Ocular injection kit, packaging, and methods of use

• US 10,390,901 B2
• Filed: 02/08/2017
• Issued: 08/27/2019
• Est. Priority Date: 02/10/2016
• Status: Active Grant

• Current Assignee: Clearside Biomedical, Inc.
• Original Assignee: Clearside Biomedical, Inc.
• Inventors: Godfrey, Thomas Edward, Andino, Rafael Victor, Hancock, Shelley Eckert, Strudthoff, Keleigh Jo
• Primary Examiner(s): Long, Robert F
• Assistant Examiner(s): Madison, Xavier A
• Application Number:
  US15/427,823
• Publication Number:
  US 20170224435A1
• Time in Patent Office: 930 Days
• Field of Search: 53492
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 2050/3008 having multiple compartments
• CPC Class Codes: A61B 2050/3015 transparent
• CPC Class Codes: A61B 50/20 Holders specially adapted for surgical or diagnostic appliances or instruments drapes with means to hold surgical instruments A61B46/23; for catheters A61M25/02
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 50/33 Trays
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61J 1/00 Containers specially adapted for medical or pharmaceutical purposes capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00
• CPC Class Codes: A61M 2205/6063 Optical identification systems
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: B65D 25/02 Internal fittings of containers made by folding or erecting blanks made of paper B65D5/44
• CPC Class Codes: B65D 25/205 Means for the attachment of labels, cards, coupons or the like; cards or coupons for the other types of rigid or semi-rigid containers B65D25/36 takes precedence
• CPC Class Codes: B65D 75/36 one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages , the recess or recesses being preformed B65D73/0057, B65D73/0092 take precedence
• CPC Class Codes: B65D 75/367 and forming several compartments
• CPC Class Codes: B65D 77/0433 the inner container being a tray or like shallow container, not formed by folding or erecting one or more blanks B65D81/3862 takes precedence

Abstract

An apparatus includes a first tray member, a second tray member, and a lid. The first tray member has a first portion and a second portion. The first portion defines a first volume, and the second portion defines a second volume configured to receive a medicament container. The second tray member defines a third volume having a sidewall including a retention portion configured to retain an ocular injector within the third volume. The second tray member is coupled within first volume such that the sidewall of the second tray member and a sidewall of the first tray member enclose the ocular injector. The lid is coupled to the first tray member about the first volume, and is constructed from a material formulated to maintain sterility of the first volume.

Claims

1. An apparatus, comprising:

a first tray member having a plurality of walls that define a first volume and an opening that provides access to the first volume;

a second tray member having a plurality of walls that define a second volume and an opening that provides access to the second volume, a wall from the plurality of walls of the second tray member including a retainer extending from the wall from the plurality of walls of the second tray member and configured to retain at least a portion of a medicament delivery device within the second volume, the opening of the second tray member providing removal access of the medicament delivery device from within the second volume,

in a first configuration, the second tray member is disposed within the first volume of the first tray member such that access to the medicament delivery device within the second volume is inhibited by a wall from the plurality of walls of the first tray member,

in a second configuration, the second tray member is physically separate from the first tray member to allow access to the medicament delivery device within the second 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 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 such that removal access of the medicament delivery device from within the second volume is inhibited.

3. The apparatus of claim 2, wherein

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 opposite the work surface.

4. 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.

5. The apparatus of claim 1, wherein:

the first tray member defines 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 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 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, further comprising:

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

11. The apparatus of claim 1, wherein in the first configuration, access to the medicament delivery device within the second volume is inhibited based at least in part collectively by an inner surface of the wall of the second tray member and an inner surface of a wall of the first tray member.

12. The apparatus of claim 1, wherein the retainer extends from the wall of the second tray member towards an interior portion of the first tray member when in the first configuration.

13. An apparatus, comprising:

a first tray member having a first plurality of side walls and a first bottom wall disposed between the first plurality of side walls, the first plurality of side walls and the first bottom wall collectively defining a first volume and an opening opposite the first bottom wall and that provides access to the first volume; and

a second tray member having a second plurality of side walls and a second bottom wall disposed between the second plurality of side walls, the second plurality of side walls and the second bottom wall collectively defining a second volume and an opening opposite the second bottom wall and that provides access to the second volume, the second tray member including a retainer extending from the second bottom wall towards the opening of the second tray member, the retainer being configured to retain a medicament delivery device within the second volume, the second tray member configured to be coupled within the first volume of the first tray member such that (1) the medicament delivery device is disposed within the first volume between an inner surface of the first bottom wall and an inner surface of the second bottom wall, and (2) the retainer extends towards the first bottom wall of the first tray member.

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

15. The apparatus of claim 13, further comprising:

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 first tray member defining a container volume that is configured to receive a medicament container; and

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

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

17. 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.

18. The apparatus of claim 13, wherein:

a protrusion extends from the wall of the first tray member; 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 second tray member is disposed within the first tray member.

19. The apparatus of claim 18, wherein:

the medicament delivery device is a medical injector;

the protrusion is a first protrusion;

the retainer is a first retainer;

the first bottom 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.

20. The apparatus of claim 18, wherein a longitudinal axis of the medicament delivery device is substantially parallel to the second bottom wall of the second tray member when the medicament delivery device in the fixed position within the second volume.

21. 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

without direct contact by an operator with the second tray member, manipulating the first tray member to release the second tray member from within the first volume to allow a gravitational force to assist in placing an outer surface of the wall of the second tray member on the sterile surface such that an opening defined by the second tray member is facing opposite the sterile surface thereby providing access to the medicament delivery device via the opening defined by the second tray member, a retainer of the second tray member maintaining the medicament delivery device in a fixed position within the second volume.

22. The method of claim 21, 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.

23. The method of claim 22, 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,

the cover member including an indicium associated with at least one of the medicament delivery device or the medicament container, the sleeve defining an 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.

24. The method of claim 21, 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.

25. The method of claim 24, wherein:

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

26. The method of claim 24, wherein the outer surface of the second tray member is placed on the sterile surface after the releasing in response to the actuation force and the gravitational force.

27. The method of claim 26, 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.

28. The method of claim 21, 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.

29. The method of claim 21, 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.

30. The method of claim 29, wherein the medicament includes at least one of triamcinolone or triamcinolone acetonide.