Methods and devices for intramuscular stimulation of upper airway and swallowing muscle groups

A method of moving the hyoid bone, and/or parts of the upper airway within an animal by two or more different controlled muscles, comprising:

• a) implanting at least one electrode into each of two or more different muscles, wherein one of the muscles is the thyrohyoid and the other muscle of the two or more different muscles is a hyoid muscle;
• b) electrically connecting each electrode to an indwelling subcutaneous signal generator capable of generating a pattern of stimulation;
• and
• c) energizing the controlled muscles at the same time with a signal of about 10 to 75 Hz by the signal generator to synergistically move the parts of the upper airway, or hyoid bone.

A method of simultaneously moving the hyoid bone and larynx and opening the upper esophageal sphincter within an human via at least one muscle attached to the hyoid bone, comprising:

• implanting at least one electrode into each of two or more said muscles;
• electrically connecting each electrode to a signal generator capable of generating a complex pattern to activate the muscle attached to the electrode;
• and
• energizing electrodes in at least two of the muscles at the same time at a frequency of 10 to 75 Hz with the signal generator, thereby synergistically moving the hyoid bone and/or opening the upper esophageal sphincter.

A method of compensating for variations in electrode placement when stimulating two or more muscles to effect a coordinated bone, sphincter, structure, tissue or cartilage movement in the hypopharynx, or upper airway movement, comprising:

• a) implanting a first electrode in a thyrohyoid muscle;
• b) implanting a second electrode in at least one hyoid muscle;
• c) stimulating the first electrode and determining the effect of stimulation on movement of the bone, sphincter, tissue, structure or cartilage;
• d) stimulating the second electrode implanted in the tissue and determining the effect of stimulation on movement of the bone, sphincter, tissue, structure or cartilage;
• and comparing the effects from c) and d) to determine an optimum coordination of signals to the first and second electrodes to obtain a desired direction and strength of the bone, sphincter, tissue, structure or cartilage movement.

A system for coordinating the onset and offset of two or more different electrical signals to electrodes implanted in tissue used to coordinately control a bone, sphincter, tissue, structure or cartilage movement in the hypopharynx, or upper airway to protect the airway, the system comprising:

• a controller with a stored program that directs a signal generator to send electrical pulses to each of at least two electrodes in a determined pattern, wherein the determined pattern of electrical pulses coordinates the onset and offset of two or more different electrical signals to the at least two electrodes to protect the airway, each signal sent to a different electrode implanted in the tissue,
• the implantable signal generator comprising a processor, wherein the processor is configured to deliver an electrical signal to each of the electrodes at overlapping time periods that are selected to induce muscle contractions in the different muscles at overlapping or identical times,
• at least two intramuscular electrodes suitable for implantation in a muscle in the hypopharynx, or upper airway,
• a switch located external to the body and configured to be activated by a human, wherein the switch is configured to communicate to the signal generator upon activation by the human, and
• a sensor device;
• wherein the controller under the direction of the stored program directs the signal generator to coordinate the onset and offset of two or more different electrical signals to activate each of the intra-muscular electrodes to move the bone, sphincter, tissue, structure or cartilage to protect the airway.

A system for moving a cartilage within a subject comprising:

• an implantable signal generator comprising a power source and a processor;
• a first electrode implantable in a first hyo-laryngeal muscle attached to the cartilage and operably connected to the signal generator;
• a second electrode implantable in a second different hyo-laryngeal muscle attached to the same cartilage and operably connected to the signal generator;
• and
• a switch located external to the body and configured to be activated by the subject, wherein the switch is configured to communicate to the signal generator upon activation by the subject;
• wherein the processor is configured to generate a signal of about 10 to 75 Hz to each of the first and second electrodes at the same time and to effect a swallow elevation and laryngeal movement velocity in the cartilage that exceeds swallow elevation and laryngeal movement velocity made by pulses sent to the muscles at separate times.

A system for control of stimulation during swallowing of a human with dysphagia comprising:

• at least two intra-muscular electrodes;
• an implantable signal generator connected to the at least two electrodes and that comprises a processor configured to control the output energy to the electrodes according to a determined pattern,
• a controller with a stored program that directs the signal generator to send electrical pulses to each of the at least two electrodes in the determined pattern, wherein the determined pattern of electrical pulses comprises a frequency of about 10 to 75 Hz and moves at least two different muscles that control hyoid bone movement so that the hyoid bone moves up at least 80% of the elevation of a normal swallow, and;
• a power supply that provides energy for the signal generator;
• a sensor configured to detect physiological movement;
• and
• a switch operable by the human that controls the signal generator, wherein the operation of the switch by the human activates the controller to direct the signal generator to send electrical pulses to each of the at least two electrodes in the determined pattern.