# US 2013/0158614 A1 · Pulse Parameters And Electrode Configurations For Reducing Patient Discomfort From Defibrillation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0158614 A1 - Document ID: US20130158614A1 - Status: Published application - Kind: A1 - Application number: 13/806,441 - Filed: 2011-06-22 - Published: 2013-06-20 - Earliest claimed: 2010-06-25 - Assignees: Smartwave Medical Ltd. - Inventors: Lazaro Salomon Azar; Avi Allon Livnat - Web page: https://patentgrep.com/patent/US20130158614A1 ## CPC - A61N 1/3906: {characterised by the form of the shockwave} - A61N 1/3925: {Monitoring; Protecting} - A61N 1/3937: {Monitoring output parameters} - A61N 1/3956: {Implantable devices for applying electric shocks to the heart, e.g. for cardioversion} - A61N 1/3918: {characterised by shock pathway, e.g. by electrode configuration} - 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) ## Abstract Devices, systems and methods relating to defibrillation and, more specifically, pulse parameters and electrode configurations for reducing patient discomfort are disclosed. Embodiments provide for an implantable defibrillator having an electrode lead system, at least one sensor for sensing a heart condition and emitting a condition signal, a controller in communication with the at least one sensor and configured to determine from the condition signal whether the heart is fibrillating and emitting a command signal if fibrillation is detected and a voltage generator communicating with the controller and the electrode system to communicate at least one defibrillation pulse to the electrode system, wherein the at least one defibrillation pulse includes at least one pulse having a voltage greater than 80 volts and a time duration up to 1000 microseconds. ## Claims ### Claim 1 An implantable defibrillator comprising: an electrode lead system having at least one lead; at least one sensor configured to sense a condition of a heart and emit a signal indicative of the condition; a controller in communication with the at least one sensor, the controller being configured to determine from the signal whether the condition of the heart is one of a state of fibrillation and emit a command signal if the condition is one of a state of fibrillation; and a voltage generator in communication with the controller and the electrode system, the voltage generator being configured to discharge at least one defibrillation pulse to the electrode system after receiving the command signal, wherein the at least one defibrillation pulse includes at least one pulse having a voltage greater than 80 volts and a time duration up to 1000 microseconds. ### Claim 2 (depends on 1) The implantable defibrillator of claim 1, wherein the at least one pulse is delivered to an atrium of the heart. ### Claim 3 (depends on 1) The implantable defibrillator of claim 1, wherein the at least one pulse is delivered to a ventricle of the heart. ### Claim 4 (depends on 1) The implantable defibrillator of claim 1, wherein the at least one pulse has an electric field strength between 100 and 700 volts per centimeter. ### Claim 5 (depends on 1) The implantable defibrillator of claim 1, wherein a total amount of energy delivered by the at least one pulse is less than 2 Joules. ### Claim 6 (depends on 1) The implantable defibrillator of claim 1, wherein the time duration of the at least one pulse is between 50 and 600 microseconds. ### Claim 7 (depends on 1) The implantable defibrillator of claim 1, wherein the time duration of the at least one pulse is between 50 and 1000 microseconds. ### Claim 8 (depends on 1) The implantable defibrillator of claim 1, wherein the time duration of the at least one pulse is between 30 and 100 microseconds. ### Claim 9 (depends on 1) The implantable defibrillator of claim 1, wherein the at least one sensor is an electrode of the electrode lead system. ### Claim 10 (depends on 1) The implantable defibrillator of claim 1, wherein the voltage of the at least one pulse is between 80 volts and 3000 volts. ### Claim 11 (depends on 1) The implantable defibrillator of claim 1, wherein the voltage of the at least one pulse is 600 volts or greater. ### Claim 12 (depends on 1) The implantable defibrillator of claim 1, wherein the at least one defibrillation pulse includes at least one pulse having electric field strength between 100 and 700 volts per centimeter, a voltage between 80 and 3000 volts and a time duration between 50 and 1000 microseconds. ### Claim 13 (depends on 1) The implantable defibrillator of claim 1, wherein the at least one pulse is synchronized to the patient's cardiac pulse. ### Claim 14 (depends on 13) The implantable defibrillator of claim 13, wherein the at least one pulse is synchronized to the patient's cardiac R wave. ### Claim 15 (depends on 1) The implantable defibrillator of claim 1, wherein the at least one pulse includes a first pulse and a second pulse, wherein the first pulse has a voltage greater than 80 volts and a time duration less than 1000 microseconds. ### Claim 16 (depends on 15) The implantable defibrillator of claim 15, wherein the second pulse has a voltage greater than 80 volts and a time duration less than 1000 microseconds. ### Claim 17 (depends on 16) The implantable defibrillator of claim 16, wherein the time duration of the second pulse is greater than 100 microseconds. ### Claim 18 (depends on 15) The implantable defibrillator of claim 15, wherein a polarity of the first pulse and a polarity of the second pulse are the same. ### Claim 19 (depends on 9) The implantable defibrillator of claim 9, wherein the first pulse and the second pulse are of opposite polarity. ### Claim 20 (depends on 9) The implantable defibrillator of claim 9, wherein the at least one pulse includes a third pulse. ### Claim 21 (depends on 2) The implantable defibrillator of claim 2, wherein the implantable defibrillator is configured to deliver a defibrillation pulse to a ventricle. ### Claim 22 (depends on 1) The implantable defibrillator of claim 1, wherein a volume of the implantable defibrillator is less than 15 cubic centimeters. ### Claim 23 (depends on 1) The implantable defibrillator of claim 1, wherein the implantable defibrillator is configured to be implanted in a location of the heart selected from the group consisting of the pulmonary vein, the subclavian pocket, a branch of the subclavian vein, the left atrium, the right atrium, the right ventricle, the superior vena cava and the inferior vena cava. ### Claim 24 (depends on 1) The implantable defibrillator of claim 1, wherein the at least one lead includes at least one electrode positioned in a location of the heart selected from the group consisting of the left atrium, the right atrium, the right ventricle, the coronary sinus of the heart, the pulmonary artery, the apex of the right ventricle and the intra-atrial septum of the heart. ### Claim 25 (depends on 24) The implantable defibrillator of claim 24, wherein the at least one electrode is used for sensing. ### Claim 26 (depends on 1) The implantable defibrillator of claim 1, wherein the at least one lead is bifurcated and contains a first sub-lead having at least one electrode positioned in the right atrium and a second sub-lead having at least one electrode positioned in at least one of the right ventricle or the left atrium. ### Claim 27 (depends on 1) The implantable defibrillator of claim 1, wherein the implantable defibrillator is implanted in the right atrium and the at least one lead is a single lead having an electrode positioned in at least one of the right ventricle or the left atrium. ### Claim 28 (depends on 27) The implantable defibrillator of claim 27, wherein the implantable defibrillator acts as an electrode positioned within the right atrium. ### Claim 29 (depends on 1) The implantable defibrillator of claim 1, wherein the at least one lead is a single lead having a first electrode positioned in the right atrium and a second electrode positioned in at least one of the right ventricle or the left atrium. ### Claim 30 (depends on 1) The implantable defibrillator of claim 1, wherein the at least one lead is a single lead having a first electrode positioned in the right atrium, a second electrode positioned in the right ventricle and a third electrode positioned in the pulmonary artery. ### Claim 31 (depends on 1) The implantable defibrillator of claim 1, wherein the at least one lead is bifurcated and contains a first sub-lead having at least one electrode positioned in the left atrium and a second sub-lead having at least one electrode positioned at apex of the right ventricle. ### Claim 32 (depends on 1) The implantable defibrillator of claim 1, wherein the electrode lead system includes a first electrode positioned in the superior vena cava and a second electrode positioned in the left atrium. ### Claim 33 (depends on 1) The implantable defibrillator of claim 1, wherein the electrode lead system includes a first electrode positioned in the superior vena cava and a second electrode positioned in the right ventricle ### Claim 34 (depends on 1) The implantable defibrillator of claim 1, wherein the electrode lead system includes a first electrode positioned in the pulmonary artery and a second electrode positioned in the left atrium. ### Claim 35 (depends on 1) The implantable defibrillator of claim 1, wherein the at least one sensor includes a first sensor and a second sensor in communication with the controller, the first sensor being an electrode for measuring electrical activity of the heart. ### Claim 36 (depends on 35) The implantable defibrillator of claim 35, wherein the second sensor of the at least one sensor includes an electrode for measuring electrical activity of the heart. ### Claim 37 (depends on 35) The implantable defibrillator of claim 35, wherein the controller is configured to determine a location of fibrillation based on signals received by from the first sensor and the second sensor. ### Claim 38 (depends on 37) The implantable defibrillator of claim 37, wherein the controller determines a location of fibrillation based on a plurality of electrocardiogram signals. ### Claim 39 (depends on 35) The implantable defibrillator of claim 35, wherein the second sensor includes a sensing device selected from the group consisting of a microphone, a blood pressure sensor, a thermal sensor, a blood oxygenation sensor, a breathing sensor and an acceleration sensor. ### Claim 40 (depends on 35) The implantable defibrillator of claim 35, wherein the controller is configured to determine a state of atrial fibrillation based on signals communicated from the first sensor and the second sensor. ### Claim 41 (depends on 1) The implantable defibrillator of claim 1, wherein the controller is configured to determine a state of atrial fibrillation based on multi-dimensional signal analysis. ### Claim 42 (depends on 1) The implantable defibrillator of claim 1, wherein the controller is configured to detect a state of ventricle fibrillation and automatically deliver the at least one defibrillation shock when ventricle fibrillation state is detected. ### Claim 43 (depends on 1) The implantable defibrillator of claim 1, the electrode lead system further comprising a first electrode and a second electrode forming a first pair of electrodes and a third electrode and a fourth electrode forming a second pair of electrodes, wherein a first voltage is applied across the first electrode and the second electrode to form a first electric field and a second voltage is applied across the third electrode and the fourth electrode to form a second electric field. ### Claim 44 (depends on 43) The implantable defibrillator of claim 43, wherein the first electric field is at an angle relative to the second electric field. ### Claim 45 (depends on 43) The implantable defibrillator of claim 43, wherein the first voltage applied across the first electrode and the second electrode and the second voltage applied across the third electrode and the fourth electrode are not applied to the heart at the same time. ### Claim 46 (depends on 1) The implantable defibrillator of claim 1, the electrode lead system further comprising a first electrode and a second electrode forming a first pair of electrodes and the first electrode and a third electrode forming a second pair of electrodes, wherein a first voltage is applied across the first electrode and the second electrode to form a first electric field and a second voltage is applied across the first electrode and the third electrode to form a second electric field. ### Claim 47 (depends on 46) The implantable defibrillator of claim 46, wherein the first electric field is at an angle relative to the second electric field. ### Claim 48 (depends on 46) The implantable defibrillator of claim 46, wherein the first voltage applied across the first electrode and the second electrode and the second voltage applied across the first electrode and the third electrode are not applied to the heart at the same time. ### Claim 49 (depends on 1) The implantable defibrillator of claim 1, the at least one pulse further comprising a monophasic pulse train having at least two pulses with substantially the same polarity, duration and voltage. ### Claim 50 (depends on 1) The implantable defibrillator of claim 1, the at least one pulse further comprising a monophasic pulse train having at least a first pulse and a second pulse with substantially the same polarity and voltage, wherein the second pulse has a greater voltage than the first pulse. ### Claim 51 (depends on 1) The implantable defibrillator of claim 1, the at least one pulse further comprising a biphasic pulse train having two pulses with the substantially the same polarity, duration and voltage. ### Claim 52 (depends on 1) The implantable defibrillator of claim 1, the at least one pulse further comprising a biphasic pulse train having at least a first pulse and a second pulse with substantially the same polarity and voltage, wherein the second pulse has a greater voltage than the first pulse. ### Claim 53 (depends on 1) The implantable defibrillator of claim 1, the at least one pulse further comprising a triphasic pulse train having at least three pulses with alternating polarity and substantially the same duration, wherein the initial voltage of each consecution pulse is approximately equal to or slightly less than the final voltage of the preceding pulse. ### Claim 54 (depends on 1) The implantable defibrillator of claim 1, the at least one pulse further comprising a monophasic pulse train having at least three pulses, wherein the initial voltage of each consecution pulse is approximately equal to or slightly less than the final voltage of the preceding pulse. ### Claim 55 (depends on 1) The implantable defibrillator of claim 1, the at least one pulse further comprising a monophasic pulse train having at least four pulses with substantially the same polarity, voltage and duration. ### Claim 56 (depends on 1) The implantable defibrillator of claim 1, the at least one pulse further comprising a monophasic pulse train having at least three pulses with substantially the same polarity and different voltage and duration. ### Claim 57 (depends on 1) The implantable defibrillator of claim 1, the at least one pulse further comprising a triphasic pulse train having at least three pulses with alternating polarity and substantially the same voltage and duration. ### Claim 58 (depends on 1) The implantable defibrillator of claim 1, the at least one pulse further comprising a triphasic pulse train having at least three pulses with alternating polarity and substantially the same duration, wherein the voltage of each consecutive pulse is larger than the voltage of the preceding pulse. ### Claim 59 (depends on 1) The implantable defibrillator of claim 1, the at least one pulse further comprising a monophasic pulse train having at least three pulses with substantially the same polarity, voltage and duration, wherein the dwell time between each pulse is substantially larger than the duration of each pulse. ### Claim 60 (depends on 1) The implantable defibrillator of claim 1, the at least one pulse further comprising a biphasic pulse train having at least a first pulse, a second pulse and a third pulse with different voltages and durations, wherein the first pulse and the second pulse are consecutive and have substantially the same polarity, the polarity of the first pulse and the second pulse being different than the polarity of the third pulse. ### Claim 61 (depends on 1) The implantable defibrillator of claim 1, the at least one pulse further comprising a pulse train having at least a first pulse of less than 2 Joules and used to measure tissue impedance. ### Claim 62 (depends on 1) The implantable defibrillator of claim 1, the at least one pulse further comprising a triphasic pulse train having at least three pulses with alternating polarity and different voltage and duration. ### Claim 63 (depends on 1) The implantable defibrillator of claim 1, the electrode lead system further comprising a first single lead contain an electrode positioned in the inter-atrial septum and a second single lead containing an electrode positioned in the coronary vein. ### Claim 64 A heart defibrillation system comprising: a defibrillator configured to be implanted in a patient, the defibrillator comprising: an electrode lead system having at least one lead; at least one sensor configured to sense a condition of a heart and emit a signal indicative of the condition; a controller in communication with the at least one sensor, the controller being configured to determine from the signal whether the condition of the heart is one of a state of fibrillation and emit a command signal if the condition is one of a state of fibrillation; a voltage generator in communication with the controller and the electrode system, the voltage generator being configured to discharge at least one defibrillation pulse to the electrode system after receiving the command signal, wherein the at least one defibrillation pulse includes at least one pulse having a voltage greater than 80 volts and a time duration up to 1000 microseconds; and a communication device disposed outside of the patient configured to communicate with the defibrillator. ### Claim 65 (depends on 64) The heart defibrillation system of claim 64, wherein the communication device includes notification circuitry configured to notify the patient that fibrillation was detected. ### Claim 66 (depends on 65) The heart defibrillation system of claim 65, wherein the notification circuitry is configured to notify the patient that fibrillation was detected and to instruct the patient to be prepared for an defibrillation shock. ### Claim 67 (depends on 65) The heart defibrillation system of claim 65, wherein the notification circuitry is configured to instruct the patient to seek medical treatment in a medical center. ### Claim 68 (depends on 65) The heart defibrillation system of claim 65, wherein notification circuitry is configured to notify the patient of a worsening cardiac condition. ### Claim 69 (depends on 64) The heart defibrillation system of claim 64, wherein the communication device is configured to initiate an atrial defibrillation shock. ### Claim 70 (depends on 64) The heart defibrillation system of claim 64, wherein the communication device is configured to notify a medical facility of a cardiac condition of the patient. ### Claim 71 (depends on 70) The heart defibrillation system of claim 70, wherein the communication device includes location determination circuitry configured to determine a location of the patient and is configured to communicate the determined location to a medical center. ### Claim 72 (depends on 70) The heart defibrillation system of claim 70, wherein the communication device is configured for bi-directional communication with the implantable defibrillator over a short range wireless communication link, and is configured for bi-directional communication with the medical center over a long-range wireless communication link. ### Claim 73 (depends on 71) The heart defibrillation system of claim 71, wherein the long-range wireless communication link is cellular communication link. ### Claim 74 (depends on 71) The heart defibrillation system of claim 71, wherein the communication device is a mobile phone. ### Claim 75 (depends on 37) The heart defibrillation system of claim 37, wherein a message communicated over the long-range communication link is a message selected from the group consisting of a synthesized voice announcement, a pre-recorded voice announcement, a short message service, a multimedia message service and electronic mail. ### Claim 76 A method for defibrillating a heart with an implantable defibrillator, the method comprising: detecting when a condition of fibrillation within the heart; configuring at least one electrical pulse parameter to define an electrical pulse having a voltage between 80 and 3000 volts and a duration between 30 and 1000 microseconds; generating a first electrical pulse in accordance with the at least one electrical pulse parameter; and discharging the first electrical pulse to the heart using an electrode lead system having at least one pair of electrodes positioned in or around the heart. ### Claim 77 (depends on 76) The method as claimed in claim 76, wherein discharging the first electrical pulse includes generating an electric field strength of between 100 to 700 volts per centimeter across the at least one pair of electrodes. ### Claim 78 (depends on 76) The method as claimed in claim 76, the method further comprising transmitting a fibrillation message to a medical center when the atrium in the heart fibrillates. ### Claim 79 (depends on 78) The method as claimed in claim 78, comprising determining a location of the implantable heart defibrillator using location determination circuitry, the location being included in a fibrillation message that enables the medical center to determine the location of the implantable defibrillation system. ### Claim 80 (depends on 78) The method as claimed in claim 78, comprising delivering a drug to the heart using the implantable heart defibrillator before discharging the first electrical pulse to the atrium of the heart. ### Claim 81 (depends on 78) The method as claimed in claim 78, comprising activating a notification circuitry configured to notify a patient of the first electrical pulse before discharging the first electrical pulse to the atrium of the heart. ### Claim 82 A method of reducing pain while defibrillating an atrium of a human heart, the method comprising: delivering at least one pulse to the atrium having a voltage greater than 600 volts and a time duration between 50 and 600 microseconds. ### Claim 83 A method of reducing pain while defibrillating a ventricle of a human heart, the method comprising: detecting a condition of ventricular fibrillation within the heart using an implantable defibrillator; configuring at least one electrical pulse parameter to define an electrical pulse having a voltage between 80 and 3000 volts and a duration of 50 to 1000 microseconds; generating a first electrical pulse in accordance with the at least one electrical pulse parameter; and discharging the first electrical pulse from the implantable defibrillator to the heart using an electrode lead system having at least one pair of electrodes positioned in or around the heart, wherein a total amount of energy delivered by the first electrical pulse is less than 2 Joules. ### Claim 84 (depends on 83) The method of claim 83, wherein the first electrical pulse is monophasic. ### Claim 85 (depends on 83) The method of claim 83, wherein the first electrical pulse is biphasic. ### Claim 86 (depends on 83) The method of claim 83, wherein the implantable defibrillator acts as an electrode of the electrode lead system.