Claims for Patent: 9,603,739

Summary for Patent: 9,603,739

Title:	Intraocular delivery devices and methods therefor
Abstract:	Injection devices for delivering pharmaceutical compositions into the eye are described. Some devices include a resistance component for controllably deploying an injection needle through the eye wall. The resistance component may be disposed on the injector device, or on a portion of the injection device housing, or on a drug reservoir. Some devices may be removably attached to a drug reservoir, for example, through a luer connector. Other devices may comprise internal luer seal for securely connecting a drug conduit of the device to the luer cavity of a drug reservoir. Yet other devices may comprise a priming-enabling element to facilitate the drug priming of a shielded needle. Related methods and systems comprising the devices are also described.
Inventor(s):	Lerner; Leonid E. (Corona Del Mar, CA)
Assignee:	OcuJect, LLC (Newport Beach, CA)
Application Number:	14/839,795
Patent Claims:	1. A needle assembly, comprising: a needle hub comprising a tubular body and comprising an input port on its proximal end configured for direct removable connection to a luer port on a distal end of a syringe, the syringe comprising a syringe body forming a drug reservoir, the needle hub further comprising a distal stop surface; a needle comprising a proximal portion and a distal portion, the proximal portion of the needle housed within the tubular body of the needle hub, and a distal end of the needle extending distally beyond the needle hub; a slidable shield operatively coupled to the needle hub, the slidable shield configured for axial movement along the needle hub between the input port and the distal stop surface and configured such that the needle is completely circumscribed by the shield when the shield is in a first, distal position with respect to the needle hub, and the distal portion of the needle extends distally beyond the shield when the shield is in a second, proximal position with respect to the needle hub; an atraumatic ocular contact surface configured to be atraumatic to the conjunctiva or corneal surfaces, the ocular contact surface comprising a perimeter and coupled to a distal end of the slidable shield; and a first resistance component comprising a clip removably attached to the tubular body of the needle hub and positioned between a distal end of the input port and the proximal end of the slidable shield, the clip abutting a radially extending annular wall of the distal end of the input port, the clip comprising a tab to facilitate removal of the clip, the first resistance component configured to reversibly prevent axial movement of the slidable shield and to maintain the slidable shield in the first, distal position with respect to the needle hub. 2. The needle assembly of claim 1, wherein the first resistance component is removably attached to the tubular body of the needle hub. 3. The needle assembly of claim 1, wherein the distal portion of the needle resides completely within a channel while the shield is in the first, distal position with respect to the needle, the channel comprising a diameter that is within 0.12 mm greater or less than an outer diameter of the needle. 4. The needle assembly of claim 1, wherein the distal portion of the needle resides completely within a channel while the shield is in the first, distal position with respect to the needle, wherein the channel comprises a first zone comprising a first diameter and a second zone comprising a second diameter, the second diameter being greater than the first diameter. 5. The needle assembly of claim 1, further comprising a plurality of projections extending radially outwardly from the perimeter of the atraumatic ocular contact surface, the plurality of projections configured to measure a precise distance between the distal end of the needle and an anatomical landmark of a patient's surface tissue, the plurality of projections comprising substantially the same shape and length. 6. The needle assembly of claim 5, wherein the plurality of projections comprises at least 3 projections. 7. The needle assembly of claim 5, wherein the plurality of projections are flexible. 8. The needle assembly of claim 6, wherein the at least 3 projections span a curvilinear distance between about 30 degrees and about 180 degrees of the perimeter of the atraumatic ocular contact surface. 9. The needle assembly of claim 1, wherein the input port comprises a luer connector. 10. The needle assembly of claim 1, wherein the ocular contact surface comprises a material comprising a Shore A durometer of between about 2 and about 70. 11. The needle assembly of claim 1, wherein the ocular contact surface comprises a material comprising a Shore A durometer of between about 5 and about 60. 12. The needle assembly of claim 1, wherein the ocular contact surface comprises a material comprising a Shore A durometer of about 18. 13. The needle assembly of claim 1, wherein the ocular contact surface comprises a material selected from the group consisting of: a polymer, silicone, and a thermoplastic elastomer. 14. The needle assembly of claim 1, wherein the ocular contact surface is fixed to the distal end of the slidable shield. 15. The needle assembly of claim 1, wherein the needle assembly is configured such that a force of between about 0.1 grams and about 100 grams is required to initiate axial movement of the slidable shield. 16. The needle assembly of claim 1, wherein the needle assembly is configured such that a force of between about 3 grams and about 30 grams is required to initiate axial movement of the slidable shield. 17. The needle assembly of claim 1, wherein the slidable shield has a fixed axial dimension. 18. A system comprising the needle assembly of claim 1, and a drug reservoir comprising one or more therapeutic agents configured for intravitreal injection. 19. The system of claim 18, wherein the one or more therapeutic agents are selected from the group consisting of ranibizumab, bevacizumab, aflibercept, Fovista, ocriplasmin, and modifications, derivatives, and analogs thereof, and combinations thereof. 20. The system of claim 18, wherein the one or more therapeutic agents comprises one or more of the group selected from: an anti-VEGF agent, an anti-PDGF agent, an anti-PDGFR-.beta. agent, an anti-complement factor agent, a steroid, a placenta-derived growth factor, or combinations thereof. 21. The system of claim 18, wherein the one or more therapeutic agents comprises an anti-complement agent, an anti-complement fraction agent, a complement-blocking agent, a complement-enhancing agent, a classic complement pathway inhibiting agent, an alternative complement inhibiting agent, a classic complement pathway potentiating agent, an alternative complement potentiating agent, or a combination thereof. 22. The needle assembly of claim 1, wherein the first resistance component comprises a clip or a lever, and wherein the needle assembly further comprising a second resistance component configured to slow axial movement of the slidable shield. 23. The needle assembly of claim 4, wherein the first diameter is within 0.12 mm greater or less than an outer diameter of the needle. 24. A needle assembly, comprising: a needle hub comprising a tubular body and comprising an input port on its proximal end for direct removable connection to a port on a distal end of a syringe comprising a drug reservoir, the needle hub further comprising a distal stop surface; a needle comprising a proximal portion and a distal portion, the proximal portion of the needle housed within the tubular body of the needle hub, and a distal end of the needle extending distally beyond the needle hub; a slidable shield operatively coupled to the needle hub, the slidable shield configured for axial movement along the needle hub between the input port and the distal stop surface and configured such that the needle is completely circumscribed by the shield when the shield is in a first, distal position with respect to the needle hub, and the distal portion of the needle extends distally beyond the shield when the shield is in a second, proximal position with respect to the needle hub; an ocular contact surface configured to be atraumatic to the conjunctiva or corneal surfaces, the ocular contact surface coupled to a distal end of the slidable shield; and a resistance component removably attached to an annular wall on the tubular body of the needle hub, the resistance component configured to reversibly prevent axial movement of the slidable shield and to maintain the slidable shield in the first, proximal position with respect to the needle hub, wherein the resistance component comprises a clip, the clip comprising a tab for facilitating removal of the clip, the clip directly contacting a distal end of the input port and the proximal end of the slidable shield, the clip comprising an axial length sufficient such that the slidable shield completely covers the needle when the clip is attached to the needle hub.

Details for Patent 9,603,739

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2032-04-02
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	06/30/2006		2032-04-02
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	08/10/2012		2032-04-02
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	10/13/2016		2032-04-02
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	03/20/2018		2032-04-02