JPH1176183A - Guide wire type intrapsychic electrocardiogram electrode having pressure sensor - Google Patents

Abstract

PROBLEM TO BE SOLVED: To easily measure an intrapsychic electrocardiogram by constituting an intrapsychic electrocardiogram electrode of a sensor part where a blood pressure measuring pressure sensor is installed in an opening part in close vicinity to a metallic X-ray untransmissive tip part, making conductive fine wiring exist in a wire lumen, and covering a wire outside surface with resin. SOLUTION: A guide wire type intrapsychic electrocardiogram electrode to insert/guide a catheter into/to a heart, is constituted of a tip part 1, a sensor part 2 and an extension part 3, and an X-ray untransmissive part composed of a spiral coil 4 round/on which a platinum fine wire is wound/installed, is arranged in the tip part 1. The sensor part 2 has a stainless steel pallium tube 8 having a lumen, and a semiconductor pressure sensor is fixed by an epoxy resin 6 by exposing a pressure receiving surface to an opening part by using a silicon chip 5 arranged in the lumen facing to the opening part arranged in its pallium tube 8 as a pedestal. In order to make the X-ray untransmissive part of the tip part 1 as a unipolar electrode, an outside surface of a guide wire except for this tip part 1 is covered with resin 10.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION The present invention relates to percutaneous angioplasty (P)
TA), electrocardiogram monitoring in percutaneous coronary angioplasty (PTCA), and more specifically, a PTA, a guide wire for guiding a catheter to a target blood vessel site in PTCA treatment, and blood pressure measurement at the blood vessel site The present invention relates to a guide wire type intracardiac electrocardiogram electrode provided with a semiconductor type pressure sensor capable of measuring an electrocardiogram at an intracardiac site close to the surface of the heart in synchronization with the above.

[0002]

BACKGROUND OF THE INVENTION Electrocardiograms are used for monitoring and measuring during cardiac catheterization or for catheterization, such as percutaneous coronary angioplasty (PTCA) or percutaneous angioplasty (PTA).
Are important parameters as items for monitoring and measurement during implementation. The above-mentioned PTCA or PTA is a treatment method which has been performed in place of the conventional surgical operation of opening the chest, which is a conventional bypass operation, that is, a blood vessel which has swelled and stabbed from the skin without opening the chest. Since the treatment is performed in a skin-like manner, the postoperative management is easy, the patient can be discharged early, and the burden on the patient is significantly reduced both psychologically and economically.

Conventionally, an electrocardiogram for monitoring a patient during the above-mentioned operation or the like includes a body surface electrocardiogram by a 12-lead electrocardiograph or an intracardiac electrocardiogram by a catheter electrode as an electrocardiogram at a site closer to the heart surface. Used.

However, recently, it has been expected that myocardial ischemia can be more accurately evaluated by observing an electrocardiogram derived from a guide wire inserted into a coronary artery, for example.
Attempts have been made to measure and monitor intracoronary electrocardiograms.
This is expected to respond more sensitively to, for example, ischemic changes, as described above, because the electrocardiogram is taken at a site closer to the heart surface as compared with the conventional body surface electrocardiogram.

[0005]

As described above, the catheterization of the heart has rapidly spread, and in particular, percutaneous coronary angioplasty (PTCA) using a balloon catheter for coronary stenosis has been frequently performed in the heart treatment. In addition, many treatments such as percutaneous angioplasty (PTA) performed as dilation of large blood vessels and peripheral blood vessels are also performed. However, it is extremely important to constantly monitor the patient's condition when performing these treatments, and it is important to use an intracardiac ECG as a surface ECG in addition to the usual body surface ECG that has been conventionally performed. It is said to be mandatory, and in some cases, blood pressure monitoring is also performed in parallel.

Therefore, conventionally, a carbon electrode which is not visible under X-ray fluoroscopy has been used as an electrode for recording an electrocardiogram used for a body surface electrocardiogram used for such treatment and examination. These carbon electrodes are more expensive than general disposable electrodes, and have drawbacks such as lead wires being easily cut and entangled, often causing noise, and being easily peeled off at the contact portion with the skin.

The inventor of the present invention has conducted intensive studies in order to solve various problems associated with the conventional carbon electrode. As a result, the present applicant has proposed various catheters for the heart which have already been proposed in Japanese Patent Application No. 9-190307. A guide wire that guides insertion and is extremely fine, but twists, bends,
Focusing on a metal guide wire with a semiconductor type pressure sensor that is not easily affected by external stress such as compression, and inserting this guide wire into the heart and using it as a monopolar electrode, it is better than a conventional body surface electrocardiogram electrode. Expected to be able to extract the potential change of the heart at a site closer to the heart surface,
This has led to the present invention.

Accordingly, it is an object of the present invention to accurately measure and monitor blood pressure in an internal part of the heart using the guide wire with a pressure sensor as a monopolar electrode, and to measure an intracardiac electrogram close to the surface of the heart. It is an object of the present invention to provide a guide wire type intracardiac electrocardiogram electrode provided with a semiconductor type pressure sensor.

[0009]

According to the present invention, there is provided a guidewire-type intracardiac electrocardiogram for guiding a catheter into a heart, particularly having an outer diameter of 0.26 to 1.05 mm and a length of 30 to 250 cm. The electrode for intracardiac electrocardiogram of the guide wire type is made of metal, especially platinum X.
A sensor part for mounting a pressure sensor for measuring blood pressure and an extension part connected to an external measuring device are mutually fixed (or welded) to the wire opaque tip part and an opening part close to the tip part, and this wire In the cavity, there is a conductive fine wiring that connects the sensor and the X-ray opaque part and the external device respectively, and the outer surface of the wire excluding the metal X-ray opaque part at the tip is covered with resin, A guide wire type intracardiac electrocardiogram electrode with a pressure sensor, characterized in that the X-ray opaque part is a monopolar electrode, is provided.

[0010]

BEST MODE FOR CARRYING OUT THE INVENTION

[Electrocardiogram for Electrocardiogram with Pressure Sensor] The guidewire-type electrode for electrocardiogram (hereinafter sometimes simply referred to as electrode for electrocardiogram) according to the present invention has a main body such as an angiography catheter or various hearts. When inserting a catheter used for catheter treatment into a blood vessel in the heart, it has a function as a guide wire used to guide the insertion, and measures or monitors the intracardiac blood pressure at the tip part The guide wire type intracardiac electrocardiogram electrode is used as a monopolar electrode which can measure the intracardiac electrogram in synchronization with the blood pressure measurement. is there.

Referring now to the specific example of FIG. 1, the electrode for an intracardiac electrogram according to the present invention has a length of 30 to 250 cm and an outer diameter of 0.26 to 1.05.
mm, consisting of a tip 1, a sensor 2 and an extension 3 which are welded together. (1) The X-ray opaque portion of the tip 1 is 10 to 30 m in length
spiral coil 4 densely wound with platinum fine wire
In the present invention, the spiral coil 4 functions as a platinum electrode. And the following extension 3
And a safety wire welded with a tin-silver alloy to a stainless steel core wire 3 'extended through the sensor unit 2, and the tip including the end of the safety wire and a part of the platinum wire is rounded. It is welded to the tin-silver alloy tip. (2) The sensor unit 2 is a stainless steel sheath tube 8 having a length of 2 to 20 mm, preferably 3 to 10 mm, and having a lumen, and the inside of the lumen facing an opening provided in the sheath tube. The semiconductor chip is fixed to the pedestal with an epoxy resin 6 so that the pressure receiving surface is exposed to the opening. (3) The extension part 3 is a tubular wire composed of a coil 9 in which a fine stainless steel wire is spirally densely wound and a stainless steel mantle tube 8, and is connected to a monitoring device for measuring blood pressure outside the body. . (4) Within the lumen of the guide wire, resin-coated conductive fine wiring 7 or 7 ′ connected to the terminal of the sensor or the X-ray opaque platinum coil at the tip 1, respectively, is internally provided, and the extension portion is provided. Each is connected to an end connector terminal. Moreover, (5) the outer surface of the guide wire except for the distal end portion 1 is coated with a resin 10 so that the platinum X-ray opaque portion of the distal end portion 1 acts as a monopolar electrode.

[0012] By inserting such a guide wire type electrode into a blood vessel in the heart as a so-called guide wire, a 12-lead electrode for attaching a carbon electrode to a body surface which has been conventionally used, or a cardiac electrode as a catheter electrode is used. It is used as an electrode for measuring an electrocardiogram similarly to a carbon electrode or the like inserted into the cavity.

However, since the guide wire type intracardiac electrocardiogram electrode of the present invention is an extremely fine wire used as a guide wire as described above, it can be inserted directly into a minute blood vessel in the heart. Unlike the conventional 12-lead electrode attached to the body surface or the thick catheter electrode inserted into the heart chamber, it can be inserted into minute blood vessels of the heart and measured in the active site. Thus, the obtained electrocardiogram is obtained by directly extracting a weak voltage of a human action potential generated in the heart from the surface of the heart, and amplifying and recording it with an electrocardiograph (voltage electrocardiograph).
The body potential recorded on the electrocardiograph by such an electrode is an extremely weak cardiac action potential of about several millivolts, which is amplified and recorded several thousand times like a conventional electrode. An electrocardiographic waveform obtained by an electrocardiograph can be monitored. In addition, since the guide wire is an electrode, such a weak electric potential can be directly measured in the blood vessel in the heart, so that the electrocardiogram can be measured without worrying about the above-mentioned problems of the conventional carbon electrode. This is a salient feature of the present invention.

Further, as in the guide wire type electrode according to the present invention, the guide wire of the main body is formed of a tubular wire in which a very thin metal wire is spirally and densely wound. When inserting this into a blood vessel, it is extremely excellent in operability, and this electrode has the feature that the electrode can be inserted at a site very close to the heart surface of the heart and that the measurement point can be monitored stably. I have.

The excellent operability includes, for example, (1) a tubular wire having a lumen, and the whole wire is a tubular coil in which a fine metal wire is spirally densely wound. When the end is rotated left and right outside the body, the movement is easily actuated by the wire inside the blood vessel along the spiral shape of the guide wire, and the guide wire can be advanced or the insertion direction can be changed. is there. (2) Since the main member of the guide wire is made of stainless steel, the guide wire is made of stainless steel, so that the elasticity unique to the metal can be used to advance the tortuous blood vessel without twisting. . (3) In addition, since these operations are performed under X-ray fluoroscopy, the metal (particularly, platinum) X-ray opaque portion at the tip is used as a shadow mark. The present applicant has already filed Japanese Patent Application No. Hei 9-190307 as described above.
The specification proposes a guide wire with a pressure sensor utilizing these features (1) to (3). Also in the guide wire type intracardiac electrocardiogram electrode of the present invention, since the above-mentioned features are utilized, the electrode can be stably inserted into a target site. By connecting to a venous pressure measurement monitor, accurate blood pressure measurement or stable blood pressure monitoring can be performed directly at the affected area and treatment site in the heart, which cannot be obtained by conventional catheterization, and the heart rate at that site can be measured. The internal potential can be measured in synchronization with the blood pressure.

The guide wire electrode is an extremely fine tubular wire having an outer diameter of 0.20 to 1.05 mm, preferably 0.24 to 1.02 mm, more preferably 0.3 to 1 mm. It is also a feature. The length varies depending on the purpose of use, but generally 30
２５０250 cm is used as appropriate, and if necessary, the outer diameter for connecting to an external measuring device is 0.26 to 1.0 at the end exposed outside the body when used.
An extension tube made of stainless steel and having a length of 100 to 200 cm and having a length of 2 mm is detachably connected and can be easily extended and used.

Therefore, in order to make the guide wire a monopolar electrode by resin coating as described above, in the present invention, 30 to 60 m from the tip of the tip of the guide wire is used.
m, preferably 35 to 50 mm, without covering the outer surface of the guide wire with a resin, leaving the platinum surface bare to act as an electrode in intracardiac blood vessels.

Therefore, the electrode for intracardiac electrocardiography according to the present invention is used as a guide wire for guiding the insertion of a catheter, is equipped with a semiconductor pressure sensor for measuring blood pressure, and functions as a monopolar electrode. At the insertion site which is the main object of the present invention, blood pressure measurement is also performed as necessary, and the intracardiac potential is taken out as a counter electrode with the earth outside the body via a blood vessel in the heart at a site near the heart surface, An intracardiac electrogram can be obtained by performing amplification recording with an electrocardiograph outside the body (see a use example described later).

It is also important for the present invention that the guide wire used in the present invention for measuring the intracardiac pressure and the intracardiac electrocardiogram is a very thin thin tube made of metal. Therefore, even under conditions that occur during use in a living body such as a blood vessel, the main body guide wire has sufficient strength and elasticity to be hardly deformed by external stress such as torsion, bending, bending, and tension. The feature is that.

On the other hand, the guide wire has poor flexibility such as flexibility because it is made of metal, but the guide wire has elasticity peculiar to metal and has a piano-like shape as described above. Since it is an extremely thin thin tube, it can be freely bent like a coil and can be handled with the same flexibility and flexibility as compared with a conventional plastic catheter.

Therefore, when the catheter is easily stretched due to external stress or heat, which tends to occur in the conventionally used plastic catheter, and the catheter is inadvertently stretched during handling, the conductive wire in the catheter may be stretched. The guide wire used in the present invention can be said to be used with almost no concern about expansion and contraction due to such temperature, tension and the like, although it may be easily broken to make measurement impossible.

Further, from the viewpoint of practical use, for example, the heart has a coronary artery, which is called a feeding tube of the heart, which supplies oxygen and nutrients to the heart itself, and branches off from the base of the aorta. It is distributed so as to wrap the heart from the surface. In such a heart, recently, a therapy for dilating a stenosis using a catheter with a balloon has been performed in PTCA (percutaneous coronary angioplasty), which is a treatment for ischemia instead of bypass surgery, using a catheter with a balloon. In order to monitor a patient, it is essential to monitor at least blood pressure, electrocardiogram, and the like.

The present inventor has succeeded in accurately measuring and monitoring the blood pressure before and after the stenosis during the PTCA operation by using the guide wire equipped with the semiconductor type pressure sensor which has already been proposed. In such treatment, monitoring and measurement by electrocardiogram are indispensable, as well as blood pressure monitoring and measurement during implementation.

However, conventionally, when such monitoring and measurement are performed, a body surface electrocardiogram using 12 lead electrodes,
Intracardiac electrocardiogram with catheter electrodes, catheterized blood pressure that requires complicated horizontal positioning, and thin tubes and wiring cables such as catheters for treatment are placed on the body surface around the heart in a disturbed manner, and operated and monitored Will be done.

Therefore, it has been described above that the blood pressure can be monitored at the site inserted into the heart chamber and the electrocardiogram in the heart chamber can be measured in synchronization with the monitoring by using the guide wire type monopolar electrode with the pressure sensor according to the present invention. In addition to reducing complexity, the number of tubes inserted into the heart can be reduced, thereby significantly reducing the burden on the patient, which is a significant feature of the present invention.

Therefore, the relationship between the activity of the heart and the above-mentioned electrocardiogram and blood pressure is described below as a reference example. In addition to the heartbeat cycle during the diastole and the systole of the heart, the waveforms of the P and QRS waveforms during the diastole An electrocardiogram appears, and during systole an ST segment and a T-wave appear and are recorded.

The blood pressure changes in response to one beat of the diastole and the systole of the heart activity, and the blood pressure value (normal value) at the main part of the heart is the systolic pressure in the aortic pressure. 90-130 mmHG (diastolic pressure; 60-90 mmH
G) In the pulmonary artery pressure, the systolic pressure is 15 to 35
mmHg (diastolic pressure; 5-10 mmHG), in the right ventricle, the systolic pressure is 25 mmHg or less (end diastolic pressure;
In the left ventricle, the systolic pressure is 80 to 120 mmHg (end diastolic pressure; 5 to 12 mmH).
g), blood is circulated throughout the body in response to these cardiac activities, and weak action potentials associated with these activities are measured as electrocardiograms.

The peaks and valleys of the waveform generally appearing on the electrocardiogram are named P, Q, R, S, and T waves in order from the left. The P wave represents atrial excitation (waveform caused by atrial depolarization), the QRS wave represents ventricular excitation (waveform caused by ventricular depolarization), and the T wave shows the ventricle being relieved from excitation (ventricular repolarization). (Waveform caused by the above).

In particular, in this electrocardiogram, it is said that the ST portion is sensitive to ischemia, and that elevation of ST appears during acute myocardial infarction and depression appears during an attack of angina. On the other hand, the blood pressure of the aortic pressure during the systole shows the maximum pressure waveform. Therefore, it is understood that if the electrocardiogram waveform and the blood pressure waveform are measured and monitored in synchronization, it is extremely significant for the diagnosis or treatment of heart disease.

[0030] The ischemia is a disease with a high frequency of heart diseases, such as angina pectoris and myocardial infarction, which has a high mortality rate, due to the stenosis or occlusion of the coronary arteries, resulting in insufficient supply of necessary blood to tissues. Contains the most important heart disease.

As these ischemic heart diseases, myocardial infarction,
Effort angina, atypical angina, painless myocardial ischemia, heart failure,
Arrhythmias, valvular diseases and the like can be mentioned. In particular, this painless myocardial ischemia is a condition in which the person does not feel painful despite changes in the state of oxygen deprivation of the heart, that is, pain and reduced sensitivity despite the occurrence of angina pectoris It is said that it is a dangerous state that you do not notice at all.

Therefore, by inserting a guide wire type intracardiac electrode with a pressure sensor and capable of measuring the surface potential of the heart proposed by the present invention into the heart, it is possible to fulfill the function as a guide wire. The blood pressure at the insertion site is measured and monitored, and the intracardiac electrogram can be measured and monitored in conjunction with the blood pressure measurement.

[Fine Wiring and Pressure Sensor] In the guide wire type intracardiac electrocardiogram electrode according to the present invention, as described above, fine conductive wiring covered with resin is present in the inner cavity of the wire, and the sensor portion is provided. The semiconductor pressure sensor is connected to an X-ray opaque platinum wire at the tip end, which is an electrode, and is connected to an external measuring instrument. As a semiconductor type pressure sensor to be mounted on the guide wire of the present invention, a diaphragm type capacitance type, semiconductor diffusion resistance type, semiconductor capacitance type, electromagnetic induction type, piezoelectric element type, force balance type, strain gauge And a thin film strain sensor type, and these can be used as appropriate.

Therefore, as the conductive fine wiring connected to the semiconductor sensor and the intracardiac electrocardiogram electrode, a micro cable in which a normal ultrafine conductive wire is covered with a fluororesin is preferably used. For the smell, a flexible printed wiring board can be appropriately used in addition to a normal conductive wire. That is, a polyester film, a fluororesin film, a polyimide film, a polyester film, a film such as a polyvinyl chloride film, a copper foil, or a flexible printed wiring material in which a ribbon-shaped copper core is bonded to the film.
Examples include a flexible printed circuit and a low-loss printed board.

[Usage Method] The guidewire type intracardiac electrocardiogram electrode according to the present invention is used alone by being inserted into a blood vessel for measuring blood pressure, intracardiac electrocardiogram, etc., but may also be used as a guidewire. It is used as a guide to insert various catheters into the target site. That is, the catheter is inserted along the guide wire previously inserted into the blood vessel while passing through the guide wire.
For example, it is used in a leading manner in order to guide the insertion of a general-purpose angiography catheter in the treatment of normal heart disease.

The platinum X-ray opaque part at the tip is
In order to prevent damage to the blood vessel wall during leading insertion, a particularly soft platinum tip member is mounted. Since the insertion is operated under fluoroscopy, this radiopaque part is confirmed as a shadow (shadow picture), which not only facilitates the insertion of the catheter, but also serves as a marker for measuring a blood pressure or other measurement site. Can be clearly monitored,
Long-term monitoring is also easy and stable.

The intracardiac electrocardiographic electrode according to the present invention can be used alone, including the in-vivo site and the extracorporeal site. In addition to the above, the extension wire is detachably connected as described above. Depending on the purpose, an extension member outside the living body may be used in combination with a connecting member such as a connection cable or an introducer and a connector member such as a torque device.

In addition, since the electrode is inserted into the living body for a long time depending on the purpose, the electrode for an intracardiac electrocardiogram composed of various members as described above is safe especially at a site to be inserted into the living body. Special consideration must be given to the dissolution, toxicity, corrosion, etc. of the material of the member from the aspect of properties.

If the main material of the electrode for intracardiac electrocardiogram of the present invention is made of a corrosion-resistant metal, that is, stainless steel, platinum or the like, the above problem does not occur. However, the purpose of the resin coating in the present invention is only In order for the guide wire to function as a monopolar electrode, the entire outer surface except the tip is coated with a resin.

[Resin Coating] In order to use the guide wire as a monopolar electrode, it is preferable to use a resin coated on the outer surface of the guide wire, preferably a Teflon-coated resin as appropriate. As a result, the electrode for intracardiac electrocardiography not only solves the above-mentioned safety problem, but also makes use of the characteristics of Teflon to make insertion into a blood vessel smoother.

Examples of the method of coating the fluororesin include a vacuum deposition method, a hot melt coating, an emulsion coating, and a solution coating.
Further, as the coating material in the present invention, in addition to the above-mentioned fluororesin, in particular, in consideration of chemical resistance, corrosion resistance, insulation, etc., epoxy, polystyrene, ethylene trifluoride, tetrafluoroethylene, polyethylene, polypropylene , Polyester and polycarbonate.

[Use] The guide wire type intracardiac electrocardiogram electrode according to the present invention itself is used as a guide for inserting and guiding various catheters to a target part of the heart as described above. At the same time as measuring the blood pressure, for example, at the target site of the coronary artery, the intracardiac electrocardiogram (or electrocardiogram waveform) close to the heart surface of the site is synchronized with this blood pressure measurement with the same accuracy as the blood pressure and stable for a long time. It enables a monitor to be used.

Thus, in the case where the guide wire type intracardiac electrode of the present invention is used, for example, the most effective treatment for the treatment of ischemic heart disease is coronary artery bypass surgery. Recently, in percutaneous coronary angioplasty (PTCA), which has become a popular alternative to this bypass operation, a guidewire-type intracardiac electrode is passed through the occluded coronary artery, and a catheter with a balloon is inserted into the occlusion part along this And, by inflating the balloon, mechanically expand the occluded vessel,
In the method of measuring recanalization, it is suitably used to measure an intracoronary electrocardiogram quickly in synchronization with the pressure measurement before and after the stenosis.

Further, as a method of treating a cardiac catheter, it is suitably used when a catheter is inserted from an artery or a vein to measure the pressure in the atrium or ventricle. Therefore, it is preferably used in combination with a catheter.

As described above, PTCA, PTA
Conducted as a prior diagnosis of catheter treatment such as
In clinical examinations such as S, the electrocardiogram is always monitored during the examination, and at the same time, the blood pressure must be checked.

In any of these cases, the use of the guidewire-type intracardiac electrode with the pressure sensor of the present invention not only provides a stable blood pressure and electrocardiogram waveform, but also improves the conventional cardiac catheter therapy. The number of catheters and other tubes to be inserted into the heart is reduced, and the number of wires placed on the surface of the heart is also reduced, so that not only is the measurement complicated, but also the physical and mental burden on the patient. Is a major feature of the present invention.

[0047]

The present invention is further described in the following examples. The method for measuring the blood pressure and the potential at a site close to the surface of the heart with the guide wire type intracardiac electrocardiographic electrode with the semiconductor type pressure sensor used in the present invention and measuring the intracardiac electrogram in synchronization with the blood pressure will be described below. explain. (1) Operating principle of semiconductor pressure sensor A semiconductor sensor that converts a pressure change into an electric resistance by a piezoresistive pressure sensor equipped with a Wheatstone bridge on a base for fixing the sensor, amplifies the measured electric resistance, The blood pressure is measured by correcting with a voltage resistance under the atmosphere by an atmospheric pressure sensor and converting the voltage into a voltage. That is, when an excitation voltage is supplied to the Wheatstone bridge circuit, the resistance is changed by the silicon membrane coming into contact with the blood flow and receiving pressure. On the other hand, a temperature resistance element provided in the temperature compensating circuit receives a change due to only the temperature, and changes the resistance difference between the two into a voltage and converts it into a pressure.

The performance of the guide wire type electrode with the semiconductor type pressure sensor used in this embodiment is as follows. Operating pressure measurement range: -25 to 300 mmHg Linearity (0 to 200 mmHg): ± 1% or less Frequency characteristics: 200 Hz Time zero point change: 5 mmHg / h or less Temperature zero point change: 0.2 mmHg / ° C Time sensitivity change: 3% / H or less Sensitivity: 25 μV / mmHg When using this guide wire electrode, the following electrical safety test is performed. (1) Leakage current test As a leakage current test in accordance with JIS T100212 method, the property state and single failure state of the exterior leakage current and the patient leakage current are measured in terms of the continuous leakage current and the patient measurement current, respectively. Next, the following performance tests are performed. (2) Rated output voltage, time zero point change, time sensitivity change According to JIS T1116, the rated output voltage and output sensitivity of the clinical invasive blood pressure monitor, a guide wire with a pressure sensor is connected to the main body, and it is confirmed that the output voltage of the terminal is within the rating. Next, the compatibility of the calibration signal was confirmed, and a guide wire electrode with a pressure sensor
For a load pressure in the range of 0 mmHg, it is confirmed that the measured pressure has a display accuracy within ± 1% of the load pressure value. 2. Time zero point change Then, after adjusting the output voltage of the output terminal to 0 volt,
Confirm that the output voltage change after one hour has passed is less than 5 mmHg / h. 3. Next, similarly, it is confirmed that the output voltage change corresponding to 100 mmHg is less than 3% / h after one hour. (3) Bending test The outer diameter used in the present invention is 0.36 mm and the length is 180 cm.
The bending strength is examined by wrapping the guide wire of No. 1 around a rod having a diameter of 50 mm and restoring the original shape when the hand is released. The guide wire electrodes used in the present invention were suitable without any abnormality.

(Usage Example 1) In a case of a coronary artery stenosis, a blood pressure was measured using a guide wire type intracardiac electrocardiogram electrode (hereinafter referred to as the present electrode) with a pressure sensor according to the present invention, in which the pressure sensor was a semiconductor type. This electrode guides the balloon catheter into the stenotic region, expands the PTCA balloon in the stenotic region, measures the blood pressure just before the stenosis before and after the procedure, and shows the results. 2 is shown. The PG waveform in the figure (A) is a pressure waveform before the balloon expansion of the stenosis part by the present electrode, and the PG waveform in the figure (B) is the pressure waveform after the balloon expansion.

(Usage Example 2) An electrocardiogram was also measured with the present electrode at the time when the blood pressure waveform diagram (A) in FIG. 2 before the PTCA balloon expansion shown in Usage Example 1 was measured, and is shown in FIG. C ₁ in the figure is an electrocardiogram corresponding to an electrode arrangement (V ₅ ) using a conventional 12-lead electrode attached to the body surface, and D _{1 in} the figure is an intracardiac electrogram at that time by the electrode of the present invention. .

(Usage Example 3) An electrocardiogram was also measured with this electrode at the time when the blood pressure waveform diagram (B) of FIG. 2 after the PTCA balloon dilation shown in Usage Example 1 was measured, and is shown in FIG. C ₂ in the figure is an electrocardiogram corresponding to an electrode arrangement (V ₅ ) using the conventional 12-lead electrode attached to the body surface, and D _{2 in} the figure is an intracardiac electrogram at that time by the electrode of the present invention. .

As is clear from the above-mentioned use examples 1 to 3, the electrocardiogram waveform of the present electrode after the blood flow became normal after the PTCA balloon dilatation showed a change which did not appear in the conventional body surface electrocardiogram. ing. That is, the guide wire type intracardiac electrocardiogram electrode with the pressure sensor according to the present invention was able to measure the electrocardiogram on the heart surface in the heart in synchronization with the blood pressure in the heart.

[0053]

EFFECT OF THE INVENTION Clinical examination of EPS, etc., PTA (percutaneous angioplasty), PTCA (percutaneous coronary angioplasty) using the guide wire type intracardiac electrocardiogram electrode with a metal pressure sensor according to the present invention. In catheter treatments such as, this electrode serves as a guide wire,
With these tests, it is possible to measure the electrocardiogram at an intracardiac site close to the heart surface in synchronization with the blood pressure measurement at the insertion site in the heart, which was essential at the time of treatment, and with a semiconductor type pressure sensor used for it Of the present invention can be provided. That is, the guide wire type intracardiac electrocardiogram electrode of the present invention can obtain an electrocardiogram waveform which cannot be detected by the conventional body surface electrocardiogram, and enables more precise examination, surgery, treatment, etc. based on the electrocardiogram.

[Brief description of the drawings]

FIG. 1 is a conceptual diagram of a guide wire type intracardiac electrocardiogram electrode with a pressure sensor according to the present invention.

FIG. 2 shows pressure waveforms before and after a PTCA operation by a guide wire type intracardiac electrocardiogram electrode with a pressure sensor according to the present invention. (A) is a pressure waveform before operation, and (B) is a pressure waveform after operation.

FIG. 3 shows an electrocardiogram waveform (D ₁ ) of a guide wire type intracardiac electrocardiogram electrode with a pressure sensor according to the present invention before a stenosis portion before PTCA operation. Waveform C ₁ is for comparison, the electrode arrangement according to 12 induction electrode paste into a conventional body surface (V
It is an electrocardiogram corresponding to ₅ ).

FIG. 4 shows an electrocardiogram waveform (D ₂ ) just before a stenosis portion after PTCA operation using a guide wire type intracardiac electrocardiogram electrode with a pressure sensor of the present invention. Waveform C ₂ is for comparison, the electrode arrangement according to 12 induction electrode paste into a conventional body surface (V
It is an electrocardiogram corresponding to ₅ ).

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Tip part (X-ray opacity) 2 Sensor part 3 Extension part 4 Spiral tubular wire made of platinum 5 Silicon chip 6 Silicon resin 7, 7 'fine wiring 8 Stainless steel outer sheath 9 Stainless steel spiral tubular wire 10 Coating resin

Claims (3)

[Claims] 1. A guidewire-type intracardiac electrocardiogram electrode for guiding a catheter to be inserted into a heart, wherein the guidewire-type intracardiac electrocardiogram electrode has a metal X-ray opaque tip and is close to the tip. A sensor part for mounting a pressure sensor for measuring blood pressure in the opening and an extension part connected to an external measuring device are fixed to each other, and a sensor and an X-ray opaque part and an external device There is a conductive fine wiring that connects
A guide wire type intracardiac electrocardiogram electrode with a pressure sensor, characterized in that the outer surface of the wire excluding the X-ray opaque portion at the tip is coated with a resin, and the X-ray opaque portion is used as a monopolar electrode. 2. A guide wire type intracardiac electrocardiogram electrode, wherein: (1) a tip portion is a helical tubular coil formed by densely winding a fine metal wire, and is extended through an extension portion and a sensor portion; The stainless steel core wire contains a stainless steel safety wire welded with a tin-silver alloy,
The end of the safety wire is welded to a tin-silver-based alloy tip with a rounded tip. (2) The sensor part is a stainless steel mantle tube with a bore inside the bore facing the opening. The semiconductor type pressure sensor is fixed to the pedestal of the silicon chip with resin so that the pressure-receiving surface is exposed. (3) The extension part is a tubular coil in which a stainless wire is densely spirally wound and a stainless steel coil. (4) A resin-coated conductive fine wire connected to a sensor terminal and a metal coil at the tip is provided in the lumen of the guide wire. 2. The guidewire type intracardiac electrocardiogram electrode according to claim 1, wherein the electrode is provided internally and connected to the connector at the end of the extension. 3. The guide wire type intracardiac electrocardiogram electrode according to claim 1, wherein the coating resin is a Teflon resin.