CN107029352B - Stimulation pulse amplitude adjusting module and implantable neural stimulation system with same - Google Patents

Abstract

The invention discloses a stimulation pulse amplitude adjusting module and an implanted nerve stimulation system with the same, wherein the stimulation pulse amplitude adjusting module comprises an initial amplitude generating unit, an adjusting unit and a processing unit, and the initial amplitude generating unit is used for generating an initial amplitude of a stimulation pulse; the adjusting unit is used for generating an amplitude configuration value; the processing unit is used for superposing the initial amplitude value and the amplitude configuration value to generate a final amplitude value. The invention realizes effective regulation of the pulse amplitude through the regulating module, thereby improving the treatment effect and improving the treatment experience of patients.

Description

Stimulation pulse amplitude modulation module and implantable neurostimulation system having the same

technical field

The invention relates to the field of implantable medicine, in particular to a stimulation pulse amplitude adjustment module and an implantable nerve stimulation system having the same.

Background technique

Implantable medical systems have been widely used in clinical medicine in recent years, usually including implantable neurostimulation systems (including deep brain stimulation system DBS, implantable cerebral cortex stimulation system CNS, implantable spinal cord stimulation system) System stimulation SCS, implantable sacral nerve stimulation system SNS, implantable vagus nerve stimulation system VNS, etc.), implantable cardiac stimulation system (commonly known as pacemaker), implantable drug infusion system (IDDS), etc.

The implantable neurostimulation system is shown in Figure 1, and usually includes the following components: a number of stimulation electrode contacts 30 (here, the left brain electrode contacts and the right brain electrode contacts are taken as examples), electrode leads 33, and extension leads 34 , a pulse generator 35 and a programmer 36 .

Taking the deep brain stimulation system DBS as an example, the pulse generator 35 conducts electrical pulses to the brain STN (Subthalamic Nucleus, subthalamic nucleus) nucleus through the extension lead 34, the electrode lead 33 and the stimulation electrode contact 30 to achieve the treatment of Parkinson's disease. the purpose of the disease.

The programmer 36 is used to adjust various stimulation parameters of the pulse generator 35, and the stimulation parameters include pulse amplitude, pulse width (ie, pulse width) and pulse frequency.

Combined with Figure 2, it is a typical bidirectional pulse stimulation waveform, that is, relative to the "voltage zero volt reference line", there are positive stimulation voltage and negative stimulation voltage at the same time.

Among them, the real therapeutic effect is the negative stimulation voltage.

Figure 2 shows the microscopic waveform of constant voltage pulse stimulation. However, in practice, the pulse amplitude PA of the negative stimulation voltage is not constant.

Combined with the enlarged view in Figure 2, as time goes by, the negative pulse amplitude PA in a predetermined stimulation period PT presents a trapezoidal state, that is, the pulse amplitude PA decreases, that is to say, it is not a real constant voltage at this time. Stimulation will bring a bad treatment experience to the patient.

The above phenomenon is caused by the change of charge on the capacitor in the implantable neurostimulation system, namely:

Q=I*Δt=C*ΔV, then ΔV=I*Δt/C.

Among them, Q is the electric quantity on the capacitor; C is the capacitance value of the capacitor; I is the stimulation current or the current value obtained by dividing the stimulation voltage by the resistance; Δt is the time change in a predetermined stimulation period PT, that is, the pulse width PW; ΔV is the amount of voltage variation, that is, the variation of the pulse amplitude PA.

It can be seen from this that the wider the pulse width PW, the greater the variation of the pulse amplitude PA, that is, the pulse amplitude PA will decrease with the increase of the pulse width PW.

In addition, in conjunction with Fig. 3, it is a typical macroscopic waveform of pulse stimulation.

It can be seen that when the stimulation is turned on and off, the change of the pulse amplitude PA is relatively sudden, and the pulse amplitude PA presents a state of steep rise and steep drop when the stimulation is turned on and off. Brought a bad treatment experience.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide a stimulation pulse amplitude adjustment module and an implantable nerve stimulation system having the same.

In order to achieve one of the above purposes of the invention, an embodiment of the present invention provides an implantable nerve stimulation pulse amplitude adjustment module, including:

an initial amplitude generating unit, which is used for generating an initial amplitude of a stimulation pulse, the stimulation pulse includes a positive stimulation pulse and a negative stimulation pulse;

an adjustment unit for generating an amplitude configuration value;

a processing unit, configured to superimpose the initial amplitude corresponding to the negative stimulation pulse and the amplitude configuration value to generate a final amplitude;

Wherein, the adjustment unit includes a micro-adjustment unit, and the micro-adjustment unit is used to generate a micro-amplitude configuration value, and within a predetermined stimulation period, the processing unit compares the initial amplitude value with the micro-amplitude configuration value The microscopic final amplitude is generated by superposition, and the microscopic final amplitude is an incremental amplitude, and the adjustment module is used to realize constant pressure stimulation.

As a further improvement of an embodiment of the present invention, the adjustment module further includes a control unit, the control unit is configured to generate a micro-enable signal, and when the micro-enable signal is at a high level, the micro-adjustment unit generates the Describe the micro-amplitude configuration value.

As a further improvement of an embodiment of the present invention, the adjustment unit includes a macro adjustment unit, and the macro adjustment unit is configured to generate a macro amplitude configuration value, and in a stimulation stage including several predetermined stimulation cycles, the processing unit will The initial amplitude value and the macroscopic amplitude configuration value are superimposed to generate several macroscopic final amplitudes corresponding to several predetermined stimulation periods, and the several macroscopic final amplitudes show a gradual trend.

As a further improvement of an embodiment of the present invention, the plurality of macroscopic final amplitudes include an increasing trend and/or a decreasing trend.

As a further improvement of an embodiment of the present invention, the adjustment module further includes a control unit, and the control unit is configured to generate a macro-enable signal. When the macro-enable signal is at a high level, the macro adjustment unit generates the macro-enable signal. Describe the macro-amplitude configuration value.

In order to achieve one of the above purposes of the invention, an embodiment of the present invention provides an implantable nerve stimulation pulse amplitude adjustment module, including:

an initial amplitude generating unit for generating an initial amplitude of the stimulation pulse;

a micro-adjustment unit for generating micro-amplitude configuration values;

a macro-adjustment unit for generating macro-amplitude configuration values;

A processing unit, in a predetermined stimulation period, the processing unit superimposes the initial amplitude value and the microscopic amplitude configuration value to generate a microscopic final amplitude value, and in a stimulation stage including a plurality of predetermined stimulation periods, the The processing unit superimposes the microscopic final amplitude and the macroscopic amplitude configuration value to generate a plurality of macroscopic final amplitudes corresponding to several predetermined stimulation cycles, and the microscopic final amplitude is an incremental amplitude, and the adjustment module is used for Achieve constant pressure stimulation.

As a further improvement of an embodiment of the present invention, the plurality of macroscopic final amplitudes include an increasing trend and/or a decreasing trend.

As a further improvement of an embodiment of the present invention, the adjustment module further includes a high-frequency clock and a frequency dividing unit, and the high-frequency clock generates a high-frequency divided clock and a low-frequency divided clock after passing through the frequency dividing unit. The sub-clock is used to control the micro-adjustment unit, and the low-frequency sub-clock is used to control the initial amplitude generating unit and the macro-adjustment unit.

In order to achieve one of the above purposes of the invention, an embodiment of the present invention provides an implantable nerve stimulation system, including the implantable nerve stimulation pulse amplitude adjustment module, a pulse generator and a stimulation electrode contact as described in any one of the above technical solutions. point, the pulse generator generates stimulation pulses according to the final amplitude generated by the conditioning module, and the pulse generator outputs the stimulation pulses to the stimulation electrode contacts.

Compared with the prior art, the beneficial effect of the present invention is that: an embodiment of the present invention realizes the effective adjustment of the pulse amplitude through the adjustment module, thereby improving the treatment effect and improving the treatment experience of the patient.

Description of drawings

1 is a schematic diagram of a prior art implantable nerve stimulation system;

2 is a microscopic diagram of a bidirectional pulse stimulation waveform in the prior art;

Fig. 3 is the macroscopic view of prior art bidirectional pulse stimulation waveform;

4 is a schematic diagram of a stimulation pulse amplitude adjustment module according to an embodiment of the present invention;

FIG. 5 is a schematic diagram of microscopic adjustment of stimulation pulse amplitude according to an embodiment of the present invention;

6 is a schematic diagram of a micro-adjustment unit according to an embodiment of the present invention;

FIG. 7 is a schematic diagram of macroscopic adjustment of stimulation pulse amplitude according to an embodiment of the present invention;

8 is a schematic diagram of several forms of macroscopic adjustment of the stimulus pulse amplitude according to an embodiment of the present invention;

FIG. 9 is a schematic diagram of a macro adjustment unit according to an embodiment of the present invention.

Detailed ways

The present invention will be described in detail below with reference to the specific embodiments shown in the accompanying drawings. However, these embodiments do not limit the present invention, and structural, method, or functional changes made by those skilled in the art according to these embodiments are all included in the protection scope of the present invention.

An embodiment of the present invention provides an implantable neurostimulation system (refer to FIG. 1 ).

Referring to FIG. 4 , the implantable nerve stimulation system includes a stimulation pulse amplitude adjustment module 100 , a pulse generator (not shown) and a stimulation electrode contact (not shown).

Wherein, the pulse generator generates stimulation pulses according to the final amplitude values (PA1' and/or PA2') generated by the adjustment module 100, and the pulse generator outputs the stimulation pulses to the stimulation electrode contacts.

For other descriptions of the implantable neurostimulation system (for example, the implantable neurostimulation system further includes electrode leads, extension leads, and programmers, etc.), reference may be made to the description of FIG. 1 , which will not be repeated here.

In this embodiment, the stimulation pulse amplitude adjustment module 100 includes an initial amplitude generation unit 10 , an adjustment unit 11 and a processing unit 12 .

The initial amplitude generating unit 10 is used for generating the initial amplitude PA of the stimulation pulse.

The adjustment unit 11 is used to generate the amplitude configuration values (PA1 and/or PA2).

The processing unit 12 is configured to superimpose the initial amplitude value PA and the amplitude configuration value (PA1 and/or PA2) to generate a final amplitude value (PA1' and/or PA2').

Here, the pulse amplitude can be effectively adjusted by the adjustment module 100, thereby improving the treatment effect and improving the patient's treatment experience.

In this embodiment, the processing unit 12 may be an AND gate unit.

In this embodiment, the adjustment unit 11 includes a micro adjustment unit 11a.

The micro adjustment unit 11a is used to generate the micro amplitude configuration value PA1. With reference to FIG. 5 , within a predetermined stimulation period PT, the processing unit 12 superimposes the initial amplitude PA and the micro amplitude configuration value PA1 And produce the microscopic final amplitude PA1'.

The adjustment module 100 further includes a control unit 13, the control unit 13 is configured to generate a micro-enable signal Micro_EN, when the micro-enable signal Micro_EN is at a high level, the micro-adjustment unit 11a generates the micro-amplitude Configure the value PA1.

That is to say, through the control of the micro-enable signal Micro_EN, the generation time of the micro-amplitude configuration value PA1 can be guaranteed to correspond one-to-one with the generation time of the initial amplitude PA in a predetermined stimulation period PT. In this way, the initial amplitude PA can be realized. Accuracy of stacking with micro-amplitude configuration value PA1.

It should be noted that the initial amplitude PA, the micro-amplitude configuration value PA1 and the micro-final amplitude PA1' all refer to preset amplitudes, for example, a series of information about the amplitudes written in the pulse generator. The initial amplitude PA, the microscopic amplitude configuration value PA1 and the microscopic final amplitude PA1' all refer to the pulse amplitude of negative stimulation.

Referring to waveform 1 in FIG. 5 , taking constant voltage stimulation as an example, the initial amplitude PA of the pulse amplitude is a constant amplitude.

For parameter waveform 2, by superimposing the micro amplitude configuration value PA1, the micro final amplitude PA1' is obtained, and the micro final amplitude PA1' is an incremental amplitude.

With reference to waveform 3, due to the influence of the change in the amount of electricity on the capacitor in the implantable neurostimulation system, when the pulse generator outputs the microscopic final amplitude PA1', the actual output is the microscopic actual amplitude PA1" shown in waveform 3. , the microscopic actual amplitude PA1” is the constant voltage amplitude.

It can be understood that, referring to the description of the background art, due to the influence of the change of the capacitance, the pulse amplitude actually output by the pulse generator will have a gradually decreasing effect. The actual output of the pulse generator in this embodiment is the corresponding microscopic final amplitude. The pulse amplitude of PA1', because the microscopic final amplitude PA1' shows an increasing trend, this and the reduction effect of the amplitude caused by the change of the capacitance can cancel each other. In this way, the microscopic actual amplitude of the actual output of the pulse generator PA" is the constant pressure amplitude, so that true constant pressure stimulation is realized within the predetermined stimulation period PT, the therapeutic effect is increased, and the side effects are reduced.

Of course, the microscopic actual amplitude PA" is not limited to the constant voltage amplitude. For example, the microscopic amplitude configuration value PA1 can be adjusted according to the actual situation of the patient, so as to realize any pulse amplitude and further improve the flexibility of the treatment.

In this embodiment, referring to FIG. 6 , the micro-adjustment unit 11a is a micro-register, the micro-register includes several micro-register bits 111a (Microscopic Reg 1 to Microscopic Reg n), and each micro-register bit 111a can store a micro-amplitude value The configuration value PA1 and the micro-amplitude configuration value PA1 are essentially a series of gradual amplitude values, and the duration occupied by the micro-amplitude configuration value PA1 stored in the microscopic register bits 111a corresponds to the duration defined by a pulse width PW.

It can be understood that when the processing unit 12 superimposes the initial amplitude value PA and the microscopic amplitude configuration value PA1 to generate the microscopic final amplitude value PA1', the microscopic final amplitude value PA1' presents a stepped shape. When the number of microscopic register bits 111a is large enough, The microscopic final amplitude PA1' changes linearly.

In this embodiment, the adjustment unit 11 further includes a macro adjustment unit 11b.

With reference to FIG. 4 , the adjustment module 100 further includes a high frequency clock HIGH CLOCK and a frequency dividing unit 14 .

The high-frequency clock HIGH CLOCK passes through the frequency dividing unit 14 to generate a high-frequency divided clock HIGH CLOCK1 and a low-frequency divided clock LOW CLOCK1. The high-frequency divided clock HIGH CLOCK1 is used to control the micro adjustment unit 11a. The divided clock LOW CLOCK1 is used to control the initial amplitude generation unit 10 and the macro adjustment unit 11b.

The frequency of the high-frequency sub-clock HIGH CLOCK1 is an integer multiple of the low-frequency sub-clock LOW CLOCK1, but not limited thereto.

Here, using the high-frequency clock HIGH CLOCK and the frequency dividing unit 14 has the following advantages: (1) The complexity and cost of the system are reduced, one clock input is used, only one input pin and one clock crystal oscillator are required, and the structure is simple; (2) ) to ensure that the high-frequency sub-clock HIGH CLOCK1 and the low-frequency sub-clock LOW CLOCK1 are the same source clock, which is very beneficial for precise timing control.

In this embodiment, the macro adjustment unit 11b is used to generate the macro amplitude configuration value PA2. Referring to FIG. 7 , in a stimulation phase including several predetermined stimulation periods PT, the processing unit 12 adjusts the initial amplitude PA and the macroscopic amplitude configuration value PA2 are superimposed to generate several macroscopic final amplitudes PA2' corresponding to several predetermined stimulation periods PT, and the several macroscopic final amplitudes PA2' show a gradual trend.

The control unit 13 is further configured to generate a macro-enable signal Macro_EN. When the macro-enable signal Macro_EN is at a high level, the macro-adjustment unit 11b generates the macro-amplitude configuration value PA2.

That is to say, through the control of the macro-enable signal Macro_EN, it can be ensured that the generation time of the macro-amplitude configuration value PA2 corresponds to the generation time of several initial amplitude values PA of several predetermined stimulation periods PT in the stimulation stage. Accuracy of superposition of several initial amplitude values PA and several macroscopic amplitude configuration values PA2 is achieved.

It should be noted that the initial amplitude PA, the macro amplitude configuration value PA2 and the macro final amplitude PA2' here all refer to preset amplitudes, such as a series of information about the amplitudes written in the pulse generator. The number of control, and the initial amplitude PA, macro amplitude configuration value PA2 and macro final amplitude PA2' all refer to the pulse amplitude of negative stimulation.

Referring to waveform 4 in FIG. 7 , taking constant voltage stimulation as an example, the initial amplitude PA of the pulse amplitude is a constant amplitude.

With reference to waveform 5, the macroscopic final amplitude PA2' is obtained by superimposing the macroscopic amplitude configuration value PA2. Several macroscopic final amplitudes PA2' in several predetermined stimulation periods PT show a gradual trend. Here, the increasing trend for a period of time and another Take, for example, a decreasing trend over a period of time.

Referring to waveform 6, when the micro-adjustment unit 11a does not perform amplitude adjustment, refer to the enlarged diagram. At this time, each macro-actual amplitude PA2" of the several macro-actual amplitudes PA2" actually output shows a decreasing trend.

Referring to waveform 7, when the micro-adjustment unit 11a performs amplitude adjustment, refer to the enlarged diagram, and each macro-actual amplitude PA2" of the several macro-actual amplitudes PA2" actually output at this time is a constant-voltage amplitude.

It can be understood that the pulse amplitude actually output by the pulse generator shows a macroscopically gradual trend, and through the reasonable setting of the macroscopic amplitude configuration value PA2, the gradual change trend includes an increasing trend and/or a decreasing trend.

With reference to Fig. 8, the situation of the pulse amplitude actually output by the pulse generator is listed on a macroscopic level.

For waveform 8, the pulse amplitude shows an increasing trend and a decreasing trend respectively at the start and end of the stimulation, while at the middle of the stimulation, the pulse amplitude is constant. Slowly reducing the stimulus when it is turned off can effectively improve the patient's treatment experience and improve the quality of treatment.

The difference between the parameter waveform 9 and the waveform 8 is that the pulse amplitude shows an increasing trend only at the start of stimulation, and the pulse amplitude is constant at other times.

The difference between the parameter waveform 10 and the waveform 8 is that the pulse amplitude shows a decreasing trend only when the stimulation is turned off, and the pulse amplitude is constant at other times.

Of course, the macroscopic situation of the pulse amplitude can also be other forms, which can be determined according to the actual situation.

In this embodiment, referring to FIG. 9 , the macro adjustment unit 11b is a macro register. The macro register includes several micro register bits 111b (Macroscopic Reg 1 to Macroscopic Reg n), and each macro register bit 111b can store a macro amplitude value The configuration value PA2, the macro-amplitude configuration value PA2 is essentially a series of interval-distributed and gradually changing amplitude values, and the duration occupied by the macro-amplitude configuration value PA2 stored in each macro register bit 111b corresponds to the duration defined by a pulse width PW, Then, the total duration occupied by the macro amplitude configuration value PA2 stored in the several macro register bits 111b corresponds to the total duration defined by the several interval pulse widths PW.

In this embodiment, the micro-adjustment unit 11a and the macro-adjustment unit 11b can be adjusted individually or jointly, and the specifics can be determined according to the actual situation.

When the micro-adjustment unit 11a and the macro-adjustment unit 11b jointly adjust, within a predetermined stimulation period PT, the processing unit 12 superimposes the initial amplitude PA and the micro-amplitude configuration value PA1 to generate a micro-final amplitude PA1', and in a stimulation stage including a plurality of predetermined stimulation periods PT, the processing unit 12 superimposes the microscopic final amplitude PA1' and the macroscopic amplitude configuration PA2 to generate a plurality of predetermined stimulation periods PT. The macroscopic final amplitude PA2', at this time, the actual output is a pulse amplitude that shows a gradual trend on the macroscopic level and a constant voltage trend on the microscopic level.

It can be understood that there is no clear sequence relationship between the adjustment processes of the micro adjustment unit 11a and the macro adjustment unit 11b.

It should be understood that although this specification is described in terms of embodiments, not every embodiment only includes an independent technical solution, and this description in the specification is only for the sake of clarity, and those skilled in the art should take the specification as a whole, and each The technical solutions in the embodiments can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

The series of detailed descriptions listed above are only specific descriptions for the feasible embodiments of the present invention, and they are not used to limit the protection scope of the present invention. Changes should all be included within the protection scope of the present invention.

Claims (9)

1. an implantable nerve stimulation pulse amplitude adjustment module is characterized in that comprising: an initial amplitude generating unit, which is used for generating an initial amplitude of a stimulation pulse, the stimulation pulse includes a positive stimulation pulse and a negative stimulation pulse; an adjustment unit for generating an amplitude configuration value; a processing unit, configured to superimpose the initial amplitude corresponding to the negative stimulation pulse and the amplitude configuration value to generate a final amplitude; Wherein, the adjustment unit includes a micro-adjustment unit, and the micro-adjustment unit is used to generate a micro-amplitude configuration value, and within a predetermined stimulation period, the processing unit compares the initial amplitude value with the micro-amplitude configuration value The microscopic final amplitude is generated by superposition, and the microscopic final amplitude is an incremental amplitude, and the adjustment module is used to realize constant pressure stimulation. 2 . The implanted nerve stimulation pulse amplitude adjustment module according to claim 1 , wherein the adjustment module further comprises a control unit, and the control unit is configured to generate a microscopic enabling signal. When the energy signal is at a high level, the microscopic adjustment unit generates the microscopic amplitude configuration value. 3 . The implanted nerve stimulation pulse amplitude adjustment module according to claim 1 , wherein the adjustment unit comprises a macroscopic adjustment unit, and the macroscopic adjustment unit is used to generate a macroscopic amplitude configuration value. 3 . In the stimulation stages of several predetermined stimulation cycles, the processing unit superimposes the initial amplitude value and the macroscopic amplitude configuration value to generate several macroscopic final amplitudes corresponding to several predetermined stimulation cycles, and the several macroscopic final amplitudes are expressed as: Gradient trend. 4 . The implantable nerve stimulation pulse amplitude adjustment module according to claim 3 , wherein the several macroscopic final amplitudes include an increasing trend and/or a decreasing trend. 5 . 5 . The implanted nerve stimulation pulse amplitude adjustment module according to claim 3 , wherein the adjustment module further comprises a control unit, and the control unit is configured to generate a macro-enable signal. When the energy signal is at a high level, the macro adjustment unit generates the macro amplitude configuration value. 6. An implantable nerve stimulation pulse amplitude adjustment module is characterized in that comprising: an initial amplitude generating unit for generating an initial amplitude of the stimulation pulse; a micro-adjustment unit for generating micro-amplitude configuration values; a macro-adjustment unit for generating macro-amplitude configuration values; A processing unit, in a predetermined stimulation period, the processing unit superimposes the initial amplitude value and the microscopic amplitude configuration value to generate a microscopic final amplitude value, and in a stimulation stage including a plurality of predetermined stimulation periods, the The processing unit superimposes the microscopic final amplitude and the macroscopic amplitude configuration value to generate a plurality of macroscopic final amplitudes corresponding to several predetermined stimulation cycles, and the microscopic final amplitude is an incremental amplitude, and the adjustment module is used for Achieve constant pressure stimulation. 7 . The implantable nerve stimulation pulse amplitude adjustment module according to claim 6 , wherein the several macroscopic final amplitudes include an increasing trend and/or a decreasing trend. 8 . 8 . The implanted nerve stimulation pulse amplitude adjustment module according to claim 6 , wherein the adjustment module further comprises a high-frequency clock and a frequency dividing unit, and the high-frequency clock passes through the frequency dividing unit. 9 . A high-frequency sub-clock and a low-frequency sub-clock are generated, the high-frequency sub-clock is used to control the micro-adjustment unit, and the low-frequency sub-clock is used to control the initial amplitude generation unit and the macro-adjustment unit. 9. An implantable nerve stimulation system, characterized in that it comprises an implantable nerve stimulation pulse amplitude adjustment module, a pulse generator and a stimulation electrode contact as described in any one of claims 1-8, the pulse A generator generates stimulation pulses according to the final amplitudes generated by the conditioning module, and the pulse generator outputs the stimulation pulses to the stimulation electrode contacts.

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