Multi-site frequency-modulated burst stimulator

Abstract

The present application provides a multi-site frequency-modulated burst pulse stimulator, comprising: a plurality of output electrodes, which constitute a plurality of stimulation sites, wherein each stimulation site comprises at least one output electrode; a pulse generating device for outputting pulse bursts through the plurality of output electrodes, wherein a first pulse frequency and at least one second pulse frequency are provided, the first pulse frequency is greater than the second pulse frequency, and the pulse generating device modulates the pulse bursts output by each stimulation site so that one of the stimulation sites outputs high-frequency pulse bursts at the first pulse frequency and the remaining stimulation sites output low-frequency pulse bursts at the second pulse frequency in the same burst cycle.

Description

Technical Field

[0001] This invention relates to the field of spinal nerve medical devices, specifically to a multi-site frequency-modulated burst pulse stimulator. Background Technology

[0002] Clinical studies have shown that implantable spinal nerve stimulators (SCS) using high-frequency stimulation can improve treatment outcomes and reduce side effects.

[0003] Existing SCS (Susceptible Stimulation Therapy) methods mostly use pulse stimulation at a single fixed frequency, while continuous high-frequency stimulation will increase power consumption and shorten the lifespan of the equipment. Furthermore, continuous high-frequency stimulation still uses a single frequency, which can easily lead to patient adaptation and reduce the therapeutic effect. Summary of the Invention

[0004] In view of this, the present invention provides a multi-site frequency-modulated burst pulse stimulator, comprising:

[0005] Multiple output electrodes form multiple stimulation sites, wherein each stimulation site includes at least one output electrode.

[0006] A pulse generator is used to output pulse clusters through the plurality of output electrodes, wherein a first pulse frequency and at least one second pulse frequency are provided, the first pulse frequency being greater than the second pulse frequency, the pulse generator modulates the pulse clusters output by each stimulation site, such that one stimulation site within the same clustering cycle outputs a high-frequency pulse cluster at the first pulse frequency, while the remaining stimulation sites output low-frequency pulse clusters at the second pulse frequency.

[0007] Optionally, the stimulation sites of the high-frequency pulse clusters output are different in two consecutive burst cycles.

[0008] Optionally, different stimulation sites may alternately output the high-frequency pulse clusters.

[0009] Optionally, there may be multiple second pulse frequencies, and the total number of first pulse frequencies and second pulse frequencies is equal to the number of stimulation sites.

[0010] Optionally, the values ​​of the multiple second pulse frequencies are not equal.

[0011] Optionally, the pulse generating device further includes a first pulse number configured to be the number of pulses in the high-frequency pulse cluster; and at least one second pulse number configured to be the number of pulses in the low-frequency pulse cluster.

[0012] Optionally, the pulse generating device further includes a first pulse amplitude and a first pulse width for configuring the pulse amplitude and pulse width of the high-frequency pulse cluster; and includes at least one second pulse amplitude and at least one second pulse width for configuring the pulse amplitude and pulse width of the low-frequency pulse cluster.

[0013] Optionally, the pulse generating device is provided with an active charge balancing mode and a passive charge balancing mode, wherein the active charge balancing mode is used for the high-frequency pulse cluster and the passive charge balancing mode is used for the low-frequency pulse cluster.

[0014] Optionally, the duration of the high-frequency pulse cluster is equal to that of the low-frequency pulse cluster; or

[0015] The durations of the high-frequency pulse clusters and the low-frequency pulse clusters are not equal.

[0016] Optionally, the first pulse frequency ranges from 2kHz to 20kHz, and the second pulse frequency ranges from 2Hz to 2kHz.

[0017] The present invention also provides an implantable spinal cord nerve stimulation system, including the above-mentioned stimulator and an external programming device, the external programming device being used to acquire the first pulse frequency and the second pulse frequency provided by the user and send them to the above-mentioned stimulator.

[0018] Optionally, the external programming device is also used to acquire the first pulse count and the second pulse count provided by the user, and send them to the stimulator.

[0019] Optionally, the external programming device is also used to acquire a first pulse amplitude and a first pulse width provided by the user, and to acquire a second pulse amplitude and a second pulse width provided by the user, and send them to the aforementioned stimulator.

[0020] The multi-site frequency-modulated cluster pulse stimulator and system provided by this invention features simultaneous multi-site stimulation, cluster stimulation, and high- and low-frequency modulation. Simultaneous multi-site stimulation can increase the treatment coverage area, while high-frequency cluster stimulation can improve the treatment effect. High- and low-frequency modulation stimulation can reduce the probability of patients developing adaptation to electrical stimulation and weakening the treatment effect. Furthermore, compared with continuous high-frequency stimulation, high- and low-frequency modulation cluster stimulation can reduce the power consumption of the pulse generator, extending the equipment's lifespan and replacement cycle. Attached Figure Description

[0021] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0022] Figure 1 This is a schematic diagram of the structure of the human implantable spinal cord stimulation system in an embodiment of the present invention;

[0023] Figure 2 This is a schematic diagram showing the comparison between the clustered stimulation waveform and the stimulation site in an embodiment of the present invention;

[0024] Figure 3 This is a schematic diagram of the stimulation waveform in the passive balance mode in an embodiment of the present invention;

[0025] Figure 4 This is a schematic diagram of the stimulation waveform in the active balancing mode of an embodiment of the present invention. Detailed Implementation

[0026] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0027] Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0028] Figure 1 An implantable spinal cord stimulation system is shown, which includes a pulse generator 11, electrode wires 12, and an external programming device 13. The pulse generator 11 is used to modulate and emit pulse signals, which are applied to the human body through the electrode wires 12. The external programming device 13 is wirelessly connected to the pulse generator 11 and can be controlled by the user by setting relevant parameters.

[0029] This invention provides a multi-site frequency-modulated burst pulse stimulator, comprising:

[0030] Multiple output electrodes form multiple stimulation sites, and these electrodes are arranged on electrode line 12. See details. Figure 2 The following description uses two stimulation sites, stimulation site a and stimulation site b, located on different electrode lines 12, each of which includes at least one electrode. Figure 2This is just an example to illustrate the stimulation site; in reality, there may be more stimulation sites, and there may be multiple stimulation sites on the same electrode line 12.

[0031] The pulse generator 11 is used to output pulse clusters through multiple output electrodes, wherein a first pulse frequency f1 and a second pulse frequency f2 are provided. In this embodiment, the value range of the first pulse frequency is 2kHz-20kHz, and the value range of the second pulse frequency is 2Hz-2kHz.

[0032] f1 and f2 can be preset and stored in the pulse generator 11, or they can be sent to the pulse generator 11 through the external programming device 13. The user can use the external programming device 13 to set specific values.

[0033] The first pulse frequency f1 should be greater than the second pulse frequency f2. The pulse generator 11 modulates the pulse clusters (or cluster pulses) output by each stimulation site. A pulse cluster consists of multiple consecutive single pulses. Figure 2 The scenario shown includes two types of pulse clusters: L and H. The time interval between adjacent pulse clusters is the cluster emission period T. In this embodiment, T = 0.2s, so the cluster emission frequency is 5Hz.

[0034] The pulses at each stimulation site have a modulation relationship. Within the same burst cycle, only one stimulation site outputs a high-frequency pulse cluster H at the first pulse frequency f1, while the other stimulation sites output a low-frequency pulse cluster L at the second pulse frequency f2. For example... Figure 2 As shown, in the first burst cycle T, stimulation site a outputs a high-frequency pulse cluster H at a first pulse frequency f1, and stimulation site b outputs a low-frequency pulse cluster L at a second pulse frequency f2. In the second burst cycle T, stimulation site b outputs a high-frequency pulse cluster H at the first pulse frequency f1, and stimulation site a outputs a low-frequency pulse cluster L at the second pulse frequency f2. These two stimulation sites alternately output high-frequency pulse clusters H, meaning that the stimulation sites outputting high-frequency pulse clusters are different in two consecutive burst cycles.

[0035] It should be noted that Figure 2 The modulation relationship shown is just a special case. There are many other ways to ensure that only one stimulation site outputs a high-frequency pulse cluster H in a bursting cycle. For example, it is also feasible for stimulation site a to output a high-frequency pulse cluster H in two consecutive bursting cycles, and then stimulation site b to output a high-frequency pulse cluster H in the third bursting cycle. There are many similar transformation methods.

[0036] Furthermore, in this embodiment, the durations of the high-frequency pulse cluster H and the low-frequency pulse cluster L are the same, while in other embodiments their durations may differ, for example, different durations or different start and end times are all possible.

[0037] The multi-site frequency-modulated cluster pulse stimulator provided in this invention features simultaneous multi-site stimulation, cluster stimulation, and high- and low-frequency modulation. Simultaneous multi-site stimulation increases the treatment coverage area, while high-frequency cluster stimulation improves the therapeutic effect. High- and low-frequency modulation stimulation reduces the probability of patient adaptation to electrical stimulation and weakened therapeutic effect. Furthermore, compared to continuous high-frequency stimulation, high- and low-frequency modulation cluster stimulation reduces pulse generator power consumption, extending equipment lifespan and replacement cycle.

[0038] In addition, the number of pulses, amplitude and pulse width can be set in the pulse generator 11. These parameters can be preset and stored in the pulse generator 11, or sent to the pulse generator 11 through the external programming device 13. The user can use the external programming device 13 to set specific values.

[0039] Specifically, the pulse generator may also be configured with a number of high-frequency pulses and a number of low-frequency pulses, which are used to configure the number of pulses in the high-frequency pulse cluster and the number of pulses in the low-frequency pulse cluster, respectively. For example, the number of high-frequency pulses is set to 1000, so that each high-frequency pulse cluster H consists of 1000 pulses; the number of low-frequency pulses is set to 20, so that each low-frequency pulse cluster L consists of 20 pulses.

[0040] The pulse generator can also be equipped with high-frequency pulse amplitude and low-frequency pulse amplitude, used to configure the pulse amplitude in each high-frequency pulse cluster and the pulse amplitude in each low-frequency pulse cluster, respectively. It can also provide two modes: constant voltage mode or constant current mode. Taking constant current mode as an example, the high-frequency pulse amplitude can be set to 2mA, making the amplitude of each pulse in each high-frequency pulse cluster H 2mA; the low-frequency pulse amplitude can be set to 3mA, making the amplitude of each pulse in each high-frequency pulse cluster L 3mA. The high-frequency pulse amplitude and the low-frequency pulse amplitude can be equal or unequal.

[0041] The pulse generator may also be equipped with high-frequency pulse width and low-frequency pulse width. For example, the high-frequency pulse width is set to 20μs, so that the pulse width of each pulse in each high-frequency pulse cluster H is 20μs; the low-frequency pulse width is set to 210μs, so that the pulse width of each pulse in each low-frequency pulse cluster L is 210μs.

[0042] exist Figure 2 Based on the two stimulation sites shown, embodiments with more stimulation sites are described below. In this embodiment, there are n stimulation sites. The pulse generator has pulse frequencies f1, f2…fn. f1 is considered the first pulse frequency, and f2…fn are considered multiple second pulse frequencies. That is, the total number of first and second pulse frequencies equals the number of stimulation sites. In this embodiment, the values ​​of f2…fn can be all unequal, or some can be equal.

[0043] The pulse generator modulates the burst pulses of each stimulation site: stimulation site 1 outputs a high-frequency pulse burst at frequency f1 in the first burst cycle, a low-frequency pulse burst at frequency f2 in the second burst cycle, and so on, and outputs a low-frequency pulse burst at frequency fn in the nth burst cycle. Therefore, the frequency usage order of stimulation site 1 in the n burst cycles is f1-f2-...-fn.

[0044] Stimulation site 2 outputs a low-frequency pulse cluster at frequency f2 in the first burst cycle, a high-frequency pulse cluster at frequency f1 in the second burst cycle, and so on, and outputs a low-frequency pulse cluster at frequency fn in the nth burst cycle. Therefore, the frequency usage order of stimulation site 2 in the n burst cycles is f2-f1-…-fn.

[0045] The stimulation site n outputs a low-frequency pulse cluster at frequency f2 in the first burst cycle, a low-frequency pulse cluster at frequency f3 in the second burst cycle, and so on, and outputs a high-frequency pulse cluster at frequency f1 in the nth burst cycle. Therefore, the order of frequency usage of stimulation site n in n burst cycles is f2-f3-…-fn-f1.

[0046] Based on the above method, high-frequency pulse clusters can be output alternately at different stimulation sites. This processing method is highly efficient and has a complex pattern, thereby further reducing the probability of patients developing adaptation to electrical stimulation and weakening the therapeutic effect. It should be noted that the above frequency usage order is not the only way to achieve this goal. For example, high-frequency pulse clusters can also be output at stimulation sites randomly, as long as the same stimulation site is not repeatedly selected in n clustering cycles.

[0047] The number, amplitude, and pulse width of the pulses can be set as described in the above embodiments. In this embodiment, pulse frequencies f1, f2, ..., fn are provided. The number, amplitude, and pulse width of the pulses can be set in two groups: one group corresponds to the pulse frequency f1 (high frequency), and the other group corresponds to f2, ..., fn (low frequency), so that the parameters of the high-frequency pulse clusters are different from those of other low-frequency pulse clusters. Alternatively, the number, amplitude, and pulse width of the pulses can be set in n groups, each corresponding to f1, ..., fn, so that the parameters of each pulse cluster are independent.

[0048] The following is combined with Figure 3 and Figure 4 This section introduces charge balance methods. Maintaining charge balance at the stimulation site is crucial during electrical pulse delivery. The stimulator in this embodiment provides two balance modes. Figure 3 The diagram shows a pulse waveform in passive charge balancing mode. After a stimulation pulse, a pulse for balancing charges is generated. The amplitude of the stimulation pulse is much larger than that of the passive balancing pulse, but the pulse width of the passive balancing pulse is larger than that of the stimulation pulse. This embodiment uses passive charge balancing mode for low-frequency pulse clusters.

[0049] Figure 4 The diagram shows the pulse waveform in the active charge balancing mode. After a stimulation pulse, a pulse for balancing charges is generated. The active balancing pulse has the same amplitude as the stimulation pulse but opposite in sign. This embodiment uses the active charge balancing mode for high-frequency pulse clusters.

[0050] Those skilled in the art will understand that embodiments of the present invention can be provided as methods, systems, or computer program products. Therefore, the present invention can take the form of a completely hardware embodiment, a completely software embodiment, or an embodiment combining software and hardware aspects. Furthermore, the present invention can 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, etc.) containing computer-usable program code.

[0051] This 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 block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions can be provided to a processor 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 processor of the computer or other programmable data processing apparatus, generate instructions for implementing the flowchart illustrations and / or block diagrams. Figure 1 One or more processes and / or boxes Figure 1 A device that provides the functions specified in one or more boxes.

[0052] These computer program instructions may also be stored in a computer-readable storage medium that can direct a computer or other programmable data processing device to function in a particular manner, such that the instructions stored in the computer-readable storage medium produce an article of manufacture including instruction means, which are implemented in a process Figure 1 One or more processes and / or boxes Figure 1 The function specified in one or more boxes.

[0053] These computer program instructions may also be loaded onto a computer or other programmable data processing equipment to cause a series of operational steps to be performed on the computer or other programmable equipment to produce a computer-implemented process, thereby providing instructions that execute on the computer or other programmable equipment for implementing the process. Figure 1 One or more processes and / or boxes Figure 1 The steps of the function specified in one or more boxes.

[0054] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A multi-site frequency modulated burst stimulator, comprising: The application comprises: a plurality of output electrodes, which constitute a plurality of stimulation sites, wherein each stimulation site comprises at least one output electrode; a pulse generator, which is configured to output pulse bursts through the plurality of output electrodes, wherein a first pulse frequency and a plurality of second pulse frequencies are provided, the values of the plurality of second pulse frequencies are all unequal, the total number of the first pulse frequency and the second pulse frequencies is equal to the number of the stimulation sites, the first pulse frequency is greater than the second pulse frequencies, and the pulse generator modulates the pulse bursts output by each stimulation site so that one stimulation site outputs a high-frequency pulse burst at the first pulse frequency in the same burst emission period, and the remaining stimulation sites output low-frequency pulse bursts at the plurality of second pulse frequencies respectively, thereby making different stimulation sites output high-frequency pulse bursts in turn.

2. The stimulator of claim 1, wherein, The pulse generator is further provided with a first pulse number for configuring the number of pulses in the high-frequency pulse burst, and at least one second pulse number for configuring the number of pulses in the low-frequency pulse burst.

3. The stimulator of claim 1, wherein, The pulse generator is further provided with a first pulse amplitude and a first pulse width for configuring the pulse amplitude and pulse width of the high-frequency pulse burst, and at least one second pulse amplitude and at least one second pulse width for configuring the pulse amplitude and pulse width of the low-frequency pulse burst.

4. The stimulator of claim 1, wherein, The pulse generator is provided with an active charge balance mode and a passive charge balance mode, which adopts the active charge balance mode for the high-frequency pulse burst and adopts the passive charge balance mode for the low-frequency pulse burst.

5. The stimulator of claim 1, wherein, The duration of the high-frequency pulse burst is equal to that of the low-frequency pulse burst; or The duration of the high-frequency pulse burst is not equal to that of the low-frequency pulse burst.

6. The stimulator according to any of claims 1-5, characterized in that, The value of the first pulse frequency ranges from 2 kHz to 20 kHz, and the value of the second pulse frequency ranges from 2 Hz to 2 kHz.

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