System and method for diaphragm stimulation
First Claim
1. A system having an electrical stimulation device for treating a subject comprising:
- an electrode configured to be implanted and electrically coupled to tissue of a subject;
a sensing device adapted to measure a respiration of the subject during a respiration cycle;
a signal source coupled to the electrode configured to provide an electrical signal to tissue of the subject through the electrode wherein the electrical stimulation device is configured to electrically stimulate phrenic nerve or diaphragm tissue to cause a contraction of at least a portion of a diaphragm and,a control unit in communication with said signal source and sensing device,wherein the signal source is in communication with the sensing device and wherein the control unit is programmed to cause the signal source to generate a first stimulation signal correlated to a respiratory parameter of the subject and which is delivered by the signal source during spontaneous respiration by the subject at a level and a period effective to maintain contraction of the diaphragm to provide a therapeutically significant lung volume change and to modify negative intrapleural pressure around lungs of the subject during at least a portion of an exhalation period of the respiration cycle, said control unit is further programmed to compare sensed respiration parameters before and after delivery of said stimulation, and programmed to adjust a subsequent stimulation signal in amplitude and/or frequency if needed to cause a diaphragm movement.
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Accused Products
Abstract
A stimulation device is provided that stimulates breathing to manipulate blood gas concentrations such as SaO2 or PCO2 and thereby treat underlying causes of breathing disorders and heart failure progression. A programmable device is provided for setting diaphragm stimulation waveforms that adjust minute ventilation about a predetermined baseline value. Normal breathing of the subject is observed to establish a baseline reference minute ventilation, and the device is programmed to produce stimulation waveforms that may provide either a decrease or an increase in the patients minute ventilation. The minute ventilation of the subject may be decreased or increased from the baseline level by decreasing or increasing a parameter that changes minute ventilators.
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Citations
33 Claims
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1. A system having an electrical stimulation device for treating a subject comprising:
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an electrode configured to be implanted and electrically coupled to tissue of a subject; a sensing device adapted to measure a respiration of the subject during a respiration cycle; a signal source coupled to the electrode configured to provide an electrical signal to tissue of the subject through the electrode wherein the electrical stimulation device is configured to electrically stimulate phrenic nerve or diaphragm tissue to cause a contraction of at least a portion of a diaphragm and, a control unit in communication with said signal source and sensing device, wherein the signal source is in communication with the sensing device and wherein the control unit is programmed to cause the signal source to generate a first stimulation signal correlated to a respiratory parameter of the subject and which is delivered by the signal source during spontaneous respiration by the subject at a level and a period effective to maintain contraction of the diaphragm to provide a therapeutically significant lung volume change and to modify negative intrapleural pressure around lungs of the subject during at least a portion of an exhalation period of the respiration cycle, said control unit is further programmed to compare sensed respiration parameters before and after delivery of said stimulation, and programmed to adjust a subsequent stimulation signal in amplitude and/or frequency if needed to cause a diaphragm movement. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A method of treating a subject comprising the steps of:
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providing a device comprising a control unit, a stimulator having at least one implantable electrode capable of sensing respiratory parameters and delivering an electrical stimulation signal, and a signal source; determining a respiratory parameter of a respiratory cycle of the subject utilizing said device; modifying the respiratory parameter of the patient by electrically stimulating phrenic nerve or diaphragm tissue of the patient with a first stimulation signal comprising a burst or series of pulses delivered from the signal source via the electrode during spontaneous respiration by the subject to cause contraction of at least a portion of a diaphragm during at least a portion of exhalation at a level and a period effective to maintain contraction of the diaphragm and provide a modified negative intrapleural pressure and a therapeutically significant lung volume change; and determining whether or not the therapeutically significant lung volume change has occurred to determine whether or not a second adjusted stimulation signal is needed. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33)
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Specification