Apparatus and methods for ocular injection

• US 10,555,833 B2
• Filed: 04/06/2018
• Issued: 02/11/2020
• Est. Priority Date: 05/03/2013
• Status: Active Grant

• Current Assignee: Clearside Biomedical, Inc.
• Original Assignee: Clearside Biomedical, Inc.
• Inventors: Andino, Rafael Victor, Zarnitsyn, Vladimir, Yoo, Jesse, Brooks, Christopher John, Kahute, Trent John, Arsenault, Justin William, Trettin, David Jackson, Bauer, Andrew Kent, Lewis, Stephanie Elaine
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Bui, Anh
• Application Number:
  US15/946,838
• Publication Number:
  US 20180333297A1
• Time in Patent Office: 676 Days
• CPC Class Codes: A61F 2250/0007 for adjusting length
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2005/31508 provided on the piston-rod
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/31 Details
• CPC Class Codes: A61M 5/3293 characterised by features of the needle hub
• CPC Class Codes: A61M 5/34 Constructions for connecting the needle , e.g. to syringe nozzle or needle hub connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 5/344 using additional parts, e.g. clamping rings or collets
• CPC Class Codes: A61M 5/346 friction fit A61M5/344 takes precedence
• CPC Class Codes: A61M 5/347 rotatable, e.g. bayonet or screw A61M5/344 takes precedence
• CPC Class Codes: A61M 5/348 snap lock, i.e. upon axial displacement of needle assembly A61M5/344 takes precedence
• CPC Class Codes: A61M 5/349 : using adhesive bond or glues
• CPC Class Codes: A61M 5/46 : having means for controlling depth of insertion
• CPC Class Codes: A61M 5/482 : Varying injection pressure, e.g. by varying speed of injection
• CPC Class Codes: A61M 5/484 : Regulating injection pressure

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

1. An apparatus, comprising:

a medicament container configured to contain a medicament;

a hub configured to be coupled to the medicament container, the hub defining a passageway configured to receive a puncture member therethrough; 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 distal end 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 first region of a target tissue, and (2) movement of the 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 second region of the target tissue, the force having a magnitude less than a threshold value.

2. The apparatus of claim 1, wherein:

a distal end surface of the hub includes a sealing portion configured to define a substantially fluid-tight seal with a target surface of the target tissue when the distal end surface is in contact with the target surface.

3. The apparatus of claim 2, wherein:

the sealing portion is symmetrical about a centerline of the passageway.

4. The apparatus of claim 2, wherein:

the target tissue is an eye and the target surface is any one of a conjunctiva of the eye or a sclera of the eye.

5. The apparatus of claim 4, wherein:

the distal end surface of the hub is configured to deform any one of (1) the conjunctiva of the eye, (2) the sclera of the eye, (3) a choroid of the eye, or (4) a retina of the eye, when the distal end surface of the hub is in contact with the target surface.

6. The apparatus of claim 1, further comprising:

the puncture member, a centerline of the puncture member being substantially normal to a surface line tangent to the hub.

7. The apparatus of claim 1?, wherein:

the threshold value is from about 2 N to about 6 N.

8. The apparatus of claim 1, wherein:

the target tissue is an eye, the first region includes at least one of a suprachoroidal space, a lower portion of the sclera, a choroid of the eye, a subretinal space of the eye, or a retina of the eye,

the second region is an upper portion of a sclera of the eye.

9. The apparatus of claim 1, wherein:

the target tissue is an eye and the target surface is a conjunctiva of the eye,

the distal end surface of the hub being configured to displace the conjunctiva towards a sclera of the eye in response to the force.

10. The apparatus of claim 1, wherein the force is applied manually.

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

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

13. The apparatus of claim 1, further comprising the medicament, the medicament being triamcinolone.

14. The apparatus of claim 1, further comprising the puncture member, the puncture member being fixedly coupled to the hub such that the hub moves with the puncture member when the puncture member is moved relative to the target tissue.

15. The apparatus of claim 1, wherein the hub is monolithically constructed with the medicament container.

16. An apparatus, comprising:

a medicament container configured to contain a medicament;

a puncture member fluidically couplable to the medicament container; 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 distal end portion of the actuation rod moves within and relative to 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 first region of a target tissue, and (2) movement of the distal end portion of the actuation rod within and relative to 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 second region of the target tissue, the force having a magnitude less than a threshold value.

17. The apparatus of claim 16, further comprising:

a hub configured to be coupled to the medicament container, a distal end surface of the hub including a sealing portion configured to define a substantially fluid-tight seal with a target surface of the target tissue when the distal end surface is in contact with the target surface.

18. The apparatus of claim 17, wherein:

the sealing portion is symmetrical about a centerline of the passageway.

19. The apparatus of claim 17, wherein:

the target tissue is an eye and the target surface is any one of a conjunctiva of the eye or a sclera of the eye.

20. The apparatus of claim 19, wherein:

the distal end surface of the hub is configured to deform any one of (1) the conjunctiva of the eye, (2) the sclera of the eye, (3) a choroid of the eye, or (4) a retina of the eye, when the distal end surface of the hub is in contact with the target surface.

21. The apparatus of claim 16, wherein:

the threshold value is from about 2 N to about 6 N.

22. The apparatus of claim 16, wherein:

the target tissue is an eye,

the first region includes at least one of a suprachoroidal space, a lower portion of the sclera, a choroid of the eye, a subretinal space of the eye, or a retina of the eye,

the second region is an upper portion of a sclera of the eye.

23. The apparatus of claim 16, wherein the force is applied manually.

24. The apparatus of claim 16, further comprising a hub fixedly coupled to the puncture member and configured to be coupled to the medicament container via a threaded coupling.

25. An apparatus, comprising:

a medicament container configured to contain a medicament;

a hub configured to be coupled to the medicament container and defining a passageway configured to receive a puncture member therethrough, the hub having a distal end surface, the distal end surface of the hub configured to contact a target surface of a target tissue when the medicament is conveyed through the puncture member; and

an actuation rod, the actuation rod configured to be coupled to the medicament container, with the medicament container coupled to the actuation rod, the actuation rod and the puncture member collectively configured such that (1) a distal end 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 first region of the target tissue, and (2) movement of the 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 second region of the target tissue, the force having a magnitude less than a threshold value.

26. The apparatus of claim 25, wherein:

the threshold value is about 6N.

27. The apparatus of claim 25, wherein:

the force is between about 0.5N and about 2N.

28. The apparatus of claim 25, wherein:

the target tissue is an eye, the target surface is any one of a conjunctiva of the eye or a sclera of the eye,

the first region includes at least one of a suprachoroidal space, a lower portion of the sclera, a choroid of the eye, a subretinal space of the eye, or a retina of the eye,

the second region is an upper portion of a sclera of the eye.

29. The apparatus of claim 25, 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 distal end surface is in contact with the target surface.

30. The apparatus of claim 25, 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 distal end surface of the hub is in contact with the target surface, the sealing portion being symmetrical about a centerline of the passageway.

31. The apparatus of claim 25, further comprising:

the puncture member, a centerline of the puncture member being substantially normal to a surface line tangent to the hub.

32. The apparatus of claim 25, wherein:

the medicament is conveyed through the puncture member in response to movement of the actuation rod within the medicament container when the distal end portion of the puncture member is disposed within the first region of the target tissue and the actuation rod is coupled to the medicament container.

33. The apparatus of claim 25, wherein:

movement of the 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 the second region of the target tissue such that the medicament is not conveyed to the second region of the target tissue.