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:
a neuromodulator comprising a housing, and at least one base electrode carried by the housing;
an implantable signal delivery device electrically coupleable to the neuromodulator, the signal delivery device comprising a lead body including:
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
lead electrodes electrically coupleable to the base electrode of the neuromodulator, 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 first set of lead electrodes are spaced apart from one another along a central longitudinal axis and the second set of lead electrodes are spaced apart from one another along the central longitudinal axis, wherein the lead electrodes are configured to be implanted proximate to and/or at least partially around 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, and wherein the central longitudinal axis extends through the first region, the intermediate region, and the second region;
one or more processors; and
tangible, non-transitory computer-readable media having instructions that, when executed by the one or more processors, cause the patient treatment system to perform operations comprising:
obtaining a physiological parameter of the patient, wherein the physiological parameter comprises at least one of heart rate or patient activity level, wherein an increase in the heart rate or the patient activity level corresponds to an increased frequency of neuromodulation pulses;
based on the obtained physiological parameter, generating the neuromodulation pulses; and
delivering the neuromodulation pulses to the CSN afferent fibers via one or more of the lead electrodes.
2 . The patient treatment system of claim 1 , 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.
3 . The patient treatment system of claim 1 , wherein a first number of lead electrodes of the first set of lead electrodes is different than a second number of lead electrodes of the second set of lead electrodes, and the first set of lead electrodes and the second set of lead electrodes span an identical distance of the lead body.
4 . The patient treatment system of claim 1 , wherein one of the first set of lead electrodes has a first width and at least one of the second set of lead electrodes has a second width greater than the first width.
5 . The patient treatment system of claim 1 , the operations further comprising identifying the CSN afferent fibers by obtaining impedance data from at least one of the first set of lead electrodes or at least one of the second set of lead electrodes, and wherein delivering the neuromodulation pulses comprises, based on the obtained impedance data, delivering the neuromodulation pulses via a first lead electrode of the first set of lead electrodes and a second lead electrode of the second set of lead electrodes.
6 . The patient treatment system of claim 1 , wherein each of the lead electrodes are individually addressable via the neuromodulator.
7 . The patient treatment system of claim 1 , wherein the signal delivery device includes conductors extending from the housing to the lead body, the at least one base electrode is a first base electrode, the neuromodulator includes a second base electrode spaced apart from the first base electrode, and each of the conductors are electrically coupled to (i) one of the first base electrode or the second base electrode, and (ii) one of the lead electrodes.
8 . The patient treatment system of claim 1 , wherein the obtained physiological parameter is indicative of cardiac muscle depolarization.
9 . The patient treatment system of claim 1 , wherein the obtained physiological parameter comprises the heart rate, and wherein delivering the neuromodulation pulses comprises delivering the neuromodulation pulses at a stimulation rate that is correlated with the obtained physiological parameter, such that a higher value of the obtained physiological parameter corresponds to the higher value of the stimulation rate.
10 . The patient treatment system of claim 1 , wherein the obtained physiological parameter comprises a first heart rate and delivering the neuromodulation pulses comprises delivering first neuromodulation pulses at a first frequency, the operations further comprising:
determining a second heart rate; and
based on the second heart rate, delivering second neuromodulation pulses at a second frequency higher than the first frequency.
11 . The patient treatment system of claim 1 , further comprising a blood pressure sensor operably coupled to the neuromodulator and configured to generate data comprising at least one of total blood pressure, diastolic blood pressure, or systolic blood pressure, wherein delivering the neuromodulation pulses is based at least in part on the generated data obtained from the blood pressure sensor.
12 . The patient treatment system of claim 1 , further comprising an acoustic sensor configured to detect cardiac depolarization, wherein generating the neuromodulation pulses is based at least in part on a signal from the acoustic sensor.
13 . The patient treatment system of claim 1 , further comprising an accelerometer configured to detect cardiac depolarization, wherein generating the neuromodulation pulses is based in part on a signal from the accelerometer.
14 . The patient treatment system of claim 1 , further comprising an accelerometer configured to output a signal indicative of an orientation of the patient, wherein generating the neuromodulation pulses is based in part on the signal from the accelerometer.
15 . 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.
16 . The patient treatment system of claim 1 , wherein the neuromodulation pulses have two or more of a pulse width of 10-1000 microseconds, a duty cycle of no more than 50%, an amplitude of 0-10 mA, and a frequency of 0-1000 Hz.
17 . The patient treatment system of claim 1 , wherein the physiological parameter is a first physiological parameter and the neuromodulation pulses are first neuromodulation pulses, and wherein the delivering the neuromodulation pulses comprises delivering the first neuromodulation pulses to the CSN afferent fibers according to first stimulation parameters, the operations further comprising:
after delivering the first neuromodulation pulses, obtaining a second physiological parameter of the patient;
based on the second physiological parameter of the patient, generating second neuromodulation pulses having second stimulation parameters; and
delivering the second neuromodulation pulses to the CSN afferent fibers according to the second stimulation parameters,
wherein the first stimulation parameters include a first frequency, a first amplitude, a first pulse width, and a first duty cycle, and the second stimulation parameters include a second frequency, a second amplitude, a second pulse width, and a second duty cycle, and wherein at least one of the first frequency, the first amplitude, the first pulse width, or the first duty cycle differ from a respective one of the second frequency, the second amplitude, the second pulse width, or the second duty cycle.
18 . The patient treatment system of claim 1 , wherein the physiological parameter is a first physiological parameter and the neuromodulation pulses are first neuromodulation pulses, and wherein delivering the neuromodulation pulses comprises delivering the first neuromodulation pulses to the CSN afferent fibers via a first group of the lead electrodes, the operations further comprising:
after delivering the first neuromodulation pulses, obtaining a second physiological parameter of the patient;
based on the second physiological parameter of the patient, generating second neuromodulation pulses; and
delivering the second neuromodulation pulses to the CSN afferent fibers via the second group of the lead electrodes different from the first group of the lead electrodes.
19 . The patient treatment system of claim 1 , wherein:
the lead electrodes on the first region span a first cross-sectional dimension along an axis, the lead electrodes on the second region span a second cross-sectional dimension along the axis, the intermediate region spans a third cross-sectional dimension along the axis, and
in the closed configuration, the first surface is spaced apart from the second surface by the third cross-sectional dimension.
20 . The patient treatment system of claim 1 , wherein, in the closed configuration, the first surface is spaced apart from the second surface by a third cross-sectional dimension across an entirety of the first region.
21 . The patient treatment system of claim 1 , further comprising: electrical contacts each electrically coupled to a corresponding one of the lead electrodes, wherein the electrical contacts are positioned on the first and second region such that a majority of a surface area of the first surface and the second surface is covered by the electrical contacts and the lead electrodes.
22 . The patient treatment system of claim 1 , wherein the first region, the intermediate region, and the second region comprise a single continuous layer such that the first set of lead electrodes and the second set of lead electrodes are coplanar in the open configuration.
23 . A patient treatment system, comprising:
a neuromodulator comprising a housing, and at least one base electrode carried by the housing;
an implantable signal delivery device electrically coupleable to the neuromodulator, the signal delivery device comprising a lead body including:
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 region is not positioned over the second region and (ii) a closed configuration in which the second region is positioned over the first region, wherein the first surface is congruent to the second surface,
a first set of lead electrodes at the first surface of the first region and spanning a first cross-sectional dimension along an axis, and
a second set of lead electrodes at the second surface of the second region and spanning a second cross-sectional dimension along the axis, wherein:
the first and second sets of lead electrodes are electrically coupleable to the base electrode of the neuromodulator,
at least a portion of the first and second sets of lead electrodes are positioned along a central longitudinal axis extending through the first region, the intermediate region, and the second region,
in the open configuration, the first surface is coplanar with the second surface and the intermediate region spans a third cross-sectional dimension along the axis,
in the closed configuration, the second region is positioned over the first region, the first surface is parallel to the second surface, and the first surface is spaced apart from the second surface by the third cross-sectional dimension, and the signal delivery device is configured to be implanted proximate to and/or at least partially around 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 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;
one or more processors; and
tangible, non-transitory computer-readable media having instructions that, when executed by the one or more processors, cause the patient treatment system to perform operations comprising:
obtaining a physiological parameter of the patient, wherein the physiological parameter comprises at least one of heart rate or patient activity level;
based on the obtained physiological parameter, generating neuromodulation pulses, wherein an increase in the heart rate or the patient activity level corresponds to an increased frequency of the neuromodulation pulses; and
delivering the neuromodulation pulses to the CSN afferent fibers via one or more of the first and second sets of lead electrodes.
24 . The patient treatment system of claim 23 , wherein the first set of lead electrodes includes at least five electrodes and the second set of lead electrodes includes at least five electrodes.
25 . The patient treatment system of claim 24 , wherein the first set of lead electrodes includes non-peripheral electrodes and peripheral electrodes laterally outward of the non-peripheral electrodes, and wherein the peripheral electrodes have a different polarity than the non-peripheral electrodes.
26 . The patient treatment system of claim 23 , wherein the first set of lead electrodes includes a first amount of electrodes and the second set of lead electrodes includes a second amount of electrodes different than the first amount, and wherein the first set of lead electrodes and the second set of lead electrodes span an identical width.
27 . The patient treatment system of claim 23 , further comprising (i) first suture holes at the first region that are laterally outward of the first set of lead electrodes, and (ii) second suture holes at the second region that are laterally outward of the second set of lead electrodes.
28 . The patient treatment system of claim 23 , wherein the base electrode is a first base electrode and the neuromodulator further comprises (i) a second base electrode within the housing, and wherein the operations further comprise sensing, via a vector including the first base electrode and the second base electrode, a signal associated with a cardiac depolarization event.
29 . The patient treatment system of claim 23 , wherein the operations further comprise sensing, via a vector including the base electrode and one of the first set of lead electrodes, a signal associated with a cardiac depolarization event.
30 . The patient treatment system of claim 23 , further comprising:
a first electrical contact on the first region and electrically coupled to one of the first set of lead electrodes; and
a second electrical contact on the second region and electrically coupled to one of the second set of lead electrodes.
31 . The patient treatment system of claim 30 , wherein the first electrical contact is positioned closer to the intermediate region than the first set of lead electrodes and/or the second electrical contact is positioned closer to the intermediate region than the second set of lead electrodes.
32 . The patient treatment system of claim 23 , 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.
33 . The patient treatment system of claim 23 , wherein generating the neuromodulation pulses comprises generating the neuromodulation pulses such that a number of the neuromodulation pulses generated per cardiac cycle is approximately consistent.
34 . The patient treatment system of claim 23 , wherein the frequency of the neuromodulation pulses is inversely correlated to an R-R interval time of the patient.