CN106725371B - Multi-battery deep brain electrical stimulation bleeding detection system - Google Patents
Multi-battery deep brain electrical stimulation bleeding detection system Download PDFInfo
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Abstract
The invention discloses a multi-battery deep brain electric stimulation bleeding detection system, which comprises at least one deep brain electric stimulator and an external device, wherein the deep brain electric stimulator comprises a stimulation electrode, a hemoglobin sensor, a pulse generator module, a charging coil, at least one main battery, at least one standby battery, a processor module and a first communication module, wherein the hemoglobin sensor is arranged near the stimulation electrode; the external device comprises a second communication module and an early warning module; the processor module controls the charging coil to charge at least one main battery and at least one standby battery, and controls the at least one standby battery to charge the at least one main battery. The electric energy of the deep brain electric stimulation bleeding detection system is rapidly supplemented through the charging mode.
Description
Technical Field
The invention relates to a deep brain electro-stimulation bleeding detection system, in particular to a multi-battery deep brain electro-stimulation bleeding detection system.
Background
Deep brain electrical stimulation (DBS) has evolved into an alternative to the destructive surgery commonly used in traditional stereotactic functional neurosurgery. DBS has proven to be an effective method, and because of its reversibility and adjustability, the rate of surgical disability is greatly reduced. Is increasingly used for treating dyskinesia, parkinsonism, epilepsy, dystonia, cluster pain, obsessive-compulsive disorder, tourette syndrome, depression and other diseases. However, deep brain electrical stimulation also has risks, and postoperative brain swelling, bleeding and the like are common, which threatens the safety of patients.
The deep brain electrical stimulation system in the prior art has more and more functions, such as increasing the function of detecting bleeding, resulting in insufficient battery power, and timely supplementing the electric power of the deep brain electrical stimulation bleeding detection system is a current technical difficulty.
Disclosure of Invention
The invention aims to overcome the defects in the technology and provide a multi-battery deep brain electro-stimulation bleeding detection system, which comprises: the device comprises at least one deep brain electric stimulator and an external device, wherein the deep brain electric stimulator comprises a stimulating electrode, a hemoglobin sensor, a pulse generator module, a charging coil, at least one main battery, at least one standby battery, a processor module and a first communication module, wherein the hemoglobin sensor is arranged near the stimulating electrode; the processor module controls the charging coil to charge at least one main battery and at least one standby battery; the processor module controls the at least one backup battery to charge the at least one main battery. The external device comprises a second communication module and an early warning module; the processor module of the deep brain electric stimulator controls the pulse generator module to generate a stimulation signal according to a program related to the stored stimulation parameters, and transmits the stimulation signal to a contact of a stimulation electrode, and the electric stimulation is carried out on a target area through contact discharge; meanwhile, the hemoglobin sensor detects the area near the sensor in real time or intermittently, the processor module judges whether hemoglobin is detected or not, once the hemoglobin is detected, bleeding can be generated at the stimulation electrode, bleeding signals are transmitted to the second communication module of the external device through the first communication module, and the early warning module carries out early warning of a bleeding mode.
Further, the deep electric stimulation bleeding detection system may further include a brain pressure sensor disposed near the stimulation electrode, when hemoglobin is detected, the brain pressure sensor detects a region near the sensor, the processor module judges whether the detected brain pressure is greater than a preset threshold, judges that the brain pressure is abnormal if the detected brain pressure is greater than the preset threshold, transmits a brain pressure abnormal signal to the second communication module of the external device through the first communication module, and the early warning module performs brain pressure abnormal mode early warning.
Further, the stimulating electrode may include a first section, a middle section, and a last section; the first section, the middle section and the last section respectively comprise at least one group of electrode contact sets, a hemoglobin sensor and a brain pressure sensor; each group of electrode contacts at least comprises two electrode contacts; the electrode contacts are respectively connected to the extension line through conductors, electrode contact groups of the first section, the middle section and the last section are arranged along the extending direction of the electrodes, and the electrode contacts of each group are arranged along the circumferential direction of the electrodes.
Further, the main battery and the standby battery are lithium ion rechargeable batteries or other rechargeable batteries.
By the system, the brain swelling and bleeding of the patient after the operation can be effectively and timely monitored.
Drawings
Fig. 1 is a diagram of a multi-cell deep brain electro-stimulation hemorrhage detection system according to the present invention.
Fig. 2 is an electrode diagram of the present invention.
11. Deep brain electrical stimulator 12. Extracorporeal device.
21. Stimulation electrode 22, hemoglobin sensor 23, pulse generator 24, processor module 25, first communication module.
31. A second communication module 32. An early warning module.
100. Feedback type deep brain electric stimulation electrode end section; 200. a feedback type deep brain electro-stimulation electrode middle section; 300. the first section of the feedback brain deep electric stimulation electrode; 101. 201, 301. Hemoglobin sensor; 102. 202, 302, brain pressure sensor; 103. 203, 303, feedback brain deep electric stimulation electrode contacts; 104. 204, 304. Insulators.
Detailed Description
The invention will be further described with reference to the drawings and examples.
Fig. 1 shows a multi-cell deep brain electro-stimulated hemorrhage detection system including an in-vivo module and an in-vitro device. The in-vivo module is specifically a deep brain electric stimulator 11 and an in-vitro device 12.
Wherein the deep brain electric stimulator 11 is used for invasive intracranial stimulation and parameter acquisition and consists of a brain stimulation electrode deeply implanted in the brain and a stimulation generator IPG implanted in front of the chest. The brain stimulation electrode has dischargeable stimulation contacts that deliver weak electrical pulses through the stimulation generator IPG. The implantation is generally performed by installing a head frame, MRI or CT scanning, preoperative planning mainly comprises the design of positioning anatomic micro-points and placing an operation needle channel, scalp incision and skull drilling are carried out afterwards, electrodes are implanted and fixed through electrophysiological positioning and intra-operative testing in the operation, and finally a stimulation generator is implanted subcutaneously, generally subcutaneously at the lower end of a collarbone, and also subcutaneously placed in the abdomen. The stimulation generator IPG is connected to the deep brain electrical stimulator 11 via a lead through the neck.
The stimulation generator IPG implanted in the chest comprises a pulse generator module 23, a processor module 24, a first communication module 25, a charging coil, at least one main battery, at least one backup battery; wherein the processor module 24 includes at least a control portion, a storage portion, and a calculation portion; the processor module controls the pulse generator module to generate a stimulation signal according to the stored stimulation parameters and a preset stimulation program, and transmits the stimulation signal to the contact point of the stimulation electrode, and the electric stimulation is carried out on the target area in the deep brain through the contact point discharge. The processor module 24 controls the charging coil to charge at least one main battery and at least one backup battery; the processor module 24 controls at least one backup battery to charge at least one main battery. The primary and backup batteries are lithium ion rechargeable or other rechargeable batteries.
Wherein the deep brain electro-stimulator further comprises a hemoglobin sensor, and can detect whether a target area has bleeding points. The processor module 24 controls the on/off of the hemoglobin sensor monitoring state by the control section. Real-time monitoring, monitoring that is turned on at certain periods, or on-the-fly monitoring of control signals to the processor module 24 may be implemented. The hemoglobin sensor can be any type of sensor suitable for use, and preferably selects a reusable light sensor which can be used for a long time without replacement and has a simpler structure and is not easy to damage. For example, the sensor may comprise a micro LED or micro infrared light emitter that emits near infrared light, and a micro light receiver. The light source emits infrared light near the maximum absorption wavelength of hemoglobin of 540nm, the absorption signal A (t) is measured by a micro light receiver with a certain distance, the signal is received by the control part and is transmitted to the calculation part for calculation to judge whether the hemoglobin is detected. The detection of hemoglobin means the discovery of bleeding points.
The specific behavior of the hemoglobin determination may be: and in the initial state or the normal physiological state of confirming no bleeding point, collecting signals for a period of time, and calculating a threshold space in the normal state. Considering the factors of partial nonlinearity, the algorithm of one embodiment is:
after eliminating the obvious interference signal, calculating the maximum value Amax, the minimum value Amin and the average value Aarg of the signals in the section,
the maximum value of the threshold interval takes the maximum value of Amax and Amax+ ((Amax-Amin)/2-Aarg),
the minimum value of the threshold interval takes the minimum value of Amin and Amin+ ((Amax-Amin)/2-Aarg);
the threshold value that is initially set is input to the memory unit of the processor module 24 and stored. When the monitoring of the hemoglobin sensor is turned on, when the detected time series of a (t) occurs, the maximum or minimum value deviation degree with respect to the threshold value is greater than 2 x ((Amax-Amin)/2-Aarg), and the deviation of the values of the several sequences following the time series in the same direction has an expanding tendency, at least not less than the deviation of the original tendency, the calculation section determines that an abnormal amount of hemoglobin is detected, and thus, the bleeding mode, the processor module 25 sends a blood warning signal to the first communication module 25 through the control section.
In the case that no bleeding warning condition occurs and no obvious trend change occurs in the readings of the hemoglobin sensor, the normal threshold of the hemoglobin sensor needs to be re-determined and calibrated every half to one year to compensate for the baseline shift.
For other methods for measuring hemoglobin or other types of sensors, if the output is a single parameter and the concentration of hemoglobin are in a general positive correlation, the above-mentioned decision algorithm can also be used for early warning of bleeding.
The deep brain electrical stimulator may also include a brain pressure sensor disposed adjacent to the stimulation electrode. Intracranial pressure is the pressure within the skull and, therefore, the pressure of the brain tissue and cerebrospinal fluid. The brain pressure sensor may be a pressure sensor, such as a capacitive mes sensor or the like. In general, the intracranial pressure and the pathological or cerebral hematoma intracranial pressure of normal people still have large difference, and can be calibrated according to the initial normal pressure, the threshold value P0 of the normal pressure and the cerebral hematoma pressure is determined, and when the measured pressure P (t) is larger than the threshold pressure P0 and P (t+1) to P (t+n) are all larger than or equal to P0, the abnormal cerebral pressure is determined. The brain pressure sensor returns the detected pressure to the processor module 24, and the calculation section of the processor module 24 calculates and determines, and if it is determined that the brain pressure is abnormal, sends the pressure to the first communication module 25.
The early warning mode of the brain pressure sensor is also controlled by the processor module 24, the early warning of the bleeding mode and the early warning of brain pressure abnormality can be respectively and independently started, controlled and alarmed, and the early warning mode can also be in the power saving requirement and the damage rate reduction of the sensor, and the processor module 24 sends out a mode of starting brain pressure monitoring through a control part after detecting hemoglobin; the hemoglobin sensor may be turned on to detect a brain pressure abnormality after the brain pressure abnormality is determined.
The default mode of the sensor is the sleep mode unless the processor issues a control command.
The extracorporeal device 12 comprises at least a processor, a second communication module 31 and an early warning module 32, and preferably also a human-machine control interface. The second communication module 31 may transmit and receive information to and from the first communication module 25, and may use wireless communication protocols such as Zigbee and bluetooth.
The external device 12 mainly plays a role of providing an abnormal state early warning, the first communication module 25 sends the information to the second communication module 31 after a bleeding mode early warning signal or a brain pressure abnormal early warning signal sent by the street processor, and the second communication module sends the signal to the early warning module through the processor or directly, so as to provide an early warning signal for doctors or patients. The early warning signals can be presented in the modes of sound, light, electricity, display screen and the like, wherein the two modes respectively adopt different early warning signals.
The extracorporeal device 12 may also have a control interface through which a physician may input preset stimulation patterns, select stimulation parameters, set parameters of the hemoglobin sensor and brain pressure sensor, set decision thresholds, etc. The processor processes the control command and sends it to the second communication module 31, which transmits it to the first communication module 31 in the body and stores the parameters in the processor module 24.
In addition, the extracorporeal device 12 may also implement bidirectional data transmission with a computer, a control center or a central processing unit through the second communication module 31. Therefore, the CPU can be used for more precisely controlling the system, and the calculated amount of parameters can be calculated more. Under such conditions, a partially more accurate hemoglobin measurement may be used, or intracranial pressure may be used to measure more brain hemodynamic parameters to provide more physiological information to the user.
For example, in one embodiment, the bleeding points are analyzed using imaging. The hemoglobin sensor adopts a miniature image acquisition device, and does not need high precision or resolution. The acquired data is sent to the microprocessor module 24, which sends each single frame of image information to the extracorporeal device with or without pre-processing such as contrast enhancement, filtering, etc. The external device or the processor can process and judge the image, if not, the image is further sent to the central processing unit. The processor performs judgment according to the color feature quantity of the image, firstly performs image segmentation, calculates each color component of the segmented small region such as RGB component, calculates statistics such as average value or central value of color difference calculated by YCbCr conversion, hue calculated by HSI conversion, saturation, G/R, B/G and the like, and judges the color feature quantity of the abnormal region which is learned before, wherein the judgment standard can automatically identify the judgment standard by a learner such as a support vector machine, an artificial neural network and the like according to the respective feature quantity. Therefore, since the specific color caused by bleeding can be detected in the region, a more accurate bleeding point judgment can be made.
In another embodiment, the intracranial pressure is determined by impedance method. Intracranial pressure can be affected by several factors, including but not limited to cardiac cycle, respiratory cycle, and slow wave cycle corresponding to natural regulation of the body by cerebral blood flow. The pressure sensor can only obtain one characteristic of pressure change, but the impedance reflects different characteristics on different time scales, such as a longer time scale for changes in cerebral blood volume, and a shorter time scale for changes in impedance associated with the cardiac cycle. Thus, from the impedance waveform, many intracranial hemodynamic parameters can be reflected in the amplitude and time characteristics of the impedance component of the waveform, including but not limited to intracranial pressure, cerebral blood volume, cerebral blood flow, cerebral perfusion pressure, and the like. Therefore, other sensors can be used for monitoring the intracranial pressure, and particularly in the case of an external processor, the parameters can be easily analyzed in a richer dimension.
In one embodiment, the stimulation electrodes are arranged in a plurality of rows, each extending into a different brain site. In another embodiment, the stimulation electrode may be multi-segmented, passing through different anatomical locations and orientations, thereby functioning to generate electrical stimulation to multiple sites in a single electrode.
In one embodiment, the stimulation electrode, including the stimulation electrode, may include a first segment 100, a middle segment 200, a last segment 300; the means, the middle end and the tail end can be separated by a distance L, and the design effectively considers the deviation of the position of the deep brain stimulation electrode 100 inserted into the nucleus 200 caused by the error conditions such as magnetic resonance deviation, electrode drift, brain collapse, operation headstock and the like. The first section, the middle section and the last section respectively comprise at least one group of electrode contact sets 104, 204 and 304, one hemoglobin sensor 102, 202 and 302 and one brain pressure sensor 103, 203 and 303, and electrodes with the sensors are feedback deep brain stimulation electrodes; the electrode contact set and the two sensors are respectively sealed by insulating materials, and an I/O port can be further included in each section to realize data transmission.
For each section of electrode, each group of electrode at least comprises two electrode contacts for stimulating the stimulated point to a sufficient area, preferably 2-8 electrode contacts, each group of electrode contacts are arranged along the circumferential direction of the electrode to form a ring shape so as to ensure the area of the electrode and reduce side effects when the electrode contacts are inserted and biased, the electrode contacts are connected to an extension line through conductors respectively, and electrode contact groups of the first section, the middle section and the last section are arranged along the extending direction of the electrode.
For a multi-segment feedback deep brain electrode, wherein a single electrode is configured to activate a hemoglobin sensor upon activation of a hemorrhage test at a spaced segment, and a single electrode is configured to activate a brain pressure sensor only in one segment, to maintain the useful life of the battery and device.
Claims (4)
1. A multi-cell deep brain electro-stimulation bleeding detection system, which is characterized in that: the detection system comprises at least one deep brain electric stimulator (11) and an external device (12), wherein the deep brain electric stimulator (11) comprises a stimulation electrode (21), a hemoglobin sensor (22) arranged near the stimulation electrode (21), a pulse generator module (23), a charging coil, at least one main battery, at least one standby battery, a processor module (24) and a first communication module (25); the extracorporeal device (12) comprises a second communication module (31) and an early warning module (32); the processor module (24) of the deep brain electric stimulator (11) controls the pulse generator module (23) to generate a stimulation signal according to the stored stimulation parameters, and transmits the stimulation signal to a contact of the stimulation electrode (21), and the electric stimulation is carried out on a target area through the contact discharge; simultaneously, the hemoglobin sensor (22) detects the area near the sensor (22) in real time or intermittently, and the processor module (24) controls the charging coil to charge the at least one main battery and the at least one standby battery; -said processor module (24) controlling said at least one backup battery to charge said at least one main battery;
the processor module (24) comprises at least a control part, a storage part and a calculation part; the processor module (24) judges whether hemoglobin is detected, and once the hemoglobin is detected, bleeding is possibly generated at the stimulation electrode (21), a bleeding signal is transmitted to the second communication module (31) of the extracorporeal device (12) through the first communication module (25), and the early warning module (32) performs early warning of a bleeding mode;
specific behavior for hemoglobin determination: collecting signals for a period of time in an initial state or in a normal physiological state without bleeding points, calculating a threshold space in the normal state, and calculating the maximum value Amax, the minimum value Amin and the average value Aarg of signals in the section after eliminating obvious interference signals;
the maximum value of the threshold interval is taken as the maximum value of Amax and Amax+ ((Amax-Amin)/2-Aarg);
the minimum value of the threshold interval takes the minimum value of Amin and Amin+ ((Amax-Amin)/2-Aarg);
when the hemoglobin sensor is turned on, when the detected time series of A (t) has a maximum or minimum value deviation from the threshold value of more than 2 x ((Amax-Amin)/2-Aarg), and the values of the sequences following the time series have an increasing tendency to deviate in the same direction, at least not less than the original tendency, the calculation section determines that an abnormal amount of hemoglobin is detected.
2. The multi-cell deep brain electro-stimulated hemorrhage detection system of claim 1, wherein: the deep electric stimulation bleeding detection system further comprises a brain pressure sensor arranged near the stimulation electrode (21), when hemoglobin is detected, the brain pressure sensor detects a region near the brain pressure sensor, the processor module (24) judges whether the detected brain pressure is larger than a preset threshold value, judges that the brain pressure is abnormal if the detected brain pressure is larger than the preset threshold value, transmits brain pressure abnormal signals to the second communication module (31) of the external device (12) through the first communication module (25), and the early warning module (32) carries out brain pressure abnormal mode early warning.
3. The multi-cell deep brain electro-stimulated hemorrhage detection system of claim 2, wherein: the stimulating electrode (21) comprises a first section, a middle section and a last section; the first section, the middle section and the last section respectively comprise at least one group of electrode contact sets, one hemoglobin sensor and one brain pressure sensor; each group of electrode contacts at least comprises two electrode contacts; the electrode contacts are respectively connected to the extension line through conductors, the electrode contact groups of the first section, the middle section and the last section are arranged along the extending direction of the electrode, and the electrode contacts of each group are arranged along the circumferential direction of the electrode.
4. The multi-cell deep brain electro-stimulated hemorrhage detection system of claim 1, wherein: the main battery and the standby battery are lithium ion rechargeable batteries.
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| CN101116610A (en) * | 2007-09-06 | 2008-02-06 | 上海交通大学 | Gastrointestinal tract hemorrhage non-invasive monitoring system |
| WO2016023126A1 (en) * | 2014-08-14 | 2016-02-18 | Functional Neuromodulation, Inc. | Brain stimulation system including multiple stimulation modes |
| US9278208B1 (en) * | 2003-10-20 | 2016-03-08 | University Of Central Florida Research Foundation, Inc. | Spatial-temporal deep brain stimulation methods and systems |
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| US8412332B2 (en) * | 2007-10-18 | 2013-04-02 | Integrated Sensing Systems, Inc. | Miniature wireless system for deep brain stimulation |
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| CN101116610A (en) * | 2007-09-06 | 2008-02-06 | 上海交通大学 | Gastrointestinal tract hemorrhage non-invasive monitoring system |
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