CN111084930A

CN111084930A - Implantable Spinal Cord Stimulation System

Info

Publication number: CN111084930A
Application number: CN201911415393.1A
Authority: CN
Inventors: 加福民; 史思伦; 薛林
Original assignee: Beijing Pins Medical Co Ltd
Current assignee: Beijing Pins Medical Co Ltd
Priority date: 2019-12-31
Filing date: 2019-12-31
Publication date: 2020-05-01
Anticipated expiration: 2039-12-31
Also published as: CN111084930B

Abstract

The present invention provides an implantable spinal cord stimulation system, the system including a stimulator adapted to be implanted in vivo and a controller external to the body, the system performing operations comprising: the controller traverses each combination of the electrode contacts of the stimulator and the value of the first stimulation parameter, so that each combination of the electrode contacts outputs a stimulation signal according to the values of the first stimulation parameter; the controller records the perception information of the user on the stimulation effect in the traversing process.

Description

Implantable spinal cord stimulation system

Technical Field

The invention relates to the field of medical instruments, in particular to an implantable spinal cord stimulation system.

Background

An Implantable Medical Device (IMD) is a Medical apparatus installed inside the body of a user, and the IMD has a battery, a chip and a sensor therein, and implements corresponding therapy depending on a set program and operation parameters, which may be set differently according to the condition of the user. IMD operating parameters are many, and operating parameter setting is relatively complicated.

Implantable spinal cord stimulation systems have been shown to be effective in treating chronic pain syndromes. Existing implanted spinal cord stimulation systems typically consist of a pulse generator, electrodes, and a patient controller. Wherein, most implanted electrodes of spinal cord stimulation systems include at least 16 contacts. After the implantation operation of the spinal cord stimulation system electrode is completed, the stimulation site and the stimulation parameters of the electrode need to be adjusted, so as to select the optimal stimulation combination. However, in the process of adjusting the parameters, the contacts and the parameters need to be manually set one by one, and due to the fact that the number of the contacts is too large, repeated labor is caused to waste labor and time.

Disclosure of Invention

In view of the above, the present invention provides an implantable spinal cord stimulation system, the system including a stimulator adapted to be implanted in vivo and a controller external to the body, the system performing operations comprising:

the controller traverses each combination of the electrode contacts of the stimulator and the value of the first stimulation parameter, so that each combination of the electrode contacts outputs a stimulation signal according to the values of the first stimulation parameter; the controller records the perception information of the user on the stimulation effect in the traversing process.

Optionally, the controller selects two adjacent electrode contacts at a time during the traversal.

Optionally, the controller starts traversing from two electrode contacts at one end of the electrode wire to the other end until all adjacent electrode contact combinations are traversed.

Optionally, the controller starts traversing from two electrode contacts located in the middle of the electrode line to two sides, and changes a traversing direction according to the sensing information in the process until all adjacent electrode contact combinations are traversed.

Optionally, the controller makes each combination of electrode contacts traverse to the other extreme value beginning with one extreme value of the first stimulation parameter respectively in the traversal process to output the stimulation signal.

Optionally, the controller may traverse each combination of electrode contacts to two extreme values with the intermediate value of the first stimulation parameter respectively in the traversal process to output the stimulation signal, and change the traversal direction in the process according to the perception information.

Optionally, the controller determines a preferred value of the first stimulation parameter from the sensory information after outputting the stimulation signal for a first set of electrode contacts traversing the value of the first stimulation parameter; and outputting stimulation signals by respectively adopting the preferred values of the first stimulation parameters when traversing other groups of electrode contacts.

Optionally, the duration of the output of the stimulation signal at each value of the first stimulation parameter is 3-5s, and the interval of switching the values of the first stimulation parameter is 0s-4 s.

Optionally, the first stimulation parameter is pulse amplitude.

Optionally, the controller further adopts a set value of a second stimulation parameter during the traversal process, so that each combination of the electrode contacts outputs a stimulation signal with a plurality of values of the first stimulation parameter and the set value of the second stimulation parameter, respectively, and the second stimulation parameter includes a pulse frequency and/or a pulse width.

According to the implantable spinal cord stimulation system provided by the invention, the automatic traversal of the stimulation parameters and the electrode contacts is executed through the in vitro controller, the corresponding subjective feeling is provided for the patient, and the controller records the subjective feeling, so that an evaluation report is finally formed. The doctor can select the optimal stimulation mode through the report content, and efficiently select the stimulation points and the values of the stimulation parameters, so that the labor cost and the time cost can be saved.

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 electrode distribution and traversal according to an embodiment of the present invention;

fig. 2 is a schematic diagram of another electrode distribution and traversal in the 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 "middle", "upper", "lower", "left", "right", "longitudinal", "transverse", and the like indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience of description and simplification of description, but do not indicate or imply that the elements referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first" and "second" 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 an implantable spinal cord stimulation system, which comprises a stimulator suitable for being implanted in a body and a controller in vitro, wherein the stimulator and the controller are respectively provided with a wireless communication module, and the controller controls the stimulator to execute actions in a wireless communication mode. The stimulator comprises a pulse generating device and an electrode wire, wherein a plurality of electrode contacts for stimulating human nerves are distributed at the end part of the electrode wire. The electrode contacts for spinal cord stimulation are typically at least 16, and the electrode contact profiles for both stimulators are shown in fig. 1 and 2. FIG. 1 is a paddle electrode in which 16 electrode contacts are located at the end of the same electrode wire; fig. 2 shows a needle electrode with two electrode wires, each having 8 electrode contacts at the ends.

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

With respect to the first aspect, one electrode contact combination comprises at least two electrodes, i.e. at least 2 of the 16 electrodes as shown in fig. 1 and 2. In a preferred embodiment, only 2 adjacent electrodes are selected at a time, i.e. each set of electrode contacts in the traversal process is two adjacent electrode contacts. For the case shown in fig. 1, the electrode contact combination may be a transverse combination 11 or a longitudinal combination 12; for the case shown in fig. 2, the electrode contact combination is either a transverse combination 21 or a longitudinal combination 22. In view of the actual implantation of the electrode contacts, the above-described longitudinal combinations are adopted in the preferred embodiment.

The controller outputs the stimulation signals by traversing all the electrode contact combinations. There are various specific traversing manners, for example, traversing from two electrode contacts located at the upper end of the electrode line (for example, the uppermost longitudinal combination 12 in fig. 1) to the lower end until traversing to the lowermost longitudinal combination 12, or conversely traversing from the lowermost end to the uppermost end, traversing from two electrode contacts in the middle to both ends, and the like are feasible, as long as it is ensured that all the combinations of the electrode contacts on two columns are traversed.

More specifically, referring to the electrode numbering in the figures in detail, traversing all adjacent electrode contact combinations is accomplished by initially outputting stimulation signals from a first set of electrode contacts, electrode 1 and electrode 2, then switching to output stimulation signals from a second set of electrode contacts, electrode 2 and electrode 3, then switching to output stimulation signals from a third set of electrode contacts, electrode 3 and electrode 4, until switching to output stimulation signals from a last set of electrode contacts, electrode 15 and electrode 16.

With respect to the second aspect, the controller will traverse the stimulation parameters used by each set of electrode contacts in outputting the stimulation signal. The stimulation parameter may be one or more of a stimulation amplitude, a stimulation frequency, and a stimulation pulse width. Because the difference between the optimal frequency f and the pulse width tu of different patients is not large in most cases, the two parameters can be preliminarily set as fixed values, only values of the stimulation amplitude are traversed, and then the frequency f and the pulse width tu can be manually adjusted.

There are various ways for the controller to traverse the values of the stimulation parameters, for example, it is possible to traverse from the maximum value to the minimum value of the stimulation parameters, or from the minimum value to the maximum value, or from the middle value to both extreme values. For example, the stimulation parameter to be traversed is pulse amplitude, which has a value range of [ U₀,U_n]The preferred voltage mode amplitude range is 0-10V and the current mode amplitude range is 0-25 mA. According to the changing step length s, the electrode contact combinations are respectively divided into U₀,U_n]The amplitude of (a) outputs a stimulus signal.

More specifically, for example, the initially traversed electrode contact combination is electrode 1 and electrode 2, at which point the traversal of the stimulation parameters is initiated such that electrode 1 and electrode 2 are sequentially lined with [ U ]₀,U_n]Then switches the next set of electrode contact combinations-electrode 2 and electrode 3, so that electrode 2 and electrode 3 are sequentially in [ U ] order₀,U_n]Outputs stimulation signals at a plurality of amplitudes, so traversing the stimulation parameters until the last set of electrode contact combinations-electrode 15 and electrode 16 in turn at [ U ]₀,U_n]Outputs a stimulation signal.

Further, the preferred range of duration for which the stimulation signal is output at the value of each stimulation parameter is 3-5s, and there may be no pauses in switching the values of the different stimulation parameters. In order to mitigate the effect of outputting the stimulation signal using the previous stimulation parameter on the user's perception, the output may also be paused for a period of time (n seconds, n > -0) during the switching of the different stimulation parameter values, preferably in the range of 0-4 s.

And the controller records the perception information of the user on the stimulation effect in the process of executing the traversal. The controller can provide a human-computer interaction interface for the user to input sensed information according to self-sensing, for example, the controller can provide options of sensing effect such as 'no effect', 'slow slightly, still painful', 'effect, slight pain', 'obvious effect, pain disappearance' and the like for the user to select, or can display scores corresponding to the descriptions of the corresponding score comparison table.

Specifically, when the controller makes each electrode contact combination continuously output the stimulation signals according to each stimulation parameter value, the perception information is recorded respectively, namely, each stimulation parameter of each stimulation contact combination corresponds to one perception information independently. By way of example, the currently traversed electrode contact combination is, for example, electrode 1 and electrode 2, when electrode 1 and electrode 2 are at stimulation amplitude U₀When outputting the stimulation signal, the user provides a perception information FL_1-2-UoThe amplitude of the stimulus becomes U₁When outputting the stimulation signal, the user provides a perception information FL_1-2-U1Until the stimulus amplitude becomes U_nWhen outputting the stimulation signal, the user provides a perception information FL_1-2-Un(ii) a Then, after traversing the electrode contacts to combine the electrode 2 and the electrode 3, the perception information FL is similarly acquired_2-3-Uo、FL_2-3-U1…FL_2-3-UnAnd obtaining sensing information corresponding to all electrode contact combinations and stimulation parameter values thereof until the last group of electrode contact combinations is traversed.

After all traversals and perception information recording is completed, a recording report can be generated, wherein all traversals and perception information corresponding to the traversals can be included. In an alternative embodiment, the generation of the log report may include only a log of the optimal stimulation parameter combination for each electrode contact combination. Such as for the FL described above_2-3-Uo、FL_2-3-U1…FL_2-3-UnThe perception information can determine the information which is best felt by the user according to the specific content, the corresponding stimulation parameters are the optimal parameters of the electrode contact combination electrodes 2 and 3, and the reporting content can be more concise and effective only by embodying the optimal parameters of all the electrode contact combinations.

The record report may be stored in the controller, or sent to a cloud storage, or sent to a doctor client. The physician can refer to the recorded report to adjust the optimal stimulation parameter combination.

According to the implantable spinal cord stimulation system provided by the embodiment of the invention, the automatic traversal of the stimulation parameters and the electrode contacts is executed through the in vitro controller, the corresponding subjective feeling is provided for the patient, the controller records the subjective feeling, and finally an evaluation report is formed. The doctor can select the optimal stimulation mode through the report content, and efficiently select the stimulation points and the values of the stimulation parameters, so that the labor cost and the time cost can be saved.

To improve the efficiency of the traversal, the controller may determine a traversal strategy during the traversal process based on the perceptual information currently provided by the user.

In a first alternative embodiment, in relation to the first aspect described above, the controller may traverse from two electrode contacts in the middle to both sides, and in the process change the direction of traversal according to the sensing information until all adjacent electrode contact combinations are traversed. By way of example, the controller starts the traversal process from the centrally located longitudinal combination 12 in fig. 1, when the electrodes 4 and 5 output stimulation signals, and the controller records the perception information FL about the electrodes 4 and 5_4-5(ii) a The controller then switches the other upper longitudinal combination-electrode 3 and electrode 4 to output stimulation signals, recording the perception information FL about electrode 3 and electrode 4_3-4. At this time, the judgment is made if FL_3-4The expressed perceptual effect is not as good as FL_4-5The expressed sensing effect is that the longitudinal combination-electrode 2 and the electrode 3 above the combination are not switched continuously for the next time, but the longitudinal combination-electrode 5 and the electrode 6 below the combination in the middle are switched to output stimulation signals; if FL_3-4The expressed perception effect is better than or equal to FL_4-5The expressed sensing effect, then the electrode 2 and the electrode 3 which are the upper longitudinal combination are switched again to output the stimulation signals.

In a second alternative embodiment, in relation to the second aspect described above, the controller is configured to traverse the electrode contacts towards the two extreme values with an intermediate value of the stimulation parameter during the traversal to output the stimulation signal, and to change the direction of traversal during the traversal in dependence on the sensory information. By way of example, assume that when currently traversing to a certain set of electrode contact combinations, the controller first causes the combinations to be combined by an amplitude [ U ]₀,U_n]Middle value of U_hOutputting a stimulation signal, the controller recording information about U_hOf the perception information FL_Uh(ii) a Then the controller turns to U_nDirection switchingNext amplitude U_h+1(increasing amplitude) output stimulation signal, controller records information about U_h+1Of the perception information FL_Uh+1At this time, a judgment is made if FL_Uh+1The expressed perceptual effect is not as good as FL_UhThe perceived effect expressed is then no longer increased for the next time, but with an amplitude FL less than the median value_Uh-1Outputting a stimulation signal; if FL_Uh+1The expressed perception effect is better than or equal to FL_UhThe expressed perception effect, the amplitude is increased again and the stimulation signal is output.

In a third alternative embodiment, a fast traversal scheme is provided, wherein the controller determines the preferred value of the stimulation parameter based on the perceptual information after outputting the stimulation signal for traversing the value of the first stimulation parameter for a first set of electrode contacts, and outputs the stimulation signal using only the preferred value of the stimulation parameter when traversing the other sets of electrode contacts thereafter, respectively. By way of example, the electrode contact combination traversed at the beginning is, for example, electrode 1 and electrode 2, such that electrode 1 and electrode 2 are sequentially lined with [ U ]₀,U_n]And obtaining corresponding perception information FL_1-2-Uo、FL_1-2-U1…FL_1-2-UnDetermining information FL that is optimal for the user's perception according to its specific content_1-2-UmThe corresponding stimulation parameter is amplitude U_mI.e. the preferred value. The number of preferred values may be one or more, for example, the user may perceive "significant effect, absence of pain" for a plurality of stimulus amplitudes, i.e. there are a plurality of preferred values. When switching to the next and subsequent electrode contact combination, the amplitude U is then respectively_mAnd outputting the stimulation signal. Therefore, the traversal times of the stimulation parameters can be reduced, and the efficiency is improved.

One specific example is provided below:

step 1: initializing a program, setting a default pulse width t0 and a default frequency f0, setting an amplitude U traversal range and a step length s, starting to execute automatic screening, and entering step 2.

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

Step 2: automatically selecting the electrode contact 1 and the adjacent electrode contact 2 by a program, selecting the lowest value in the traversal range of the amplitude U to start stimulation, setting the stimulation duration to be 3-5s, and then entering the step 3;

and step 3: selecting a feeling option or scoring by the patient according to the stimulation under the current parameters, and entering the step 4;

and 4, step 4: the program automatically stops stimulating for a period of time to slow down the influence of the previous stimulation, and the step 5 is entered; (optional step 4)

And 5: other parameters are unchanged, the stimulation amplitude is increased according to the step length s, stimulation is started, the steps 3-5 are repeated until the set range of the amplitude U is traversed, and the step 6 is carried out;

step 6: changing the selected contact, selecting the contact 2 and the adjacent contact 3, selecting the lowest value in the traversal range of the amplitude a, starting stimulation, and repeating the steps 3-5. Entering step 7 until all contact combinations are traversed;

for electrodes with 16 contacts as shown in FIG. 1 or FIG. 2, the traversal order is preferably 1-2+, 2-3+ … 7-8+ sequentially traversing one row of electrodes, wherein after testing 7-8+, the additional 7+ 8-row is tested, and then traversing the other row of electrode contacts 9-16 in this manner.

And 7: after all sensory records of the patient are completed, a record report is formed.

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 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 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

1. An implantable spinal cord stimulation system, the system comprising a stimulator adapted to be implanted in vivo and a controller external to the body, the system performing operations comprising:

2. The system of claim 1, wherein the controller selects two adjacent electrode contacts at a time during the traversal.

3. The system of claim 2, wherein the controller traverses from two electrode contacts at one end of an electrode wire to the other end until all adjacent electrode contact combinations are traversed.

4. The system of claim 2, wherein the controller traverses from two electrode contacts located in the middle of the electrode wire to both sides, and changes the direction of traversal in the process according to the sensing information until all adjacent electrode contact combinations are traversed.

5. The system of claim 1, wherein the controller is configured to traverse each combination of electrode contacts during the traversal beginning at one extreme of the first stimulation parameter and beginning at another extreme to output the stimulation signal.

6. The system of claim 1, wherein the controller is configured to traverse each combination of electrode contacts to two extreme values with a median value of the first stimulation parameter during the traversal to output the stimulation signal, and to change the direction of traversal during the traversal based on the perception information.

7. The system of claim 1, wherein the controller determines a preferred value of the first stimulation parameter from the sensory information after outputting the stimulation signal for traversing the values of the first stimulation parameter for the first set of electrode contacts; and outputting stimulation signals by respectively adopting the preferred values of the first stimulation parameters when traversing other groups of electrode contacts.

8. A system according to any of claims 1-7, wherein the duration of the output of the stimulation signal at each value of the first stimulation parameter is 3-5s, and the interval between switching the values of the first stimulation parameter is 0s-4 s.

9. The system of any one of claims 1-7, wherein the first stimulation parameter is pulse amplitude.

10. The system according to any of claims 1-7, wherein the controller further assumes a set value for a second stimulation parameter during the traversal, such that each combination of electrode contacts outputs a stimulation signal at a plurality of values for the first stimulation parameter and the set value for the second stimulation parameter, respectively, the second stimulation parameter comprising a pulse frequency and/or a pulse width.