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EP-4734896-A2 - BIOPOLYMER-BASED TYMPANOSTOMY TUBES WITH PROGRAMMABLE, TUNABLE, AND ON-DEMAND DEGRADATION

EP4734896A2EP 4734896 A2EP4734896 A2EP 4734896A2EP-4734896-A2

Abstract

Disclosed herein is an ear tube including at least one biopolymer. The ear tube has at least one characteristic centrifugal property selected from the group consisting of: i) a uniform density across at least a portion of the ear tube, ii) at least a portion of the ear tube is optically nontransparent, iii) at least a portion of the ear tube is free of exterior layering, iv) at least a portion of the ear tube is free of interior layering, v) at least a portion of the ear tube is interiorvoid-free, vi) at least a portion of the ear tube is free of cylindrical extrusion gaps, and vii) at least a portion of the ear tube is free of layering.

Inventors

  • KAPLAN, DAVID L.
  • FITZPATRICK, Vincent P.
  • LEUNG, Glenn
  • PATTEN, Riley
  • LOVETT, MICHAEL L.
  • REMENSCHNEIDER, Aaron
  • HARTNICK, Christopher

Assignees

  • Trustees Of Tufts College
  • Massachusetts Eye and Ear Infirmary

Dates

Publication Date
20260506
Application Date
20240701

Claims (20)

  1. 1. An ear tube comprising at least one biopolymer, the ear tube having at least one characteristic centrifugal property selected from the group consisting of: i) a uniform density across at least a portion of the ear tube; ii) at least a portion of the ear tube is optically nontransparent; iii) at least a portion of the ear tube is free of exterior layering; iv) at least a portion of the ear tube is free of interior layering; v) at least a portion of the ear tube is interior- void-free; vi) at least a portion of the ear tube is free of cylindrical extrusion gaps; and vii) at least a portion of the ear tube is free of layering.
  2. 2. The ear tube of claim 1 , wherein at least one of an outer flange or an inner flange of the ear tube is angled.
  3. 3. The ear tube of claim 2, wherein the at least one of the outer flange or inner flange defines a plane which is inclined at an angle with respect to a plane disposed perpendicular to an axis of a main tube of the ear tube.
  4. 4. The ear tube of claim 3, wherein the angle is between 15 degrees and 45 degrees, including but not limited to, at least 15 degrees, at least 30 degrees, or at least 45 degrees.
  5. 5. The ear tube of claim 2, wherein at least one of the outer flange or inner flange comprises an insertion protuberance.
  6. 6. The ear tube of claim 1 , wherein an outer flange and an inner flange of the ear tube are at least one of same or different with respect to at least one of a thickness, a relative angle, a shape, an orientation, or a geometry.
  7. 7. The ear tube of claim 1, wherein the ear tube has a uniform diameter throughout its length.
  8. 8. The ear tube of claim 1, wherein the ear tube has a non-uniform diameter along its length.
  9. 9. The ear tube of claim 1 , wherein the ear tube tapers along its length.
  10. 10. The ear tube of claim 1, wherein the ear tube has a uniform density throughout.
  11. 1 1 . The ear tube of claim 1 , wherein the ear tube comprises a cross-sectional profile that is uniform throughout the ear tube.
  12. 12. The ear tube of claim 11, wherein the uniform cross-sectional profile is determined by at least one of a visual inspection, scanning electron microscopy, fluorescence microscopy, DSC, TEM, XRD, EPMA, or FTIR.
  13. 13. The ear tube of claim 11, wherein the cross-sectional profile relates to at least one of a density, an absence of voids, a consistent pattern, or a chemical profile.
  14. 14. The ear tube of claim 1, wherein a main tube of the ear tube has an axial length at least several times its diameter.
  15. 15. The ear tube of claim 1, wherein the ear tube comprises at least one biopolymer, the at least one biopolymer is an aqueous silk solution, an aqueous alginate solution, an aqueous fibrinogen solution, an aqueous chitosan solution, or an aqueous collagen solution.
  16. 16. The ear tube of claim 1, wherein the ear tube is formed via centrifugal molding.
  17. 17. The ear tube of claim 1, wherein the ear tube is designed to degrade on demand.
  18. 18. The ear tube of claim 17, wherein degradation commences when the ear tube is exposed to a solvent.
  19. 19. The ear tube of claim 18, wherein the solvent is at least one of a glucose solution, hydrogen peroxide, carbamide peroxide, an alcohol, a calcium chelator, or EDTA.
  20. 20. The ear tube of claim 1, wherein the ear tube is a tympanostomy tube.

Description

BIOPOLYMER-BASED TYMPANOSTOMY TUBES WITH PROGRAMMABLE, TUNABLE, AND ON-DEMAND DEGRADATION CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application relates to, incorporates by reference for all purposes, and claims priority to United States Provisional Patent Application 63/511,548, filed June 30, 2023. INCORPORATION BY REFERENCE [0002] This application incorporates by reference the following patents in their entirety for all purposes: U.S. Patent 4468218, which issued on August 28, 1984, and U.S. Patent 11229726, which issued on January 25, 2022. This application also incorporates by reference a related provisional application, United States Provisional Application Number 63/511,572, filed on June 30, 2023 and entitled “CENTRIFUGALLY-MOLDED ARTICLES AND METHODS”, which provides a description of one particular method by which the ear tubes described herein can be made. GOVERNMENT FUNDING STATEMENT [0003] This invention was made with government support under P41EB027062 awarded by the National Institutes of Health. The government has certain rights in the invention. BACKGROUND [0004] Myringotomy and tympanostomy tube placement (M&T), is one of the most common pediatric surgeries in the United States, with nearly 700,000 children undergoing this procedure annually. These ventilation tubes (typical height and diameter of ~3 mm) are inserted following an incision (myringotomy) in the tympanic membrane (TM) as a means of bypassing the dysfunctional Eustachian tube and allowing drainage of the middle ear space. [0005] Current commercially available tympanostomy tubes are made of synthetic, bioinert, and non-degradable materials such as fluoroplastic or silicone that are designed to self-extrude. Unfortunately, the extrusion process can be unpredictable, resulting in tubes that prematurely extrude or become stuck within the eardrum or ear canal and require surgical removal. Furthermore, tubes may become clogged or coated with biofilm resulting in non- ventilation of the middle ear or persistent otorrhea (ear drainage), in which case parents must administer antibiotic otic topical drops for up to a week. Given the sheer volume of M&T procedures, complications from tympanostomy tubes represent a significant burden on pediatric health - and innovative solutions in materials and designs that resolve complications from tympanostomy tubes would carry a large impact. [0006] There are no current solutions that exist that address the issues described above. All existing commercial products are bioinert and non-resorbable. Furthermore, no existing product offers an “on-demand” degradation capability. Current approaches to issues with an implanted tympanostomy tube rely on surgical intervention under general anesthesia to remove the ear tube. [0007] A need exists for new ear tubes that overcome one or more of the aforementioned shortcomings. SUMMARY [0008] In some aspects, the techniques described herein relate to an ear tube including at least one biopolymer, the ear tube having at least one characteristic centrifugal property selected from the group consisting of: i) a uniform density across at least a portion of the ear tube; ii) at least a portion of the ear tube is optically nontransparent; iii) at least a portion of the ear tube is free of exterior layering; iv) at least a portion of the ear tube is free of interior layering; v) at least a portion of the ear tube is interior- void-free; vi) at least a portion of the ear tube is free of cylindrical extrusion gaps; and vii) at least a portion of the ear tube is free of layering. [0009] In some aspects, the techniques described herein relate to an ear tube including at least one material assembled via an aqueous solution, the ear tube having at least one characteristic centrifugal property selected from the group consisting of: i) a uniform density across at least a portion of the ear tube; ii) at least a portion of the ear tube is optically nontransparent; iii) at least a portion of the ear tube is free of exterior layering; iv) at least a portion of the ear tube is free of interior layering; v) at least a portion of the ear tube is interior-void-free; vi) at least a portion of the ear tube is free of cylindrical extrusion gaps; and vii) at least a portion of the ear tube is free of layering. [0010] In some aspects, the techniques described herein relate to an ear tube, including: a hollow cylindrical body having at least one flanged end, wherein the ear tube includes at least one biopolymer, the ear tube having at least one characteristic centrifugal property selected from the group consisting of: i) a uniform density across at least a portion of the ear tube; ii) at least a portion of the ear tube is optically nontransparent; iii) at least a portion of the ear tube is free of exterior layering; iv) at least a portion of the ear tube is free of interior layering; v) at least a portion of the ear tube is interior- void-free; vi) at least a portion of the ear tube