Apparatus and methods for drug delivery using multiple reservoirs

• US 10,188,550 B2
• Filed: 05/30/2014
• Issued: 01/29/2019
• Est. Priority Date: 06/03/2013
• Status: Active Grant

• Current Assignee: Clearside Biomedical, Inc.
• Original Assignee: Clearside Biomedical, Inc.
• Inventors: Andino, Rafael Victor, Patel, Samirkumar R., Zarnitsyn, Vladimir, Brooks, Christopher John
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Doubrava, John A
• Application Number:
  US14/894,161
• Publication Number:
  US 20160106584A1
• Time in Patent Office: 1,705 Days
• Field of Search: 604 86- 91
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61M 2005/31598 having multiple telescopically sliding coaxial pistons encompassing volumes for components to be mixed
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• CPC Class Codes: A61M 5/284 comprising means for injection of two or more media, e.g. by mixing

Abstract

A cartridge, including a first member that defines an inner volume and a second member disposed therein, is disposed in a housing. A first reservoir is disposed in the inner volume in a position distal to the second member. The first member is partially disposed in a second reservoir, defined by the housing. The second member is configured to be moved from a first position, in which the first reservoir contains a drug and the second reservoir is fluidically isolated from the inner volume, toward a second position, in which the first reservoir and the second reservoir are in fluid communication with the inner volume, such that the second reservoir receives a volume of the drug from the first reservoir. The first member and the second member are collectively moved relative to the second reservoir to expel the volume of the drug from the second reservoir.

Claims

1. An apparatus, comprising:

a housing;

a cartridge assembly, at least a portion of the cartridge assembly configured to be movably disposed in the housing, the cartridge assembly including a first movable member and a second movable member, the second movable member including a seal member configured to form a fluidic seal with an inner surface of the first movable member, the first movable member defining an inner volume bounded by the seal member and the inner surface of the first movable member, at least a portion of the second movable member being movably disposed in the inner volume between a first position and a second position relative to the first movable member;

a first reservoir disposed within the inner volume such that the first reservoir is disposed in a distal position relative to the second movable member, the first reservoir containing a drug when the second movable member is in its first position relative to the first movable member, the first reservoir not being in fluid communication with the inner volume when the second movable member is in its first position, the first reservoir being placed in fluid communication with the inner volume when the second movable member is in its second position relative to the first movable member, the first movable member including a valve member configured to be transitioned from a closed configuration when the second movable member is in its first position relative to the first movable member to an open configuration (1) when the second movable member is moved toward its second position relative to the first movable member, and (2) in response to an increase in pressure within the first reservoir by distal movement of the second movable member from its first position towards its second position, the valve member further configured to be transitioned from the open configuration to the closed configuration after the second movable member is moved towards its second position relative to the first movable member; and

a second reservoir at least partially defined by the housing, a portion of the first movable member being movably disposed in the second reservoir, the second reservoir being fluidically isolated from the inner volume when the second movable member is in its first position relative to the first movable member and the valve member is in its closed configuration, the second reservoir being placed in fluid communication with the inner volume when the second movable member is moved toward its second position relative to the first movable member to receive a volume of the drug from the first reservoir and the valve member is in its open configuration, the first movable member and the second movable member collectively configured to be moved distally from a first position relative to the housing to a second position relative to the housing to expel the volume of the drug from the second reservoir.

2. The apparatus of claim 1, wherein the housing has a proximal end portion and a distal end portion, the proximal end portion defining an opening to receive at least a portion of the cartridge assembly, the distal end portion being physically and fluidically coupled to a puncture member, the puncture member being in fluid communication with the second reservoir.

3. The apparatus of claim 2, wherein the puncture member is configured to puncture ocular tissue of a patient.

4. The apparatus of claim 1, wherein the second reservoir includes a volumetric indicator.

5. The apparatus of claim 1, wherein the first reservoir is a deformable reservoir, the first reservoir including a portion configured to break open when the second movable member is moved toward its second position relative to the first movable member.

6. The apparatus of claim 1, wherein the first reservoir is a deformable reservoir, the first reservoir configured to be transitioned from a substantially undeformed configuration, in which the first reservoir contains the drug, to a deformed configuration, in which the volume of the drug is disposed substantially outside of the first reservoir.

7. The apparatus of claim 6, wherein the first movable member includes an inner surface that forms a shoulder configured to be in contact with the first reservoir, the shoulder configured to transition the first reservoir, at a point of the contact, from the substantially undeformed configuration to the deformed configuration in response to the movement of the second movable member from its first position to its second position relative to the first movable member.

8. The apparatus of claim 1, further comprising:

a safety tab movably coupled to the housing, the safety tab configured to be placed in contact with first movable member to selectively limit a movement of the first movable member relative to the housing.

9. The apparatus of claim 1, wherein the valve member is a check valve, a ball valve, a diaphragm valve, a stop valve, or a duckbill valve.

10. The apparatus of claim 1, wherein the valve member is a one way valve.

11. The apparatus of claim 1, further comprising:

an actuator configured to transition the valve between its closed configuration and its open configuration, the actuator including at least one of a toggle, a switch, a button, a slide, or a knob.

12. The apparatus of claim 1, wherein the valve member is a first valve member, the housing including a second valve member disposed in the second reservoir.

13. The apparatus of claim 1, wherein the inner volume is a first inner volume and the housing defines a second inner volume and is configured to receive a portion of a safety tab such that the safety tab extends from a first radial side of the housing to a second radial side of the housing, traversing the second inner volume, the first radial side being located opposite the second radial side, and engages the first movable member to selectively limit movement of the first movable member relative to the housing when the safety tab is engaged with the first movable member and the housing.

14. The apparatus of claim 1, wherein the valve member is a first valve member, the second reservoir further including a second valve member, the second valve member configured to be transitioned from a closed configuration to an open configuration in response to the first movable member being moved distally from the first position relative to the housing to the second position relative to the housing.

15. The apparatus of claim 1, wherein the housing has a proximal end portion and a distal end portion, the proximal end portion defining an opening to receive at least a portion of the cartridge assembly, the distal end portion being physically and fluidically coupled to a puncture member, the puncture member configured to be in fluid communication with the second reservoir in response to an increase in pressure in the second reservoir.

16. An apparatus, comprising:

a housing having a distal end portion, the distal end portion defining a substantially rigid reservoir physically and fluidically coupled to a puncture member, the puncture member configured to puncture ocular tissue of a patient; and

a cartridge assembly configured to be movably disposed in the housing, the cartridge assembly including a first movable member and a second movable member, at least a portion of the first movable member configured to be disposed in the substantially rigid reservoir, the first movable member having a shoulder and defining an inner volume, at least a portion of the second movable member being movably disposed in the inner volume between a first position and a second position, the cartridge assembly including a deformable reservoir disposed within the inner volume between the shoulder and the second movable member,

the shoulder having an inner surface including a protrusion configured to pierce the deformable reservoir when the second movable member is moved relative to the first movable member from its first position to its second position to transition the deformable reservoir from a first configuration, in which a drug is contained within the deformable reservoir, to a second configuration, in which a volume of the drug is disposed substantially outside the deformable reservoir, the substantially rigid reservoir being fluidically isolated from the inner volume when the second movable member is in its first position, the substantially rigid reservoir configured to receive the volume of the drug from the inner volume when the second movable member is moved relative to the first movable member toward its second position, the first movable member of the cartridge assembly being movable relative to the housing from a first position to a second position to deliver the volume of the drug, via the puncture member, from the second reservoir to the ocular tissue, the shoulder further having an outer surface configured to contact a safety tab when the safety tab is movably coupled to the housing, the contact with the safety tab further configured to selectively limit movement of the first movable member relative to the housing.

17. The apparatus of claim 16, wherein the puncture member defines a lumen in fluid communication with the substantially rigid reservoir, the first movable member of the cartridge assembly configured to move relative to the housing from its first position to its second position such that a pressure within the substantially rigid reservoir is sufficient to urge a flow of the drug through the lumen.

18. The apparatus of claim 16, wherein the puncture member has a proximal end portion and a distal end portion, the proximal end portion being physically and fluidically coupled to the substantially rigid reservoir, the distal end portion forming a beveled edge, the beveled edge configured to pierce ocular tissue while minimizing deformation at or near a pierce site.

19. The apparatus of claim 16, wherein the second movable member is configured to move relative to the first movable member from its first position toward its second position in response to an applied force such that a pressure within the inner volume is increased from a first pressure to a second pressure, the second pressure being sufficient to transition the deformable reservoir from the its first configuration to its second configuration.

20. The apparatus of claim 19, wherein the first movable member includes a valve member, the valve member configured to be in a closed configuration when a pressure within the inner volume is less than the second pressure, the valve member configured to transition from the closed configuration to the open configuration when a pressure within the inner volume is substantially equal to the second pressure.

21. The apparatus of claim 16, wherein the shoulder includes at least one protrusion, the protrusion having a barbed surface configured to puncture the deformable reservoir to place the deformable reservoir in its second configuration.

22. The apparatus of claim 16, wherein:

the first movable member and the second movable member are configured to be moved in a same direction relative to the housing to deliver the volume of the drug.

23. An apparatus, comprising:

a housing defining a first inner volume configured to receive a safety tab, a distal end portion of the housing being physically and fluidically coupled to a puncture member configured to puncture ocular tissue;

a first movable member defining a second inner volume and movably disposed in the first inner volume of the housing, the safety tab configured to extend from a first radial side of the housing to a second radial side of the housing, traversing a portion of the first inner volume of the housing, when releasably coupled to the housing to engage the first movable member to selectively limit movement of the first movable member relative to the housing, the first radial side being located opposite the second radial side;

a second movable member at least partially disposed in the second inner volume of the first movable member and being movable relative to the first movable member between a first position and a second position;

a first reservoir disposed within the second inner volume of the first movable member, the first reservoir configured to be transitioned between a first configuration, in which the first reservoir contains a drug, and a second configuration, in which a volume of the drug is disposed within the second inner volume of the first movable member and substantially outside of the first reservoir, when the second movable member is moved from its first position to its second position, respectively; and

a second reservoir at least partially defined by the housing, a portion of the first movable member being movably disposed in the second reservoir, the second reservoir being fluidically isolated from the second inner volume of the first movable member when the second movable member is in its first position, the second reservoir being placed in fluid communication with the second inner volume of the first movable member to receive the volume of the drug when the second movable member is moved toward its second position, the first movable member configured to be disengaged from the safety tab and moved within the second reservoir from a first position to a second position to deliver the volume of the drug, via the puncture member, from the second reservoir to the ocular tissue.

24. The apparatus of claim 23, wherein the safety tab is removably coupled to the housing, the safety tab configured to be removed from the housing when the second movable member is placed in its second position relative to the first movable member.

25. The apparatus of claim 23, wherein the second reservoir includes a volumetric indicator, the second position of the second movable member being associated with the second reservoir receiving a predetermined volume of the drug, the predetermined volume of the drug being determined based at least in part on the volumetric indicator.

26. The apparatus of claim 23, wherein the second movable member is configured to be moved substantially concurrently with the first movable member, relative to the housing, to deliver the volume of the drug from the second reservoir.

27. The apparatus of claim 23, wherein first reservoir is a deformable pouch, the first movable member including an inner surface configured to puncture a portion of the first reservoir to transition the first reservoir from its first configuration to its second configuration.

28. The apparatus of claim 23, wherein:

the first inner volume of the housing defines a slot configured to receive the safety tab.

29. The apparatus of claim 23, wherein:

the safety tab is configured to be disposed between the distal end portion of the housing and a proximal end portion of the housing when the safety tab is engaged with the first movable member.

30. The apparatus of claim 23, wherein the first movable member is partially disposed within the first inner volume when the safety tab is releasably coupled to the housing to selectively limit movement of the first movable member relative to the housing.