Lacrimal system drug delivery device

Patent metadata

Field	Value
Publication number	US-10993834-B2
Application number	US-201414760307-A
Country	US
Kind code	B2
Filing date	Jan 14, 2014
Priority date	Jan 15, 2013
Publication date	May 4, 2021
Grant date	May 4, 2021

Abstract

This invention is in the field of medical intervention related to the lacrimal system. The invention relates to a lacrimal system device and methods of using the device for drug delivery to an eye, sinuses and/or periocular tissues.

First claim

I claim:

1. A lacrimal system drug delivery device, comprising:
a) a self-compressible reservoir at a distal end of said lacrimal system drug delivery device to receive a fluid, fill to distortion, and provide a force to deliver said fluid at a fixed rate between 0.1 microliters and 30.0 microliters per day for a minimum of one week, said self-compressible reservoir having a reservoir port for loading and delivering said fluid, and said self-compressible reservoir having elastic properties to compress said fluid inside said self-compressible reservoir responsive to said distortion;
b) a first lumen connected to said reservoir port, to load said fluid into said self-compressible reservoir; and
c) a second lumen to deliver said fluid from said self-compressible reservoir, wherein the first lumen is not comprised within the second lumen, wherein said second lumen terminates with a flow limiting port in at least one punctum in contact with a tear film of an eye, said flow limiting port located at a proximal end of said lacrimal system drug delivery device.

2. The device of claim 1 , wherein said fluid comprises a composition with an active ingredient.

3. The device of claim 1 , wherein said self-compressible reservoir enables anatomical fixation.

4. The device of claim 3 , wherein said anatomical fixation is a device retention feature.

5. The device of claim 1 , wherein said reservoir port is connected to an internal plunger.

6. The device of claim 5 , wherein said reservoir port is connected to internal springs connected to said internal plunger.

7. The device of claim 6 , wherein said device further comprises a microelectromechanical systems spring pressure regulator.

8. The device of claim 1 , wherein said device is made of bioerodible materials.

9. The device of claim 1 , wherein said device is made of microporous materials.

10. The device of claim 1 , wherein said device is made of nanoporous materials.

11. The device of claim 1 , wherein said device is made of medical grade materials.

12. The device of claim 1 , wherein said flow limiting port comprises at least one hole.

13. The device of claim 1 , wherein said flow limiting port comprises a filter.

14. The device of claim 1 , wherein said flow limiting port comprises at least one ePTFE membrane.

15. The device of claim 1 , wherein a flow of said fluid out of said device is additionally gravity dependent.

16. The device of claim 15 , wherein the flow of said fluid out of said device is limited by a gravity dependent valve.

17. A method of treatment of a subject comprising a lacrimal system comprising at least one lacrimal duct, at least one punctum, a lacrimal sac and a nasolacrimal duct, the method comprising:
a) providing:
i) a lacrimal system drug delivery device, comprising:
A) a self-compressible, elastic reservoir at a distal end of said lacrimal system drug delivery device capable of insertion inside said lacrimal sac, said self-compressible, elastic reservoir to receive a fluid, fill to distortion, and provide a force to deliver said fluid at a fixed rate between 0.1 microliters and 30.0 microliters per day for a minimum of one week,
B) a first lumen to deliver said fluid into said self-compressible, elastic reservoir; and
C) a second lumen to deliver said fluid from said self-compressible, elastic reservoir, wherein the first lumen is not comprised within the second lumen, said second lumen terminating with a flow limiting port in said at least one punctum in contact with a tear film of an eye, said flow limiting port at a proximal end of said lacrimal system drug delivery device,

b) inserting said drug delivery device into said lacrimal system;
c) providing said fluid comprising a composition with at least one active ingredient to said self-compressible, elastic reservoir, and
d) administering said composition to said subject using said lacrimal system drug delivery device.

18. The method of claim 17 , wherein said device further comprises at least one internal spring connected to an internal plunger connected to a reservoir port.

19. The method of claim 18 , wherein said internal plunger enables a constant release of said composition without relying on said elastic reservoir.

20. The method of claim 18 , wherein said device further comprises a microelectromechanical systems spring pressure regulator.

21. The method of claim 17 , wherein said device further comprises a cut-off valve.

22. The method of claim 21 , wherein a flow out of said device is controlled by said cut-off valve that is accessible by an operator to decrease said flow at given times when treatment is not desired.

23. The method of claim 17 , wherein said device comprises bioerodible materials.

24. The method of claim 23 , wherein said device comprises internal composition columns with said bioerodible materials.

25. The method of claim 24 , wherein an erosion of said bioerodible materials opens up inlet pores to said internal composition columns to enable pulsed dosing of said composition.

26. The method of claim 17 , wherein said at least one active ingredient is selected from the group consisting of artificial tears, glaucoma drops, anti-inflammatory agents, nonsteroidal agents, antibiotics, biologics, proteins, aptamers, nucleic acids, cytokines, plasma, sympathomimetics, parasympathomimetics, prostaglandin analogues, beta blockers, alpha-agonists, and anti-VEGF agents.

27. The method of claim 17 , wherein said flow limiting port regulates a flow of said composition from said device.

28. The method of claim 17 , wherein said flow limiting port comprises at least one ePTFE membrane.

29. The method of claim 17 , wherein said flow limiting port comprises at least one layer of ePTFE material.

Assignees

• Univ Colorado Regents

Inventors

• Kahook Malik

Classifications

• A61F2250/0003

  having an inflatable pocket filled with fluid, e.g. liquid or gas · CPC title

• A61K9/0048

  Eye, e.g. artificial tears · CPC title

• A61P27/02

  Ophthalmic agents · CPC title

• A61M2210/0612

  Eyes · CPC title

• A61F9/00772

  Apparatus for restoration of tear ducts · CPC title