CN111870810A - Carotid sinus baroreceptor stimulation device - Google Patents
Carotid sinus baroreceptor stimulation device Download PDFInfo
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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
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
-
- 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
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36114—Cardiac control, e.g. by vagal stimulation
- A61N1/36117—Cardiac control, e.g. by vagal stimulation for treating hypertension
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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
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
- A61N1/36135—Control systems using physiological parameters
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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- Heart & Thoracic Surgery (AREA)
- Electrotherapy Devices (AREA)
Abstract
The invention relates to a carotid sinus baroreceptor stimulation device, which comprises an electrode tip, an internal control system and an external control system, wherein the electrode tip is wrapped on the outer wall of a carotid sinus blood vessel; the electrode tip includes an activation device that delivers electrical stimulation to activate carotid sinus baroreceptors and a sensing device that monitors the heart rate and blood pressure of the subject by sensing the stretching and beating of the vessel wall; the internal control system is implanted subcutaneously, and the internal control system is connected with the sensing device and the activation device; the internal control system compares the heart rate and blood pressure detected by the sensing device to predetermined thresholds, and the internal control system decides whether to deliver a stimulus or change the stimulus voltage of the activation device based on the results of the comparison. The present invention modulates blood pressure, autonomic nervous system activity and neurohormonal secretion by selectively activating baroreceptors to minimize adverse effects on the heart, vasculature and other organ tissues.
Description
Technical Field
The invention relates to the field of medical appliances, in particular to a carotid sinus baroreceptor stimulation device.
Background
In published PCT application No. WO 02/026314, direct activation of baroreceptors is described to induce changes in the baroreflex system to control blood pressure. US patent 6073048A discloses a baroreflex system adjustment method that stimulates a baroreflex arc based on various cardiovascular and pulmonary parameters. The existing implantable medical device, BAROSTIM NEO, for treating heart failure and hypertension adopts the CVRx patent technology, activates a baroreceptor through micro-current, induces the change of a baroreflex system, helps a human body to recover the natural mechanism of cardiovascular regulation so as to treat chronic heart failure and hypertension, and can reduce sympathetic nerve activity, increase parasympathetic nerve activity and finally recover autonomic nervous system balance. Activated baroreceptors are present in the carotid sinus, a structure located at the bifurcation of the common carotid artery, which contains stretch receptors (baroreceptors) that are sensitive to blood pressure, and in the aortic arch. The receptor receptors signal the brain via the carotid sinus nerve and the brain regulates the cardiovascular system through activation of the sympathetic nervous system to maintain normal blood pressure. However, the stimulation mode of the device is a constant voltage continuous stimulation blood pressure reflex system, the stimulation mode cannot be changed according to the specific situation of a patient, and the high voltage required by nerve stimulation may damage the carotid sinus nerve, may increase the occurrence rate of hypotension events and may increase the blood pressure of the patient. For example, a patient may be experiencing periods of reduced blood pressure or hypotension, and the device is still delivering current to stimulate baroreceptors, resulting in hypotension in the patient.
Disclosure of Invention
The technical problem to be solved by the present invention is to provide a carotid sinus baroreceptor stimulation device that regulates blood pressure, autonomic nervous system activity, and neurohormonal secretion by selectively activating baroreceptors to minimize their adverse effects on the heart, vasculature, and other organ tissues.
The technical scheme adopted by the invention for solving the technical problems is as follows: constructing a carotid sinus baroreceptor stimulation device, an electrode tip, an internal control system and an external control system, wherein the electrode tip is wrapped on the outer wall of a carotid sinus blood vessel; the electrode tip includes an activation device that delivers electrical stimulation to activate carotid sinus baroreceptors and a sensing device that monitors the heart rate and blood pressure of the subject by sensing the stretching and beating of the vessel wall; the internal control system is implanted subcutaneously, and the internal control system is connected with the sensing device and the activation device; the internal control system compares the heart rate and blood pressure detected by the sensing device with predetermined thresholds, and the internal control system decides whether to deliver stimulation or change the stimulation voltage of the activation device based on the result of the comparison; the external control system is connected with the internal control system and controls the stimulation voltage of the activation device through the external control system.
In the above scheme, the activation device is a metal electrode plate, and the activation device conducts the micro-current of stimulation sent by the internal control system to the blood vessel wall around the carotid sinus and activates the baroreceptor of the carotid sinus.
In the scheme, the sensing device is a net-shaped structure wrapped outside the blood vessel wall, the surface of the sensing device is insulated and has biocompatibility, and metal wires are embedded in the net-shaped structure and connected with an internal control system; when blood pressure changes, the blood vessels deform slightly, which leads to deformation of the net structure outside the blood vessel wall, and the metal wires change slightly in length, and the change of the small amount of metal wires is converted into the change of micro-current.
In the above scheme, the electrode head further comprises a fixer fixed on the outer surface of the blood vessel wall through medical soft tissue adhesive, the fixer is made of an insulating soft material with biocompatibility, and the fixer, the activation device and the sensing device are integrally formed.
In the above scheme, the internal control system includes a control module, a processor, a memory and a power supply module, the processor is connected to the sensing device, the processor determines whether to modify the operation of the control module according to data detected by the sensing device and by combining an operation profile, the operation profile includes a low-voltage neural stimulation algorithm, a high-voltage neural stimulation algorithm, a medium-voltage neural stimulation algorithm, a daytime neural stimulation algorithm and a nighttime neural stimulation algorithm, and the operation profile is stored in the memory.
In the above scheme, the control module comprises a controller, a system state detection device, a temperature detection circuit and a bluetooth communication device; the processor comprises a stimulation signal generating circuit, a stimulation signal feedback circuit and a driver; the power supply module comprises a battery, a power supply management system, a wireless charging management system and a wireless energy receiving system; the internal control system is charged in a wireless charging mode and is connected with the external control system through the Bluetooth communication equipment, and interactive control is achieved.
In the above scheme, the external control system comprises a display, a stimulation voltage regulator, a stimulation frequency regulator, a power supply start fingerprint identification button and a buzzer, wherein the display displays real-time blood pressure and heart rate of a subject, and the working state and stimulation parameters of the current stimulation instrument, the stimulation voltage regulator regulates the stimulation voltage delivered by the activation device, and the stimulation frequency regulator regulates the duration and interval time of the delivery of stimulation.
The carotid sinus baroreceptor stimulation device has the following beneficial effects:
the invention sends corresponding electrical stimulation by sensing the change of the blood pressure and the heart rate of the patient, induces the change of the baroreceptor signal to control the output of the sympathetic nerve signal, and further changes the blood pressure, the heart rate, the cardiac output, the autonomic nervous system activity and the neurohormonal secretion. The baroreceptor activating devices are located in the left or right carotid sinus, near the common carotid bifurcation, and for purposes of the present invention, these receptors can be activated as long as they provide the desired effect. These receptors will provide afferent signals, i.e. blood pressure and heart rate information to the brain, causing the brain to induce changes in the baroreflex system, thereby modulating organ activity to maintain the desired hemodynamics and organ perfusion. Baroreceptor activation devices include a variety of devices that use mechanical, electrical, chemical, biological, or other means to activate baroreceptors. Baroreceptors can be activated directly or indirectly through adjacent vascular tissue. The present invention utilizes electrical stimulation to activate baroreceptors, the baroreceptor activation device being located outside the vessel wall. The electrode tip of the present invention is adapted to wrap around the carotid sinus and the design minimizes irritation to tissue outside the blood vessel.
The present invention utilizes a control system to generate control signals that modulate a baroreceptor activation device. The control system may operate in an open or closed loop mode, preferably with a stimulation regime selected to promote long term efficacy and minimize energy requirements. For example, in the open loop mode, the patient or physician may remotely interface with the control system to adjust the control signal. In the closed loop mode, the control signal may be adjusted based on feedback information from the blood pressure and heart rate sensors, wherein the preset algorithm defining the regimen of administering stimulation may be determined by a programmed algorithm. Theoretically, uninterrupted activation of baroreceptors may result in reduced sensitivity of the baroreceptors or baroreflex system, thereby reducing the effectiveness of the treatment. Thus, different stimulation protocols may be selected to tune the baroreceptor activation device to ensure that the baroreceptors and baroreflex system respond in time to the stimulation. In order to solve the problems of low blood pressure and other conditions needing to increase blood pressure, the invention provides a heart rate and blood pressure sensing device which can selectively activate a pressure sensor signal according to the self blood pressure and heart rate of a patient, thereby preventing the blood pressure or the heart rate from being too low, and reducing the occurrence condition related to the low blood pressure.
Drawings
The invention will be further described with reference to the accompanying drawings and examples, in which:
FIG. 1 is a schematic view of the installed positions of an electrode head and an internal control system in the upper torso of a human body;
FIG. 2 is a schematic view of the electrode head wrapped around the underside of the bifurcation of the internal and external carotid arteries;
FIG. 3 is a schematic view of the electrode head structure;
FIG. 4 is a schematic diagram of an internal control system;
FIG. 5 is a block diagram of the internal logic of the internal control system;
FIG. 6 is a flow chart of a neural stimulation algorithm;
fig. 7 is a schematic diagram of an external control system.
Detailed Description
For a more clear understanding of the technical features, objects and effects of the present invention, embodiments of the present invention will now be described in detail with reference to the accompanying drawings.
The invention specifically comprises an electrode head 03 wrapped around the carotid sinus, an internal control system 04, an external control system 05, and a flexible electrical lead 06 for rejection response, and the specific embodiments are described with reference to the drawings.
Fig. 1 is a schematic view of the upper torso of a human body showing the major arteriovenous and related anatomical structures, with an internal control system 04 embedded subcutaneously and a sensing device 02 and a baroreceptor activating device 01 together forming an electrode head 03 that wraps around the carotid sinus.
Fig. 2 shows that the carotid artery is bifurcated into an internal carotid artery and an external carotid artery at the carotid sinus, and the electrode tip 03 is wrapped around the lower part of the bifurcation of the internal carotid artery and the external carotid artery.
Fig. 3 is a schematic diagram of the structure of electrode tip 03, which comprises 2 devices, the upper device is a baroreceptor activating device 01, which sends out electrical stimulation to activate carotid sinus baroreceptors, the lower device is a sensing device 02, which senses the stretching and beating of the blood vessel wall to monitor the heart rate and blood pressure of a subject, and an electrode tip holder 15. The activation device 01, the feedback device 02 and the holder 15 are made of an integral insulating silicone rubber and are integrally formed.
The activation device 01 is a metal electrode plate, and can conduct the micro-current of stimulation sent by the control system to the blood vessel wall around the carotid sinus to activate the carotid sinus baroreceptor. Sensing device 02 is a network structure of wrapping around the vascular wall outside, its surface is insulating and has the soft material of biological affinity such as silica gel, the inside is buried there is the wire, when blood pressure changes, the blood vessel can take place micro-deformation, thereby lead to the network structure of vascular wall outside to take place deformation, the wire of the inside and then take place the micro-change on the length, the micro-change of this kind of length can turn into the change of little current, treater 08 turns into the blood pressure value with the change value of this kind of little current, the number of times that the minute takes place little current change turns into the rhythm of the heart. The electrode head fixer 15 is an open tubular structure made of an insulating soft material with biocompatibility, has good ductility, is connected with the sensing device 01 and the sensing device 02, and is fixed on the outer surface of the blood vessel wall by coating medical soft tissue adhesive on the inner wall of the electrode head fixer.
Fig. 4 is an internal control system 04 comprising a control module 07, a processor 08, a memory 09, a power module 10, the processor being primarily connected to a sensing device 02, the sensing device primarily collecting sensed heart rate and blood pressure information and inputting it to the processor 08, the processor 08 utilizing one or more algorithms (e.g., computer programs) to determine whether to modify the operation of the control module 07. The algorithm may compare the sensed heart rate and blood pressure to predetermined thresholds (or ranges) and, based on the results of the comparison, decide whether to deliver stimulation or continue to interact with the control module 07 to change the stimulation voltage. The processor 08 may employ a low voltage neural stimulation algorithm, a high voltage neural stimulation algorithm, a medium voltage neural stimulation algorithm, a daytime neural stimulation algorithm, a nighttime neural stimulation algorithm, etc., which are also referred to as operational profiles, stored in the memory 09. To address hypotension, sinus bradycardia, sinus tachycardia and other conditions requiring increased blood pressure. As shown in FIG. 5, the high voltage stimulation of the present invention is a stimulation voltage and corresponding frequency that reduces blood pressure by 30%; low voltage stimulation is the stimulation voltage and corresponding frequency which can reduce the blood pressure by 10 percent; the medium voltage stimulation is the stimulation voltage and the corresponding frequency for reducing the blood pressure by 20 percent.
Fig. 6 is an internal logic block diagram of the internal control system 04, and the control module 07 includes a controller, a system state detection device, a temperature detection circuit, and a bluetooth communication device; the processor 08 comprises a stimulation signal generating circuit, a stimulation signal feedback circuit and a driver; the power supply module 10 includes a battery, a power supply management system, a wireless charging management system, and a wireless energy receiving system. The internal control system 04 charges the instrument through a wireless charging technology, and the internal control system 04 is connected with the external control system 05 through the Bluetooth communication equipment to realize interactive control.
Fig. 7 is an external control system 05, which includes a display 11, a stimulus voltage regulator 12, a stimulus frequency regulator 13, a power start button/fingerprint recognition button 14, and a buzzer 16. The display 11 displays the subject's real-time blood pressure and heart rate, the current stimulator operating state and stimulation parameters (stimulation voltage and frequency). The stimulation voltage regulator 12 can regulate the stimulation voltage delivered by the baroreceptor activation device 01 to a level of 0.1V, with the maximum voltage being determined by the physician according to the physiological condition of the subject. The stimulus frequency regulator 13 regulates the duration and interval time of stimulus delivery to be accurate to 1 second; a power supply start button/fingerprint recognition button 14, the start of the external control system using a fingerprint recognition system to ensure that it is the patient himself; the buzzer 16 may sound an alarm when the internal control system 04 fails, the battery is too low, or the sensing device 02 fails, so as to remind the patient to charge the stimulator or to control the stimulator by using an external control system.
The electrode head 03 is connected to electrical conductors 06 (including sensor cables and electrical control cables) which are connected to the driver of the processor 08 in the internal control system 04. The driver may include a power amplifier, a pulse generator, or the like to selectively transmit electrical control signals to the baroreceptor activation device 01. As previously mentioned, the electrical control signals generated by the driver may be continuous, periodic, sporadic, or a combination thereof, as dictated by algorithms contained in the processor 08 of the internal control system 04. The continuous control signal comprises a constant pulse, a constant pulse train, a trigger pulse and a trigger pulse train. The periodic control signal includes a signal having a specified start time (e.g., the start of every minute, hour, or day) and a specified duration (e.g., 1 second, 1 minute, 1 hour). The contextual control signal includes each of the above-described continuous control signals triggered by the episode (e.g., blood pressure rise above a particular threshold, etc.). The electric signal transmitted to the vessel wall through the electric control cable on the electrode head 03 can directly activate the baroreceptors of the vessel wall, and the baroreceptors can be activated by the electric signal to send a signal to the brain through the baroreflex system so as to reduce the blood pressure, the activity of the sympathetic nervous system and the neurohormonal level of the human body and increase the activity of the parasympathetic nervous system, so that the electric signal is beneficial to the cardiovascular system and other systems. The methods described herein will achieve at least one therapeutic goal.
The memory 09 may contain sense signals, control signals, and data related to values and commands provided by external control system 05 inputs. The memory 09 may also contain software for one or more algorithms that define one or more functional relationships between the control signals and the sense signals. The algorithm may selectively activate or deactivate the control signal based on the sense signal.
The internal control system 04 may operate as a closed loop with feedback from the sensing device 02 or as an open loop with the external control system 05. The driver of the processor 08 can thus be driven automatically by the internal control system 04 or manually by the external control system 05. The external control system 05 can also be a patient's mobile phone or computer, connected to the internal control system 04 by bluetooth by installing corresponding control software, sending or receiving control signals wirelessly or changing the software and related algorithms contained in the memory 09.
The internal control system 04 is fully implanted subcutaneously in the implanted position shown in fig. 1, the electrical lead 06 passes through the subcutaneous tunnel connecting the internal control system 04 and the electrode head 03, and the electrode head 03 is implanted in the position shown in fig. 2. The above operation is sufficient by a minimally invasive surgical technique.
While the present invention has been described with reference to the embodiments shown in the drawings, the present invention is not limited to the embodiments, which are illustrative and not restrictive, and it will be apparent to those skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope of the invention as defined in the appended claims.
Claims (7)
1. A carotid sinus baroreceptor stimulation device is characterized by comprising an electrode tip, an internal control system and an external control system, wherein the electrode tip is wrapped on the outer wall of a carotid sinus blood vessel;
the electrode tip includes an activation device that delivers electrical stimulation to activate carotid sinus baroreceptors and a sensing device that monitors the heart rate and blood pressure of the subject by sensing the stretching and beating of the vessel wall;
the internal control system is implanted subcutaneously, and the internal control system is connected with the sensing device and the activation device; the internal control system compares the heart rate and blood pressure detected by the sensing device with predetermined thresholds, and the internal control system decides whether to deliver stimulation or change the stimulation voltage of the activation device based on the result of the comparison; the external control system is connected with the internal control system and controls the stimulation voltage of the activation device through the external control system.
2. The carotid sinus baroreceptor stimulation device of claim 1, wherein the activation device is a metal electrode pad that conducts a micro-current of stimulation from an internal control system to the vessel wall surrounding the carotid sinus to activate the carotid sinus baroreceptors.
3. The carotid sinus baroreceptor stimulation device of claim 1, wherein the sensing device is a mesh wrapped around the wall of the blood vessel, insulated on its surface and biocompatible, with wires embedded inside the mesh, the wires being connected to an internal control system; when blood pressure changes, the blood vessels deform slightly, which leads to deformation of the net structure outside the blood vessel wall, and the metal wires change slightly in length, and the change of the small amount of metal wires is converted into the change of micro-current.
4. The carotid sinus baroreceptor stimulation device of claim 1, wherein the electrode head further comprises a holder fixed to the outer surface of the vessel wall by a medical soft tissue adhesive, the holder being made of an insulating and biocompatible soft material, the holder being integrally formed with the activation device and the sensing device.
5. The carotid sinus baroreceptor stimulation device of claim 1, wherein the internal control system comprises a control module, a processor, a memory, and a power module, the processor is connected to the sensing device, the processor determines whether to modify the operation of the control module based on data detected by the sensing device in conjunction with an operational profile, the operational profile comprising a low voltage neural stimulation algorithm, a high voltage neural stimulation algorithm, a medium voltage neural stimulation algorithm, a daytime neural stimulation algorithm, and a nighttime neural stimulation algorithm, the operational profile being stored in the memory.
6. The carotid sinus baroreceptor stimulation device of claim 5, wherein the control module comprises a controller, a system state detection device, a temperature detection circuit, and a Bluetooth communication device; the processor comprises a stimulation signal generating circuit, a stimulation signal feedback circuit and a driver; the power supply module comprises a battery, a power supply management system, a wireless charging management system and a wireless energy receiving system; the internal control system is charged in a wireless charging mode and is connected with the external control system through the Bluetooth communication equipment, and interactive control is achieved.
7. The carotid sinus baroreceptor stimulation device of claim 6, wherein the external control system comprises a display, a stimulation voltage regulator, a stimulation frequency regulator, a power-on fingerprint recognition button, and a buzzer, wherein the display displays the subject's real-time blood pressure and heart rate, the current operating state of the stimulator, and stimulation parameters, wherein the stimulation voltage regulator regulates the stimulation voltage delivered by the activation device, and wherein the stimulation frequency regulator regulates the duration and interval of the delivery of the stimulation.
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2020
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| CN110380519A (en) * | 2019-08-27 | 2019-10-25 | 北京有感科技有限责任公司 | A kind of wireless charging system and its charging method of pacemaker |
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