IP Library Granted Patent US 11,559,428
Granted Patent B2
US 11,559,428 · App. 16/510,238 · Granted Jan 24, 2023

Apparatus and methods for ocular injection

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
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Quick Facts
Patent No.
US 11,559,428
App. No.
16/510,238
Granted
Jan 24, 2023
Kind
B2
Abstract

An apparatus includes a housing coupled to a medicament container, which is coupled to a needle. An injection assembly is disposed within the housing and includes an energy storage member and an actuation rod. A distal end portion of the actuation rod is disposed within the medicament container. The energy storage member can produce a force on a proximal end portion of the actuation rod sufficient to move the distal end portion of the actuation rod within the medicament container. This can convey at least a portion of a substance from the medicament container via the needle when a distal tip of the needle is disposed within a first region of a target location. The force is insufficient to move the distal end portion of the actuation rod within the medicament container when the distal tip of the needle is disposed within a second region of the target location.

Claims (42)

1. An apparatus, comprising:

a housing, the housing configured to contain a medicament and be coupled to a puncture member; and

an injection assembly disposed within the housing, the injection assembly including an energy storage member and an actuation rod, a distal end portion of the actuation rod configured to be disposed within the housing, the energy storage member configured to produce a force on the actuation rod, the force sufficient to move the distal end portion of the actuation rod within the housing to convey at least a portion a medicament from the housing via the puncture member when a distal tip of the puncture member is disposed within a first region of a target location, the force insufficient to move the distal end portion of the actuation rod within the housing to convey the at least the portion of the medicament from the housing when the distal tip of the puncture member is disposed within a second region of the target location.

2. The apparatus of claim 1 , wherein:

the first region of the target location has a first density; and

the second region of the target location has a second density, the second density higher than the first density.

3. The apparatus of claim 1 , wherein:

the first region of the target location produces a first backpressure on the distal tip of the puncture member; and

the second region of the target location produces a second backpressure on the distal tip of the puncture member, the second backpressure higher than the first backpressure.

4. The apparatus of claim 1 , wherein:

the target location is an eye;

the first region is a suprachoroidal space of the eye; and

the second region is a sclera of the eye.

5. The apparatus of claim 1 , wherein the force is between about 2 N and about 6 N.

6. The apparatus of claim 1 , wherein the actuation rod and the housing are collectively configured such that the force produces an injection pressure within the housing of between about 100 kPa and about 500 kPa.

7. The apparatus of claim 1 , wherein the actuation rod moves distally within the housing in response to the force when the distal tip of the puncture member is disposed within the first region of the target location.

8. The apparatus of claim 1 , wherein:

the injection assembly includes a release member configured to move between a first position and a second position, the release member configured to release the energy storage member when moved from the first position to the second position.

9. The apparatus of claim 1 , wherein the puncture member is fixedly coupled to the housing.

10. The apparatus of claim 1 , wherein the injection assembly includes a guide rod fixedly coupled within the housing, the actuation rod configured to slide about the guide rod when the energy storage member is released.

11. The apparatus of claim 1 , wherein the energy storage member is any one of a spring, a compressed gas container or a container containing a propellant.

12. The apparatus of claim 1 , further comprising:

the medicament container, the medicament container containing at least one of a VEGF, a VEGF inhibitor or a combination thereof.

13. The apparatus of claim 1 , further comprising an adjustment member coupled to a distal end portion of the housing.

14. The apparatus of claim 1 , further comprising an adjustment member slideably disposed about the puncture member.

15. The apparatus of claim 14 , wherein the adjustment member is configured to conform to an outer surface of the target location to form a fluid-tight seal with the outer surface of the target location when the adjustment member is in contact with the outer surface.

16. An apparatus, comprising:

a housing, the housing configured to contain a medicament and be coupled to a puncture member;

an injection assembly disposed within the housing, the injection assembly including an energy storage member and an actuation rod, a distal end portion of the actuation rod configured to be disposed within the housing, the energy storage member configured to produce a force on the actuation rod, the force sufficient to move the distal end portion of the actuation rod within the housing to convey at least a portion a medicament from the housing via the puncture member when a first backpressure is produced on a distal tip of the puncture member, the force insufficient to move the distal end portion of the actuation rod within the housing to convey the at least the portion of the medicament from the housing when a second backpressure higher than the first backpressure is produced on the distal tip of the puncture member.

17. The apparatus of claim 16 , wherein the puncture member is fixedly coupled to the housing.

18. The apparatus of claim 16 , wherein:

the first backpressure is produced on the distal tip of the puncture member when the distal tip of the puncture member is disposed within a first region of a target location,

the second backpressure is produced on the distal tip of the puncture member when the distal tip of the puncture member is disposed within a second region of the target location.

19. The apparatus of claim 18 , wherein:

the first region of the target location has a first density; and

the second region of the target location has a second density, the second density higher than the first density.

20. The apparatus of claim 18 , wherein:

the target location is an eye;

the first region is a suprachoroidal space of the eye; and

the second region is a sclera of the eye.

21. The apparatus of claim 16 , wherein the force is between about 2 N and about 6 N.

22. The apparatus of claim 16 , wherein the actuation rod and the housing are collectively configured such that the force produces an injection pressure within the housing of between about 100 kPA and about 500 kPA.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2019
From: ANDINO, RAFAEL VICTOR; ZARNITSYN, VLADIMIR
To: CLEARSIDE BIOMEDICAL, INC.
Reel/Frame 051235/0067 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2019
From: KAHUTE, TRENT JOHN; ARSENAULT, JUSTIN WILLIAM; TRETTIN, DAVID JACKSON; BAUER, ANDREW KENT; LEWIS, STEPHANIE ELAINE
To: THRIVE CONSULTING, LLC
Reel/Frame 051235/0112 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2019
From: YOO, JESSE
To: CLEARSIDE BIOMEDICAL, INC.
Reel/Frame 051235/0142 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2019
From: THRIVE CONSULTING, LLC
To: CLEARSIDE BIOMEDICAL, INC.
Reel/Frame 051235/0171 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2019
From: BROOKS, CHRISTOPHER JOHN
To: HABITECH DESIGN & DEVELOPMENT WORKS LLC
Reel/Frame 051235/0183 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2019
From: HABITECH DESIGN & DEVELOPMENT WORKS LLC
To: CLEARSIDE BIOMEDICAL, INC.
Reel/Frame 051235/0200 →
Continuity (12)
Continuation 16381213 · Apr 11, 2019
Continuation 15946838 · Apr 6, 2018
Continuation 15714441 · Sep 25, 2017
Continuation 15472551 · Mar 29, 2017
Continuation 15399239 · Jan 5, 2017
Continuation 14268687 · May 2, 2014
Provisional Application 61953147 · Mar 14, 2014
Provisional Application 61944214 · Feb 25, 2014
Provisional Application 61827371 · May 24, 2013
Provisional Application 61819048 · May 3, 2013
Provisional Application 61819052 · May 3, 2013
Related Publication 20190350755A1 · Nov 21, 2019
Cited By (6)
US 1,106,444 US 1,116,103 US 1,120,314 US 12,274,865 US 12,649,031 US 12,691,227