IP Library Granted Patent US 11,596,545
Granted Patent B2
US 11,596,545 · App. 16/178,162 · Granted Mar 7, 2023

Systems and methods for ocular drug delivery

Inventors: Rafael Victor Andino (Grayson, GA); Thomas Edward Godfrey (Suwanee, GA); Shelley Eckert Hancock (Atlanta, GA); Samirkumar Patel (Atlanta, GA); Keleigh Jo Mahn (Southeast Atlanta, GA); Jesse Yoo (Snellville, GA); Vladimir Zarnitsyn (Atlanta, GA)
Assignee: CLEARSIDE BIOMEDICAL, INC.
A61F9/0017A61K9/0051A61N1/0428A61N1/30A61N1/325A61F9/00781A61K9/0021A61K9/10
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Quick Facts
Patent No.
US 11,596,545
App. No.
16/178,162
Granted
Mar 7, 2023
Kind
B2
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.

Claims (69)

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 charge sufficient to convey the medicament from the reservoir to a distal end of the puncture member at a delivery depth within a predetermined range in the eye, the delivery depth dependent on an intensity of the charge;

a controller configured to adjust the charge to convey the medicament to the predetermined delivery depth; and

a sensor, the sensor configured to detect at least one of a position of the distal end portion of the housing, a level of the medicament within the reservoir, or an indication of delivery depth of the medicament.

22. The apparatus of claim 21 , wherein the predetermined range is between about 900 μm and about 1100 μm.

23. The apparatus of claim 21 , further comprising:

a contact member coupled to the distal end portion of the housing and configured to cut 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 configured to produce the charge sufficient to convey the medicament from the reservoir to a targeted region through a second pathway below the outer portion of the eye.

24. The apparatus of claim 21 , wherein the medicament is encapsulated in a carrier that is disposed within the reservoir, the carrier having an ionic charge.

25. The apparatus of claim 21 , 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 a targeted 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.

26. The apparatus of claim 21 , further comprising:

a puncture member fluidically coupled to the reservoir and configured to deliver the medicament to the delivery depth within the predetermined range in the eye.

27. The apparatus of claim 21 , wherein the predetermined range in the eye includes the suprachoroidal space of the eye.

28. 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; 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; and

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 at a delivery depth within a predetermined range in the eye, the delivery depth dependent on an intensity of the charge,

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 a targeted 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.

29. The apparatus of claim 28 , further comprising:

a puncture member defining a pathway, the puncture member fluidically coupleable to the reservoir and configured to deliver the medicament to the targeted region within the eye.

30. The apparatus of claim 28 , wherein the predetermined range in the eye includes the suprachoroidal space of the eye.

31. 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;

an electrode coupled to the housing, the electrode configured to produce a charge 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; and a controller configured to adjust the charge to convey the medicament to the medicament delivery depth within the predetermined range;

a puncture member defining a pathway, the puncture member fluidically coupleable to the reservoir and configured to deliver the medicament to a targeted region within the eye; and

a contact member fixedly coupled to the housing, the contact member configured to move relative to the housing from a vertical orientation to a horizontal orientation to move an outer portion of the eye to define a pathway through which a distal end portion of the puncture member can be disposed,

the distal end portion of the housing defining a channel in fluid communication with the reservoir, inner walls of the channel defining an opening through which the medicament can be conveyed to the targeted region; and

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.

32. The apparatus of claim 31 , wherein the predetermined range in the eye includes the subretinal space of the eye.

Assignments (10)
CORRECTIVE ASSIGNMENT TO CORRECT THE THE NAME OF THE THIRD INVENTOR PREVIOUSLY RECORDED AT REEL: 051537 FRAME: 0066. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Oct 12, 2022
From: ANDINO, RAFAEL VICTOR; GODFREY, THOMAS EDWARD; HANCOCK, SHELLEY ECKERT; PATEL, SAMIRKUMAR; STRUDTHOFF, KELEIGH JO; YOO, JESSE; ZARNITSYN, VLADIMIR
To: CLEARSIDE BIOMEDICAL, INC.
Reel/Frame 061660/0544 →
CORRECTIVE ASSIGNMENT TO CORRECT THE THE NAME OF THE THIRD INVENTOR PREVIOUSLY RECORDED AT REEL: 051537 FRAME: 0024. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Oct 12, 2022
From: ANDINO, RAFAEL VICTOR; GODFREY, THOMAS E; HANCOCK, SHELLEY ECKERT; PATEL, SAMIRKUMAR; STRUDTHOFF, KELEIGH JO; YOO, JESSE; ZARNITSYN, VLADIMIR
To: CLEARSIDE BIOMEDICAL, INC.
Reel/Frame 061660/0656 →
CORRECTIVE ASSIGNMENT TO CORRECT THE THIRD INVENTOR'S NAME PREVIOUSLY RECORDED AT REEL: 051537 FRAME: 0147. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT . Recorded Oct 12, 2022
From: ANDINO, RAFAEL VICTOR; GODFREY, THOMAS EDWARD; HANCOCK, SHELLEY ECKERT; PATEL, SAMIRKUMAR; STRUDTHOFF, KELEIGH JO; YOO, JESSE; ZARNITSYN, VLADIMIR
To: CLEARSIDE BIOMEDICAL, INC.
Reel/Frame 061660/0698 →
CORRECTIVE ASSIGNMENT TO CORRECT THE THE NAME OF THE THIRD INVENTOR PREVIOUSLY RECORDED AT REEL: 051537 FRAME: 0115. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Oct 12, 2022
From: ANDINO, RAFAEL VICTOR; GODFREY, THOMAS EDWARD; HANCOCK, SHELLEY ECKERT; PATEL, SAMIRKUMAR; STRUDTHOFF, KELEIGH JO; YOO, JESSE; ZARNITSYN, VLADIMIR
To: CLEARSIDE BIOMEDICAL, INC.
Reel/Frame 061660/0805 →
RELEASE OF SECURITY INTEREST Recorded Jul 7, 2020
From: SILICON VALLEY BANK
To: CLEARSIDE BIOMEDICAL, INC.
Reel/Frame 053139/0929 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 16, 2020
From: ANDINO, RAFAEL VICTOR; GODFREY, THOMAS EDWARD; ECKERT, SHELLEY ELIZABETH; PATEL, SAMIRKUMAR; STRUDTHOFF, KELEIGH JO; YOO, JESSE; ZARNITSYN, VLADIMIR
To: CLEARSIDE BIOMEDICAL, INC.
Reel/Frame 051537/0147 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 16, 2020
From: ANDINO, RAFAEL VICTOR; GODFREY, THOMAS EDWARD; ECKERT, SHELLEY ELIZABETH; PATEL, SAMIRKUMAR; STRUDTHOFF, KELEIGH JO; YOO, JESSE; ZARNITSYN, VLADIMIR
To: CLEARSIDE BIOMEDICAL, INC.
Reel/Frame 051537/0024 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 16, 2020
From: ANDINO, RAFAEL VICTOR; GODFREY, THOMAS EDWARD; ECKERT, SHELLEY ELIZABETH; PATEL, SAMIRKUMAR; STRUDTHOFF, KELEIGH JO; YOO, JESSE; ZARNITSYN, VLADIMIR
To: CLEARSIDE BIOMEDICAL, INC.
Reel/Frame 051537/0066 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 16, 2020
From: ANDINO, RAFAEL VICTOR; GODFREY, THOMAS EDWARD; ECKERT, SHELLEY ELIZABETH; PATEL, SAMIRKUMAR; STRUDTHOFF, KELEIGH JO; YOO, JESSE; ZARNITSYN, VLADIMIR
To: CLEARSIDE BIOMEDICAL, INC.
Reel/Frame 051537/0115 →
SECURITY INTEREST Recorded Aug 29, 2019
From: CLEARSIDE BIOMEDICAL, INC.
To: SILICON VALLEY BANK
Reel/Frame 050217/0270 →