# US 2021/0330973 A1 · External pacing device with discomfort management > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2021/0330973 A1 - Document ID: US20210330973A1 - Status: Published application - Kind: A1 - Application number: 17/371,612 - Filed: 2021-07-09 - Published: 2021-10-28 - Earliest claimed: 2012-05-31 - Assignees: ZOLL Medical Corporation - Applicants: Zoll Medical Corporation - Inventors: Jason T. Whiting; Thomas E. Kaib; Rachel H. Carlson; Gregory R. Frank; Gary A. Freeman - Web page: https://patentgrep.com/patent/US20210330973A1 ## CPC - A61N 1/3625: {External stimulators} - A61B 5/282: Holders for multiple electrodes (for introduction into the body A61B5/287) - A61B 5/361: Detecting fibrillation - A61B 5/6831: {Straps, bands or harnesses} - A61N 1/046: {Specially adapted for shock therapy, e.g. defibrillation} - A61N 1/0484: {Garment electrodes worn by the patient} - A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)} - A61N 1/3621: {for treating or preventing abnormally high heart rate} - A61N 1/3925: {Monitoring; Protecting} - A61B 2562/17: Comprising radiolucent components - A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]} - 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) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A method of controlling discomfort of a patient during external pacing by an external medical device includes detecting a cardiac condition of the patient; receiving, via a user interface, discomfort information descriptive of the discomfort experienced by the patient; determining from the discomfort information whether the patient is conscious or unconscious; responsive to determining from the discomfort information that the patient is unconscious, executing, via at least one therapy electrode disposed on the patient, at least one pacing routine, the at least one pacing routine being associated with the cardiac condition; and responsive to determining from the discomfort information that the patient is conscious, adjusting at least one characteristic of the at least one pacing routine. ## Claims ### Claim 1 A method of controlling discomfort of a patient during external pacing by an external medical device, the method comprising: detecting a cardiac condition of the patient; receiving, via a user interface, discomfort information descriptive of the discomfort experienced by the patient; determining from the discomfort information whether the patient is conscious or unconscious; responsive to determining from the discomfort information that the patient is unconscious, executing, via at least one therapy electrode disposed on the patient, at least one pacing routine, the at least one pacing routine being associated with the cardiac condition; and responsive to determining from the discomfort information that the patient is conscious, adjusting at least one characteristic of the at least one pacing routine. ### Claim 2 (depends on 1) The method of claim 1, further comprising adjusting the at least one characteristic of the at least one pacing routine to an upper bound of a range of values responsive to determining from the discomfort information that the patient is unconscious. ### Claim 3 (depends on 1) The method of claim 1, wherein adjusting the at least one characteristic of the at least one pacing routine includes adjusting at least one of an amplitude of pacing pulses, a width of the pacing pulses, a rate of the pacing pulses, a waveform of the pacing pulses, a period of the pacing pulses, a duty cycle of the pacing pulses, or a ramp time constant of the pacing pulses. ### Claim 4 (depends on 1) The method of claim 1, wherein receiving the discomfort information descriptive of the discomfort experienced by the patient comprises detecting an amount of pressure exerted by the patient on an element of the user interface. ### Claim 5 (depends on 4) The method of claim 4, wherein receiving the discomfort information descriptive of the discomfort experienced by the patient comprises determining a duration of time the element of the user interface remains actuated. ### Claim 6 (depends on 4) The method of claim 4, wherein detecting the amount of pressure exerted by the patient on the element of the user interface comprises detecting the amount of pressure exerted by the patient on a strain gauge, a force sensor, a piezoelectric transducer, or a rotating spring-loaded dial. ### Claim 7 (depends on 1) The method of claim 1, wherein the user interface further comprises a force sensor, the method further comprising detecting, by the force sensor, a force applied by the user squeezing at least one surface of the force sensor. ### Claim 8 (depends on 1) The method of claim 1, wherein adjusting at least one characteristic of the at least one pacing routine comprises optimizing the at least one characteristic along a scale comprising at least one of a linear scale, a logarithmic scale, or an exponential scale. ### Claim 9 (depends on 8) The method of claim 8, wherein adjusting at least one characteristic of the at least one pacing routine comprises optimizing the at least one characteristic at least in part by executing a regression analysis using historical values of the at least one characteristic ### Claim 10 (depends on 1) The method of claim 1, wherein the cardiac condition comprises at least one of bradycardia and asystole. ### Claim 11 (depends on 1) The method of claim 1, wherein executing the at least one pacing routine comprises executing at least one of fixed rate pacing, fixed energy pacing, adjustable rate pacing, and capture management pacing. ### Claim 12 (depends on 1) The method of claim 1, further comprising executing a baseline process during an initial fitting of the external medical device to the patient. ### Claim 13 (depends on 12) The method of claim 12, wherein executing the baseline process comprises determining a range of values for a discomfort parameter corresponding to the at least one pacing routine. ### Claim 14 (depends on 12) The method of claim 12, wherein executing the baseline process further comprises setting the at least one characteristic of the at least one pacing routine to an appropriate level based on a physiological condition of the patient. ### Claim 15 A non-transitory computer readable medium storing sequences of instructions executable by at least one processor, the sequences of instructions instructing the at least one processor to control discomfort of a patient during external pacing by an external medical device, the sequences of instructions including instructions to: detect a cardiac condition of the patient; receive, via a user interface, discomfort information descriptive of the discomfort experienced by the patient; determine from the discomfort information whether the patient is conscious or unconscious; responsive to determining from the discomfort information that the patient is unconscious, execute, via at least one therapy electrode disposed on the patient, at least one pacing routine, the at least one pacing routine being associated with the cardiac condition; and responsive to determining from the discomfort information that the patient is conscious, adjust at least one characteristic of the at least one pacing routine. ### Claim 16 (depends on 15) The non-transitory computer readable medium of claim 15, wherein the sequences of instructions further include instructions to adjust the at least one characteristic of the at least one pacing routine to an upper bound of a range of values responsive to determining from the discomfort information that the patient is unconscious. ### Claim 17 (depends on 15) The non-transitory computer readable medium of claim 15, wherein the sequences of instructions further include instructions to adjust the at least one characteristic of the at least one pacing routine includes adjusting at least one of an amplitude of pacing pulses, a width of the pacing pulses, a rate of the pacing pulses, a waveform of the pacing pulses, a period of the pacing pulses, a duty cycle of the pacing pulses, or a ramp time constant of the pacing pulses. ### Claim 18 (depends on 15) The non-transitory computer readable medium of claim 15, wherein the instructions to receive the discomfort information descriptive of the discomfort experienced by the patient comprise instructions to detect an amount of pressure exerted by the patient on an element of the user interface. ### Claim 19 (depends on 15) The non-transitory computer readable medium of claim 15, wherein the instructions to adjust the at least one characteristic of the at least one pacing routine comprise instructions to optimize the at least one characteristic along a scale comprising at least one of a linear scale, a logarithmic scale, or an exponential scale. ### Claim 20 (depends on 19) The non-transitory computer readable medium of claim 19, wherein the instructions to adjust the at least one characteristic of the at least one pacing routine comprise instructions to optimize the at least one characteristic at least in part by executing a regression analysis using historical values of the at least one characteristic.