# US 10,765,860 B2 · Subcutaneous implantation medical device with multiple parasternal-anterior electrodes > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,765,860 B2 - Document ID: US10765860B2 - Status: Granted - Kind: B2 - Application number: 15/973,195 - Filed: 2018-05-07 - Published: 2019-11-07 - Granted: 2020-09-08 - Earliest claimed: 2018-05-07 - Assignees: Pacesetter, Inc. - Applicants: Pacesetter, Inc. - Inventors: Xiaoyi Min; Kyungmoo Ryu; Keith Victorine; Stuart Rosenberg; Gene A. Bornzin - Web page: https://patentgrep.com/patent/US10765860B2 ## CPC - A61N 1/0587: {Epicardial electrode systems; Endocardial electrodes piercing the pericardium} - A61N 1/0504: {Subcutaneous electrodes} - A61N 1/3918: {characterised by shock pathway, e.g. by electrode configuration} - A61N 1/3956: {Implantable devices for applying electric shocks to the heart, e.g. for cardioversion} - 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 A subcutaneous implantable medical device and method (SIMD) provided. A pulse generator (PG) is configured to be positioned subcutaneously within a lateral region of a chest of a patient. The PG has a housing that includes a PG electrode. The PG has an electronics module. An elongated lead is electrically coupled to the pulse generator. The elongated lead includes a first electrode that is configured to be positioned along a first parasternal region proximate a sternum of the patient and a second electrode that is configured to be positioned at an anterior region of the patient. The first and second electrodes are coupled to be electrically common with one another. The electronics module is configured to provide electrical shocks for antiarrhythmic therapy along at least one shocking vector between the PG electrode and the first and second electrodes. ## Claims ### Claim 1 A subcutaneous implantable medical device (SIMD), comprising: a pulse generator (PG) configured to be positioned subcutaneously within a lateral region of a chest of a patient, the PG having a housing that includes a PG electrode, the PG having an electronics module; and an elongated lead that is electrically coupled to the pulse generator, the elongated lead including a first electrode that is configured to be positioned subcutaneously along a first parasternal region proximate a sternum of the patient and a second electrode that is configured to be positioned subcutaneously at an anterior region of the patient, wherein the first and second electrodes are coupled to be electrically common with one another, wherein the PG is further configured to be positioned relative to a vertical direction substantially aligned with an apex of a heart to define at least one shocking vector between the PG and the first and second electrodes that passes through a ventricle of the heart, wherein the electronics module is configured to provide electrical shocks for antiarrhythmic therapy along the at least one shocking vector, wherein the lead, the first electrode and the second electrode are not attached to bone. ### Claim 2 (depends on 1) The SIMD of claim 1, wherein the anterior region represents a second parasternal region, the second electrode configured to be oriented to extend in a common direction with the first electrode, the first and second electrodes located on left and right sides of the sternum, the first and second electrodes configured to be spaced apart by a distance of between 1.5 cm and 8 cm as measured in a direction transverse to a midline of the sternum. ### Claim 3 (depends on 2) The SIMD of claim 2, wherein the first and second electrodes are configured to be positioned along opposite sides of the sternum and separated from one another by a predetermined distance greater than a width of the sternum. ### Claim 4 (depends on 2) The SIMD of claim 2, wherein at least one of the first and second electrodes has an active length of 7-11 cm and the predetermined distance separating the first and second electrodes is 6.0 to 8.5 cm. ### Claim 5 (depends on 1) The SIMD of claim 1, wherein the anterior region is locate proximate to a lower end of the sternum, the second electrode configured to be oriented to extend in a non-parallel direction relative to a direction of the first electrode, the second electrode located at relative to a midline of the sternum that is vertically below the first electrode, the first electrode having a length that is greater than a length of the second electrodes. ### Claim 6 (depends on 5) The SIMD of claim 5, wherein the length of the first electrode is 7.0 cm to 11.0 cm, and the length of the second electrode is 5.0 cm to 6.5 cm. ### Claim 7 (depends on 1) The SIMD of claim 1, wherein the lead includes a lead body having a base segment with a proximal end to be electrically coupled to a header of the PG, the lead including first and second distal branches at a distal end of the lead, the first and second electrodes provided on the first and second distal branches, respectively. ### Claim 8 (depends on 7) The SIMD of claim 7, wherein the lead body further comprises a Y-connector connecting the first and second distal branches to a distal end of the base segment. ### Claim 9 (depends on 1) The SIMD of claim 1, wherein the pulse generator and the first and second electrodes define the at least one shocking vector that provides to a defibrillation threshold of at most 20 Joules. ### Claim 10 (depends on 1) The SIMD of claim 1, wherein the pulse generator and the first and second electrodes define the at least one shocking vector there between through a left ventricle that exhibits an impedance along the shocking vector that is no more than 64 ohms. ### Claim 11 (depends on 1) The SIMD of claim 1, wherein the pulse generator and the first and second electrodes define the at least one shocking vector there between that exhibits an impedance along the shocking vector that is no more than 56.2 ohms. ### Claim 12 (depends on 1) The SIMD of claim 1, wherein either: i) the first and second electrodes are configured to be positioned along opposite sides of the sternum or ii) the second electrodes is configured to extend transversely to the sternum and to be located proximate to a lower end of the sternum in a non-parallel orientation with the first electrode. ### Claim 13 (depends on 1) The SIMD of claim 1, wherein the first and second electrodes are configured to be positioned beneath skin, but above layers of skeletal muscle tissue, rib bones, and costal cartilage. ### Claim 14 A method comprising: implanting a pulse generator (PG) within a lateral region of a chest of a patient, the PG having a housing that includes a PG electrode; and implanting at least one lead having first and second electrodes that are coupled to be electrically common with one another, wherein the first and second electrodes are elongated, the implanting comprising positioned the first electrode subcutaneously along a first parasternal region proximate to a sternum of the patient and positioning the second electrode subcutaneously at an anterior region of the patient and positioning the PG relative to a vertical direction substantially aligned with an apex of a heart to define at least one shocking vector between the PG and the first and second electrodes that passes through a ventricle of the heart; attaching the lead, the first electrode and the second electrode to muscle tissue; and configuring the electronics module to provide electrical shocks for antiarrhythmic therapy along the at least one shocking vector. ### Claim 15 (depends on 14) The method of claim 14, further comprising positioning the first and second electrodes at a dual parasternal position on left and right sides of the sternum, extending in a common direction and spaced apart by a distance of 1.5 cm to 8.5 cm. ### Claim 16 (depends on 15) The method of claim 15, further comprising positioning the first and second electrodes along opposite sides of the sternum. ### Claim 17 (depends on 15) The method of claim 15, wherein at least one of the first and second electrodes has an active length of 8-11 cm and the predetermined distance separating the first and second electrodes is 6.0 to 8.5 cm. ### Claim 18 (depends on 15) The method of claim 15, wherein the pulse generator is configured to generate a defibrillating energy of at most 40 Joules. ### Claim 19 (depends on 14) The method of claim 14, further comprising positioning the second electrode proximate to a lower end of the sternum and orienting the second electrode to extend in a non-parallel direction relative to a direction of the first electrode, locating the second electrode at a position, relative to a midline of the sternum, that is vertically below the first electrode. ### Claim 20 (depends on 19) The method of claim 19, wherein the non-parallel direction orients a longitudinal axis of the second electrode perpendicular to a longitudinal axis of the first electrode. ### Claim 21 (depends on 14) The method of claim 14, wherein the implanting further comprises either: i) positioning the first and second electrodes along opposite sides of the sternum; or ii) positioning the second electrodes to extend transversely to the sternum and to be located proximate to a lower end of the sternum in a non-parallel orientation with the first electrode. ### Claim 22 (depends on 14) The method of claim 14, wherein the implanting further comprises positioning the first and second electrodes beneath skin, but above layers of skeletal muscle tissue, rib bones, and costal cartilage.