Systems and methods for ocular drug delivery

Patent metadata

Field	Value
Publication number	US-11596545-B2
Application number	US-201816178162-A
Country	US
Kind code	B2
Filing date	Nov 1, 2018
Priority date	May 2, 2016
Publication date	Mar 7, 2023
Grant date	Mar 7, 2023

Abstract

Devices, methods, and kits for ocular drug delivery are described herein. An apparatus can include a housing, an energy storage member, a barrel, and a hub. The housing contains the energy storage member. A proximal end portion of the barrel is coupled to a distal end portion of the housing. The barrel is configured to contain medicament and includes at least a portion of a piston and an elastomeric member. The piston is configured to move the elastomeric member within the barrel in response to a force produced by the energy storage member. The hub is coupled to a distal end portion of the barrel. An inner surface of the hub defines a nozzle through which the medicament flows when the elastomeric member moves within the barrel. The nozzle and the energy storage member are collectively configured to produce a fluid jet to access a target location within an eye.

First claim

The invention claimed is:

1. An apparatus, comprising:
a housing having a distal end portion configured to contact a surface of an eye, the housing defining a reservoir configured to contain a medicament having an ionic charge, the reservoir having walls with a charge opposite a charge of the medicament such that the reservoir is configured to hold the medicament in the reservoir;
a puncture member fluidically coupled to the reservoir and configured to be inserted into and deliver the medicament to a target region within the eye;
an electrode operably coupled to the medicament disposed within the reservoir, the electrode configured to produce a charge sufficient to convey the medicament from the reservoir to a distal end of the puncture member within the target region within the eye,
a controller configured to send a signal to the electrode to adjust the charge such that the medicament is conveyed from the reservoir; and
a sensor, the sensor configured to detect at least one of the charge of the electrode, a level of the medicament within the reservoir, or an indication of delivery depth of the medicament.

2. The apparatus of claim 1 , wherein the medicament delivery depth is within a predetermined range.

3. The apparatus of claim 2 , wherein the predetermined range is between about 900 μm and about 1100 μm.

4. The apparatus of claim 1 , further comprising:
a contact member coupled to the distal end portion of the housing and configured to move an outer portion of the eye to define a first pathway through which the distal end portion of the housing can be disposed, the electrode being configured to produce the charge sufficient to convey the medicament from the reservoir to the targeted region through a second pathway below the first pathway and the outer portion of the eye.

5. The apparatus of claim 1 , wherein the reservoir contains the electrode.

6. The apparatus of claim 1 , wherein the medicament is encapsulated in a carrier that is disposed within the reservoir, the carrier having an ionic charge.

7. The apparatus of claim 1 , wherein an inner wall of the reservoir has an ionic charge that is opposite the ionic charge of the medicament.

8. The apparatus of claim 1 , wherein the controller is configured to change an ionic charge of the reservoir to match the ionic charge of the medicament such that the medicament is repelled out of the reservoir.

9. The apparatus of claim 1 , wherein the distal end portion of the housing defines a channel in fluid communication with the reservoir, inner walls of the channel define an opening, the apparatus further comprising:
a membrane covering the opening and having an ionic charge such that when the ionic charge of the membrane is similar to the ionic charge of the medicament, the membrane limits the medicament from passing therethrough, and when the ionic charge of the membrane is different from the ionic charge of the medicament, the medicament can pass therethrough, the electrode configured to produce the ionic charge of the membrane.

10. The apparatus of claim 1 , further comprising a contact member movably coupled to the distal end portion of the housing, the contact member configured to move an outer portion of the eye to define a first pathway through which the distal end portion of the housing can be disposed.

11. The apparatus of claim 1 , wherein the charge is sufficient to convey the medicament from the reservoir to a delivery depth within a predetermined range in the eye, the delivery depth dependent on an intensity of the charge.

12. An apparatus, comprising:
a housing having a distal end portion configured to contact a surface of an eye, the housing defining a reservoir configured to contain a medicament having an ionic charge, the reservoir having walls with a charge opposite a charge of the medicament such that the reservoir is configured to hold the medicament in the reservoir;
a puncture member defining a lumen, the puncture member fluidically coupled to the reservoir and configured to deliver the medicament to a target region within the eye;
an electrode operably coupled to the medicament disposed within the reservoir, the electrode configured to produce a charge sufficient to convey the medicament from the reservoir to a distal end of the puncture member within the target region within the eye through the lumen below an outer portion of the eye;
a controller configured to send a signal to the electrode to adjust the charge such that the medicament is conveyed from the reservoir; and
a sensor, the sensor configured to detect at least one of the charge of the electrode, a level of the medicament within the reservoir, or an indication of delivery depth of the medicament.

13. The apparatus of claim 12 , wherein the controller is configured to send a signal to the electrode to convey the medicament to a medicament delivery depth within a predetermined range between about 900 μm and about 1100 μm.

14. The apparatus of claim 12 , wherein an inner wall of the reservoir has an ionic charge that is opposite the ionic charge of the medicament.

15. The apparatus of claim 12 , wherein the distal end portion of the housing defines a channel in fluid communication with the reservoir, inner walls of the channel define an opening through which the medicament can be conveyed to the target region, the apparatus further comprising:
a membrane covering the opening and having an ionic charge such that when the ionic charge of the membrane is similar to the ionic charge of the medicament, the membrane limits the medicament from passing therethrough, and when the ionic charge of the membrane is different from the ionic charge of the medicament, the medicament can pass therethrough, the electrode configured to produce the ionic charge of the membrane.

16. The apparatus of claim 12 , wherein the charge is sufficient to convey the medicament from the reservoir to a delivery depth within a predetermined range in the eye, the delivery depth dependent on an intensity of the charge.

17. The apparatus of claim 12 , further comprising:
a contact member coupled to the housing, the contact member configured to move an outer portion of the eye to define a pathway through which the distal end portion of the housing is disposed.

18. The apparatus of claim 17 , wherein the contact member is movably coupled to the housing between a first position in which the contact member is configured to initiate contact with the outer portion of the eye and a second position in which the contact member has moved the outer portion of the eye to define the pathway.

19. The apparatus of claim 17 , wherein the contact member includes at least one of a sharp edge or blade configured to at least one of cut or move the outer portion of the eye to define the pathway.

20. The apparatus of claim 12 , wherein the outer portion of the eye includes a conjunctiva.

21. An apparatus, comprising:
a housing having a distal end portion configured to contact a surface of an eye, the housing defining a reservoir configured to contain a medicament having an ionic charge, the reservoir having walls with a charge opposite a charge of the medicament such that the reservoir is configured to hold the medicament in the reservoir;
a puncture member defining a lumen, the puncture member fluidically coupled to the reservoir and configured to deliver the medicament to a target region within the eye;
an electrode coupled to the medicament disposed within the reservoir, the electrode configured to produce a cha

Assignees

• Clearside Biomedical Inc

Inventors

• Andino Rafael Victor
• Godfrey Thomas Edward
• Hancock Shelley Eckert
• Patel Samirkumar
• Mahn Keleigh Jo
• Yoo Jesse
• Zarnitsyn Vladimir

Classifications

• A61F9/0017 Primary

  implantable in, or in contact with, the eye, e.g. ocular inserts · CPC title

• A61N1/0428

  Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs · CPC title

• A61N1/325

  for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body (electrodes for external use A61N1/0428) · CPC title

• A61K9/10

  Dispersions; Emulsions · CPC title

• A61F9/00781

  Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment (drainage implants in general A61M27/002) · CPC title