System for neuromodulation

Abstract

Systems and methods for a neuromodulation system are provided. In one example, the neuromodulation system includes a stimulation element, a stimulation controller, and a stimulation feedback acquisition system that includes a reference trigger input module configured such that the temporal relationship between a provided stimulation via the stimulation element and the stimulation controller, and a stimulation response received by the stimulation feedback acquisition system can be characterized.

Claims

1. A neuromodulation system comprising: at least one stimulation element; at least one stimulation controller; and at least one stimulation feedback acquisition system; wherein the at least one stimulation controller is configured to generate a reference trigger signal and stimulation control signals to the stimulation element; wherein the at least one stimulation feedback acquisition system includes a reference trigger input module configured to characterize a time delay between a provided stimulation, via the stimulation element, and the reference trigger signal provided by the stimulation controller.

2. The neuromodulation system of claim 1, wherein the characterization of the temporal relationship enables synchronizing the clocks of one or more of the stimulation element, the stimulation controller, the stimulation feedback acquisition system and the reference trigger input module.

3. The neuromodulation system of claim 1, wherein the at least one stimulation feedback acquisition system comprises a stimulation feedback acquisition base station and at least one sensor; and wherein the sensor is any of a sequence of event sensor, a motion sensor, a EMG, an afferent signal sensor, an efferent signal sensor, an impedance sensor, an EEG, a BCI, and a camera-based sensor.

4. The neuromodulation system according to claim 1, wherein the stimulation feedback acquisition system comprises two identical or non-identical sensors; and wherein the two sensors are synchronized.

5. The neuromodulation system of claim 1, wherein the neuromodulation system comprises one or more subsystems, wherein the subsystems comprise at least one of a programmer, a passive electrical means, a microprocessor, a wireless link (WL), a communication module (COM) and a telemetry module (TEL) module.

6. The neuromodulation system of claim 5, wherein the communication module (COM) comprises a Bluetooth module (BT) and the telemetry module (TEL) comprises any of a Near Field Magnetic Induction (NFMI) module or a Near Field Electromagnetic Induction (NFEMI) module.

7. The neuromodulation system of claim 1, wherein the stimulation controller is configured and arranged to provide a reference trigger signal; and wherein the reference trigger signal is recorded by the stimulation feedback acquisition system.

8. The neuromodulation system of claim 7, wherein the reference trigger signal is any of an electrical signal, a Bluetooth signal, a NFMI signal and a NFEMI signal.

9. The neuromodulation system of claim 7, wherein the reference trigger signal is a NFMI signal, and wherein the stimulation controller includes a passive electrical component configured and arranged to convert a NFMI signal into an electrical signal, wherein the electrical signal is recorded by the stimulation feedback acquisition system.

10. The neuromodulation system of claim 9, wherein the passive electrical component is a sticker; and wherein the sticker is placed on the skin of a patient.

11. The neuromodulation system of claim 9, wherein the passive electrical component is configured to be integrated into a clothing of the patient.

12. The neuromodulation system of claim 1, wherein the stimulation element is configured and arranged to provide an under-threshold signal, wherein the under-threshold signal does not lead to stimulation of a subject but is detectable by the stimulation feedback acquisition system as a reference trigger signal.

13. The neuromodulation system of claim 1, wherein the stimulation controller is configured and arranged to be connected to a connector; wherein the connector is connected to the stimulation feedback acquisition system.

14. The neuromodulation system of claim 12, wherein the connector is an external connector; and wherein a sensor is mounted on the external connector, the sensor configured to recognize a reference trigger signal provided by the stimulation controller.

15. The neuromodulation system of claim 14, wherein the stimulation feedback acquisition base station records a time of recognizing the reference trigger signal by the sensor.

16. The neuromodulation system of claim 1, further comprising a programmer communicatively coupled to one or more of the stimulation controller, the stimulation element, the reference trigger input module, and the stimulation feedback acquisition system.

17. The neuromodulation system of claim 16, wherein the programmer is an application installed on a mobile device.

18. The neuromodulation system of claim 16, wherein the programmer is configured to program the stimulation controller to deliver one or more of the provided stimulation and a reference trigger signal.

Description

BRIEF DESCRIPTION OF THE FIGURES

(1) Further details and advantages of the present invention shall now be disclosed in connection with the drawings.

(2) It is shown in

(3) FIG. 1 a general layout of an embodiment of the neuromodulation system for movement reconstruction and/or restoration of a patient according to the present invention;

(4) FIG. 2 a schematic illustration of a patient equipped with one embodiment of the neuromodulation system disclosed in FIG. 1 comprising two sensors and a connector;

(5) FIG. 3 a schematic illustration of a patient equipped with one embodiment the neuromodulation system disclosed in FIG. 1 comprising a communication module;

(6) FIG. 4 a schematic illustration of a patient equipped with one embodiment of the neuromodulation system disclosed in FIG. 1 comprising a telemetry (NFMI) module;

(7) FIG. 5 a schematic illustration of a patient equipped with a further embodiment of the neuromodulation system disclosed in FIG. 1 comprising a telemetry (NFEMI) module;

(8) FIG. 6 shows a schematic illustration of a patient equipped with one embodiment of the neuromodulation system disclosed in FIG. 1 comprising a passive electrical component; and

(9) FIG. 7 shows a schematic illustration of a patient equipped with one embodiment of a neuromodulation system disclosed in FIG. 1 using an electrical reference trigger signal provided by the IPG.

DETAILED DESCRIPTION

(10) FIG. 1 shows a general layout of an embodiment of the neuromodulation system 10 for movement reconstruction and/or restoration of a patient according to the present invention.

(11) The neuromodulation system 10 comprises a stimulation element 12.

(12) In this embodiment, the stimulation element 12 is an implantable pulse generator IPG.

(13) In general, any other type of implantable and/or non-implantable stimulation element 12 could be generally possible.

(14) The IPG is implanted in the body of the patient.

(15) The neuromodulation system 10 further comprises a stimulation controller 14.

(16) Additionally, the neuromodulation system comprises a stimulation feedback acquisition system 16.

(17) In this embodiment, the stimulation feedback acquisition system 16 comprises a stimulation feedback acquisition base station 16a and a sensor 16b.

(18) It could be generally possible that the feedback acquisition system 16 comprises more than one sensor 16b.

(19) It could be generally possible that the feedback acquisition system 16 comprises at least two identical and/or non-identical sensors 16b.

(20) It could be generally possible that the at least two sensors 16b are synchronized.

(21) It could be generally possible that the at least two identical and/or non-identical sensors 16b form a sensor network.

(22) There is also a reference trigger input module 18.

(23) The stimulation element 12 is communicatively connected to the stimulation controller 14.

(24) The stimulation element 12 is also communicatively connected to the reference trigger input module 18.

(25) The connection between the stimulation element 12 and the stimulation controller 14 and the stimulation element 12 and the reference trigger input module 18 is in the shown embodiment a direct and bidirectional connection.

(26) However, also an indirect and/or unidirectional connection (i.e. with another component of the neuromodulation 10 in between) would be generally possible.

(27) The connection between the stimulation element 12 and the stimulation controller 14 and the stimulation element 12 and the reference trigger input module 18 is established in the shown embodiment by a wireless network WSN.

(28) However, also a cable bound connection would be generally possible.

(29) Moreover, the stimulation controller 14 is connected to the stimulation feedback acquisition system 16.

(30) The stimulation controller 14 is also connected to the reference trigger input module 18.

(31) The connection between the stimulation controller 14 and the stimulation feedback acquisition system 16 and the stimulation controller 14 and the reference trigger input module 18 is in the shown embodiment a direct and bidirectional connection.

(32) However, also an indirect and/or unidirectional connection (i.e. with another component of the neuromodulation system 10 in between) would be generally possible.

(33) The connection between stimulation controller 14 and the stimulation feedback acquisition system 16 and the stimulation controller 14 and the reference trigger input module 18 is established in the shown embodiment by a wireless network WSN.

(34) However, also a cable bound connection would be generally possible.

(35) Moreover, the stimulation feedback acquisition system 16 is connected to the reference trigger input module 18.

(36) The connection between the stimulation feedback acquisition system 16 and the reference trigger input module 18 is in the shown embodiment a direct and bidirectional connection.

(37) However, also an indirect and/or unidirectional connection (i.e. with another component of the neuromodulation 10 in between) would be generally possible.

(38) The connection between the stimulation feedback acquisition system 16 and the reference trigger input module 18 is established in the shown embodiment by a wireless network WSN.

(39) However, also a cable bound connection would be generally possible.

(40) The stimulation controller 14 provides a stimulation signal to the stimulation element 12 (e.g., IPG).

(41) The stimulation element 12 provides stimulation to the patient via a lead 20 comprising electrodes.

(42) The lead 20 could comprise multiple electrodes.

(43) A physiological response to the stimulation by the stimulation element 12 and the lead 20 comprising electrodes is recognized by the stimulation feedback acquisition system 16.

(44) In particular, the response to the stimulation by the stimulation element 12 and the lead 20 is recognized by the sensor 16b of the stimulation feedback acquisition system 16.

(45) The stimulation controller 14 provides a reference trigger signal.

(46) The reference trigger signal is recorded by the feedback acquisition system 16.

(47) In particular, the reference trigger signal is recognized by the sensor 16b of the stimulation feedback acquisition system 16.

(48) In this embodiment, the reference trigger signal could be provided by the stimulation controller 14 at the same time as the stimulation signal to the stimulation element 12 is provided.

(49) In alternative embodiments, the reference trigger signal could be provided by the stimulation controller 14 before the stimulation signal to the stimulation element 12 and the lead 20 is provided.

(50) In alternative embodiments, the reference trigger signal could be provided by the stimulation controller 14 after the stimulation signal to the stimulation element 12 and the lead 20 is provided.

(51) The time of recognizing the physiological response to the stimulation by the stimulation element 12 by the sensor 16b is recorded by the stimulation feedback acquisition base station 16a.

(52) The reference trigger input module 18 characterizes the temporal relationship as part of the full recruitment curve between providing the reference trigger signal by the stimulation controller 14 and recognizing by the sensor 16b and the stimulation provided by the stimulation element 12 and the lead 20 and recognizing the response of stimulation by the sensor 16b.

(53) In this embodiment, the temporal relationship characterized by the reference trigger input module 18 is a time delay.

(54) In this embodiment, the reference trigger input module 18 enables correction of the time delay induced by the feedback acquisition system 16.

(55) By utilizing the reference trigger input module 18, a reference trigger input on the basis of the time delay is provided for optimizing stimulation parameters for a certain type of movement.

(56) In this embodiment, the characterization of the temporal relationship could enable synchronizing the clocks of the stimulation element 12 and/or the stimulation controller 14 and/or the feedback acquisition system 16, including the sensor 16b and/or the base station 16a, and/or the reference trigger input module 18 and/or the wireless network WSN.

(57) Not shown in FIG. 1 is that the reference trigger signal could communicate the sensor 16b the relative time with respect to the stimulation by the stimulation element 12.

(58) In general, it could be possible that the reference trigger signal is used to start data acquisition of the stimulation feedback acquisition system 16.

(59) In general, it could be possible that the reference trigger signal is used to start data acquisition of the sensor 16b of the stimulation feedback acquisition system.

(60) It could be generally possible that the reference trigger signal and the stimulation signal provided by the stimulation controller 14 are the same signal.

(61) Not shown in FIG. 1 is that the neuromodulation system 10 could further comprise one or more subsystems, including but not limited to a programmer 22, a passive electrical component, a microprocessor, a wireless link WL, a communication module COM and/or a telemetry module TEL

(62) Not shown in FIG. 1 is that the communication module COM could be or could comprise a Bluetooth module BT and the telemetry module TEL could be or could comprise a Near Field Magnetic Induction (NFMI) module or a Near Field Electromagnetic Induction (NFEMI) module.

(63) Not shown in FIG. 1 is that the reference trigger signal could be an electrical signal, a Bluetooth signal, a NFMI signal and/or a NFEMI signal.

(64) Not shown in FIG. 1 is that the temporal relationship between all possible subsystems of the neuromodulation system 10 may be characterized by the reference trigger input module 18.

(65) Not shown in FIG. 1 is that the clocks of said further subsystems of the neuromodulation system 10 may be synchronized.

(66) Not shown in FIG. 1 is that in this embodiment, the sensor 16b is a surface EMG electrode.

(67) In particular, in this embodiment the sensor 16b is a surface EMG electrode placed on the skin of the patient.

(68) In particular, in this embodiment the sensor 16b is a surface EMG electrode placed on the skin of a leg of the patient P.

(69) However, in general, the sensor 16b as a surface EMG electrode could be placed on the skin of any part of the body of a patient P.

(70) In an alternative embodiment, an intramuscular EMG electrode could be used as a sensor 16b.

(71) In an alternative embodiment, an electrode array (intramuscular or surface electrode array) could be used as the sensor 16b.

(72) Not shown in FIG. 1 is that alternative sensors 16b of the feedback acquisition system 16 for measuring the physiological response to the stimulation could be or could comprise at least one of a sequence of event sensor and/or a motion sensor and/or an EMG, and/or a afferent signal sensor and/or an efferent signal sensor and/or impedance sensor and/or BCI and or camera-based system.

(73) Not shown in FIG. 1 is that a sensor could be implemented as a camera-based system that detects muscular activation.

(74) Not shown in FIG. 1 is that an implanted stimulation element and/or stimulation electrode and/or array of electrodes could also be used as a sensor.

(75) FIG. 2 shows a schematic illustration of a patient P equipped the neuromodulation system 110 comprising two sensors 116b and a connector 24.

(76) The neuromodulation system 110 comprises the structural and functional features as disclosed for neuromodulation system 10 in FIG. 1. The corresponding references are indicated as 100+x (e.g. stimulation element 112).

(77) In this embodiment, the patient P is equipped with said neuromodulation system 110.

(78) The neuromodulation system 110 additionally comprises a programmer 122.

(79) In this embodiment, the programmer 122 is an application installed on a mobile device.

(80) In general, other embodiments of a programmer 122 are possible.

(81) The neuromodulation system 110 further comprises a connector 24.

(82) In this embodiment, the connector 24 is an external connector 24.

(83) Further, the neuromodulation system 110, in particular the stimulation feedback acquisition system 116, comprises two identical sensors 116b.

(84) In this embodiment, the external connector 24 is connected to the stimulation feedback acquisition system 116.

(85) In particular, one sensor 116b is mounted on the external connector 24.

(86) One sensor 116b is placed on the skin of a patient P.

(87) The two sensors 116b are synchronized.

(88) In this embodiment, the programmer 122 is connected to the stimulation controller 114.

(89) The connection between the programmer 122 and the stimulation controller 114 is in the shown embodiment a direct and bidirectional connection.

(90) However, also an indirect and/or unidirectional connection (i.e. with another component of the neuromodulation 110 in between) would be generally possible.

(91) The connection between the programmer 122 and the stimulation controller 114 is established in the shown embodiment by a wireless network WSN.

(92) However, also a cable bound connection would be generally possible.

(93) In this embodiment, the programmer 122 is also communicatively connected to the stimulation element 112 (e.g., IPG), the reference trigger input module 118 and/or the stimulation feedback acquisition system 116.

(94) The connection between the programmer 122 and the stimulation element 112, the reference trigger input module 118 and the stimulation feedback acquisition system 116 is a direct and bidirectional connection.

(95) The connection between the programmer 122 and the stimulation element 112, the reference trigger input module 118 and the stimulation feedback acquisition system 116 is established in the shown embodiment by a wireless network WSN.

(96) However, also an indirect and/or unidirectional connection (i.e. with another component of the neuromodulation 110 in between) would be generally possible.

(97) In general, the connection between the programmer 122 and the stimulation element 112, the reference trigger input module 118 and/or the stimulation feedback acquisition system 116 could be a wireless or cable-bound connection.

(98) The stimulation controller 114 is connected to the external connector 24

(99) In this embodiment, the stimulation controller 114 is directly connected to the external connector 24.

(100) However, also an indirect connection between the external connector 24 and the stimulation controller 114 could be generally possible.

(101) The programmer 122 programs the stimulation controller 114 to deliver a reference trigger signal.

(102) The reference trigger signal provided by the stimulation controller 114 is recognized by the sensor 116b mounted on the external connector 24.

(103) The time of recognizing the reference trigger signal by the sensor 116b mounted on the external connector 24 is recorded by the stimulation feedback acquisition base station 116a.

(104) The programmer 122 programs the stimulation controller 114 to deliver stimulation.

(105) The stimulation controller 114 provides a stimulation signal to the stimulation element 112.

(106) The stimulation element 112 provides stimulation to the patient P via the lead 120 comprising electrodes.

(107) A physiological response to the stimulation by the stimulation element 112 and the lead 120 comprising electrodes is recognized by the stimulation feedback acquisition system 116.

(108) In particular, the response to the stimulation by the stimulation element 112 and the lead 120 is recognized by the sensor 116b placed on the skin of the patient P.

(109) The time of recognizing the physiological response to the stimulation by the stimulation element 112 by the sensor 116b placed on the skin of the patient P is recorded to the stimulation feedback acquisition base station 116a.

(110) The reference trigger input module 118 characterizes the temporal relationship as part of the full recruitment curve between providing the reference trigger signal by the stimulation controller 114 and recognizing by sensor 116b mounted on the external connector 24 and the stimulation provided by the stimulation element 112 and the lead 120 and recognizing the response of stimulation by the sensor 116b placed on the skin of the patient P.

(111) In this embodiment, the characterization of the temporal relationship enables synchronizing the clocks of the stimulation element 112 and/or the stimulation controller 114 and/or the sensor 116b mounted on the external connector and/or the sensor 116b placed on the skin of the patient P and/or the stimulation feedback acquisition base station 116a, and/or the reference trigger input module 118.

(112) In general, the programmer 122 could be used by a person, including but not limited to a therapist, physiotherapist, or patient to provide inputs to the stimulation controller 114, including but not limited to selecting, starting, and stopping a task or configuring stimulation parameters.

(113) In particular, the programmer 122 could allow adjusting the stimulation parameters of a task, while the task is running.

(114) Not shown in FIG. 2 is that the feedback acquisition system 16 could comprise two non-identical sensors 116b or more than 2 identical or non-identical sensors 116b.

(115) FIG. 3 shows a schematic illustration of a patient P equipped with the neuromodulation system 210 comprising a communication module COM.

(116) The neuromodulation system 210 comprises the structural and functional features as disclosed for neuromodulation system 10 in FIG. 1. The corresponding references are indicated as 200+x (e.g. stimulation element 212).

(117) In this embodiment, the patient P is equipped with a neuromodulation system 210.

(118) The neuromodulation system 210 further comprises a communication module COM 208.

(119) In this embodiment, the communication module COM 308 comprises a Bluetooth module BT 309.

(120) The stimulation controller 214 comprises a Bluetooth interface 32.

(121) The neuromodulation system 210 additionally comprises a programmer 222, with the structure and function of the programmer 122 as disclosed in FIG. 2.

(122) The connection between the programmer 222 and the stimulation controller 214 is established in the shown embodiment by the communication module COM 308, i.e. the Bluetooth module BT.

(123) In this embodiment also the stimulation element 212 (e.g., IPG), the stimulation controller 214, the stimulation feedback acquisition system 216 including the sensor 216b and/or the base station 216a and/or the reference trigger input module 218 are also connected via the Bluetooth module BT (shown by dashed lines).

(124) However, also cable bound connections would be generally possible.

(125) The programmer 222 programs the stimulation controller 214 to deliver a reference trigger signal via the Bluetooth interface 32.

(126) The reference trigger signal is a Bluetooth signal.

(127) The reference trigger signal, i.e. the Bluetooth signal, is communicated to the sensor 216b via the Bluetooth module BT 309.

(128) The stimulation feedback acquisition base station 216a records the time of recording the Bluetooth signal by the sensor 216b.

(129) The programmer 222 programs the stimulation controller 214 to deliver stimulation.

(130) The stimulation controller 214 provides a stimulation signal to the stimulation element 212.

(131) The stimulation element 212 provides stimulation to the patient P via the lead 220 comprising electrodes.

(132) A physiological response to the stimulation by the stimulation element 212 and the lead 220 comprising electrodes is recognized by the stimulation feedback acquisition system 216.

(133) In particular, the response to the stimulation by the stimulation element 212 and the lead 220 is recognized by the sensor 216b of the stimulation feedback acquisition system 216.

(134) The stimulation feedback acquisition base station 216a records the time of recognizing the response to the stimulation by the sensor 216b.

(135) FIG. 4 shows a schematic illustration of a patient P equipped with the neuromodulation system 310 comprising a telemetry module TEL.

(136) The neuromodulation system 310 comprises the structural and functional features as disclosed for neuromodulation system 10 in FIG. 1. The corresponding references are indicated as 300+x (e.g. stimulation element 312).

(137) In this embodiment, a patient P is equipped with a neuromodulation system 310.

(138) In this embodiment, the neuromodulation system 310 comprises a telemetry module TEL.

(139) The telemetry module TEL comprises a NFMI module.

(140) The stimulation controller 314 comprises a NFMI interface 26.

(141) The NFMI interface 26 is in contact with the skin of the patient P.

(142) The neuromodulation system 310 additionally comprises a programmer 322, with the structure and function of the programmer 122 as disclosed in FIG. 2.

(143) The connection between the programmer 322 and the stimulation controller 314 is established in the shown embodiment via the NFMI module (dashed line).

(144) In this embodiment also the stimulation element 312, the stimulation controller 314, the feedback acquisition system 316 including the sensor 316b and/or the base station 316a, and/or the reference trigger input module 318 are also connected via the NFMI module (shown by dashed lines).

(145) However, also cable bound connections and/or other wireless connections would be generally possible.

(146) The programmer 322 programs the stimulation controller 314 to deliver a reference trigger signal.

(147) The stimulation controller 314 provides a reference trigger signal via the NFMI interface 26.

(148) The reference trigger signal is a NFMI signal.

(149) The NFMI signal is recorded by the sensor 316b.

(150) It is generally possible, that the NFMI signal is partially or fully transmitted via the body of the patient P, including the skin, and recorded by the sensor 316b.

(151) The stimulation feedback acquisition base station 316a records the time of recording the NFMI signal by the sensor 316b.

(152) The programmer 322 programs the stimulation controller 314 to deliver stimulation.

(153) The stimulation controller 314 provides a stimulation signal to the stimulation element 312.

(154) The stimulation element 312 provides stimulation to the patient P via the lead 320 comprising electrodes.

(155) A physiological response to the stimulation by the stimulation element 312 and the lead 320 comprising electrodes is recognized by the feedback acquisition system 316.

(156) In particular, the response to the stimulation by the IPG 312 and the lead 320 is recognized by the sensor 316b of the feedback acquisition system 316.

(157) The stimulation feedback acquisition base station 316a records the time of recognizing the response to the stimulation by the sensor 316b.

(158) The time of recognizing the physiological response to the stimulation by the IPG 312 by the sensor 316b is recorded by the stimulation feedback acquisition base station 316a.

(159) The characterization of the temporal relationship enables synchronizing the clock of the programmer 322 and the IPG 312 and/or the stimulation controller 314 and/or the feedback acquisition system 316 and/or the reference trigger input module 318.

(160) Not shown in FIG. 4 is that the telemetry module TEL may alternatively and/or additionally comprise one or more of a Medical Implant Communication System (MICS).

(161) MICS is a low-power, short-range, high-data-rate, 401-406 MHz (the core band is 402-405 MHz) communication network.

(162) Not shown in FIG. 4 is that the telemetry module TEL may alternatively and/or additionally comprise one or more of a Medical Data Service System (MEDS).

(163) MEDS systems may operate in spectrum within the frequency bands 401 MHz to 402 MHz and 405 MHz to 406 MHz.

(164) It is not shown in FIG. 4 that any other type of telemetry module known in the art is generally possible.

(165) FIG. 5 shows a perspective view of a patient P equipped with the neuromodulation system 410 comprising a telemetry module TEL

(166) The neuromodulation system 410 comprises the structural and functional features as disclosed for neuromodulation system 10 in FIG. 1. The corresponding references are indicated as 400+x (e.g. stimulation element 412).

(167) In this embodiment, a patient P is equipped with a neuromodulation system 410.

(168) In this embodiment, the neuromodulation system 410 comprises a telemetry module TEL.

(169) The telemetry module TEL comprises an NFEMI module.

(170) The stimulation controller 414 comprises an NFEMI interface 28.

(171) The NFEMI interface 28 is in contact with the skin of the patient P.

(172) The neuromodulation system 410 additionally comprises a programmer 422, with the structure and function of the programmer 122 as disclosed in FIG. 2.

(173) The connection between the programmer 422 and the stimulation controller 414 is established in the shown embodiment via the NFEMI module (dashed line).

(174) In this embodiment also the stimulation element 412, the stimulation controller 414 and/or the NFEMI interface 28, the feedback acquisition system 416 including the sensor 416b and the base station 416a and the reference trigger input module 418 are connected via the NFEMI module (shown by dashed lines).

(175) However, also cable bound connections and/or other wireless connections would be generally possible.

(176) The programmer 422 programs the stimulation controller 414 to provide a reference trigger signal.

(177) The reference trigger signal is an NFEMI signal.

(178) The NFEMI signal is provided by the NFEMI interface 28.

(179) The NFEMI signal is transmitted via the skin/body of the patient P.

(180) The NFEMI signal could alternatively and/or additionally be transmitted via air.

(181) The NFEMI signal is recorded by the sensor 416b.

(182) The stimulation feedback acquisition base station 416a records the time of recording the NFEMI signal by the sensor 416b.

(183) The programmer 422 programs the stimulation controller 414 to deliver stimulation.

(184) The stimulation controller 414 provides a stimulation signal to the IPG 412.

(185) The stimulation element 412 provides stimulation to the patient P via the lead 420 comprising electrodes.

(186) A physiological response to the stimulation by the stimulation element 412 and the lead 420 comprising electrodes is recognized by the stimulation feedback acquisition system 416.

(187) In particular, the response to the stimulation by the stimulation element 412 and the lead 420 is recognized by the sensor 416b of the stimulation feedback acquisition system 416.

(188) The stimulation feedback acquisition base station 416a records the time of recognizing the response to the stimulation by the sensor 416b.

(189) The reference trigger input module 418 characterizes the temporal relationship as part of the full recruitment curve between providing the reference trigger signal, i.e. the NFEMI signal by the NFEMI interface 28 of the stimulation controller 414 and recognizing by the sensor 416b and the stimulation provided by the IPG 412 and the lead 420 and recognizing the response of stimulation by the sensor 416b.

(190) In this embodiment, the characterization of the temporal relationship enables synchronizing the clocks of the stimulation element 412 and/or the stimulation controller 414 and/or the NFEMI interface 28 and/or the sensor 416b and/or the base station 416a of the stimulation feedback acquisition system 416, and/or the reference trigger input module 418 and/or the programmer 422.

(191) FIG. 6 shows a perspective view of a patient P equipped with the neuromodulation system 510 comprising a passive electrical component 30.

(192) The neuromodulation system 510 comprises the structural and functional features as disclosed for neuromodulation systems 10 and/or 310 in FIGS. 1 and 4. The corresponding references are indicated as 500+x or 200+x (e.g. stimulation element 512).

(193) In this embodiment, a patient P is equipped with a neuromodulation system 510.

(194) In this embodiment, the neuromodulation system 510 comprises a passive electrical component 30.

(195) In this embodiment, the passive electrical component 30 is included in a sticker.

(196) In this embodiment, the sticker is in placed on the skin of the patient P.

(197) In general, other embodiments of passive electrical component 30 are possible.

(198) The sticker is in contact to the stimulation controller 514.

(199) In this embodiment, the sticker is in direct contact to the stimulation controller 514.

(200) In this embodiment, the sticker is placed between the skin of the patient P and the stimulation controller 514.

(201) The programmer 522 programs the stimulation controller 514 to deliver a reference trigger signal.

(202) The reference trigger signal is a NFMI signal.

(203) The NFMI signal is delivered by the NFMI interface 26 of the stimulation controller 514.

(204) The NFMI signal is converted into an electrical signal by the sticker 30.

(205) The electrical signal is transmitted via the body of the patient P.

(206) The electrical signal is recorded by the sensor 516b.

(207) The stimulation feedback acquisition base station 516a records the time of recording the NFMI signal by the sensor 516b.

(208) In other words, the passive electrical component 30, i.e. the sticker, converts the NFMI signal into an electrical signal and the signal is recorded by the stimulation feedback acquisition system 516.

(209) The programmer 522 programs the stimulation controller 514 to deliver stimulation.

(210) The stimulation controller 514 provides a stimulation signal to the stimulation element 512.

(211) The stimulation element 512 provides stimulation to the patient P via the lead 520 comprising electrodes.

(212) A physiological response to the stimulation by the stimulation element 512 and the lead 520 comprising electrodes is recognized by the feedback acquisition system 516.

(213) In particular, the response to the stimulation by the IPG 512 and the lead 520 is recognized by the sensor 516b of the stimulation feedback acquisition system 516.

(214) The stimulation feedback acquisition base station 516a records the time of recognizing the response to the stimulation by the sensor 516b.

(215) It is not shown in FIG. 6 that the signal provided by the telemetry module TEL could be another signal than a NFMI signal, and the signal converted by the sticker could be another signal than an electrical signal.

(216) It is not shown in FIG. 6 that the passive electrical component may alternatively and/or additionally be configured and arranged to be inserted and/or integrated into and/or onto the clothing of the patient, including but not limited to a top, a longsleeve, a pullover, a jacket, one or more gloves, armlets, socks, tights, a belt and/or a pouch worn by the patient equipped with the system.

(217) FIG. 7 shows a perspective view of a patient P equipped with the neuromodulation system 610 using an electrical reference trigger signal provided by the IPG 612.

(218) The neuromodulation system 610 comprises the structural and functional features as disclosed for neuromodulation system 10 in FIG. 1. The corresponding references are indicated as 600+x (e.g. stimulation element 612).

(219) In this embodiment, a patient P is equipped with a neuromodulation system 610.

(220) The neuromodulation system 610 further comprises a programmer 622, with the structure and function of the programmer 122 as disclosed in FIG. 2.

(221) The stimulation element 612 (e.g., IPG) is implanted close to the skin of the patient P.

(222) In particular, the IPG 612 is implanted less than 2 cm under the skin of the patient P.

(223) In an alternative embodiment, the IPG 612 could be implanted deeper in the body of the patient P.

(224) The programmer 622 programs the stimulation controller (not shown) to deliver a reference trigger signal.

(225) In this embodiment, the reference trigger signal is an electrical trigger signal.

(226) In this embodiment, the reference trigger signal is delivered via a casing of the stimulation element 612.

(227) In particular, for the reference trigger signal a waveform is chosen, which does not lead to stimulation of the patient P near the stimulation element 612.

(228) The reference trigger signal, i.e. the electrical trigger signal, pulls down or pushes up the skin potential of the patient P.

(229) A change in skin potential is recorded by the sensor 616b of the stimulation feedback acquisition system 616.

(230) In other words, an under-threshold signal is provided by the casing of the stimulation element 612.

(231) The under-threshold signal does not lead to stimulation of the patient P but is detectable by the stimulation feedback acquisition system 616 as a reference trigger signal.

(232) The time of recognizing the change in skin potential in response to the reference trigger signal provided by the casing of the stimulation element 612 by the sensor 616b is recorded by the stimulation feedback acquisition base station 616a.

(233) The programmer 622 programs the stimulation controller (not shown) to deliver stimulation.

(234) The stimulation controller 614 provides a stimulation signal to the stimulation element 612.

(235) The stimulation element 612 provides stimulation to the patient P via the lead 620 comprising electrodes.

(236) A physiological response to the stimulation by the stimulation element 612 and the lead 620 comprising electrodes is recognized by the stimulation feedback acquisition system 616.

(237) In particular, the physiological response to the stimulation by the stimulation element 612 and the lead 620 is recognized by the sensor 616b of the stimulation feedback acquisition system 616.

(238) The time of recognizing the physiological response to the stimulation by the stimulation element 612 and the lead 620 by the sensor 616b is recorded by the stimulation feedback acquisition base station 616a.

(239) The reference trigger input module 618 characterizes the temporal relationship as part of the full recruitment curve between providing the reference trigger signal by the casing of the stimulation element 612 and recognizing the evoked skin potentials by the sensor 616b and the stimulation provided by the stimulation element 612 and the lead 620 and recognizing the response to the stimulation by the sensor 616b.

(240) Not shown in FIG. 7 is that the reference trigger signal could alternatively and/or additionally be provided by the lead 620 comprising electrodes.

(241) Note that the example control and estimation routines included herein can be used with various system configurations. The control methods and routines disclosed herein may be stored as executable instructions in non-transitory memory and may be carried out by a neuromodulation system 10, 110, 210, 310, 410, 510, 610 e.g. as a part of the stimulation system 12, 112, 212, 312, 412, 512, 612, the stimulation controller 14, 114, 214, 314, 414, 514, 614, the stimulation feedback acquisition system 16, 116, 216, 316, 416, 516, 616, the reference input module 18, 118, 218, 318, 418, 518, 618, the programmer 22, 122, 222, 322, 422, 522, 622 and other system hardware. The specific routines described herein may represent one or more of any number of processing strategies such as event-driven, interrupt-driven, multi-tasking, multi-threading, and the like. As such, various actions, operations, and/or functions illustrated may be performed in the sequence illustrated, in parallel, or in some cases omitted. Likewise, the order of processing is not necessarily required to achieve the features and advantages of the example embodiments described herein but is provided for ease of illustration and description. One or more of the illustrated actions, operations and/or functions may be repeatedly performed depending on the particular strategy being used. Further, the described actions, operations and/or functions may graphically represent code to be programmed into non-transitory memory of a computer readable storage medium in the stimulation controller 14, 114, 214, 314, 414, 514, 614, where the described actions are carried out by executing the instructions in a neuromodulation system 10, 110, 210, 310, 410, 510, 610 including the various hardware components.

REFERENCES

(242) 10 Neuromodulation system 12 Stimulation element/IPG 14 Stimulation controller 16 Stimulation feedback acquisition system 16a (Stimulation feedback aquisition) base station 16b Sensor/surface EMG electrode 18 Reference trigger input module 20 Lead 22 Programmer 24 Connector/external connector 26 NFMI interface 28 NFEMI interface 30 Passive electrical component/sticker 32 Bluetooth interface 110 Neuromodulation system 112 Stimulation element/IPG 114 Stimulation controller 116 Stimulation feedback acquisition system 116a (Stimulation feedback acquisition) base station 116b Sensor/surface EMG electrode 118 Reference trigger input module 120 Lead 122 Programmer 210 Neuromodulation system 212 Stimulation element/IPG 214 Stimulation controller 216 Stimulation feedback acquisition system 216a (Stimulation feedback acquisition) base station 216b Sensor/surface EMG electrode 218 Reference trigger input module 220 Lead 222 Programmer 308 Communication module COM 309 Bluetooth module BT 310 Neuromodulation system 312 Stimulation element/IPG 314 Stimulation controller 316 Stimulation feedback acquisition system 316a (Stimulation feedback acquisition) base station 316b Sensor/surface EMG electrode 318 Reference trigger input module 320 Lead 322 Programmer 410 Neuromodulation system 412 Stimulation element/IPG 414 Stimulation controller 416 Stimulation feedback acquisition system 416a (Stimulation feedback acquisition) base station 416b Sensor/surface EMG electrode 418 Reference trigger input module 420 Lead 422 Programmer 510 Neuromodulation system 512 Stimulation element/IPG 514 Stimulation controller 516 Stimulation feedback acquisition system 516a (Stimulation feedback acquisition) base station 516b Sensor/surface EMG electrode 518 Reference trigger input module 520 Lead 522 Programmer 610 Neuromodulation system 612 Stimulation element/IPG 614 Stimulation controller 616 Stimulation feedback acquisition system 616a (Stimulation feedback acquisition) base station 616b Sensor/surface EMG electrode 618 Reference trigger input module 620 Lead 622 Programmer P Patient BT Bluetooth CNS Central Nervous System COM Communication module EES Epidural Electrical Stimulation FES Functional Electrical Stimulation MICS Medical Implant Communication System MEDS Medical Data Service System NFMI Near Field Magnetic Induction NFEMI Near-field electromagnetic induction PNS Peripheral Nervous System WL Wireless link WSN Wireless network TEL Telemetry module