CN111420276A - Implanted nerve stimulation equipment and system with frequency conversion function - Google Patents

Implanted nerve stimulation equipment and system with frequency conversion function Download PDF

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Publication number
CN111420276A
CN111420276A CN202010209055.9A CN202010209055A CN111420276A CN 111420276 A CN111420276 A CN 111420276A CN 202010209055 A CN202010209055 A CN 202010209055A CN 111420276 A CN111420276 A CN 111420276A
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CN
China
Prior art keywords
frequency conversion
stimulation
conversion parameters
frequency
groups
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CN202010209055.9A
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Chinese (zh)
Inventor
马伯志
郝红伟
李青峰
陈浩
李路明
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Tsinghua University
Beijing Pins Medical Co Ltd
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Tsinghua University
Beijing Pins Medical Co Ltd
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Priority to CN202010209055.9A priority Critical patent/CN111420276A/en
Publication of CN111420276A publication Critical patent/CN111420276A/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36067—Movement disorders, e.g. tremor or Parkinson disease

Abstract

The invention provides an implanted nerve stimulation device with a frequency conversion function and a system, wherein the device comprises a control unit, a parameter storage unit and an output unit; the parameter storage unit is used for storing a plurality of groups of frequency conversion parameters, and the frequency conversion parameters comprise stimulation frequency and at least one parameter of amplitude, pulse width, stimulation contact and duration; the control unit is used for acquiring at least two groups of frequency conversion parameters and controlling the output unit to output at least two corresponding pulse sequences according to the at least two groups of frequency conversion parameters.

Description

Implanted nerve stimulation equipment and system with frequency conversion function
Technical Field
The invention relates to the field of implantable medical equipment, in particular to implantable nerve stimulation equipment with a frequency conversion function and a system.
Background
Conventional implantable Deep Brain Stimulators (DBS) mostly use pulsed stimulation at a single fixed frequency. However, clinical studies have shown that DBS has no significant therapeutic effect on the symptoms of tremor, rigidity, unresponsiveness, and postural instability in some parkinson patients. For other patients, DBS may bring side effects such as cognitive decline, depression, language dysfunction, balance ability decline, etc., causing patients to have symptoms such as memory decline, difficulty speaking, easy falling, etc. Moreover, once a patient becomes adaptive to a fixed frequency stimulus, the therapeutic effect decreases over time.
Some DBS currently try to solve the inefficiency problem by increasing the stimulation frequency, but there are many drawbacks to continuous high frequency stimulation. First, increasing the frequency of stimulation also increases the risk of side effects. Secondly, the increased power consumption of continuous high frequency stimulation leads to a shortened service life of the device. Finally, continuous high frequency stimulation still uses a single frequency, and cannot solve the problem that the treatment effect is reduced due to the adaptation of the patient.
Disclosure of Invention
In view of the above, the present invention provides an implantable neurostimulation device with frequency conversion function, which comprises a control unit, a parameter storage unit and an output unit; the parameter storage unit is used for storing a plurality of groups of frequency conversion parameters, and the frequency conversion parameters comprise stimulation frequency and at least one parameter of amplitude, pulse width, stimulation contact and duration; the control unit is used for acquiring at least two groups of frequency conversion parameters and controlling the output unit to output at least two corresponding pulse sequences according to the at least two groups of frequency conversion parameters.
Optionally, the control unit is configured to sequentially and cyclically use at least two groups of the frequency conversion parameter control output units to sequentially and cyclically output at least two corresponding pulse sequences.
Optionally, the parameter storage unit is configured to store a plurality of stimulation program groups, each stimulation program group including a plurality of sets of frequency conversion parameters; the control unit is used for selecting one stimulation program group and controlling the output unit to output various corresponding pulse sequences by utilizing multiple groups of frequency conversion parameters of the selected stimulation program group.
Optionally, the frequency conversion parameter further includes an interval time for indicating a time interval between a next pulse sequence and a currently output pulse sequence.
Optionally, the device further includes a communication unit, configured to connect to an external programming device, so that the external programming device sets the frequency conversion parameter in the parameter storage unit.
The invention also provides a control method of the implantable nerve stimulation device, which comprises the following steps:
determining at least two groups of frequency conversion parameters, wherein the frequency conversion parameters comprise stimulation frequency and at least one parameter of amplitude, pulse width, stimulation contact and duration;
and generating two corresponding pulse sequences according to the at least two groups of frequency conversion parameters.
Optionally, the stimulation frequencies in the sets of frequency conversion parameters determined to be used are different.
Optionally, the determined sets of frequency conversion parameters other than the stimulation frequency are at least partially different.
Optionally, the frequency conversion parameter further includes an interval time, which is used to indicate the interval time between the next pulse sequence and the currently generated pulse sequence; generating two corresponding pulse sequences according to the at least two groups of frequency conversion parameters, including:
timing after outputting a corresponding pulse sequence by using the current frequency conversion parameter;
and when the timing reaches the interval time of the current frequency conversion parameter, generating a corresponding pulse sequence by using the next frequency conversion parameter.
The invention also provides an implantable nerve stimulation system, which comprises the stimulation equipment and in-vitro program control equipment, wherein the in-vitro program control equipment is used for setting the frequency conversion parameters.
According to the frequency conversion stimulation equipment provided by the embodiment of the invention, the parameter storage unit can be configured with multiple groups of frequency conversion parameters, wherein multiple stimulation frequencies and combinations of the stimulation frequencies and the amplitude, pulse width, stimulation contact and duration parameters are provided, and the control unit can enable the output unit to output multiple corresponding pulse sequences by adopting multiple groups of frequency conversion parameters, so that more stimulation means are provided, different clinical requirements can be better met, and the frequency conversion stimulation equipment has potential value particularly for treating pain through spinal cord stimulation.
According to the frequency conversion stimulation method provided by the embodiment of the invention, a plurality of stimulation frequencies and combination of the stimulation frequencies, a plurality of amplitudes, pulse widths, stimulation contacts and duration parameters are adopted, and a plurality of corresponding pulse sequences can be output, so that more stimulation means are provided, different clinical requirements can be better met, and the frequency conversion stimulation method has potential value particularly for treating pain through spinal cord stimulation.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.
FIG. 1 is a schematic diagram of an implantable neurostimulation system in an embodiment of the present invention;
FIG. 2 is a schematic diagram of various pulse sequences in an embodiment of the present invention;
FIG. 3 is a schematic diagram of a pulse sequence combination according to an embodiment of the present invention;
fig. 4 is a schematic diagram of an implantable neurostimulation device in an embodiment of the present invention;
fig. 5 is a schematic diagram of a preferred implantable neurostimulation device in an embodiment of the present invention.
Detailed Description
The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
In the description of the present invention, it should be noted that the terms "first", "second", and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. In addition, the technical features involved in the different embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.
The embodiment of the invention provides a frequency conversion stimulation method of implantable neural stimulation equipment. As shown in fig. 1, the method may be performed by the external programming device 1, the stimulator 2, or both:
at least two sets of frequency conversion parameters are determined. The frequency conversion parameters comprise stimulation frequency and at least one of four parameters of amplitude, pulse width, stimulation contact and duration. The set of frequency conversion parameters includes at least a stimulation frequency and at least one other parameter. For the convenience of understanding, the present embodiment is described by including 5 parameters of stimulation frequency, amplitude, pulse width, stimulation contact point, and duration at the same time, for example, n sets of frequency conversion parameters, where the 1 st set of frequency conversion parameters is [ frequency f1, amplitude a1, pulse width w1, stimulation contact point p1, duration t1], the 2 nd set of frequency conversion parameters is [ frequency f2, amplitude a2, pulse width w2, stimulation contact point p2, duration t2], … …, and the nth set of frequency conversion parameters is [ frequency fn, amplitude an, pulse width wn, stimulation contact point pn, duration tn ].
Each set of frequency conversion parameters can determine a corresponding pulse sequence, the pulse sequence is composed of a plurality of pulse signals, the stimulation frequency in the parameters refers to the frequency of the pulse sequence, the amplitude refers to the extreme value of each pulse signal in the pulse sequence, the pulse width refers to the time for each pulse signal in the pulse sequence to reach the extreme value, and the duration refers to the time length for outputting the pulse sequence.
With respect to stimulation contacts, stimulator 2 generally includes a plurality of channels, each of which has a plurality of stimulation contacts (electrodes) disposed thereon, each of which is operable to output a sequence of pulses for electrically stimulating different locations within a human body, such as deep brain or spinal cord. The stimulating contacts in the frequency conversion parameters of the present application are used to indicate which contact outputs the pulse sequence. For example, the stimulator 2 has 16 stimulation contacts, and the stimulation contact parameter of the frequency conversion parameters is used to indicate which one or more of the 16 stimulation contacts outputs the pulse sequence. As an exemplary illustration, assuming that the stimulation contact parameters in a certain set of frequency conversion parameters are "1, 3, 5", the frequency is 1kHz, the pulse width is 50us, and the duration is 1s, it means that three contacts 1, 3, 5 are indicated, and a pulse sequence is output at a frequency of 1kHz and a pulse width of 50us, and lasts for 1 s.
And after the frequency conversion parameters are determined, outputting corresponding multiple pulse sequences according to the determined multiple groups of frequency conversion parameters. For example, it is determined that 3 different sets of frequency conversion parameters are used, which can correspond to 3 pulse sequences shown in fig. 2 according to the above description. As a specific example, for example, the 1 st set of frequency conversion parameters is [ frequency 10kHz, pulse width 30us, duration 100ms ], the 2 nd set of frequency conversion parameters is [ frequency 1kHz, pulse width 50us, duration 1s ], and the 3 rd set of frequency conversion parameters is [ frequency 40Hz, pulse width 210us, duration 10s ].
The various pulse sequences corresponding to the multiple sets of frequency conversion parameters determined to be used should be output alternately, that is, the multiple sets of frequency conversion parameters should be used alternately, but the order of use is not limited. For example, for the three pulse sequences shown in fig. 2, pulse A, B, C for short, a-B-C may be output in the order of 3 sets of frequency conversion parameters, C-B-a may be output out of order, B-a-C may be output, and so on.
In actual use, the frequency conversion parameters can be set artificially, and in order to ensure the frequency conversion effect, at least part of groups of stimulation frequencies in the frequency conversion parameters used by the equipment are unequal. As a preferred embodiment, the stimulation frequencies in the sets of frequency conversion parameters determined to be used are different, such as the above-mentioned 3 sets of frequency conversion parameters, wherein the stimulation frequencies are 10kHz, 1kHz and 40Hz respectively. Other parameters such as amplitude, pulse width, stimulation contact, duration may be partially different, or the same.
To ensure that the frequency of the pulse train is effective for most patients, the stimulation frequency should be within a set range, i.e., the frequency of the pulse train output by the stimulator 2 should be within a safe and effective range, which is 2Hz-20 kHz. This range is 2Hz to 250Hz when applied to deep brain stimulators.
The value range of the duration can be 1ms-24 h. The amplitude can be in the range of 0-10V or 0-25 mA. The range of the pulse width is 20us-1000 us. The user can set the frequency conversion parameters within the above range. In addition, the stimulation waveforms at different frequencies can be set to passive charge balance or active charge balance as desired.
According to the frequency conversion stimulation method provided by the embodiment of the invention, a plurality of stimulation frequencies and combination of the stimulation frequencies, a plurality of amplitudes, pulse widths, stimulation contacts and duration parameters are adopted, and a plurality of corresponding pulse sequences can be output, so that more stimulation means are provided, different clinical requirements can be better met, and the frequency conversion stimulation method has potential value particularly for treating pain through spinal cord stimulation.
In a preferred embodiment, the frequency conversion parameter further comprises an interval time indicating a time interval between a next pulse sequence and a currently output pulse sequence, the interval time being in a range of 0-100 seconds. Thus, the process of outputting two corresponding pulse sequences by using multiple sets of frequency conversion parameters can be described as follows: timing after outputting a corresponding pulse sequence by using the current frequency conversion parameter; and when the timing reaches the interval time of the current frequency conversion parameter, outputting a corresponding pulse sequence by using the next frequency conversion parameter. As shown in fig. 3, when the pulse train a is output by using the 1 st set of frequency conversion parameters, i.e. the duration reaches 100ms, the timing is started, and assuming that the interval time in the 1 st set of frequency conversion parameters is T1, the pulse train B is output by using the 2 nd set of frequency conversion parameters when the timing reaches T1. Similarly, when the timing reaches T2 after the pulse sequence B is finished, the 3 rd group of frequency conversion parameters are used for outputting the pulse sequence C, and when the timing reaches T3 after the pulse sequence B is finished, the next group of frequency conversion parameters are used for outputting the corresponding pulse sequence.
The preferred scheme enables the interval time between various pulse sequences to be set respectively, and the interval time in each group of frequency conversion parameters can be completely different, partially same or same, thereby further enriching stimulation means.
In order to improve efficiency and convenience, multiple groups of frequency conversion parameters can be used in sequence and circularly to output corresponding multiple pulse sequences. For example, for the above example, after the pulse train C is outputted using the 3 rd set of frequency conversion parameters, the pulse train a is outputted again using the 1 st set of frequency conversion parameters, so that the stimulator 2 outputs the pulse train a-B-C-a-B-C … … in a cyclic manner.
The embodiment of the invention also provides implanted nerve stimulation equipment with a frequency conversion function, which can be spinal cord stimulation equipment or deep brain electrical stimulation equipment. As shown in fig. 4, as a stimulator implanted in a human body, the apparatus includes a control unit 41, a parameter storage unit 42, and an output unit 43, and the output unit 43 is connected to a plurality of electrodes for outputting a pulse sequence. The parameter storage unit 41 is used for storing multiple sets of frequency conversion parameters, including stimulation frequency, and at least one parameter of amplitude, pulse width, stimulation contact point and duration. The control unit 41 is configured to obtain at least two sets of frequency conversion parameters, and control the output unit 43 to output at least two corresponding pulse sequences according to the at least two sets of frequency conversion parameters. The content related to the correspondence between the frequency conversion parameter and the pulse sequence can refer to the above method, and is not described herein again.
The stimulation device further comprises a communication unit 44 for connecting the external programmable device to perform wireless communication, and a user can set the frequency conversion parameters in the parameter storage unit 42 through the external programmable device, such as adding, modifying or deleting various frequency conversion parameters and other parameters.
According to the frequency conversion stimulation equipment provided by the embodiment of the invention, the parameter storage unit can be configured with multiple groups of frequency conversion parameters, wherein multiple stimulation frequencies and combinations of the stimulation frequencies and the amplitude, pulse width, stimulation contact and duration parameters are provided, and the control unit can enable the output unit to output multiple corresponding pulse sequences by adopting multiple groups of frequency conversion parameters, so that more stimulation means are provided, different clinical requirements can be better met, and the frequency conversion stimulation equipment has potential value particularly for treating pain through spinal cord stimulation.
In view of the limited number of sets of frequency conversion parameters stored in the parameter storage unit 42 in actual use, the control unit 41 may be configured to sequentially cyclically use at least two sets of frequency conversion parameters to control the output unit 43 to sequentially cyclically output at least two corresponding pulse sequences.
In a preferred embodiment, the frequency conversion parameter further comprises an interval time indicating the interval time between the next pulse sequence and the currently output pulse sequence. For the usage of the interval, reference may be made to the above method, which is not described herein again.
As shown in fig. 5, in one embodiment, the parameter storage unit is embodied as a parameter register 52, in which a plurality of stimulation program groups 1 … program groups m are configured, and each stimulation program group can be respectively configured with a plurality of sets of frequency conversion parameters. In this embodiment, 5 frequency conversion parameters of stimulation frequency, amplitude, pulse width, stimulation contact point and duration are included. For example, the stimulation frequency can be configured in the program group 111… stimulation frequency1nAmplitude of the vibration11… amplitude1nPulse width of11… pulse width1nStimulating contact11… stimulating contact1nDuration of time11… duration1n(ii) a Configurable stimulation frequency in the program set mm1… stimulation frequencymnAmplitude of the vibrationm1… amplitudemnPulse width ofm1… pulse widthmnStimulating contactm1… stimulating contactmnDuration of timem1… durationmn. In an actual product, the number of the program groups can be 1-16, and the number of the frequency conversion parameter groups in the program groups can be 1-16. The user can set the program groups and the frequency conversion parameters therein respectively.
The control unit is specifically a logic and control circuit 51, which selects a stimulation program group and controls a stimulation pulse output circuit 53 (output unit) to output a plurality of corresponding pulse sequences by using a plurality of groups of frequency conversion parameters in the selected stimulation program group. According to the preferred scheme, a user can set a plurality of program groups for the stimulator, the stimulator adopts all parameters in a certain program group to perform frequency conversion stimulation, when the frequency conversion parameters need to be switched, another program group can be switched to use, and the switching operation of a large number of frequency conversion parameters can be completed.
The stimulator stimulation device provided by the invention can be compatible with a stimulation mode with a single frequency, for example, the control unit only selects one group of frequency conversion parameters (parameters such as a unique stimulation frequency) and can only output a unique pulse sequence. The user can switch between the frequency conversion mode and the single frequency mode, and when the frequency conversion mode is switched, the method can be executed to perform frequency conversion stimulation.
As will be appreciated by one skilled in the art, embodiments of the present invention may be provided as a method, system, or computer program product. Accordingly, the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment or an embodiment combining software and hardware aspects. Furthermore, the present invention may take the form of a computer program product embodied on one or more computer-usable storage media (including, but not limited to, disk storage, CD-ROM, optical storage, and the like) having computer-usable program code embodied therein.
The present invention is described with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the invention. It will be understood that each flow and/or block of the flow diagrams and/or block diagrams, and combinations of flows and/or blocks in the flow diagrams and/or block diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a microcontroller of a general purpose computer, special purpose computer, embedded processor, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the microcontroller of the computer or other programmable data processing apparatus, create means for implementing the functions specified in the flowchart flow or flows and/or block diagram block or blocks.
These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including instruction means which implement the function specified in the flowchart flow or flows and/or block diagram block or blocks.
These computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified in the flowchart flow or flows and/or block diagram block or blocks.
It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.

Claims (10)

1. An implantable nerve stimulation device with a frequency conversion function is characterized by comprising a control unit, a parameter storage unit and an output unit; the parameter storage unit is used for storing a plurality of groups of frequency conversion parameters, and the frequency conversion parameters comprise stimulation frequency and at least one parameter of amplitude, pulse width, stimulation contact and duration; the control unit is used for acquiring at least two groups of frequency conversion parameters and controlling the output unit to output at least two corresponding pulse sequences according to the at least two groups of frequency conversion parameters.
2. The apparatus according to claim 1, wherein the control unit is configured to sequentially cyclically use at least two groups of the variable frequency parameter control output units to sequentially cyclically output at least two corresponding pulse sequences.
3. The apparatus according to claim 1 or 2, wherein the parameter storage unit is configured to store a plurality of stimulation program groups, each stimulation program group including a plurality of sets of frequency conversion parameters; the control unit is used for selecting one stimulation program group and controlling the output unit to output various corresponding pulse sequences by utilizing multiple groups of frequency conversion parameters of the selected stimulation program group.
4. The apparatus of claim 1, wherein the frequency conversion parameter further comprises an interval time indicating a time interval between a next pulse sequence and a currently output pulse sequence.
5. The device according to claim 1, further comprising a communication unit for connecting an external programming device to set the variable frequency parameters in the parameter storage unit.
6. A method of controlling an implantable neurostimulation device, comprising:
determining at least two groups of frequency conversion parameters, wherein the frequency conversion parameters comprise stimulation frequency and at least one parameter of amplitude, pulse width, stimulation contact and duration;
and generating two corresponding pulse sequences according to the at least two groups of frequency conversion parameters.
7. The method of claim 6, wherein the stimulation frequencies in the sets of frequency conversion parameters determined for use are different.
8. The method of claim 7, wherein the determined sets of frequency conversion parameters are at least partially different than the excitation frequency.
9. The method of claim 6, wherein the frequency conversion parameters further include an interval time indicating a time interval between a next pulse sequence and a currently generated pulse sequence; generating two corresponding pulse sequences according to the at least two groups of frequency conversion parameters, including:
timing after generating a corresponding pulse sequence by using the current frequency conversion parameters;
and when the timing reaches the interval time of the current frequency conversion parameter, generating a corresponding pulse sequence by using the next frequency conversion parameter.
10. An implantable neurostimulation system, characterized in that it comprises a stimulation device according to any of claims 1-5, and an in vitro programming device for setting the frequency conversion parameters.
CN202010209055.9A 2020-03-23 2020-03-23 Implanted nerve stimulation equipment and system with frequency conversion function Pending CN111420276A (en)

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