Synapse Biomedical, Inc.

University Hospitals of Cleveland

Raymond P Onders

Anthony R Ignagni

James E Gelbke

Timothy J Crish

J Thomas Mortimer

Described herein are methods of detecting the presence or progression of neuromuscular disorders (including ALS) based at least in part on diaphragm EMG signals taken at different points in time from the same implanted electrode(s). Signals may be used to diagnose or to monitor progression of a disorder or to track a treatment. Thus, diaphragm EMG signal may be used as a marker (e.g., a 'biomarker') for the detection or progression of a neurological disorder such as ALS. The characteristics or parameters of diaphragm EMG signals may be used to create an activity index, which may be output or compared and further analyzed. These signals may also be analyzed to show a difference between the left and right sides of the diaphragm.

Devices and methods for assessing motor point electromyogram as a biomarker

Described herein are methods and systems for improving or adapting a breathing pattern of a patient with disordered breathing toward a more helpful state, as well as systems and devices for adapting breathing. These methods and systems may be used for improving sleep in patients with sleep disordered breathing and a system by which to implement devices for performing these methods.

Device and method of neuromodulation to effect a functionally restorative adaption of the neuromuscular system

An implantable medical electrode system for intramuscular use that is readily removable is provided, as well as methods for its use. The system includes an electrode, an electrical lead mechanically and electrically connected to the electrode and extending proximally, and a tether bonded to the electrode and extending proximally. A conductor with an insulated portion enwraps the electrical lead; an uninsulated portion enwraps the electrode. Some embodiments may include a tissue-piercing guide such as a needle. In some embodiments, the electrode includes a barb, although in some of these embodiments the tether does not extend through the barb. The method of using the system includes inserting the through a target tissue, pulling the electrode with the needle into the target tissue, and extending the electrical lead and tether proximally to an electrical connection. Methods are further provided for removing the electrode which take advantage of structural features of the system.

Removable intramuscular electrode

A method of placing an electrode in a peritoneal cavity including the following steps: inserting an endoscope through a patient's mouth into the patient's stomach; passing the endoscope through an opening in the stomach into the peritoneal cavity; and using the endoscope to place the electrode in contact with tissue within the peritoneal cavity other than stomach tissue. Another aspect of the invention provides a method of electrically mapping tissue accessed from a peritoneal cavity including the following steps: inserting an endoscope through a patient's mouth into the patient's stomach; passing the endoscope through an opening in the stomach into the peritoneal cavity; passing an electrode through the endoscope; placing the electrode in contact with tissue within the peritoneal cavity other than stomach tissue; and applying a mapping stimulation signal to the electrode from a mapping stimulator.

Method and apparatus for transgastric neurostimulation

A method of conditioning a diaphragm of a patient is provided. The method can include the steps of implanting an electrode adjacent a target site in the diaphragm of the patient and operating the electrode to deliver a sufficient amount of electrical stimulation to the target site in the diaphragm of the patient to cause the diaphragm to contract.

System and method for conditioning a diaphragm of a patient

Systems and methods are provided to improve respiratory function. Systems include an external electrical stimulator coupled to electrodes that stimulates diaphragm contraction and may optionally include a positive pressure mechanical ventilator. The system further includes an electrode suitable for temporary implantation. Electrical stimulation is provided to specific portions of the diaphragm, such as one hemidiaphragm preferentially over another. By preferentially contracting one hemidiaphragm, a specific portion of a lung may be expanded, such as a posterior portion. By the provision of the negative intrathoracic pressure from diaphragm contraction, greater expansion of specific portion of lung is achieved in relationship to air pressure within the lung, thereby improving compliance. Supplementation of stimulated diaphragm contraction with positive pressure driven air flow from a PPMV directs the air flow to specific portions of the lung. Such portion may include a posterior portion of a lung, and may cause a clearing of atelectasis in that portion.

Ventilatory assist system and methods to improve respiratory function

A diaphragm pacing stimulatory method and a system to implement the method are provided to improve respiratory function and the quality of sleep in patients whose sleep is compromised by poor respiration. The diaphragm pacing method includes adaptations that make it particularly compatible with the onset of sleep and sustaining sleep. Embodiments of the method are operated independently of breathing effort the patient may make during sleep. Patients for whom the invention is appropriate include those with a neuromuscular disease, such as amyotrophic lateral sclerosis (ALS). System elements include an external electrical stimulator coupled to one or more implanted electrodes that stimulate diaphragm contraction. The system and method provide for a pacing of the diaphragm, improved breathing, and improved sleep. Features of improved sleep include longer sleep time, an increased amount of REM sleep, and fewer episodes of wakefulness and restlessness.

Method of improving sleep disordered breathing

An apparatus for use with a cannula includes a rigid rod which is receivable and movable in the cannula throughout a range of operative positions in which inner and outer end portions of the rod extend longitudinally outward from the inner and outer ends of the cannula. The apparatus further includes a contact electrode which is configured to be supported on the inner end portion of the rigid rod for movement with the rigid rod through the cannula.

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Shaker Heights, OH, United States of America

Raymond P Onders