Systems and methods for delivery of a therapeutic agent

Patent metadata

Field	Value
Publication number	US-11045390-B2
Application number	US-201916376387-A
Country	US
Kind code	B2
Filing date	Apr 5, 2019
Priority date	Apr 6, 2018
Publication date	Jun 29, 2021
Grant date	Jun 29, 2021

Abstract

The present disclosure relates to nozzles for removing a preservative from a fluid comprising a therapeutic agent to an eye. More particularly, the nozzles disclosed herein may minimize patient exposure to preservative by rapidly and selectively removing a preservative from a solution comprising a therapeutic agent. An example nozzle may comprise a flow diverter which directs a flow path from a fluid inlet to a fluid outlet over a length longer than the distance from the inlet to the outlet. In some cases, the nozzle may comprise a preservative removing agent.

First claim

What is claimed is:

1. A device for removing a preservative from a formulation comprising a therapeutic agent, the device comprising:
a nozzle comprising:
a fluid outlet;
an inlet cap comprising one or more apertures, the one or more apertures in the inlet cap comprising a fluid inlet;
a flow diverter, wherein the flow diverter is configured to limit a flow between the fluid inlet and the fluid outlet when the device is not in use, wherein the flow diverter is configured to divert regions of a fluid flow path in a plurality of different directions, a total distance along the fluid flow path through a matrix from the fluid inlet to the fluid outlet being longer than a distance along an axis from the fluid inlet to the fluid outlet; and
the matrix disposed within the nozzle, wherein the matrix is configured to absorb at least 50 percent of the preservative from the formulation comprising the therapeutic agent and the preservative.

2. The device of claim 1 , further comprising an outlet cap comprising one or more apertures, the one or more apertures in the outlet cap comprising the fluid outlet, wherein the outlet cap has a hydraulic permeability less than 10 Darcy.

3. The device of claim 2 , wherein either of the inlet cap or the outlet cap comprises a screen or a mesh.

4. The device of claim 2 , wherein either of the inlet cap or the outlet cap comprises a filter, wherein the filter comprises a pore size of about 0.2 microns.

5. The device of claim 2 , wherein either of the inlet cap or the outlet cap is prewetted with the preservative.

6. The device of claim 2 , wherein the hydraulic permeability of the inlet cap or the outlet cap is about 0.1 Darcy.

7. The device of claim 2 , wherein a pore size of the one or more apertures in the inlet cap or the outlet cap is less than a particle size of the matrix.

8. The device of claim 7 , wherein a pore size of the one or more apertures in the inlet cap or the outlet cap is about 0.2 microns.

9. The device of claim 1 , wherein a first drop of the formulation from the device and a tenth drop of the formulation from the device comprise equal concentrations of the preservative to within 10%.

10. The device of claim 1 , wherein a drop of the formulation from the device dispensed on a first day and a second drop dispensed on a seventh day comprise equal concentrations of the preservative to within 10% at a drop rate of at least one drop per day.

11. The device of claim 1 , wherein the formulation is forced through the nozzle from the fluid inlet to the fluid outlet and wherein forcing the formulation through the nozzle removes the preservative from the formulation.

12. The device of claim 11 , wherein at least 50 percent of the preservative is removed from the formulation and wherein at least 50 percent of the therapeutic agent is retained.

13. The device of claim 11 , wherein the device further comprises a reservoir containing the formulation, and wherein the reservoir is configured to have an internal pressure which increases with increasing squeeze pressure exerted by a user to form a drop.

14. The device of claim 13 , wherein the squeeze pressure is within a range from 0.01 Atm to 0.5 Atm.

15. The device of claim 13 , wherein the internal pressure comprises a pressure within a range from 1 Atm to 5 Atm.

16. The device of claim 13 , wherein the drop is formed within a time defined by a range between 0.1 seconds and 10 seconds.

17. The device of claim 13 , wherein the drop comprises a volume defined by a range between 1 μL and 100 μL.

18. The device of claim 1 , wherein the inlet cap has a hydraulic permeability less than 10 Darcy.

19. The device of claim 1 , wherein the hydraulic permeability of the inlet cap is less than a hydraulic permeability of the matrix.

Assignees

• Tearclear Corp
• Univ Florida

Inventors

• Golub Howard L
• Chauhan Anuj
• Williams Michael

Classifications

• B01D35/02

  Filters adapted for location in special places, e.g. pipe-lines, pumps, stop-cocks, (B01D35/05 takes precedence; {water pipe system filters E03B3/18, E03B7/07; dirt catchers in sewers E03F; filters or strainers for pipe-lines in general B08B, E03F; object or dirt catching devices in sinks or the like E03C1/26; suction strainers or filters for pumps F04B53/005, F04D29/70}) · CPC title

• A61J1/1456 Primary

  using liquid filters · CPC title

• A61F9/0008 Primary

  Introducing ophthalmic products into the ocular cavity or retaining products therein (putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00) · CPC title

• B65D1/08

  adapted to discharge drops · CPC title

• B65D41/20

  Caps or cap-like covers with membranes, e.g. arranged to be pierced · CPC title