in one direction or in the other direction).

A first DC electrode group 31G and a second DC electrode group 32G are attached to the tip region of the tube member 10. Further, an electrode 33 for potential measurement is attached to the tip region of the tube member 10 between the first DC electrode group 31G and the second DC electrode group 32G.
Here, the "electrode group" is a set of a plurality of electrodes that form the same pole (have the same polarity) or have the same purpose and are mounted at narrow intervals (for example, 5 mm or less). Refers to the body.

  In the first DC electrode group, a plurality of electrodes forming the same pole (-pole or + pole) are mounted at narrow intervals in the tip region of the tube member. Here, the number of electrodes forming the first DC electrode group is, for example, 4 to 13 and preferably 8 to 10 though it varies depending on the width and the arrangement interval of the electrodes.

In the present embodiment, the first DC electrode group 31G is composed of eight electrodes 31 mounted in the tip region of the tube member 10.
The electrodes 31 forming the first DC electrode group 31G are connected to the terminals of the same pole in the DC power supply device via the lead wires (the lead wires 41 forming the first lead wire group 41G) and the electrode connector 50 described later. ing.

Here, the width (length in the axial direction) of the electrode 31 is preferably 2 to 5 mm.
If the width of the electrode 31 is too narrow, the amount of heat generated when a voltage is applied becomes excessive, which may damage the surrounding tissue. On the other hand, if the width of the electrode 31 is too wide, the flexibility of the portion of the tube member 10 where the first DC electrode group 31G is provided may be impaired. The mounting interval of the electrodes 31 (distance between adjacent electrodes) is preferably 1 to 5 mm.
When the intracardiac defibrillation catheter 100 is used (when it is placed in the heart chamber), the first DC electrode group 31G is located, for example, in the coronary vein (CS).

  The second DC electrode group is separated from the mounting position of the first DC electrode group of the tube member toward the base end side, and a plurality of electrodes forming a pole (+ pole or − pole) opposite to the first DC electrode group are arranged at narrow intervals. It is installed in. Here, the number of electrodes forming the second DC electrode group is, for example, 4 to 13 and preferably 8 to 10 though it varies depending on the width and the arrangement interval of the electrodes.

In the present embodiment, the second DC electrode group 32G is composed of eight electrodes 32 mounted on the tube member 10 so as to be separated from the mounting position of the first DC electrode group 31G toward the base end side.
The electrodes 32 forming the second DC electrode group 32G are the same pole terminal (first DC electrode group) in the DC power supply device via the lead wire (lead wire 42 forming the second lead wire group 42G) and a connector described later. 31G is connected to the terminal of the opposite pole to that to which 31G is connected).

  Thereby, voltages having mutually 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 has a negative pole, the other electrode group has a positive pole).

Here, the width (length in the axial direction) of the electrode 32 is preferably 2 to 5 mm.
If the width of the electrode 32 is too narrow, the amount of heat generated when a voltage is applied becomes excessive and may damage the surrounding tissue. On the other hand, if the width of the electrode 32 is too wide, the flexibility of the portion of the tube member 10 where the second DC electrode group 32G is provided may be impaired. The mounting interval of the electrodes 32 (distance between adjacent electrodes) is preferably 1 to 5 mm.
When the intracardiac defibrillation catheter 100 is used (when placed in the heart chamber), the second DC electrode group 32G is located in, for example, the right atrium (RA).

In the present embodiment, the potential measuring electrode 33 is attached to the tip region of the tube member 10 between the first DC electrode group 31G and the second DC electrode group 32G.
The electrode 33 is connected to the electrocardiograph via a lead wire (lead wire 43 forming the third lead wire group 43G) and an electrode connector 50 described later.

  Here, the width (length in the axial direction) of the electrode 33 is preferably 0.5 to 2.0 mm. If the width of the electrode 33 is too wide, the measurement accuracy of the cardiac potential will be reduced, and it will be difficult to identify the site where the abnormal potential has occurred. The mounting interval of the electrodes 33 (distance between adjacent electrodes) is preferably 1.0 to 10.0 mm.

  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.

  The electrodes 31 and 32 forming the first DC electrode group 31G and the second DC electrode group 32G, and the electrode 33 for measuring the potential are made of platinum or a platinum-based alloy in order to improve the contrast of X-rays. It is preferable that

The first lead wire group 41G shown in FIG. 2 is an assembly of eight lead wires 41 connected to each of the eight electrodes 31 forming the first DC electrode group 31G.
With the first lead wire group 41G (lead wire 41), each of the eight electrodes 31 forming the first DC electrode group 31G can be electrically connected to the DC power supply device.

  The eight electrodes 31 forming the first DC electrode group 31G are connected to different lead wires 41, respectively. Each of the lead wires 41 is welded to the inner peripheral surface of the electrode 31 at the tip portion thereof, and enters the sub-lumen 14L through the side hole formed in the tube wall of the tip region of the tube member 10. The eight lead wires 41 that have entered the sub-lumen 14L extend to the sub-lumen 14L as a first lead wire group 41G.

The second lead wire group 42G shown in FIG. 2 is an assembly of eight lead wires 42 connected to each of the eight electrodes 32 forming the second DC electrode group 32G.
With the second lead wire group 42G (lead wire 42), each of the eight electrodes 32 forming the second DC electrode group 32G can be electrically connected to the DC power supply device.

  The eight electrodes 32 forming the second DC electrode group 32G are connected to different lead wires 42, respectively. Each of the lead wires 42 is welded to the inner peripheral surface of the electrode 32 at the tip portion thereof, and enters the sub-lumen 17L through the side hole formed in the tube wall of the tip end region of the tube member 10. The eight lead wires 42 that have entered the sub-lumen 17L extend to the sub-lumen 17L as a second lead wire group 42G.

  As described above, the first lead wire group 41G extends to the sub-lumen 14L and the second lead wire group 42G extends to the sub-lumen 17L, so that both are completely inside the tube member 10. Isolated and isolated. Therefore, when a voltage necessary for defibrillation is applied, inside the tube member 10, 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 from being short-circuited.

The third lead wire group 43G shown in FIG. 2 is an assembly of four lead wires 43 connected to each of the potential measuring electrodes 33.
Each of the electrodes 33 can be connected to the electrocardiograph by the third lead wire group 43G (lead wire 43).

  The four electrodes 33 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 sub-lumen 12L from the side hole formed in the tube wall of the tube member 10. The four lead wires 43 that have entered the sub-lumen 12L extend to the sub-lumen 12L as a third lead wire group 43G.

  Each of the lead wire 41, the lead wire 42, and the lead wire 43 is a resin-coated wire in which the outer peripheral surface of a metal conductor 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. 1, reference numeral 50 denotes an electrode connector, which is arranged on the base end side (outside) of the handle. Inside the electrode connector 50, a plurality of terminals (not shown) are provided.
In the figure, 51 and 52 are external cords for guiding the lead wire group extending from the inside of the handle 20 to the electrode connector 50.

  In FIG. 1, reference numeral 60 denotes a guide wire connector, which is arranged on the proximal side (outside) of the handle. The base end of the guide wire connector 60 is a guide wire port 61.

In FIGS. 2, 4 to 6, FIG. 8 and FIG. 9 (FIG. 9A, FIG. 9B), 71 and 72 are operation wires.
As shown in FIGS. 2, 4, and 5 (FIG. 5C), the operation wire 71 extends in the sub-lumen 11L of the tube member 10, and the operation wire 72 extends in the sub-lumen 15L.
The distal ends of the operation wires 71, 72 are fixed to positions (the circumferential position of the tube member 10) facing each other in the distal end portion 101 of the tube member 10 via an anchor member 75 described later.

  The operation wires 71 and 72 are made of stainless steel or a Ni—Ti-based superelastic alloy, but they are not necessarily made of metal. The operation wire 71 may be made of, for example, a high-strength non-conductive wire.

Neither lead wire (group) extends to the sub-lumens 11L and 15L to which the operation wires 71 and 72 extend.
Thus, when the tip of the tube member 10 is deflected, the operation wires 71 and 72 that move in the axial direction by the operation cause the lead wire 41, the lead wire 42, and the lead wire extending inside the tube member 10. The line 43 is not damaged (eg, scratched).

In FIGS. 1 and 3 to 5, reference numeral 80 is a chip member.
The tip member 80 that constitutes the intracardiac defibrillation catheter 100 has a hardness that does not exceed the hardness of the constituent material of the tube member 10 (the lowest hardness when the hardness of the tube member 10 changes stepwise). It is made of resin.
Examples of the resin that constitutes the chip member 80 include thermoplastic resins such as PEBAX (registered trademark).
The hardness of the resin forming the chip member 80 is preferably 25D to 63D, and more preferably 35D to 40D.

  As shown in FIGS. 3 to 5 (FIGS. 5A, 5B, and 5C), the distal end portion 101 of the tube member 10 has a first reduced diameter portion 1011 and a second reduced diameter portion 1012, and has two stages. It has been reduced in diameter.

The first reduced diameter portion 1011 of the tube member 10 is composed of a cylindrical tube constituent portion in which the central lumen 10L and the sub-lumens 11L to 18L are formed.
The first reduced diameter portion 1011 can be formed by cutting the tube member 10 with a cutting amount that allows the sub-lumens 11L to 18L to remain.

The second reduced diameter portion 1012 of the tube member 10 is composed of a cylindrical tube constituent portion that defines and forms the central lumen 10L on the tip side of the first reduced diameter portion 1011.
The second reduced diameter portion 1012 can be formed by cutting the tube member 10 with a cutting amount that allows the central lumen 10L to remain.

  As shown in FIGS. 3 to 5 (FIG. 5B), a cylindrical anchor member 75 is attached to the tip side of the first reduced diameter portion 1011 so as to cover the outer periphery of the second reduced diameter portion 1012. There is.

The inner diameter of the anchor member 75 is substantially the same as the outer diameter of the second reduced diameter portion 1012, so that the outer circumference of the second reduced diameter portion 1012 is covered (the second reduced diameter portion 1012 is inside the anchor member 75). Anchor member 75 may be attached (as is inserted into).
The outer diameter of the anchor member 75 is substantially the same as the outer diameter of the first reduced diameter portion 1011.

  As shown in FIGS. 4 to 6, the distal ends of the operation wires 71 and 72 are fixed to the tube wall of the anchor member 75, and the distal ends of the operation wires 71 and 72 are fixed to the tube wall of the anchor member 75. Each of the wires 71 and 72 is inserted into the sub-lumens 11L and 15L that are open at the tip of the first reduced diameter portion 1011.

As shown in FIG. 7, the tip member 80 includes a base end portion 81 having a relatively large inner diameter and a tip end portion 82 having a relatively small inner diameter.
The outer diameter of the tip member 80 is the same over the entire length.

  As shown in FIGS. 4 and 5, the inner diameter of the base end portion 81 of the tip member 80 is substantially the same as the outer diameter of the first reduced diameter portion 1011 (outer diameter of the anchor member 75), and the tip end of the tip member 80. The inner diameter of the portion 82 is substantially the same as the outer diameter of the second reduced diameter portion 1012.

  The length of the tip member 80 is the total length of the first reduced diameter portion 1011 and the second reduced diameter portion 1012 (the length from the base end of the first reduced diameter portion 1011 to the tip of the second reduced diameter portion 1012). ), The length of the base end portion 81 of the tip member 80 is the total length of the first reduced diameter portion 1011 and the anchor member 75 (from the base end of the first reduced diameter portion 1011 to the anchor member 75). The length up to the tip) is the same.

  As a result, the tip member 80 covers the outer circumference of the first reduced diameter portion 1011 and the anchor member 75 at the base end portion 81 and the outer circumference of the second reduced diameter portion 1012 at the tip end portion 82 thereof, that is, A state in which the first reduced diameter portion 1011 and the anchor member 75 are accommodated inside the base end portion 81, and the distal end portion of the second reduced diameter portion 1012 protruding from the distal end of the anchor member 75 is accommodated inside the distal end portion 82. The tip end of the tip member 80 is attached to the tip end of the tube member 10, and the tip end of the second reduced diameter portion 1012 is aligned.

As shown in FIG. 8, the proximal end portion 102 of the tube member 10 is inserted into the inside of the handle 20 from the distal end of the handle 20, and extends inside the handle 20 in the proximal direction to arrange the rotation operation portion 23. It passes through the axial position, and extends from the base end portion 202 of the handle 20 to the outside of the handle 20.
In the figure, reference numeral 25 denotes an adjustment pin fixed to the handle main body 21 at the rotation center of the rotation operation portion 23, and the adjustment pin has a through hole through which the tube member 10 can be inserted.

As shown in FIG. 1, a guide wire connector 60 is connected to the proximal end of the tube member 10 (proximal end portion 102) extending to the outside of the handle 20, whereby the central lumen 10L of the tube member 10 and the guide. The guide wire port 61 of the wire connector 60 communicates.
With such a configuration, a guide wire insertion path from the guide wire port 61 of the guide wire connector 60 to the tip opening of the central lumen 10L (guide wire lumen) of the tube member 10 is secured.

  As shown in FIGS. 8 and 9 (FIGS. 9A and 9B), the wire fastener 231 of the rotation operation portion 23 is provided on the tube wall of the proximal end portion 102 of the tube member 10 extending inside the handle 20. A first side hole 111 extending from the sub-lumen 11L to the outer peripheral surface of the tube member 10 is formed at a position in the circumferential direction of the tube member 10 corresponding to the sub-lumen 11L on the more distal side, and the wire of the rotary operation part 23 is formed. A first side hole 115 extending from the sub-lumen 15L to the outer peripheral surface of the tube member 10 is formed at a circumferential position of the tube member 10 corresponding to the sub-lumen 15L on the tip side of the fastener 232.

The proximal end portion of the operation wire 71 extending to the sub-lumen 11L of the tube member 10 extends to the outside of the tube member 10 (inside the handle 20) through the first side hole 111, and is used for operation. The proximal end of the wire 71 is fixed to the wire fastener 231 of the rotary operation part 23 of the handle 20.
The proximal end portion of the operating wire 72 extending to the sub-lumen 15L of the tube member 10 extends to the outside of the tube member 10 (inside the handle 20) through the first side hole 115, The proximal end of the operation wire 72 is fixed to the wire fastener 232 of the rotary operation part 23 of the handle 20.
The operation wire 71 or the operation wire 72 is pulled by operating the rotation operation part 23, whereby the tip of the tube member 10 is deflected in one direction or the other direction.

  As shown in FIGS. 8, 10 and 11, on the tube wall of the proximal end portion 102 of the tube member 10 extending inside the handle 20, the sub-lumen 12L closer to the proximal end side than the rotation operation portion 23 is. , 13L, 14L, 16L, 17L, 18L at the circumferential position of the tube member 10, the second side holes 122, 123, 124 from each of these sub-lumens to the outer peripheral surface of the tube member 10, 126, 127 and 128 are formed.

The base end portion of the first lead wire group 41G extending to the sub-lumen 14L of the tube member 10 is enclosed by the first insulating tube 46 and passes through the second side hole 124 to allow the tube member 10 to pass through. It extends to the outside (inside the handle 20).
Further, the base end portion of the second lead wire group 42G extending to the sub-lumen 17L of the tube member 10 passes through the second side hole 127 while being enclosed in the second insulating tube 47. It extends to the outside of 10 (inside of the handle 20).
In addition, the base end portion of the third lead wire group 43G extending to the sub-lumen 12L of the tube member 10 passes through the second side hole 122 while being enclosed in the third insulating tube 48, and the tube member. It extends to the outside of 10 (inside of the handle 20).

Here, the tip end portions (about 10 mm from the tip end) of the insulating tubes 46, 47, 48 are inserted into the sub-lumens 14L, 17L, 12L from the second side holes 124, 127, 122, respectively. The insulating tubes 46, 47, 48 are connected to the sub-lumens 14L, 17L, 12L, respectively.
The base ends of the insulating tubes 46, 47, and 48 open near the electrode connector 50.

  The proximal end portion of the first lead wire group 41G extending to the outside of the tube member 10 (inside the handle 20) extends to the outside of the handle 20 while being contained in the first insulating tube 46, and the external cord By being extended inside 52, it is guided to the vicinity of the electrode connector 50, extends from the base end opening of the first insulating tube 46 in the vicinity of the electrode connector 50, and is distributed to the eight lead wires 41 constituting the same. The base end of each of these lead wires 41 is connected to a predetermined terminal of the electrode connector 50.

  The proximal end portion of the second lead wire group 42G extending to the outside of the tube member 10 (inside the handle 20) extends to the outside of the handle 20 while being contained in the second insulating tube 47, and the external cord By being extended inside 51, it is guided to the vicinity of the electrode connector 50, extends from the base end opening of the second insulating tube 47 in the vicinity of the electrode connector 50, and is separated into the eight lead wires 42 constituting the same. The base ends of these lead wires 42 are connected to predetermined terminals of the electrode connector 50.

  The proximal end portion of the third lead wire group 43G extending to the outside of the tube member 10 (inside the handle 20) extends to the outside of the handle 20 while being contained in the third insulating tube 48, and Along with the second lead wire group 42G contained in the insulating tube 47, it is guided to the vicinity of the electrode connector 50 by extending inside the outer cord 51, and in the vicinity of the electrode connector 50, the third insulating tube 48. Of the lead wire 43, which extends from the base end opening of the lead wire 43 and is separated into four lead wires 43, which are connected to predetermined terminals of the electrode connector 50.

  According to the intracardiac defibrillation catheter 100 of the present embodiment, since the tip member 80 constituting the catheter is made of a resin having a hardness not exceeding the hardness of the constituent material of the tube member 10, the tip vena cava is separated from the inferior vena cava. The tip member 80 does not damage the inner wall of the right atrium even when it is used in the procedure according to the above method.

  Further, the first reduced diameter portion 1011 and the anchor member 75 are housed inside the base end portion 81, and the tip portion of the second reduced diameter portion 1012 protruding from the tip of the anchor member 75 is housed inside the tip end portion 82. In this state, the tip member 80 is attached to the tip end portion 101 of the tube member 10, and the tip end of the tip member 80 and the tip end of the second reduced diameter portion 1012 are aligned with each other until the tip end of the tip member 80 reaches the second end. Since the reduced diameter portion 1012 is inserted inside the tip member 80, the tip member 80 of the tip member 80 (the second reduced portion) of the tube member 10 not only at the base end portion 81 but also at the tip end portion 82 thereof. Since it is fixed to the diametrical portion 1012), it is made of resin, but has a high fixing strength to the tube member 10, and, for example, a radial direction with respect to the tip portion 82 of the tip member 80. Also as a force is applied, it is not such as to fall off from the distal end portion 101 of the tube member 10.

  Further, the tip end of the tip member 80 and the tip end of the second reduced diameter portion 1012 are aligned with each other, and the second reduced diameter portion 1012 (the tube component portion that defines and forms the central lumen 10L is formed inside the tip member 80 over its entire length. ) Is extended, a step is not formed in the insertion path of the guide wire from the proximal end of the tube member 10 to the distal end of the tip member 80 (the distal end of the defibrillation catheter 100), and the guide wire Excellent insertability.

  Further, in the insertion path of the guide wire from the proximal end of the tube member 10 to the distal end of the tip member 80, good lubricity and chemical resistance can be exhibited by the material forming the inner wall of the central lumen 10L.

  Further, the base end portion 102 of the tube member 10 in which the central lumen 10L is formed is inserted from the tip end of the handle 20 into the inside thereof, extends in the base end direction of the handle 20, and the base end portion 202 of the handle 20. To the outside of the handle 20 and the guide wire connector 60 is connected to the proximal end of the tube member 10, so that the guide wire port 61 of the guide wire connector 60 leads to the tip (defibrillation) of the tip member 80. The insertion path of the guide wire to the dynamic catheter 100) can be reliably ensured.

  Further, since the tube member 10 having the multi-lumen structure has high strength, it is not crushed or kinked even if it is interfered with by the rotary operation part 23 or the operation wires 71, 72 inside the handle 20, and therefore, The insertability of the guide wire is not impaired by the tip deflection operation or the like by the rotation operation unit 23.

  In addition, the proximal ends of the operation wires 71 and 72 are extended from the first side holes 111 and 115 formed in the proximal end 102 of the tube member 10 to the outside of the tube member 10 (inside the handle 20). Therefore, while the base end of the tube member 10 is located outside the handle 20, the base ends of the operation wires 71 and 72 are respectively attached to the wire fasteners 231 and 232 of the rotary operation unit 23. Can be fixed.

  In addition, the base end portion of the first lead wire group 41G that is contained in the first insulating tube 46 is extended to the outside of the tube member 10 (the inside of the handle 20) through the second side hole 124, and The base end portion of the second lead wire group 42G in a state of being enclosed in the 2 insulating tube 47 is extended to the outside of the tube member 10 (inside the handle 20) through the second side hole 127, and the third insulating property is obtained. Since the base end portion of the third lead wire group 43G enclosed in the tube 48 can be extended to the outside of the tube member 10 (inside the handle 20) through the second side hole 122, the first lead. The base end of the constituent electrode 41 of the wire group 41G, the base end of the constituent electrode 42 of the second lead wire group 42G, and the base end of the constituent electrode 43 of the third lead wire group 43G are connected to predetermined terminals of the electrode connector 50. be able to.

  Further, since the sub-lumen 14L in which the first lead wire group 41G extends and the sub-lumen 17L in which the second lead wire group 42G extends are not adjacent to each other in the circumferential direction of the tube member 10, they correspond to each other. When extending the first lead wire group 41G and the second lead wire group 42G to the outside of the tube member 10 from the second side holes 124 and 127 formed at the circumferential position, ensure a short circuit between them. Can be prevented.

  Further, since the second side holes 124, 127, 122 are formed on the base end side with respect to the rotary operation part 23, the first lead wire group 41G, the second lead wire group 42G or the third lead wire group 43G can be formed. Since the constituent lead wires 41, 42, 43 are protected by the tube member 10, they are not interfered with by the rotary operation part 23 or the operation wires 71, 72.

Although one embodiment of the present invention has been described above, the present invention is not limited to these and various modifications can be made.
For example, in the present embodiment, the distal end portion 101 of the tube member 10 is reduced in diameter in two stages, and the distal end portion 101 is configured by the first reduced diameter portion 1011 and the second reduced diameter portion 1012, and the base ends having different inner diameters are provided. The tip member 80 is composed of the portion 81 and the tip end portion 82. The tip end portion of the tube member is formed by one reduced diameter portion (a cylindrical tube constituent portion that defines and forms the central lumen), and this reduced diameter portion is formed. A cylindrical tip member may be attached so as to cover it.

  Further, in the present embodiment, the base end portion 102 of the tube member 10 is extended inside the handle 20 and is extended outside from the base end portion 202 of the handle 20 to thereby guide the guide wire port 61 of the guide wire connector 60. The guide wire insertion path from the handle is secured, but the proximal end of the tube member inserted inside the handle is located near the distal end of the handle, and the central lumen formed in the tube member and the proximal end of the handle. A lumen tube that communicates with the guide wire port of the guide wire connector disposed on the side may be extended inside the handle to secure an insertion path for the guide wire.

100 Intracardiac defibrillation catheter 10 Tube member 101 Tube member distal end portion 1011 First reduced diameter portion 1012 Second reduced diameter portion 102 Tube member proximal end portion 10L Central lumen 11L to 18L
111,115 1st side hole 122-124,126-128 2nd side hole 191 Inner (core) part 192 Outer (shell) part 20 Handle 202 Base end part 21 of handle 21 Handle body 23 Rotation operation part 231,232 Wire fastening Tool 24 Strain relief 25 Adjustment pin 31G First DC electrode group 31 Electrode 32G Second DC electrode group 32 Electrode 33 Electrode 35 Tip chip 41G First lead wire group 41 Lead wire 42G Second lead wire group 42 Lead wire 43G Third lead wire group 43 Lead Wire 46 First Insulating Tube 47 Second Insulating Tube 48 Third Insulating Tube 50 Electrode Connector 51, 52 External Cord 60 Guide Wire Connector 61 Guide Wire Port 71, 72 Operation Wire 75 Anchor Member 80 Chip Member 81 Chip member Base end 82 of tip member

Claims (2)

A catheter for defibrillation inserted into a heart chamber,
An insulating tube member,
A tip member attached to the tip of the tube member,
A handle attached to the proximal end of the tube member,
A first electrode group including a plurality of ring-shaped electrodes attached to the distal end region of the tube member, and a plurality of ring-shaped electrodes spaced from the first electrode group toward the base end side and attached to the distal end region of the tube member A second electrode group consisting of electrodes,
A first lead wire group consisting of a plurality of lead wires each having a tip connected to the plurality of electrodes forming the first electrode group;
A second lead wire group composed of a plurality of lead wires each having a tip connected to the plurality of electrodes forming the second electrode group ;
A distal end of the tube member, the distal end of which is fixed, and the proximal end of which includes at least one operation wire capable of being pulled ,
In the heart chamber, defibrillation is performed by applying voltages of different polarities to the first electrode group and the second electrode group,
The tube member has a multi-lumen structure in which a central lumen through which a guide wire can be inserted and a plurality of sub-lumens arranged around the central lumen are formed.
The lead wire forming the first lead wire group and the lead wire forming the second lead wire group extend in different sub-lumens of the tube member,
The operation wire extends in a sub-lumen different from a sub-lumen in which the lead wire configuring the first lead wire group or the second lead wire group extends,
A distal end portion of the tube member defines a first lumen having a central lumen and a sub-lumen in which the operation wire extends, and the central lumen at the distal end side of the first lumen. And a cylindrical second reduced diameter portion to be formed,
The tip end side of the first reduced diameter portion has an outer diameter substantially the same as the outer diameter of the first reduced diameter portion and an inner diameter substantially the same as the outer diameter of the second reduced diameter portion, A cylindrical member shorter than the axial length of the second reduced diameter portion, wherein an anchor member for fixing the distal end of the operation wire is attached to the distal end portion of the tube member,
The tip member is made of a resin whose hardness does not exceed the hardness of the material forming the tube member, a through hole is formed along the axial direction, and has an outer diameter substantially the same as the outer diameter of the tube member. Have,
The axial length of the tip member is substantially the same as the combined length of the first reduced diameter portion and the second reduced diameter portion,
The tip member includes a base end portion having an inner diameter substantially the same as the outer diameter of the first reduced diameter portion and a distal end portion having an inner diameter substantially the same as the outer diameter of the second reduced diameter portion. The second reduced diameter projecting from the tip end of the anchor member at the tip end portion of the tip member, and covering the outer periphery of the first reduced diameter portion and the anchor member at the base end portion of the tip member. Is attached to the distal end of the tube member so as to cover the outer periphery of the section,
The intracardiac defibrillation catheter , wherein the tip of the tip member and the tip of the second reduced diameter portion substantially coincide with each other. The central lumen is formed by a lumen tube made of a fluorine resin or a polyolefin resin having a hardness of 50D or more,
The intracardiac defibrillation catheter according to claim 1, wherein the tip member is made of a thermoplastic resin having a hardness of 35D to 40D.