# US 10,369,361 B2 · Leads for implantable medical device that affects pressures within the intrathoracic cavity through diaphragmatic stimulation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,369,361 B2 - Document ID: US10369361B2 - Status: Granted - Kind: B2 - Application number: 15/498,303 - Filed: 2017-04-26 - Published: 2017-11-02 - Granted: 2019-08-06 - Earliest claimed: 2016-04-29 - Assignees: VisCardia, Inc. - Applicants: VisCardia, Inc. - Inventors: Peter T. Bauer; Edward Chinchoy; Jay Snell - Web page: https://patentgrep.com/patent/US10369361B2 ## CPC - A61N 1/3601: {of respiratory organs} - A61B 5/021: Measuring pressure in heart or blood vessels - A61B 5/0215: by means inserted into the body - A61B 5/03: Measuring fluid pressure within the body other than blood pressure, e.g. cerebral pressure {; Measuring pressure in body tissues or organs (determining bladder or urethral pressure A61B5/205)} - A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)} - A61B 5/113: occurring during breathing - A61B 5/1135: {by monitoring thoracic expansion} - A61B 5/283: Invasive - A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS] - A61B 5/349: Detecting specific parameters of the electrocardiograph cycle - A61B 5/352: Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval - A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)} - A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)} - A61B 7/04: Electric stethoscopes - A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)} - A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence) - A61N 1/3627: {for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy} - A61N 1/37217: {characterised by the communication link, e.g. acoustic or tactile} - A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition - A61B 5/1102: {Ballistocardiography} - A61B 2562/0204: Acoustic sensors - A61B 2562/0219: Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches - A61N 1/36585: {controlled by two or more physical parameters} - 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 lead for placement on a diaphragm includes a sensor assembly, a connector, and a lead body. The sensor assembly includes a housing having a first end surface and a second end surface opposite the first end surface. The first end surface is intended to contact the diaphragm. The sensor assembly includes at least one fixation structure also associated with the first end surface. The fixation structure is configured to preserve the hermetic integrity of the intrathoracic cavity. The fixation structure may extend through the diaphragm and transition to a state that forms a seal between itself and tissue of the diaphragm. Alternatively, the fixation structure may surround the sensor assembly and form a seal between itself and the surface of the diaphragm. ## Claims ### Claim 1 A lead configured for implant on a surface of a biological membrane forming part of a hermetically sealed biological cavity, the lead comprising: a sensor assembly at a distal end of the lead, and comprising: a housing having a first end surface and a second end surface opposite the first end surface; a sensor structure associated with the first end surface, and comprising at least one sensor; and at least one fixation structure associated with the first end surface and comprising a projecting structure that extends away from the first end surface of the housing, and configured to preserve the hermetic integrity of the biological cavity after implant of the lead; a connector at a proximal end of the lead, and comprising at least one conductor pin; and a lead body extending between the sensor assembly and the connector, and comprising at least one conductor that electrically couples the at least one sensor to the at least one conductor pin, wherein the projecting structure comprises a wire and at least a portion of the wire is configured to actively transition from a first state, wherein the portion of the wire has a first diameter, and a second state, wherein the portion of the wire has a second diameter greater than the first diameter. ### Claim 2 (depends on 1) The lead of claim 1, wherein at least one sensor comprises an electrode. ### Claim 3 (depends on 2) The lead of claim 2, wherein the electrode is in a form of one of a flat surface electrode, or a ring electrode. ### Claim 4 (depends on 1) The lead of claim 1, wherein sensor structure comprises a plurality of sensors, and the plurality of sensors comprises at least one electrode and at least one motion sensor. ### Claim 5 (depends on 1) The lead of claim 1, wherein the sensor structure comprises a ring having a circumference, and comprises a plurality of sensors spaced apart around the circumference. ### Claim 6 (depends on 1) The lead of claim 1, wherein the projecting structure is characterized by a protruding length defined as a length between the surface of the sensor structure and a distal tip of the projecting structure. ### Claim 7 (depends on 1) The lead of claim 1, wherein the projecting structure comprises a proximal section end near the first end surface of the housing and a distal section opposite the proximal end, and only the distal section is configured to transition from the first state to the second state. ### Claim 8 A lead configured for implant on a surface of a biological membrane forming part of a hermetically sealed biological cavity, the lead comprising: a sensor assembly at a distal end of the lead, and comprising: a housing having a first end surface and a second end surface opposite the first end surface; a sensor structure associated with the first end surface, and comprising at least one sensor; and at least one fixation structure comprising a projecting structure in the form of a helix that extends away from the first end surface of the housing, and configured to preserve the hermetic integrity of the biological cavity after implant of the lead; a connector at a proximal end of the lead, and comprising at least one conductor pin; and a lead body extending between the sensor assembly and the connector, and comprising at least one conductor that electrically couples the at least one sensor to the at least one conductor pin, wherein the projecting structure comprises a middle section between a proximal section and a distal section, wherein a wire forming the middle section has a diameter that is less than the diameter of a wire forming the proximal section and a wire forming the distal section. ### Claim 9 (depends on 8) The lead of claim 8, wherein the projecting structure comprises a sensor. ### Claim 10 (depends on 8) The lead of claim 8, wherein the at least one fixation structure further comprises an extension member surrounding the projecting structure and having a maximum diameter greater than a maximum diameter of the housing. ### Claim 11 (depends on 10) The lead of claim 10, wherein the extension member is formed of a material configured to form a seal with the surface of the biological membrane. ### Claim 12 (depends on 10) The lead of claim 10, wherein the extension member comprises an adhesive configured to form a seal with the surface of the biological membrane. ### Claim 13 A lead configured for implant on a surface of a biological membrane forming part of a hermetically sealed biological cavity, the lead comprising: a sensor assembly at a distal end of the lead, and comprising: a housing having a first end surface and a second end surface opposite the first end surface; a sensor structure associated with the first end surface, and comprising a ring having a circumference and one or more electrodes and one or more motion sensors located on the ring and spaced apart around the circumference; and at least one fixation structure comprising a projecting structure configured to extend through the biological membrane, and an extension member surrounding the projecting structure and configured to form a hermetic seal with the surface of the biological membrane, which formed seal surrounds an area where the projecting structure extends through the biological membrane to thereby preserve the hermetic integrity of the biological cavity; a connector at a proximal end of the lead, and comprising a plurality of conductor pins; and a lead body extending between the sensor assembly and the connector, and comprising a plurality of conductors that electrically couple the one or more electrodes and the one or more motion sensors to the plurality of conductor pins. ### Claim 14 (depends on 13) The lead of claim 13, wherein the projecting structure comprises a helix extending away from the first end surface of the housing. ### Claim 15 (depends on 13) The lead of claim 13, wherein: the sensor assembly is characterized by a central axis extending through the housing, the lead body is characterized by a longitudinal axis that extends between a distal end of the lead body and a proximal end of the lead body, and the longitudinal axis of the lead body and the central axis of the sensor assembly are offset from each other. ### Claim 16 (depends on 15) The lead of claim 15, further comprising a grip structure extending from the second end surface in the direction of the central axis, and configured to be received by a gripping structure of an implant tool. ### Claim 17 (depends on 13) The lead of claim 13, wherein the projecting structure comprises a sensor. ### Claim 18 (depends on 13) The lead of claim 13, wherein the extension member has a maximum diameter greater than a maximum diameter of the housing. ### Claim 19 (depends on 13) The lead of claim 13, wherein the extension member is formed of a material configured to form a seal with the surface of the biological membrane. ### Claim 20 (depends on 13) The lead of claim 13, wherein the extension member comprises an adhesive configured to form a seal with the surface of the biological membrane.