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EP-4512351-B1 - A PLACEMENT DEVICE

EP4512351B1EP 4512351 B1EP4512351 B1EP 4512351B1EP-4512351-B1

Inventors

  • VAUGHAN, JOHN
  • O'DRISCOLL, OLIVE
  • Grimes, Carol

Dates

Publication Date
20260513
Application Date
20181102

Claims (15)

  1. A tympanostomy tube (1) comprising: a proximal flange (4, 504), an inter-flange connector (2, 502) with a lumen (3, 503), and a distal flange (6, 506), wherein the distal flange (6, 506) is more flexible than the proximal flange (4, 504) wherein the proximal flange comprises a plurality of axial through hole passageways (10, 510), and characterized in that , the distal flange (6, 506) is configured to be folded axially to a deployment position and to release radially to a deployed position, and in that each passageway has an arcuate shape with an outer concave surface (13, 513) facing radially inwardly.
  2. A tympanostomy tube as claimed in claim 1, wherein at least one passageway (10, 510) has a radially inner surface which is adjacent an external surface of the inter-flange connector.
  3. A tympanostomy tube as claimed in either of claims 1 or 2, wherein there is at least one pair of diametrically opposed passageways (10, 510).
  4. A tympanostomy tube as claimed in any of claims 1 to 3, wherein the proximal flange (4, 504) is of a first material and the distal flange (6, 506) is of a second material, and said first material is more rigid than the second material.
  5. A tympanostomy tube as claimed in any of claims 1 to 4, wherein the distal flange (506) comprises a plurality of tabs (515) at least one of which has a radial part (516) extending in a direction which has a primarily radial component and a guide part (517) extending in a direction which has a primarily axial component when the tube is relaxed, and the guide part is arranged to form a tapered configuration narrowing in the distal direction when the distal flange is pressed radially inwardly.
  6. A tympanostomy tube placement device (100, 600) comprising: a stem (107, 607) connected to a deployment mechanism or having a coupler for connection to a deployment mechanism; a needle (104, 604) having a tip (106, 606) configured to pierce a tympanic membrane, the needle having a longitudinal axis; and a retainer (120, 620) comprising a plurality of fingers (121, 621) extending axially at a distance from said longitudinal axis; a tympanostomy tube as claimed in any preceding claim, wherein in a pre-deployment position the retainer fingers (121, 621) extend through the proximal flange passageways and press the tube distal flange (6, 15, 515) inwardly, and the retainer (120, 620) is movable from a pre-deployment distal position at which it is adapted to press radially inwardly against the tube distal flange to retain said distal flange in a folded position, to a deployment proximal position at which the tube distal flange is free to spring out radially to a deployed position.
  7. A placement device as claimed in claim 6, further comprising a handle connected to the stem.
  8. A placement device as claimed in claim 7, wherein the stem is rotatable with respect to the handle, and the device further comprises a user actuator (404) for rotation of the stem, wherein the needle is lockable (125, 127) in the stem so that it rotates with the stem.
  9. A placement device as claimed in any of claims 6 to 8, wherein the stem is cranked (107, 401, 680) or bent along its length.
  10. A placement device as claimed in claim 9, wherein the tube distal flange (6, 506) comprises a plurality of tabs (15, 515) aligned in circumferential position with a retainer finger (121, 621) and being pressed inwardly by said finger in the pre-deployed position.
  11. A placement device as claimed in claim 10, wherein the tabs are substantially equally circumferentially spaced.
  12. A placement device as claimed in any of claims 6 to 11, wherein the retainer or the needle comprise an axial guide member (130, 630) configured to fit in the lumen (3, 503) of the tube pre-deployment.
  13. A placement device as claimed in any of claims 6 to 12, wherein the needle (604) comprises a recess (650) proximally of the tip (606) and configured to receive a folded-down part (517) of a tab of a tube distal flange (515).
  14. A placement device as claimed in claim 13, wherein the recess (650) is annular.
  15. A placement device as claimed in claims 13 or 14, wherein the needle and the tube distal flange tabs are configured to form an arrow shaped formation when the distal flange is folded down.

Description

INTRODUCTION Field of the Invention The invention relates to tympanostomy tubes and placement devices. Prior Art Discussion When patients are treated surgically for conditions in the ear, for example Otitis Media, they are typically treated by a tympanostomy tube being placed for ventilation. A tympanostomy tube is a small tube which is placed in the tympanic membrane (or "ear drum") manually by a surgeon, typically under general anaesthetic in an operating theatre. The surgeon cleans wax from the ear canal, makes a small incision in the tympanic membrane, uses suction to remove any fluid in the middle ear, and then positions the tube in the tympanic membrane. The tube equalizes the pressure between the middle and outer ear and ventilates the middle ear space. Tympanostomy tube placement is the most common reason why children undergo surgery with a general anaesthetic. At present, when it is desired to place a tympanostomy tube, it is typically done manually because the inner flange needs to be particularly wide to stay in the tympanic membrane for an extended period of time. The tympanostomy tube sometimes requires a lead-in feature on the inner flange of the tube to aid insertion of the manual placement using current ENT instrumentation. A placement device allows tympanostomy tubes to be placed safely and quickly in a clinical setting, allowing tubes to be placed without the need for general anaesthesia in all patients. WO2013/155169 (Acclarent) and US4744792 (Richards Medical Co.) describe tympanostomy tubes. WO2011/008948 (Acclarent) describes a tympanostomy tube and a placement device wherein the tip creates an incision in the tympanic membrane and ejects a tympanostomy tube into the membrane. A tympanostomy tube is restrained by sleeves surrounding it so that its flanges lie axially. The sleeves are withdrawn during deployment to allow the flanges to un-fold to the radial position. WO2013/113022 (Entra Tympanic LLC) describes a placement and removal device which has vacuum channels to immobilize the membrane during the tube placement. In this case the tube's flanges are not folded, the tube retaining the same physical configuration throughout. The invention is directed towards providing a placement device for effective deployment of a tube, especially a tube having a wide distal flange for a long dwell time or "time to extrusion". The time to extrusion is dependent on the clinical requirement of the patient. SUMMARY OF THE INVENTION A tympanostomy tube placement device has a stem with a needle having a tip configured to pierce a tympanic membrane. A retainer is on the needle and comprises fingers extending axially at a distance from said axis and equal circumferential separations in one example. The retainer is movable from a distal position at which it presses radially inwardly against the tube distal flange tabs to retain the distal flange in a folded position, to a proximal position at which the tube distal flange is free to spring out radially to a deployed position. The retainer fingers extend through tube proximal flange passageways and press the tube distal flange inwardly, while leaving a distally-facing face of the proximal flange exposed radially outwardly of the retainer . Hence, the proximal flange has its final deployed configuration throughout, and so can act as a physical stop member against the tympanic membrane and also provides visualisation for the surgeon because it extends radially outwardly of the stem. In various aspects we describe a tympanostomy tube placement device comprising: a stem connected to a deployment mechanism or having a coupler for connection to a deployment mechanism;a needle having a tip configured to pierce a tympanic membrane, the needle having a longitudinal axis; anda retainer comprising a plurality of fingers extending axially at a distance from said longitudinal axis;wherein the retainer is movable from a pre-deployment distal position at which it is adapted to press radially inwardly against a tube distal flange to retain said distal flange in a folded position, to a deployment proximal position at which a tube distal flange is free to spring out radially to a deployed position. Preferably, there are at least two diametrically opposed retainer fingers. Preferably, the fingers have an arcuate cross-sectional shape with a concave internal surface. The device may further comprise a handle connected to the stem, and the stem may be rotatable with respect to the handle, and there may be a user actuator for rotation of the stem. Preferably, the needle is lockable in the stem so that it rotates with the stem. Preferably, the needle comprises a lock member for engagement within a recess of the stem. Preferably, the stem is cranked or bent along its length. Preferably, the placement device further comprises: a tympanostomy tube comprising a proximal flange, an inter-lumen connector, anda distal flange, and in which the proximal flange comprises passageways; and in