JP2003126273A - Extracorporeal multisite pacing pacemaker - Google Patents

Abstract

PROBLEM TO BE SOLVED: To supply an extracorporeal pacemaker temporarily lessening burden on a patient, permitting prior confirmation to individual patients of effectiveness and necessary functions, optimal parameters through a trial use for a fixed period in the selection and setting of specifications (model) of a permanent embedded pacemaker and determination of a method and a pattern of use corresponding with the patients by increasing output while improving the contraction synchronousness of the heart as a whole including the atrium and ventricles. SOLUTION: The extracorporeal multisite pacing pacemaker has an atrium electrode embedded and dwelling in the atrium, a right ventricle electrode embedded and set in the right ventricle, and a left ventricle electrode embedded and dwelling in or near the left ventricle (the left ventricle side from the coronary sinus). Furthermore, an output regulation mechanism capable of changing the relative timing of electrical stimulation outputted from the electrodes installed in the atrium, the right ventricle, and the left ventricle.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an external pacemaker capable of multisite pacing for stimulating multiple sites (multisites) of the heart to treat heart failure.

[0002]

2. Description of the Related Art In a patient with heart failure, the stimulatory transmission system of the heart cannot function normally for some reason. Therefore,
It has been widely practiced to implant pacemakers in the body and to stimulate the atria / ventricle of the heart by means of leads in communication with the pacemaker, allowing the heart to beat periodically.

In normal heart failure, one lead is implanted in the atrium and one lead in the ventricle to suppress stimulation when a self-pulse is detected in the atrium or ventricle, and to pace the heart muscle when the self-pulse does not occur. A dual chamber type pacemaker having a function is widely used. By using such a dual-chamber type pacemaker, it can be comfortably applied to the living body (highly biocompatible).
The pulsation can be controlled.

However, even in this physiological dual-chamber pacemaker, the ventricle side usually places the lead in the right ventricle, so that the left ventricle side functional disorder (left bundle branch block etc.) and DCM.
When there is (dilated cardiomyopathy), there is a problem that the movement of the left ventricle does not sufficiently contract, and the blood flow (cardiac output) does not rise well.

Therefore, recently, a multi-site type pacemaker for pacing multiple regions of the heart (atria, both ventricles, etc.) has been attracting attention. This type of pacemaker can alleviate the above problems, increase the cardiac output and reduce the burden on the heart.

However, the effectiveness and adaptability of the above-mentioned multi-site type implantable pacemaker cannot be judged unless it is actually used for a patient, and what kind of setting ( There is also a problem that it is not possible to judge whether the parameter) / usage method is preferable without trying for a certain period. However, since the existing multi-site type pacemakers only have a permanent implantable type, it is very risky to confirm the effectiveness after implanting the pacemaker in the body.

On the other hand, a pulse generator (generator)
The extracorporeal pacemaker, which has been put out of the body, has been conventionally used because it has a merit that it is only necessary to perform the operation of installing electrodes in the body, and it is easy to perform maintenance and inspection of instruments and exchange of batteries. However, since this external pacemaker uses leads inside and outside the body, there is a risk of infection if the wound area is not kept clean, and it is inconvenient to carry a generator. Their use is often limited to the temporary prevention of arrhythmia, or emergency treatment up to heart transplantation or implantation of an internal pacemaker. In addition, since the external pacemaker was not necessary for the above-mentioned use, there was no one capable of adjusting / changing the parameter setting and usage pattern, and much less the multi-site type pacemaker.

[0008]

SUMMARY OF THE INVENTION Therefore, the main object of the present invention is to solve the following two problems. First, there is a supply of a pacemaker that temporarily reduces the burden on the heart by increasing the stroke volume while improving the contraction synchrony of the entire heart such as the atrium and both ventricles. Secondly, by trialing each individual patient for a certain period of time and confirming its effectiveness, required functions, and optimal set values (parameters) in advance, the standard (model) of the permanent implantable pacemaker can be confirmed. It is a supply of temporary or trial confirmation type pacemakers that can confirm the selection and setting and the usage method and form suitable for the patient.

[0009]

SUMMARY OF THE INVENTION In the present invention, the above-mentioned problems are solved by designing an external multi-site pacemaker capable of adjusting and changing the setting and the usage pattern according to the condition of each patient. Then, by testing the multi-site pacemaker for a certain period of time on the patient, its effectiveness and applicability can be confirmed. Furthermore, by setting and changing the parameters of this multi-site pacemaker and the usage pattern (method?),
It is possible to select the optimum setting value and usage pattern for the patient. In this way, select a permanent implantable pacemaker that reflects the confirmed standards and settings, as well as the usage pattern,
Alternatively, it is possible to select the optimum setting.

That is, in an extracorporeal pacemaker that detects and / or outputs at a plurality of parts of the heart, a right atrial electrode implanted and placed in the right atrium and a right ventricle implanted and placed in the right ventricle. An electrode and a left ventricle electrode that is implanted / placed in the left ventricle or in the vicinity of the left ventricle (from the coronary sinus to the left ventricle side), and further placed in each of the right atrium, right ventricle, and left ventricle. An external multi-site pacing pacemaker having an output adjusting mechanism capable of changing the relative output timing (timing) of electrical stimulation (signal) output from electrodes.

[0011]

Further, in the present invention, by adding features and requirements as described below to the above requirements, a more desirable embodiment can be realized. One of them is, for example, the timing of contraction synchronization between the right ventricle and the left ventricle. Normally, the right ventricle and the left ventricle simultaneously contract by pacing at the same time, but some patients can obtain a more physiological cardiac output by slightly shifting the timing. That is, as one of the preferred embodiments, an external multi-site pacemaker capable of arbitrarily setting which of the right ventricle and the left ventricle precedes and how much the timing is shifted. Hereinafter, preferred embodiments will be individually described.

In a preferred embodiment, the output adjusting mechanism delays the output timing from each electrode placed in each part of the right ventricle and the left ventricle by a predetermined time from the output timing from the right atrium electrode. The external multi-site pacing pacemaker capable of being used as described above.

Further, the delay time between the output timing from the right atrium electrode and the output timing from the right ventricle electrode, and the delay time between the output timing from the right atrium electrode and the output timing from the left ventricle electrode are individually (independent). The above-mentioned extracorporeal multi-site pacing type pacemaker having a control means that can be changed and adjusted.

The above-mentioned external multi-site pacing can synchronize the output timing from the right ventricle electrode with the output timing from the left ventricle electrode, or can delay both output timings by a predetermined time. Type pacemaker. By the control means, it is possible to independently adjust / change the delay of the output timing in each part, for example, the atrial-right ventricular pacing delay or the atrial-left ventricular pacing delay. In each of the above-described embodiments, a device having the output adjustment mechanism (output adjustment device) is installed outside the body, and the output timing of the electrical stimulation of each electrode placed in each part of the heart from outside the body is adjusted / changed. This makes it possible to apply optimal settings and usage methods for each patient.

Further, in the above-mentioned extracorporeal type multi-site pacing type pacemaker, it is desirable that the present invention has a control means capable of adjusting / changing various parameters of an electric signal output from an electrode placed at each site. For example, parameters to be changed or adjusted include output voltage, pulse width (cycle), sensitivity, mode, and delay between parts. In terms of output voltage, right atrial output voltage,
There are right ventricle output voltage and left ventricle output voltage, and in pulse width (cycle), there are atrial pulse width, right ventricle pulse width, and left ventricle pulse width. Similar to the adjustment / change of the output timing described above, the control means can change / adjust each of these parameters independently from outside the body, and can control while confirming the fit state of the patient. Hereinafter, embodiments will be described individually.

[0016] As an embodiment, the above-mentioned external multi-type having a control means capable of (independently) changing / adjusting the output voltage of the electrical stimulation output from each electrode placed in each chamber of the atrium, the right ventricle and the left ventricle It is a site pacing pacemaker.

Further, the above-mentioned external multi-site having a control means capable of independently changing and adjusting the pulse width (cycle) of the electrical stimulation output from each electrode placed in each chamber of the atrium, the right ventricle and the left ventricle It is a pacing type pacemaker.

Further, when self-stimulation (self-wave) from a living body is detected, it is desirable that the self-wave allows both a mode for outputting electrical stimulation and a mode for suppressing the output. That is, when an electrode placed in any of the above-mentioned both ventricles detects a spontaneous stimulation (self-wave) from at least one of the respective ventricles, an electrical stimulation is made from each electrode of both ventricles in synchronization with the self-wave. The external multi-site pacing pacemaker is capable of selecting a mode for outputting the electric field or a mode for suppressing electrical stimulation from the electrodes of both ventricles.

[0019]

An embodiment of the present invention will be illustrated below with reference to the drawings. Table 1 shows the types of setting parameters in the extracorporeal multi-site pacing type pacemaker of the present invention and preferable ranges for changing and adjusting the parameters.

[0020]

[Table 1]

In the above table, the left column shows the types of functions and parameters to be set. Then, the right column shows the range of numerical values to be adjusted / changed. Some parameters remain fixed depending on the type. From the top of the table,
Briefly explained in order, the mode is basically ICH
D [Inter-Society Commission on Heart Desease: 3
The first letter represents the stimulation site and the second the second letter.
The letter represents the detection site, and the third letter represents the control function. ] Various modes defined by the code can be selected. As described in the table, DDDBiAT (defined as pacing the atrium in synchronization with an atrial event and simultaneously pacing both ventricles after a certain time) as described in the table. D
It is also possible to change the setting and make it function, such as DDBiAV (defined as pacing both ventricles at the same time after a certain time after sensing an atrial event or atrial pacing). Rate is 1 of pacemaker
Shows the number of pacing per minute, 30-200bp
It can be adjusted within the range of m. i

Lines 4 to 9 of Table 1 show setting parameters related to the atrium. The atrial output voltage indicates the voltage of electrical stimulation output to the atrial electrode, that is, the output voltage of the stimulation wave, and can be adjusted / changed at 0.1 to 20 Volt (V). Further, it is variable in 0.5V increments from 0.1 to 5.0V, and is variable in 1.0V increments from 5.0 to 10V. The stimulation waveform output to the atrial electrode is usually represented by a rectangular wave, but the atrial pulse width indicates the temporal width of the rectangular wave,
It is specified to 1.0 ± 0.05 ms. The atrial sensitivity is a sensitivity capable of detecting the self-stimulation (self-wave) at the atrial electrode, and can be changed in the range of 0.1 to 10 mV for each 0.1 mV.

The atrial refractory period is a period set to prevent the pacemaker from reacting (outputting) in the atrium after a predetermined period of the previous pulse or a predetermined period when a self-wave is detected. Between
Adjustment / change is possible every 0 ms.

Lines 10 to 16 of Table 1 show setting parameters relating to the right ventricle. The right ventricle output voltage indicates the voltage of electrical stimulation output to the right ventricle electrode,
It can be adjusted and changed at 30 Volt (V). The right ventricular output voltage is variable in 0.2V increments from 0.1 to 3.0V, and from 0.5 to 6.0V in 3.0 to 6.0V increments.
It can be changed in steps of 1.0V up to 0V. The right ventricle pulse width represents the time width of the stimulation wave to the right ventricle electrode, and is 0.5 to
It can be changed every 0.1 ms within a range of 2.0 ms. The right ventricle sensitivity is the sensitivity that can detect self-stimulation (self-wave) in the right ventricle electrode, and is in the range of 1.0 to 20 mV,
It is variable every 0.2 mV.

What is the right ventricle refractory period or right ventricle blanking?
The setting of refractory period and blanking period in the right ventricle, respectively, in the range of 200 to 2000 ms, 4
It is set to a fixed value of 0 ms.

The A-VR delay indicates a pacing delay (output delay time) between the atrium and the right ventricle, and the delay in the period until the output to the right ventricle is based on the output or detection of electrical stimulation from the atrium. In the range of 40 to 500 ms,
It can be adjusted / changed at 10 ms intervals.

Lines 17 to 22 of Table 1 show setting parameters related to the left ventricle. As described in each setting parameter of the right ventricle, each parameter of the left ventricle is set by adjustment / change or a fixed value as described in the table. [A-VL delay indicates a pacing delay (output delay time) between the atrium and the left ventricle, and sets the delay of the period until the output to the left ventricle with reference to the output of electrical stimulation from the atrium. . ]

1 to 3 show a generator 1 for changing and adjusting the electrical stimulus output from the external multi-site pacing type pacemaker of the present invention to each site. The generator 1 corresponds to the output adjusting device described above. This generator 1 is installed outside the body, and the control means is divided for each detection site from each site of the heart or each site that outputs an electrical stimulus. For example, FIG. 2 shows an operation panel when the generator 1 is viewed from the front. The atrial control unit 2 controls the atrium from the left side, the right ventricle control unit 3 controls the right ventricle in the middle, and the left side controls the left ventricle in the right side. The ventricle control unit 4.

In the atrial or ventricular control units 2, 3 and 4, the knobs 2a, 3a and 4a for adjusting / changing the detection sensitivity of each part (atria, right ventricle, left ventricle) and the output voltage of each part are set. The knobs 2b, 3b, 4b for adjusting / changing are provided. In each control unit, knobs 2c, 3c, 4c for adjusting / changing the pulse width of electrical stimulation to each part are provided between the detection sensitivity knob and the output voltage knob. Below the pulse width knobs (2c, 3c, 4c) of each control unit, a pair of lead plug jacks 2e, 3e,
4e is formed so that the leads communicating with the electrodes of the respective parts can be inserted. Further, a rate knob 5 for adjusting / changing a rate (pacing rate) at which an electrical stimulus is output per minute is formed in the central middle section.

FIG. 1 shows an operation panel when the generator is viewed from above. An A-VR Delay knob 6 is provided on the upper left side, an A-VL Delay knob 7 is provided on the lower left side, and an A-Blanking knob 8 is provided on the central upper stage. , A- in the lower center
The Ref knob 9, the RV-Ref knob 10 is formed on the upper right side, and the LV-Ref knob 11 is formed on the lower right side. The A-VR Delay knob 6 is for adjusting and changing the AV delay of the atrium and the right ventricle, and the A-VL Delay knob 7 is the AV of the atrium and the left ventricle.
It is for adjusting and changing the delay. A-Blan
The king knob 8 is for setting the atrial blanking so that the ventricular side does not detect an atrial pacing event, and the A-Ref knob 9 and the R-V-Ref knob 1 are set.
0 and L-V-Ref knob 11 are atrial refractory period,
It is for setting the right ventricular refractory period and the left ventricular refractory period. A Mode knob 12 that can set a pacing mode defined by the ICHD code is formed in the middle of the right end.

FIG. 3 shows the generator 1 as viewed from the side, and a transparent acrylic cover 13 for protecting the knobs is attached to the upper part of the generator 1, and the side of the generator 1 is used for carrying the main body of the generator 1. Carrying handle 1
4 are formed.

[0032]

According to the external pacemaker of the present invention,
Various effects as described below can be obtained. 1. By being able to improve left (ventricular) diastolic dysfunction,
Left (ventricular) ventricular ejection force can be increased. As a result, the ejection volume of the entire heart can be improved. The asynchrony of each ventricle can be reduced, resulting in improved patient hemodynamics. 2. The effectiveness of using a multi-site pacemaker can be confirmed in advance for individual patients. 3. The required settings (parameters) for each patient, the compatible standards (models), etc. can be known in advance, which can be used to select a permanent implantable pacemaker or to know the optimum setting, and the efficiency can be improved. The optimal pacemaker can be provided to each patient.

[Brief description of drawings]

FIG. 1 is a schematic plan view of an operation panel of an output adjusting device (generator) as seen from above in an embodiment of an external pacemaker according to the present invention.

FIG. 2 is a schematic front view of the operation panel of the generator seen from the front.

FIG. 3 is a schematic side view of an operation panel of the generator viewed from a side surface direction.

[Explanation of symbols]

1. Output adjustment device (generator) 2. Atrial control unit 2a. Detection sensitivity setting knob (for atria) 2b. Output voltage setting knob (〃) 2c. Pulse width setting knob (〃) 2e. Lead plug jack (〃) 3. Right ventricle control unit 3a. Detection sensitivity setting knob (for right ventricle) 3b. Output voltage setting knob (〃) 3c. Pulse width setting knob (〃) 3e. Lead plug jack (〃) 4. Left ventricle control unit 4a. Detection sensitivity setting knob (for left ventricle) 4b. Output voltage setting knob (〃) 4c. Pulse width setting knob (〃) 4e. Lead plug jack (〃) 5. Rate setting knob 6. A-VR Delay setting knob 7. A-VL Delay setting knob 8. A-Blanking setting knob 9. A-Ref setting knob 10. R-V-Ref setting knob 11. LV-Ref setting knob 12. Mode setting knob 13. Protective cover 14. Carrying handle

   ─────────────────────────────────────────────────── ─── Continued front page    (72) Inventor Tetsuya Yamashita             12-17 Kako-cho, Naka-ku, Hiroshima City, Hiroshima Prefecture Stock Association             Company JMS (72) Inventor Yutaka Takano             12-17 Kako-cho, Naka-ku, Hiroshima City, Hiroshima Prefecture Stock Association             Company JMS F-term (reference) 4C053 KK02 KK07

Claims (8)

[Claims] 1. Detection or / in a plurality of parts of the heart
In an external pacemaker that outputs and outputs, a right atrial electrode that is implanted and placed in the right atrium and an implant that is placed in the right ventricle.
A right ventricle electrode to be placed and a left ventricle electrode to be implanted / placed in the left ventricle or in the vicinity of the left ventricle (from the coronary sinus to the left ventricle side), and each of the right atrium, right ventricle, and left ventricle. An external multi-site pacing pacemaker having an output adjusting mechanism capable of changing the relative output timing (timing) of electrical stimulation (or signal) output from each electrode placed in the site. 2. The output adjusting mechanism can delay the output timing from each electrode placed in each part of the right ventricle and the left ventricle by a predetermined time from the output timing from the right atrium electrode. The external multi-site pacing type pacemaker according to claim 1. 3. A delay time between the output timing from the right atrium electrode and the output timing from the right ventricle electrode, and a delay time between the output timing from the right atrium electrode and the output timing from the left ventricle electrode (independent). The extracorporeal multi-site pacing pacemaker according to any one of claims 1 and 2, further comprising a control means that can be changed and adjusted. 4. The output timing from the right ventricle electrode can be synchronized with the output timing from the left ventricle electrode, or both output timings can be delayed by a predetermined time. Extracorporeal multi-site pacing type pacemaker according to the section. 5. The output voltage of electrical stimulation output from each electrode placed in each chamber of the atrium, the right ventricle, and the left ventricle (independently)
The extracorporeal multi-site pacing pacemaker according to any one of claims 1 to 4, further comprising a control means that can be changed and adjusted. 6. The control means capable of independently changing and adjusting the pulse width (cycle) of the electrical stimulation output from each electrode placed in each chamber of the atrium, the right ventricle and the left ventricle. An external multi-site pacing pacemaker according to any one of the items. 7. When the electrode placed in any of the above-mentioned both ventricles detects a spontaneous stimulus (self-wave) from at least one of the respective ventricles, the electrodes of both ventricles are synchronized with the self-wave. You can also select the mode to output electrical stimulation,
The extracorporeal multi-site pacing pacemaker according to any one of claims 1 to 6, wherein a mode for suppressing electrical stimulation from each electrode of both ventricles can be selected. 8. As the mode, even in DDDBiAT,
Alternatively, the external multi-site pacing pacemaker according to claim 7, which can be selected by DDDBiAV.