Implantable medical device and pulse stimulation method thereof

Abstract

The present invention provides an implantable medical device and a pulse stimulation method thereof. The implantable medical device has at least two channels for outputting pulse signals. The method comprises obtaining offset information for indicating the phase difference between different groups of pulse signals; determining at least two timing cycles according to the offset information, wherein the sum of all the timing cycles is the pulse cycle; and controlling different channels to output pulse signals respectively according to the pulse cycles, wherein the lengths of the at least two timing cycles are used to determine the phase difference between the pulse signals of different channels.

Description

Technical Field

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

[0002] As clinical application requirements continue to change, the functions of pulse generators in implantable medical devices are constantly improving. Pulse generators usually have multiple signal output channels and can stimulate multiple parts. However, the stimulation frequency of different channels is fixed and the pulse phase is fixed.

[0003] Taking two stimulation sites as an example, the implanted device uses a timer to control the two output channels to generate pulses with a fixed timing cycle. For example, the first channel used to stimulate the first site generates a rising edge at the starting point of the nth timing cycle, and the second channel used to stimulate the second site generates a rising edge at the starting point of the n+1th timing cycle. Therefore, the stimulation frequency f = 1 / (2*timing cycle), and the pulse phase difference between the two channels is fixed at 180°.

[0004] As clinical research deepens, there are signs that in some cases, using different phase differences at different stimulation sites may produce different effects. However, existing implantable medical devices can only adjust the stimulation frequency, but cannot set the phase difference. Summary of the invention

[0005] In view of this, an embodiment of the present invention provides a pulse stimulation method for an implantable medical device, wherein the implantable medical device has at least two channels for outputting pulse signals, and the method includes:

[0006] Acquiring offset information for indicating phase differences between different groups of pulse signals;

[0007] Determine at least two timing cycles according to the offset information, the sum of all the timing cycles being the pulse period;

[0008] The different channels are controlled to output pulse signals respectively according to the pulse period, wherein the lengths of the at least two timing periods are used to determine the phase difference of the pulse signals between different channels.

[0009] Optionally, the phase difference ranges from [0°, 360°).

[0010] Optionally, there are two timing cycles, and when the offset information indicates that the phase difference between different groups of pulse signals is 180 degrees, the two timing cycles are equal; when the offset information indicates that the phase difference between different groups of pulse signals is not equal to 180 degrees, the two timing cycles are not equal.

[0011] Optionally, the two timing cycles are switched to output pulse signals.

[0012] Optionally, the implantable medical device has two channels for outputting pulse signals; for each pulse cycle, controlling the different channels to output pulse signals respectively according to the pulse cycle includes:

[0013] Enable the first timing cycle, so that the rising edge of the pulse of the first channel is the starting point of the first timing cycle, and the falling edge is within the first timing cycle;

[0014] The second timing cycle is switched so that the rising edge of the pulse of the second channel is the starting point of the second timing cycle and the falling edge is within the second timing cycle.

[0015] Accordingly, the present invention also provides an implantable medical device, comprising: at least one processor; and a memory communicatively connected to the at least one processor; wherein the memory stores instructions executable by the one processor, and the instructions are executed by the at least one processor so that the at least one processor executes the pulse stimulation method as described in any one of claims 1-5.

[0016] The present invention also provides an implantable medical device having at least two channels for outputting pulse signals, and the device further comprises:

[0017] A setting unit, for obtaining offset information indicating a phase difference between different groups of pulse signals;

[0018] A calculation unit, used to determine at least two timing cycles according to the offset information, the sum of all the timing cycles being the pulse period;

[0019] A control unit is used to control different channels to output pulse signals respectively according to the pulse period, wherein the length of the at least two timing periods is used to determine the phase difference of the pulse signals between different channels.

[0020] Optionally, the phase difference ranges from [0°, 360°).

[0021] Optionally, there are two timing cycles, and when the offset information indicates that the phase difference between different groups of pulse signals is 180 degrees, the two timing cycles are equal; when the offset information indicates that the phase difference between different groups of pulse signals is not equal to 180 degrees, the two timing cycles are not equal.

[0022] Optionally, the control unit alternately switches the two timing cycles to control different channels to output pulse signals;

[0023] The implantable medical device has two channels for outputting pulse signals; for each pulse cycle, the control unit enables a first timing cycle so that the rising edge of the pulse of the first channel is the starting point of the first timing cycle, and the falling edge is within the first timing cycle; and switches to a second timing cycle so that the rising edge of the pulse of the second channel is the starting point of the second timing cycle, and the falling edge is within the second timing cycle.

[0024] The implantable medical device and pulse stimulation method thereof provided by the present invention allow the user to provide phase difference information, and the device determines multiple timing cycles based on the information, and outputs multiple pulse signals based on the multiple timing cycles, so that different channels output multiple pulse signals with adjustable phase differences, thereby realizing different therapies and meeting diverse clinical therapy needs. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0026] Figure 1 is a schematic structural diagram of an implantable medical system in an embodiment of the present invention;

[0027] Figure 2 A waveform diagram of a pulse signal in an embodiment of the present invention;

[0028] Figure 3 is another waveform diagram of the pulse signal in the embodiment of the present invention;

[0029] Figure 4 is a third waveform diagram of the pulse signal in the embodiment of the present invention;

[0030] Figure 5 Schematic diagram of the structure of an implantable medical device in an embodiment of the present invention. DETAILED DESCRIPTION

[0031] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0032] In the description of the present invention, it should be noted that the terms "first" and "second" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance. In addition, 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.

[0033] Figure 1 An implantable medical system is shown, which can be specifically rechargeable and non-rechargeable products such as DBS (deep brain stimulation), VNS (vagusneve stimulation), SCS (Spinalcord stimulation) and SNM (Sacral Neuromodulation). The system includes an in-vivo device 1 and an out-vivo device 2, wherein the out-vivo device 2 is provided with an interactive function unit 21, an out-vivo control unit 22 and an out-vivo communication unit 23; the in-vivo device 1 is provided with an in-vivo control unit 11, an in-vivo communication unit 12 and a plurality of signal output channels. Taking the DBS product as an example, the in-vivo device 1 is provided with two channels, a first channel 13 and a second channel 14. These channels are used to output pulse signals, and they can be implanted in different parts of the brain respectively.

[0034] The present invention provides a pulse stimulation method for controlling the above-mentioned multiple signal output channels to output pulse signals. The method can be executed by an external control unit 22 or an internal control unit 11. The method comprises the following steps:

[0035] S1, obtaining offset information for indicating the phase difference between different groups of pulse signals. The offset information can be a phase difference value in degrees; or a time value in milliseconds or microseconds. This information can be set by the user, for example, the user can set the offset information through the interactive function unit 21 of the external device 2.

[0036] S2, multiple timing cycles are determined according to the offset information, and the sum of all timing cycles is the pulse period. In a preferred embodiment, two timing cycles T1 and T2 are used, and the pulse period T = T1 + T2. T1 and T2 can be equal or unequal, and can be calculated according to the offset information, or queried using a table lookup. For example, some phase difference values ​​can be preset, and these phase difference values ​​are set to correspond to different multiple timing cycles. When the user provides the offset information, the multiple timing cycles corresponding to it can be queried.

[0037] S3, controls different channels to output pulse signals according to the pulse cycle, and the length of the timing cycle is used to determine the phase difference of the pulse signals between different channels. Figure 2As shown in the waveform, the pulse periods of the two signals output by the first channel 13 and the second channel 14 are both T, and the phase difference of the second channel lags behind the first channel for: The phase difference between the first channel 13 and the second channel 14 for: Therefore, the phase difference depends on the length of the two timing cycles T1 and T2. In a preferred embodiment, the range of the phase difference is [0°, 360°), and the user is allowed to provide offset information corresponding to this range. The user can enter any value within this range, and the appropriate number of timing cycles is determined through step S2, and the corresponding phase difference is reflected in this step.

[0038] As a special case, see Figure 3 In the waveform shown, when T1 is equal to T2, the phase difference between the pulse signals of the two channels is 180°.

[0039] The pulse stimulation method provided according to the embodiment of the present invention allows the user to provide phase difference information, and the device determines multiple timing cycles based on the information, and outputs multiple pulse signals based on the multiple timing cycles, so that different channels output multiple pulse signals with adjustable phase differences, thereby realizing different therapies and meeting diverse clinical therapy needs.

[0040] In a preferred embodiment, the pulse signal is generated by alternately switching two timing cycles. Figure 4 The pulse signals of multiple cycles are shown, and the timing cycles T1 and T2 are switched alternately, so that the phase difference between the second channel and the first channel in each cycle is The phase difference between the first channel and the second channel in each cycle is

[0041] Furthermore, the two channels do not have a high level at the same time. Specifically, for each pulse cycle, the rising edge of the pulse of the first channel is the starting point of the first timing cycle T1, the falling edge is within the first timing cycle T1, and the second channel has no rising edge and falling edge within T1; after switching to the second timing cycle, the rising edge of the pulse of the second channel is the starting point of the second timing cycle, the falling edge is within the second timing cycle, and the first channel has no rising edge and falling edge within T2.

[0042] The embodiment of the present invention also provides an implantable medical device, which may be the above-mentioned in-vivo device or in-vitro device, such as Figure 5 The device shown includes a setting unit 51 , a calculation unit 52 , and a control unit 53 .

[0043] The setting unit 51 obtains the offset information indicating the phase difference between different groups of pulse signals, and the details can refer to the above step S1. If it is an external device, the offset information can be directly obtained by interacting with the user; if it is an internal device, the offset information can be obtained by communicating with the external device.

[0044] The calculation unit 52 is used to determine at least two timing cycles according to the offset information, and the sum of all the timing cycles is the pulse period. For details, please refer to the above step S2, which will not be repeated here.

[0045] The control unit 53 is used to control different channels to output pulse signals according to the pulse period, wherein the length of the timing period is used to determine the phase difference of the pulse signals between different channels, and the details can be referred to the above step S3. If it is an in-vivo device, each channel can be directly controlled to output pulse signals; if it is an out-vivo device, these timing periods can be sent to it by communicating with the in-vivo device, and the in-vivo device performs the pulse output action.

[0046] The implantable medical device provided according to an embodiment of the present invention allows the user to provide phase difference information, and the device determines multiple timing cycles based on the information, and outputs multiple pulse signals based on the multiple timing cycles, so that different channels output multiple pulse signals with adjustable phase differences, thereby realizing different therapies and meeting diverse clinical therapy needs.

[0047] In a preferred embodiment, the phase difference ranges from [0°, 360°).

[0048] In a preferred embodiment, there are two timing cycles. When the offset information indicates that the phase difference between different groups of pulse signals is 180 degrees, the two timing cycles are equal; when the offset information indicates that the phase difference between different groups of pulse signals is not equal to 180 degrees, the two timing cycles are not equal.

[0049] In a preferred embodiment, the implantable medical device alternately switches between two timing cycles to output a pulse signal.

[0050] Furthermore, for each pulse cycle, the control unit first enables the first timing cycle, so that the rising edge of the pulse of the first channel is the starting point of the first timing cycle, and the falling edge is within the first timing cycle; then switches to the second timing cycle, so that the rising edge of the pulse of the second channel is the starting point of the second timing cycle, and the falling edge is within the second timing cycle.

[0051] Those skilled in the art will appreciate that embodiments of the present invention may be provided as methods, systems, or computer program products. Therefore, the present invention may take the form of a complete hardware embodiment, a complete software embodiment, or an embodiment combining software and hardware. Moreover, the present invention may take the form of a computer program product implemented 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.

[0052] The present invention is described with reference to flowcharts and / or block diagrams of methods, devices (systems), and computer program products according to embodiments of the present invention. It should be understood that each process and / or block in the flowchart and / or block diagram, as well as the combination of processes and / or blocks in the flowchart and / or block diagram, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer, an embedded processor, or other programmable data processing device to produce a machine, so that the instructions executed by the processor of the computer or other programmable data processing device generate instructions for implementing the processes in the flowchart and / or block diagram. Figure 1 A process or multiple processes and / or boxes Figure 1 A device that provides the functions specified in a block or multiple blocks.

[0053] These computer program instructions may also be stored in a computer-readable memory capable of directing a computer or other programmable data processing device to operate in a specific manner, so that the instructions stored in the computer-readable memory produce an article of manufacture comprising an instruction device, which implements the process Figure 1 A process or multiple processes and / or boxes Figure 1 A function specified in one or more boxes.

[0054] These computer program instructions can also be loaded onto a computer or other programmable data processing device so that a series of operating steps are executed on the computer or other programmable device to produce a computer-implemented process, thereby providing instructions for implementing the process in the computer or other programmable device. Figure 1 A process or multiple processes and / or boxes Figure 1 The steps for the functions specified in one or more boxes.

[0055] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims

1. A pulse stimulation method for an implantable medical device, wherein the implantable medical device has two channels for outputting pulse signals, characterized in that: The method comprises: Acquiring offset information for indicating phase differences between different groups of pulse signals; Determine two timing cycles according to the offset information, the sum of the two timing cycles being the pulse period; The different channels are controlled to output pulse signals respectively according to the pulse period, wherein the lengths of the two timing periods are used to determine the phase difference of the pulse signals between different channels, and the pulse signal is generated by switching the timing period within the pulse period, so that the corresponding two channels output a multi-channel pulse signal with an adjustable phase difference.

2. The method according to claim 1, characterized in that: The range of the phase difference is [0°, 360°).

3. The method according to claim 1, characterized in that When the offset information indicates that the phase difference between different groups of pulse signals is 180 degrees, the two timing cycles are equal; when the offset information indicates that the phase difference between different groups of pulse signals is not equal to 180 degrees, the two timing cycles are not equal.

4. The method according to claim 3, characterized in that In the process of controlling different channels to output pulse signals according to the pulse periods respectively, the two timing periods are switched alternately to output pulse signals.

5. The method according to claim 4, characterized in that The implantable medical device has two channels for outputting pulse signals; For each pulse cycle, controlling the different channels to output pulse signals respectively according to the pulse cycle includes: Enable the first timing cycle, so that the rising edge of the pulse of the first channel is the starting point of the first timing cycle, and the falling edge is within the first timing cycle; The second timing cycle is switched so that the rising edge of the pulse of the second channel is the starting point of the second timing cycle and the falling edge is within the second timing cycle.

6. An implantable medical device, characterized in that: include: at least one processor; And a memory communicatively connected to the at least one processor; wherein the memory stores instructions executable by the one processor, and the instructions are executed by the at least one processor so that the at least one processor executes the pulse stimulation method as described in any one of claims 1-5.

7. An implantable medical device having two channels for outputting pulse signals, characterized in that: Also includes: A setting unit, for obtaining offset information indicating a phase difference between different groups of pulse signals; a calculation unit, configured to determine two timing periods according to the offset information, wherein the sum of the two timing periods is a pulse period; A control unit is used to control different channels to output pulse signals according to the pulse period, wherein the lengths of the two timing periods are used to determine the phase difference of the pulse signals between different channels, and a pulse signal is generated by switching the timing period within the pulse period, so that the corresponding two channels output multi-channel pulse signals with adjustable phase difference.

8. The device according to claim 7, characterized in that The range of the phase difference is [0°, 360°).

9. The device according to claim 7, characterized in that When the offset information indicates that the phase difference between different groups of pulse signals is 180 degrees, the two timing cycles are equal; when the offset information indicates that the phase difference between different groups of pulse signals is not equal to 180 degrees, the two timing cycles are not equal.

10. The device according to claim 9, characterized in that The control unit alternately switches the two timing cycles to control different channels to output pulse signals; The implantable medical device has two channels for outputting pulse signals; for each pulse cycle, the control unit enables a first timing cycle, so that the rising edge of the pulse of the first channel is the starting point of the first timing cycle, and the falling edge is within the first timing cycle; The second timing cycle is switched so that the rising edge of the pulse of the second channel is the starting point of the second timing cycle and the falling edge is within the second timing cycle.

Images