US 12,138,436 B2
Intratympanic injector devices and needles for delivery of drugs and methods of use
Kevin W. Sacherman, Brisbane, CA (US); Andrew Ayoob, Brisbane, CA (US); Signe Erickson, Brisbane, CA (US); Hugo Peris, Brisbane, CA (US); Charles Limb, Brisbane, CA (US); and Eugene De Juan, Jr., Brisbane, CA (US)
Assigned to Spiral Therapeutics Inc., South San Francisco, CA (US)
Appl. No. 17/433,401
Filed by Spiral Therapeutics, Inc., Brisbane, CA (US)
PCT Filed Feb. 24, 2020, PCT No. PCT/US2020/019517
§ 371(c)(1), (2) Date Aug. 24, 2021,
PCT Pub. No. WO2020/176419, PCT Pub. Date Sep. 3, 2020.
Claims priority of provisional application 62/810,162, filed on Feb. 25, 2019.
Prior Publication US 2022/0126028 A1, Apr. 28, 2022
Int. Cl. A61M 5/46 (2006.01); A61B 1/227 (2006.01); A61M 5/32 (2006.01)
CPC A61M 5/46 (2013.01) [A61B 1/227 (2013.01); A61M 5/3287 (2013.01); A61M 2210/0668 (2013.01)] 12 Claims
OG exemplary drawing
 
1. A system for delivering one or more therapeutics to a region of an ear, the region being internal to a tympanic membrane, the system comprising:
a canal guide configured to be inserted within and fittingly engaged with walls of an ear canal, the canal guide comprising:
a viewing lumen extending between a proximal end of the canal guide to a distal-most end of the canal guide, the distal-most end of the canal guide sized to remain external to the tympanic membrane; and
a guide lumen extending from a proximal opening near the proximal end of the canal guide to a distal opening near the distal-most end of the canal guide, wherein the guide lumen curves from a first axis to a second axis, the first axis extending through the proximal opening and the second axis extending through the distal opening;
a housing having a handle portion extending downwardly away from the canal guide, wherein the guide lumen of the canal guide is eccentric relative to a longitudinal axis of the canal guide, wherein the canal guide is adjustably attached to the housing such that the position of the guide lumen relative to the housing is adjusted by rotation, and wherein the guide lumen of the canal guide is adjustable around the longitudinal axis as the canal guide is rotated; and
a needle assembly comprising a flexible shaft sized to extend through the guide lumen of the canal guide, the flexible shaft defining a fluid delivery lumen,
wherein the canal guide provides alignment of the needle assembly within the ear canal relative to the tympanic membrane.