CN116832322A - Nerve stimulation system for pacing heart - Google Patents
Nerve stimulation system for pacing heart Download PDFInfo
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Classifications
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- A—HUMAN NECESSITIES
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- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
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- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
- A61N1/36135—Control systems using physiological parameters
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- A—HUMAN NECESSITIES
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- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/3621—Heart stimulators for treating or preventing abnormally high heart rate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/37—Monitoring; Protecting
Abstract
The invention relates to a nerve stimulation system for pacing a heart, and belongs to the technical field of medical appliances. The present invention provides a neurostimulation system for pacing a heart, comprising a neurostimulation subsystem and a pacing heart subsystem, wherein the neurostimulation subsystem comprises a first pulse generator, a first lead, and a first electrode, the neurostimulation subsystem is configured to collect an electrical signal of the first electrode, the first pulse generator is configured to stimulate nerve tissue through the first electrode; the pacing cardiac subsystem includes a second pulse generator, a second lead, and a second electrode, the pacing cardiac subsystem configured to acquire electrical signals of the second electrode, the second pulse generator configured to stimulate cardiac tissue through the second electrode. The nerve stimulation system greatly improves the safety and the self-adaptability of the implantable medical device, and has the functions of sensing heart rate, adjusting full-automatic output parameters and controlling the heart rate in a bidirectional manner.
Description
Technical Field
The invention relates to a nerve stimulation system for pacing a heart, and belongs to the technical field of medical appliances.
Background
Blood in the human body is pumped out by the heart and flows to the whole body through blood vessels. Each time the heart beats, blood is pumped toward the blood vessel. The pressure at which blood pushes against the wall of a blood vessel is called blood pressure. Hypertension is a condition in which blood vessels have a continuously elevated pressure. The normal blood pressure range refers to systolic pressures of less than 120mmHg and diastolic pressures of less than 80mmHg. If the blood pressure is higher than 120/80 but lower than 140/90, it is defined as the early stage of hypertension (pre-hypertension). Hypertension occurs if the blood pressure is higher than 140/90. Hypertension is caused by a number of diseases, such as lack of exercise, obesity, prolonged excessive intake of salt, prolonged smoking or alcoholism, familial inheritance, and other diseases. The higher the blood pressure, the more laborious the heart is pushing the blood. If left uncontrolled, hypertension can lead to heart disease, cardiac hypertrophy, and heart failure; hypertension may bulge the vessel wall, presenting a weak point, making it more prone to blockage or bursting; vascular hypertension can cause blood to soak into the brain, resulting in stroke; hypertension may also lead to renal failure, blindness and cognitive dysfunction. Hypertension is the source of cardiovascular and cerebrovascular diseases, and controlling blood pressure is the basis for preventing other diseases.
The blood pressure of most patients with hypertension can be controlled at satisfactory level after the patients with hypertension are treated by antihypertensive drugs, and when the blood pressure is still above the target level or at least 4 antihypertensive drugs are needed to reach the standard after the patients with hypertension, of which 15% -20%, use 3 antihypertensive drugs (including diuretics) which are combined reasonably in sufficient quantity on the basis of improving life style, are called refractory hypertension (or refractory hypertension). These patients still cannot achieve the control of blood pressure to reach the standard after receiving normative antihypertensive treatment, and the risk of cardiovascular and cerebrovascular adverse events of the patients is several times that of common patients. In addition, patients suffering from refractory hypertension have survival times of not more than 5 years, so there is an urgent need to explore new blood pressure control methods.
The implanted baroreflex stimulation device is a novel method for treating refractory hypertension, is a popular research direction in the current medical field, and has wide clinical application prospect. Baroreceptors exist in carotid arteries and aortic adventitia, and receive mechanical tension signals from blood vessels, and the signals are transmitted into a bulbar solitary nucleus through nerves, and after cell replacement, the functions of the sympathetic and vagus nerves are regulated. When blood pressure rises in normal population, baroreceptor signals are enhanced, thereby inhibiting sympathetic nerve activity, up-regulating vagal nerve activity, down-regulating blood pressure by negative feedback through effects of slowing heart rate, heart contractility, vasodilation, natriuresis and the like; and arterial pressure reflex function in the hypertension group is reduced, so that the blood pressure can not be effectively and negatively regulated. The pressure reflection activation system utilizes the principle, and corrects arterial pressure reflection function of the hypertension group by human intervention, thereby achieving the effect of reducing blood pressure.
The therapeutic efficacy of implantable medical devices depends on the one hand on the positioning of the electrodes during surgery; on the other hand, effective collection and scientific analysis of post-operative patient signs are also critical factors. At present, an implantable nerve stimulator device generally adopts a control system, namely a single open-loop stimulation system, namely, the stimulation parameters are set in vitro according to clinical experience by doctors, the stimulation parameters of patients generally remain unchanged until the next medical treatment, and the open-loop stimulation mode cannot respond to the change of the illness state of the patients in time, so that the optimal treatment effect cannot be exerted, and a larger medical error is possibly caused. In addition, current implantable neurostimulator devices function more singly, and more simply by stimulating nerve tissue to reduce blood pressure, failing to sense cardiac electrical signals and/or pace the heart.
Disclosure of Invention
In view of the above, the present invention provides a neurostimulation system for pacing the heart, which greatly improves the safety and adaptivity of an implantable medical device, and has the functions of sensing the heart rate, adjusting the fully automatic output parameters, and controlling the heart rate in both directions.
In order to achieve the above purpose, the invention adopts the following technical scheme:
in a first aspect, the present invention provides a neurostimulation system for pacing a heart, comprising a neurostimulation subsystem and a pacing heart subsystem, wherein,
the nerve stimulating subsystem includes a first pulse generator, a first lead, and a first electrode, the nerve stimulating subsystem configured to collect an electrical signal of the first electrode, the first pulse generator configured to stimulate nerve tissue through the first electrode;
the pacing cardiac subsystem includes a second pulse generator, a second lead, and a second electrode, the pacing cardiac subsystem configured to acquire electrical signals of the second electrode, the second pulse generator configured to stimulate cardiac tissue through the second electrode.
In a preferred embodiment, the device further comprises an external wireless program control device which is in bidirectional wireless communication with the first pulse generator and the second pulse generator, and a display interface which is connected with the external wireless program control device.
In the present invention, when the number of the pulse generators is 2, the first pulse generator and the second pulse generator are substantially different pulse generators. When the number of pulse generators is 1, the neural stimulation subsystem and the pacing cardiac subsystem share the same pulse generator, then the first pulse generator and the second pulse generator are substantially the same pulse generator.
In the present invention, the interior of the pulse generator includes an integrated circuit comprising: other functional circuits such as a sign signal filter, a sense amplifier, an analog-to-digital converter, an embedded processor, a voltage/current output circuit, and the like.
In a preferred embodiment, the method comprises a preset parameter closed-loop control mode, wherein the preset parameter closed-loop control mode comprises the following steps:
when the pacing cardiac subsystem is not on,
the preset parameters are set by an external wireless program control instrument,
the electrical signal acquired by the first electrode is sensed,
comparing the electric signal acquired by the first electrode with preset parameters,
and determining whether to continue to stimulate the nerve tissue according to the comparison result.
In a preferred embodiment, the preset parameters include, but are not limited to, pulse frequency of the neural stimulation, pulse amplitude of the neural stimulation, pulse width of the neural stimulation, lower heart rate of the pacing heart, upper heart rate of the pacing heart, location of the first electrodes, number of the first electrodes, location of the second electrodes, and/or number of the second electrodes, etc.
In a more preferred embodiment, the neural stimulation has a lower heart rate of 60 beats/min. That is, when the electrical signal (such as heart rate signal) collected by the first electrode is less than 60 times/minute, the nerve tissue is stopped being stimulated; when the electrical signal (such as the heart rate signal) collected by the first electrode is higher than 60 times/minute, the nerve tissue is continuously stimulated.
When the pacing cardiac subsystem is turned on,
the preset parameters are set by an external wireless program control instrument,
the electrical signal collected by the second electrode is sensed,
comparing the electric signal acquired by the second electrode with preset parameters,
and determining whether to perform cardiac pacing according to the comparison result.
In a preferred embodiment, the preset parameters include, but are not limited to, pulse frequency of the neural stimulation, pulse amplitude of the neural stimulation, pulse width of the neural stimulation, lower heart rate of the pacing heart, upper heart rate of the pacing heart, location of the first electrodes, number of the first electrodes, location of the second electrodes, and/or number of the second electrodes, etc.
In a more preferred embodiment, the pacing heart has a lower limit heart rate of 60 beats/minute and an upper limit heart rate of 130 beats/minute. In one aspect, cardiac pacing is performed when the electrical signal (e.g., heart rate signal) acquired by the second electrode is less than 60 beats/minute; when the electrical signal (e.g., heart rate signal) acquired by the second electrode is greater than 60 beats/minute, no cardiac pacing is performed. On the other hand, when the electrical signal (such as the heart rate signal) acquired by the second electrode is higher than 130 times/min, cardiac pacing is not performed; when the electrical signal (e.g., heart rate signal) acquired by the second electrode is less than 130 beats/min, cardiac pacing is performed.
In a preferred embodiment, the method further comprises a fully automatic closed-loop control mode, wherein the fully automatic closed-loop control mode comprises:
the electrical signal acquired by the first electrode is sensed,
after processing by the embedded processor, automatically configuring appropriate nerve stimulation parameters,
and adjusting nerve stimulation parameters in time according to the electric signals collected by the first electrode.
In a more preferred embodiment, the fully automatic closed loop control mode includes:
the electrical signal collected by the second electrode is sensed,
after processing by the embedded processor, automatically configuring appropriate cardiac pacing parameters,
and timely adjusting the cardiac pacing parameters according to the electric signals acquired by the second electrode.
In a preferred embodiment, the electrical signal acquired by the first electrode comprises a heart rate signal.
In a preferred embodiment, the electrical signal acquired by the second electrode comprises a heart rate signal.
In a preferred embodiment, the preset parameter closed-loop control mode and the full-automatic closed-loop control mode are switched by an external wireless program control instrument.
In a preferred embodiment, the neurostimulation subsystem and the pacing cardiac subsystem may operate simultaneously or independently.
In a preferred embodiment, the pacing cardiac subsystem paces the heart using a VVI mode.
In the present invention, the VVI pacing mode refers to: the second electrode paces a ventricle, senses a self-ventricular signal, and inhibits the second electrode from giving out an impulse after the self-ventricular signal is sensed.
In a second aspect, there is provided the use of a neurostimulation system according to the invention for the treatment of hypertension.
In a preferred embodiment, the neurostimulation system comprises a neurostimulation subsystem and a pacing cardiac subsystem, wherein,
the nerve stimulating subsystem includes a first pulse generator, a first lead, and a first electrode, the nerve stimulating subsystem configured to collect an electrical signal of the first electrode, the first pulse generator configured to stimulate nerve tissue through the first electrode;
the pacing cardiac subsystem includes a second pulse generator, a second lead, and a second electrode, the pacing cardiac subsystem configured to acquire electrical signals of the second electrode, the second pulse generator configured to stimulate cardiac tissue through the second electrode.
In a preferred embodiment, the device further comprises an external wireless program control device which is in bidirectional wireless communication with the first pulse generator and the second pulse generator, and a display interface which is connected with the external wireless program control device.
In the present invention, when the number of the pulse generators is 2, the first pulse generator and the second pulse generator are substantially different pulse generators. When the number of pulse generators is 1, the neural stimulation subsystem and the pacing cardiac subsystem share the same pulse generator, then the first pulse generator and the second pulse generator are substantially the same pulse generator.
In the present invention, the interior of the pulse generator includes an integrated circuit comprising: other functional circuits such as a sign signal filter, a sense amplifier, an analog-to-digital converter, an embedded processor, a voltage/current output circuit, and the like.
In a preferred embodiment, the method comprises a preset parameter closed-loop control mode, wherein the preset parameter closed-loop control mode comprises the following steps:
when the pacing cardiac subsystem is not on,
the preset parameters are set by an external wireless program control instrument,
the electrical signal acquired by the first electrode is sensed,
comparing the electric signal acquired by the first electrode with preset parameters,
and determining whether to continue to stimulate the nerve tissue according to the comparison result.
In a preferred embodiment, the preset parameters include, but are not limited to, pulse frequency of the neural stimulation, pulse amplitude of the neural stimulation, pulse width of the neural stimulation, lower heart rate of the pacing heart, upper heart rate of the pacing heart, location of the first electrodes, number of the first electrodes, location of the second electrodes, and/or number of the second electrodes, etc.
In a more preferred embodiment, the neural stimulation has a lower heart rate of 60 beats/min. That is, when the electrical signal (such as heart rate signal) collected by the first electrode is less than 60 times/minute, the nerve tissue is stopped being stimulated; when the electrical signal (such as the heart rate signal) collected by the first electrode is higher than 60 times/minute, the nerve tissue is continuously stimulated.
When the pacing cardiac subsystem is turned on,
the preset parameters are set by an external wireless program control instrument,
the electrical signal collected by the second electrode is sensed,
comparing the electric signal acquired by the second electrode with preset parameters,
and determining whether to perform cardiac pacing according to the comparison result.
In a preferred embodiment, the preset parameters include, but are not limited to, pulse frequency of the neural stimulation, pulse amplitude of the neural stimulation, pulse width of the neural stimulation, lower heart rate of the pacing heart, upper heart rate of the pacing heart, location of the first electrodes, number of the first electrodes, location of the second electrodes, and/or number of the second electrodes, etc.
In a more preferred embodiment, the pacing heart has a lower limit heart rate of 60 beats/minute and an upper limit heart rate of 130 beats/minute. In one aspect, cardiac pacing is performed when the electrical signal (e.g., heart rate signal) acquired by the second electrode is less than 60 beats/minute; when the electrical signal (e.g., heart rate signal) acquired by the second electrode is greater than 60 beats/minute, no cardiac pacing is performed. On the other hand, when the electrical signal (such as the heart rate signal) acquired by the second electrode is higher than 130 times/min, cardiac pacing is not performed; when the electrical signal (e.g., heart rate signal) acquired by the second electrode is less than 130 beats/min, cardiac pacing is performed.
In a preferred embodiment, the method further comprises a fully automatic closed-loop control mode, wherein the fully automatic closed-loop control mode comprises:
the electrical signal acquired by the first electrode is sensed,
after processing by the embedded processor, automatically configuring appropriate nerve stimulation parameters,
and adjusting nerve stimulation parameters in time according to the electric signals collected by the first electrode.
In a more preferred embodiment, the fully automatic closed loop control mode includes:
the electrical signal collected by the second electrode is sensed,
after processing by the embedded processor, automatically configuring appropriate cardiac pacing parameters,
and timely adjusting the cardiac pacing parameters according to the electric signals acquired by the second electrode.
In a preferred embodiment, the electrical signal acquired by the first electrode comprises a heart rate signal.
In a preferred embodiment, the electrical signal acquired by the second electrode comprises a heart rate signal.
In a preferred embodiment, the preset parameter closed-loop control mode and the full-automatic closed-loop control mode are switched by an external wireless program control instrument.
In a preferred embodiment, the neurostimulation subsystem and the pacing cardiac subsystem may operate simultaneously or independently.
In a preferred embodiment, the pacing cardiac subsystem paces the heart using a VVI mode.
In the present invention, the VVI pacing mode refers to: the second electrode paces a ventricle, senses a self-ventricular signal, and inhibits the second electrode from giving out an impulse after the self-ventricular signal is sensed.
In a third aspect, there is provided a hypertension treatment system comprising a neurostimulation system according to the invention.
In a preferred embodiment, the neurostimulation system comprises a neurostimulation subsystem and a pacing cardiac subsystem, wherein,
the nerve stimulating subsystem includes a first pulse generator, a first lead, and a first electrode, the nerve stimulating subsystem configured to collect an electrical signal of the first electrode, the first pulse generator configured to stimulate nerve tissue through the first electrode;
the pacing cardiac subsystem includes a second pulse generator, a second lead, and a second electrode, the pacing cardiac subsystem configured to acquire electrical signals of the second electrode, the second pulse generator configured to stimulate cardiac tissue through the second electrode.
In a preferred embodiment, the device further comprises an external wireless program control device which is in bidirectional wireless communication with the first pulse generator and the second pulse generator, and a display interface which is connected with the external wireless program control device.
In the present invention, when the number of the pulse generators is 2, the first pulse generator and the second pulse generator are substantially different pulse generators. When the number of pulse generators is 1, the neural stimulation subsystem and the pacing cardiac subsystem share the same pulse generator, then the first pulse generator and the second pulse generator are substantially the same pulse generator.
In the present invention, the interior of the pulse generator includes an integrated circuit comprising: other functional circuits such as a sign signal filter, a sense amplifier, an analog-to-digital converter, an embedded processor, a voltage/current output circuit, and the like.
In a preferred embodiment, the method comprises a preset parameter closed-loop control mode, wherein the preset parameter closed-loop control mode comprises the following steps:
when the pacing cardiac subsystem is not on,
the preset parameters are set by an external wireless program control instrument,
the electrical signal acquired by the first electrode is sensed,
comparing the electric signal acquired by the first electrode with preset parameters,
and determining whether to continue to stimulate the nerve tissue according to the comparison result.
In a preferred embodiment, the preset parameters include, but are not limited to, pulse frequency of the neural stimulation, pulse amplitude of the neural stimulation, pulse width of the neural stimulation, lower heart rate of the pacing heart, upper heart rate of the pacing heart, location of the first electrodes, number of the first electrodes, location of the second electrodes, and/or number of the second electrodes, etc.
In a more preferred embodiment, the neural stimulation has a lower heart rate of 60 beats/min. That is, when the electrical signal (such as heart rate signal) collected by the first electrode is less than 60 times/minute, the nerve tissue is stopped being stimulated; when the electrical signal (such as the heart rate signal) collected by the first electrode is higher than 60 times/minute, the nerve tissue is continuously stimulated.
When the pacing cardiac subsystem is turned on,
the preset parameters are set by an external wireless program control instrument,
the electrical signal collected by the second electrode is sensed,
comparing the electric signal acquired by the second electrode with preset parameters,
and determining whether to perform cardiac pacing according to the comparison result.
In a preferred embodiment, the preset parameters include, but are not limited to, pulse frequency of the neural stimulation, pulse amplitude of the neural stimulation, pulse width of the neural stimulation, lower heart rate of the pacing heart, upper heart rate of the pacing heart, location of the first electrodes, number of the first electrodes, location of the second electrodes, and/or number of the second electrodes, etc.
In a more preferred embodiment, the pacing heart has a lower limit heart rate of 60 beats/minute and an upper limit heart rate of 130 beats/minute. In one aspect, cardiac pacing is performed when the electrical signal (e.g., heart rate signal) acquired by the second electrode is less than 60 beats/minute; when the electrical signal (e.g., heart rate signal) acquired by the second electrode is greater than 60 beats/minute, no cardiac pacing is performed. On the other hand, when the electrical signal (such as the heart rate signal) acquired by the second electrode is higher than 130 times/min, cardiac pacing is not performed; when the electrical signal (e.g., heart rate signal) acquired by the second electrode is less than 130 beats/min, cardiac pacing is performed.
In a preferred embodiment, the method further comprises a fully automatic closed-loop control mode, wherein the fully automatic closed-loop control mode comprises:
the electrical signal acquired by the first electrode is sensed,
after processing by the embedded processor, automatically configuring appropriate nerve stimulation parameters,
and adjusting nerve stimulation parameters in time according to the electric signals collected by the first electrode.
In a more preferred embodiment, the fully automatic closed loop control mode includes:
the electrical signal collected by the second electrode is sensed,
after processing by the embedded processor, automatically configuring appropriate cardiac pacing parameters,
and timely adjusting the cardiac pacing parameters according to the electric signals acquired by the second electrode.
In a preferred embodiment, the electrical signal acquired by the first electrode comprises a heart rate signal.
In a preferred embodiment, the electrical signal acquired by the second electrode comprises a heart rate signal.
In a preferred embodiment, the preset parameter closed-loop control mode and the full-automatic closed-loop control mode are switched by an external wireless program control instrument.
In a preferred embodiment, the neurostimulation subsystem and the pacing cardiac subsystem operate simultaneously or independently.
In a preferred embodiment, the pacing cardiac subsystem paces the heart using a VVI mode.
In the present invention, the VVI pacing mode refers to: the second electrode paces a ventricle, senses a self-ventricular signal, and inhibits the second electrode from giving out an impulse after the self-ventricular signal is sensed.
In a fourth aspect, a medical system is provided comprising a neurostimulation system according to the invention.
In a preferred embodiment, the neurostimulation system comprises a neurostimulation subsystem and a pacing cardiac subsystem, wherein,
the nerve stimulating subsystem includes a first pulse generator, a first lead, and a first electrode, the nerve stimulating subsystem configured to collect an electrical signal of the first electrode, the first pulse generator configured to stimulate nerve tissue through the first electrode;
the pacing cardiac subsystem includes a second pulse generator, a second lead, and a second electrode, the pacing cardiac subsystem configured to acquire electrical signals of the second electrode, the second pulse generator configured to stimulate cardiac tissue through the second electrode.
In a preferred embodiment, the device further comprises an external wireless program control device which is in bidirectional wireless communication with the first pulse generator and the second pulse generator, and a display interface which is connected with the external wireless program control device.
In the present invention, when the number of the pulse generators is 2, the first pulse generator and the second pulse generator are substantially different pulse generators. When the number of pulse generators is 1, the neural stimulation subsystem and the pacing cardiac subsystem share the same pulse generator, then the first pulse generator and the second pulse generator are substantially the same pulse generator.
In the present invention, the interior of the pulse generator includes an integrated circuit comprising: other functional circuits such as a sign signal filter, a sense amplifier, an analog-to-digital converter, an embedded processor, a voltage/current output circuit, and the like.
In a preferred embodiment, the method comprises a preset parameter closed-loop control mode, wherein the preset parameter closed-loop control mode comprises the following steps:
when the pacing cardiac subsystem is not on,
the preset parameters are set by an external wireless program control instrument,
the electrical signal acquired by the first electrode is sensed,
comparing the electric signal acquired by the first electrode with preset parameters,
and determining whether to continue to stimulate the nerve tissue according to the comparison result.
In a preferred embodiment, the preset parameters include, but are not limited to, pulse frequency of the neural stimulation, pulse amplitude of the neural stimulation, pulse width of the neural stimulation, lower heart rate of the pacing heart, upper heart rate of the pacing heart, location of the first electrodes, number of the first electrodes, location of the second electrodes, and/or number of the second electrodes, etc.
In a more preferred embodiment, the neural stimulation has a lower heart rate of 60 beats/min. That is, when the electrical signal (such as heart rate signal) collected by the first electrode is less than 60 times/minute, the nerve tissue is stopped being stimulated; when the electrical signal (such as the heart rate signal) collected by the first electrode is higher than 60 times/minute, the nerve tissue is continuously stimulated.
When the pacing cardiac subsystem is turned on,
the preset parameters are set by an external wireless program control instrument,
the electrical signal collected by the second electrode is sensed,
comparing the electric signal acquired by the second electrode with preset parameters,
and determining whether to perform cardiac pacing according to the comparison result.
In a preferred embodiment, the preset parameters include, but are not limited to, pulse frequency of the neural stimulation, pulse amplitude of the neural stimulation, pulse width of the neural stimulation, lower heart rate of the pacing heart, upper heart rate of the pacing heart, location of the first electrodes, number of the first electrodes, location of the second electrodes, and/or number of the second electrodes, etc.
In a more preferred embodiment, the pacing heart has a lower limit heart rate of 60 beats/minute and an upper limit heart rate of 130 beats/minute. In one aspect, cardiac pacing is performed when the electrical signal (e.g., heart rate signal) acquired by the second electrode is less than 60 beats/minute; when the electrical signal (e.g., heart rate signal) acquired by the second electrode is greater than 60 beats/minute, no cardiac pacing is performed. On the other hand, when the electrical signal (such as the heart rate signal) acquired by the second electrode is higher than 130 times/min, cardiac pacing is not performed; when the electrical signal (e.g., heart rate signal) acquired by the second electrode is less than 130 beats/min, cardiac pacing is performed.
In a preferred embodiment, the method further comprises a fully automatic closed-loop control mode, wherein the fully automatic closed-loop control mode comprises:
the electrical signal acquired by the first electrode is sensed,
after processing by the embedded processor, automatically configuring appropriate nerve stimulation parameters,
and adjusting nerve stimulation parameters in time according to the electric signals collected by the first electrode.
In a more preferred embodiment, the fully automatic closed loop control mode includes:
the electrical signal collected by the second electrode is sensed,
after processing by the embedded processor, automatically configuring appropriate cardiac pacing parameters,
and timely adjusting the cardiac pacing parameters according to the electric signals acquired by the second electrode.
In a preferred embodiment, the electrical signal acquired by the first electrode comprises a heart rate signal.
In a preferred embodiment, the electrical signal acquired by the second electrode comprises a heart rate signal.
In a preferred embodiment, the preset parameter closed-loop control mode and the full-automatic closed-loop control mode are switched by an external wireless program control instrument.
In a preferred embodiment, the neurostimulation subsystem and the pacing cardiac subsystem may operate simultaneously or independently.
In a preferred embodiment, the pacing cardiac subsystem paces the heart using a VVI mode.
In the present invention, the VVI pacing mode refers to: the second electrode paces a ventricle, senses a self-ventricular signal, and inhibits the second electrode from giving out an impulse after the self-ventricular signal is sensed.
In the present invention, the term "electrode" may refer to a conductor through which an electrical current enters or exits a nonmetallic medium. In some cases, the conductor may be substantially enclosed in an insulator with one or more contacts exposed to transmit or receive electrical current to the nonmetallic medium.
In the present invention, the term "wire" may refer to a conductor (metal or nonmetal) having a size of micrometer or less. The wire may have an unconstrained longitudinal dimension (or length) and a constrained transverse dimension (or diameter). Since the carotid sinus nerve is most closely spaced from other nerves, the diameter of the lead is preferably less than 1.5mm, and more preferably less than 1 mm. In some cases, each lead includes at least two electrodes, e.g., each lead may include 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, or more electrodes. Two or more electrodes may be implanted within the nerve. For example, the nerve may be the carotid sinus nerve, the glossopharyngeal nerve, or other nerve that includes one or more fibers that control blood pressure. For multiple electrodes, the inter-electrode distance is preferably approximately 0.5mm to locate small areas of tissue.
In the present invention, the term "nerve" may refer to a cell that uses electrical and chemical signals to transmit information. In some cases, the term "nerve" may be used to refer to one or more components of the peripheral nervous system.
Compared with the prior art, the invention has the beneficial effects that:
the invention provides a nerve stimulation system for pacing heart, which is used as a novel control system with a nerve stimulation subsystem and a pacing heart subsystem, has the function of a nerve stimulation instrument and is used for treating refractory hypertension; but also has the function of a cardiac pacemaker for cardiac pacing and cardiac sensing.
During the continuous rising of blood pressure, the sensitivity of carotid sinus baroreceptors is reduced, the regulation function of the carotid sinus baroreceptors is gradually weakened or even eliminated, and the carotid sinus baroreceptors can be activated to play a role in reducing blood pressure. The nerve stimulating subsystem in the nerve stimulating system stimulates carotid sinus nerve through electric pulse, activates carotid sinus baroreceptors, and transmits the excitation to the brain, so that the reflex causes the enhancement of the excitability of the vagus nerve, and the reduction of heart beat, heart rate drop, myocardial contraction force and peripheral vascular dilation are caused, thereby playing a role in reducing blood pressure. However, continuous decrease in heart rate causes decrease in heart ejection volume, which leads to insufficient blood supply to vital organs of the whole body, wherein brain and heart are the most sensitive to insufficient blood supply, and damage such as insufficient blood supply to brain and insufficient blood supply to heart may be caused. Therefore, the invention collects the heart rate signal while reducing the blood pressure, and stops stimulating the carotid sinus baroreceptors if the collected heart rate signal is lower than the preset parameters.
The pacing heart subsystem in the nerve stimulation system stimulates heart tissues through electric pulses, and adopts a VVI pacing working mode to control heart rate. The modes of operation of the pacing cardiac subsystem include ventricular pacing and ventricular sensing. The sensing module collects heart rate signals or other related signals, and after processing in the embedded processor, changes the output of the pacing pulses. This control is also known as R-wave inhibited ventricular pacing or ventricular on demand pacing. Pacing control delivers pacing pulses only when "needed".
The nerve stimulation system for pacing the heart greatly improves the safety and the self-adaptability of the implanted medical equipment, particularly the nerve stimulation instrument, and has the functions of sensing the heart rate, adjusting the full-automatic output parameters and controlling the heart rate bidirectionally while reducing the blood pressure.
Drawings
The invention will be further described with reference to the accompanying drawings and detailed description.
FIG. 1 is a schematic diagram of an implantable pulse generator for treating a hypertensive disorder in accordance with one embodiment of the present invention;
FIG. 2 is a closed loop control flow diagram according to one embodiment of the invention;
FIG. 3 is a control flow diagram of an embedded processor according to one embodiment of the invention;
FIG. 4A is a timing diagram of one control of the present invention in the treatment of hypertension;
fig. 4B is a timing diagram of another control of the present invention in treating hypertension.
Reference numerals:
110: a pulse generator; 120: a first wire; 120 , : a second wire; 121: a first electrode; 121,: a second electrode; 130: a heart rate signal; 140: carotid sinus nerve; 150: displaying an interface; 151: electromagnetic waves; 152: an external wireless program control instrument; 153: a data serial port;
200: an analog switch; 210: a signal filter; 220: a sense amplifier; 230: an analog-to-digital converter; 240: an embedded processor; 250: a voltage/current output circuit;
300: a perception module; 320: and presetting parameters.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. The following description of at least one exemplary embodiment is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
In the description of the present invention, unless specifically stated otherwise, the relative arrangement of parts and steps, numerical expressions and numerical values set forth in these embodiments do not limit the scope of the present invention. Meanwhile, it should be understood that the sizes of the respective parts shown in the drawings are not drawn in actual scale for convenience of description. Techniques, methods, and apparatus known to one of ordinary skill in the relevant art may not be discussed in detail, but should be considered part of the authorization specification where appropriate. In all examples shown and discussed herein, any specific values should be construed as merely illustrative, and not a limitation. Thus, other examples of the exemplary embodiments may have different values. It should be noted that: like reference numerals and letters denote like items in the following figures, and thus once an item is defined in one figure, no further discussion thereof is necessary in subsequent figures.
In describing the present invention, spatially relative terms such as "above … …," "above … …," "upper surface at … …," "above," and the like may be used herein for ease of description to describe one device or feature's spatial positional relationship to another device or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "above" or "over" other devices or structures would then be oriented "below" or "beneath" the other devices or structures. Thus, the exemplary term "above … …" may include both orientations of "above … …" and "below … …". The device may also be positioned in other different ways (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
In the description of the present invention, unless otherwise indicated, the meaning of "a plurality" is two or more. For example, a plurality of electrodes refers to two electrodes or more than two electrodes; the terms "upper," "lower," "left," "right," "front," "rear," "inner," "outer," "vertical," "horizontal," "leading," "trailing," and the like are used for convenience in describing and simplifying the description based on the orientation or positional relationship shown in the drawings, and do not denote or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be construed as limiting the invention. Furthermore, the terms "first," "second," "third," "fourth," and the like are used merely to distinguish between a plurality of similar elements and are not intended to represent any difference in importance or order among the elements; moreover, the terms "first," "second," "third," "fourth," and the like are used for descriptive purposes only and are not to be construed as indicating or implying an implicit indication of the number of features indicated; thus, a feature defining "a first", "a second", "a third", "a fourth", etc. may explicitly or implicitly include one or more such feature.
In the description of the present invention, it should be noted that, unless explicitly specified and limited otherwise, the terms "connected," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
It should be appreciated that reference throughout this specification to "one embodiment," "an embodiment," or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of the phrases "in one embodiment," "in an embodiment," or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
Referring to fig. 1, a schematic diagram of an application in an implantable pulse generator for treating a hypertensive disorder in accordance with one embodiment of the present invention is shown; referring to FIG. 2, a closed loop control flow diagram is shown according to one embodiment of the present invention; referring to FIG. 3, a control flow diagram of an embedded processor is shown, according to one embodiment of the invention; referring to fig. 4A, there is shown a control timing diagram of the present invention as applied in the treatment of hypertensive disorders; referring to fig. 4B, another control timing diagram of the present invention is shown as applied in the treatment of hypertensive disorders.
As shown in fig. 1, a neurostimulation system for pacing a heart includes a neurostimulation subsystem and a pacing heart subsystem, wherein,
the nerve stimulation subsystem includes a first pulse generator, a first lead 120, and a first electrode 121, the nerve stimulation subsystem configured to collect electrical signals of the first electrode 121, the first pulse generator configured to stimulate nerve tissue through the first electrode 121. In an embodiment of the present invention, the first pulse generator is preferably (but not necessarily) implanted in the subcutaneous tissue pocket near the right axilla, the first lead 120 is tunneled subcutaneously to the cervical right carotid sinus nerve, and the first electrode 121 is secured to the carotid sinus nerve 140.
The pacing cardiac subsystem includes a second pulse generator, a second lead 120, and a second electrode 121, the pacing cardiac subsystem being configured to acquire an electrical signal, such as a heart rate signal 130, of the second electrode 121, the second pulse generator being configured to stimulate cardiac tissue through the second electrode 121.
The neurostimulation system for pacing the heart further includes an external wireless programmer 152 in bi-directional wireless communication with the first pulse generator and the second pulse generator, and a display interface 150 coupled to the external wireless programmer 152. In an embodiment of the present invention, the number of pulse generators is 1, the nerve stimulating subsystem and the pacing heart subsystem share the same pulse generator, and the first pulse generator and the second pulse generator are substantially the same pulse generator 110. The pulse generator 110 can convert the collected electric signals into electromagnetic waves 151 through an internal wireless communication module and send the electromagnetic waves 151 to the external wireless program control instrument 152, the external wireless program control instrument 152 is connected with the display interface 150 through a data serial port 153, wifi, bluetooth and other modes, and finally the collected electric signals are displayed and/or stored in the display interface, so that a doctor or a researcher can conveniently perform the next operation.
In the case of electrical stimulation therapy, the first electrode 121 is connected to the pulse generator 110 by a first lead 120. The pulse generator 110 comprises electronic components that generate electrical stimulation pulses that are transmitted via the first lead 120 to the first electrode 121, thereby stimulating the associated nerve surrounding the first electrode 121 for the treatment of hypertensive disorders. Meanwhile, the pulse generator 110 transmits an electrical stimulation signal to the second electrode 121 through the second wire 120, thereby stimulating heart tissue and achieving the VVI synchronous cardiac pacing function.
As shown in fig. 2, the pulse generator 110 internally includes an integrated circuit including: signal filter 210, sense amplifier 220, analog to digital converter 230, embedded processor 240, voltage/current output circuit 250, and other functional circuits.
As shown in fig. 2, the embedded processor 240 controls the analog switch 200 to select an appropriate electrode (the first electrode 121 or the second electrode 121 ’ ) Collecting heart rate signal, passing through signal filter 210, and entering sense amplifier 220 to make first electrode 121 or second electrode 121 ’ And amplifying the collected high-frequency filtered signals. Because the collected heart rate signals are very weak, the heart rate signals need to be amplified firstly and then enter a low-pass filter to filter high-frequency noise so as to obtain a clear signal, and then enter the high-pass filter to transmit alternating current signals; the processed signals are sent to an analog-digital converter 230 to be converted into digital signals, and then the digital signals are sent to an embedded processor 240 to be processed; finally, the embedded processor 240 generates specific parameters (pulse width, amplitude, frequency) according to the built-in algorithm, and transmits the voltage/current pulse stimulus to the first electrode 121 or the second electrode 121 through the voltage/current output circuit 250 ’ Stimulating the corresponding target spot.
Both the neurostimulation subsystem and the pacing cardiac subsystem in the neurostimulation system for pacing the heart employ the closed-loop control flow illustrated in fig. 2. The 2 closed-loop control flows can work simultaneously or only one of the two closed-loop control flows can be selected. The electrode analog switch 200 is controlled according to the built-in algorithm, and the positions and the number of the electrodes are selected. In embodiments of the present invention, single electrode, dual electrode, or multiple electrode modes may be employed. If a single electrode is used, the electrode array is used as a neutral electrode, and only one of the nerve stimulation subsystem and the pacing heart subsystem can work; if a double electrode is used, one electrode in the electrode array is used as an anode, and the other electrode in the electrode array is used as a cathode, 2 electrodes can be arranged to stimulate nerve tissue, one electrode can be used for stimulating nerve tissue, and one electrode can be used for pacing the heart; if multi-electrode stimulation is used, the multi-electrode is used as an anode, the multi-electrode is used as a cathode, and the nerve stimulating subsystem and the pacing heart subsystem can be independently arranged according to the needs of patients.
In an embodiment of the present invention, a neural stimulation system for pacing a heart includes a preset parameter closed-loop control mode, the preset parameter closed-loop control mode including:
When the pacing cardiac subsystem is not on,
preset parameters are set by the external wireless programmer 152,
the electrical signal acquired by the first electrode 121 is sensed,
the electrical signal acquired by the first electrode 121 is compared with a preset parameter,
and determining whether to continue to stimulate the nerve tissue according to the comparison result.
In an embodiment of the present invention, the preset parameters include, but are not limited to, pulse frequency of the neural stimulation, pulse amplitude of the neural stimulation, pulse width of the neural stimulation, lower heart rate of the pacing heart, upper heart rate of the pacing heart, positions of the first electrodes, number of the first electrodes, positions of the second electrodes, and/or number of the second electrodes, etc.
In the present embodiment, the lower limit heart rate for neural stimulation is 60 beats/min. That is, when the electrical signal (e.g., heart rate signal) collected by the first electrode 121 is less than 60 times/minute, the nerve tissue is stopped being stimulated; when the electrical signal (e.g., heart rate signal) collected by the first electrode 121 is higher than 60 times/minute, the nerve tissue is continuously stimulated.
When the pacing cardiac subsystem is turned on,
acquiring preset parameters set by the external wireless programmer 152,
the sensing of the second electrode 121, the acquired electrical signal,
The second electrode 121, the collected electrical signal is compared with a preset parameter,
and determining whether to perform cardiac pacing according to the comparison result.
In an embodiment of the present invention, the preset parameters include, but are not limited to, pulse frequency of the neural stimulation, pulse amplitude of the neural stimulation, pulse width of the neural stimulation, lower heart rate of the pacing heart, upper heart rate of the pacing heart, positions of the first electrodes, number of the first electrodes, positions of the second electrodes, and/or number of the second electrodes, etc.
In the embodiment of the invention, the lower limit heart rate of the pacing heart is 60 times/min, and the upper limit heart rate of the pacing heart is 130 times/min. In one aspect, cardiac pacing is performed when the second electrode 121 acquires an electrical signal (e.g., heart rate signal) less than 60 beats/minute; when the second electrode 121, the acquired electrical signal (e.g., heart rate signal) is higher than 60 beats/min, no cardiac pacing is performed. On the other hand, when the second electrode 121 is used for collecting electric signals (such as heart rate signals) higher than 130 times/min, cardiac pacing is not performed; when the second electrode 121, the acquired electrical signal (e.g., heart rate signal) is less than 130 beats/minute, cardiac pacing is performed.
In an embodiment of the present invention, the neural stimulation system for pacing the heart further comprises a fully automatic closed-loop control mode, the fully automatic closed-loop control mode comprising:
The electrical signal acquired by the first electrode 121 is sensed,
after processing by the embedded processor, automatically configuring appropriate nerve stimulation parameters,
the nerve stimulation parameters are adjusted in time according to the electrical signals collected by the first electrode 121.
In an embodiment of the present invention, the full-automatic closed-loop control mode includes:
the sensing of the second electrode 121, the acquired electrical signal,
after processing by the embedded processor, automatically configuring appropriate cardiac pacing parameters,
the cardiac pacing parameters are adjusted in time based on the acquired electrical signals from the second electrode 121.
In an embodiment of the invention, the electrical signal collected by the first electrode 121 comprises a heart rate signal, and the electrical signal collected by the second electrode 121 comprises a heart rate signal.
In embodiments of the present invention, the neurostimulation subsystem and the pacing heart subsystem may operate simultaneously or independently, wherein the pacing heart subsystem paces the heart using a VVI mode. The VVI pacing mode refers to: the second electrode 121 paces the heart chamber and senses a self-ventricular signal, which after sensed inhibits the second electrode from delivering an impulse.
In the embodiment of the invention, the preset parameter closed-loop control mode and the full-automatic closed-loop control mode are switched by an external wireless program control instrument.
In fig. 3, the physical parameter is a heart rate signal.
As shown in fig. 3, the preset parameter closed-loop control mode is:
the clinician selects appropriate parameters such as pulse frequency of neural stimulation, pulse amplitude of neural stimulation, pulse width of neural stimulation, lower limit heart rate g1 of neural stimulation, lower limit heart rate g2 of pacing heart, upper limit heart rate g3 of pacing heart, position of first electrode, number of first electrodes, position of second electrode, number of second electrodes, etc. according to the test data in vitro through the display interface 150, and then sends the parameters to the register of the pulse generator through the electromagnetic wave 151, and preset parameters 320 are set first. The clinician then turns on the pulse generator and the integrated circuit outputs stimulation pulses to the first electrode 121 in accordance with the set preset parameters 320, acting at the carotid sinus nerve 140. Meanwhile, the sensing module 300 senses the heart rate signal collected by the first electrode 121, compares the heart rate signal collected by the first electrode 121 with the lower limit heart rate g1 (i.e., the preset value g 1) of the nerve stimulation, and stops the stimulation (i.e., stops stimulating the nerve tissue) if the heart rate signal collected by the first electrode 121 is lower than the lower limit heart rate g1 of the nerve stimulation; if the heart rate signal acquired by the first electrode 121 is higher than the lower limit rate g1 of neural stimulation, a stimulation pulse is output (i.e., the neural tissue continues to be stimulated).
When the pacing heart subsystem is started, the sensing module 300 senses the second electrode 121, and the collected heart rate signal enters the embedded processor, so that on one hand, the second electrode 121 is monitored, whether the collected heart rate signal is lower than the lower limit rate g2 of the pacing heart (namely, a preset value g 2) or not is monitored, and if the collected heart rate signal is lower than the preset value g2, the heart pacing function is started, and pacing pulses are output (namely, the heart pacing pulses are output); conversely, cardiac pacing function is not turned on (i.e., pacing is stopped); on the other hand, the second electrode 121 is monitored simultaneously, whether the collected heart rate signal is lower than the upper limit rate g3 (i.e. a preset value g 3) of the pacing heart, if the collected heart rate signal is lower than the preset value g3, the heart pacing function is started, and pacing pulses are output (i.e. the heart pacing pulses are output); otherwise, cardiac pacing function is not turned on (i.e., pacing is stopped).
With this closed loop feedback control of the patient, the clinician needs to set appropriate configuration parameters based on the acquired heart rate signals and experience before implantation of the neurostimulation system for pacing the heart, and then the pulse generator 110 always performs closed loop negative feedback with fixed parameters.
As shown in fig. 3, the fully automatic closed-loop control mode is:
without the intervention of a clinician or patient, the pulse generator automatically adjusts the parameters of the stimulus according to the sensing module 300 in accordance with the embedded processor. After the neural stimulation system for pacing the heart is implanted, the sensing module 300 acquires the heart rate signal through the first electrode 121, processes the heart rate signal, and then enters the embedded processor to calculate a proper output parameter, and configures the proper output parameter into a register. The output module outputs the stimulating pulse to the first electrode 121 according to the requirement, and the heart rate signal enters the embedded processor through the first electrode 121 to timely adjust the nerve stimulating parameters. Likewise, after implantation of the neurostimulation system for pacing the heart, the sensing module 300 passes through the second electrode 121 ’ And collecting heart rate signals, processing the heart rate signals, then entering an embedded processor to calculate proper output parameters, and configuring the output parameters into a register. The output module outputs pacing pulses to the second electrode 121 as needed ’ At the same time, the heart rate signal passes through the second electrode 121 ’ And (5) entering an embedded processor to timely adjust the cardiac pacing parameters.
The full-automatic closed-loop control mode of the invention not only plays a role in closed-loop monitoring treatment effect, but also adjusts nerve stimulation parameters and/or cardiac pacing parameters in time according to the condition of a patient, thereby realizing optimization of the treatment effect, increasing the response to the sudden condition of the patient and improving the safety of a nerve stimulation system for pacing the heart. By adopting the full-automatic closed-loop control mode, patients do not need to go to a hospital frequently to modify the configuration, and the times of postoperative follow-up are saved.
Fig. 4A is a control timing diagram of the present invention applied in treating hypertension, if the corresponding collected physical parameter is the heart rate signal 130, the neural stimulation output and the pulse frequency are synchronously controlled. t1 is the refractory period after the sensing module 300 detects the heart rate signal, and the time from the first input pulse of the sensing module 300 is counted, and the neural stimulation is not output in t1, which is generally a fixed time. And after the t1 time is finished, the nerve stimulation is output, the t2 time is continuously stimulated, the t2 time is nerve stimulation duration time, the t2 time is not fixed time, the change of the heart rate signal is timely changed along with the change of the heart rate signal, the t2 time is correspondingly shortened when the heart rate obtained according to the built-in algorithm is higher, and the t2 time is correspondingly lengthened when the heart rate obtained according to the built-in algorithm is lower. t3 is the listening time, at which stage neural stimulation is stopped, waiting for the heart rate signal to be received. the time t3 is affected by both the patient's real-time heart rate and the lower limit heart rate g2 of the paced heart. This timing control ensures that there is a neural stimulation pulse output for each heart rate interval. the time t2 and t3 are not fixed and are influenced by preset parameters and sensing feedback signals.
FIG. 4B is a timing diagram of another control sequence for controlling nerve stimulation output and pulse rate asynchronously in treating hypertension according to the present invention. t4 is the neural stimulation output duration during which the heart rate signal is not monitored. After t4 is finished, a t5 monitoring phase is entered, in which the heart rate signal 130 is monitored, and an average value is calculated after a plurality of heart rate signals are continuously monitored.
It is to be understood that this invention is not limited to the particular methodology, protocols, and materials described, as these may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention which will be limited only by the appended claims.
Those skilled in the art will also recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are also encompassed by the appended claims. It should be noted that, in the present specification, each embodiment is described in a progressive manner, and each embodiment is mainly described as different from other embodiments, and identical and similar parts between the embodiments are all enough to be referred to each other.
While alternative embodiments of the present invention have been described, additional variations and modifications in those embodiments may occur to those skilled in the art once they learn of the basic inventive concepts. It is therefore intended that the following appended claims be interpreted as including alternative embodiments and all such alterations and modifications as fall within the scope of the embodiments of the invention.
Finally, it is also noted that in the present invention, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that an article or terminal that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such article or terminal. Without further limitation, an element defined by the phrase "comprising one … …" does not exclude that an additional identical element is present in an article or terminal device comprising the element.
While the foregoing has been described in some detail by way of illustration of the principles and embodiments of the invention, and while in accordance with the principles and implementations of the invention, those skilled in the art will readily recognize that the invention is not limited thereto.
Claims (10)
1. A neural stimulation system for pacing a heart, comprising a neural stimulation subsystem and a pacing heart subsystem, wherein,
the nerve stimulating subsystem includes a first pulse generator, a first lead, and a first electrode, the nerve stimulating subsystem configured to collect an electrical signal of the first electrode, the first pulse generator configured to stimulate nerve tissue through the first electrode;
the pacing cardiac subsystem includes a second pulse generator, a second lead, and a second electrode, the pacing cardiac subsystem configured to acquire electrical signals of the second electrode, the second pulse generator configured to stimulate cardiac tissue through the second electrode.
2. The neurostimulation system of claim 1, further comprising an external wireless programmer in two-way wireless communication with the first pulse generator and the second pulse generator, a display interface coupled to the external wireless programmer.
3. The neurostimulation system of claim 1, wherein the neurostimulation subsystem and the pacing cardiac subsystem are operable simultaneously or independently.
4. A neural stimulation system according to claim 3, comprising a preset parameter closed loop control mode comprising:
When the pacing cardiac subsystem is not on,
the preset parameters are set by an external wireless program control instrument,
the electrical signal acquired by the first electrode is sensed,
comparing the electric signal acquired by the first electrode with preset parameters,
determining whether to continue stimulating the neural tissue according to the comparison result;
when the pacing cardiac subsystem is turned on,
the preset parameters are set by an external wireless program control instrument,
the electrical signal collected by the second electrode is sensed,
comparing the electric signal acquired by the second electrode with preset parameters,
and determining whether to perform cardiac pacing according to the comparison result.
5. The neurostimulation system of claim 4, further comprising a fully automatic closed-loop control mode, said fully automatic closed-loop control mode comprising:
the electrical signal acquired by the first electrode is sensed,
after processing by the embedded processor, automatically configuring appropriate nerve stimulation parameters,
timely adjusting nerve stimulation parameters according to the electric signals collected by the first electrode;
preferably, the fully automatic closed-loop control mode includes:
the electrical signal collected by the second electrode is sensed,
after processing by the embedded processor, automatically configuring appropriate cardiac pacing parameters,
and timely adjusting the cardiac pacing parameters according to the electric signals acquired by the second electrode.
6. The neurostimulation system of claim 5, wherein the pre-set parameter closed-loop control mode and the fully automatic closed-loop control mode are switched by an in vitro wireless programmer.
7. The neurostimulation system of claim 1, wherein the pacing heart subsystem paces the heart using VVI mode.
8. Use of the neurostimulation system of any one of claims 1-7 for treating hypertension.
9. A hypertension treatment system comprising the neurostimulation system of any one of claims 1-7.
10. A medical system comprising the neurostimulation system of any one of claims 1-7.
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| CN202310553826.XA CN116832322A (en) | 2023-05-16 | 2023-05-16 | Nerve stimulation system for pacing heart |
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| CN202310553826.XA CN116832322A (en) | 2023-05-16 | 2023-05-16 | Nerve stimulation system for pacing heart |
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| CN116832322A true CN116832322A (en) | 2023-10-03 |
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Effective date of registration: 20240325 Address after: Room 002, B901, Block B, Operation and Maintenance International Headquarters Building, 501 East Chang'an Street, National Civil Aerospace Industry Base, Xi'an City, Shaanxi Province, 710100 Applicant after: Tianhua Medical Devices (Xi'an) Co.,Ltd. Country or region after: China Address before: 710000 Room 002, B901, Block B, Operation and Maintenance International Headquarters Building, 501 East Chang'an Avenue, Xi'an National Civil Aerospace Industrial Base, Shaanxi Province Applicant before: Xi'an Dunbo Medical Equipment Co.,Ltd. Country or region before: China |