Dynamic baseline adjustment for stimulus application system

The system addresses the challenge of fluctuating physiological baselines by dynamically adjusting stimulation thresholds, ensuring precise and timely electrical stimulation delivery.

WO2026062416A1PCT designated stage Publication Date: 2026-03-26INOPASE INC
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Patent Information

Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Filing Date
2024-09-20
Publication Date
2026-03-26

AI Technical Summary

Technical Problem

Existing stimulus application systems fail to accurately deliver electrical stimulation based on fluctuating physiological baselines, leading to suboptimal timing and effectiveness.

Method used

A stimulus application system with an implant device that dynamically adjusts a stimulation threshold based on real-time physiological data, using a sensor to detect signals, a controller to process and compare data against a dynamically changing baseline, and a stimulus circuit to apply electrical stimulation when needed.

Benefits of technology

Enables precise and timely electrical stimulation delivery, optimizing treatment efficacy by adapting to variations in physiological signals.

✦ Generated by Eureka AI based on patent content.

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Abstract

Disclosed herein are systems and methods for applying a stimulus to a target object based on sensed physiological data relating to the target object. A stimulation threshold for when to trigger stimulation of the target object based on a baseline indicating a need for stimulation can be continually adjusted based on the sensed data to more accurately activate stimulation at the appropriate time.
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Description

[0001] DYNAMIC BASELINE ADJUSTMENT FOR STIMULUS APPLICATION SYSTEM

[0002] Technical Field

[0003] The present disclosure relates to a stimulus application system for applying electrical stimulation to a location in a patient’s body.

[0004] Background

[0005] U.S. Patent Application No. 2017 / 0216607 discloses a neural implant device which comprises a circuit configured to receive an input signal and to generate an electrical signal based on the received input signal. However, this conventional neural implant device has drawbacks that control based on the internal physiological signals is not performed, and thus, stimulus corresponding to the status of the object person may not be applied.

[0006] PCT Publication No. WO 2023 / 1888437 provides a stimulus application system, an implant device, a controller device, a method for controlling a controller device, and a program, capable of applying stimulus corresponding to the status of the object. In particular, the publication discloses an implant device implanted in an object body which is an animal including a human being that can be wirelessly communicably connected to a controller device arranged outside of the object body. The implant device can include circuitry for detection which detects an electrical signal representing a physiological signal at a predetermined part in the object body, circuitry for transmission / reception which transmits detection information representing time variation of the detected electrical signal, and receives, from the controller device, a stimulation instruction representing a stimulus to be applied to the object body, and circuitry for application which applies an electrical stimulus to a predetermined part in the object body, on the basis of the stimulation instruction received by the circuitry for transmission / reception. In some applications, systems such as the above have been used for stimulating a nerve. However, it has been found that a baseline of the physiological signal detected from the nerve may vary over time such that determining a stimulation instruction based on a constant threshold may not accurately provide stimulation at the times when it is needed.

[0007] Summary

[0008] Disclosed herein are systems and methods for applying a stimulus to a target object based on sensed physiological data relating to the target object. A stimulation threshold for when to trigger stimulation of the target object based on a baseline indicating a need for stimulation can be continually adjusted based on the sensed data to more accurately activate stimulation at the appropriate time.

[0009] In an embodiment, a stimulus application system can include an implant device configured to be implanted in a body of a patient including a sensor unit configured to detect physiological signals at a predetermined detection location in the body at predetermined time intervals and a stimulus circuit unit configured to apply an electrical stimulus to a predetermined stimulation location in the body upon receiving a stimulation instruction. The system can further include at least one controller configured to receive detection information pertaining to the physiological signals detected by the sensor unit at each predetermined time interval, process the detection information for each predetermined time interval for comparison to a baseline level, with the baseline level dynamically changeable for each predetermined time interval, and generate a stimulation instruction if the processed detection information for a current time interval exceeds the baseline level for the current time interval by a threshold amount.

[0010] In embodiments, the at least one controller is further configured to process the detection information for each predetermined time interval by decoding the detection information.

[0011] In embodiments, the at least one controller is configured to compare the detection information to the baseline level by comparing the decoded detection information to the baseline level.

[0012] In embodiments, the at least one controller is further configured, for each current time interval, to generate a flat data level comprising averaged processed detection information over a predetermined period of time, generate an adjustment threshold based on the flat data level and selectively change the baseline level based on a comparison of the adjustment threshold to the flat data level.

[0013] In embodiments, the adjustment threshold is a predetermined percentage higher than the flat data level.

[0014] In embodiments, the at least one controller is configured to compare the adjustment threshold data to the flat data level by comparing the adjustment threshold for the current time interval to the flat data level for the previous time interval.

[0015] In embodiments, the at least one controller is configured to set the baseline level for the current time interval to the flat data level for the current time interval if the adjustment threshold for the current time interval is lower than the flat data level for the previous time interval.

[0016] In embodiments, the at least one controller is configured to keep the baseline level for the previous time interval as the baseline level for the current time interval if the adjustment threshold for the current time interval is not lower than the flat data level from the previous time interval and the baseline level for the previous time interval is lower than the flat data level for the previous time interval.

[0017] In embodiments, the at least one controller is configured to set the baseline level for the current time interval to the flat data level for the previous time interval if the adjustment threshold for the current time interval is not lower than the flat data level from the previous time interval and the baseline level for the previous time interval is not lower than the flat data level for the previous time interval.

[0018] In embodiments, the predetermined stimulation location is a nerve.

[0019] In embodiments, the predetermined detection location is a nerve.

[0020] In embodiments, the nerve is the sacral nerve.

[0021] In embodiments, the detection information comprises nerve activity data.

[0022] In embodiments, the at least one controller is part of the implant device.

[0023] In an embodiment, the system can further include a wearable recharging device configured to recharge a battery of the implant device.

[0024] In embodiments the system can further include an external programmer configured to wirelessly communicate with the implant device and the at least one controller is part of the external programmer.

[0025] In an embodiment a method includes applying electrical stimulation to a predetermined stimulation location in a body of a patient using the implant device and / or the system as described above.

[0026] The above summary is not intended to describe each illustrated embodiment or every implementation of the subject matter hereof. The figures and the detailed description that follow more particularly exemplify various embodiments.

[0027] Brief Description of Drawings

[0028] Subject matter hereof may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying figures, in which:

[0029] FIG. 1 is a structural block diagram showing an example of a stimulus application system according to an aspect of the present disclosure.

[0030] FIG. 2 is a functional block diagram showing an example of an implant device according to an aspect of the present disclosure.

[0031] FIG. 3 is a functional block diagram showing an example of a control unit of an implant device according to an aspect of the present disclosure.

[0032] FIG. 4 is a flowchart showing an operation example of a stimulus application system according to an aspect of the present disclosure.

[0033] FIGS. 5 A-5B depict decoded nerve activity data over time according to an aspect of the disclosure.

[0034] FIG. 6 depicts a flowchart of steps in a method of calculating a dynamic baseline for a stimulus application system according to an aspect of the disclosure.

[0035] FIGS. 7A-7B depict examples of the method described with respect to FIG. 6.

[0036] While various embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the disclosed inventions to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter described herein.

[0037] Detailed Description

[0038] The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0039] As exemplified in FIG. 1, a stimulus application system 1 according to an aspect of the present disclosure includes an implant device 10 implanted in an object body which is an animal including a human being and a programmer 20 and charging device 30 which can be arranged outside of the object body. Stimulus application system 1 may further communicate with a cloud platform 40.

[0040] Implant device 10, depicted in FIG. 2, can include a transmission / reception unit 11, a power supply unit 12, a stimulus circuit unit 13, a sensor unit 14, and a control unit 15.

[0041] The transmission / reception unit 11 of the implant device 10 can transmit data to the programmer 20 arranged outside of the object body, in accordance with instructions input from the control unit 15. Further, the transmission / reception unit 11 can receive data from the programmer 20 and output the data to the control unit 15. In various embodiments, a widely known data transmission / reception method can be adopted, such as NFC, Wi-Fi, Bluetooth (registered trademark), RFID wireless communication standard, and the like. According to an embodiment, the transmission / reception unit 11 can receive wireless power transfer from the recharging device 30 and output the received power to the power supply unit 12.

[0042] The power supply unit 12 can be provided with a battery B and supply power to each unit of the implant device 10. Battery of power supply unit 12 can be wirelessly recharged, as will be described in more detail below.

[0043] The stimulus circuit unit 13 is under control of the control unit 15 and can apply a stimulus to the object body through electrodes arranged at predetermined parts (hereinbelow, referred to as stimulation parts) in the object body. Herein, the stimulation part where the electrode is arranged is a part to which stimulus to a nerve etc., can be applied, as used in Spinal Cord Stimulation, Sacral Neuro Modulation, Vagus Nerve Stimulation, Deep Brain Stimulation, and the like. The stimulation parts can be selected in accordance with the type of stimulus to be applied to the object body. For the arrangement of the electrodes of the stimulus circuit unit 13, arrangements widely known as the arrangements used for the above-mentioned various stimulation methods can be adopted. Therefore, detailed explanation therefor is omitted here. Further, the stimulus may be a periodical electric signal, a single pulse signal, etc., and an amplitude, a frequency, a duration, a pulse width, and the like of the signal can be controlled by the control unit 15.

[0044] The sensor unit 14 can detect electric signals representing physiological signals of the object body (for example, signals representing the physiological signals at the detection parts of the object body, by the magnitude of potential thereof), through the electrodes arranged at predetermined parts (hereinbelow, referred to as detection parts) in the object body. The physiological signal can include one or more of membrane potential, Nerve action potential, Organ pressure, Tissue impedance, temperature, and other signals acting as biomarkers, in the object body, and the physiological signal can be selected in accordance with a rule predetermined depending on the type of stimulus to be applied. Further, the stimulation part and the detection part may be different parts, adjacent (comparatively close) parts, or the same part.

[0045] The control unit 15 can include a program controller device such as a CPU, and a storage device such as a memory. The control unit 15 can process detection information representing the electrical signal detected by the sensor unit 14 (for example, in case that the electrical signal represents the physiological signal at the detection part in the object body by the magnitude of its potential, the detection information is information representing the magnitude of the potential). The control unit 15 can analyze the detection information representing the detected electrical signal every time that the electrical signal is detected, or can store the information representing the electrical signals detected for a plurality of times in a memory, etc., and then process the information representing the detection information stored in the memory, at a predetermined time. Namely, for example, the detection information may include information representing an electrical signal as a result of one-time detection, or may include information representing a plurality of electrical signals as a result of a plurality of times of detection (representing detection information representing the time variation of the detected electrical signal).

[0046] Further, the control unit 15 can provide instructions (stimulation instruction) to the stimulation circuit 13. The control unit 15 can determine parameters such as the frequency and the intensity (amplitude) of the electrical signal to be applied to the object body as a stimulus, the pulse width (in case that the electrical signal is a pulse signal), and in addition, the time when the stimulus is to be applied, the duration of the stimulus, and the like. Then, the control unit 15 can control the stimulus circuit unit 13 so that the stimulus of the electrical signal defined by the determined parameters is applied.

[0047] The programmer 20 can be arranged at a position outside of the object body and wirelessly communicable with the implant device 10. In some embodiments, the programmer 20 can provide initial or updated programming of parameters for the implant 10 to follow and the processor of the implant 20 then carries out detection, analysis and stimulation functions independently. For example, a physician may program the implant 10 with the programmer 20 during an office visit, with the implant 10 then operating without need for further external instruction. The programmer 20 can also receive historical therapy data stored by the implant. Such data can include, for example, sensor data detected by sensor unit 14, stimulation data provided by stimulation circuit 13, etc. The programmer 20 can also transmit data to and receive data from artificial intelligence system 40, as will be described in more detail below.

[0048] Recharging device 30 can be a wearable recharger configured to transmit power to recharge the battery in the power supply unit 12 of the implant. Wearable recharger 30 can be selectively worn by the user when the implant needs to be charged and then removed from the user as desired. In embodiments, recharging device 30 can provide an indication of a charging status and / or battery level of the power supply unit 12 of the implant. Wearable recharger 30 can itself be recharged by connection to a power source. Further details regarding wireless power technology that can be used with aspects of the disclosure can be found in U.S. Patent Publication No. 2023 / 0344273, which is hereby incorporated by reference herein in its entirety.

[0049] Cloud platform 40 can employ, for example, any available cloud computing service. Programmer 20 can communicate information to and receive information from cloud platform 40 over WiFi communications or other known communication modalities. Cloud platform 40 can include data storage that stores data relating to system 1. In embodiments, programmer 20 can transmit historical data received from implant 10 for a plurality of patients to cloud platform 40. Cloud platform may further include an Artificial Intelligence (Al) system that can analyze the historical data and provide suggestion for improvements to therapy provided by implant 10. For example, cloud platform 40 may store a separate file for each patient using an implant 10. The Al system may analyze the data across all patients, a group of patients, etc. and provide suggestions for modifications to improve therapy for one or more individual patients based on the analysis.

[0050] Referring now to Figure 3, an operation example of the control unit 15 of the implant device 10 will be explained. According to an embodiment, the control unit 15 executes the programming received from the programmer 20 and stored in a storage device. To carry out the programming, the control unit 15 functionally comprises a reception unit 151, a stimulus determination unit 152, and an instruction transmission unit 153.

[0051] The reception unit 151 can receive detection information detected by the sensor unit 14, the detection information being a detection result of the electrical signal detected by the sensor unit 14 as a physiological signal of the object body. On the basis of the detection information received by the reception unit 151, the stimulus determination unit 152 can determine the details of the stimulus to be applied to the object body by the stimulation circuit 13. As mentioned above, the detection information represents an electrical signal at a predetermined detection part in the object body, detected by the sensor unit 14. The stimulus determination unit 152 can use this detection information to acquire information regarding the time variation of the physiological signal at the predetermined part in the object body. For example, when the detection information includes information representing one electrical signal, as a result of detection for one time, the stimulus determination unit 152 can accumulate and store the detection information for a plurality of times to acquire information representing the time variation of the electrical signal (physiological signal at a predetermined part in the object body).

[0052] For example, the stimulus determination unit 152 determines the type of stimulus with reference to stimulus setting information in which a plurality of mutually different stimulus applying conditions are associated with information representing the details of the stimulus corresponding to each stimulus applying condition. The stimulus setting information can be set in advance and transmitted to implant 10 by programmer 20 and stored in the storage device. The stimulus determination unit 152 can output the information representing the details of the stimulus to the instruction transmission unit 153.

[0053] The instruction transmission unit 153 can transmit the stimulation instruction representing the details of the stimulus determined by the stimulus determination unit 152, to be carried out by the stimulation circuit 13. The stimulus setting information used here may be defined on the basis of the detection result of the electrical signal representing the physiological signal, which is acquired by the sensor unit 14.

[0054] Figure 4 depicts a flowchart showing an operation example of a stimulus application system according to an aspect of the present disclosure. In the following example, the implant device 10 is implanted in the object body, i.e., the body of a human being, and electrodes for providing stimuli are arranged at the stimulation parts and the detection parts used for Sacral Neuro Modulation. The sensor unit 14 of the implant device 10 senses nerve activity of the sacral nerve. In other examples, stimulation application system can be employed in a similar manner to stimulate other nerves or areas of the body.

[0055] In this process, first, the sensor unit 14 of the implant device 10 detects the electrical signals representing the physiological signals in the human body by the electrodes arranged in the detection parts, and generates detection information representing the detected electrical signals(Sl 1). The sensor unit 14 transmits the generated detection information to the control unit 15 of the implant device 10, at a predetermined time (for example, every time that the detection is performed) (S 12). Then, the implant device 10 examines whether or not an instruction is received from the control unit 14 within a predetermined time (S13). If no instruction is received (S13: No), the process returns to Step SI 1, and is continued.

[0056] In Step SI 2, the control unit 15 receives and stores the detection information transmitted by the sensor unit 14 (S21). The detection information stored in Step S21 is processed to decode the information to obtain nerve activity data (S22) after a predetermined number of data points are stored. In one embodiment, the information is decoded after 2048 at data points are stored. Further details on one example of this decoding process can be found in copending PCT Application No. PCT / IB24 / XXXXX entitled SYSTEMS AND METHODS FOR STIMULATION APPLICATION ACCOUNTING FOR LEAD MIGRATION, filed on the same day as the present application, which is hereby incorporated by reference in its entirety.

[0057] Once the decoded nerve activity data is obtained at Step S22, the data is compared to a baseline level (S23). The baseline is set as the minimum nerve activity intensity of each data gathering cycle. It is then determined if the data is above the baseline by a threshold amount (i.e., stimulation threshold) (S24), and if so details of a stimulation to be applied are determined (S25). If the data is not above the baseline by a threshold amount at Step S24, the system reverts to Step S21. Further details regarding calculation of and comparison with the baseline are detailed below.

[0058] The controller unit 15 transmits an instruction representing the details of the stimulus determined in Step S25 to the stimulation circuit 13 (S26). If the stimulation circuit 13 receives the instruction from the control unit 15 in Step S13 (S13: Yes), the stimulation circuit 13 applies parameters, such as a frequency, an amplitude, etc., of the electrical signal as a stimulus to be applied to the human body in which the implant device 10 is implanted, and controls a current to be applied to the stimulation part through the electrode so that the stimulus of the electrical signal with the determined parameters is to be applied (S14). The stimulus application system 1 according to the present aspect repeats the operations from Step SI 1 to Step S14, and the operations from Step S21 to Step S26. Accordingly, according to an example of the present aspect, the stimulus to be applied is varied in accordance with the status of the object human body, etc., and thus, a stimulus suitable for the status of the object can be applied.

[0059] In one example, this stimulus application system can be used for suppressing the symptoms of overactive bladder (OAB) by stimulating the sacral nerve. Referring now to Figure 5A, one example of decoded nerve activity data 50 over time is depicted. As noted above, to determine when stimulation should be delivered a baseline 52 of the nerve activity data is set and therapy is delivered upon the nerve activity 50 exceeding the baseline 52 by a stimulation threshold amount 54. The stimulation threshold 54, may be, for example 10% above the baseline. In embodiments, stimulation threshold can be predetermined by a physician and programmed into implant device 10 using programmer 20. Alternatively and / or additionally, the stimulation threshold can also be automatically determined by programmer 20 based on the analyzed patient data and programmed into implant device 20.

[0060] Setting the stimulation threshold too high would risk giving stimulation too late to manage the patient’s symptoms and setting the stimulation threshold too low would make the stimulation similar to constant stimulation that does not provide stimulation specifically when needed. To balance these concerns, for example, nerve activity data can be recorded for multiple voiding cycles and reviewed by the physician to determine an appropriate percentage for the threshold for activating stimulation to best manage a given patient’s symptoms.

[0061] The example depicted in Figure 5 A sets the baseline 52 as a constant value based on the minimum nerve activity during the initial voiding cycle. However, it has been found that the baseline nerve activity for a given voiding cycle tends to fluctuate over time. For example, in the nerve activity 52 depicted in Figure 5A, the minimum nerve activity in each voiding cycle is continually going lower. As such, therapy using a constant baseline set during the initial cycle is not provided at the optimal time during a given subsequent voiding cycle. Methods and systems disclosed herein therefore provide a dynamic baseline 62 as depicted in Figure 5B that enables a dynamic stimulation threshold 64 (e.g., 10% above the baseline level for a given voiding cycle). This baseline 62 can be recalculated for each voiding cycle resulting in the ability to provide therapy at the optimal time within a given cycle.

[0062] Figure 6 depicts a flowchart of steps in a method of calculating a dynamic baseline for a stimulus application system according to an aspect of the disclosure. Initially the decoded nerve activity is obtained (S61). Flat data of averaged decoded nerve activity data obtained in step S61 is then generated (S62). The same decoded nerve activity data is maintained for a period of time (e.g., 10 seconds) to minimize data fluctuations and improve detection accuracy. After 10 seconds, the flat data is updated with the next decoded nerve activity result, which is maintained for the following 10 seconds, and so on.

[0063] Next, an adjustment threshold to trigger a baseline data adjustment is generated (S63). The adjustment threshold can be, e.g., 20% higher in amplitude than the flat data generated in step S62. This adjustment threshold will be used to define the baseline data for each voiding cycle. In embodiments, this threshold can similarly be predetermined by a physician and programmed into the implant device 10 with the programmer 20 based on an analysis of recorded nerve activity data for a given patient. The adjustment threshold can be alternatively or additionally be automatically determined by programmer 20 based on the analyzed data and programmed into implant device 10.

[0064] The baseline data is then generated. To do so, first it is determined if the new adjustment threshold data determined at step S63 from the current cycle is lower than the previous flat data from the prior cycle (S64). If the determination at step S64 is that the new adjustment threshold data is lower than the previous flat data, then the new flat data is set as the new baseline data (S65). If the determination at step S64 is that the new adjustment threshold data is not lower than the previous flat data, it is next checked if the previous baseline data from the prior cycle is lower than the previous flat rate data (S66). If the previous baseline data is lower than the previous flat rate data in step S66, then the previous baseline data is kept as the new baseline data (S67). If at step S66, the previous baseline data is not lower than the previous flat rate data, then the previous flat data is set as the new baseline data (S68). These steps will then repeat each cycle to provide a dynamically adjusted baseline. Repeating the process will resulting in the dynamically changing baseline 62 depicted in Figure 5B. The corresponding stimulation threshold 64 then automatically adjusts along with the baseline 62 as described above.

[0065] Examples of the method described with respect to Figure 6 can be seen with reference to Figures 7A-7B. There are essentially three results that can be obtained by following this method:

[0066] A) If the new threshold data in a cycle is lower than the flat data from the previous cycle, then the new flat data in the current cycle is set as the new baseline data for that cycle,

[0067] B) If 1) the new threshold data in a cycle is not lower than the flat data from the previous cycle and 2) the baseline data from the previous cycle is lower than the flat data from the previous cycle, then the baseline data from the previous cycle is kept as the new baseline data in the current cycle, and

[0068] C) If 1) the new threshold data in a cycle is not lower than the flat data from the previous cycle and 2) the baseline data from the previous cycle is not lower than the flat data from the previous cycle, then the flat data from the previous cycle is set as the new baseline data for the current cycle.

[0069] One example of result (A) can be seen in Figure 7A, which depicts decoded nerve data 70, threshold data 72, flat data 74 and baseline data 76 over time. In the third voiding cycle depicted between 310 seconds and 320 seconds, the threshold data 723 falls below the flat data 742 from the previous cycle between 300 seconds and 310 seconds. As such, the baseline data 763 in the current third cycle is set equal to the flat data 743 in the current cycle. The same result occurs in the fourth depicted time period between 320 and 330 seconds, where the threshold data 724 is below the is below the previous flat data 743, so the baseline data 764 for the current cycle is set equal to the flat data 744 for that cycle.

[0070] Examples of result (B) can be seen in Figure 7B, which similarly depicts decoded nerve data 80, threshold data 82, flat data 84 and baseline data 86 over time. Across each time period in this graph, the threshold data 82 is not lower than the previous flat data 84. In addition, in the third time period between 70 seconds and 80 seconds, the threshold data 823 is not lower than the previous flat data 842 and the baseline data 862 is lower than the previous flat data 842. As such, the baseline data from the previous time periods 862 remains the same baseline data for the current time period 863.

[0071] An example of result (C) can also be seen in Figure 7B. At the time of the first transition in the data just before 61 seconds, the threshold data 821 is not lower than the previous flat data 841 and the baseline data 861 is not lower than the previous flat data 821. The baseline data at 862 is then set equal to the previous flat data 841.

[0072] With regard to the above detailed description, like reference numerals used therein may refer to like elements that may have the same or similar dimensions, materials, and configurations. While particular forms of embodiments have been illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and scope of the embodiments herein. Accordingly, it is not intended that the invention be limited by the forgoing detailed description.

[0073] The entirety of each patent, patent application, publication, and document referenced herein is hereby incorporated by reference. Citation of the above patents, patent applications, publications and documents is not an admission that any of the foregoing is pertinent prior art, nor does it constitute any admission as to the contents or date of these documents.

[0074] Modifications may be made to the foregoing embodiments without departing from the basic aspects of the technology. Although the technology may have been described in substantial detail with reference to one or more specific embodiments, changes may be made to the embodiments specifically disclosed in this application, yet these modifications and improvements are within the scope and spirit of the technology. The technology illustratively described herein may suitably be practiced in the absence of any element(s) not specifically disclosed herein. The terms and expressions which have been employed are used as terms of description and not of limitation and use of such terms and expressions do not exclude any equivalents of the features shown and described or portions thereof and various modifications are possible within the scope of the technology claimed. Although the present technology has been specifically disclosed by representative embodiments and optional features, modification and variation of the concepts herein disclosed may be made, and such modifications and variations may be considered within the scope of this technology.

Claims

What is claimed is:

1. A stimulus application system, comprising: an implant device configured to be implanted in a body of a patient including a sensor unit configured to detect physiological signals at a predetermined detection location in the body at predetermined time intervals and a stimulus circuit unit configured to apply an electrical stimulus to a predetermined stimulation location in the body upon receiving a stimulation instruction; and at least one controller configured to: receive detection information pertaining to the physiological signals detected by the sensor unit at each predetermined time interval; process the detection information for each predetermined time interval for comparison to a baseline level, wherein the baseline level is dynamically changeable for each predetermined time interval; and generate a stimulation instruction if the processed detection information for a current time interval exceeds the baseline level for the current time interval by a threshold amount.

2. The system of claim 1, wherein the at least one controller is further configured to process the detection information for each predetermined time interval by decoding the detection information.

3. The system of claim 2, wherein the at least one controller is configured to compare the detection information to the baseline level by comparing the decoded detection information to the baseline level.

4. The system of any of claims 1-3, wherein the at least one controller is further configured, for each current time interval, to: generate a flat data level comprising averaged processed detection information over a predetermined period of time; generate an adjustment threshold based on the flat data level; and selectively change the baseline level based on a comparison of the adjustment threshold to the flat data level.

5. The system of claim 4, wherein the adjustment threshold is a predetermined percentage higher than the flat data level.

6. The system of claim 4, wherein the at least one controller is configured to compare the adjustment threshold data to the flat data level by comparing the adjustment threshold for the current time interval to the flat data level for the previous time interval.

7. The system of claim 6, wherein the at least one controller is configured to set the baseline level for the current time interval to the flat data level for the current time interval if the adjustment threshold for the current time interval is lower than the flat data level for the previous time interval.

8. The system of claim 6, wherein the at least one controller is configured to keep the baseline level for the previous time interval as the baseline level for the current time interval if the adjustment threshold for the current time interval is not lower than the flat data level from the previous time interval and the baseline level for the previous time interval is lower than the flat data level for the previous time interval.

9. The system of claim 6, wherein the at least one controller is configured to set the baseline level for the current time interval to the flat data level for the previous time interval if the adjustment threshold for the current time interval is not lower than the flat data level from the previous time interval and the baseline level for the previous time interval is not lower than the flat data level for the previous time interval.

10. The system of any preceding claim, wherein the predetermined stimulation location and predetermined sensing location is a nerve.

11. The system of claim 10, wherein the nerve is the sacral nerve.

12. The system of any of claims 1-11, wherein the at least one controller is part of the implant device.

13. The system of claims 1-12, further comprising a wearable recharging device configured to recharge a battery of the implant device.

14. The system of any of claims 1-13, further comprising an external programmer configured to wirelessly communicate with the implant device, wherein the at least one controller is part of the external programmer.

15. A method of applying electrical stimulation to a predetermined stimulation location in a body of a patient using the system of any of claims 1-14.

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