Enhanced systems, processes and apparatus for facilitating intranasal treatment of a patient and products thereby
Inventors
Eldredge, Stephen • Ericksen, Corey • O'Driscoll, Jeffrey • Pipkin, William
Assignees
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Publication Number
US-10166351-B2
Publication Date
2019-01-01
Expiration Date
Abstract
Systems are disclosed for facilitating intranasal treatment of a patient's sphenopalatine/pterygopalatine recess. Likewise the instant system is effective for addressing acute pain conditions, and is refined enough to be performed by physician's assistants, nurses, and other well-trained practitioners. Apparatus involved includes a sheath hub, a catheter hub, an arresting element, and an engagement element in embodiments. Engagement between the arresting element and the engagement element prevents rotation of the sheath hub with respect to the catheter hub.
Core Innovation
The invention is an apparatus facilitating intranasal treatment of a patient's sphenopalatine/pterygopalatine recess. The apparatus includes a sheath hub and a catheter hub configured for relative translation between an inserted position and an extended position, and the catheter hub carries an insertion portion having a lumen and a coupling portion with a treatment receiving port in fluid communication with the lumen.
The insertion end of the catheter has an intrinsic curvature specifically adapted to access the sphenopalatine/pterygopalatine recess between the patient's middle sinus turbinate and superior sinus turbinate for delivering a medication at a posterior of the sphenopalatine/pterygopalatine recess. The sheath straightens the intrinsic curvature of the catheter when the catheter hub is positioned in the extended position, and the sheath is structurally rigid enough to maintain the intrinsic curvature of the catheter in a straightened form until the insertion end exits from a distal end portion of the sheath.
The distal end portion of the sheath is tapered and rotationally symmetric such that the distal end slopes to a vertex, with the vertex aligning with a beginning of a curve of the tip of the insertion end to form a continuous transition when the catheter hub is positioned in the extended position. An arresting element and an engagement element cooperate to facilitate insertion and continuously engage as the catheter hub is received in the catheter hub receiving space and repositioned along a longitudinal axis of the sheath hub, and the engagement prevents rotation of the sheath hub with respect to the catheter hub.
The treatment receiving port communicates with the catheter lumen for pharmaceutical delivery or electrical stimulation.
Claims Coverage
The provided material includes one independent apparatus claim with multiple integrated inventive features.
Intranasal recess access via intrinsic-curvature catheter
An insertion end of the catheter has an intrinsic curvature specifically adapted to access the sphenopalatine/pterygopalatine recess between the patient's middle sinus turbinate and superior sinus turbinate for delivering a medication at a posterior of the sphenopalatine/pterygopalatine recess.
Sheath straightening and maintained curvature until catheter exit
The sheath straightens the intrinsic curvature of the catheter when the catheter hub is positioned in an extended position, and the sheath is structurally rigid enough to maintain the intrinsic curvature of the catheter in a straightened form until the insertion end of the catheter exits from a distal end portion of the sheath.
Continuous transition geometry at distal sheath vertex
The distal end portion of the sheath is tapered and rotationally symmetric such that the distal end slopes to a vertex, with the vertex aligning with a beginning of a curve of the tip of the insertion end to form a continuous transition when the catheter hub is positioned in the extended position.
Treatment receiving port in fluid communication with catheter lumen
The catheter hub carries a treatment receiving port in fluid communication with the lumen.
Arresting and engagement elements preventing rotation during translation
An arresting element and an engagement element cooperate to facilitate insertion and continuously engage as the catheter hub is received in the catheter hub receiving space and repositioned along a longitudinal axis of the sheath hub, and the engagement prevents rotation of the sheath hub with respect to the catheter hub.
The inventive concept centers on intranasal delivery to the sphenopalatine/pterygopalatine recess using a hub-based sheath/catheter system in which the sheath straightens an intrinsic-curvature catheter and provides a continuous transition at the sheath vertex, while arresting and engagement elements continuously prevent rotation during hub translation, with delivery via a treatment receiving port in fluid communication with the catheter lumen.
Stated Advantages
Improved tolerability and headache improvement/resolution reported in prototype clinical outcomes.
Low reported adverse-event burden in the prototype clinical outcomes.
Documented Applications
Intranasal treatment targeting the sphenopalatine/pterygopalatine recess/ganglia for acute pain, including headaches.
Prototype clinical use reporting tolerability and headache improvement/resolution.
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