Lacrimal drug delivery device

Patent metadata

Field	Value
Publication number	US-12011390-B2
Application number	US-202117524610-A
Country	US
Kind code	B2
Filing date	Nov 11, 2021
Priority date	May 20, 2016
Publication date	Jun 18, 2024
Grant date	Jun 18, 2024

Abstract

A lacrimal drug delivery device includes a reservoir configured to hold a drug. The reservoir is moveable between a relaxed state and an expanded state. A connector is fluidly coupled to the reservoir and a lumen is formed in the connector wherein the drug is configured to flow from the reservoir to an delivery site through the lumen. A hydrogel is within the lumen and configured to absorb the drug from the reservoir and deliver the drug from the lumen at the delivery site. The hydrogel includes a first section which absorbs the drug at a first rate of absorption. A delivery guide is detachably coupled to the reservoir to deliver the reservoir into a lacrimal sac of a patient.

First claim

What is claimed is:

1. A lacrimal drug delivery device comprising:
a reservoir configured to hold a therapeutic agent, the reservoir configured to transition between a relaxed state and an expanded state;
a delivery guide;
a connector comprising:
a first lumen in fluid communication with the reservoir and configured to deliver the therapeutic agent from the reservoir to an eye of a subject;
a second lumen in fluid communication with the reservoir and configured to receive the delivery guide therein to deliver the therapeutic agent into the reservoir;

a hydrogel disposed within the first lumen and configured to control a flow rate of the therapeutic agent from the reservoir to the eye; and
a plug releasably couplable to the delivery guide, the plug configured to release from the delivery guide and seal the second lumen to prevent the therapeutic agent from flowing through the second lumen after the delivery guide delivers the therapeutic agent into the reservoir.

2. The lacrimal drug delivery device of claim 1 , further comprising the therapeutic agent.

3. The lacrimal drug delivery device of claim 1 , further comprising a faceplate at a proximal end of the connector.

4. The lacrimal drug delivery device of claim 1 , wherein, when the therapeutic agent is delivered into the reservoir, the reservoir transitions from the relaxed state to the expanded state; wherein, when the therapeutic agent is delivered to the eye, the reservoir transitions from the expanded state to the relaxed state.

5. The lacrimal drug delivery device of claim 1 , wherein, when the reservoir is in the expanded state, the reservoir applies a constant force onto the therapeutic agent such that the therapeutic agent flows from the reservoir at a consistent flow rate.

6. The lacrimal drug delivery device of claim 1 , wherein an internal chamber of the reservoir defines a relaxed diameter when the reservoir is in the relaxed state and an expanded diameter when the reservoir is in the expanded state, wherein the relaxed diameter is between 0.25 mm and 1.5 mm, wherein the expanded diameter is between 3.0 mm and 6.0 mm.

7. The lacrimal drug delivery device of claim 1 , wherein the first lumen is formed in the connector and the second lumen is formed in the connector.

8. The lacrimal drug delivery device of claim 1 , wherein the plug is configured to release from the delivery guide and seal the second lumen as the delivery guide is removed from the second lumen.

9. The lacrimal drug delivery device of claim 1 , wherein the plug is releasably coupled to the delivery guide via at least one of an adhesive, a threaded connection, or a ball and detent structure.

10. A method for inhibiting onset of an ocular disease in the eye of the subject in need thereof, the method comprising:
implanting the lacrimal drug delivery device of claim 1 into the eye of the subject;
delivering the therapeutic agent into the reservoir through the second lumen of the lacrimal drug delivery device;
sealing the second lumen with the plug; and
delivering the therapeutic agent through to the eye of the subject through the first lumen of the lacrimal drug delivery device.

11. The method of claim 10 , wherein implanting the lacrimal drug delivery device comprises inserting the lacrimal drug delivery device through a punctum of the eye of the subject such that the reservoir is within a lacrimal sac of the eye of the subject and the connector is within a lacrimal duct of the eye of the subject; wherein the reservoir is in the relaxed state during implanting; wherein the reservoir transitions from the relaxed state to the expanded state when the therapeutic agent is delivered into the reservoir through the second lumen.

12. A lacrimal drug delivery device comprising:
a reservoir configured to hold a therapeutic agent, the reservoir configured to transition between a relaxed state and an expanded state;
a connector comprising:
a first lumen in fluid communication with the reservoir and configured to deliver the therapeutic agent from the reservoir to an eye of a subject;
a second lumen in fluid communication with the reservoir and configured to receive a delivery guide therein to deliver the therapeutic agent into the reservoir;
a hydrogel disposed within the first lumen and configured to control a flow rate of the therapeutic agent from the reservoir to the eye;
a plug provided in the second lumen and configured to be releasably couplable to the delivery guide; and
the delivery guide including a guide wire having an opening therethrough, the delivery guide removably positionable within the second lumen, wherein, when the delivery guide is positioned in the second lumen, the delivery guide is removably couplable to the lacrimal drug delivery device to implant the lacrimal drug delivery device into the eye of the subject, wherein, when the delivery guide is positioned in the second lumen, the delivery guide is configured to deliver the therapeutic agent through the opening and into the reservoir such that the reservoir transitions from the relaxed state to the expanded state, wherein, when the plug is releasably coupled to the delivery guide, the delivery guide is configured to release the plug to seal the second lumen.

13. The lacrimal drug delivery device of claim 12 , further comprising the therapeutic agent.

14. The lacrimal drug delivery device of claim 12 , further comprising a faceplate at a proximal end of the connector.

15. The lacrimal drug delivery device of claim 12 , wherein, when the therapeutic agent is delivered into the reservoir, the reservoir transitions from the relaxed state to the expanded state; wherein, when the therapeutic agent is delivered to the eye, the reservoir transitions from the expanded state to the relaxed state.

16. The lacrimal drug delivery device of claim 12 , wherein, when the reservoir is in the expanded state, the reservoir applies a compressive force onto the therapeutic agent such that the therapeutic agent flows from the reservoir at a consistent flow rate.

17. The lacrimal drug delivery device of claim 12 , wherein an internal chamber of the reservoir defines a relaxed diameter when the reservoir is in the relaxed state and an expanded diameter when the reservoir is in the expanded state, wherein the relaxed diameter is between 0.25 mm and 1.5 mm, wherein the expanded diameter is between 3.0 mm and 6.0 mm.

18. The lacrimal drug delivery device of claim 12 , wherein the delivery guide is configured to release the plug to seal the second lumen after the delivery guide delivers the therapeutic agent through the opening and into the reservoir.

19. A method for inhibiting onset of an ocular disease in the eye of the subject in need thereof, the method comprising:
implanting the lacrimal drug delivery device of claim 12 , with the delivery guide removably coupled to the second lumen, into the eye of the subject;
delivering the therapeutic agent, with the delivery guide, into the reservoir through the second lumen of the lacrimal drug delivery device; and
delivering the therapeutic agent through to the eye of the subject through the first lumen of the lacrimal drug delivery device.

20. The method of claim 19 , wherein implanting the lacrimal drug delivery device comprises inserting the lacrimal drug delivery device through a punctum of the eye of the subject such that the reservoir is within a lacrimal sac of the eye of the subject and the connector is within a lacrimal duct of the eye of the subject; wherein the reservoir is in the

Assignees

• Univ Colorado Regents

Inventors

• Schieber Andrew
• Thai Linda
• Kahook Malik

Classifications

• A61K45/00

  Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00 · CPC title

• A61K9/0051

  Ocular inserts or implants · CPC title

• A61P27/02

  Ophthalmic agents · 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