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1. (WO2017139375) OCULAR INJECTION KIT, PACKAGING, AND METHODS OF USE
Note: Text based on automatic Optical Character Recognition processes. Please use the PDF version for legal matters

What is claimed is:

1. An apparatus, comprising:

a first tray member defining a first volume and an opening providing access to the first volume;

a second tray member defining a second volume, a wall of the second tray member including a retainer configured to retain at least a portion of a medicament delivery device within the second volume, the second tray member configured to be disposed within first volume such that the wall of the second tray member and a wall of the first tray member enclose the medicament delivery device within the first volume; and

a cover member coupled to the first tray member about the opening, the cover member configured to maintain sterility of the first volume.

2. The apparatus of claim 1 , wherein the opening of the first tray member is obstructed by the wall of the second tray member and an opening defined by the second tray and providing access to the second volume is covered by the wall of the first tray member when the second tray member is disposed within the first tray member.

3. The apparatus of claim 1, wherein:

the first tray member includes a locking portion configured to matingly engage a flange of the second tray member to couple the second tray member within the first volume of the first tray member; and

an outer surface of the first tray member including an actuation portion against which an actuation force is applied, the actuation portion configured to deform to release the flange from the locking portion when the actuation force is applied.

4. The apparatus of claim 2, wherein

the opening of the second tray member is covered by the wall of the first tray member when the second tray member is disposed within the first tray member; and

an outer surface of the wall of the second tray member is configured to be placed, after being removed from the first volume, on a work surface within a sterile field such that the opening of the second tray member is exposed.

5. The apparatus of claim 1, wherein:

the wall of the first tray member includes a protrusion; and

the retainer of the second tray member defines a retainer opening configured to receive a portion of the medicament delivery device, the protrusion and the retainer configured to maintain the medicament delivery device in a fixed position within the third volume when the when the second tray member is disposed within the first tray member.

6. The apparatus of claim 5, wherein:

the medicament delivery device is a medical injector;

the retainer is a first retainer defining a first retainer opening configured to receive a first portion of a barrel of the medical injector; and

the second the second tray member includes a second retainer defining a second retainer opening configured to receive a second portion of the barrel of the medical injector, the protrusion of the first tray member configured to engage a third portion of the barrel of the medical injector when the second tray member is disposed within the first tray member, the third portion of the barrel between the first portion and the second portion.

7. The apparatus of claim 5, wherein:

the medicament delivery device is a medical injector;

the protrusion is a first protrusion;

the retainer is a first retainer;

the wall of the first tray member includes a second protrusion; and

the second tray member includes a second retainer configured to receive a portion of a needle assembly, the second protrusion and the second retainer configured to maintain the needle assembly in a fixed needle position within the third volume, spaced apart from the medical injector.

8. The apparatus of claim 1, wherein the first tray member defines a container volume configured to receive a medicament container, the container volume being exposed when the cover member is coupled to the first tray member, the apparatus further comprising:

a sleeve configured to be disposed about the first tray member when the second tray member is coupled within first volume, the sleeve configured to cover the container volume and a portion of the cover member disposed about the first volume.

9. The apparatus of claim 8, wherein:

the cover member includes an indicium associated with at least one of the medicament delivery device or the medicament container; and

the sleeve defines an opening, the opening aligned with the cover member when the sleeve is disposed about the first tray member such that the indicium is visible through the opening.

10. The apparatus of claim 8, wherein:

an outer surface of the sleeve includes an indicium associated with an instruction for using the medicament delivery device.

11. The apparatus of claim 8, further comprising:

the medicament container containing a medicament, the medicament including at least one of mycophenolate, infliximab, nepafenac, azathioprine, cyclosphosphamide, dexamethasone, difluprednate, fluocinolone, fluorometholone, leteprednol, prednisolone acetate, prednisolone sodium phosphate, rimexolone, triamcinolone, bromfenac, diclofenac, fluibiprofen, ketorolac, adalimumab, etanercept, certolizumab, gotimumab, daclizumab, rituximab, abatacept, basiliximab, belimumab, anakinra, efalizuma, alefacept, and natalizumab.

12. The apparatus of claim 8, further comprising:

the medicament container containing a medicament, the medicament including at least one of triamcinolone or triamcinolone acetonide.

13. An apparatus, comprising:

a first tray member having a first portion and a second portion, the first portion defining a first volume, the second portion defining a container volume, the container volume configured to receive a medicament container;

a second tray member defining a second volume, the second tray member including a retainer configured to retain a medicament delivery device within the second volume, the second tray member configured to be coupled within the first volume such that the medicament delivery device is disposed within the first volume; and

a cover member configured to be coupled to the first tray member about the first volume, the cover member configured to maintain sterility of the first volume, the container volume being exposed when the cover member is coupled to the first tray member.

14. The apparatus of claim 13, wherein the medicament delivery device is any one of a syringe, a pen inj ector, a transdermal delivery device, an inhaler, or a nebulizer.

15. The apparatus of claim 13, wherein:

the medicament container is a vial containing a medicament; and

the medicament delivery device includes a reservoir configured to receive a dose of the medicament from the medicament container after the medicament delivery device is removed from the second volume.

16. The apparatus of claim 13, further comprising:

a sleeve configured to be disposed about the first tray member when the second tray member is coupled within first volume, the sleeve configured to cover the container volume and a portion of the cover member disposed about the first volume.

17. The apparatus of claim 16, wherein:

the cover member includes an indicium associated with at least one of the medicament delivery device or the medicament container; and

the sleeve defines an opening, the opening aligned with the cover member when the sleeve is disposed about the first tray member such that the indicium is visible through the opening.

18. The apparatus of claim 13, wherein the second tray member is configured to be coupled within first volume such that a wall of the second tray member and a wall of the first tray member enclose the medicament delivery device within the first volume.

19. The apparatus of claim 18, wherein:

the first tray member defines an opening providing access to the first volume; and the second tray member defines an opening providing access to the second volume, the opening of the first tray member being obstructed by the wall of the second tray member and the opening of the second tray member being covered by the wall of the first tray member when the second tray member is disposed within the first tray member.

20. The apparatus of claim 13, wherein:

the first tray member includes a locking portion configured to matingly engage a flange of the second tray member to couple the second tray member within the first volume of the first tray member,

an outer surface of the first tray member including an actuation portion against which an actuation force is applied, the actuation portion configured to deform to release the flange from the locking portion when the actuation force is applied.

21. The apparatus of claim 13, wherein:

the first tray member includes a wall having a protrusion; and

the retainer of the second tray member defines a retainer opening configured to receive a portion of the medicament delivery device, the protrusion and the retainer configured to maintain the medicament delivery device in a fixed position within the second volume when the when the second tray member is disposed within the first tray member.

22. The apparatus of claim 21 , wherein:

the medicament delivery device is a medical injector;

the protrusion is a first protrusion;

the retainer is a first retainer;

the wall of the first tray member includes a second protrusion; and

the second tray member includes a second retainer configured to receive a portion of a needle assembly, the second protrusion and the second retainer configured to maintain the needle assembly in a fixed needle position within the second volume, spaced apart from the medical injector.

23. The apparatus of claim 21 , wherein a longitudinal axis of the medicament delivery device is substantially parallel to a wall of the second tray member when the medicament delivery device in the fixed position within the second volume.

24. The apparatus of claim 21 , wherein

the second tray member defines an opening providing access to the second volume, the opening of the second tray member being covered by the wall of the first tray member when the second tray member is disposed within the first tray member; and

an outer surface of the wall of the second tray member is configured to be placed, after being removed from the first volume, on a work surface within a sterile field such that the opening of the second tray is exposed.

25. A method, comprising:

orienting a tray assembly such that an opening defined by a first tray member is spaced apart from and facing a sterile surface, the tray assembly including the first tray member and a second tray member, the first tray member defining a first volume, the opening of the first tray member providing access to the first volume, the second tray member defining a second volume within which a medicament delivery device is retained, the second tray member coupled within the first volume such that a wall of the second tray member and a wall of the first tray member enclose the medicament delivery device; and

releasing the second tray member from within the first volume to place the second tray member on the sterile surface such that an opening defined by the second tray member and providing access to the second volume is facing opposite the sterile surface, a retainer of the second tray member maintaining the medicament delivery device in a fixed position within the second volume.

26. The method of claim 25, further comprising:

removing, before the orienting, a cover member from about the first volume, the cover member constructed from a material formulated to maintain sterility of the first volume.

27. The method of claim 26, wherein the first tray member defines a container volume within which a medicament container is retained, the medicament container being exposed when the cover member is coupled to the first tray member, the method further comprising: removing a sleeve from about the tray assembly before the removing the cover member from about the first volume.

28. The method of claim 27, wherein:

the cover member includes an indicium associated with at least one of the medicament delivery device or the medicament container; and

the sleeve defines an opening, the opening aligned with the cover member when the sleeve is disposed about the tray assembly member such that the indicium is visible through the opening.

29. The method of claim 25, wherein:

the first tray member includes a locking portion configured to matingly engage a flange of the second tray member to couple the second tray member within the first volume of the first tray member; and

the releasing includes applying an actuation force against an outer surface of the first tray member to deform the locking portion to release the flange from the locking portion.

30. The method of claim 29, wherein:

the releasing is performed without contact between a user applying the actuation force and the second tray member.

31. The method of claim 29, wherein an outer surface of the second tray member is placed on the sterile surface after the releasing in response to the actuation force and a gravitational force.

32. The method of claim 31 , wherein the wall of the second tray member includes the outer surface and a lateral portion that extends from and surrounds the outer surface, the wall portion defining, in part, the second volume, the lateral portion providing a barrier to preserve the integrity of the second volume.

33. The method of claim 25, wherein:

the wall of the first tray member includes a protrusion; and

the retainer of the second tray member defines a retainer opening configured to receive a portion of the medicament delivery device, the protrusion and the retainer configured to maintain the medicament delivery device in a fixed position within the second volume before the releasing.

34. The method of claim 33, wherein:

the medicament delivery device is a medical injector;

the protrusion is a first protrusion;

the retainer is a first retainer;

the wall of the first tray member includes a second protrusion; and

the second tray member includes a second retainer configured to receive a portion of a needle assembly, the second protrusion and the second retainer configured to maintain the needle assembly in a fixed needle position within the second volume before the releasing.

35. The method of claim 25, wherein the medicament delivery device is a medical injector, the retainer is a first retainer, the second tray member includes a second retainer configured to receive a portion of a needle assembly, the second retainer configured to maintain the needle assembly in a fixed needle position within the second volume before the releasing, the method further comprising:

removing, after the releasing the second tray member, the medical injector from retainer; and

coupling the needle assembly to the medical injector.

36. The method of claim 25, wherein the first tray member defines a container volume within which a medicament container is retained, the medicament delivery device is a medical injector including a container adapter coupled to a distal end portion of a barrel, the method further comprising:

removing the medicament container from the container volume;

coupling, after the releasing the second tray member, the barrel of the medicament injector to the medical container via the container adapter; and

actuating the medical injector to withdraw a dose of medicament from the medicament container into the barrel.

37. The method of claim 36, wherein the medicament includes at least one of mycophenolate, infliximab, nepafenac, azathioprine, cyclosphosphamide, dexamethasone, difluprednate, fluocinolone, fluorometholone, leteprednol, prednisolone acetate, prednisolone sodium phosphate, rimexolone, triamcinolone, bromfenac, diclofenac, fluibiprofen, ketorolac, adalimumab, etanercept, certolizumab, gotimumab, daclizumab, rituximab, abatacept, basiliximab, belimumab, anakinra, efalizuma, alefacept, and natalizumab.

38. The method of claim 36, wherein the medicament includes at least one of triamcinolone or triamcinolone acetonide.

39. A kit, comprising:

a medical injector;

a medicament container; and

a tray assembly, the tray assembly including:

a first tray member defining a first volume and a container volume, the medicament container retained within the second volume;

a second tray member defining a second volume within which the medical injector is disposed, a wall of the second tray member including a retainer that retains the medical inj ector within the second volume, the second tray member coupled within first volume such that the wall of the second tray member and a wall of the first tray member enclose the medical injector; and

a cover member coupled to the first tray member about the first volume, the cover member configured to maintain sterility of the first volume.

40. The kit of claim 39, wherein:

the first tray member includes a locking portion configured to matingly engage a flange of the second tray member to couple the second tray member within the first volume of the first tray member; and

an outer surface of the first tray member including an actuation portion against which an actuation force is applied, the actuation portion configured to deform to release the flange from the locking portion when the actuation force is applied.

41. The kit of claim 39, wherein

the opening of the second tray member is covered by the wall of the first tray member when the second tray member is disposed within the first tray member; and

an outer surface of the wall of the second tray member is configured to be placed, after being removed from the first volume, on a work surface within a sterile field such that the opening of the second tray is exposed.

42. The kit of claim 39, wherein the first tray member defines a container volume configured to receive a medicament container, the container volume being exposed when the cover member is coupled to the first tray member, the apparatus further comprising:

a sleeve configured to be disposed about the first tray member when the second tray member is coupled within first volume, the sleeve configured to cover the container volume and a portion of the cover member disposed about the first volume.

43. The kit of claim 42, wherein:

the cover member includes an indicium associated with at least one of the medicament delivery device or the medicament container; and

the sleeve defines an opening, the opening aligned with the cover member when the sleeve is disposed about the first tray member such that the indicium is visible through the opening.

44. The kit of claim 42, wherein:

an outer surface of the sleeve includes an indicium associated with an instruction for using the medical injector.

45. The kit of claim 39, wherein the medicament container contains a medicament, the medicament including at least one of mycophenolate, infliximab, nepafenac, azathioprine, cyclosphosphamide, dexamethasone, difluprednate, fluocinolone, fluorometholone, leteprednol, prednisolone acetate, prednisolone sodium phosphate, rimexolone, triamcinolone, bromfenac, diclofenac, fluibiprofen, ketorolac, adalimumab, etanercept, certolizumab, gotimumab, daclizumab, rituximab, abatacept, basiliximab, belimumab, anakinra, efalizuma, alefacept, and natalizumab.

46. The kit of claim 39, wherein the medicament container contains a medicament, the medicament including at least one of triamcinolone or triamcinolone acetonide.