Implantable microstimulation system for treatment of sleep apnea
First Claim
1. A method of treating sleep apnea comprising:
- implanting at least one microstimulator at a selected tissue site near a muscle or nerve associated with closing and opening an airway passage, the microstimulator including a pair of electrodes, hermetically sealed electrical circuitry connected to the pair of electrodes, and means for generating an electrical stimulus and applying said stimulus to the pair of electrodes, and wherein the microstimulator is housed within a tubular housing having a form factor of 0.4 or less, where form factor is defined as the diameter of the housing over its length, and wherein the diameter of the microstimulator housing is no greater than 4 mm;
selectively controlling the microstimulator to generate an electrical stimulus; and
applying the electrical stimulus to the muscle or nerve at the selected tissue site for the purpose of eliciting a muscle contraction that opens the airway passage.
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Accused Products
Abstract
One or more implantable microminiature electronic devices, termed “microstimulators”, are used to treat sleep apnea. The microstimulators are implanted at strategic locations within the patient and are then controlled in a manner so as to stimulate muscle and nerve tissue in a constructive manner which helps open blocked airways. In one embodiment, the microstimulators sense blockage of a patient'"'"'s airway and provide electrical stimuli in a closed loop fashion to open the airway. In another embodiment, at least one microstimulator treats sleep apnea in an open loop fashion by providing electrical stimulation pulses in a rhythm or cycle having a period corresponding approximately to the natural respiratory rhythm of the patient. Such open loop stimulation entrains the patient'"'"'s respiratory rate to follow the pattern set by the microstimulator so that stimulation is applied to open the airway during a period of inspiration by the patient. The microstimulator devices receive power and programming (control) signals by inductive or RF coupling from an external transmitter, either during actual use by the sleeping patient or during recharging periods in the awake patient.
761 Citations
13 Claims
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1. A method of treating sleep apnea comprising:
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implanting at least one microstimulator at a selected tissue site near a muscle or nerve associated with closing and opening an airway passage, the microstimulator including a pair of electrodes, hermetically sealed electrical circuitry connected to the pair of electrodes, and means for generating an electrical stimulus and applying said stimulus to the pair of electrodes, and wherein the microstimulator is housed within a tubular housing having a form factor of 0.4 or less, where form factor is defined as the diameter of the housing over its length, and wherein the diameter of the microstimulator housing is no greater than 4 mm;
selectively controlling the microstimulator to generate an electrical stimulus; and
applying the electrical stimulus to the muscle or nerve at the selected tissue site for the purpose of eliciting a muscle contraction that opens the airway passage. - View Dependent Claims (2, 3, 4, 5)
implanting at least two microstimulators at a selected target site near an airway passage, each microstimulator including telemetry means for generating a signal indicative of a sensed condition, and at least one of the two microstimulators including means for generating an electrical stimulation pulse; sensing obstruction of the airway passage by sensing relative motion between the at least two microstimulators; and
applying the electrical stimulus in response to sensing no motion between the at least two microstimulators for a predetermined time period.
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3. The method of claim 1 wherein the step of selectively controlling the microstimulator comprises coupling a modulated ac signal into the microstimulator, the ac signal providing power for operation of the microstimulator, and the modulation of the ac signal providing control information that controls the microstimulator to produce a desired sequence of electrical stimuli.
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4. The method of claim 1 wherein the step of implanting at least one microstimulator comprises non-invasively implanting the at least one microstimulator through the lumen of a needle or laparoscopic instrument deep into the target tissue.
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5. The method of claim 1 wherein each microstimulator includes a rechargeable battery for providing operating power for the microstimulator, and wherein the step of selectively controlling the microstimulator comprises regularly recharging the rechargeable battery by inductively coupling charging power into the microstimulator from an external coil (26), and modulating the charging power with control information that selectively programs the microstimulator to operate in a prescribed manner.
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6. A method of treating sleep apnea comprising:
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(a) identifying an airway passage that is blocked;
(b) non-invasively implanting a microstimulator into target muscle tissue that controls the opening and closure of the airway passage identified in step (a);
(c) sensing when the airway passage is obstructed; and
(d) in response to sensing an obstructed airway in step (c), stimulating the target muscle tissue with electrical stimuli generated by the implanted microstimulator. - View Dependent Claims (7, 8)
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9. A minimally-invasive system for treatment of sleep apnea comprising:
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at least one leadless injectable microstimulator injectable to be positioned adjacent muscle tissue that at least partially controls the opening and closing of an oropharyngeal airway during sleep;
means for controlling the at least one leadless injectable microstimulator to stimulate the muscle tissue associated with the oropharyngeal airway in accordance with a regular, open-loop, pattern whose period corresponds approximately to the natural respiratory rhythm of a patient, wherein the patient'"'"'s respiratory rate is entrained to follow the pattern set by the microstimulator so that stimulation is applied to open the oropharyngeal airway during a period of inspiration by the patient. - View Dependent Claims (10, 11, 12, 13)
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Specification