Tympanostomy tube and placement device
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.
1 . 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.
2 . The tympanostomy tube applicator as claimed in claim 1 , wherein the needle and the retainer are configured to move axially to cause radial release of the tube distal flange from the retainer.
3 . The tympanostomy tube applicator as claimed in claim 1 , wherein the distal flange of the tube comprises wings, and the retainer comprises recesses, the recesses configured for radially constraining said wings.
4 . The tympanostomy tube applicator of claim 2 , wherein the applicator comprises a stop surface configured to stop axial movement of the tube proximal flange, such that the retainer is configured to, during axial movement of the needle and retainer in the proximal direction squeeze the tube against the stop surface to cause the distal flange to release.
5 . The tympanostomy tube applicator as claimed in claim 4 , wherein the stop surface is on a sleeve into which the needle is inserted, and wherein the sleeve is configured to receive at least part of the retainer when the needle is retracted.
6 . The tympanostomy tube applicator as claimed in claim 1 , wherein the needle is arranged to move axially to cause release of the tube distal flange from the retainer, and wherein the applicator comprises a stop surface to stop axial movement of the tube proximal flange, such that the retainer squeezes the tube against the stop surface to cause the distal flange to release during axial movement of the needle in the proximal direction; and wherein the retainer is a single discrete component independent of the needle.
7 . The tympanostomy tube applicator as claimed in claim 1 , wherein the distal flange of the tube comprises one or more eyelets, and the retainer comprises one or more fingers configured to each engage one of the one or more eyelets on the tube distal flange, constraining the distal flange, thereby in the folded, pre-deployed configuration.
8 . The tympanostomy tube applicator as claimed in claim 1 , wherein the applicator is a cartridge for attachment to a handle with a mechanism for movement of said needle.
9 . The tympanostomy tube applicator as claimed in claim 1 , wherein the applicator further comprises an integral handle with a mechanism for movement of the needle.
10 . 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.
11 . The method of deploying a tympanostomy tube as claimed in claim 10 , wherein the needle is moved axially to release the distal flange.
12 . The method of deploying a tympanostomy tube as claimed in claim 10 , wherein the needle is moved axially to release the distal flange; and wherein the needle movement is in the proximal direction.
13 . The method of deploying a tympanostomy tube as claimed in claim 10 , wherein the needle is moved rotationally to release the distal flange.
14 . The method of deploying a tympanostomy tube as claimed in claim 10 , wherein the adhesive bond is broken during a needle withdrawal and/or the movement of the retainer.
15 . The method of deploying a tympanostomy tube as claimed in claim 10 , wherein the tube distal flange is retained in the folded configuration by mechanical engagement, and the tube distal flange includes parts which mechanically engage the retainer and distal flange retaining parts are sheared upon a retraction of the needle and/or the movement of the retainer.
16 . The method as claimed in claim 10 , wherein the tube distal flange is retained in the folded configuration by mechanical engagement, and the tube distal flange includes one or more eyelets which mechanically engage the retainer and are sheared upon a retraction of the needle and/or the movement of the retainer.
17 . The method of deploying a tympanostomy tube as claimed in claim 10 , wherein the tube distal flange further comprises a magnetic member, the retainer is comprised of a ferromagnetic metal, and magnetism between the magnetic member and the retainer constrains the distal flange in the folded configuration.
18 . The method of claim 16 , wherein the sheared portions of the distal flange are retracted into the retainer under the needle tip.