JP5579681B2 - Electrode catheter - Google Patents

Description

  The present invention relates to an electrode catheter, and more particularly to an electrode catheter that can be easily inserted into the left atrial pulmonary vein and enables stable mapping in cardiac electrophysiological examination.

  In electrophysiological examination of the heart, an electrode catheter is generally inserted into the left atrial pulmonary vein. However, when performing the electrode approach into the four pulmonary veins, there is a problem that it is difficult to control the catheter and it takes time to insert.

  As a technique related to this, a technique has been proposed in which an electrode catheter having a circular tip is inserted and placed in the pulmonary vein (see, for example, Patent Document 1).

  However, the conventional electrode catheter described in Patent Document 1 is difficult to insert into the pulmonary vein because the tip portion has a circular shape, and the circular cross-section becomes oblique after insertion. There is a problem that it takes time to hold the shape for the reason.

  As another technique, a technique using an electrode catheter in which the tip is a basket-shaped electrode assembly has been proposed (see, for example, Patent Document 2).

  In the conventional electrode catheter described in Patent Document 2, the basket is expanded in the pulmonary vein and the shape is easily maintained.

Japanese Patent No. 4350346 Japanese Patent No. 4118666

  However, the electrode catheter described in Patent Document 2 has a problem that it takes time until insertion because it is difficult to align the pulmonary vein opening.

In addition, there are structural problems shown below.
(1) Although a guide sheath is used for guidance to the pulmonary vein opening, the outer diameter of the catheter is increased by the guide sheath and the burden on the blood vessel increases.
(2) Due to the basket shape, blood clots are likely to form at both ends of the basket.
(3) In particular, a blood clot is likely to be formed in the lumen at the proximal end of the basket, blood enters the lumen and is coagulated, and movement of expansion and contraction of the basket is inhibited.

  Accordingly, an object of the present invention is to provide an electrode catheter that facilitates insertion into the pulmonary vein and maintenance of the electrode position, suppresses thrombus formation, and reduces the burden on the patient.

  In order to achieve the above object, one aspect of the present invention provides the following electrode catheter.

[1] a flexible tube;
An assembly in which a proximal end is connected to the distal end of the tube and a plurality of spinal columns are joined to each distal end;
Electrodes provided on the surface of the spine of the assembly;
An assembly puller wire having one end fixed to the distal end of the spine of the assembly through the center of the assembly from the lumen of the tube;
A tube puller wire provided in the lumen of the tube and having one end connected to the tip of the tube;
A control handle provided at the proximal end of the tube, connected to the other end of the assembly pulling wire and the other end of the tube pulling wire;
By one of the operation of the rotary operation or sliding operation of the front end portion of the front Symbol control handle, by being pulled in the aggregate puller wire, the central portion of the spine radiate,
By rotating operation or other one of the operation of the slide operation of the front end portion of the front Symbol control handle, by being pulled into the tube puller wire, electrode catheter, characterized in that the tip of the tube is bent.

[ 2 ] The electrode catheter according to [ 1 ], wherein the control handle independently operates the assembly and the tube.

[ 3 ] The electrode catheter according to [1] or [2] , further including a branch portion provided between a proximal end of the tube and the control handle, to which a water injection tube is connected.

[ 4 ] The electrode catheter according to [ 3 ], wherein the tube is provided with a lumen connected to a water injection tube in a lumen, and the lumen houses the assembly puller wire.

  According to the first aspect of the present invention, insertion into the pulmonary vein and holding of the electrode position can be facilitated, the generation of thrombus can be suppressed, and the burden on the patient can be reduced.

According to the first aspect of the present invention, the assembly can be retracted and inserted without opening, so that a guide sheath is not required, the number of medical devices to be used can be reduced, and the cost can be reduced.

According to the first aspect of the present invention, the direction of the assembly can be manipulated, and guidance to the pulmonary vein opening becomes easy.

According to the second aspect of the present invention, the control handle can independently operate the assembly and the tube.

According to the third aspect of the present invention, insertion into the pulmonary vein and holding of the electrode position can be facilitated, the generation of thrombus can be suppressed, and the burden on the patient can be reduced.

According to the fourth aspect of the present invention, it is possible to suppress the obstruction of the basket expansion movement due to the thrombus that is easily generated at the terminal of the assembly, and it is possible to reduce the burden on the blood vessel without increasing the catheter outer diameter.

FIGS. 1A and 1B are schematic views showing an example of the configuration of the electrode catheter according to the first embodiment of the present invention. FIG. 2 is a schematic cross-sectional view showing an example of the configuration of the joint portion between the distal end of the tube and the proximal end of the assembly according to the embodiment of the present invention. FIGS. 3A and 3B are schematic views showing an operation example of the assembly and the tube when the control handle of the electrode catheter is operated. FIG. 4 is a schematic diagram illustrating an example of a configuration of an electrode catheter having a water injection function according to the second embodiment. FIG. 5 is a schematic cross-sectional view showing the internal structure of the connecting branch where the water injection tube and the control handle are connected.

[First Embodiment]
(Configuration of electrode catheter)
Hereinafter, embodiments of the present invention will be described with reference to the drawings.

  FIGS. 1A and 1B are schematic views showing an example of the configuration of the electrode catheter according to the first embodiment of the present invention.

  The electrode catheter 1 </ b> A includes a flexible tube 10, an assembly 20 attached to the distal end of the tube 10, a connection portion 70, a control handle 40, and a connector 50, and is illustrated via the connector 50. It is used in a state where it is connected to a medical measurement device that does not, for example, detects an electrocardiogram or the like.

  The length, thickness, material, etc. of the tube 10 can be adjusted and selected as appropriate. For example, the tube 10 has an inner diameter of 1.9 mm, an outer diameter of 2.3 mm, and a length of about 1300 mm, and has a Shore D 40 to 74 hardness as a thermoplastic composition. Polyamide elastomer or polyamide resin can be used. Further, the tube 10 is provided with a mesh-like braid 17 as a reinforcing layer under the outer layer.

  The assembly 20 has four to eight spines 20a, and the tip of the spine 20a is joined by welding together with the assembly pulling wire 12 described later, and is preferably covered with a plastic cap 20b made of polyamide elastomer. The spinal column 20a can be made of, for example, a polyamide elastomer or a polyurethane resin having an inner diameter of 0.4 mm, an outer diameter of 0.6 mm, a length of 30 mm, and a Shore D35 to 55 hardness as a thermoplastic composition. 1 to 3 electrodes 30 made of a platinum alloy tube are arranged at predetermined intervals. An electrode made of a platinum alloy tube may be disposed on the surface of the cap 20b.

  The control handle 40 is provided at the base end of the tube 10 via the connecting portion 70, and has a 5 to 12-pole connector 50 at the base end of the control handle 40.

  When the control handle 40 has 11 to 20 electrodes, two cables 60 are connected to the base end of the control handle 40 as shown in FIG. Further, it is connected to the connector 51. The electrode catheter 1A is used in a state where it is connected to a medical measurement device (not shown) via connectors 50 and 51, and detects, for example, an electrocardiogram.

  The example shown in FIG. 1 is a case where the assembly 20 is provided with 4 to 20 electrodes 30, and each electrode 30 is electrically connected to a lead wire 31 (see FIG. 2) passing through the tube 10. The lead wire 31 is connected and connected to the connector 50.

  FIG. 2 is a schematic cross-sectional view illustrating an example of a configuration of a joint portion between the distal end of the tube 10 and the proximal end of the assembly 20 according to the embodiment of the present invention.

  The tube 10 is provided with a lumen 11 for water injection in which a fluorine-based material such as polyethylene terephthalate having an inner diameter of 1.0 mm and an outer diameter of 1.2 having a high water resistance or polytetrafluoroethylene having a high slip property is formed in a tube shape. And the distal end of the lumen 11 is located at the proximal end center of the assembly 20. The lumen 11 has an assembly pulling wire 12 made of a high-strength metal body with high bending rigidity in its lumen.

  The assembly pulling wire 12 is a core material made of, for example, nickel / titanium alloy or stainless steel and having a diameter of 0.25 mm, and is tapered so that the diameter of the bent portion of the tube 10 described later is 0.15 mm. By switching the outer diameter, the flexibility of the tube 10 is reinforced, and the bending of the distal end portion of the tube 10 is facilitated. In addition, the lumen 11 may have a uniform diameter of the assembly pulling wire 12 of 0.15 mm in order to increase the amount of liquid ejected.

  The assembly 20 is connected to the assembly pulling wire 12, and has a high bending rigidity and a core material 21 made of a high-strength metal body, and a lead wire 31 connected to the electrode 30. Yes.

  The core material 21 constituting the assembly 20 is made of, for example, a thermoplastic plastic composition such as polyethylene terephthalate on the surface of a flat material made of nickel / titanium alloy or stainless steel having a width of 0.25 mm and a thickness of 0.1 mm. It is coated with a thickness of 02 mm.

  The distal end of the assembly 20 is joined by a plurality of core members 21 and the assembly pulling wire 12, and the proximal end of the assembly 20 is an inner layer pipe 14 made of stainless steel having an inner diameter of 1.2 mm and an outer diameter of 1.32 mm. The lumen 11 and the assembly pulling wire 12 are disposed inside the inner layer tube 14 and sandwiched between the outer layer tubes 15 having an inner diameter of 1.54 mm and an outer diameter of 1.64 mm.

  The tube pulling wire 13 for bending the distal end of the tube 10 and the flat plate material 16 for determining the bent shape are joined to the inner layer tube 14 respectively. For example, the flat plate 16 is a metal body made of nickel / titanium alloy or stainless steel having a width of 0.8 mm and a thickness of 0.07 mm. Further, the length and thickness of the flat plate 16 may be arbitrarily changed and adjusted according to the shape of the bend.

(Operation)
FIGS. 3A and 3B are schematic views showing an operation example of the assembly 20 and the tube 10 when the control handle 40 of the electrode catheter 1A is operated.

  As shown in FIG. 3A, when the knob 41 of the control handle 40 is rotated in the direction Ra, the aggregate pulling wire 12 is pulled, whereby the distal end of the aggregate 20 is pulled in the proximal direction, The center of the spine 20a of the body 20 opens radially.

  3B, when the knob 41 of the control handle 40 is slid in the direction Pa, the tube pulling wire 13 is pulled, so that the inner layer tube 14 bends the flat plate 16 and the tube 10 The tip of the bend.

  When the knob 41 of the control handle 40 is operated in the reverse direction of FIG. 3A or 3B, the aggregate 20 or the tip of the tube 10 returns to its original shape. Also, the tip of the tube 10 may be bent by rotating the knob 41, and the assembly 20 may be opened by sliding the knob 41, and recombination is free.

(Effects of the first embodiment)
According to the first embodiment described above, since the function of bending the tip of the tube 10 corresponding to the basket base end by operating the control handle 40 is provided, the direction of the assembly 20 corresponding to the basket is manipulated. Can be easily guided to the pulmonary vein opening. Further, since the assembly 20 can be inserted without being opened, a guide sheath is not required, the number of medical devices to be used can be reduced, and the cost can be reduced. Moreover, since a guide sheath is unnecessary, the outer diameter of the catheter can be reduced, and the burden on the patient can be reduced.

[Second Embodiment]
FIG. 4 is a schematic diagram illustrating an example of a configuration of an electrode catheter having a water injection function according to the second embodiment.

  The electrode catheter 1B has a connection branching portion 71 for the water injection tube 72 between the proximal end of the tube 10 and the control handle 40, instead of the connection portion 70 of the electrode catheter 1A of the first embodiment. The connecting branch 71 has a branched water injection tube 72, and supplies a liquid such as a physiological saline or a contrast medium injected from the water injection tube 72 to the assembly 20 through the lumen of the tube 10, The injected liquid is ejected from the proximal end of the assembly 20 (hereinafter referred to as “flash”).

  FIG. 5 is a schematic cross-sectional view showing the internal structure of the connecting branch portion 71 to which the water injection tube 72 and the control handle 40 are connected.

  The connecting branch portion 71 has a two-layer structure, and the water injection tube 72 is connected to the inner layer of the connecting branch portion 71. The inner layer of the connecting branch 71 is connected to the lumen 11, and the assembly pulling wire 12 connected to the control handle 40 passes through the lumen. The connecting branch 71 has a valve 73 made of silicon rubber at the base end of the inner layer, and the valve 73 prevents water from flowing to the control handle 40 during water injection.

  The tube 10 is connected to the outer layer of the connecting branch portion 71, and the tube pulling wire 13 and the lead wire 31 are connected to the control handle 40 through the space between the inner layer and the outer layer of the connecting branch portion 71.

(Effect of the second embodiment)
According to the second embodiment described above, in addition to the effects of the first embodiment, the liquid can be injected from the water injection tube 72 and the function of flushing from the proximal end of the assembly 20 corresponding to the basket is provided. Thrombus that tends to be generated in the basket terminal can be suppressed by injecting a heparin agent.

  In addition, since the lumen for the assembly pulling wire 12 and the lumen for flushing for operation of the assembly 20 corresponding to the basket are shared by the lumen 11, the basket can be expanded by a thrombus that is easily generated at the terminal of the assembly 20 corresponding to the basket. Can be prevented. Further, by sharing the lumen 11, the burden on the blood vessel can be reduced without increasing the catheter outer diameter.

[Other embodiments]
The present invention is not limited to the above embodiment, and various modifications can be made without departing from the spirit of the present invention.

1A, 1B Electrode catheter 10 Tube 11 Lumen 12 Assembly pulling wire 13 Tube pulling wire 14 Inner layer tube 15 Outer layer tube 16 Flat plate 20 Assembly 20a Spinal column 20b Cap 21 Core material 30 Electrode 31 Lead wire 40 Control handle 41 Knob 50 Connector 51 Connector 60 Cable 70 Connection 71 Connection branch 72 Water injection tube 73 Valve

Claims (4)

A flexible tube;
An assembly in which a proximal end is connected to the distal end of the tube and a plurality of spinal columns are joined to each distal end;
Electrodes provided on the surface of the spine of the assembly;
An assembly puller wire having one end fixed to the distal end of the spine of the assembly through the center of the assembly from the lumen of the tube;
A tube puller wire provided in the lumen of the tube and having one end connected to the tip of the tube;
A control handle provided at the proximal end of the tube, connected to the other end of the assembly pulling wire and the other end of the tube pulling wire;
By one of the operation of the rotary operation or sliding operation of the front end portion of the front Symbol control handle, by being pulled in the aggregate puller wire, the central portion of the spine radiate,
By rotating operation or other one of the operation of the slide operation of the front end portion of the front Symbol control handle, by being pulled into the tube puller wire, electrode catheter, characterized in that the tip of the tube is bent.   The electrode catheter according to claim 1, wherein the control handle performs the operation of the assembly and the operation of the tube independently.   The electrode catheter according to claim 1, further comprising a branch portion provided between a proximal end of the tube and the control handle, to which a water injection tube is connected. The electrode catheter according to claim 3, wherein the tube is provided with a lumen connected to a water injection tube in an inner cavity, and the lumen accommodates the assembly pulling wire.

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