Implantable medical device and pulse generation method thereof

Abstract

The present invention provides an implantable medical device and a pulse generation method thereof, comprising a data receiving module that receives data sent by an in vitro controller and stores the data in a data storage module in a certain storage format; a clock generation module that generates a clock signal and provides it to a timing control module, and the timing control module formulates a timing control signal according to the clock signal; the data storage module outputs the data to a pulse output module in accordance with the timing control signal; and the pulse output module generates and outputs a stimulation pulse. In the present invention, data is stored in a certain storage manner and output in a specific timing, so that the waveform of the generated stimulation pulse is arbitrary, the flexibility of the pulse stimulation is improved, and stimulation pulses of corresponding waveforms can be output for different implanted individuals and different diseases, which increases the competitiveness of the product and broadens the scope of treatment.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to an implantable medical device and a pulse generating method thereof. Background Art

[0002] Active implantable medical device (AIMD) refers to medical devices that are intended to be implanted in the human body and require the use of electricity, gas, etc. to drive the device, such as implantable cardiac pacemakers, implantable defibrillators, implantable neurostimulators, implantable bladder stimulators, implantable sphincter stimulators, implantable diaphragm stimulators, implantable active medication devices, etc.

[0003] With the development of technology, the power supply systems of many active implantable medical devices are currently designed to be implantable, such as implantable cardiac pacemakers, which are used to generate cardiac stimulation signals to achieve the purpose of treating cardiac dysfunction such as chronic arrhythmias. The waveform of the pacing pulse generated by the implantable cardiac pacemaker requires the control system to have a corresponding waveform control program to generate specific stimulation pulses. Another example is the deep brain stimulation (DBS) device, which has become the preferred treatment for advanced Parkinson's disease worldwide due to its superior clinical effect to destructive surgery, minimally invasive surgical process that does not damage brain tissue, and reversible treatment options. For deep brain stimulators, a control system is also required to generate specific stimulation pulses.

[0004] The existing pulse generation technology can only realize some pulse types, and cannot realize pulse output of arbitrary waveforms. This has certain limitations in clinical use. Some patients cannot achieve a good therapeutic effect under the existing stimulation conditions. If the waveform of the stimulation pulse can be adjusted and multiple stimulation methods can be tried, the therapeutic effect can be improved to a great extent. Summary of the invention

[0005] The object of the present invention is to provide an implantable medical device and a pulse generating method thereof, so as to generate stimulation pulses of arbitrary waveforms.

[0006] To achieve the above-mentioned purpose, the present invention provides an implantable medical device, including an in vitro controller and an implantable pulse generator, wherein the implantable pulse generator includes a data receiving module, a data storage module, a timing control module, a clock generation module and a pulse output module, wherein the data receiving module is used to receive data sent by the in vitro controller and store the data in the data storage module in a certain storage format; the clock generation module is used to generate a clock signal and provide it to the timing control module; the timing control module is used to formulate a timing control signal according to the clock signal, so that the data storage module outputs the data to the pulse output module according to the timing control signal; and the pulse output module is used to generate and output stimulation pulses. .

[0007] Optionally, the in vitro controller includes a parameter input module and a data sending module, the parameter input module is used to obtain stimulation parameters and send the stimulation parameters to the data sending module; the data sending module is used to convert the stimulation parameters into data and send it to the data receiving module.

[0008] Optionally, the data sending module and the data receiving module perform data transmission wirelessly.

[0009] Optionally, the implantable medical device further includes an electrode terminal, and the pulse output module generates a pulse waveform and outputs it to the electrode terminal.

[0010] Optionally, the clock generation module also provides a clock signal to the data storage module.

[0011] Optionally, the data stored in the data storage module includes stimulation segment data, intermittent segment data, equilibrium segment constant data and cutoff segment data in sequence.

[0012] The present invention also provides a pulse generation method for an implantable medical device, comprising:

[0013] The data receiving module receives the data sent by the in vitro controller and stores the data in a data storage module according to a certain storage format;

[0014] The clock generation module generates a clock signal and provides it to the timing control module, and the timing control module formulates a timing control signal according to the clock signal;

[0015] The data storage module outputs data to the pulse output module according to the timing control signal; and

[0016] The pulse output module generates and outputs stimulation pulses.

[0017] Optionally, the data stored in the data storage module includes stimulation segment data, intermittent segment data, equilibrium segment constant data and cutoff segment data in sequence.

[0018] Optionally, the storage addresses of the stimulation segment data, the intermittent segment data, the balance segment constant data and the cutoff segment data start from a low address and rise in sequence.

[0019] 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 as follows:

[0020] The first control signal is at a low level during an idle time;

[0021] When the first rising edge of the clock signal output by the clock generation module arrives, the first control signal changes from a low level to a high level;

[0022] Determine the relationship between the counter value M of the clock generating module and the sum N1 of the number of the stimulation segment data, the intermittent segment data, the balance segment constant data and the cutoff segment data; if M≥N1, the first control signal changes from a high level to a low level; if M<N1, the first control signal maintains a high level.

[0023] Optionally, the second control signal is formulated as follows:

[0024] The second control signal is at a low level during an idle time;

[0025] Determine the relationship between the counter value M of the clock generation module and the sum N2 of the number of the stimulation segment data, the intermittent segment data and the balance segment constant data, if M≥N2, the second control signal changes from a low level to a high level, if M<N2, the second control signal remains at a low level;

[0026] It is determined whether the first control signal is at a low level. If the first control signal is at a low level, the level of the second control signal becomes a low level. If the first control signal is at a high level, the level of the second control signal remains unchanged.

[0027] Optionally, the third control signal is formulated as follows:

[0028] The third control signal is at a low level during idle time;

[0029] Determine the relationship between the counter value M of the clock generation module and the sum N1 of the number of the stimulation segment data, the intermittent segment data, the balance segment constant data and the cutoff segment data. If M≥N1-1, the third control signal changes from a low level to a high level. If M<N1-1, the third control signal remains at a low level.

[0030] It is determined whether the level of the first control signal is low. If the first control signal is low, the level of the third control signal becomes low. If the first control signal is high, the level of the third control signal remains unchanged.

[0031] Optionally, the fourth control signal is formulated as follows:

[0032] The fourth control signal is at a low level during idle time;

[0033] Determine the relationship between the counter value M of the clock generation module and the sum N1 of the number of the stimulation segment data, the intermittent segment data, the balance segment constant data and the cutoff segment data; if M≥N1, the fourth control signal changes from a low level to a high level; if M<N1, the fourth control signal remains at a low level;

[0034] It is determined whether the level of the first control signal is a low level. If the first control signal is a low level, the level of the fourth control signal becomes a low level. If the first control signal is a high level, the level of the fourth control signal remains unchanged.

[0035] Optionally, the level state of the fifth control signal is determined by the level states of the first control signal, the second control signal, the third control signal and the fourth control signal.

[0036] Optionally, the decision formula for 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: fifth control signal = (first control signal XOR second control signal) or (third control signal XOR fourth control signal).

[0037] Optionally, the data storage module outputs data according to the rising edge of the clock signal generated by the clock generation module and the level state of the fifth control signal; each time the clock generation module generates a rising edge of a clock signal, it determines whether the level of the fifth control signal is a high level; if the fifth control signal is a high level, the data storage module outputs a data, and the data storage address in the data storage module increases by 1; if the fifth control signal is a low level, the data storage module does not output data, and the data storage address in the data storage module does not change.

[0038] In summary, the present invention provides an implantable medical device and a pulse generation method thereof, including a data receiving module that receives data sent by an in vitro controller and stores the data in a data storage module in a certain storage format; a clock generation module that generates a clock signal and provides it to a timing control module, and the timing control module formulates a timing control signal according to the clock signal; the data storage module outputs the data to a pulse output module according to the timing control signal; and the pulse output module generates and outputs stimulation pulses. In the present invention, data is stored in a certain storage manner and output according to a specific timing, so that the waveform of the generated stimulation pulse is arbitrary, the flexibility of the pulse stimulation is improved, and stimulation pulses of corresponding waveforms can be output for different implanted individuals and different diseases, which increases the competitiveness of the product and broadens the scope of treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 It is a schematic diagram of the structure of an implantable medical device provided in one embodiment of the present invention.

[0040] Figure 2 is a schematic diagram of pulse generation of an implantable medical device provided by an embodiment of the present invention;

[0041] Figure 3 A schematic diagram of pulse generation of an implantable medical device provided by another embodiment of the present invention;

[0042] Figure 4 It is a flow chart of a pulse generation method for an implantable medical device provided by one embodiment of the present invention.

[0043] Wherein, the accompanying drawings are marked as follows:

[0044] 100-external controller; 110-parameter input module; 120-data sending module; 200-implantable pulse generator; 210-data receiving module; 220-data storage module; 230-timing control module; 240-clock generating module; 250-pulse output module; 300-electrode end; 400-storage format; 401-first control signal; 402-second control signal; 403-third control signal; 404-fourth control signal; 405-fifth control signal; 406-clock signal; 407, 412-analog waveform; 408-stimulation segment data; 409-interval segment data; 410-balance segment constant data; 411-cutoff segment data. DETAILED DESCRIPTION

[0045] Implantable medical devices are usually introduced into the human body in whole or in part through surgery, or introduced into a natural orifice through medical intervention, and remain in the human body after completing the above procedures. Therefore, their intended use is to be implanted in the human body, and they usually need to rely on electrical energy to work, and then generate specific stimulation pulse waveforms to stimulate the corresponding human tissues. However, due to the specific circumstances of the implanted individuals and the different diseases treated, the output stimulation waveforms are also different. Therefore, it is necessary to add a pulse waveform control module to the implantable medical device to achieve the function of adjusting the pulse waveform. Taking implantable brain pacemakers as an example, users currently use asymmetric rectangular wave stimulation, while doctors need other waveform stimulations when conducting scientific research, such as asymmetric Gaussian waves or asymmetric sine waves. In addition, different users may also use different waveform stimulations to achieve the purpose of precise treatment. However, existing implantable brain pacemaker products all use asymmetric rectangular wave stimulation, and the waveform cannot be changed, which has great limitations in doctors' scientific research or clinical practice.

[0046] In response to the above problems, the present invention provides an implantable medical device and a pulse generation method thereof, including a data receiving module that receives data sent by an in vitro controller and stores the data in a data storage module in a certain storage format; a clock generation module that generates a clock signal and provides it to a timing control module, and the timing control module formulates a timing control signal according to the clock signal; the data storage module outputs the data to a pulse output module according to the timing control signal; and the pulse output module generates and outputs stimulation pulses. In the present invention, data is stored in a certain storage manner and output according to a specific timing, so that the waveform of the generated stimulation pulse is arbitrary, the flexibility of the pulse stimulation is improved, and stimulation pulses of corresponding waveforms can be output for different implanted individuals and different diseases, which increases the competitiveness of the product and broadens the scope of treatment.

[0047] The implantable medical device and the pulse generation method thereof of the present invention are further described in detail below in conjunction with the accompanying drawings and specific embodiments. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the accompanying drawings are in a very simplified form and are not in precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. Embodiment 1

[0048] Figure 1 Schematic diagram of the structure of the implantable medical device provided in this embodiment. Figure 1As shown, this embodiment provides an implantable medical device for generating stimulation pulses of arbitrary waveforms, including an in vitro controller 100, an implantable pulse generator 200 and an electrode terminal 300, wherein the implantable pulse generator 200 includes a data receiving module 210, a data storage module 220, a timing control module 230, a clock generating module 240 and a pulse output module 250. The data receiving module 210 is used to receive data sent by the in vitro controller 100 and store the data in the data storage module 220 according to a certain storage format; the clock generating module 240 is used to generate a clock and provide it to the timing control module 230; the timing control module 230 is used to formulate a timing control signal according to the clock and provide it 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 used to generate a pulse waveform according to the data and output it to the electrode terminal 300. The electrode terminal 300 can be an electrode line or a port connected to the electrode line.

[0049] The in vitro controller 100 includes a parameter input module 110 and a data sending module 120. The parameter input module 110 is used to obtain stimulation parameters and send the stimulation parameters to the data sending module 120; the data sending module 120 is used to convert the stimulation parameters into data and send the data to the data receiving module 210. The data sending module 120 and the data receiving module 210 perform data transmission in a wireless manner, and the pulse output module 250 outputs the pulse waveform to the electrode end 300 in a common manner.

[0050] In addition to providing a clock signal to the timing control module 230, the clock generation module 240 also provides a clock signal to the data storage module 220. In other embodiments of the present invention, the clock generation module 240 can also provide a clock to the data receiving module 210 and the pulse output module 250.

[0051] The implantable medical device provided in this embodiment further includes a first power supply and a second power supply (not shown in the figure), and the first power supply and the second power supply provide power for the external controller 100 and the implantable pulse generator 200 respectively.

[0052] Accordingly, the present invention also provides a pulse generation method for an implantable medical device, using the above-mentioned implantable medical device, Figure 3 A flow chart of a pulse generation method for an implantable medical device provided in this embodiment, such as Figure 3 As shown, a pulse generation method for an implantable medical device includes:

[0053] S01: The data receiving module receives data sent by the in vitro controller and stores the data in a data storage module according to a certain storage format;

[0054] S02: The clock generation module generates a clock signal and provides it to the timing control module, and the timing control module formulates a timing control signal according to the clock signal;

[0055] S03: the data storage module outputs data to the pulse output module according to the timing control signal; and

[0056] S04: The pulse output module generates and outputs stimulation pulses.

[0057] Figure 2 The timing diagram of the timing control module in the implantable medical device provided in this embodiment will be referred to below. Figures 1 to 3 The pulse generation method of the implantable medical device provided in this embodiment is described in detail.

[0058] Specifically, first, step S01 is executed, 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 a certain storage format 400 .

[0059] The storage format 400 refers to dividing the data received by the data receiving module 210 into different data segments and storing them in the data storage module 220 in a certain order. In this embodiment, the data stored in the data storage module 220 includes stimulation segment data 408, intermittent segment data 409, balance segment constant data 410 and cutoff segment data 411. Among them, the stimulation segment data 408 has a total of 100 data, the storage address is, for example, from 00 to 99, and the range of each data is from 0 to 65535; the intermittent segment data 409 has a total of 1 data, the storage address is, for example, 100, and the data range is from 0 to 65535; the balance segment constant data 410 has a total of 1 data, the storage address is, for example, 101, and the data range is from 0 to 65535; the cutoff segment data 411 has a total of 1 data, the storage address is, for example, 102, and the data range is from 0 to 65535. The stimulation segment data 408, the intermittent segment data 409, the balance segment constant data 410 and the cutoff segment data 411 are stored starting from the low address and rising in sequence.

[0060] Next, step S02 is executed, the clock generation module 240 generates a clock signal and provides it to the timing control module 230, and the timing control module 230 formulates a timing control signal according to the clock signal.

[0061] The timing control signal includes 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, that is, when the implantable medical device is in an idle state, the level of the first control signal 401 in the initial state is low; 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 to high; the relationship between the counter value M of the clock generation module 240 and the sum N1 of the number of the stimulation segment data 408, the intermittent segment data 409, the balance segment constant data 410 and the cutoff segment data 411 is determined. If M≥N1, the first control signal 401 changes from high to low; if M<N1, the first control signal 401 remains high.

[0062] The formulation method of the second control signal 402 is as follows: the second control signal 402 is at a low level during idle time; the relationship between the counter value M of the clock generation module 240 and the sum N2 of the number of the stimulation segment data 408, the intermittent segment data 409 and the balance segment constant data 410 is determined. If M≥N2, the second control signal 402 changes from a low level to a high level. If M<N2, the second control signal 402 remains at a low level. It is determined whether the first control signal 402 is at a low level. If the first control signal 401 is at a low level, the level of the second control signal 402 changes to a low level. If the first control signal 401 is at a high level, the level of the second control signal 402 remains unchanged.

[0063] The formulation method of the third control signal 403 is as follows: the third control signal 403 is at a low level during idle time; the relationship between the counter value M of the clock generation module 240 and the sum N1 of the number of the stimulation segment data 408, the intermittent segment data 409, the balance segment constant data 410 and the cutoff segment data 411 is determined; if M≥N1-1, the third control signal 403 changes from a low level to a high level; if M<N1-1, the third control signal 403 remains at a low level; it is determined whether the level of the first control signal 401 is low; if the first control signal 401 is at a low level, the level of the third control signal 403 changes to a low level; if the first control signal 401 is at a high level, the level of the third control signal 403 remains unchanged.

[0064] The formulation method of the fourth control signal 404 is as follows: the fourth control signal 404 is at a low level during idle time; the relationship between the counter value M of the clock generation module 240 and the sum N1 of the number of the stimulation segment data 408, the intermittent segment data 409, the balance segment constant data 410 and the cutoff segment data 411 is determined; if M≥N1, the fourth control signal 404 changes from a low level to a high level; if M<N1, the fourth control signal 404 remains at a low level; it is determined whether the level of the first control signal 401 is at a low level; if the first control signal 401 is at a low level, the level of the fourth control signal 404 changes to a low level; if the first control signal 401 is at a high level, the level of the fourth control signal 404 remains unchanged.

[0065] 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. Exemplarily, 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 = (first control signal 401 XOR second control signal 402) or (third control signal 403 XOR fourth control signal 404), wherein, when the two control signals are both high or low at the same time, the XOR gate output is low; when one of the two control signals is high and the other is low, the XOR gate output is high. In other embodiments of the present invention, other decision formulas may also be used.

[0066] 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, the clock generation module 230 determines whether the level of the fifth control signal 405 is a high level each time it generates a rising edge of the clock signal 406. If the fifth control signal 405 is a high level, the data storage module 220 outputs a data, and the data storage address in the data storage module 220 increases by 1. If the fifth control signal 405 is a low level, the data storage module 220 does not output data, and the data storage address in the data storage module 220 does not change.

[0067] 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 timing control signal, generates a corresponding pulse waveform and outputs it to the electrode end 300, so as to output a stimulation pulse of any waveform. Exemplarily, 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, the output stimulation pulse simulation waveform is as follows: Figure 2 As shown in 407. Embodiment 2

[0068] This embodiment provides a pulse generation method for an implantable medical device. The pulse waveform generated in this embodiment is an asymmetric Gaussian waveform.

[0069] refer to Figure 1 and Figure 3 As shown, first, the data receiving module 210 receives Gaussian data sent by the in vitro controller 100 and stores the Gaussian data in a certain storage format 400 to the data storage module 220 .

[0070] The Gaussian data (hexadecimal data) is stored in the data receiving module 210 according to the following storage format. Figure 3 A data point on the analog waveform 412, for example, 0 represents the lowest point, and 9500 represents the highest positive value.

[0071] Then, the clock generation module 240 generates a clock signal 206 and provides it to the timing control module 230. The timing control module 230 formulates a timing control signal according to the clock signal 206. When each rising edge of the clock signal 406 arrives, a data is output, and then a corresponding Gaussian waveform is output in the stimulation segment L. The timing control signal includes 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 specific formulation method refers to Example 1.

[0072] 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 it to the electrode end 300, and obtains the overall stimulation waveform (asymmetric Gaussian wave) as shown in FIG. Figure 3 As shown in 412.

[0073] The storage format of Gaussian data is:

[0074] data0 = 0 ;data1 = 0 ;data2 = 0 ;data3 = 0 ;data4 = 0 ;

[0075] data5 = 0 ;data6 = 0 ;data7 = 0 ;data8 = 0 ;data9 = 0 ;

[0076] data10 = 0 ;data11 = 0 ;data12 = 0 ;data13 = 0 ;data14 = 0 ;

[0077] data15 = 0 ;data16 = 0 ;data17 = 0 ;data18 = 0 ;data19 = 0 ;

[0078] data20 = 0 ;data21 = 1 ;data22 = 3 ;data23 = 5 ;data24 = 9 ;

[0079] data25 = 16 ;data26 = 26 ;data27 = 42 ;data28 = 68 ;data29 = 105 ;

[0080] data30 = 160 ;data31 = 238 ;data32 = 348 ;data33 = 497 ;data34 = 697 ;

[0081] data35 = 956 ;data36 = 1285;data37 = 1693;data38 = 2185;data39 = 2763;

[0082] data40 = 3424;data41 = 4156;data42 = 4944;data43 = 5762;data44 = 6579;

[0083] data45 = 7360;data46 = 8068;data47 = 8666;data48 = 9120;data49 = 9403;

[0084] data50 = 9500;data51 = 9403;data52 = 9120;data53 = 8666;data54 = 8068;

[0085] data55 = 7360;data56 = 6579;data57 = 5762;data58 = 4944;data59 = 4156;

[0086] data60 = 3424;data61 = 2763;data62 = 2185;data63 = 1693;data64 = 1285;

[0087] data65 = 956;data66 = 697;data67 = 497;data68 = 348;data69 = 238;

[0088] data70 = 160; data71 = 105; data72 = 68; data73 = 42; data74 = 26;

[0089] data75 = 16;data76 = 9;data77 = 5;data78 = 3;data79 = 1;

[0090] data80 = 0 ;data81 = 0 ;data82 = 0 ;data83 = 0 ;data84 = 0 ;

[0091] data85 = 0 ;data86 = 0 ;data87 = 0 ;data88 = 0 ;data89 = 0 ;

[0092] data90 = 0 ;data91 = 0 ;data92 = 0 ;data93 = 0 ;data94 = 0 ;

[0093] data95 = 0 ;data96 = 0 ;data97 = 0 ;data98 = 0 ;data99 = 0 ;

[0094] data100 = 0 .

[0095] It should be noted that the specific functional module structure of the implantable pulse generator of the present invention may be different, and the timing control ideas implemented may also be different, but it should be understood that without departing from the technical principles of the present invention, the timing formulation method formed by changing their implementation methods should also fall within the scope of protection of the present invention.

[0096] In summary, the present invention provides an implantable medical device and a pulse generation method thereof, including a data receiving module that receives data sent by an in vitro controller and stores the data in a data storage module in a certain storage format; a clock generation module that generates a clock signal and provides it to a timing control module, and the timing control module formulates a timing control signal according to the clock signal; the data storage module outputs the data to a pulse output module according to the timing control signal; and the pulse output module generates and outputs stimulation pulses. In the present invention, data is stored in a certain storage manner and output according to a specific timing, so that the waveform of the generated stimulation pulse is arbitrary, the flexibility of the pulse stimulation is improved, and stimulation pulses of corresponding waveforms can be output for different implanted individuals and different diseases, which increases the competitiveness of the product and broadens the scope of treatment.

[0097] The above description is only a description of the preferred embodiment of the present invention, and is not any limitation on the scope of rights of the present invention. Any technical personnel in this field can make possible changes and modifications to the technical solution of the present invention by using the methods and technical contents disclosed above without departing from the spirit and scope of the present invention. Therefore, any simple modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention shall fall within the protection scope of the technical solution of the present invention.

Claims

1. An implantable medical device for generating stimulation pulses of arbitrary waveform, characterized in that: It includes an in vitro controller and an implantable pulse generator, wherein the implantable pulse generator includes a data receiving module, a data storage module, a timing control module, a clock generation module and a pulse output module, wherein the data receiving module is used to receive data sent by the in vitro controller and store the data in the data storage module according to a certain storage format; The clock generation module is used to generate a clock signal and provide it to the timing control module; The timing control module is used to formulate a timing control signal according to the clock signal, so that the data storage module outputs the data to the pulse output module according to the timing control signal; the pulse output module is used to generate and output stimulation pulses; The data stored in the data storage module includes stimulation segment data, intermittent segment data, equilibrium segment constant data and cutoff segment data in sequence; 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; The method for formulating the first control signal is: The first control signal is at a low level during an idle time; When the first rising edge of the clock signal output by the clock generation module arrives, the first control signal changes from a low level to a high level; Determine the relationship between the counter value M of the clock generation module and the sum N1 of the number of the stimulation segment data, the intermittent segment data, the balance segment constant data and the cutoff segment data. If M≥N1, the first control signal changes from a high level to a low level. If M<N1, the first control signal remains at a high level. The second control signal is formulated as follows: The second control signal is at a low level during an idle time; Determine the relationship between the counter value M of the clock generation module and the sum N2 of the number of the stimulation segment data, the intermittent segment data and the balance segment constant data, if M≥N2, the second control signal changes from a low level to a high level, if M<N2, the second control signal remains at a low level; Determine whether the first control signal is at a low level, if the first control signal is at a low level, the level of the second control signal becomes a low level, if the first control signal is at a high level, the level of the second control signal remains unchanged; The method for formulating the third control signal is: The third control signal is at a low level during idle time; Determine the relationship between the counter value M of the clock generation module and the sum N1 of the number of the stimulation segment data, the intermittent segment data, the balance segment constant data and the cutoff segment data. If M≥N1-1, the third control signal changes from a low level to a high level. If M<N1-1, the third control signal remains at a low level. Determine whether the level of the first control signal is low, if the first control signal is low, the level of the third control signal becomes low, if the first control signal is high, the level of the third control signal remains unchanged; The fourth control signal is formulated as follows: The fourth control signal is at a low level during idle time; Determine the relationship between the counter value M of the clock generation module and the sum N1 of the number of the stimulation segment data, the intermittent segment data, the balance segment constant data and the cutoff segment data; if M≥N1, the fourth control signal changes from a low level to a high level; if M<N1, the fourth control signal remains at a low level; Determine whether the level of the first control signal is a low level, if the first control signal is a low level, the level of the fourth control signal becomes a low level, if the first control signal is a high level, the level of the fourth control signal remains unchanged; The level state of the fifth control signal is determined by the level states of the first control signal, the second control signal, the third control signal and the fourth control signal; The 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: fifth control signal = (first control signal XOR second control signal) or (third control signal XOR fourth control signal); The data storage module outputs data according to the rising edge of the clock signal generated by the clock generation module and the level state of the fifth control signal; each time the clock generation module generates a rising edge of a clock signal, it determines whether the level of the fifth control signal is a high level. If the fifth control signal is a high level, the data storage module outputs a data, and the data storage address in the data storage module is incremented by 1. If the fifth control signal is a low level, the data storage module does not output data, and the data storage address in the data storage module does not change.

2. The implantable medical device according to claim 1, characterized in that: The in vitro controller includes a parameter input module and a data sending module. The parameter input module is used to obtain stimulation parameters and send the stimulation parameters to the data sending module; the data sending module is used to convert the stimulation parameters into data and send them to the data receiving module.

3. The implantable medical device according to claim 2, characterized in that: The data sending module and the data receiving module perform data transmission in a wireless manner.

4. The implantable medical device according to claim 1, characterized in that: The implantable medical device further comprises an electrode terminal, and the pulse output module generates a stimulation pulse shape and outputs it to the electrode terminal.

5. The implantable medical device according to claim 1, characterized in that: The clock generation module also provides a clock signal to the data storage module.

6. A computer-readable storage medium, characterized in that: A computer program is stored thereon, and when the computer program is executed by a processor, the following pulse generation method of an implantable medical device is performed, including: The data receiving module receives the data sent by the in vitro controller and stores the data in a data storage module according to a certain storage format; The clock generation module generates a clock signal and provides it to the timing control module, and the timing control module formulates a timing control signal according to the clock signal; The data storage module outputs data to the pulse output module according to the timing control signal; and The pulse output module generates and outputs stimulation pulses; The data stored in the data storage module includes stimulation segment data, intermittent segment data, equilibrium segment constant data and cutoff segment data in sequence; 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; The method for formulating the first control signal is: The first control signal is at a low level during an idle time; When the first rising edge of the clock signal output by the clock generation module arrives, the first control signal changes from a low level to a high level; Determine the relationship between the counter value M of the clock generation module and the sum N1 of the number of the stimulation segment data, the intermittent segment data, the balance segment constant data and the cutoff segment data. If M≥N1, the first control signal changes from a high level to a low level. If M<N1, the first control signal remains at a high level. The second control signal is formulated as follows: The second control signal is at a low level during an idle time; Determine the relationship between the counter value M of the clock generation module and the sum N2 of the number of the stimulation segment data, the intermittent segment data and the balance segment constant data, if M≥N2, the second control signal changes from a low level to a high level, if M<N2, the second control signal remains at a low level; Determine whether the first control signal is at a low level, if the first control signal is at a low level, the level of the second control signal becomes a low level, if the first control signal is at a high level, the level of the second control signal remains unchanged; The method for formulating the third control signal is: The third control signal is at a low level during idle time; Determine the relationship between the counter value M of the clock generation module and the sum N1 of the number of the stimulation segment data, the intermittent segment data, the balance segment constant data and the cutoff segment data. If M≥N1-1, the third control signal changes from a low level to a high level. If M<N1-1, the third control signal remains at a low level. Determine whether the level of the first control signal is low, if the first control signal is low, the level of the third control signal becomes low, if the first control signal is high, the level of the third control signal remains unchanged; The fourth control signal is formulated as follows: The fourth control signal is at a low level during idle time; Determine the relationship between the counter value M of the clock generation module and the sum N1 of the number of the stimulation segment data, the intermittent segment data, the balance segment constant data and the cutoff segment data; if M≥N1, the fourth control signal changes from a low level to a high level; if M<N1, the fourth control signal remains at a low level; Determine whether the level of the first control signal is a low level, if the first control signal is a low level, the level of the fourth control signal becomes a low level, if the first control signal is a high level, the level of the fourth control signal remains unchanged; The level state of the fifth control signal is determined by the level states of the first control signal, the second control signal, the third control signal and the fourth control signal; The 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: fifth control signal = (first control signal XOR second control signal) or (third control signal XOR fourth control signal); The data storage module outputs data according to the rising edge of the clock signal generated by the clock generation module and the level state of the fifth control signal; each time the clock generation module generates a rising edge of a clock signal, it determines whether the level of the fifth control signal is a high level. If the fifth control signal is a high level, the data storage module outputs a data, and the data storage address in the data storage module is incremented by 1. If the fifth control signal is a low level, the data storage module does not output data, and the data storage address in the data storage module does not change.

7. The computer-readable storage medium according to claim 6, wherein: The storage addresses of the stimulation segment data, the intermittent segment data, the balance segment constant data and the cutoff segment data start from a low address and rise in sequence.

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