# US 10,118,037 B2 · System, method, and device for providing feedback to a patient during electrical stimulation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,118,037 B2 - Document ID: US10118037B2 - Status: Granted - Kind: B2 - Application number: 15/044,147 - Filed: 2016-02-16 - Published: 2016-12-15 - Granted: 2018-11-06 - Earliest claimed: 2015-06-09 - Assignees: Nuvectra Corporation - Applicants: Nuvectra Corporation - Inventors: Norbert Kaula; Yohannes Iyassu - Web page: https://patentgrep.com/patent/US10118037B2 ## CPC - A61N 1/36132: {using patient feedback} - A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)} - A61N 1/3605: {Implantable neurostimulators for stimulating central or peripheral nerve system} - A61N 1/37247: {User interfaces, e.g. input or presentation means} - G16H 20/30: relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising - G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture - G16H 40/63: for local operation - G16H 40/67: for remote operation - G16H 50/50: for simulation or modelling of medical disorders - G16Z 99/00: Subject matter not provided for in other main groups of this subclass - A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control} - A61N 1/36107: {Sexual dysfunction (stimulating genital organs A61N1/36007)} - A61N 1/36185: {Selection of the electrode configuration} - A61N 1/37264: {Changing the program; Upgrading firmware} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA - G16Z: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR ## Abstract Feedback regarding electrical stimulation is provided to a patient. Electrical stimulation is applied to the patient. The electrical stimulation is applied by varying an electrical stimulation parameter. A signal is communicated to the patient via an electronic device. The signal is correlated with the electrical stimulation parameter such that the signal varies in association with the varying of the electrical stimulation parameter. The communicating is performed while the electrical stimulation is applied. Feedback is received from the patient in response to the electrical stimulation. Based on the received feedback from the patient, the electrical stimulation is adjusted. ## Claims ### Claim 1 An electronic device configured to communicate feedback to a patient while electrical stimulation generated by a pulse generator is applied to the patient, the electronic device comprising: a communications component for conducting telecommunications with an electronic programmer, wherein the electronic programmer is configured to program an electrical stimulation amplitude of the electrical stimulation such that the stimulation amplitude is being varied by the pulse generator while the electrical stimulation is applied to the patient, and wherein the communications component is configured to obtain the electrical stimulation amplitude via the telecommunications; a sensor component configured to detect a patient engagement with the electronic device in response to the electrical stimulation, the patient engagement being indicative of a perceived efficacy of the electrical stimulation; a microcontroller electronically coupled to the communications component and configured to generate instructions based on a varying of the electrical stimulation amplitude received from the communications component; and a feedback component electronically coupled to the communications component and the sensor component and configured to: generate a first signal in response to the sensor component detecting the patient engagement with the electronic device; and based on the instructions generated by the microcontroller, generate and communicate, to the patient while the electrical stimulation is applied, a second signal that is correlated with the electrical stimulation amplitude such that the second signal varies as the electrical stimulation amplitude is being varied. ### Claim 2 (depends on 1) The electronic device of claim 1, wherein the electrical stimulation amplitude comprises a stimulation current amplitude. ### Claim 3 (depends on 1) The electronic device of claim 1, wherein the second signal comprises a haptic signal, a visual signal, an audible signal, or a temperature-based signal. ### Claim 4 (depends on 3) The electronic device of claim 3, wherein the feedback component comprises: a tactile mechanism to communicate the haptic signal, one or more light-emitting diodes (LEDs) or a numeric display to communicate the visual signal, one or more speakers to communicate the audible signal, or a housing to communicate the temperature-based signal. ### Claim 5 (depends on 1) The electronic device of claim 1, wherein the second signal is linearly correlated with the electrical stimulation amplitude. ### Claim 6 A medical system, comprising: a pulse generator configured to generate electrical stimulation pulses as a part of an electrical stimulation for a patient; an electronic programmer configured to program the pulse generator to generate the electrical stimulation pulses such that an electronic stimulation amplitude is varied while the electrical stimulation is delivered to the patient; and a patient feedback device that includes: a transceiver configured to conduct wireless communication with the electronic programmer; a microcontroller electronically coupled to the transceiver and configured to receive data gathered by the transceiver in the wireless communication; a sensor component electronically coupled to the microcontroller and configured to detect a patient engagement with the patient feedback device in response to the electrical stimulation, the patient engagement being indicative of a perceived efficacy of the electrical stimulation; and a feedback component electronically coupled to the microcontroller and configured to: receive instructions from the microcontroller; based on the instructions received from the microcontroller, generate and communicate, to the patient while the electrical stimulation is applied, a signal that is correlated with the electrical stimulation amplitude such that the signal varies as the electrical stimulation amplitude is being varied. ### Claim 7 (depends on 6) The medical system of claim 6, wherein the electronic programmer is further configured to adjust the electrical stimulation based on the detected patient engagement. ### Claim 8 (depends on 6) The medical system of claim 6, wherein the electrical stimulation amplitude comprises: a stimulation current amplitude. ### Claim 9 (depends on 6) The medical system of claim 6, wherein the second signal comprises: a haptic signal, a visual signal, an audible signal, or a temperature-based signal. ### Claim 10 (depends on 9) The medical system of claim 9, wherein the feedback component comprises: a tactile mechanism to communicate the haptic signal, one or more light-emitting diodes (LEDs) or a numeric display to communicate the visual signal, one or more speakers to communicate the audible signal, or a housing to communicate the temperature-based signal. ### Claim 11 (depends on 6) The medical system of claim 6, wherein the second signal is linearly correlated with the electrical stimulation amplitude. ### Claim 12 A medical system, comprising: a pulse generator configured to generate electrical stimulation; a lead configured to deliver the electrical stimulation to a patient; an electronic programming device that includes: a first user interface; a first transceiver configured to conduct electronic communication with external devices including the pulse generator, wherein the electronic programming device is configured to program the pulse generator via instructions sent through the first transceiver such that the pulse generator generates the electrical stimulation; and a first microcontroller configured to send instructions to the first user interface such that the first user interface communicates a signal to the patient as the electrical stimulation is being delivered; and an electronic patient feedback device that includes: a second user interface; a second transceiver configured to conduct electronic communication with the electronic programming device; a user feedback detection mechanism configured to receive a feedback from the patient in response to the electrical stimulation; and a second microcontroller configured to obtain, via the second transceiver, a status of the electrical stimulation, wherein the second microcontroller is further configured to send instructions to the second user interface such that the second user communicates the signal to the patient as the electrical stimulation is being delivered; wherein the signal varies as a function of an electrical stimulation amplitude of the electrical stimulation that is being programmed by the electronic programming device. ### Claim 13 (depends on 12) The medical system of claim 12, wherein the electronic patient feedback device is configured to generate a feedback signal in response to a physical engagement by the patient. ### Claim 14 (depends on 13) The medical system of claim 13, wherein the electronic patient feedback device is configured to wirelessly communicate the feedback signal to the electronic programming device. ### Claim 15 (depends on 12) The medical system of claim 12, wherein the electrical stimulation amplitude comprises: a stimulation current amplitude. ### Claim 16 (depends on 12) The medical system of claim 12, wherein the signal comprises: a haptic signal, a visual signal, an audible signal, or a temperature-based signal. ### Claim 17 (depends on 16) The medical system of claim 16, wherein the electronic patient feedback device comprises: a tactile mechanism to communicate the haptic signal to the patient, one or more light-emitting diodes (LEDs) or a numeric display to communicate the visual signal to the patient, one or more speakers to communicate the audible signal to the patient, or a housing to communicate the temperature-based signal to the patient. ### Claim 18 (depends on 12) The medical system of claim 12, wherein the signal varies as a linear function of the stimulation amplitude. ### Claim 19 (depends on 12) The medical system of claim 12, wherein the electrical stimulation delivered to the patient comprises a sub-threshold stimulation. ### Claim 20 (depends on 12) The medical system of claim 12, wherein the pulse generator is configured to generate the electrical stimulation to stimulate a spinal cord of the patient, a sacral nerve of the patient, or a pudendal nerve of the patient.