Tympanostomy tube and placement device
AssigneeKarl Storz GmbH & Co. KG
InventorsJohn Vaughan, Olive O'Driscoll, Carol Grimes
Life of this patent
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Abstract
A tympanostomy tube placement device has a needle with a tip, and a retainer at the needle tip. The retainer is within and retains by pulling radially inwardly a tympanostomy tube distal flange in a folded configuration extending distally. Movement of the needle tip in the proximal direction causes the adhesive bond to break and the distal flange releases to an unconstrained deployed position. Due to the axial folding of the distal flange its radial dimension does not affect deployment through the membrane.
Claims18
A tympanostomy tube applicator comprising:
- a needle with a tip and a stem, and a stem flange on the stem, a retainer positioned coaxially around the needle stem, between the tip and the stem flange, the retainer comprising an axial through-hole, and a tympanostomy tube mounted on the retainer and coaxial therewith, the tube comprising a proximal flange, a bridge with a lumen, and a distal flange, with the needle stem extending coaxially through the lumen of the tube and the through-hole of the retainer, wherein at least part of the retainer is configured to fit within the lumen of the tympanostomy tube, and the retainer is configured to radially constrain the tympanostomy tube distal flange in a folded configuration, the folded configuration having a direction with a primarily axial component such that movement of the needle tip causes the distal flange to release from the retainer to a deployed position having a direction with a primarily radial component, the applicator further comprising an adhesive connecting the distal flange to the retainer, thereby radially constraining the tube distal flange in the folded, pre-deployed configuration.
A method of deploying a tympanostomy tube across a tympanic membrane, in which:
- the tube comprises a proximal flange, a bridge, a distal flange, and a lumen, the method is performed with an applicator comprising a needle with a stem, a stem flange, and a tip, and a retainer with an axial through hole mounted around the needle stem, between the tip and the stem flange;
- the tube is mounted on the retainer with the needle stem through the tube lumen and through the retainer through-hole, and the tube distal flange is radially constrained in a folded configuration by the retainer to have a primarily axial component facing distally;
- and in which the method comprises steps of piercing the tympanic membrane with the needle tip and locating the needle so that the tube distal flange is distal of the membrane and the tube bridge passes through the membrane, moving the retainer relative to the tube to cause separation of the tube distal flange from the retainer, freeing the distal flange to spring out in an unconstrained radial orientation, wherein the tube distal flange is adhered to the retainer with an adhesive, creating, thereby, an adhesive bond between the distal flange and the retainer.
Dependencies are inferred from the claim text.