Granted Patent B2

US 12,201,558 · App. 18/156,684 · Granted Jan 21, 2025

Inventors: Rafael Victor Andino (Grayson, GA); Vladimir Zarnitsyn (Atlanta, GA); Jesse Yoo (Snellville, GA); Christopher John Brooks (Glen Cove, NY); Trent John Kahute (Atlanta, GA); Justin William Arsenault (Atlanta, GA); David Jackson Trettin (Atlanta, GA); Andrew Kent Bauer (Atlanta, GA); Stephanie Elaine Lewis (Atlanta, GA)

Assignee: Clearside Biomedical, Inc.

A61F9/0017A61J1/201A61J1/2055A61J1/2096A61M5/2033A61M5/2053A61M5/31A61M5/3293A61M5/34A61M5/344A61M5/346A61M5/347A61M5/348A61M5/349A61M5/46A61M5/482A61M37/0015A61F2250/0007A61F2250/0069A61M2005/31508A61M2037/0023A61M2037/0061A61M2210/0612

Abstract

Claims (42)

1. An apparatus, comprising:

a medicament container, the medicament container including an adeno-associated virus (AAV);

a housing configured to receive a portion of the medicament container;

a hub configured to be coupled to the medicament container and defining a passageway through which a puncture member is disposed, the hub being fixedly coupled to the puncture member such that the hub moves with the puncture member when the puncture member is moved relative to an eye, a distal end surface of the hub being configured to contact a target surface of the eye when the AAV is conveyed through the puncture member; and

an actuation rod at least partially disposed within the medicament container, the medicament container, the actuation rod, and the puncture member collectively configured such that (1) a portion of the actuation rod moves within the medicament container in response to a manually-applied force on the actuation rod when a distal end portion of the puncture member is disposed within a suprachoroidal space of the eye, and (2) movement of a distal end portion of the actuation rod within the medicament container in response to the force on the actuation rod is limited when the distal end portion of the puncture member is disposed within a portion of a sclera of the eye, the force having a magnitude less than a threshold value.

2. The apparatus of claim 1 , wherein the threshold value is from about 2N to about 6N.

3. The apparatus of claim 1 , wherein the target surface is any one of a conjunctiva of the eye or the sclera of the eye.

4. The apparatus of claim 1 , wherein the distal end surface of the hub includes a sealing portion configured to define a substantially fluid-tight seal with the target surface when the AAV is conveyed through the puncture member.

5. The apparatus of claim 4 , wherein the sealing portion is symmetrical about a centerline of the passageway of the hub.

6. The apparatus of claim 1 , wherein a centerline of the puncture member is substantially normal to a surface line tangent to the hub.

7. The apparatus of claim 1 , wherein the force is between about 0.5N and about 2N.

8. The apparatus of claim 1 , wherein the hub is configured to be coupled to the medicament container via a threaded coupling.

9. The apparatus of claim 1 , wherein at least a portion of the medicament container is transparent.

10. The apparatus of claim 1 , wherein the distal end surface of the hub is convex.

11. The apparatus of claim 1 , wherein a centerline of the puncture member is substantially normal to a surface line tangent to the hub, wherein a proximal-most end of the puncture member terminates within the passageway of the hub, and wherein the distal end surface of the hub is convex.

12. A kit, comprising:

a vial containing an adeno-associated virus (AAV); and

a medical injector, the medical injector including:

a housing, the housing configured to be coupled to a medicament container;

the medicament container, the medicament container configured to receive the AAV from the vial;

a hub, the hub configured to be coupled to the medicament container and defining a passageway through which a puncture member is disposed, the puncture member being fixedly coupled to the hub, at least a portion of a distal end surface of the hub having (1) a hemispherical shape, and (2) a sealing portion configured to define a substantially fluid-tight seal with a target surface of an eye when the AAV is conveyed through the puncture member; and

an actuation rod, the actuation rod configured to be at least partially disposed within the medicament container,

the medicament container, the actuation rod, and the puncture member collectively configured such that (1) a portion of the actuation rod moves within the medicament container in response to a manually-applied force on the actuation rod when a distal end portion of the puncture member is disposed within a suprachoroidal space of the eye, and (2) movement of a distal end portion of the actuation rod within the medicament container in response to the force on the actuation rod is limited when the distal end portion of the puncture member is disposed within a portion of a sclera of the eye, the force having a magnitude less than a threshold value.

13. The kit of claim 12 , wherein the threshold value is from about 2N to about 6N.

14. The kit of claim 12 , wherein the target surface is any one of a conjunctiva of the eye or the sclera of the eye.

15. The kit of claim 12 , wherein the sealing portion is symmetrical about a centerline of the passageway of the hub.

16. The kit of claim 12 , wherein a centerline of the puncture member is substantially normal to a surface line tangent to the hub.

17. The kit of claim 12 , wherein the force is between about 0.5N and about 2N.

18. The kit of claim 12 , wherein the hemispherical shape is convex.

19. The kit of claim 12 , wherein the hub is configured to be coupled to the medicament container via a threaded coupling.

20. The kit of claim 12 , wherein at least a portion of the medicament container is transparent.

21. The kit of claim 12 , wherein the hub is a first hub and the puncture member is a first puncture member, the kit further comprising a second hub and a second puncture member fixedly coupled to the second hub, the second hub configured to be coupled to the medicament container when the first hub is not coupled to the medicament container.

22. An apparatus, comprising:

a medicament container configured to contain an adeno-associated virus (AAV);

a housing configured to receive a portion of the medicament container;

a hub configured to be coupled to the medicament container and defining a passageway through which a puncture member is disposed, the hub being fixedly coupled to the puncture member such that the hub moves with the puncture member when the puncture member is moved relative to an eye, at least a portion of a distal end surface of the hub having a convex shape, the hub being configured to contact a target surface of the eye when the AAV is conveyed through the puncture member, a proximal-most end of the puncture member terminating within the passageway of the hub; and

an actuation rod at least partially disposed within the medicament container, the medicament container, the actuation rod, and the puncture member collectively configured such that (1) a portion of the actuation rod moves within the medicament container in response to a force on the actuation rod when a distal end portion of the puncture member is disposed within a suprachoroidal space of the eye, and (2) movement of a distal end portion of the actuation rod within the medicament container in response to the force on the actuation rod is limited when the distal end portion of the puncture member is disposed within a portion of a sclera of the eye, the force having a magnitude less than a threshold value.

23. The apparatus of claim 22 , wherein the threshold value is from about 2N to about 6N.

24. The apparatus of claim 22 , wherein a centerline of the puncture member is substantially normal to a surface line tangent to the hub.

25. The apparatus of claim 22 , wherein the force is between about 0.5N and about 2N.

26. The apparatus of claim 22 , wherein the force is applied manually.

27. The apparatus of claim 22 , wherein the portion of the sclera is an upper portion of the sclera.

Assignments (7)

Continuity (13)

References Cited (400)