Catheter tray, packaging system, instruction insert, and associated methods

• US 9,522,753 B2
• Filed: 04/11/2013
• Issued: 12/20/2016
• Est. Priority Date: 12/21/2007
• Status: Active Grant

• Current Assignee: Medline Industries Incorporated (Medline Holdings Incorporated)
• Original Assignee: Medline Industries Incorporated (Medline Holdings Incorporated)
• Inventors: Tomes, Jennifer E., Dickinson, Sarah, Adler, Deborah, Maze, Jack, Savage, Alberto, Chua, Kenneth, Wilson, Earl, Kutsch, John
• Primary Examiner(s): Marcetich, Adam
• Application Number:
  US13/860,902
• Publication Number:
  US 20130277248A1
• Time in Patent Office: 1,349 Days
• Field of Search: 206/364, 206/366, 206/438, 206/571, 220/500, 434/262, 604/370, 604/540, 604/544
• US Class Current: 1/1
• CPC Class Codes: A61B 2050/3008 having multiple compartments
• CPC Class Codes: A61B 2050/3015 transparent
• CPC Class Codes: A61B 42/00 Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof
• CPC Class Codes: A61B 46/00 Surgical drapes
• 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: A61J 2205/40 by shape or form, e.g. by using shape recognition
• CPC Class Codes: A61J 2205/50 using icons or symbolic figures, e.g. by a graphical representation symbolising the type of pathology or the organ by an image
• CPC Class Codes: A61L 2202/18 Aseptic storing means
• CPC Class Codes: A61L 2202/182 Rigid packaging means
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30
• 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: B65B 11/00 Wrapping, e.g. partially or wholly enclosing, articles or quantities of material, in strips, sheets or blanks, of flexible material bundling articles by applying narrow strips or bands of flexible material B65B13/00

Abstract

A tray (100) for accommodating a coiled medical device, such as a catheter assembly (700), includes a first compartment (101), a second compartment (102), and a third compartment (103). The catheter assembly (700) and devices associated with a catheterization procedure, such as syringes (701,702) containing sterile water and lubricating jelly and a specimen container (703) can be disposed within the tray. Printed instructions (1001) can be included with the tray (100). One or more layers of wrap material (2200) can be folded about the tray (100) to enclose the tray (100) and other items, such as an additional layer of wrap material (2701), packaged liquid hand sanitizer (2401), and packaged gloves (2402). When a health care services provider (3101) unfolds the wrap material, the same can be used to create a sterile field beneath a patient (3201).

Claims

1. A method of packaging a medical procedure kit comprising:

providing a single level tray having one or more compartments for receiving a coiled medical device, a first syringe, and a second syringe, the single level tray comprising a surface defining at least two compartments;

placing the coiled medical device, the first syringe, and the second syringe within the single level tray, the placing comprising placing the first syringe in a first compartment defining a mnemonic device indicating which of the first syringe or the second syringe should be used first in a catheterization procedure;

placing the single level tray on at least one layer of wrap material;

enclosing the single level tray in the at least one layer of wrap material by folding the at least one layer of wrap material about the single level tray; and

disposing an outer packaging about both the single level tray and the at least one layer of wrap material.

2. The method of claim 1, further comprising enclosing between one or more folds of the at least one layer of wrap material one or more medical devices.

3. The method of claim 2, wherein the one or more medical devices comprise gloves, hand sanitizer, alcohol wipes, instructions for using the medical procedure kit, or combinations thereof.

4. The method of claim 1, further comprising affixing one of an instruction tag, printed instructions, a checklist, or combinations thereof to the outer packaging, the one of an instruction tag, printed instructions, a checklist, or combinations thereof comprising indicia regarding use of the medical procedure kit.

5. The method of claim 4, wherein the one of an instruction tag, printed instructions, a checklist, or combinations thereof comprises a peelable flap that, when opened, reveals instructional material therein.

6. The method of claim 1, wherein the folding the at least one layer of wrap material about the single level tray comprises:

folding a first portion of the at least one layer of wrap material about a first side of the single level tray; and

folding a second portion of the at least one layer of wrap material about a second side of the single level tray.

7. The method of claim 6, wherein the folding the at least one layer of wrap material about the single level tray further comprises:

folding a third portion of the at least one layer of wrap material about a third side of the single level tray;

folding a fourth portion of the at least one layer of wrap material about a fourth side of the single level tray; and

tucking at least one of the first portion, the second portion, the third portion, or the fourth portion of the at least one layer of wrap material beneath at least another of the first portion, the second portion, the third portion, or the fourth portion of the at least one layer of wrap material.

8. The method of claim 7, further comprising disposing a layer of additional wrap material along folded portions of the at least one layer of wrap material prior to the folding the fourth portion of the at least one layer of wrap material about the fourth side of the single level tray.

9. The method of claim 8, wherein the tucking the at least one of the first portion, the second portion, the third portion, or the fourth portion of the at least one layer of wrap material beneath the at least another of the first portion, the second portion, the third portion, or the fourth portion of the at least one layer of wrap material encloses the layer of additional wrap material within portions of the at least one layer of wrap material.

10. The method of claim 1, wherein the single level tray comprises at least the first compartment and a second compartment, wherein the first compartment and the second compartment are separated by a first barrier.

11. The method of claim 1, wherein the coiled medical device comprises a Foley catheter.

12. The method of claim 11, wherein the first syringe and the second syringe are ordered within the single level tray in accordance with their use during the catheterization procedure.

13. The method of claim 11, the first compartment defining a lubricating jelly application chamber, further comprising lubricating at least a portion of the Foley Catheter in the lubricating jelly application chamber.

14. The method of claim 11, the single level tray comprising a surface defining at least two compartments, with at least one compartment defining a lubricating jelly application compartment.

15. The method of claim 14, the lubricating jelly application compartment to receive lubricating jelly from one of the first syringe or the second syringe to lubricate at least some of the coiled medical device when the coiled medical device is passed from a second compartment to the first compartment.

16. The method of claim 11, the single level tray comprising printed instructions disposed thereon to dispense lubricating jelly into a compartment of the single level tray.

17. The method of claim 16, wherein the printed instructions are one or more of printed, placed upon, or molded into the single level tray.

18. The method of claim 11, further comprising enclosing one or more medical devices within the outer packaging with the single level tray.

19. The method of claim 1, further comprising including printed instructions for using the single level tray.

20. The method of claim 19, the single level tray defining a lubricating jelly application chamber, the coiled medical device comprising a Foley catheter, the printed instructions instructing application of lubricating jelly to the Foley catheter using the lubricating jelly application chamber.

21. The method of claim 19, the at least two compartments further comprising a second compartment separated from the first compartment by a wall, the printed instructions instructing passage of at least some of the coiled medical device into lubricating jelly to lubricate the at least some of the coiled medical device.

22. The method of claim 1, the first compartment supporting the first syringe at a shallower depth within the single level tray than the second syringe.

23. The method of claim 1, the first compartment supporting the first syringe and the second syringe at different heights based upon use during the catheterization procedure.

24. The method of claim 23, wherein a higher of the first syringe or the second syringe is for use in the catheterization procedure before a lower of the first syringe or the second syringe.

25. The method of claim 24, the at least two compartments further comprising a second compartment separated from the first compartment by a wall, further comprising placing the coiled medical device within the second compartment.

26. The method of claim 25, the at least two compartments bounded by a perimeter wall that is less than three inches in height.

27. The method of claim 26, the single level tray comprising a single tray.

28. The method of claim 1, further comprising disposing a fluid bag within a second compartment.

29. A catheter package assembly with instructions, comprising

a single level tray having a coiled medical device disposed therein, the single level tray comprising a surface defining at least two compartments;

a first syringe and a second syringe disposed within the single level tray, with at least the first syringe disposed in a first compartment defining a mnemonic device indicating which of the first syringe or the second syringe should be used first in a catheterization procedure;

one or more layers of wrap folded about the single level tray so as to enclose the single level tray within the one or more layers of wrap, ending in one or more folds;

one or more of an instruction set, one or more medical devices, or combinations thereof disposed within the one or more folds; and

a thermally sealed bag disposed about the single level tray.

30. The catheter package assembly of claim 29, wherein the one or more layers of wrap comprises four portions of wrap folded about four sides of the single level tray, respectively, with at least one portion of the four portions of wrap folded beneath at least another portion of the four portions of wrap to enclose the single level tray.

31. The catheter package assembly of claim 30, further comprising an additional layer of wrap enclosed within one or more of the four portions of wrap.

32. The catheter package assembly of claim 31, wherein the one or more layers of wrap and the additional layer of wrap are different colors.

33. The catheter package assembly of claim 29, further comprising an instruction tag affixed to the thermally sealed bag, the instruction tag comprising indicia regarding at least one of valid reasons for using the coiled medical device or a checklist for using the coiled medical device.

34. The catheter package assembly of claim 29, wherein the single level tray comprises:

a single layer contoured surface defining at least three compartments separated by barriers and a perimeter wall, the at least three compartments comprising;

the first compartment comprising a first compartment base member;

a second compartment comprising a second base member;

a first barrier separating the first compartment from the second compartment;

a third compartment comprising a third base member; and

a second barrier separating the second compartment from the third compartment.

35. The catheter package assembly of claim 29, wherein at least one of the one or more layers of wrap comprises a central sterile reprocessing wrap.

36. The catheter package assembly of claim 29,

wherein:

the first syringe and the second syringe are ordered within the single level tray in accordance with their use during the catheterization procedure;

the first compartment to support the first syringe and the second syringe at different heights;

the at least two compartments bounded by a perimeter wall less than three inches in height;

the first compartment defines one or more contours for accommodating flanges of one or more of the first syringe or the second syringe; and

the at least two compartments further comprising a second compartment separated from the first compartment by a wall, the coiled medical device disposed within the second compartment.

37. The catheter package assembly of claim 29, the first compartment defining a lubricating jelly application chamber to lubricate at least a portion of the coiled medical device.

38. The catheter package assembly of claim 29,

wherein:

the first syringe and the second are ordered within the single level tray in accordance with their use during the catheterization procedure; and

the at least two compartments comprising the first compartment to support the first syringe and the second syringe.

39. The catheter package assembly of claim 38, the first compartment defining one or more contours for accommodating flanges of one or more of the first syringe or the second syringe.

40. The catheter package assembly of claim 38, the first compartment defining a lubricating jelly application chamber to lubricate at least a portion of the coiled medical device.

41. The catheter package assembly of claim 38, the first compartment supporting the first syringe at a shallower depth within the single level tray than the second syringe.

42. The catheter package assembly of claim 38, the first compartment supporting the first syringe and the second syringe at different heights based upon use during the catheterization procedure.

43. The catheter package assembly of claim 42, wherein a higher of the first syringe or the second syringe is for use in the catheterization procedure before a lower of the first syringe or the second syringe.

44. The catheter package assembly of claim 43, the at least two compartments further comprising a second compartment separated from the first compartment by a wall with an opening, the coiled medical device disposed within the second compartment.

45. The catheter package assembly of claim 44, the at least two compartments bounded by a perimeter wall less than three inches in height.

46. The catheter package assembly of claim 45, the single level tray comprising a single tray.

47. The catheter package assembly of claim 46, the coiled medical device comprising a fluid bag.

48. The catheter package assembly of claim 47, the fluid bag disposed within the second compartment.

49. The catheter package assembly of claim 38, the first compartment defining a lubricating jelly application compartment.

50. The catheter package assembly of claim 49, the lubricating jelly application compartment to receive lubricating jelly from one of the first syringe or the second syringe to lubricate at least some of the coiled medical device when the coiled medical device is passed from a second compartment to the first compartment.

51. The catheter package assembly of claim 50, the single level tray comprising printed instructions disposed thereon to dispense the lubricating jelly into a compartment of the single level tray.

52. The catheter package assembly of claim 51, wherein the printed instructions are one or more of printed, placed upon, or molded into the single level tray.

53. The catheter package assembly of claim 29, wherein the first syringe and the second syringe are ordered within the single level tray in accordance with their use during the catheterization procedure.

54. The catheter package assembly of claim 53, the first compartment supporting the first syringe.

55. The catheter package assembly of claim 54, the first compartment defining a lubricating jelly application chamber to lubricate at least a portion of the coiled medical device.

56. The catheter package assembly of claim 55, further comprising printed instructions for using the single level tray.

57. The catheter package assembly of claim 56, the printed instructions instructing application of lubricating jelly to the coiled medical device using the lubricating jelly application chamber.

58. The catheter package assembly of claim 56, the at least two compartments further comprising a second compartment separated from the first compartment by a wall with an opening, the printed instructions instructing passage of at least some of the coiled medical device through the opening into lubricating jelly to lubricate the at least some of the coiled medical device.