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Publication Number
US-10413358-B2
Publication Date
2019-09-17
Expiration Date
Abstract
A catheter suitable for delivering an electric current to the body, in particular a catheter having electrodes that can be positioned independently of the main elongate shaft of the catheter. More particularly the catheters include a movable sleeve that incorporates the electrodes. A movable sleeve includes one or more electrodes and advances in the construction of the electrodes and related components is disclosed. Methods for positioning electrodes at a treatment site in the body for diagnostic or therapeutic applications, particularly electrical pharyngeal stimulation are also disclosed.
Core Innovation
The disclosed invention relates to a multi-functional catheter for delivering an electrical stimulus to a body to assist recovery from dysphagia. A pharyngeal stimulation catheter includes an elongate shaft having a position indicator and a sleeve incorporating one or more electrodes. The sleeve is sized to co-axially surround and be movable along the elongate shaft such that a correct position of the sleeve relative to the elongate shaft is indicated by the position indicator before the catheter is inserted into the body.
A releasable fastener fixes the correct position of the sleeve so the elongate shaft and the sleeve can be inserted while affixed together in the correct position into the body. In this arrangement, the elongate shaft is within a stomach of the body and the electrodes on the sleeve are located within a stimulation target region in an oropharynx. The elongate shaft is releasable from the sleeve and is selectively removable from the body without removal of the sleeve from the body.
The catheter separates electrode-based pharyngeal electrical stimulation from functions provided by an elongate shaft, such as an enteral nutrition function and diagnostic functions. The disclosures include electrical stimulation combined with pressure sensing associated with an upper oesophageal sphincter pressure zone and stimulation combined with pH sensing for stomach location confirmation. The stimulation functionality can be removed by selectively removing the stimulation sleeve while leaving the feeding tube in situ.
Claims Coverage
The document includes two independent claims: one directed to a pharyngeal stimulation catheter and one directed to a method of delivering an electrical stimulus to induce pharyngeal stimulation. The independent claims share a core structure of an elongate shaft with a position indicator and a movable, electrode-carrying co-axial sleeve that is fixed in a correct position prior to insertion to place electrodes within an oropharyngeal stimulation target, with electrical stimulation delivered through the electrodes.
Movable co-axial electrode sleeve on elongate shaft with position indicator
A sleeve incorporating one or more electrodes, sized to co-axially surround and be movable along the elongate shaft such that a correct position of the sleeve relative to the elongate shaft is indicated by the position indicator before the catheter is inserted into the body.
Releasable fastener fixing correct sleeve position for target placement
A releasable fastener which fixes the correct position of the sleeve such that the elongate shaft and the sleeve can be inserted while affixed together in the correct position into the body, allowing the elongate shaft to be within a stomach of the body and ensuring the one or more electrodes on the sleeve are located within a stimulation target region in an oropharynx of the body.
Selective removal of elongate shaft without removal of sleeve
The elongate shaft is releasable from the sleeve and selectively removable from the body without removal of the sleeve from the body.
Method of sliding, fixing, and delivering pharyngeal stimulation via electrodes
Sliding a sleeve comprising one or more electrodes over an elongate shaft having a position indicator, fixing the sleeve to the elongate shaft once in a correctly indicated position prior to inserting the catheter with the sleeve affixed to the elongate shaft into the body so the elongate shaft is within a stomach and the electrodes are within a stimulation target in an oropharynx, and delivering an electrical stimulus through the electrodes to induce the pharyngeal stimulation.
Across the independent claims, the inventive coverage centers on a movable, co-axial, electrode-carrying sleeve guided by a position indicator, releasable fixation to place electrodes within an oropharyngeal stimulation target while the shaft is in a stomach, releasable or selective removal of the shaft, and a corresponding method that slides, fixes, inserts, and delivers an electrical stimulus through the electrodes.
Stated Advantages
Assists recovery from dysphagia by delivering an electrical stimulus to induce pharyngeal stimulation.
Documented Applications
Pharyngeal electrical stimulation for assisting recovery from dysphagia.
Combining pharyngeal stimulation with pressure sensing associated with the upper oesophageal sphincter pressure zone.
Combining pharyngeal stimulation with pH sensing for stomach location confirmation.
Selective removal of stimulation functionality by removing the stimulation sleeve while leaving an elongate shaft, enabling separation of electrode-based stimulation from other elongate shaft functions such as enteral nutrition.
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