JP3472996B2 - Multi-electrode probe - Google Patents

Description

Detailed Description of the Invention

[0001]

The present invention relates to, for example, WPW (Wolff-
Parkinson-White) syndrome, paroxysmal supraventricular tachycardia and other conduction pathway arrhythmias and tachyarrhythmia such as atrial flutter, fibrillation and ectopic stimuli such as ventricular tachycardia ,
The present invention relates to a multi-electrode probe used for an electrophysiological test performed in advance.

[0002]

2. Description of the Related Art Conventionally, an electrophysiological test performed prior to tachyarrhythmia treatment has one or 2 to 10 electrodes provided around the distal end, and a lead wire is extended inside a hollow catheter for measurement. This is done using multiple cardiac catheters configured to connect to the device. For example, in an accessory arrhythmia such as WPW syndrome, it is necessary to specify the position of the accessory pathway existing in the heart valve annulus. Measurements on the left ventricle side are relatively easy to insert a multi-electrode catheter because the thick coronary sinus runs through the mitral valve annulus, but on the right ventricle side, the right coronary artery is inserted. Is running,
Conventional catheters are thick and it is difficult to insert them into the blood vessels of the right coronary arteries, and there is no choice but to make measurements while moving from point to point in the ventricle, resulting in a very laborious test. The inspection took several hours. Problems of such a conventional inspection method, that is, it takes time to find a diagnosis site such as a secondary conduction path because an inspection is performed with a catheter having a small number of electrodes, and in order to measure a wide area because the number of electrodes is small. , The distance between the electrodes had to be lengthened, and it was difficult to accurately determine the sub-conduction path site. When trying to increase the number of electrodes with a conventional catheter, the signal line for transmitting signals was Since the number of catheters increases and the outer diameter of the catheter becomes thicker, it is difficult to inspect the right heart side.Because the electrode is attached to the tip of the signal line, the process of connecting the signal line and the electrode is required. Therefore, a means for solving the problems such as the inability to use multiple electrodes for the catheter has been proposed by the inventors of the present application (Teruhiko Ouchi) in JP-A-6-335460. As shown in FIG. 6, this conventional example uses a Ni--Ti alloy PTCA (Percutaneous Tracing).
nsluminal Coronary Angioplasty) A thin wire 12 which is a signal wire is wound in a coil shape with 12 threads on a bar-shaped core material 11 in which a guide wire is tapered. These twelve thin wires (signal wires) 12 are made of carbon steel wire as shown in FIG. 7, and the surface thereof is insulated by a copper foil layer and a gold plating layer 13 for lowering impedance and a resin such as polyester. Since the layers are covered with the cladding structure, they act as 12 independent intracardiac potential signal transmission lines (signal lines). Further, the core material 11 is made of Ti-Ni alloy, Cu-Zn alloy and Ni-A.
There is also disclosed an example in which a thin wire (signal wire) 12 is wound around a tube made of a superelastic alloy (shape memory alloy) such as an L alloy. And 12 thin wires (signal wires) wound around the core material 11.
A part of the insulating film of 12 is peeled off for about one turn, and the gold plating layer 13 is exposed inside and the conductive part is used as an intracardiac electrode, or a ring-shaped electrode is attached to this peeled part. , If the electrode area is wide,
In addition, twelve thin wires 12 are laid along the axial direction of the core material 11, the insulating portion of the thin wires 12 is peeled off at the portion where the electrode is to be provided, and the peeled portion is wound in a single line. There is also disclosed an example in which a multi-electrode probe having electrodes with a certain width is formed by making the line recede again. Thus, in this conventional example, the number of electrodes can be increased without increasing the outer diameter of the cardiac probe for electrophysiological examination, the examination time can be shortened, and the probe having such a small diameter can be used. By using
The probe can be inserted into the right coronary artery, which has been difficult in the past, and the distance between the electrodes can be shortened. Therefore, the detection accuracy of the accessory conduction path portion can be improved.

By the way, in the above-mentioned conventional example, a plurality of thin wires (signal wires) 12 are adhered along the length direction on the core material 11. The means for adhering between them has not been disclosed and remains as a research subject. As described above, a number of thin wires 12 corresponding to the electrode wires disclosed in this conventional example are wound in a coil shape (spiral shape) around the outer peripheral surface of the rod-shaped or tube-shaped core material 11 in a free state where they are not adhered to each other. Case (the former is shown in FIG. 3 of the same publication, the latter is shown on page 2, column 2 of the same publication)
It has been found that individual loosening of the thin wire 12 (disclosed in lines 27 to 29) and fluctuations in the outer diameter of the spiral winding corresponding to the looseness are likely to occur, which causes unstable winding accuracy. This unstable phenomenon was more remarkable as the number of the thin wires 12 increased, and as a result, it occurred as a problem in implementing multiple electrodes. In the case where the thin wires 12 of a number corresponding to the number of electrodes found in the conventional example are formed in a bundle shape or a hollow spiral winding inside the cylindrical core material 11 in a free state where they are not bonded (conventional) (Disclosed in FIG. 12 of the example publication), during operation of the catheter, that is, when bending is applied in the three-dimensional direction,
There is a high risk that the thin wires (signal wires) 12 are entangled with each other, and there is a problem that crosstalk is likely to occur when measuring the intracardiac potential. Further, even in the case of a hollow spiral wound thin wire as shown in FIG. 12 of the publication, since the hollow spiral winding is performed by the thin wire itself, the wire diameter is a general-purpose product for maintaining the spiral winding shape and is 12 electrodes. In this case, a thickness of φ0.15 to 0.07 mm is required, and it has been found that there is a problem that the outer diameter increases as a result of ensuring the rigidity, which goes against the original problem solving described above.

Furthermore, the thin wire having the above-mentioned cladding structure
Since 12 (signal lines) are bundled in parallel and wound around the core material 11, it is difficult to visually recognize the contrast (definition) between the end electrode and the connection portion of the external electrode terminal, which may cause miswiring. In other words, when the twelve thin wires 12 are set as one unit and the units are repeatedly arranged on the core material 11, there is a problem that the division of each unit is difficult to visually recognize.

An object of the present invention is to solve the above-mentioned problems newly generated in the above-mentioned prior art.

[0006]

In order to achieve the above object, the multi-electrode probe of the present invention has the following constitution.
That is, a strip-like shape in which a plurality of signal lines provided with an insulating coating are arranged.
Parallel lines, in a multi-electrode probe is brought into close contact with the surface of the core material of the multielectrode probe to be inserted into a living body, the strip parallel
Line, the signal line is covered with two or more different colored coating on the surface of the colored insulating coating layer to form a bonding layer for bonding by heating or solvent coating between the respective signal lines
It was

In the multi-electrode probe of the present invention, the colored insulating coating layer , the fusion bonding layer, the electrode forming portion,
Is wound closely coiled a plurality of signal lines having a
The signal lines are bonded together with and .

Further, the conductor is used as a core material, and its surface is colored completely.
Parallel strips of multiple signal lines with edge coating and fusion layer
The basic color unit consists of several lines.
The colored insulation coating layer is colored differently for each signal line.
Is made. Further, when the signal line is composed of, for example, 20 poles of bonded strip-shaped parallel linear element wires, the colored insulating coating portion is colored into five basic color units of red, blue, green, black and orange. 4 arrays are formed.

[0009]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT A preferred embodiment of the present invention will now be described in detail with reference to the accompanying drawings.

FIG. 1 shows a signal wire 2 wound around a rod-shaped core material 1 of this embodiment in a strip shape and in a parallel wire shape.
The diameter of the core material 1 is, for example, φ0.32 mm, and the diameter of the signal wire 2 constituting the strip-shaped parallel wire 6 wound in a coil shape is φ0.0.
A 4 mm thin wire is used. FIG. 2 shows a cross-sectional view of the signal line 2, the core of which is a conductor with a diameter of 0.02.
A 5 mm gold wire 3 is used, a colored insulating coating layer (colored layer) 4 such as polyurethane enamel is formed on the surface thereof, and an alcohol-soluble fusing layer 5 is formed on the surface of the colored layer 4. The alcohol-soluble fusion-bonding layer 5 is transparent and does not hinder the visual recognition of the colored layer 4, and the signal lines 2 can be closely adhered to each other by applying alcohol as a solvent or heating. For example, a copolymer of 6-nylon and 66-nylon or polyvinyl butyral is used as the fusible alcohol layer 5, and the fusible material is coated with alcohol or heated to function as an adhesive agent for each signal line ( Thin wires 2) are closely adhered to each other.

As shown in FIG. 3, for example, the signal lines 2 forming the strip parallel lines 6 forming the electrodes of 20 poles are red, blue,
Each of the five basic color units of green, black and orange is colored, and the alcohol fusible welding layer 5 is formed on each of these colored lines. Then, the strip-shaped parallel lines 6 having a predetermined length for one product are processed. This strip-shaped parallel wire 6 is processed by a bobbin (not shown) in which each color wire is wound, and a 20-pole signal wire 2 in which four color wire units are arranged in the five basic color units (as shown in the drawing). (Not shown) and the fusion layer 5 is melted by heating or applying alcohol to bond the individual wires. afterwards,
After performing a terminal treatment for separating the bonded portions of the ends of the plurality of signal lines 2 formed of the strip parallel lines 6 , the signal lines 2 forming the strip parallel lines 6 are wound in a coil shape on the surface of the core material 1.
As another embodiment of the manufacturing process, as shown in FIG. 4, when the signal lines 2 forming the strip-shaped parallel lines 6 are arranged in four in five colors to form a signal line 2, 20 ... Group of 20 electrodes, In the portion corresponding to the length of one multi-electrode probe in advance, the strand of the portion corresponding to the later electrode formation portion 7 is not adhered by the length required for the electrode formation, and remains as the strand. That is, after processing in a state where the parallel lines are not formed, as shown in FIG. 5, the strip-shaped parallel lines 6 are cut to a fixed length for each length of one multi-electrode probe, that is, 20 steps are cut, and the core 1 is cut. The strip parallel line 6 is spirally (coiled) wound. This spiral (coil) winding process and device are wound by a winding device as shown in FIG. 6 of JP-A-6-335460. That is, if it is omitted in the description, both ends of the rod-shaped core material 1 are
Fixed by a chuck that can be rotated in the axial direction of the
Is formed into, for example, 20 parallel strips 6 which are bundled in parallel and is passed through a winding guide and fixed to a chuck at the beginning of winding. The winding start chuck is fixed to a chuck for fixing the core material 1, and rotates in accordance with the rotation of the core material 1. The winding guide is axially fed in the axial direction of the core material 1 by the rotation of the guide feed (screw rod). In this state, in order to wind the signal wire 2 including the spiral electrode around the core material 1, The winding guide is rotated in synchronization with the movement of the winding position of the signal wire 2 around the core material 1 to move the winding guide. The movement amount of the winding guide is set by the diameter of the core material 1 and the width of the signal line 2. In this way, with the signal wire 2 wound around the core material 1, these 20 signal wires 2 are
A part of the colored insulating coating layer 4 and the fusion bonding layer 5 are peeled off for about one round to expose the conductor gold wire 3 as a core material inside thereof, and the portion is used as an intracardiac electrode. In addition, a separate cylindrical electrode can be attached to this peeled portion to increase the electrode area.

As described above, the present embodiment corresponds to claim 1.
Then, the signal line provided with the colored insulating coating layer 4 as the insulating coating portion
A multi-electrical wire that inserts a strip-shaped parallel line 6 in which a plurality of 2 are arranged in a living body
Multi-electrode probe closely attached to the surface of the core material 1 of the polar probe
In, the strip-shaped parallel line 6 is different from the signal line 2 by two or more.
The surface of the colored insulating coating layer 4 is covered with a colored film,
For bonding between the signal lines 2 by heating or applying solvent
The fusion layer 5 is formed and corresponds to claim 2.
Then, the colored insulating coating layer 4, the fusion bonding layer 5, and the electrode forming portion 7 are
The plurality of signal lines 2 provided are closely wound in a coil shape.
And the signal lines 2 are bonded together with
According to claim 3, the conductor is used as a core material.
A plurality of colored insulating coating layers 4 and fusion-bonding layers 5 are formed on the surface.
Several strip-shaped parallel lines 6 of the signal line 2 are used as basic color units,
This basic color unit includes a colored insulating coating layer 4 for each signal line 2.
Are formed with different colors.

As described above, according to this embodiment, since the plurality of signal lines 2 are covered with the coloring layer 4 of any of the five colors for each signal line, the tips of the signal lines 2 are covered. When the order of the color arrangement of the electrodes and the order of the color arrangement of the external output electrodes are changed, erroneous wiring, for example, that the wiring is exchanged, can be immediately found on the way, and erroneous wiring can be prevented. In addition, in the strip-shaped parallel line of the signal line 2, a plurality of (five in the embodiment) strands that are individually colored are used as basic color (five colors of the embodiment) units, and the units are repeated. By arranging them, it is possible to obtain a multi-electrode probe having strip-shaped parallel lines 6 made of multi-element strands that are integral multiples of the basic color.

Further, the strip-shaped parallel wires 6 to which a plurality of element wires (signal wires) are respectively adhered are wound in a spiral shape (coil shape) while closely adhering to the outer peripheral surface of the core material 1 of a rod-shaped body or a cylindrical body. Also, even when the core material 1 is bent in multiple directions in three-dimensional directions, the strands that have been apt to come apart in the past are strip parallel lines 6
Since the multi-electrode probe having the signal line 2 is deformed integrally with the core material 1, flexibility for bending is not impaired.
Further, in this embodiment, the plurality of signal lines 2 bonded together are wound as coils (spirals) while closely adhering to the core material 1 as strip-shaped parallel lines 6, so that the outer diameter in an arbitrary cross section after spiral winding is completely adhered. If the core material 1 has a diameter of 6
Therefore, the diameter of the multi-electrode probe can be reduced and the wall thickness can be reduced. Further, since the strip-shaped parallel lines 6 (signal lines) are formed by bonding the respective strands of wire, the strip-shaped parallel lines 6 (signal line) are more resistant to deformation stress such as bending and tension as compared with the single strands of wire, and the core 1 is It is possible to prevent loosening of the individual wires 2 and variation of the outer diameter of the spiral winding corresponding to the winding of the coil (spiral) while closely contacting each other. Further, even if the number of strands is large, it can be handled as one unit of parallel lines, so that the handling property in the manufacturing process is excellent. Further, in the process of processing the strip-shaped parallel lines 6, the long strip-shaped parallel lines 6 (length of one multi-electrode probe × N times) are continuously processed, and thereafter, a predetermined length for one multi-electrode probe is obtained. By cutting based on the cutting margin of the sword, the strip-shaped parallel lines 6 (signal lines) can be obtained in large quantities and at low cost.

The embodiments of the present invention are not limited to the above-mentioned ones. For example, the wires having the number of colored layers corresponding to the number of electrodes are bonded by melting the fusion layers. Of course, the present invention is also applied to a multi-electrode probe having a structure in which a cylindrical core material is passed inside in a bundle shape or a hollow spiral shape.

[0016]

According to the present invention, since a plurality of signal lines composed of strip-shaped parallel lines are covered with a colored insulation coating layer for each element wire, the color arrangement of the tip electrode and the external output terminal is inspected to make a mistake. In addition to preventing wiring, each element wire is adhered by the fusion layer, so it is strong against deformation stress such as bending and tension, and it is possible to prevent disconnection, looseness of individual element wires and fluctuation of outer diameter based on them. It can be prevented. Furthermore, by bonding each signal line,
It is possible to reduce the variation in the capacitance between the lines, improve the detection accuracy when measuring the intracardiac potential, and prevent the entanglement between the signal lines, thereby reducing the crosstalk.

Further, according to the present invention, a plurality of signal lines composed of strip-shaped parallel lines are respectively adhered to each other, and are spirally wound (coiled) while closely adhering to the outer peripheral surface of the rod-shaped or cylindrical core material. Since it is an electrode probe, the flexibility due to bending is not impaired even in multi-directional bending of the core material in three-dimensional directions, and the outer diameter in an arbitrary cross section after coil winding is, in the case of perfect adhesion,
The diameter is the sum of the diameter of the core material and twice the diameter of the strands of the parallel wire, and it is possible to meet the demands for thinning and low wall thickness of the multi-electrode probe.
It can be inserted into the blood vessel of the right coronary artery.

Further, according to the present invention, a plurality of signal wires each of which is composed of strip-shaped parallel lines are treated as a basic color unit by using several strands each of which is colored with a different color. It is possible to obtain a multi-electrode probe having a signal line composed of strip-shaped parallel lines of multiple strands having an integral multiple of color.

[Brief description of drawings]

FIG. 1 is a front view showing a state where an electrode (exposed gold wire) is formed by winding a signal wire (small-diameter wire) of a present embodiment around a core material in a coil shape.

FIG. 2 is a cross-sectional view of a signal line of this embodiment.

FIG. 3 is a perspective view showing a 1-unit signal line group composed of 20-pole strip parallel lines of the present embodiment.

FIG. 4 is a perspective view showing a continuous processing state of N-fold long strip parallel lines having a length corresponding to one multi-electrode probe of the present embodiment.

5 is a perspective view showing a state after the standard length cutting shown in FIG. 4;

FIG. 6 is a perspective view showing a state in which an electrode is formed by winding a thin wire (signal wire) of a conventional example around a core material in a coil shape.

FIG. 7 is a partially cutaway oblique sectional view showing a structure of a small-diameter wire (signal wire) of a conventional example.

[Explanation of symbols]

1 core material of multi-electrode probe 2 signal wire (thin wire) 3 thin gold wire (exposed electrode) 4 colored insulating coating layer (colored layer) 5 fusion layer 6 strip-shaped parallel wire 7 electrode forming part

Front page continuation (56) Reference JP-A-6-335460 (JP, A) Special Table 10-510731 (JP, A) (58) Fields investigated (Int.Cl. ⁷ , DB name) A61B 5 / 04

Claims (3)

(57) [Claims] 1. A plurality of signal lines provided with an insulating coating are arranged.
A strip parallel lines, in a multi-electrode probe is brought into close contact with the surface of the core material of the multielectrode probe to be inserted into a living body, the strip
In the parallel lines, the signal lines are covered with two or more different colored coatings, and a fusion layer for bonding between the signal lines by heating or solvent coating is formed on the surface of the colored insulating coating layer. Characteristic multi-electrode probe. 2. The colored insulating coating layer , the fusion layer and the electrode
Multielectrode probe of claim 1, wherein the plurality of signal lines and a forming portion, characterized in that the signal lines cross together Once wound closely coiled are bonded. 3. A <br/> present number of strip-shaped parallel lines of a plurality of signal lines forming the colored insulating coating layer and the bonding layer on the surface of the guide member as a core material as a basic color units, the base color unit Is before
The multi-electrode probe according to claim 1 , wherein the colored insulating coating layer is formed with a different color for each signal line .