Claims for Patent: 9,408,746

Summary for Patent: 9,408,746

Title:	Device and method for intraocular drug delivery
Abstract:	Devices for delivering pharmaceutical formulations into the eye are described. The devices may be integrated to include features that allow safe and atraumatic manipulation of the devices with one hand. For example, accurate placement, including proper angulation, of the device on the eye and injection of a pharmaceutical formulation into the eye can be performed using one hand. The devices may also include improved safety features. For example, the devices may include an actuation mechanism that controls the rate and depth of injection into the eye. Some devices include a dynamic resistance component capable of adjusting the amount of pressure applied to the eye surface. Related methods and systems comprising the devices are also described.
Inventor(s):	Lerner; Leonid E. (Corona Del Mar, CA), Shubayev; Igor (San Diego, CA)
Assignee:	OcuJect, LLC (Newport Beach, CA)
Application Number:	13/077,929
Patent Claims:	1. An injection device for intraocular drug delivery comprising: a housing having a proximal end and a distal end; a conduit having a proximal end and a distal end, the proximal end of the conduit proximate and fluidly connected to an input port; a dynamic sleeve concentrically disposed about the conduit and the housing and having a distal end and a fixed axial length; an arcuate atraumatic ocular contact surface at the dynamic sleeve distal end; a measuring component comprising a plurality of measuring members extending radially from a perimeter of the arcuate atraumatic ocular contact surface, the plurality of measuring members spaced apart from each other, the plurality of measuring members comprising the same size and shape; wherein the dynamic sleeve is movable between a first configuration in which the conduit extends distally beyond the dynamic sleeve distal end for intraocular injection and a second configuration in which the conduit is retracted completely within the dynamic sleeve distally and within the housing proximally; and wherein the housing, the conduit and the dynamic sleeve are combined into a single integrated device. 2. The injection device of claim 1, wherein the dynamic sleeve further comprises a mobility control component. 3. The injection device of claim 1, wherein the injection device comprises a locking mechanism configured to control movement of the dynamic sleeve. 4. The injection device of claim 1, further comprising an active agent reservoir. 5. The injection device of claim 1, wherein the measuring component comprises three or more radially extending measuring members. 6. The injection device of claim 1, wherein the plurality of radially extending measuring members are disposed on one side of the atraumatic ocular contact surface. 7. The injection device of claim 5, wherein the three or more radially extending measuring members are disposed 360 degrees about the circumference of the ocular contact surface. 8. The injection device of claim 1, wherein the atraumatic ocular contact surface is convex or concave. 9. The injection device of claim 1, wherein the atraumatic ocular contact surface comprises one or more traction elements. 10. The injection device of claim 1, wherein the atraumatic ocular contact surface comprises a thermoplastic elastomer. 11. The injection device of claim 1, wherein the atraumatic ocular contact surface comprises a material selected from the group consisting of nylon fiber, cotton fiber, hydrogel, spongiform material, styrofoam, other foams, thermoplastic polymers, silicone, plastic, polypropylene, polyethylene, polytetrafluoroethylene, and combinations thereof. 12. The injection device of claim 1, further comprising a manual, automated, or partially automated actuation mechanism. 13. The injection device of claim 4, wherein the reservoir contains an active agent selected from the group consisting of steroidal anti-inflammatories, nonsteroidal antiinflammatories, anti-infectives, anti-allergens, cholinergic antagonists and agonists, adrenergic antagonists and agonists, anti-glaucoma agents, neuroprotection agents, agents for cataract prevention or treatment, anti-platelet agents, anti-proliferatives, anti-tumor agents, complement inhibitors, vitamins, growth factors, agents to inhibit growth factors, gene therapy vectors, chemotherapy agents, protein kinase inhibitors, small interfering RNAs, analogs, derivatives, and modifications thereof, and combinations thereof. 14. The injection device of claim 4, wherein the reservoir contains an active agent selected from the group consisting of ranibizumab, bevacizumab, pegaptanib, dexamethasone, dexamethasone sodium phosphate, triamcinolone, triamcinolone acetonide, fluocinolone, taxol-like drugs, aflibercept, anecortave acetate, limus family compounds, and combinations thereof. 15. The injection device of claim 12, wherein the actuation mechanism has a first non-deployed state, and a second deployed state, and when in the second deployed state, the actuation mechanism is configured to advance the conduit through an eye wall up to a predetermined conduit length. 16. The injection device of claim 1, wherein the injection device further comprises a trigger coupled to the housing. 17. The injection device of claim 16, wherein the trigger is operatively connected to a plunger. 18. The injection device of claim 4, wherein the reservoir contains an active agent selected from the group consisting of agents to inhibit growth factors and complement inhibitors. 19. The injection device of claim 18, wherein the active agent comprises an anti-05 agent. 20. The injection device of claim 19, wherein the active agent is selected from the group consisting of anti-C5a and anti-C5b agents. 21. An injection device for drug delivery comprising: a conduit having a proximal end and a distal end, the proximal end of the conduit proximate and fluidly connected to an input port; a dynamic sleeve concentrically disposed about the conduit and having a distal end and a fixed axial length; an arcuate atraumatic ocular contact surface at the dynamic sleeve distal end; and a measuring component comprising a plurality of measuring members extending radially from a perimeter of the arcuate atraumatic ocular contact surface, the plurality of measuring members spaced apart from each other, the plurality of measuring members comprising the same size and shape, wherein the dynamic sleeve is movable between a first configuration in which the conduit extends distally beyond the dynamic sleeve distal end for injection into a patient and a second configuration in which the conduit is retracted completely within the dynamic sleeve distally. 22. The injection device of claim 21, comprising at least three measuring members.

Details for Patent 9,408,746

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2030-03-31
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	06/30/2006		2030-03-31
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	08/10/2012		2030-03-31
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	10/13/2016		2030-03-31
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	03/20/2018		2030-03-31
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	11/18/2011		2030-03-31