Implantable spinal cord stimulation system

Abstract

An implantable spinal cord stimulation system includes a stimulator adapted for implantation in a body and a controller external to the body. The system performs operations including the controller iterating over respective combinations of electrode contacts of the stimulator and values of a first stimulation parameter, causing respective combinations of electrode contacts to output stimulation signals at a plurality of values of the first stimulation parameter, and the controller recording, during the iterating, perceptual information of a user regarding effects of the stimulation.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, and in particular to an implantable spinal cord stimulation system. BACKGROUND

[0002] An implantable medical device (IMD) is a medical device installed inside the body of a user. The device has a battery, a chip, and a sensor inside, and implements a corresponding therapy by using a set program and operating parameters, which can be set differently according to the condition of the user. There are many operating parameters of the IMD, and the setting of the operating parameters is complex.

[0003] An implantable spinal cord stimulation system has been proven to be effective in treating chronic pain syndrome. The existing implantable spinal cord stimulation system generally consists of a pulse generator, electrodes, and a patient controller. Most of the implantable spinal cord stimulation systems have at least 16 contacts. After the implantation of the electrodes of the spinal cord stimulation system is completed, the stimulation sites and stimulation parameters of the electrodes need to be adjusted to select the best stimulation combination. However, in the process of adjusting the parameters, the setting of the contacts and the parameters needs to be completed manually one by one, and because the number of contacts is too large, the repetitive labor will seriously waste the cost of manpower and time. SUMMARY

[0004] Therefore, the present application provides an implantable spinal cord stimulation system, which includes a stimulator adapted to be implanted in the body and a controller outside the body, and the system performs operations including the following contents:

[0005] The controller iterates through each combination of electrode contacts of the stimulator and values of first stimulation parameters, and each combination of electrode contacts outputs a stimulation signal with a plurality of values of the first stimulation parameters; and the controller records the perception information of the user for the stimulation effect during the iteration.

[0006] Optionally, the controller selects two adjacent electrode contacts each time during the iteration.

[0007] Optionally, the controller starts from two electrode contacts at one end of an electrode line and iterates to the other end until all adjacent electrode contact combinations are iterated.

[0008] Optionally, the controller starts from two electrode contacts in the middle of an electrode line and iterates to both sides, and changes the direction of iteration according to the perception information during the iteration until all adjacent electrode contact combinations are iterated.

[0009] Optionally, the controller causes each combination of electrode contacts to traverse from one extreme value of the first stimulation parameter to another extreme value of the first stimulation parameter to output stimulation signals in the traversing process.

[0010] Optionally, the controller causes each combination of electrode contacts to traverse from a middle value of the first stimulation parameter to two extreme values of the first stimulation parameter to output stimulation signals in the traversing process, and changes the traversing direction according to the perception information in the process.

[0011] Optionally, the controller determines a preferred value of the first stimulation parameter according to the perception information after outputting stimulation signals for the first stimulation parameter values for the first group of electrode contacts; and uses the preferred value of the first stimulation parameter to output stimulation signals when traversing other groups of electrode contacts.

[0012] Optionally, the duration of outputting stimulation signals for each value of the first stimulation parameter is 3-5s, and the interval time for switching the value of the first stimulation parameter is 0s-4s.

[0013] Optionally, the first stimulation parameter is pulse amplitude.

[0014] Optionally, the controller also uses a set value of a second stimulation parameter in the traversing process, and causes each combination of electrode contacts to output stimulation signals with a plurality of values of the first stimulation parameter and the set value of the second stimulation parameter, and the second stimulation parameter includes pulse frequency and / or pulse width.

[0015] The implantable spinal cord stimulation system provided by the present application performs automatic traversal of stimulation parameters and electrode contacts through an external controller, and subjective feelings of a patient are provided and recorded by the controller to finally form an evaluation report. A doctor can select the best stimulation mode through the report content, and efficiently select a stimulation point and a value of a stimulation parameter, thereby saving labor and time costs. BRIEF DESCRIPTION OF DRAWINGS

[0016] In order to more clearly illustrate the specific embodiments of the present application or the technical solutions in the prior art, the following will briefly introduce the drawings needed to be used in the specific embodiments or prior art description. Obviously, the drawings in the following description are some embodiments of the present application, and those skilled in the art can also obtain other drawings according to these drawings without creative labor.

[0017] Figure 1 An electrode distribution and traversal schematic diagram in an embodiment of the present application;

[0018] Figure 2 Another electrode distribution and traversal schematic diagram in an embodiment of the present application. DETAILED DESCRIPTION

[0019] The technical solutions of the present application will be described clearly and completely below in conjunction with the drawings. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of protection of the present application.

[0020] In the description of the present application, it should be noted that the terms "middle", "upper", "lower", "left", "right", "longitudinal", "transverse" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the indicated elements must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application. In addition, the terms "first" and "second" are only for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0021] In addition, the technical features involved in the different embodiments of the present application described below can be combined with each other as long as they do not conflict with each other.

[0022] The embodiment of the present application provides an implantable spinal cord stimulation system, which comprises a stimulator suitable for implantation in the body and a controller outside the body, and the two devices are respectively provided with a wireless communication module, and the controller controls the stimulator to perform actions through wireless communication. The stimulator of the present application comprises a pulse generating device and an electrode wire, and a plurality of electrode contacts for stimulating human nerves are distributed at the end of the electrode wire. The electrode contacts of the spinal cord stimulation are generally at least 16, Figure 1 and Figure 2 The distribution diagrams of the electrode contacts of two stimulators are shown. Figure 1 It is a paddle-shaped electrode, in which 16 electrode contacts are located at the end of the same electrode wire; Figure 2 It is a needle-shaped electrode, which has two electrode wires, and 8 electrode contacts are distributed at the end of each electrode wire.

[0023] In order to improve the efficiency of the postoperative electrode contact and parameter selection process of the implantable spinal cord stimulation system, the controller of the embodiment will traverse each combination of the electrode contacts of the stimulator and the values of the stimulation parameters, so that each combination of the electrode contacts outputs a stimulation signal with a plurality of values of the stimulation parameters. Specifically, the controller of the embodiment will traverse from two aspects, the first aspect is the combination of the electrode contacts, and the second aspect is the value of the stimulation parameter.

[0024] Regarding the first aspect, an electrode contact combination includes at least two electrodes, i.e. Figure 1 and Figure 2at least two of the 16 electrodes shown. In a preferred embodiment, only two adjacent electrodes are selected at a time, i.e. each set of electrode contacts in the traversal is two adjacent electrode contacts. For the case shown, the electrode contact combinations can be either the lateral combinations 11 or the longitudinal combinations 12; for the case shown, the electrode contact combinations are either the lateral combinations 21 or the longitudinal combinations 22. In a preferred embodiment, the above-described longitudinal combinations are used, taking into account the actual implantation of the electrode contacts. Figure 1 Figure 2 For the case shown, the electrode contact combinations are either the lateral combinations 21 or the longitudinal combinations 22. In a preferred embodiment, the above-described longitudinal combinations are used, taking into account the actual implantation of the electrode contacts.

[0025] The controller traverses all electrode contact combinations and outputs stimulation signals. The traversal can be performed in various ways, for example starting from the two electrode contacts at the upper end of the electrode line (e.g. the uppermost longitudinal combination 12 in Fig. 1) and proceeding towards the lower end, or vice versa, starting from the two electrode contacts at the lower end and proceeding towards the upper end, starting from the two electrode contacts in the middle and proceeding towards the two ends, etc., as long as all electrode contact combinations in the two columns are traversed. Figure 1

[0026] More specifically, referring to the electrode numbers in the figure, the first set of electrode contacts - electrode 1 and electrode 2 - is initially used to output stimulation signals, then the second set of electrode contacts - electrode 2 and electrode 3 - is switched to output stimulation signals, then the third set of electrode contacts - electrode 3 and electrode 4 - is switched to output stimulation signals, and so on until the last set of electrode contacts - electrode 15 and electrode 16 - is switched to output stimulation signals, thereby completing the traversal of all adjacent electrode contact combinations.

[0027] With regard to the second aspect, the controller traverses the stimulation parameters used by each set of electrode contacts when outputting stimulation signals. The stimulation parameters can be one or more of the stimulation amplitude, the stimulation frequency and the stimulation pulse width. Since the optimum frequency f and pulse width tu for different patients differ only slightly in most cases, these two parameters can be initially set to fixed values, and only the stimulation amplitude is traversed, after which the frequency f and the pulse width tu can be adjusted manually.

[0028] The controller can traverse the stimulation parameters in various ways, for example starting from the maximum value of the stimulation parameter and proceeding towards the minimum value, or vice versa, starting from the middle value and proceeding towards the two extreme values, etc. For example, the stimulation parameter to be traversed is the pulse amplitude, and the range of values is [U0, U n ], where the preferred voltage mode amplitude range is 0-10 V and the preferred current mode amplitude range is 0-25 mA. According to the step size s, each electrode contact combination outputs stimulation signals with amplitudes in the range [U0, U n ].

[0029] ​​More specifically, for example, the electrode contact combination traversed at the beginning is electrode 1 and electrode 2, at this time the stimulation parameters are started to be traversed, electrode 1 and electrode 2 output stimulation signals with multiple amplitudes in [U0, U n ] in turn, then the next electrode contact combination - electrode 2 and electrode 3 is switched, electrode 2 and electrode 3 output stimulation signals with multiple amplitudes in [U0, U n ] in turn, and so on, until the last electrode contact combination - electrode 15 and electrode 16 outputs stimulation signals with multiple amplitudes in [U0, U n ] in turn.

[0030] Further, the preferred range of the duration of outputting stimulation signals at each value of the stimulation parameter is 3-5s, and the process of switching different values of the stimulation parameter can be without pause. In order to slow down the impact on the user's perception of outputting stimulation signals using the last stimulation parameter, the process of switching different values of the stimulation parameter can also be paused for a period of time (n seconds, n >= 0), preferably 0-4s.

[0031] The controller records the user's perception information of the stimulation effect in the process of performing the above traversal. For this purpose, the controller can provide a human-computer interaction interface, so that the user can input the perception information according to self-perception, such as the controller can provide options for the perception effect, such as "no effect", "slightly slow down, still painful", "effective, slightly painful", "obvious effect, pain disappears" and the like for the user to select, or can display a score, which corresponds to the description of the corresponding scoring table.

[0032] Specifically, the controller records the perception information when each electrode contact combination outputs stimulation signals with each value of the stimulation parameter, that is, each stimulation parameter of each stimulation contact combination independently corresponds to a perception information. As an example, for example, the electrode contact combination traversed at the beginning is electrode 1 and electrode 2, when electrode 1 and electrode 2 output stimulation signals with a stimulation amplitude U0, the user provides a perception information FL 1-2-Uo , when the stimulation amplitude becomes U1, the user provides a perception information FL 1-2-U1 , and so on, until the stimulation amplitude becomes U n , the user provides a perception information FL 1-2-Un ; then after the electrode contact combination electrode 2 and electrode 3 is traversed, the perception information FL 2-3-Uo , FL 2-3-U1 … FL 2-3-Un is similarly obtained, and so on, until the last electrode contact combination is traversed, thereby obtaining the perception information corresponding to all electrode contact combinations and their stimulation parameter values.

[0033] After all traversal and sensing information recording is completed, a recording report can be generated, which may include all traversal combinations and their corresponding sensing information. In an optional embodiment, the recording report may only include the recording of the optimal stimulation parameter combination for each electrode contact combination. For example, for the FL mentioned above... 2-3-Uo FL 2-3-U1 …FL 2-3-Un Based on its specific content, this perceived information can determine the information that the user feels most comfortable with. The corresponding stimulation parameters are the optimal parameters for the electrode contact combination, electrode 2 and electrode 3. Only reflecting the optimal parameters for all electrode contact combinations can make the report more concise and effective.

[0034] The recorded reports can be stored on the controller, sent to cloud storage, or sent to the doctor's client. Doctors can refer to the recorded reports to adjust the optimal combination of stimulation parameters.

[0035] The implantable spinal cord stimulation system provided by this invention automatically traverses stimulation parameters and electrode contacts via an external controller. The patient provides corresponding subjective feedback, which is recorded by the controller and ultimately generates an evaluation report. Doctors can use this report to select the optimal stimulation method and efficiently choose stimulation points and parameter values, thereby saving labor and time costs.

[0036] To improve traversal efficiency, the controller can determine the traversal strategy based on the currently provided perceptual information from the user during the traversal process.

[0037] In a first optional embodiment, regarding the first aspect described above, the controller can traverse from the two central electrode contacts outwards, changing the traversal direction based on sensing information during the process, until all adjacent electrode contact combinations have been traversed. As an example, the controller starts from... Figure 1 The longitudinal assembly 12 located in the middle begins the traversal process. At this time, electrodes 4 and 5 output stimulation signals, and the controller records the sensing information FL about electrodes 4 and 5. 4-5 Then the controller switches to another vertical combination above – electrodes 3 and 4 – to output stimulation signals and records the sensory information FL about electrodes 3 and 4. 3-4 At this point, a judgment is made: if FL... 3-4 The perceived effect expressed is not as good as FL. 4-5 The perceived effect will then shift from switching the upper vertical combination—electrodes 2 and 3—to switching the lower vertical combination—electrodes 5 and 6—to output stimulation signals; if FL 3-4 The perceived effect expressed is better than or equal to FL. 4-5 The perceived effect will then be further stimulated by switching the vertical combination above – electrodes 2 and 3 – to output stimulation signals.

[0038] In the second alternative embodiment, in relation to the second aspect described above, the controller makes the electrode contacts traverse from the middle value of the stimulation parameter to the two extreme values to output the stimulation signal in the traversal process, and changes the traversal direction according to the perception information in the process. As an example, assume that the current traversal is to a certain set of electrode contact combination, the controller first makes the combination output the stimulation signal at the middle value U n of the amplitude [U0, U h 1], and records the perception information FL h of U Uh ; then the controller switches to the next amplitude U n ( increasing amplitude) in the direction of U h+1 1, and outputs the stimulation signal, and the controller records the perception information FL h+1 of U Uh+1 ; at this time, a judgment is made, if the perception effect expressed by FL Uh+1 is not as good as the perception effect expressed by FL Uh , then the next time the amplitude is not increased any more, but the stimulation signal is output at an amplitude smaller than the middle value U Uh-1 ; if the perception effect expressed by FL Uh+1 is better or equivalent to the perception effect expressed by FL Uh , then the next time the amplitude is increased to output the stimulation signal.

[0039] In the third alternative embodiment, a fast traversal scheme is provided, after the controller outputs the stimulation signal by traversing the values of the first stimulation parameter for the first set of electrode contacts, the preferred value of the stimulation parameter is determined according to the perception information, and then when the other sets of electrode contacts are traversed, the stimulation signal is output only by using the preferred value of the stimulation parameter. As an example, assume that the electrode contact combination traversed at the beginning is electrode 1 and electrode 2, and the electrode 1 and electrode 2 output the stimulation signal at multiple amplitudes in [U0, U n 1] in turn, and the corresponding perception information FL 1-2-Uo , FL 1-2-U1 … FL 1-2-Un is obtained, and according to the specific content, the information FL 1-2-Um that the user feels optimal is determined, and the corresponding stimulation parameter is the amplitude U m , i.e. the preferred value. The number of preferred values can be one or more, for example, the user perceives multiple stimulation amplitudes as "obvious effect, pain disappears", i.e. there are multiple preferred values. When switching to the next set and subsequent electrode contact combination, the stimulation signal is output at the amplitude U m . In this way, the number of traversals of the stimulation parameter can be reduced, and the efficiency is improved.

[0040] A specific embodiment is provided below:

[0041] Step 1: Program initialization, set the default pulse width t0, default frequency f0, set the amplitude U range and step size s, start the automatic screening, enter step 2.

[0042] Wherein the pulse width t0 is any value selected from 20-1000μs, preferably 210μs; the frequency is any value selected from 2-10000Hz, preferably 40Hz; the voltage mode amplitude range is 0-10V, the current mode amplitude range is 0-25mA. The amplitude U adjustment range is preferably 0-3V or 0-5mA, and the step size s is preferably 0.5V or 0.5mA.

[0043] Step 2: The program automatically selects electrode contact 1 and its adjacent electrode contact 2, and starts stimulation from the lowest value in the amplitude U range. The stimulation duration can be set to 3-5s, and then enters step 3;

[0044] Step 3: The patient selects the feeling option or scores according to the current parameter under the stimulation, and enters step 4;

[0045] Step 4: The program automatically stops stimulation for a period of time to reduce the influence of the last stimulation, and enters step 5; (Step 4 is an optional step)

[0046] Step 5: Other parameters remain unchanged, increase the stimulation amplitude by step size s, start stimulation, repeat steps 3-5 until the amplitude U set range is traversed, enter step 6;

[0047] Step 6: Change the selected contact, select contact 2 and adjacent contact 3, select the lowest value in the amplitude a range, start stimulation, repeat steps 3-5. Until all contact combinations are traversed, enter step 7;

[0048] For the 16-contact electrode as shown in Figure 1 or Figure 2 The traversal order is preferably 1-2+, 2-3+, …, 7-8+ in sequence, where after testing 7-8+, 7+8- is additionally tested, and then another column of electrode contacts 9-16 is traversed in this manner.

[0049] Step 7: After all patient feeling records are completed, a record report is formed.

[0050] Those skilled in the art will appreciate that embodiments of the present application can be readily used as software, hardware, or a combination of software and hardware. In a software embodiment, various software modules in accordance with embodiments of the present application are stored in a memory such as a computer program product (e.g., a disk storage) and executed by a computer processor. As such, various program modules in accordance with embodiments of the present application can comprise program instructions stored on computer-readable media, such as magnetic or optical disks, or memory such as an erasable programmable read only memory (EPROM), an electrically erasable programmable read only memory (EEPROM), or flash memory. Program instructions can also be downloaded to a computer's memory from the Internet and / or another network. It is to be understood that the present application can be implemented in various forms of hardware, software, or a combination thereof, and that the present disclosure encompasses one or more of the following embodiments.

[0051] The present application is described in reference to the drawings using a flowchart and / or a block diagram of the method, apparatus (system) and computer program product according to embodiments of the application. It will be understood that each block of the flowchart and / or block diagram, and combinations of 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, 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, create means for implementing the functions specified in the flowchart and / or block diagram block or blocks. Figure 1 one or more functions specified in the flowchart and / or block diagram block or blocks. Figure 1 one or more functions specified in the flowchart and / or block diagram block or blocks.

[0052] These computer program instructions can 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 instructions which implement the function specified in the flowchart and / or block diagram block or blocks. Figure 1 one or more functions specified in the flowchart and / or block diagram block or blocks. Figure 1 one or more functions specified in the flowchart and / or block diagram block or blocks.

[0053] These computer program instructions can 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 and / or block diagram block or blocks. Figure 1 one or more functions specified in the flowchart and / or block diagram block or blocks. Figure 1 one or more functions specified in the flowchart and / or block diagram block or blocks.

[0054] Obviously, the embodiments described above are only examples and are not intended to limit the present application. Based on the above description, those skilled in the art can make other variations and changes of different forms. It is not necessary or possible to enumerate all the embodiments. The obvious variations and changes derived therefrom are still within the scope of protection of the present application.

Claims

1. An implantable spinal cord stimulation system, the system comprising a stimulator adapted for implantation in a body and a controller external to the body, characterized in that, The system performs operations comprising: The controller iterates through respective combinations of electrode contacts of the stimulator and values of the first stimulation parameter to cause the respective combinations of electrode contacts to output stimulation signals at the values of the first stimulation parameter; the controller records the perceptual information of the user on the stimulation effect during the iteration; the controller selects two adjacent electrode contacts each time during the iteration, and the combinations of electrode contacts are either transverse combinations or longitudinal combinations.

2. The system of claim 1, wherein, The controller starts the iteration from two electrode contacts at one end of the electrode line to the other end, until all adjacent combinations of electrode contacts are iterated.

3. The system of claim 1, wherein, The controller starts the iteration from two electrode contacts at the middle of the electrode line to both sides, and changes the direction of iteration according to the perceptual information during the iteration, until all adjacent combinations of electrode contacts are iterated.

4. The system of claim 1, wherein, The controller causes the respective combinations of electrode contacts to output stimulation signals by iterating from one extreme value of the first stimulation parameter to the other extreme value during the iteration.

5. The system of claim 1, wherein, The controller causes the respective combinations of electrode contacts to output stimulation signals by iterating from a middle value of the first stimulation parameter to both extreme values during the iteration, and changes the direction of iteration according to the perceptual information during the iteration.

6. The system of claim 1, wherein, The controller determines a preferred value of the first stimulation parameter according to the perceptual information after the iteration of the values of the first stimulation parameter to output stimulation signals for a first group of electrode contacts; the preferred value of the first stimulation parameter is used to output stimulation signals when other groups of electrode contacts are iterated.

7. The system of any one of claims 1-6, wherein, The duration of outputting stimulation signals at each value of the first stimulation parameter is 3-5s, and the interval time of switching the values of the first stimulation parameter is 0s-4s.

8. The system of any one of claims 1-6, wherein, The first stimulation parameter is pulse amplitude.

9. The system of any one of claims 1-6, wherein, The controller also uses a set value of a second stimulation parameter to cause the respective combinations of electrode contacts to output stimulation signals at the values of the first stimulation parameter and the set value of the second stimulation parameter during the iteration; the second stimulation parameter includes pulse frequency and / or pulse width.

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