CN113663219A - Implantable medical device and pulse generation method thereof - Google Patents

Implantable medical device and pulse generation method thereof Download PDF

Info

Publication number
CN113663219A
CN113663219A CN202010407765.2A CN202010407765A CN113663219A CN 113663219 A CN113663219 A CN 113663219A CN 202010407765 A CN202010407765 A CN 202010407765A CN 113663219 A CN113663219 A CN 113663219A
Authority
CN
China
Prior art keywords
data
control signal
module
level
segment
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202010407765.2A
Other languages
Chinese (zh)
Inventor
夏俊伟
何庆
龚嘉骏
郑国辉
张经理
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai Shenyi Medical Technology Co ltd
Original Assignee
Shanghai Shenyi Medical Technology Co ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shanghai Shenyi Medical Technology Co ltd filed Critical Shanghai Shenyi Medical Technology Co ltd
Priority to CN202010407765.2A priority Critical patent/CN113663219A/en
Publication of CN113663219A publication Critical patent/CN113663219A/en
Pending legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37252Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data

Abstract

The invention provides an implantable medical device and a pulse generating method thereof, comprising a data receiving module, a data storage module and a pulse generating module, wherein the data receiving module receives data sent by an in vitro controller and stores the data to the data storage module according to a certain storage format; the clock generation module generates a clock signal and provides the clock signal to the time sequence control module, and the time sequence control module formulates a time sequence control signal according to the clock signal; the data storage module outputs data to the pulse output module according to the time sequence control signal; the pulse output module generates and outputs a stimulation pulse. The invention stores the data according to a certain storage mode and outputs the data according to a specific time sequence, so that the waveform of the generated stimulation pulse has arbitrariness, the flexibility of pulse stimulation is improved, the stimulation pulse with the corresponding waveform can be output according to different implantation individuals and different diseases, the competitiveness of the product is increased, and the treatment range is widened.

Description

Implantable medical device and pulse generation method thereof
Technical Field
The invention relates to the field of medical instruments, in particular to implantable medical equipment and a pulse generation method thereof.
Background
Active Implantable Medical Device (AIMD) refers to a Medical Device that is intended for use in a human body and needs to be driven by electricity, gas, etc., such as an Implantable cardiac pacemaker, an Implantable defibrillator, an Implantable neurostimulator, an Implantable bladder stimulator, an Implantable sphincter stimulator, an Implantable diaphragm stimulator, an Implantable Active drug-taking Device, etc.
With the development of technology, the power supply system of many active implantable medical devices is designed to be implantable, such as an implantable cardiac pacemaker (cardiac pacemaker), which is used to generate a cardiac stimulation signal for the purpose of treating cardiac dysfunction such as chronic arrhythmia. The waveform of the pacing pulse generated by the implantable cardiac pacemaker requires a corresponding waveform control program in the control system to generate a specific stimulation pulse. Also for example, Deep Brain Stimulation (DBS) device has become the first therapeutic approach for advanced parkinson's disease worldwide due to its clinical effects superior to destructive surgery, minimally invasive surgical procedures that do not destroy brain tissue, and reversibility of treatment protocols. For deep brain stimulators, the control system is also required to generate specific stimulation pulses.
The existing pulse generation technology can only realize part of pulse types and cannot realize pulse output of any waveform. This has certain limitation in clinical use, and some patients can not have a better therapeutic effect under the existing stimulation conditions, so if the waveform of the stimulation pulse can be adjusted and multiple stimulation modes are tried, the therapeutic effect can be improved to a greater extent.
Disclosure of Invention
The invention aims to provide an implantable medical device and a pulse generation method thereof, which are used for generating stimulation pulses with arbitrary waveforms.
In order to achieve the above object, the present invention provides an implantable medical device, including an external controller and an implantable pulse generator, where the implantable pulse generator includes a data receiving module, a data storage module, a timing control module, a timing generation module, and a pulse output module, and the data receiving module is configured to receive data sent by the external controller and store the data in a certain storage format to the data storage module; the clock generation module is used for generating a clock signal and providing the clock signal to the time sequence control module; the time sequence control module is used for formulating a time sequence control signal according to the clock signal so as to enable the data storage module to output the data to the pulse output module according to the time sequence control signal; the pulse output module is used for generating and outputting stimulation pulses. .
Optionally, the in vitro controller includes a parameter input module and a data sending module, where the parameter input module is configured to obtain a stimulation parameter and send the stimulation parameter to the data sending module; the data sending module is used for converting the stimulation parameters into data and sending the data to the data receiving module.
Optionally, the data sending module and the data receiving module perform data transmission in a wireless manner.
Optionally, the implantable medical device further includes an electrode terminal, and the pulse output module generates a pulse waveform and outputs the pulse waveform to the electrode terminal.
Optionally, the clock generation module further provides a clock signal to the data storage module.
Optionally, the data stored in the data storage module sequentially includes stimulation segment data, intermittent segment data, constant data of the balance segment, and cutoff segment data.
The invention also provides a pulse generation method of the implantable medical device, which comprises the following steps:
the data receiving module receives data sent by the external controller and stores the data to the data storage module according to a certain storage format;
the clock generation module generates a clock signal and provides the clock signal to the time sequence control module, and the time sequence control module formulates a time sequence control signal according to the clock signal;
the data storage module outputs data to the pulse output module according to the time sequence control signal; and
the pulse output module generates and outputs a stimulation pulse.
Optionally, the data stored in the data storage module sequentially includes stimulation segment data, intermittent segment data, constant data of the balance segment, and cutoff segment data.
Optionally, the storage addresses of the stimulus segment data, the pause segment data, the balance segment constant data, and the cutoff segment data start from a low address and sequentially rise.
Optionally, the timing control signal includes a first control signal, a second control signal, a third control signal, a fourth control signal, and a fifth control signal, wherein the first control signal is formulated by:
the first control signal is at a low level at an idle time;
when a first rising edge of a clock signal output by the clock generation module arrives, the first control signal is changed from a low level to a high level;
and judging the magnitude relation between the counter value M of the clock generation module and the sum N1 of the numbers of the stimulation segment data, the intermittent segment data, the balance segment constant data and the cutoff segment data, if M is more than or equal to N1, changing the first control signal from high level to low level, and if M is less than N1, keeping the first control signal at high level.
Optionally, the method for formulating the second control signal includes:
the second control signal is at a low level at an idle time;
judging the magnitude relation between the counter value M of the clock generation module and the sum N2 of the numbers of the stimulation segment data, the intermittent segment data and the balance segment constant data, if M is larger than or equal to N2, changing the second control signal from low level to high level, and if M is smaller than N2, keeping the second control signal at low level;
and judging whether the first control signal is at a low level, if so, changing the level of the second control signal to be at a low level, and if so, keeping the level of the second control signal unchanged.
Optionally, the method for formulating the third control signal includes:
the third control signal is at a low level at an idle time;
judging the magnitude relation between the counter value M of the clock generation module and the sum N1 of the numbers of the stimulation segment data, the intermittent segment data, the balance segment constant data and the cut-off segment data, if M is larger than or equal to N1-1, the third control signal is changed from low level to high level, and if M is smaller than N1-1, the third control signal keeps low level;
and judging whether the level of the first control signal is low, if the level of the first control signal is low, changing the level of the third control signal into low level, and if the level of the first control signal is high, keeping the level of the third control signal unchanged.
Optionally, the fourth control signal is formulated by:
the fourth control signal is at a low level at an idle time;
judging the magnitude relation between the counter value M of the clock generation module and the sum N1 of the numbers of the stimulation segment data, the intermittent segment data, the balance segment constant data and the cutoff segment data, if M is larger than or equal to N1, changing the fourth control signal from low level to high level, and if M is smaller than N1, keeping the fourth control signal at low level;
and judging whether the level of the first control signal is low level, if so, changing the level of the fourth control signal into low level, and if so, keeping the level of the fourth control signal unchanged.
Optionally, a level state of the fifth control signal is determined by level states of the first control signal, the second control signal, the third control signal and the fourth control signal.
Optionally, a decision formula of the level state of the fifth control signal and the level states of the first control signal, the second control signal, the third control signal, and the fourth control signal is: the fifth control signal (the first control signal exclusive or the second control signal) or (the third control signal exclusive or the fourth control signal).
Optionally, the data storage module outputs data according to a rising edge of a clock signal generated by the clock generation module and a level state of the fifth control signal; the clock generation module judges whether the level of the fifth control signal is high level or not every time the clock generation module generates a rising edge of a clock signal, if the fifth control signal is high level, the data storage module outputs a datum, the data storage address in the data storage module is increased by 1, and if the fifth control signal is low level, the data storage module does not output the datum, and the data storage address in the data storage module does not change.
In summary, the present invention provides an implantable medical device and a pulse generating method thereof, including a data receiving module receiving data sent by an external controller and storing the data in a data storage module according to a certain storage format; the clock generation module generates a clock signal and provides the clock signal to the time sequence control module, and the time sequence control module formulates a time sequence control signal according to the clock signal; the data storage module outputs data to the pulse output module according to the time sequence control signal; the pulse output module generates and outputs a stimulation pulse. The invention stores the data according to a certain storage mode and outputs the data according to a specific time sequence, so that the waveform of the generated stimulation pulse has arbitrariness, the flexibility of pulse stimulation is improved, the stimulation pulse with the corresponding waveform can be output according to different implantation individuals and different diseases, the competitiveness of the product is increased, and the treatment range is widened.
Drawings
Fig. 1 is a schematic structural diagram of an implantable medical device according to an embodiment of the present invention.
FIG. 2 is a schematic diagram of pulse generation for an implantable medical device provided by an embodiment of the present invention;
FIG. 3 provides a schematic diagram of pulse generation for an implantable medical device according to another embodiment of the present invention;
fig. 4 is a flowchart of a pulse generation method of an implantable medical device according to an embodiment of the present invention.
Wherein the reference numerals are:
100-an in vitro controller; 110-parameter input module; 120-a data transmission module; 200-an implanted pulse generator; 210-a data receiving module; 220-a data storage module; 230-a timing control module; 240-a clock generation module; 250-a pulse output module; 300-electrode end; 400-storage format; 401 — a first control signal; 402-a second control signal; 403-a third control signal; 404-fourth control signal; 405-a fifth control signal; 406-a clock signal; 407. 412-analog waveform; 408-stimulation segment data; 409-intermittent segment data; 410-balance segment constant data; 411-cutoff data.
Detailed Description
Implantable medical devices are typically introduced into the body, either totally or partially, surgically or through medical intervention, into a natural orifice and remain in the body after the procedure is completed, and therefore their intended use is implantation into the body and typically require operation on electrical energy, followed by generation of a specific stimulation pulse waveform to stimulate the corresponding body tissue. However, the stimulation waveforms output are different depending on the specific conditions of the implanted individual and the disease to be treated. Therefore, a pulse waveform control module needs to be additionally added to the implantable medical device to achieve the function of adjusting the pulse waveform. Taking an implanted cerebral pacemaker as an example, the user currently uses asymmetric rectangular wave stimulation, and needs other waveform stimulation such as asymmetric Gaussian wave or asymmetric sine wave during the scientific research of doctors. In addition, different users can also stimulate with different waveforms to achieve the purpose of accurate treatment. However, the existing implanted brain pacemaker products are stimulated by asymmetric rectangular waves, and the waveforms cannot be changed, so that the implantable brain pacemaker has great limitations in scientific research or clinical application of doctors.
In order to solve the problems, the invention provides an implantable medical device and a pulse generating method thereof, which comprises a data receiving module, a data storage module and a pulse generating module, wherein the data receiving module is used for receiving data sent by an external controller and storing the data into the data storage module according to a certain storage format; the clock generation module generates a clock signal and provides the clock signal to the time sequence control module, and the time sequence control module formulates a time sequence control signal according to the clock signal; the data storage module outputs data to the pulse output module according to the time sequence control signal; the pulse output module generates and outputs a stimulation pulse. The invention stores the data according to a certain storage mode and outputs the data according to a specific time sequence, so that the waveform of the generated stimulation pulse has arbitrariness, the flexibility of pulse stimulation is improved, the stimulation pulse with the corresponding waveform can be output according to different implantation individuals and different diseases, the competitiveness of the product is increased, and the treatment range is widened.
The implantable medical device and the pulse generating method thereof according to the present invention will be described in further detail with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become more apparent from the following description. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is provided solely for the purpose of facilitating and distinctly claiming the embodiments of the present invention.
Example one
Fig. 1 is a schematic structural diagram of an implantable medical device provided in this embodiment. As shown in fig. 1, the present embodiment provides an implantable medical device for generating stimulation pulses with arbitrary waveforms, including an in vitro controller 100, an implantable pulse generator 200 and an electrode terminal 300, where the implantable pulse generator 200 includes a data receiving module 210, a data storage module 220, a timing control module 230, a timing generation module 240 and a pulse output module 250. The data receiving module 210 is configured to receive data sent by the external controller 100 and store the data in the data storage module 220 according to a certain storage format; the clock generation module 240 is configured to generate a clock and provide the clock to the timing control module 230; the timing control module 230 is configured to formulate a timing control signal according to the clock and provide the timing control signal to the data storage module 220, and the data storage module 220 outputs the stored data to the pulse output module 250 according to the timing control signal; the pulse output module 250 is configured to generate a pulse waveform according to the data and output the pulse waveform to the electrode terminal 300. The electrode terminal 300 may be an electrode wire or a port connected to the electrode wire.
The in vitro controller 100 comprises a parameter input module 110 and a data transmission module 120, wherein the parameter input module 110 is used for acquiring stimulation parameters and transmitting the stimulation parameters to the data transmission module 120; the data sending module 120 is configured to convert the stimulation parameters into data and send the data to the data receiving module 210. The data transmitting module 120 and the data receiving module 210 perform data transmission in a wireless manner, and the pulse output module 250 outputs a pulse waveform to the electrode terminal 300 in a general manner.
The clock generation module 240 provides a clock signal to the data storage module 220 in addition to the clock signal to the timing control module 230. In other embodiments of the present invention, the clock generating module 240 may further provide a clock to the data receiving module 210 and the pulse output module 250.
The implantable medical device provided in this embodiment further includes a first power supply and a second power supply (not shown), which respectively provide power to the external controller 100 and the implantable pulse generator 200.
Correspondingly, the present invention further provides a pulse generating method of an implantable medical device, where the implantable medical device is adopted, fig. 3 is a flowchart of the pulse generating method of the implantable medical device provided in this embodiment, and as shown in fig. 3, the pulse generating method of the implantable medical device includes:
s01: the data receiving module receives data sent by the external controller and stores the data to the data storage module according to a certain storage format;
s02: the clock generation module generates a clock signal and provides the clock signal to the time sequence control module, and the time sequence control module formulates a time sequence control signal according to the clock signal;
s03: the data storage module outputs data to the pulse output module according to the time sequence control signal; and
s04: the pulse output module generates and outputs a stimulation pulse.
Fig. 2 is a timing diagram of a timing control module in the implantable medical device provided in this embodiment, and a pulse generation method of the implantable medical device provided in this embodiment will be described in detail below with reference to fig. 1 to 3.
Specifically, step S01 is executed first, and the data receiving module 210 receives the data sent by the in-vitro controller 100 and stores the data in the data storage module 220 according to the certain storage format 400.
The storage format 400 is to divide the data received by the data receiving module 210 into different data segments and store the data segments in the data storage module 220 in a certain order. The data stored in the data storage module 220 in this embodiment includes stimulus segment data 408, pause segment data 409, equilibrium segment constant data 410, and cutoff segment data 411. Wherein, the stimulation segment data 408 has 100 data, the storage address is from 00 to 99, and each data range is from 0 to 65535; the intermittent segment data 409 has 1 data, the storage address is 100 for example, and the data range is 0 to 65535; the balanced segment constant data 410 has 1 data, the storage address is 101 for example, and the data range is 0 to 65535; the expiration segment data 411 has 1 data, for example, 102, storage address, and data range from 0 to 65535. The stimulus segment data 408, the pause segment data 409, the balance segment constant data 410, and the cutoff segment data 411 are stored from a low address and sequentially rise.
Next, step S02 is executed, the clock generation module 240 generates a clock signal and provides the clock signal to the timing control module 230, and the timing control module 230 formulates a timing control signal according to the clock signal.
The timing control signals include a first control signal 401, a second control signal 402, a third control signal 403, a fourth control signal 404, and a fifth control signal 405. The method for formulating the first control signal 401 is as follows: the level of the first control signal 401 in the initial state is low level, that is, the implantable medical device is at an idle time, and the level of the first control signal 401 in the initial state is low level; when the first rising edge of the clock signal 406 output by the clock generation module 240 arrives, the first control signal 401 changes from low level to high level; judging the magnitude relation between the counter value M of the clock generation module 240 and the sum N1 of the numbers of the stimulus segment data 408, the pause segment data 409, the balance segment constant data 410 and the cutoff segment data 411, if M is larger than or equal to N1, the first control signal 401 changes from high level to low level, and if M is smaller than N1, the first control signal 401 keeps high level.
The method for formulating the second control signal 402 comprises the following steps: the second control signal 402 is at a low level at an idle time; judging the magnitude relation between the counter value M of the clock generation module 240 and the sum N2 of the numbers of the stimulus segment data 408, the pause segment data 409 and the balance segment constant data 410, if M is more than or equal to N2, the second control signal 402 changes from low level to high level, and if M is less than N2, the second control signal 402 keeps low level; whether the first control signal 402 is at a low level is determined, if the first control signal 401 is at a low level, the level of the second control signal 402 is changed to a low level, and if the first control signal 401 is at a high level, the level of the second control signal 402 is kept unchanged.
The third control signal 403 is formulated as follows: the third control signal 403 is low at idle; judging the magnitude relation between the counter value M of the clock generation module 240 and the sum N1 of the numbers of the stimulus segment data 408, the pause segment data 409, the balance segment constant data 410 and the cutoff segment data 411, if M is more than or equal to N1-1, the third control signal 403 is changed from low level to high level, and if M is less than N1-1, the third control signal 403 is kept at low level; it is determined whether the level of the first control signal 401 is low, if the first control signal 401 is low, the level of the third control signal 403 is changed to low, and if the first control signal 401 is high, the level of the third control signal 403 is maintained.
The fourth control signal 404 is formulated as follows: the fourth control signal 404 is at a low level at an idle time; judging the magnitude relation between the counter value M of the clock generation module 240 and the sum N1 of the numbers of the stimulus segment data 408, the pause segment data 409, the balance segment constant data 410 and the cutoff segment data 411, if M is more than or equal to N1, the fourth control signal 404 is changed from low level to high level, and if M is less than N1, the fourth control signal 404 keeps low level; whether the level of the first control signal 401 is a low level is determined, if the first control signal 401 is a low level, the level of the fourth control signal 404 is changed to a low level, and if the first control signal 401 is a high level, the level of the fourth control signal 404 is kept unchanged.
The level state of the fifth control signal 405 is determined by the level states of the first control signal 401, the second control signal 402, the third control signal 403, and the fourth control signal 404. For example, the decision formula of the level state of the fifth control signal 405 and the level states of the first control signal 401, the second control signal 402, the third control signal 403, and the fourth control signal 404 is: the fifth control signal 405 (the first control signal 401 xored the second control signal 402) or (the third control signal 403 xored the fourth control signal 404), wherein when both control signals are high or low at the same time, the output of the xor gate is low; when the two control signals have a high level and a low level, the output of the exclusive-OR gate is at a high level. In other embodiments of the present invention, other decision formulas may be used.
Next, step S03 is executed, and the data storage module 220 outputs data to the pulse output module 250 according to the timing control signal. Specifically, the data storage module 220 receives the timing control signal formulated by the timing control module 230, and outputs data according to the rising edge of the clock signal 406 generated by the clock generation module 230 and the level state of the fifth control signal 405. That is, each time the clock generating module 230 generates a rising edge of the clock signal 406, it is determined whether the level of the fifth control signal 405 is high, if the fifth control signal 405 is high, the data storage module 220 outputs a data, and the data storage address in the data storage module 220 is incremented by 1, and if the fifth control signal 405 is low, the data storage module 220 does not output data, and the data storage address in the data storage module 220 is not changed.
Next, step S04 is executed, and the pulse output module 250 generates and outputs a stimulation pulse. The pulse output module 250 receives the specific data sent by the data storage module 220 according to the time sequence control signal, generates a corresponding pulse waveform, and outputs the pulse waveform to the electrode terminal 300, thereby realizing the output of stimulation pulses with any waveform. Illustratively, the analog waveforms of the stimulation pulses output according to the first control signal 401, the second control signal 402, the third control signal 403, the fourth control signal 404, and the fifth control signal 405 are shown as 407 in fig. 2.
Example two
The present embodiment provides a pulse generation method for an implantable medical device, and a pulse waveform generated in the present embodiment is an asymmetric gaussian waveform.
Referring to fig. 1 and 3, first, the data receiving module 210 receives the gaussian data sent by the in-vitro controller 100 and stores the gaussian data in the data storage module 220 according to a certain storage format 400.
The gaussian data (16-ary data) is stored in the data receiving module 210 according to the following storage format. The different data corresponds to a data point on the simulated waveform 412 in fig. 3, e.g., 0 represents the lowest point and 9500 represents the highest forward value.
Then, the clock generation module 240 generates the clock signal 206 and provides the clock signal to the timing control module 230, the timing control module 230 formulates a timing control signal according to the clock signal 206, each clock signal 406 comes along with a rising edge, outputs a data, and then outputs a corresponding gaussian waveform in the stimulation segment L. The timing control signals include a first control signal 401, a second control signal 402, a third control signal 403, a fourth control signal 404, and a fifth control signal 405, and the specific formulation method refers to the first embodiment.
Next, the pulse output module 250 receives the specific data sent by the data storage module 220 according to the timing control signal, generates a corresponding pulse waveform and outputs the pulse waveform to the electrode terminal 300, so as to obtain an overall stimulation waveform (asymmetric gaussian wave) as shown in 412 in fig. 3.
Storage format of gaussian data:
data0=0;data1=0;data2=0;data3=0;data4=0;
data5=0;data6=0;data7=0;data8=0;data9=0;
data10=0;data11=0;data12=0;data13=0;data14=0;
data15=0;data16=0;data17=0;data18=0;data19=0;
data20=0;data21=1;data22=3;data23=5;data24=9;
data25=16;data26=26;data27=42;data28=68;data29=105;
data30=160;data31=238;data32=348;data33=497;data34=697;
data35=956;data36=1285;data37=1693;data38=2185;data39=2763;
data40=3424;data41=4156;data42=4944;data43=5762;data44=6579;
data45=7360;data46=8068;data47=8666;data48=9120;data49=9403;
data50=9500;data51=9403;data52=9120;data53=8666;data54=8068;
data55=7360;data56=6579;data57=5762;data58=4944;data59=4156;
data60=3424;data61=2763;data62=2185;data63=1693;data64=1285;
data65=956;data66=697;data67=497;data68=348;data69=238;
data70=160;data71=105;data72=68;data73=42;data74=26;
data75=16;data76=9;data77=5;data78=3;data79=1;
data80=0;data81=0;data82=0;data83=0;data84=0;
data85=0;data86=0;data87=0;data88=0;data89=0;
data90=0;data91=0;data92=0;data93=0;data94=0;
data95=0;data96=0;data97=0;data98=0;data99=0;
data100=0。
it should be noted that the specific functional module structures of the implanted pulse generator of the present invention may be different, and the implemented timing control concept is also different, but it should be understood that the timing making method formed by changing their implementation manner without departing from the technical principle of the present invention also falls into the protection scope of the present invention.
In summary, the present invention provides an implantable medical device and a pulse generating method thereof, including a data receiving module for receiving data sent by an external controller and storing the data in a data storage module according to a certain storage format; the clock generation module generates a clock signal and provides the clock signal to the time sequence control module, and the time sequence control module formulates a time sequence control signal according to the clock signal; the data storage module outputs data to the pulse output module according to the time sequence control signal; the pulse output module generates and outputs a stimulation pulse. The invention stores the data according to a certain storage mode and outputs the data according to a specific time sequence, so that the waveform of the generated stimulation pulse has arbitrariness, the flexibility of pulse stimulation is improved, the stimulation pulse with the corresponding waveform can be output according to different implantation individuals and different diseases, the competitiveness of the product is increased, and the treatment range is widened.
The above description is only for the purpose of describing the preferred embodiments of the present invention and is not intended to limit the scope of the claims of the present invention, and any person skilled in the art can make possible the variations and modifications of the technical solutions of the present invention using the methods and technical contents disclosed above without departing from the spirit and scope of the present invention, and therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention belong to the protection scope of the technical solutions of the present invention.

Claims (16)

1. An implantable medical device for generating stimulation pulses of arbitrary waveforms, comprising an external controller and an implantable pulse generator, wherein the implantable pulse generator comprises a data receiving module, a data storage module, a time sequence control module, a time sequence generation module and a pulse output module, and the data receiving module is used for receiving data sent by the external controller and storing the data to the data storage module according to a certain storage format; the clock generation module is used for generating a clock signal and providing the clock signal to the time sequence control module; the time sequence control module is used for formulating a time sequence control signal according to the clock signal so as to enable the data storage module to output the data to the pulse output module according to the time sequence control signal; the pulse output module is used for generating and outputting stimulation pulses.
2. The implantable medical device of claim 1, wherein the in vitro controller comprises a parameter input module and a data transmission module, the parameter input module being configured to obtain stimulation parameters and transmit the stimulation parameters to the data transmission module; the data sending module is used for converting the stimulation parameters into data and sending the data to the data receiving module.
3. The implantable medical device of claim 2, wherein the data transmitting module and the data receiving module wirelessly transmit data.
4. The implantable medical device of claim 1, further comprising an electrode terminal, wherein the pulse output module generates a stimulation pulse shape and outputs the stimulation pulse shape to the electrode terminal.
5. The implantable medical device of claim 1, wherein the clock generation module further provides a clock signal to the data storage module.
6. The implantable medical device of claim 1, wherein the data stored by the data storage module comprises stimulation segment data, intermittent segment data, equilibrium segment constant data, and cutoff segment data, in that order.
7. A method of pulse generation for an implantable medical device, comprising:
the data receiving module receives data sent by the external controller and stores the data to the data storage module according to a certain storage format;
the clock generation module generates a clock signal and provides the clock signal to the time sequence control module, and the time sequence control module formulates a time sequence control signal according to the clock signal;
the data storage module outputs data to the pulse output module according to the time sequence control signal; and
the pulse output module generates and outputs a stimulation pulse.
8. The method of claim 7, wherein the data stored in the data storage module sequentially comprises stimulation segment data, rest segment data, equilibrium segment constant data, and cutoff segment data.
9. The method of claim 8, wherein the stimulation segment data, the rest segment data, the balance segment constant data, and the cutoff segment data are stored at addresses starting from a low address and sequentially increasing.
10. The method of claim 9, wherein the timing control signals comprise a first control signal, a second control signal, a third control signal, a fourth control signal, and a fifth control signal, and wherein the first control signal is formulated by:
the first control signal is at a low level at an idle time;
when a first rising edge of a clock signal output by the clock generation module arrives, the first control signal is changed from a low level to a high level;
and judging the magnitude relation between the counter value M of the clock generation module and the sum N1 of the numbers of the stimulation segment data, the intermittent segment data, the balance segment constant data and the cutoff segment data, if M is more than or equal to N1, changing the first control signal from high level to low level, and if M is less than N1, keeping the first control signal at high level.
11. The method of claim 10, wherein the second control signal is formulated by:
the second control signal is at a low level at an idle time;
judging the magnitude relation between the counter value M of the clock generation module and the sum N2 of the numbers of the stimulation segment data, the intermittent segment data and the balance segment constant data, if M is larger than or equal to N2, changing the second control signal from low level to high level, and if M is smaller than N2, keeping the second control signal at low level;
and judging whether the first control signal is at a low level, if so, changing the level of the second control signal to be at a low level, and if so, keeping the level of the second control signal unchanged.
12. The method of claim 11, wherein the third control signal is formulated by:
the third control signal is at a low level at an idle time;
judging the magnitude relation between the counter value M of the clock generation module and the sum N1 of the numbers of the stimulation segment data, the intermittent segment data, the balance segment constant data and the cut-off segment data, if M is larger than or equal to N1-1, the third control signal is changed from low level to high level, and if M is smaller than N1-1, the third control signal keeps low level;
and judging whether the level of the first control signal is low, if the level of the first control signal is low, changing the level of the third control signal into low level, and if the level of the first control signal is high, keeping the level of the third control signal unchanged.
13. The method of claim 12, wherein the fourth control signal is formulated by:
the fourth control signal is at a low level at an idle time;
judging the magnitude relation between the counter value M of the clock generation module and the sum N1 of the numbers of the stimulation segment data, the intermittent segment data, the balance segment constant data and the cutoff segment data, if M is larger than or equal to N1, changing the fourth control signal from low level to high level, and if M is smaller than N1, keeping the fourth control signal at low level;
and judging whether the level of the first control signal is low level, if so, changing the level of the fourth control signal into low level, and if so, keeping the level of the fourth control signal unchanged.
14. The method of claim 13, wherein a level state of the fifth control signal is determined by a level state of the first, second, third, and fourth control signals.
15. The method of claim 14, wherein the decision formula of the level state of the fifth control signal and the level states of the first, second, third and fourth control signals is: the fifth control signal (the first control signal exclusive or the second control signal) or (the third control signal exclusive or the fourth control signal).
16. The method of claim 15, wherein the data storage module outputs data according to a rising edge of the clock signal generated by the clock generation module and a level state of the fifth control signal; the clock generation module judges whether the level of the fifth control signal is high level or not every time the clock generation module generates a rising edge of a clock signal, if the fifth control signal is high level, the data storage module outputs a datum, the data storage address in the data storage module is increased by 1, and if the fifth control signal is low level, the data storage module does not output the datum, and the data storage address in the data storage module does not change.
CN202010407765.2A 2020-05-14 2020-05-14 Implantable medical device and pulse generation method thereof Pending CN113663219A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202010407765.2A CN113663219A (en) 2020-05-14 2020-05-14 Implantable medical device and pulse generation method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202010407765.2A CN113663219A (en) 2020-05-14 2020-05-14 Implantable medical device and pulse generation method thereof

Publications (1)

Publication Number Publication Date
CN113663219A true CN113663219A (en) 2021-11-19

Family

ID=78537283

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202010407765.2A Pending CN113663219A (en) 2020-05-14 2020-05-14 Implantable medical device and pulse generation method thereof

Country Status (1)

Country Link
CN (1) CN113663219A (en)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101648053A (en) * 2009-09-03 2010-02-17 清华大学 Double-channel embedded nerve stimulator
CN204485073U (en) * 2015-03-16 2015-07-22 北京品驰医疗设备有限公司 A kind of patient body outer controller of implantable medical devices
CN104941068A (en) * 2015-06-17 2015-09-30 美敦力公司 Implantable medical device with clock and self-timing component
CN105079960A (en) * 2014-12-31 2015-11-25 清华大学 Implanted electric pulse stimulation system

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101648053A (en) * 2009-09-03 2010-02-17 清华大学 Double-channel embedded nerve stimulator
CN105079960A (en) * 2014-12-31 2015-11-25 清华大学 Implanted electric pulse stimulation system
CN204485073U (en) * 2015-03-16 2015-07-22 北京品驰医疗设备有限公司 A kind of patient body outer controller of implantable medical devices
CN104941068A (en) * 2015-06-17 2015-09-30 美敦力公司 Implantable medical device with clock and self-timing component

Similar Documents

Publication Publication Date Title
CN106139397B (en) A kind of implanted electric pulse stimulation system
US20190167995A1 (en) Systems and methods for enhancing function of spine stabilization muscles associated with a spine surgery intervention
RU2511071C2 (en) System and method for data transfer between implanted devices
US20070053466A1 (en) Frequency shift keying demodulation technique
AU2019200386A1 (en) Flexible circuit for an impantable device
US11794021B2 (en) Interleaving stimulation patterns provided by an implantable pulse generator
US11826573B2 (en) Stimulation waveforms with high- and low-frequency aspects in an implantable stimulator device
US11331488B2 (en) Systems and methods for enhancing function of spine stabilization muscles associated with a spine surgery intervention
CN106139399B (en) A kind of electric pulse stimulation test device and the test system using the device
CN109011141B (en) Single-phase and double-phase constant-current electrical stimulator for rat brain
US6577898B2 (en) Bi-directional telemetry system and method for transmitting data at high transmission rate
EP3586911B1 (en) Implantable extraocular muscle neuromuscular stimulator and parameter setting method therefor
CN113663219A (en) Implantable medical device and pulse generation method thereof
Schulman et al. Battery powered BION FES network
CN207356362U (en) Implanted extraocular muscle neuromuscular stimulators
CN106039564A (en) Implantable nerve electrical stimulation control device, implantable nerve electrical stimulation control system and implantable nerve electrical stimulation control method
US20220387799A1 (en) Methods and systems for charge balancing of electrical stimulation
US11679261B2 (en) Systems and methods for enhancing function of spine stabilization muscles associated with a spine surgery intervention
AT407708B (en) Modularly adaptable stimulation system for versatile use in functional electrostimulation
George et al. Implementation of digital stimulus generation system for a passive programmable medical implant
Marin et al. New developments for high performance implantable stimulators: first 3 Mbps up to 4.46 Mbps demodulator chip through a wireless transcutaneous link
Journee Commentary on Chapter 9: electronics

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination