Implantable spinal cord stimulation system and method of information recording and adjustment thereof

Abstract

The present application provides an implantable spinal cord stimulation system and its information recording and adjustment method, wherein the spinal cord stimulation information recording method comprises: presenting a body surface segmental sensory distribution map, which comprises a plurality of dermatome regions; obtaining a user-selected dermatome region, which represents a part where the patient perceives the existence of pain reduction or tingling; and recording the combination of electrode contacts and the stimulation parameters of the current output stimulation signal in association with the user-selected dermatome region.

Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to an implantable spinal cord stimulation system and its information recording and adjustment method. Background Technology

[0002] An implantable medical device (IMD) is a medical device installed inside a user's body. This device contains a battery, a chip, and sensors, and relies on set programs and operating parameters to implement corresponding therapies. These operating parameters can be set differently according to the user's condition.

[0003] Implantable spinal cord stimulation (SCR) systems have been proven effective in treating chronic pain syndromes. Existing SCR systems generally consist of a pulse generator, electrodes, and a patient controller. Most SCR systems have at least 16 electrode contacts. After the implantation surgery, significant time is required to set and select the optimal stimulation sites and parameters to choose the best combination of stimulation. Furthermore, the implanted electrode positions are susceptible to displacement due to various factors, which can render the original stimulation method ineffective.

[0004] Currently, when implanted electrodes are suspected of being misaligned, patients need to undergo X-ray examination to identify the displacement, but this method of identification is not very convenient. Summary of the Invention

[0005] In view of this, the present invention provides a method for recording spinal cord stimulation information, the method being executed by an external controller of an implanted spinal cord stimulation system, the method comprising:

[0006] Presents a segmental sensory distribution map of the body surface, including multiple dermatome regions;

[0007] Obtain the dermatome area selected by the user, which indicates the area where the patient perceives reduced pain or tingling sensation;

[0008] The combination of electrode contacts and stimulation parameters of the current output stimulation signal are associated and recorded with the dermatome region selected by the user.

[0009] The present invention also provides a method for recording spinal cord stimulation information, the method being executed by an external controller of an implanted spinal cord stimulation system, the method comprising:

[0010] Presents a segmental sensory distribution map of the body surface, including multiple dermatome regions;

[0011] Iterate through all combinations of electrode contacts and stimulation parameters of the stimulator, so that each combination of electrode contacts outputs stimulation signals in sequence;

[0012] During the traversal process, the dermatome region selected by the user is obtained, and the combination of the selected dermatome region and its corresponding electrode contact and stimulation parameters are associated and recorded. The region selected by the user represents the area where the patient perceives reduced pain or numbness.

[0013] Optionally, the above traversal and recording operations specifically include:

[0014] The system acquires the user-selected combination of electrode contacts and its corresponding stimulation parameters, and controls the stimulator to output stimulation signals.

[0015] Obtain the dermatome region selected by the user on the segmental sensory distribution map of the body surface in response to the current stimulus process;

[0016] The selected dermatome region is associated with the current electrode contact combination and the current stimulation parameters and recorded accordingly.

[0017] Repeat the above steps until all required electrode contact combinations and stimulation parameters have been explored.

[0018] The present invention also provides a method for displaying spinal cord stimulation information, the method being executed by an external controller of an implanted spinal cord stimulation system, the method comprising:

[0019] Presents a segmental sensory distribution map of the body surface, which includes multiple dermatome regions, and at least some of the dermatome regions are associated with combinations of electrode contacts and stimulation parameters;

[0020] Obtain the dermatome area selected by the user. The selected dermatome area represents the area where the patient perceives reduced pain or tingling.

[0021] Combined with the selected dermatome region, it displays the combination of its associated electrode contacts and stimulation parameters.

[0022] The present invention also provides a spinal cord stimulation modulation method, the method being executed by an external controller of an implantable spinal cord stimulation system, the method comprising: presenting a segmental sensory distribution map of the body surface, including multiple dermatome regions, and at least some of the dermatome regions being associated with a combination of electrode contacts;

[0023] The combination of the user-selected dermatome region and the first electrode contact of the current output stimulation signal is obtained. The selected dermatome region represents the area where the patient perceives reduced pain or tingling.

[0024] The displacement of the electrode contacts within the body is determined based on the combination of the user-selected dermatome and the first electrode contact.

[0025] The combination of electrode contacts that output stimulation signals is adjusted according to the displacement.

[0026] Optionally, determining the displacement of the electrode contact within the body based on the combination of the dermatome region and the first electrode contact includes:

[0027] Determine the dermatome region associated with the combination of the first electrode contacts;

[0028] The displacement of the electrode contacts within the body is determined based on the dermatome region associated with the combination of the first electrode contacts and the dermatome region selected by the user.

[0029] Optionally, determining the displacement of the electrode contact within the body based on the combination of the dermatome region and the first electrode contact includes:

[0030] Determine the combination of second electrode contacts associated with the user-selected dermatome region;

[0031] The displacement of the electrode contacts within the body is determined based on the combination of the first electrode contacts and the combination of the second electrode contacts.

[0032] Optionally, the at least part of the dermatome region is also associated with stimulation parameters and corresponding sensory information, which is used to indicate the patient's perception of pain reduction or tingling.

[0033] Determining the displacement of the electrode contact within the body based on the combination of the dermatome region and the first electrode contact includes:

[0034] Determine the dermatome region associated with the combination of first electrode contacts, and determine the first stimulation parameters used in the current output stimulation signal and their associated sensory information;

[0035] Obtain the user's perception information regarding the first stimulus parameter;

[0036] Determine whether the dermatome region associated with the combination of the first electrode contacts is different from the dermatome region selected by the user, and determine whether the perceptual information associated with the first stimulation parameter is the same as the perceptual information currently provided by the user.

[0037] When the dermatome region associated with the combination of the first electrode contacts is different from the dermatome region selected by the user, and the perceptual information associated with the first stimulation parameter is the same as the perceptual information currently provided by the user, the displacement of the electrode contacts in the body is determined.

[0038] Optionally, determining the displacement of the electrode contact within the body based on the combination of the dermatome region and the first electrode contact includes:

[0039] Determine the dermatome region associated with the combination of the first electrode contacts, and determine the first stimulation parameters used for the current output stimulation signal;

[0040] Obtain the user's perception information regarding the first stimulus parameter;

[0041] Determine the second stimulus parameter associated with the currently provided perceptual information by the user;

[0042] Determine whether the dermatome region associated with the combination of the first electrode contacts is different from the dermatome region selected by the user, and determine whether the first stimulation parameter is the same as the second stimulation parameter;

[0043] When the dermatome region associated with the combination of the first electrode contacts is different from the dermatome region selected by the user, and the first stimulation parameter is the same as the second stimulation parameter, the displacement of the electrode contacts in the body is determined.

[0044] Optionally, the segmental sensory distribution map of the body surface in the above methods is a three-dimensional model map, and the dermatome region is a band-shaped region.

[0045] Optionally, during the presentation and acquisition of the user-selected dermatome region using the above methods, the display angle and size of the 3D model diagram are adjusted according to the user's operation, so that the user can rotate and view it and perform local zooming.

[0046] Accordingly, the present invention also provides an implantable spinal cord stimulation system, comprising a stimulator suitable for implantation in the human body and an external controller, the system being used to perform the above-described spinal cord stimulation information recording method.

[0047] Accordingly, the present invention also provides an implantable spinal cord stimulation system, including a stimulator suitable for implantation in the human body and an external controller, the system being used to perform the above-described spinal cord stimulation information display method.

[0048] Accordingly, the present invention also provides an implantable spinal cord stimulation system, comprising a stimulator suitable for implantation in the human body and an external controller, the system being used to perform the above-described spinal cord stimulation modulation method.

[0049] The spinal cord stimulation information recording method and system provided by this invention offer users a visualized segmental sensory distribution map of the body surface, enabling patients to accurately express their perception of stimulation therapy and thus accurately record the correspondence between stimulation points and parameters and dermatome regions. In subsequent use, when patients experience unsatisfactory stimulation therapy effects, the recorded information can be retrieved to determine whether implantation site misalignment has occurred, thereby assisting doctors in adjusting stimulation sites and parameters.

[0050] The spinal cord stimulation information display method and system provided by this invention offer users a visualized segmental sensory distribution map of the body surface, enabling patients to accurately express their perception of stimulation therapy, thereby accurately obtaining the stimulation touchpoints and stimulation parameters associated with the dermatome region expressed by the patient. By comparing the actual operating status information of the system, it is possible to quickly determine whether the implanted electrodes have been misaligned.

[0051] The spinal cord stimulation modulation method and system provided by this invention offer users a visualized segmental sensory distribution map of the body surface, enabling patients to accurately express their perception of stimulation therapy. When a patient feels the stimulation effect is unsatisfactory, the system can determine whether the implanted electrode is misaligned, as well as the direction and distance of displacement, by comparing the electrode contact point currently outputting the stimulation signal with the electrode contact point associated with the affected dermatome region expressed by the patient. Based on this displacement, the system can automatically adjust the electrode contact point outputting the stimulation signal. This automatic adjustment in the event of electrode misalignment alleviates or eliminates the impact of misalignment on the patient, offering significant convenience. Attached Figure Description

[0052] 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.

[0053] Figure 1 This is a schematic diagram of an electrode contact distribution in an embodiment of the present invention;

[0054] Figure 2 This is a schematic diagram of another electrode contact distribution in an embodiment of the present invention;

[0055] Figure 3 This is a schematic diagram of a spinal cord stimulator implanted in the human body in an embodiment of the present invention;

[0056] Figure 4 This is a segmental sensory distribution map of the body surface presented to the user by the system in this embodiment of the invention. Detailed Implementation

[0057] 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.

[0058] In the description of this invention, it should be noted that the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0059] 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.

[0060] This invention provides an implantable spinal cord stimulation system, comprising a stimulator suitable for implantation and an external controller. Both devices are equipped with wireless communication modules, and the controller controls the stimulator to perform actions via wireless communication. The stimulator includes a pulse generator and electrode wires, with multiple electrode contacts distributed at the ends of the electrode wires for stimulating human nerves. The spinal cord stimulator typically has at least 16 electrode contacts. Figure 1 and Figure 2 The electrode contact distribution diagrams for the two stimulators are shown. Figure 1 It is a paddle-shaped electrode, wherein electrode contacts 1 to 16 are located at the ends of the same electrode contact line; Figure 2 It is a needle-shaped electrode with two electrode lines, and electrode contacts 1 to 16 are distributed on the two electrode contact lines.

[0061] In one embodiment, the implantable spinal cord stimulation system performs a spinal cord stimulation information recording method applicable to the system setup or initialization phase, such as when a doctor sets up the system after the implantation surgery of the spinal cord stimulation system electrode contacts. Figure 3 The diagram shows a stimulator implanted in the human body, with the electrode contacts of the stimulator located within the spinal canal to electrically stimulate the spinal nerves. The spinal cord has 31 segments, giving rise to 31 pairs of spinal nerves, including 8 pairs of cervical (C) nerves, 12 pairs of thoracic (T) nerves, 5 pairs of lumbar (L) nerves, 5 pairs of sacral (S) nerves, and 1 pair of coccygeal nerves.

[0062] A dermatome refers to the corresponding skin region innervated by the sensory axons of each spinal cord segment, and is referred to as a dermatome region in this application. The distribution of sensory nerves in the skin of the body can be divided into two types: radicular segmental distribution and peripheral nerve distribution. The segmental distribution of human skin sensation is most prominent in the neck and trunk, with dermatomes arranged sequentially, each forming a ring-like band encircling the trunk and neck.

[0063] The system in this embodiment performs the following operations:

[0064] Presenting a segmental sensory distribution map of the body surface, specifically as follows: Figure 4As shown, this includes multiple dermatome regions, such as cervical dermatome regions C1-C8, trunk dermatome regions T1-T12, lumbar dermatome regions L1-L5, and sacral dermatome regions S1-S5. This image is displayed on the screen of an external controller, preferably a user-operable touchscreen. In a preferred embodiment, the system displays a three-dimensional model of the segmental sensory distribution on the body surface, where the dermatome regions are strip-shaped areas. Furthermore, the three-dimensional model can be scaled and rotated, and the user can operate it via the touchscreen. The system adjusts the display angle and size of the three-dimensional model according to the user's operation, allowing the user to rotate, view, and zoom in on specific areas.

[0065] The doctor sets the combination of stimulation parameters and electrode contacts that have a therapeutic effect on the patient, so that the stimulator outputs stimulation signals in the current set state.

[0066] After stimulation begins, the controller acquires the dermatome region selected by the user, indicating the area where the patient perceives reduced pain or tingling sensations. This is the location where stimulation of the spinal nerve produces these sensations, such as any one or more dermatome regions T1 to T12. The doctor or patient can select the dermatome region via the controller's input device, for example, by clicking on the corresponding location on the touchscreen.

[0067] The combination of electrode contacts currently outputting stimulation signals and their stimulation parameters are associated and recorded with the dermatome region selected by the user. Generally, multiple electrode contacts will output stimulation signals simultaneously, hence the term "electrode contact combination." Stimulation parameters may specifically include one or more of the following: stimulation frequency, stimulation amplitude, and stimulation pulse width. For example, if the user selects dermatome region T4, and electrode contacts 1 and 2 are currently outputting stimulation signals with frequency f, amplitude u, and pulse width t, then the associated recording of T4, f, u, and t can also be interpreted as marking these parameters at the location of dermatome region T4 on the segmental sensory distribution map, indicating that this combination of electrode contacts and stimulation parameters are acting on the patient's dermatome region T4 at this time.

[0068] The spinal cord stimulation information recording method and system provided in this embodiment of the invention provide users with a visualized segmental sensory distribution map of the body surface, enabling patients to accurately express their perception of stimulation therapy, thereby accurately recording the correspondence between stimulation points and parameters and dermatome regions. In subsequent use, when patients feel that the stimulation therapy is not effective, the recorded information can be retrieved to determine whether the implantation position has been misaligned, thereby assisting doctors in adjusting the stimulation site and parameters.

[0069] In another embodiment, the implantable spinal cord stimulation system performs another method for recording spinal cord stimulation information. This method is applicable to the system setup or initialization phase, such as when the doctor sets up the system after the implantation surgery of the spinal cord stimulation system electrode contacts. The main difference from the previous embodiment is that the stimulation system in this embodiment traverses each combination of the stimulator's electrode contacts and the values ​​of the stimulation parameters, causing each combination of electrode contacts to output stimulation signals with multiple stimulation parameter values. During the traversal, the correspondence between the traversed sites and parameters and the dermatome regions is recorded. Specifically, the system in this embodiment performs the following operations:

[0070] This presents a segmental sensory distribution map of the body surface, including multiple dermatome regions. Please refer to... Figure 4 The above embodiments and descriptions will not be repeated here.

[0071] The system iterates through all combinations of electrode contacts and stimulation parameters of the stimulator, causing each combination of electrode contacts to output stimulation signals sequentially. In this embodiment, multiple desired electrode contact combinations can be preset, such as all combinations considered capable of producing a therapeutic effect on the patient, or combinations of electrode contacts near adjacent effective combinations, or all possible combinations.

[0072] Taking all possible combinations as an example, combined with Figure 1 or Figure 2 For example, starting with the first electrode contact combination—electrode contact 1 and electrode contact 2—electrode contact 1 and electrode contact 2 are sequentially arranged in [U0, U... n At least one amplitude of the stimulus signal is output in the [U0, U] group, and then the next set of electrode contact combinations - electrode contact 2 and electrode contact 3 - is switched, such that electrode contact 2 and electrode contact 3 are sequentially in the [U0, U] group. n At least one amplitude of the stimulus signal is output in the [U0, U] parameter, and this process is repeated for all electrode contacts and stimulus parameters until the last set of electrode contact combinations - electrode contact 15 and electrode contact 16 - are sequentially output with amplitudes in the [U0, U] parameter. n At least one amplitude output stimulus signal in ]

[0073] During the traversal process, the user-selected dermatome regions are acquired, and the combinations of selected dermatome regions and their corresponding electrode contacts, along with stimulation parameters, are associated and recorded. The user-selected regions represent areas where the user perceives reduced pain or tingling sensations. For each combination of electrode contacts and stimulation parameters encountered during the traversal, the user selects the corresponding region in the segmental sensory distribution map of the body surface based on subjective perception. This completes the marking of all necessary segmental sensory distribution maps of the body surface, and the records are then integrated and saved.

[0074] In optional embodiments, since the electrode contact combination in this embodiment can output stimulation signals sequentially using multiple stimulation parameters, the user's perception of different stimulation parameters for the same set of electrode contacts may differ. Therefore, the user can also be provided with optional specific perception information options, such as "no effect," "slight relief, still quite painful," "effective, slight pain," and "significant effect, pain disappears," for the user to choose from. Alternatively, a score can be displayed, corresponding to the description in a corresponding rating table. Then, the optimal stimulation parameters are determined based on the specific perception information provided by the user. When performing correlation recording, only the optimal stimulation parameters can be recorded to reduce unnecessary data volume.

[0075] In a preferred embodiment, the process of traversing and associating records specifically includes the following steps:

[0076] Step 1: Obtain the electrode contact combination selected by the user and its corresponding stimulation parameters, and control the stimulator to output stimulation signals. This step involves manually setting a desired electrode contact combination and stimulation parameters, and then starting stimulation for a period of time.

[0077] Step 2: Obtain the dermatome region selected by the user on the segmental sensory distribution map of the body surface in response to the current stimulation process. The patient expresses the location where they perceive tingling or reduced pain, and then selects the corresponding location on the distribution map. During stimulation, the distribution map can be displayed continuously or popped up after a period of stimulation.

[0078] Step 3: Record the selected dermatome region in association with the current electrode contact combination and the current stimulation parameters;

[0079] Repeat steps 1 through 3 above until all required electrode contact combinations and stimulation parameters have been traversed. Each required electrode contact combination and parameter during the traversal process is manually set. Doctors can select the content to be traversed based on the patient's actual situation and response, thereby improving the efficiency and value of information recording.

[0080] After recording stimulation information according to the scheme of the above embodiment, the implanted spinal cord stimulation system can perform a spinal cord stimulation information display operation. This operation is applicable to various situations such as follow-up, system examination, adjustment of system parameters, or when the patient feels that the treatment effect is unsatisfactory. The system in this embodiment performs the following operations:

[0081] A segmental sensory distribution map of the body surface is presented, including multiple dermatome regions, and at least some of these dermatome regions are associated with combinations of electrode contacts and stimulation parameters. This associated information is recorded according to the method of the above embodiments, indicating the correspondence between the electrode contacts and stimulation parameters outputting stimulation signals in the stimulation system currently performing the treatment and the patient's dermatome regions.

[0082] Obtain the dermatome area selected by the user. Based on the patient's reported areas of reduced pain or tingling sensation, in such cases... Figure 4 Select the corresponding location from the segmental sensory distribution map of the body surface shown.

[0083] The system displays the associated electrode contact combinations and stimulation parameters in conjunction with the selected dermatome region. During this process, the user-selected dermatome region can have multiple possibilities. For example, if the user selects dermatome region T4, the system displays the associated electrode contact combinations—electrode contact 1 and electrode contact 2 (displaying their numbers)—as well as the stimulation parameters f, u, and t (displaying their names and values). The system can then retrieve the current operating status information of the stimulation system to determine if electrode contact 1 and electrode contact 2 are currently outputting stimulation signals with stimulation parameters f, u, and t. If they are consistent, it indicates that the system is functioning normally and the implanted electrode contacts are not misaligned. If they are inconsistent, it means that when the information was recorded previously, the area affected by the current electrode contact combination and stimulation parameters should not have been T4, indicating a system malfunction or possible misalignment of the implanted electrode contacts.

[0084] Another possibility is that, for example, if a user selects the dermatome region T3 and finds that there is no associated combination of electrode contacts, this means that no electrode contacts had a perceptual effect on this region when information was previously recorded, but now the patient perceives that this region is affected. This also indicates a system malfunction or that the implanted electrode contacts may be misaligned.

[0085] Therefore, by displaying the electrode contacts and parameters associated with the user-selected dermatome region, users can at least determine whether the stimulation system is functioning properly and whether the implanted electrode contacts are misaligned.

[0086] The spinal cord stimulation information display method and system provided in this embodiment of the invention provide users with a visualized segmental sensory distribution map of the body surface, enabling patients to accurately express their perception of stimulation therapy, thereby accurately obtaining the stimulation touchpoints and stimulation parameters associated with the dermatome region expressed by the patient. By comparing the actual working status information of the system, it is possible to quickly determine whether the implanted electrodes have been misaligned.

[0087] Furthermore, after recording stimulation information according to the scheme described in the above embodiments, the implantable spinal cord stimulation system can perform an automatic adjustment of the stimulation contact points, which is suitable for situations where the patient feels the treatment effect is unsatisfactory. The system in this embodiment performs the following operations:

[0088] The distribution map of segmental sensory information on the body surface is presented, which includes multiple dermatome regions, and at least some of the dermatome regions are associated with combinations of electrode contacts.

[0089] The system acquires the user-selected dermatome region and the combination of the first electrode contact currently outputting the stimulation signal. The selected dermatome region represents the area where the user perceives reduced pain or tingling sensations. For example, when a patient feels the treatment is ineffective, the system can adjust the stimulation based on the patient's reported areas of reduced pain or tingling sensations. Figure 4 The segmental sensory distribution map of the body surface shown is selected at the corresponding location - dermatome region T5. Simultaneously, the controller can determine the combination of electrode contacts currently outputting the stimulus signal from the stimulator, such as electrode contact 3 and electrode contact 4.

[0090] As a first alternative implementation, the dermatome region associated with the combination of first electrode contacts, i.e., the dermatome region associated with electrode contacts 3 and 4, can be determined using pre-recorded association information. Therefore, the displacement of the electrode contacts within the body can be determined based on the dermatome region associated with the combination of first electrode contacts and the dermatome region selected by the user. For example, if the recorded dermatome region associated with electrode contacts 3 and 4 is T4 instead of T5, this inconsistency indicates that the implanted electrode has shifted downwards, and the displacement distance can be determined to be one dermatome region. Then, the combination of electrode contacts outputting the stimulation signal is adjusted according to the determined displacement. For example, in the above case, the adjustment should be reversed, adjusting to allow electrode contacts 2 and 3 to output the stimulation signal, thereby improving the stimulation effect.

[0091] As a second alternative implementation, the combination of second electrode contacts associated with a user-selected dermatome region can be determined using pre-recorded association information; specifically, the combination of electrode contacts associated with dermatome region T5. Therefore, the displacement of the electrode contacts within the body can be determined based on the combination of the first and second electrode contacts. For example, if the recorded combination of electrode contacts associated with dermatome region T5 is electrode contacts 2 and 3, instead of the current combination of electrode contacts 3 and 4, this inconsistency indicates that the implanted electrode has shifted upwards, and the displacement distance can be determined to be the distance between adjacent electrodes. Then, the combination of electrode contacts outputting the stimulation signal can be adjusted according to the determined displacement. For example, in the above case, the adjustment should be reversed, adjusting to allow electrode contacts 4 and 5 to output the stimulation signal, thereby improving the stimulation effect.

[0092] The spinal cord stimulation modulation method and system provided by this invention offer users a visualized segmental sensory distribution map of the body surface, enabling patients to accurately express their perception of stimulation therapy. When a patient feels the stimulation effect is unsatisfactory, the system can determine whether the implanted electrode is misaligned, as well as the direction and distance of displacement, by comparing the electrode contact point currently outputting the stimulation signal with the electrode contact point associated with the affected dermatome region expressed by the patient. Based on this displacement, the system can automatically adjust the electrode contact point outputting the stimulation signal. This automatic adjustment in the event of electrode misalignment alleviates or eliminates the impact of misalignment on the patient, offering significant convenience.

[0093] Furthermore, in embodiments of the above information recording method, the controller can also record the stimulation parameters of the electrode contact combination, as well as the user's perceptual information regarding this area and parameters. Thus, at least a portion of the dermatome in the presented segmental sensory distribution map of the body surface is also associated with stimulation parameters and corresponding perceptual information. This perceptual information and stimulation parameters can also be used to determine or verify whether the implanted electrode has shifted.

[0094] As a third alternative implementation, the dermatome region associated with the combination of first electrode contacts (the electrode contacts currently outputting the stimulation signal) can first be determined, along with the first stimulation parameter used in the current output stimulation signal (the parameter currently used by the stimulator) and its associated sensory information. For example, the combination of first electrode contacts might be electrode contact 3 and electrode contact 4, and the parameter currently used by the stimulator might be u. 3-4 u that was recorded 3-4 Associated perceptual information L0.

[0095] Then, the user's perceptual information regarding the first stimulus parameter is obtained. At this point, options can be provided to allow the user to describe their current sensation, such as obtaining perceptual information L. n .

[0096] After obtaining this information, it is determined whether the dermatome region associated with the combination of the first electrode contacts is different from the dermatome region selected by the user, and whether the perceptual information associated with the first stimulation parameter is the same as the perceptual information currently provided by the user.

[0097] When the dermatome region associated with the combination of the first electrode contacts is different from the dermatome region selected by the user, and the perceptual information associated with the first stimulation parameter is the same as the perceptual information currently provided by the user, the displacement of the electrode contacts in the body is determined, and then adjustments are made based on the displacement.

[0098] As an example, it is determined whether the skin region associated with electrode contacts 3 and 4 is consistent with the user-selected region T5. According to the first optional implementation method described above, if they are inconsistent, it indicates displacement. However, this still needs to be verified through user perception. Specifically, it is necessary to determine u 3-4 The associated perceptual information L0 and the currently provided perceptual information L n Whether they are consistent, when the skin region associated with electrode contacts 3 and 4 is inconsistent with the user-selected region T5, and L0 and L n Only when they are consistent is misalignment confirmed and displacement further determined, and then adjustment is made. This is because if L0 and L... n Inconsistency indicates that poor stimulus effect is not necessarily caused by misalignment, and further investigation is needed. Only when L0 and L... n When the results are consistent, it indicates that the misalignment has been verified from both the dermatome region and sensory information. Adjustments should only be made under these circumstances to improve accuracy and safety.

[0099] As a fourth alternative implementation, the dermatome region associated with the combination of first electrode contacts (the electrode contacts currently outputting the stimulation signal) can first be determined, along with the first stimulation parameter used in the current output stimulation signal (the parameter currently used by the stimulator). For example, the combination of first electrode contacts might be electrode contact 3 and electrode contact 4, and the parameter currently used by the stimulator might be u. 3-4 .

[0100] Then, the user's perceptual information regarding the first stimulus parameter, and its associated second stimulus parameter, is obtained. At this point, options can be provided for the user to describe their current sensation, such as obtaining perceptual information L. n And query its associated stimulus parameter u n .

[0101] After obtaining this information, it is determined whether the dermatome region associated with the combination of the first electrode contacts is different from the dermatome region selected by the user, and whether the first stimulation parameter is the same as the second stimulation parameter.

[0102] When the combination of the first electrode contacts is associated with a different dermatome region than the dermatome region selected by the user, and the first stimulation parameter is the same as the second stimulation parameter, the displacement of the electrode contacts in the body is determined.

[0103] For example, it is determined whether the skin region associated with electrode contacts 3 and 4 matches the user-selected region T5. According to the first optional implementation described above, if they do not match, it indicates displacement. However, this still needs to be verified through the user's perception. The currently provided perception information L needs to be retrieved using pre-recorded information. n Associated stimulus parameter un Determine u n and u 3-4 Whether they are consistent or not, if they are inconsistent, it indicates that the poor stimulation effect is not necessarily caused by misalignment, and further examination should be carried out. Only when u n with u 3-4 When the results are consistent, it indicates that the misalignment has been verified from both the dermatome region and sensory information. Adjustments should only be made under these circumstances to improve accuracy and safety.

[0104] 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.

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 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. An implantable spinal cord stimulation system, comprising: The system comprises a stimulator adapted to be implanted in a human body and a controller outside the body, and is used for: presenting a body surface segmental sensation distribution map, wherein a plurality of dermatome regions are included, and at least part of the dermatome regions are associated with a combination of electrode contacts; acquiring a user-selected dermatome region and a combination of first electrode contacts currently outputting a stimulation signal, the selected dermatome region representing a part where the patient perceives that there is a pain reduction or tingling sensation; determining a displacement of the electrode contacts in the body according to the user-selected dermatome region and the combination of the first electrode contacts; adjusting the combination of the electrode contacts outputting the stimulation signal according to the displacement; wherein the determining of the displacement of the electrode contacts in the body according to the combination of the dermatome region and the first electrode contacts comprises: determining a dermatome region associated with the combination of the first electrode contacts; determining the displacement of the electrode contacts in the body according to the dermatome region associated with the combination of the first electrode contacts and the user-selected dermatome region; or, the determining of the displacement of the electrode contacts in the body according to the combination of the dermatome region and the first electrode contacts comprises: determining a combination of second electrode contacts associated with the user-selected dermatome region; determining the displacement of the electrode contacts in the body according to the combination of the first electrode contacts and the combination of the second electrode contacts.

2. The system of claim 1, wherein, the at least part of the dermatome regions are further associated with stimulation parameters and corresponding perception information, the perception information being used to represent a degree of the patient's perception of the pain reduction or tingling sensation; the determining of the displacement of the electrode contacts in the body according to the combination of the dermatome region and the first electrode contacts comprises: determining a dermatome region associated with the combination of the first electrode contacts, and determining a first stimulation parameter adopted by the current output stimulation signal and its associated perception information; acquiring perception information provided by the user for the first stimulation parameter; judging whether the dermatome region associated with the combination of the first electrode contacts is different from the user-selected dermatome region, and judging whether the perception information associated with the first stimulation parameter is the same as the current perception information provided by the user; when the dermatome region associated with the combination of the first electrode contacts is different from the user-selected dermatome region, and the perception information associated with the first stimulation parameter is the same as the current perception information provided by the user, determining the displacement of the electrode contacts in the body; or, the determining of the displacement of the electrode contacts in the body according to the combination of the dermatome region and the first electrode contacts comprises: determining a dermatome region associated with the combination of the first electrode contacts, and determining a first stimulation parameter adopted by the current output stimulation signal; acquiring perception information provided by the user for the first stimulation parameter; determining a second stimulation parameter associated with the current perception information provided by the user; judging whether the dermatome region associated with the combination of the first electrode contacts is different from the user-selected dermatome region, and judging whether the first stimulation parameter is the same as the second stimulation parameter; when the dermatome region associated with the combination of the first electrode contacts is different from the user-selected dermatome region, and the first stimulation parameter is the same as the second stimulation parameter, determining the displacement of the electrode contacts in the body.

3. The system of claim 1, wherein, the system is further used for: presenting a segmental sensory distribution map of the body surface, which includes a plurality of dermatome regions; acquiring a user-selected dermatome region, which represents a site where the patient perceives a pain reduction or tingling sensation; associating and recording the combination of electrode contacts and the stimulation parameters of the current output stimulation signal with the user-selected dermatome region.

4. The system of claim 1, wherein, The system is also used for: presenting a segmental sensory distribution map of the body surface, which includes a plurality of dermatome regions; traversing each combination of electrode contacts and stimulation parameters of the stimulator, and outputting stimulation signals in sequence according to each combination of electrode contacts; acquiring a user-selected dermatome region during the traversal process, and associating and recording the selected dermatome region and the corresponding combination of electrode contacts and stimulation parameters, wherein the user-selected region represents a site where the patient perceives a pain reduction or tingling sensation.

5. The system of claim 4, wherein, The traversal and recording operations specifically include: acquiring a user-selected combination of electrode contacts and the corresponding stimulation parameters, and controlling the stimulator to output stimulation signals; acquiring a user-selected dermatome region on the segmental sensory distribution map of the body surface for the current stimulation process; associating and recording the selected dermatome region and the current combination of electrode contacts and the current stimulation parameters; repeating the above steps until all required combinations of electrode contacts and stimulation parameters are traversed.

6. The system of any one of claims 1-5, wherein, The dermatome regions in the segmental sensory distribution map of the body surface are also associated with perception information, which represents the degree of perception of pain reduction or tingling sensation by the patient.

7. The system of any one of claims 1-5, wherein, The segmental sensory distribution map of the body surface is a three-dimensional model map, and the dermatome regions are belt-shaped regions.

8. The system according to any one of claims 1-5, wherein during the process of presenting and acquiring a user-selected dermatome region, the display angle and size of the three-dimensional model map are adjusted according to the user's operation, so as to allow the user to rotate and view and zoom in or out locally.

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