Apparatus and methods for ocular injection

• US 10,517,756 B2
• Filed: 04/11/2019
• Issued: 12/31/2019
• 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:
  US16/381,213
• Publication Number:
  US 20190231592A1
• Time in Patent Office: 264 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. 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 housing of the medical injector is in contact with a target surface of the target tissue;

with the distal end portion of the puncture member disposed within a first region of the target tissue and the distal end surface of the housing in contact with the target surface, exerting a force on an actuation rod of the medical injector, the force configured to produce distal movement of the puncture member relative to the housing such that the distal end portion of the puncture member enters a second region of the target tissue, distal movement of the puncture member relative to the housing in response to the force being limited when the distal end portion of the puncture member is disposed within the second region of the target tissue; and

conveying, in response to the exerting and the distal end portion of the puncture member being disposed within the second region of the target tissue, a substance from the medical injector into the second region of the target tissue via the puncture member, the force being insufficient to overcome a backpressure of the first region to convey the medicament into the first region of the target tissue via the puncture member when the distal end portion of the puncture member is disposed within the first region.

2. The method of claim 1, wherein the puncture member is moved relative to the housing via hydraulics.

3. The method of claim 1, wherein the force is sufficient to overcome a backpressure of the second region such that movement of the distal end portion of the puncture member relative to the hub is reduced and the substance is conveyed into the second region of the target tissue when the distal end portion of the puncture member moves from the first region to the second region.

4. The method of claim 1, wherein the force is less than about 6 N and is provided by an energy storage member of the medical injector.

5. The method of claim 1, wherein:

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

6. 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 substance being at least one of a VEGF, a VEGF inhibitor, a PDGFR inhibitor, or a combination thereof.

7. The method 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 second 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.

8. The method of claim 7, wherein the first region is an upper portion of a sclera of the eye.

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

10. The method of claim 1, wherein the distal end surface of the housing includes a sealing portion configured to define a fluid-tight seal with the target surface, the sealing portion being symmetrical about a centerline of the puncture member.

11. The method of claim 1, wherein the inserting is performed before the exerting is performed.

12. The method of claim 1, wherein the exerting the force on the actuation rod causes the actuation rod and the puncture member to move linearly within the housing of the medical injector when the distal end portion of the puncture member is disposed within the first region of the target tissue.

13. The method of claim 12, wherein the exerting the force on the actuation rod causes the actuation rod to move linearly within the medical injector when the distal end portion of the puncture member is disposed within the second region of the target tissue such that the substance from the medicament container is conveyed into the target tissue via the puncture member.

14. The method of 1, further comprising:

during the exerting the force on the actuation rod, maintaining a sealing force on the medical injector such that distal end surface of the housing forms a substantially fluid-tight seal with the target surface.

15. 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;

applying a first force to a housing of the medical injector such that a distal end surface of the housing contacts a target surface of the target tissue to fluidically isolate the delivery passageway; and

while maintaining the first force, applying a second force to an actuation rod of the medical injector to move the puncture member distally relative to the housing such that a distal end portion of the puncture member moves from a first region within the target tissue to a second region with the target tissue, a substance from within the medical injector being conveyed to the target tissue in response to the distal end portion of the puncture member being disposed in the second region and not the first region,

the second force being insufficient to overcome a backpressure of the first region to convey the medicament into the first region of the target tissue via the puncture member when the distal end portion of the puncture member is disposed within the first region.

16. The method of claim 15, wherein the puncture member is moved within the medical injector via hydraulics.

17. The method of claim 15, wherein the first force is less than about 6 N.

18. The method of claim 15, 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.

19. The method of claim 15, 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 substance being at least one of a VEGF, a VEGF inhibitor, a PDGFR inhibitor, or a combination thereof.

20. The method of claim 15, 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 second 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.

21. The method of claim 20, wherein the first region is an upper portion of a sclera of the eye.

22. A method, comprising:

inserting a distal end portion of a puncture member of a medical injector into a first region of a target tissue to define a delivery passageway within the target tissue, the puncture member placing a substance within a housing of the medical injector in fluid communication with the first region, an adjustment member being movably disposed within the medical injector and forming a substantially fluid-tight seal with a side wall of medical injector;

after the inserting and with the distal end portion of the puncture member disposed in the first region of the target tissue, exerting a force on the adjustment member such that the force in conjunction with the substantially fluid-tight seal produces movement of the distal end portion of the puncture member relative to the housing and from the first region to 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 second region of the target tissue.

23. The method of claim 22, wherein the force is insufficient to overcome a backpressure of the first region to convey the medicament into the target tissue via the puncture member when the distal end portion of the puncture member is disposed within the first region, the force being sufficient to overcome a frictional force formed by the substantially fluid-tight seal such that the force produces distal movement of the adjustment member within the medical injector.

24. The method of claim 23, wherein the force is sufficient to overcome a backpressure of the second region to convey the medicament into the target tissue via the puncture member when the distal end portion of the puncture member is disposed within the second region.

25. The method of claim 22, wherein the adjustment member is moved within the medical injector via hydraulics.

26. The method of claim 22, 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 second 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.

27. The method of claim 26, wherein the first region is an upper portion of a sclera of the eye.

28. The method of 22, further comprising:

during the exerting the force on the adjustment member, maintaining a force on the medical injector such that a distal end surface of the housing forms a substantially fluid-tight seal with the target surface.