Apparatus and methods for ocular injection

Patent metadata

Field	Value
Publication number	US-9539139-B2
Application number	US-201414268687-A
Country	US
Kind code	B2
Filing date	May 2, 2014
Priority date	May 3, 2013
Publication date	Jan 10, 2017
Grant date	Jan 10, 2017

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.

First claim

The invention claimed is:

1. An apparatus, comprising:
a housing configured to receive a portion of a medicament container;
a hub coupled to the housing, the hub defining a passageway configured to receive a puncture member therethrough, the hub having a convex distal end surface, the distal end surface of the hub configured to contact a target surface of a target tissue when a substance 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 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.

2. 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 distal end surface is in contact with the target surface.

3. 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 distal end surface of the hub is in contact with the target surface, the sealing portion being symmetrical about a centerline of the passageway.

4. The apparatus of claim 1 , 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 2N to about 6N.

8. The apparatus of claim 1 , 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.

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. An apparatus, comprising:
a housing configured to receive a portion of a medicament container;
a hub coupled to the housing, the hub 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 a substance is conveyed through the puncture member; and
an actuation rod at least partially disposed within the medicament container,
the puncture member fixedly coupled to the hub such that the hub moves with the puncture member when the puncture member is moved relative to the target surface
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 the 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.

11. The apparatus of claim 10 , 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.

12. The apparatus of claim 10 , 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.

13. The apparatus of claim 10 , 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.

14. The apparatus of claim 13 , 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.

15. The apparatus of claim 10 , wherein:
a centerline of the puncture member is substantially normal to a surface line tangent to the hub.

16. The apparatus of claim 10 , wherein:
the threshold value is from about 2N to about 6N.

17. The apparatus of claim 10 , 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.

18. The apparatus of claim 10 , wherein:
at least a portion of the distal end surface of the hub has a hemispherical shape.

19. An apparatus, comprising:
a housing configured to receive a portion of a medicament container;
a hub, the hub coupled to the housing 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 a substance is conveyed through the puncture member; and
an actuation rod, the actuation rod configured to be coupled to 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 the target tissue and the actuation rod is coupled to the medicament container, 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 and the actuation rod is coupled to the medicament container, the force having a magnitude less than a threshold value.

20. The apparatus of claim 19 , wherein:
the thres

Assignees

• Clearside Biomedical Inc

Inventors

• Andino Rafael Victor
• Zarnitsyn Vladimir
• Brooks Christopher John
• Kahute Trent John
• Arsenault Justin William
• Trettin David Jackson
• Bauer Andrew Kent
• Lewis Stephanie Elaine

Classifications

• A61M2210/0612

  Eyes · CPC title

• A61M5/3293

  characterised by features of the needle hub · CPC title

• A61M5/46

  having means for controlling depth of insertion · CPC title

• A61M5/346

  friction fit (A61M5/344 takes precedence) · CPC title

• A61M2037/0061

  Methods for using microneedles · CPC title