Apparatus and methods for ocular injection

• US 9,180,047 B2
• Filed: 10/24/2014
• Issued: 11/10/2015
• Est. Priority Date: 05/03/2013
• Status: Active Grant

• Current Assignee: Clearside Biomedical, Inc.
• Original Assignee: Clearside Biomedical, Inc.
• Inventors: Zarnitsyn, Vladimir, Brooks, Christopher John, Andino, Rafael Victor, Yoo, Jesse
• Primary Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US14/523,243
• Publication Number:
  US 20150051581A1
• Time in Patent Office: 382 Days
• US Class Current: 1/1
• 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. A method, comprising:

inserting a distal end portion of a puncture member of a medical injector into a target tissue to define a delivery passageway within the target tissue and such that a distal end surface of a hub of the medical injector is in contact with a target surface of the target tissue;

exerting a force on an actuation rod of the medical injector when the distal end surface of the hub is in contact with the target surface, the force having magnitude of less than a threshold value, the force produces movement of a distal end portion of the actuation rod within a medicament container when the distal end portion of the puncture member is disposed within a first region of the target tissue, movement of the distal end portion of the actuation rod within the medicament container being limited when the distal end portion of the puncture member is disposed within a second region of the target tissue; and

conveying, in response to the exerting, a substance from the medicament container into the target tissue via the puncture member when the distal end portion of the puncture member is disposed within the first region of the target tissue.

2. The method of claim 1, wherein the threshold value is about 6 N.

3. The method of claim 1, wherein:

the inserting is performed such that a centerline of the delivery passageway and a surface line tangent to the target surface defines an angle of entry of between about 75 degrees and about 105 degrees.

4. The method of claim 1, wherein the inserting is performed such that a centerline of the puncture member is substantially normal to the target surface.

5. The method 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.

6. The method of claim 5, wherein:

the second region is an upper portion of a sclera of the eye, the delivery passageway extending through the sclera of the eye; and

the first region includes at least one of a suprachoroidal space, a lower portion of the sclera, a choroid of the eye, or a subretinal space of the eye, the conveying includes conveying the substance into at least one of the suprachoroidal space, the lower portion of the sclera, the choroid, or the subretinal space.

7. The method of claim 5, wherein the substance is at least one of a VEGF, a VEGF inhibitor, a PDGFR inhibitor, or a combination thereof.

8. The method of claim 1, wherein the inserting includes deforming the target surface with the distal end surface of the hub.

9. The method 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, the sealing portion being symmetrical about a centerline of the puncture member.

10. The method of claim 1, wherein the delivery passageway extends through a sclera of the eye, the conveying includes conveying the substance into at least one of a suprachoroidal space, a lower portion of the sclera, a choroid of the eye, or a subretinaal space of the eye, the method further comprising:

adjusting, before the conveying, a length of t ie puncture member extending from the distal end surface of the hub.

11. The method 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,

the inserting is performed such that a centerline of the delivery passageway and a surface line tangent to the target surface defines an angle of entry of between about 75 degrees and about 105 degrees, the inserting includes deforming the target surface with the distal end surface of the hub, the distal end surface of the hub including a sealing portion configured to define a substantially fluid-tight seal with the target surface, the sealing portion being symmetrical about a centerline of the puncture member.

12. A method, comprising:

inserting a distal end portion of a puncture member of a medical injector into a target tissue to define a delivery passageway within the target tissue, the inserting is performed such that a centerline of the puncture member and a surface line tangent to a target surface of the target tissue define an angle of entry of between about 75 degrees and about 105 degrees;

placing a distal end surface of a hub of the medical injector into contact with a target surface of the target tissue to fluidically isolate the delivery passageway, the distal end surface of the hub including a convex sealing portion configured to define a substantially fluid-tight seal with the target surface; and

conveying, after the placing, a substance into the target tissue via the puncture member.

13. The method of claim 12, wherein:

the inserting is performed such that the centerline of the puncture member is substantially normal to the surface line tangent to the target surface.

14. The method of claim 12, 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.

15. The method of claim 14, wherein:

the delivery passageway extends through a sclera of the eye; and

the conveying includes conveying the substance into at least one of a suprachoroidal space, a lower portion of the sclera, a choroid of the eye, or subretinal space of the eye.

16. The method of claim 14, wherein the substance is at least one of a VEGF, a VEGF inhibitor, a PDGFR inhibitor, or a combination thereof.

17. The method of claim 12, wherein the placing includes deforming the target surface.

18. The method of claim 12, wherein the target tissue is an eye, the method further comprising:

adjusting, after the placing, a distance between the distal end portion of the puncture member and the target surface of the eye when the distal end portion of the puncture member is initially disposed within a scelera of the eye.

19. The method of claim 12, further comprising:

exerting a force on an actuation rod of the medical injector when the distal end surface of the hub of the medical injector is in contact with the target surface, the force produces movement of a distal end portion of the actuation rod within a medicament container when the distal end portion of the puncture member is disposed within a first region of the target tissue, movement of the distal end portion of the actuation rod within the medicament container being limited when the distal end portion of the puncture member is disposed within a second region of the target tissue.

20. A method, comprising:

inserting a distal end portion of a puncture member of a medical injector into an eye to define a delivery passageway within a sclera of the eye and such that a distal end surface of a hub of the medical injector is in contact with a surface of the eye, the puncture member coupled to the hub such that the hub moves with the puncture member during the inserting; and

applying, after the inserting, a force to the medical injector such that a substance is conveyed from a medicament container of the medical injector via the puncture member when a distal tip of the puncture member is disposed within at least one of a suprachoroidal space, a lower portion of the sclera, a choroid of the eye, or a subretinal space of the eye, the force being insufficient to convey the substance from the medicament container via the puncture member when the distal tip of the puncture member is disposed within an upper portion of the sclera of the eye.

21. The method of claim 20, wherein the force is less than about 6 N.

22. The method of claim 20, wherein the force is between about 0.5 N and about 2 N.

23. The method of claim 20, wherein the puncture member has a length between about 900 μ

m and about 1100 μ

m.

24. The method of claim 20, wherein the substance includes at least one of a VEGF, a VEGF inhibitor, or a PDGFR inhibitor.

25. The method of claim 20, further comprising:

placing, before the applying;

the distal end surface of the hub of the medical injector into contact with a conjunctiva of the eye to fluidically isolate the delivery passageway; and

maintaining the distal end surface of the hub in contact with the conjunctiva while the substance is being conveyed.

26. The method of claim 25, wherein the placing includes deforming the conjunctiva with the distal end surface of the hub.

27. The method of claim 20, wherein the inserting is performed such that a centerline of the puncture member is substantially normal to a target surface of the target tissue.

28. A method, comprising:

inserting a distal end portion of a puncture member of a medical injector into an eye to define a delivery passageway within the eye and such that a distal end surface of a hub of the medical injector is in contact with a target surface of the eye, the inserting includes deforming the target surface of the eye with the distal end surface of the hub;

exerting a force on an actuation rod of the medical injector when the distal end portion of the puncture member is disposed in the eye, the force having magnitude of less than a threshold value, the medical injector configured such that the force is sufficient to move a distal end portion of the actuation rod within a medicament container when the distal end portion of the puncture member is disposed within a first region of the eye, the medical injector configured such that the force is insufficient to move the distal end portion of the actuation rod within the medicament container when the distal end portion of the puncture member is disposed within a second region of the eye; and

defining, in response to the exerting, at least a portion of a suprachoroidal space within the eye when the distal end portion of the puncture member is disposed within the first region.

29. The method of claim 28, wherein:

the inserting is performed such that a centerline of the delivery passageway and a surface line tangent to the surface defines an angle of entry of between about 75 degrees and about 105 degrees.

30. The method of claim 28, further comprising:

conveying a substance into the suprachoroidal space of the eye.