Devices for and methods of diagnosis and/or monitoring dysphagia
Inventors
Assignees
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Publication Number
US-10743810-B2
Publication Date
2020-08-18
Expiration Date
Abstract
The use of a device to measure patient sensory response through the application of an incrementally increased electrical current to the oropharynx.
Core Innovation
The invention relates to determining whether a patient is suffering from dysphagia and monitoring a patient's recovery from dysphagia using pharyngeal electrical stimulation. A variable electrical current is applied to a patient's oropharynx via at least one electrode mounted on or about an elongate catheter body inserted into a patient by oral or nasal insertion. The device records a patient's sensory response to the applied electrical stimulation and uses the recorded sensory response to make a dysphagia determination or to monitor recovery.
The control unit includes an electrical current generator, a non-volatile memory for storing patient sensory response data and control sensory response data, a recorder for recording the patient's sensory response, and a processor for comparing the patient's sensory response to a control sensory response stored in the non-volatile memory. The comparison is used to determine whether the patient is suffering from dysphagia or to monitor a patient's recovery from dysphagia, with the control sensory response data representing healthy range, dysphagia range, or patient-specific historical/control curves.
In described implementations, the catheter can include a nasal gastrointestinal feeding tube with an electrode mounted on a sleeve that is selectively movable relative to the feeding tube. The invention is further supported by evaluation in tracheotomy patients in which pharyngeal electrical stimulation was compared to sham, showing changes in the sensory threshold over treatment that correlate with swallowing recovery in the treatment arm and not in the control arm.
Claims Coverage
The document includes two independent claims: one directed to determining whether a patient is suffering from dysphagia and one directed to monitoring a patient's recovery from dysphagia. Across both independent claims, the inventive content is centered on a variable-current catheter electrode delivering electrical stimulation to the oropharynx, recording a patient sensory response, and comparing it to stored control sensory response data using a processor with non-volatile memory.
Oropharynx electrical stimulation using an orally or nasally inserted catheter with variable electrical current
A catheter for oral or nasal insertion including an elongate body with at least one electrode mounted on or about the elongate body, where the at least one electrode receives a variable electrical current to apply electrical stimulation to the patient's oropharynx.
Recording patient sensory response and comparing to stored control sensory response data
A control unit comprising an electrical current generator, non-volatile memory storing patient sensory response data and control sensory response data, a recorder configured to record the patient's sensory response to the applied electrical stimulation, and a processor comparing the patient's sensory response to a control sensory response stored in the non-volatile memory to determine whether the patient is suffering from dysphagia or to monitor recovery.
Monitoring recovery from dysphagia by comparing recorded sensory response to control data
Monitoring a patient's recovery from dysphagia by recording the patient's sensory response to oropharynx stimulation delivered by the catheter and comparing the recorded sensory response to control sensory response stored in the non-volatile memory.
Nasally implemented catheter with electrode on selectively movable sleeve relative to feeding tube
A catheter implementation in which the catheter comprises a nasal gastrointestinal feeding tube, and the at least one electrode is mounted on a sleeve that is selectively movable relative to the feeding tube.
Collectively, the independent claims require catheter-based variable electrical stimulation to the oropharynx, recording of patient sensory response, and processor-based comparison against stored control sensory response data in non-volatile memory, with one claim determining dysphagia and another monitoring recovery. Dependent refinement specifies a nasal gastrointestinal feeding tube with an electrode mounted on a selectively movable sleeve.
Stated Advantages
Enables determining whether a patient is suffering from dysphagia.
Enables monitoring a patient's recovery from dysphagia.
Documented Applications
Used in tracheotomy patients in a randomized controlled trial comparing pharyngeal electrical stimulation to sham, with sensory threshold changes over treatment correlating with swallowing recovery in the treatment arm.
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