Dysphagia recovery by electrical stimulation

Inventors

Hamdy, Shaheen

Assignees

University of ManchesterPhagenesis Ltd

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Publication Number

US-8092433-B2

Patent

Publication Date

2012-01-10

Expiration Date


Abstract

A device for assisting recovery from dysphagia, and a method of preventing and/or treating dysphagia. The device includes a catheter suitable for insertion into the body of a patient, for the introduction of nutrients to the stomach of said patient, and electrodes located on a surface of the catheter, the electrodes being positioned such that when the catheter is inserted into a patient the electrodes are in a suitable position for applying electrical pharyngeal stimulation.

Core Innovation

The invention relates to a therapeutic device and method for assisting recovery from dysphagia by treatment at periodic predetermined intervals with electrical pharyngeal stimulation to stimulate the swallow centers. A catheter suitable for insertion through the nose or mouth includes a tube having an aperture located proximate to a distal end for the introduction of nutrients to the stomach of the patient. The catheter carries a single pair of electrodes positioned on a surface of the catheter so that, when the distal end is positioned in the stomach, the electrodes are positioned for applying electrical pharyngeal stimulation to an intra-luminal surface of the patient’s pharynx.

A key aspect is confirming that the electrodes are in good electrical contact with, and suitable for applying electrical pharyngeal stimulation to, the intra-luminal surface of the patient’s pharynx. The device includes an impedance measuring unit for determining electrode contact, and an indicator in the form of a visible marker configured to provide operator confirmation that the electrodes are in a suitable position with respect to the intra-luminal surface prior to applying electrical pharyngeal stimulation.

The disclosed system can further include additional stimulation modalities and control features, including applying a second swallowing stimulus at periodic predetermined intervals and using a stimulator arranged to apply transcranial magnetic stimulation. The catheter can also include a catheter position indicator comprising a physical mark on an external surface. In addition, the document describes providing intra-luminal active agent delivery using a dissolvable coating on at least a portion of a surface of the catheter, with release of chemical agents such as quinine hydrochloride or citric acid.

Claims Coverage

The partial content includes two independent claims covering a therapeutic device and an associated method. Across these independent claims, the main inventive features are electrode-in-pharynx electrical stimulation synchronized to periodic predetermined intervals, catheter insertion with nutrient introduction, confirmation of electrode-to-pharyngeal contact using impedance measurement, and operator confirmation of suitable electrode positioning using an indicator.

Catheter with nutrient introduction aperture and intra-luminal pharyngeal electrode positioning

A catheter suitable for insertion through the nose or mouth of a patient, including a tube having an aperture located proximate to a distal end for the introduction of nutrients to the stomach, where a single pair of electrodes on the catheter surface are positioned so that, when the distal end is positioned in the stomach, the electrodes are in a suitable position for applying electrical pharyngeal stimulation to an intra-luminal surface of the patient’s pharynx.

Impedance-based determination of electrode-to-pharyngeal mucosa contact

An impedance measuring unit for determining when the electrodes are in good electrical contact with, and suitable for applying electrical pharyngeal stimulation to, the intra-luminal surface of the patient’s pharynx; and confirming desired contact before applying electrical pharyngeal stimulation.

Operator confirmation of suitable electrode positioning using a visible marker

An indicator in the form of a visible marker configured to provide an operator with confirmation that the single pair of electrodes is in a suitable position with respect to the intra-luminal surface of the patient’s pharynx prior to applying electrical pharyngeal stimulation.

Catheter position indicator using a physical external mark and confirmation before stimulation

A method where inserting a catheter through the nose or mouth includes a catheter position indicator comprising a physical mark on an external surface to indicate that the catheter is located in a predetermined position wherein the electrodes are in contact with pharyngeal mucosa and the distal end is in the patient’s stomach; applying electrical pulses capable of inducing pharyngeal stimulation to the single pair of electrodes, while using an impedance measuring device to determine physical contact and confirming desired contact prior to applying electrical pharyngeal stimulation.

Together, the independent claims require an intra-luminal catheter with electrodes positioned for pharyngeal stimulation during dysphagia recovery, confirmation of electrode contact with pharyngeal mucosa using impedance measurement, and operator confirmation of suitable electrode positioning using an indicator or physical external mark before applying stimulation.

Stated Advantages

Assists recovery from dysphagia by treatment at periodic predetermined intervals with electrical pharyngeal stimulation to stimulate the swallow centers.

Documented Applications

Therapeutic assistance for recovery from dysphagia using electrical pharyngeal stimulation delivered via a catheter with electrodes positioned in the pharynx while nutrients are introduced to the stomach.

Taste-mediated rehabilitation of swallowing pathways using chemical delivery of aversive taste (e.g., quinine hydrochloride) to enhance cortico-pharyngeal responses described in the experimental support.

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