US 11,298,543 B2Granted

Responsive neurostimulation for the treatment of chronic cardiac dysfunction

AssigneesLivaNova USA, Inc., East Tennessee State University

InventorsImad Libbus, Badri Amurthur, Bruce H. KenKnight, Jeffrey L. Ardell

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Abstract

Systems and methods are provided for delivering neurostimulation therapies to patients for treating chronic heart failure. A neural fulcrum zone is identified and ongoing neurostimulation therapy is delivered within the neural fulcrum zone. The implanted stimulation device includes a physiological sensor for monitoring the patient's response to the neurostimulation therapy on an ambulatory basis over extended periods of time and a control system for adjusting stimulation parameters to maintain stimulation in the neural fulcrum zone based on detected changes in the physiological response to stimulation.

Claims20

Dependent claims

A neurostimulation system, comprising:

an electrode assembly;
and
a neurostimulator coupled to the electrode assembly, the neurostimulator comprising:
a control circuit;
and
a memory operably coupled to the control circuit and comprising instructions that, when executed by the control circuit, cause the control circuit to:
deliver a first plurality of stimulation signals having a first frequency to a patient via the electrode assembly;
detect a transition heart rate response corresponding to a neural fulcrum zone responsive to a first subset of the first plurality of stimulation signals, the transition heart rate response being between a heart rate associated with a tachycardia condition and a heart rate associated with a bradycardia condition;
detect that delivering the first subset of stimulation signals does not produce a predetermined level of change in the heart rate of the patient;
deliver a second plurality of stimulation signals having a second frequency to the patient via the electrode assembly, the second frequency being greater than the first frequency;
detect the transition heart rate response corresponding to the neural fulcrum zone responsive to a second subset of the second plurality of stimulation signals;
detect that delivering the second subset of stimulation signals does produce the predetermined level of change in the heart rate of the patient;
and
deliver the second subset of stimulation signals to the patient via the electrode assembly.

11 more elements

A method of operating a neurostimulator coupled to an electrode assembly, comprising:

delivering a first plurality of stimulation signals having a first frequency to a patient via the electrode assembly;
detecting a transition heart rat response corresponding to a neural fulcrum zone responsive to a first subset of the first plurality of stimulation signals, the transition heart rate response being between a heart rate associated with a tachycardia condition and a heart rate associated with a bradycardia condition;
detecting that delivering the first subset of stimulation signals does not produce a predetermined level of change in the heart rate of the patient;
delivering a second plurality of stimulation signals having a second frequency to the patient via the electrode assembly, the second frequency being greater than the first frequency;
detecting the transition heart rate response corresponding to the neural fulcrum zone responsive to a second subset of the second plurality of stimulation signals;
detecting that delivering the second subset of stimulation signals does produce the predetermined level of change in the heart rate of the patient;
and
delivering the second subset of stimulation signals to the patient via the electrode assembly.

5 more elements

A memory coupled to a processor and comprising instructions that, when executed by the processor, cause the processor to:

deliver a first plurality of stimulation signals having a first frequency to a patient via an electrode assembly;
detect a transition heart rate response corresponding to a neural fulcrum zone responsive to a first subset of the first plurality of stimulation signals, the transition heart rate response between a heart rate associated with a bradycardia condition;
detect that delivering the first subset of stimulation signals does not produce a predetermined level of change in the heart rate of the patient;
deliver a second plurality of stimulation signals having a second frequency to the patient via the electrode assembly, the second frequency being greater than the first frequency;
detect the transition heart rate response corresponding to the neural fulcrum zone responsive to the second subset of the second plurality of stimulation signals;
detect that delivering the second subset of stimulation signals does produce the predetermined level of change in the heart rate of the patient;
and
deliver the second subset of stimulation signals to the patient via the electrode assembly.

5 more elements

Dependencies are inferred from the claim text.

Facts

Application: 16/234,097Filed 27 Dec 2018 · continuation
Priority: 7 May 2014
Published: US 2019/0126045 A12 May 2019
Granted: 12 Apr 2022
Term ends: Not estimatedThe source records don’t support an estimate.

Classification8 codes

A61N 1/36114
Adapted for a particular treatment: cardiac control, e.g. by vagal stimulation
A61N 1/36053
Implantable neurostimulators for stimulating central or peripheral nerve system: adapted for vagal stimulation
A61N 1/36135
Control systems: using physiological parameters
A61N 1/36139
Using physiological parameters: with automatic adjustment

Family

Application14/271,714Parent of this continuation · filed 7 May 2014
Application14/861,390Parent of this continuation · filed 22 Sep 2015
Application15/267,922Parent of this continuation · filed 16 Sep 2016
Application15/805,062Parent of this continuation · filed 6 Nov 2017
US 2019/0126045 A1Pre-grant publication · published 2 May 2019
US 10,166,391 B2Parent of this continuation
US 9,808,626 B2Parent of this continuation
US 9,446,237 B2Parent of this continuation
US 9,272,143 B2Parent of this continuation
US 2015/0321001 A1Published application
US 2016/0008603 A1Published application
US 2017/0001012 A1Published application
US 2018/0117333 A1Published application
US 11,298,543 B2This patent

From the US filing history. Foreign family members aren’t listed.

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