Apparatus and methods for ocular injection

• US 9,770,361 B2
• Filed: 03/29/2017
• Issued: 09/26/2017
• 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): Eisenberg, Rebecca E
• Application Number:
  US15/472,551
• Publication Number:
  US 20170224534A1
• Time in Patent Office: 181 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 housing configured to receive at least a portion of a medicament container;

an adjustment member operably coupled to the housing and a puncture member;

a hub, the hub coupled to the housing and defining a passageway configured to receive the 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, the adjustment member, and the puncture member collectively configured such that (1) (a) a distal end portion of the actuation rod moves within the medicament container, (b) a length of the puncture member extending distally from the distal end surface of the hub increases, and (c) the adjustment member transitions from a first configuration to a second configuration, 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 puncture member relative to the distal end surface of the hub 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 adjustment member being in the second configuration when the distal end portion of the puncture member is disposed within the second region, the force having a magnitude less than a threshold value.

2. The apparatus of claim 1, wherein the actuation rod, the adjustment member, and the puncture member are collectively configured such that the length of the puncture member extending distally from the distal end surface of the hub increases in response to the force on the actuation rod when the distal end portion of the puncture member is disposed within the first region of the target tissue and the distal end surface of the hub is in contact with the target surface of the target tissue.

3. The apparatus of claim 1, wherein the threshold value is about 6N.

4. The apparatus of claim 1, wherein the force is between about 0.5N and about 2N.

5. The apparatus of claim 1, wherein:

the target tissue is an eye, the target surface is 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 the sclera of the eye the apparatus further comprising;

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

6. The apparatus of claim 1, wherein:

the force is insufficient to convey the 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.

7. The apparatus of claim 1, wherein:

the substance is conveyed through the puncture member in response to the force on the actuation rod when the distal end portion of the puncture member is disposed within the second region of the target tissue and the adjustment member is in the second configuration.

8. The apparatus of claim 1, wherein with the distal end surface of the hub in contact with the target surface and the actuation rod coupled to the medicament container,

the force on the actuation rod causes the length of the puncture member extending distally from the distal end surface of the hub to increase such that the distal end portion of the puncture member is moved from within the first region of the target tissue to the second region of the target tissue.

9. The apparatus of claim 1, wherein with the distal end surface of the hub in contact with the target surface and the actuation rod coupled to the medicament container,

the force on the actuation rod causes the adjustment member to transition from the first configuration to the second configuration such that the length of the puncture member extending distally from the distal end surface of the hub increases and the distal end portion of the puncture member is moved from within the first region of the target tissue to the second region of the target tissue.

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

11. The apparatus of claim 1, wherein:

at least a portion of the puncture member is disposed within a passageway defined by the adjustment member.

12. The apparatus of claim 1, wherein the adjustment member is configured such that the length extending distally from the distal end surface of the hub cannot increase beyond about 1200 μ

m in response to the force,

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

13. The apparatus of claim 1, wherein at least a portion of the adjustment member moves towards the distal end surface of the hub when the adjustment member transitions from the first configuration to the second configuration.

14. The apparatus of claim 1, wherein the adjustment member defines a lumen configured to place the medicament container in fluid communication with the puncture member.

15. The apparatus of claim 1, wherein the hub is configured to limit movement of the adjustment member relative to the housing.

16. The apparatus of claim 1, wherein the adjustment member is disposed within the hub.

17. The apparatus of claim 1, wherein the adjustment member is formed from at least one of an elastomeric material, thermoplastic, rubber, or silicone.

18. The apparatus of claim 1, wherein the adjustment member is coupled to the hub via at least one of a press fit, a snap fit, a threaded coupling, a mechanical fastener, or an adhesive.

19. The apparatus of claim 1, wherein the adjustment member is fixedly coupled to the puncture member.

20. An apparatus, comprising:

a housing configured to receive at least 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;

an adjustment member operably coupled to the puncture member; and

an actuation rod, the actuation rod configured to be coupled to the medicament container, the adjustment member configured to transition from a first configuration to a second configuration 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, a length of the puncture member extending distally from the distal end surface of the hub increasing in response to the adjustment member transitioning from the first configuration to the second configuration, the force having a magnitude less than a threshold value.

21. The apparatus of claim 20, wherein at least one of the threshold value is about 6N or the force is between about 0.5N and about 2N.

22. The apparatus of claim 20, 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 the sclera of the eye,

the apparatus further comprising;

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

23. The apparatus of claim 20, wherein:

the force is insufficient to convey the 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 and the adjustment member is in the first configuration.

24. The apparatus of claim 20, wherein:

the substance is conveyed through the puncture member in response to the force on the actuation rod when the distal end portion of the puncture member is disposed within the second region of the target tissue and the adjustment member is in the second configuration.

25. The apparatus of claim 20, wherein with the distal end surface of the hub in contact with the target surface,

the force on the actuation rod causes the adjustment member to transition from the first configuration to the second configuration such that the length of the puncture member extending distally from the distal end surface of the hub increases and the distal end portion of the puncture member is moved from within the first region of the target tissue to the second region of the target tissue.

26. The apparatus of claim 20, wherein the force is sufficient to overcome a backpressure of the second region such that movement of the puncture member relative to the distal end surface of the hub is reduced and the substance is conveyed into the target tissue when the distal end portion of the puncture member moves from the first region to the second region and the adjustment member transitions to the second configuration.

27. The apparatus of claim 20, wherein at least a portion of the puncture member is disposed within a passageway defined by the adjustment member, the adjustment member being formed from at least one of an elastomeric material, thermoplastic, rubber, or silicone.

28. The apparatus of claim 20, wherein at least a portion of the adjustment member moves towards the distal end surface of the hub when the adjustment member transitions from the first configuration to the second configuration.

29. The apparatus of claim 20, wherein the hub is configured to limit movement of the adjustment member relative to the housing.

30. The apparatus of claim 20, wherein the adjustment member is coupled to the hub via at least one of a press fit, a snap fit, a threaded coupling, a mechanical fastener, or an adhesive.