PATIENT TREATMENT SYSTEMS FOR SENSING CARDIAC DEPOLARIZATION AND/OR STIMULATING THE CAROTID SINUS NERVE, AND ASSOCIATED DEVICES AND METHODS
Patient treatment systems and methods for sensing cardiac depolarization and/or stimulating the carotid sinus nerve are disclosed herein. Exemplary patient treatment systems can include a neuromodulator and an implantable signal delivery device electrically coupleable to the neuromodulator. The signal delivery device comprises a lead body including a first region, a second region positionable over the first region, and lead electrodes. The patient treatment system further comprises computer-readable media having instructions that cause the patient treatment system to perform operations comprising: (i) obtaining a physiological parameter of the patient, (ii) generating neuromodulation pulses based on the obtained physiological parameter, and (iii) delivering the neuromodulation pulses to the CSN afferent fibers via one or more of the lead electrodes. The physiological parameter can include at least one of blood pressure, heart rate, bioimpedance, or activity level of the patient.
1 . A patient treatment system, comprising:
an implantable signal delivery device electrically coupleable to the neuromodulator, the signal delivery device including a lead body and lead electrodes carried by the lead body, the lead electrodes configured to be implanted proximate to and/or at least partially around carotid sinus nerve (CSN) afferent fibers of a patient suffering from hypertension; and
a neuromodulator electrically coupleable to the signal delivery device configured for delivering neuromodulation pulses to the CSN afferent fibers via one or more of the lead electrodes, wherein the neuromodulation pulses delivered to the CSN afferent fibers via the one or more of the lead electrodes have stimulation characteristics that mimic a natural and desirable baroreceptor response of a person without hypertension.
2 . The patient treatment system of claim 1 , wherein the neuromodulator is further configured for delivering second neuromodulation pulses to address or treat one or more additional indications, including obstructive sleep apnea (OSA), central sleep apnea, and/or heart failure.
3 . The patient treatment system of claim 2 , wherein the second neuromodulation pulses are delivered (i) along with complementary and/or synergistic carotid sinus nerve (CSN) stimulation, and/or (ii) by the neuromodulator and/or another neuromodulation device, and wherein delivering the second neuromodulation pulses optionally includes providing cardiac resynchronization therapy, cardiac contractility modulation therapy, and/or stimulating a diaphragm of the patient.
4 . The patient treatment system of claim 1 , wherein the neuromodulation pulses delivered to the CSN afferent fibers via the one or more of the lead electrodes comprise a burst of individual pulses over a single cardiac cycle of the patient.
5 . The patient treatment system of claim 4 , wherein each subsequent individual pulse of the burst of individual pulses varies in delay relative to an immediately previous pulse of the burst of individual pulses.
6 . The patient treatment system of claim 5 , wherein the delays of the burst of individual pulses gradually increase over time.
7 . The patient treatment system of claim 1 , wherein the neuromodulation pulses include a first pulse having a first delay from an immediately preceding pulse, a second pulse having a second delay from the immediately preceding pulse, and a third pulse having a third delay from the immediately preceding pulse, wherein the third delay is longer than the second delay and the second delay is longer than the first delay.
8 . The patient treatment system of claim 1 , wherein the neuromodulator is configured for storing a plurality of profiles associated with a physical, mental, and/or emotional state of the patient, selecting one of the plurality of profiles in response to input from the patient, and adjusting stimulation characteristics of the neuromodulation pulses delivered to the CSN afferent fibers via the one or more of the lead electrodes in response to the selection of the one of the plurality of profiles.
9 . The patient treatment system of claim 1 , wherein the neuromodulator is configured for varying stimulation parameters of the neuromodulation pulses delivered to the CSN afferent fibers via the one or more of the lead electrodes based on a time of day.
10 . The patient treatment system of claim 1 , wherein the neuromodulator is configured for iteratively delivering sets of neuromodulation pulses to the CSN afferent fibers via one or more of the lead electrodes over a plurality of cardiac cycles, obtaining physiological parameters of the patient over the plurality of cardiac cycles in response to the sets of neuromodulation pulses delivered to the CSN afferent fibers via the one or more of the lead electrodes, and adjusting stimulation parameters of a set of neuromodulation pulses delivered to the CSN afferent fibers via the one or more of the lead electrodes over a subsequent cardiac cycle based on the physiological parameters of the patient obtained during previous ones of the plurality of cardiac cycles of the patient.
11 . The patient treatment system of claim 1 , wherein the neuromodulator is further configured for obtaining a physiological parameter of the patient, wherein the physiological parameter comprises at least one of blood pressure, heart rate, bioimpedance, or patient activity level, and generating the neuromodulation pulses based on the obtained physiological parameter.
12 . The patient treatment system of claim 1 , wherein the neuromodulator is further configured for sensing a cardiac depolarization event via a vector formed from at least one base electrode associated with the neuromodulator, and generating the neuromodulation pulses based on the sensed cardiac depolarization event.
13 . The patient treatment system of claim 1 ,
wherein the lead body includes:
a first region including a first surface,
a second region including a second surface,
an intermediate region between the first region and the second region, wherein the signal delivery device includes (i) an open configuration in which the first surface is coplanar with the second surface and (ii) a closed configuration in which the second region is positioned over the first region and the first surface is parallel to the second surface, and wherein, in the closed configuration, the first surface is spaced apart from the second surface by a cross-sectional dimension of the intermediate region, and
wherein the lead electrodes include:
a first set of lead electrodes on the first surface of the first region; and
a second set of lead electrodes on the second surface of the second region,
wherein the lead electrodes are configured to be implanted proximate to and/or at least partially around the carotid sinus nerve (CSN) afferent fibers of a patient such that (i) the first set of lead electrodes are configured to be positioned over a first side of the CSN afferent fibers of the patient, and (ii) the second set of lead electrodes are configured to be positioned over a second side of the CSN afferent fibers opposite the first side.
14 . The patient treatment system of claim 13 , wherein the first set of lead electrodes are spaced apart from one another along a central longitudinal axis, the second set of lead electrodes are spaced apart from one another along the central longitudinal axis, and the central longitudinal axis extends through the first region, the intermediate region, and the second region.
15 . The patient treatment system of claim 13 , wherein the first set of lead electrodes comprises a plurality of electrodes, and the second set of lead electrodes comprises a single electrode having a surface area at least equal to a total surface area of the plurality of electrodes.
16 . The patient treatment system of claim 13 , further comprising:
a first tapered tab extending laterally outward from a first side portion of the first region away from the intermediate region; and
a second tapered tab extending laterally outward from a second side portion of the second region away from the intermediate region.
17 . The patient treatment system of claim 16 , wherein each of the first tapered tab and the second tapered tab comprises one or more of an alignment and/or orientation feature.
18 . The patient treatment system of claim 13 , wherein, when the first region is positioned over the second region, each one of the first set of lead electrodes is aligned with a corresponding one of the second set of lead electrodes.
19 . The patient treatment system of claim 13 , wherein the first region, the intermediate region, and the second region comprise a single continuous layer.
20 . A method for treating hypertension in a patient using the patient treatment system of claim 1 , comprising:
implanting the signal delivery device within the patient; and
delivering the neuromodulation pulses from the implanted neuromodulator to the CSN afferent fibers via the implanted one or more of the lead electrodes, thereby treating the hypertension of the patient.