Implantable medical systems, devices and methods for delivering asymptomatic diaphragmatic stimulation
Inventors
Bauer, Peter T. • Harris, Gregg
Assignees
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Publication Number
US-11957914-B2
Publication Date
2024-04-16
Expiration Date
Abstract
Transcardiac diaphragmatic stimulation includes detecting a cardiac event based on signals sensed through a cardiac event sensor located in or on a region of a heart in proximity to a diaphragm, and delivering an ADS therapy through an ADS therapy mechanism that is located in proximity with the region of the heart, to induce a contraction of the diaphragm without inducing a contraction of the heart. The cardiac event sensor may be located a) on an interior surface of a cardiac wall that abuts the diaphragm, or 2) on an exterior surface of the heart, between a cardiac wall and the diaphragm. The ADS therapy mechanism may be located: a) on an interior surface of a cardiac wall that abuts the diaphragm, 2) on a superior surface of the diaphragm that abuts a cardiac wall, or 3) on an inferior surface of the diaphragm at a region of the diaphragm that abuts the heart.
Core Innovation
The invention provides implantable medical systems and methods for transcardiac diaphragmatic stimulation in which asymptomatic diaphragmatic stimulation (ADS) is delivered responsive to detection of a cardiac event. A cardiac event is detected based on signals sensed through a cardiac event sensor located in or on a region of a heart in proximity to a diaphragm. Responsive to the detection, an ADS therapy mechanism located in proximity with the region of the heart delivers ADS to capture a muscle of the diaphragm to induce a transient contraction of a portion of a hemisphere of the diaphragm that is less than the entirety of the hemisphere of the diaphragm.
The ADS therapy is configured to induce diaphragm contraction without inducing contraction of the heart by coordinating delivery with timing relationships to the cardiac event. In particular, the ADS therapy is delivered during a refractory period of the heart associated with the cardiac event to avoid inducing a contraction of the heart. Timing logic may use delay periods to deliver ADS at an end of the delay into heart refractory periods.
The invention further provides device configurations that place the cardiac event sensor and the ADS therapy mechanism in proximity with the heart–diaphragm interface. Placement is described such that the sensor and/or ADS therapy mechanism can be located in or on a region of a heart in proximity to a diaphragm, including at an interior heart-wall abutting diaphragm or an exterior heart surface between heart and diaphragm. Systems are described with multi-piece IMDs and specialized transcardiac lead variants, as well as leadless devices implanted between heart wall and diaphragm.
Claims Coverage
The provided independent claims are clm-00001, clm-00018, and clm-00038. Across these claims, the independent claim coverage is centered on three inventive features: cardiac event sensing near a heart–diaphragm region, ADS delivery by a nearby ADS therapy mechanism, and coordination of the ADS to produce partial transient diaphragm contraction without inducing heart contraction.
Cardiac-event sensing in a heart region in proximity to a diaphragm
Detecting a cardiac event based on signals sensed through a cardiac event sensor located in or on a region of a heart in proximity to a diaphragm.
ADS therapy mechanism positioned in proximity with the heart region
Delivering asymptomatic diaphragmatic stimulation (ADS) therapy through an ADS therapy mechanism located in proximity with the region of the heart.
Partial transient diaphragm contraction without heart contraction
Configuring the ADS therapy to capture a muscle of the diaphragm to induce a transient contraction of a portion of a hemisphere of the diaphragm that is less than the entirety of the hemisphere of the diaphragm, without inducing a contraction of the heart.
ADS delivered during a refractory period associated with the cardiac event
Delivering the ADS therapy to the diaphragm through the ADS therapy mechanism during a refractory period of the heart associated with the cardiac event to avoid inducing a contraction of the heart.
Leadless or lead-based device placement between heart and diaphragm
Including a cardiac event sensor and an ADS therapy mechanism, with lead-based implementations extending through a cardiac wall and through the diaphragm into an abdominal cavity.
Across clm-00001, clm-00018, and clm-00038, the independent claim coverage requires coordinated cardiac-event detection near a heart–diaphragm region and ADS delivery via a nearby ADS therapy mechanism to induce only a partial, transient diaphragm contraction. The independent claims also require avoiding heart contraction by delivering the ADS during a heart refractory period, and they further specify lead or device placement associated with the heart–diaphragm interface.
Stated Advantages
Induces a transient contraction of a portion of a hemisphere of the diaphragm that is less than the entirety of the hemisphere of the diaphragm.
Avoids inducing a contraction of the heart by delivering ADS during a refractory period of the heart associated with the cardiac event.
Documented Applications
Transcardiac diaphragmatic stimulation using an implantable medical device that detects a cardiac event and delivers asymptomatic diaphragmatic stimulation (ADS) to induce diaphragm contraction without inducing heart contraction.
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