Claims for Patent: 9,320,647

Summary for Patent: 9,320,647

Title:	Device and method for intraocular drug delivery
Abstract:	Injection 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:	13/249,087
Patent Claims:	1. An injection device for intraocular drug delivery through an injection site comprising: a housing sized and shaped for manipulation with one hand, the housing having a proximal end, a distal end, and a longitudinal axis; a resistance band at least partially surrounding the housing having a thickness between about 0.01 mm to about 5 mm; a dynamic resistance component having a proximal end and a distal end movably carried by the housing; an ocular contact surface at the dynamic resistance component distal end; a conduit at least partially within the housing, the conduit having a proximal end, a distal end, and a lumen extending therethrough; and a sectoral measuring component coupled to the distal end of the housing and having a central core, the central core having a circumference and comprising three members including a first member, a second member, and a third member extending radially outwardly away from the longitudinal axis and the circumference, each of the three members being sized and configured to touch a limbus line of an eye, wherein the sectoral measuring component can be rotated to a first orientation in which only a tip of the first member touches the limbus line when the tip of the first member is perpendicular to the limbus line of the eye indicating that the injection site is localized at a first distance from the limbus line; wherein the sectoral measuring component can be rotated to a second orientation in which the tip of the first member and a tip of the second member touches the limbus line when the tip of the first member and the tip of the second member is perpendicular to the limbus line indicating that the injection site is localized at a second distance from the limbus line different from the first distance, wherein the ocular contact surface has a perimeter, and the perimeter encloses a fixed shape, wherein the dynamic resistance component has a first configuration in which the conduit is completely circumscribed by the dynamic resistance component distally and by the housing proximally, and a second configuration in which the conduit extends distally beyond the dynamic resistance component for intraocular injection. 2. The injection device of claim 1, wherein the actuation mechanism comprises a slidable control lever. 3. The injection device of claim 1, wherein the three radially extending members are configured to span between 1 degree and 180 degrees of arc around the circumference of the central core. 4. The injection device of claim 1, wherein the three radially extending members are configured to span between 45 degrees and 90 degrees of arc around the circumference of the central core. 5. The injection device of claim 1, wherein the sectoral measuring component is configured to rotate about the longitudinal axis. 6. The injection device of claim 1, wherein the dynamic resistance component comprises a dynamic sleeve. 7. An integrated device for intraocular drug delivery through an injection site comprising: a housing sized and shaped for manipulation with one hand, the housing having a proximal end, a distal end, and a longitudinal axis; a sectoral measuring component coupled to the distal end of the housing and having a central core, the central core having a circumference and comprising three members including a first member, a second member, and a third member extending radially outwardly away from the longitudinal axis and the circumference, each of the three members being sized and configured to touch a limbus line of an eye, wherein the sectoral measuring component can be rotated to a first orientation in which a tip of only the first member touches the limbus line when the tip of the first member is perpendicular to the limbus line indicating that the injection site is localized at a first distance from the limbus line; wherein the sectoral measuring component can be rotated to a second orientation in which the tip of the first member and a tip of the second member touches the limbus line when the tip of the first member and the tip of the second member is perpendicular to the limbus line indicating that the injection site is localized at a second distance from the limbus line different from the first distance; a conduit at least partially within the housing, the conduit having a proximal end, a distal end, and a lumen extending therethrough; wherein the sectoral measuring component is rotatable about the longitudinal axis independent of and relative to the housing. 8. The integrated device of claim 7, wherein the three radially extending members are configured to span between 1 degree and 180 degrees of arc around the circumference of the central core. 9. The integrated device of claim 7, wherein the three radially extending members are configured to span between 45 degrees and 90 degrees of arc around the circumference of the central core. 10. The integrated device of claim 7, wherein the three members comprise tab or spoke members. 11. The integrated device of claim 7, wherein the three members have substantially the same shape and length. 12. The integrated device of claim 7, wherein the first distance is about 4 mm and the second distance is about 3.5 mm. 13. An injection device for intraocular drug delivery comprising: a housing sized and shaped for manipulation with one hand, the housing having a wall, a proximal end, a distal end, and a longitudinal axis; an ocular contact surface at the housing distal end, the ocular contact surface carried by a dynamic resistance component comprising a tubular body movable between a proximal position and a distal position; a conduit at least partially within the housing, the conduit having a proximal end, a distal end, and a lumen extending therethrough; an actuation mechanism coupled to the housing and operably connected to a reservoir for holding an agent; an atraumatic sectoral measuring component coupled to the distal end of the housing and having a central core, the central core having a circumference and comprising three members extending radially outwardly away from the longitudinal axis and the circumference, wherein each of the three members has substantially the same shape and length and span a curvilinear distance between about 30 degrees and about 180 degrees of the circumference of the central core, wherein axial movement of the ocular contact surface can be accomplished to the distal position without change to any transverse dimension of the tubular body; wherein the ocular contact surface is rotatable about the longitudinal axis independent of and relative to the housing, wherein the dynamic resistance component has a configuration in which the conduit is completely circumscribed by the dynamic resistance component distally and by the housing proximally, wherein the dynamic resistance component is concentrically disposed about the conduit and at least part of the housing. 14. The injection device of claim 13, wherein the agent is selected from the group consisting of anti-neovascularization agents, anti-VEGF agents, anti-PDGF agents, anti-vascular permeability agents, protein kinase C inhibitors, EGF inhibitors, tyrosine kinase inhibitors, steroidal anti-inflammatories, nonsteroidal anti-inflammatories, anti-infectives, anti-allergens, cholinergic antagonists and agonists, adrenergic antagonists and agonists, anti-glaucoma agents, neuroprotection agents, agents for cataract prevention or treatment, 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, aptamers, antibodies or antibody fragments, growth factor receptors and receptor fragments, analogs, derivatives, and modifications thereof, and combinations thereof. 15. The injection device of claim 13, wherein the agent is selected from the group consisting of ranibizumab, bevacizumab, VEGF-trap, VEGF receptor fragments or analogs, pegaptanib, dexamethasone, dexamethasone sodium phosphate, triamcinolone, triamcinolone acetonide, fluocinolone, taxol-like drugs, aflibercept, anecortave acetate, and limus family compounds. 16. The injection device of claim 13, wherein the dynamic resistance component comprises a dynamic sleeve. 17. The injection device of claim 13, further comprising a resistance band wholly or partially surrounding the housing. 18. The injection device of claim 13, comprising an access port in the wall of the housing. 19. The injection device of claim 18, comprising a stopper for sealing the access port. 20. An injection device for drug delivery comprising: a housing sized and shaped for manipulation with one hand, the housing having a proximal end, a distal end, and a longitudinal axis; a resistance band at least partially surrounding the housing having a thickness between about 0.01 mm to about 5 mm; a dynamic resistance component having a fixed axial length, a proximal end and a distal end movably carried by the housing; a patient contact surface at the dynamic resistance component distal end; and a conduit at least partially within the housing, the conduit having a proximal end, a distal end, and a lumen extending therethrough, the conduit fluidly connected to the input port; and an atraumatic sectoral measuring component configured to determine an ocular injection site coupled to a distal end of the housing and having a central core, the central core having a circumference and comprising three tab or spoke members extending radially outwardly away from the longitudinal axis and the circumference, wherein each of the three members has the same shape and length, wherein the patient contact surface has a perimeter, and the perimeter encloses a fixed shape, wherein the dynamic resistance component has a first configuration in which the conduit is completely circumscribed by the dynamic resistance component distally and by the housing proximally, and a second configuration in which the conduit extends distally beyond the dynamic resistance component for injection.

Details for Patent 9,320,647

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
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	08/16/2018		2030-03-31