CONTINUOUS GLUCOSE MONITORING ON-BODY SENSOR

• US 20160022179A1
• Filed: 03/10/2014
• Published: 01/28/2016
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Embecta Corporation
• Original Assignee: Becton, Dickinson & Co
• Inventors: Prudden, John, Salemme, James, Linnane, Jennifer, Di Resta, Ellen, Gundlach, Jack, Sullivan Treacy, Ann
• Granted Patent: US 10,357,191 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/6832 using adhesives A61B5/259 takes precedence
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/68335 including release sheets or liners
• CPC Class Codes: A61B 5/6848 Needles

Abstract

An on-body sensor (OBS) (5610) having a continuous monitoring (CGM) device is disclosed for use in identifying an analyte, such as glucose in blood or interstitial fluid (ISF), using a biomaterial, such as glucose binding protein (GBP), that is brought into contact with the analyte. The on-body sensor (5610) incorporating the CGM device includes a housing (5625′) which provides protection to the CGM device while providing comfort to a user wearing the device. The OBS also includes an adhesive structure that provides a comfortable, discreet and secure user experience.

Claims

1. An on-body device for sensing an analyte in a living body, comprising:

a cover at least partially containing a glucose monitoring sensor; and

a first bottom surface adapted to be adhered to skin, and further adapted to reduce at least one of skin irritation and nuisance to a user.

2. The on-body device of claim 1, further comprising a handle adapted to force the cover in a direction of a user.

3. The on-body device of claim 2, wherein the handle is removable.

4. The on-body device of claim 2, wherein the handle is made of a fabric material.

5. The on-body device of claim 2, wherein the handle has a substantially narrow and elongated shape, and wherein the cover is formed by silicone.

6. The on-body device of claim 2, wherein the cover and the handle have an hourglass-like shape.

7. The on-body device of claim 1, wherein the first bottom surface comprises a first adhesive.

8. The on-body device of claim 7, further comprising a first adhesive release paper that can be removed to expose the first adhesive

9. The on-body device of claim 8, first adhesive release paper comprises opposing flaps that are adapted to be joined together above the cover.

10. The on-body device of claim 1, further comprising a handle hinged to a top surface of the cover.

11. The on-body device of claim 10, wherein the handle is adapted to be rotated to a substantially parallel position with respect to a top surface of the cover.

12. The on-body device of claim 1, further comprising a telescoping stabilizer securable to a user and adapted to act as a guide during a needle insertion.

13. The on-body device of claim 12, wherein the telescoping stabilizer is received into a body of the cover during the needle insertion.

14. The on-body device of claim 1, wherein the cover comprises cutout portions adapted to enable independent flexibility of a perimeter of the cover.

15. The on-body device of claim 1, further comprising a knob adapted to aid in inserting and removing a needle.

16. The on-body device of claim 1, further comprising a window adapted to enable a use to visually inspect a continuous a device within the cover.

17. The on-body device of claim 1, further comprising a battery pod to house a battery.

18. The on-body device of claim 1, further comprising scooped sides.

19. The on-body device of claim 18, further comprising exposed elastomer.

20. The on-body device of claim 1, further comprising a fabric bandage material adhesive.

21. The on-body device of claim 1, further comprising a removable foam layer.

22. The on-body device of claim 1, further comprising flat adhesive petals around a perimeter of the on-body device.

23. The on-body device of claim 1, further comprising a needle inserter colored to match the cover.

24. The on-body device of claim 1, comprising a lanyard-style handle.

25. The on-body device of claim 1, comprising a recessed center portion.

26. The on-body device of claim 1, further comprising flex zones adapted to flex the on-body device and conform to the user.

27. The on-body device of claim 1, further comprising sloped top surfaces and a center flex zone.

28. The on-body device of claim 1, wherein the on-body device has a gradual reduced thickness from a central position out to a peripheral position.

29. The on-body device of claim 1, wherein the on-body device is substantially diamond-shaped.

30. The on-body device of claim 1, wherein the on-body device has a domed ellipse shape.

31. The on-body device of claim 1, wherein the on-body device has a substantially hourglass shape.

32. The on-body device of claim 1, wherein the on-body device has an annular shape.

33. The on-body device of claim 1, wherein the on-body device has a smooth radial exterior surface.

34. The on-body device of claim 1, wherein the on-body device has subtle curved outer edges.

35. The on-body device of claim 1, further comprising textured recess portions adapted to improve a handling of the on-body device during application and removal.

36. The on-body device of claim 1, further comprising a slight compound curved adhesive surface

37. The on-body device of claim 1, wherein the cover comprises an overlapping square design.

38. The on-body device of claim 1, wherein the cover comprises having a fading grip pattern design.

39. The on-body device of claim 1, wherein the cover comprises a knit pattern design.

40. The on-body device of claim 1, wherein the cover comprises a lattice design.

41. The on-body device of claim 1, wherein the cover comprises having a random dots pattern.

42. The on-body device of claim 1, wherein the cover comprises is mounted on a foam layer ring.

43. The on-body device of claim 1, wherein the cover comprises a recessed portion adapted to receive a needle inserter assembly.

44. The on-body device of claim 43, wherein the needle inserter assembly comprises a second adhesive

45. The on-body device of claim 44, further comprising a second adhesive release paper that can be removed to expose the second adhesive

46. The on-body device of claim 1, wherein the cover is formed from a semi-flexible material.

47. The on-body device of claim 1, wherein the cover is formed of a foam-like material.

48. The on-body device of claim 1, wherein the cover is sloped and flexible.

49. The on-body device of claim 1, wherein the cover has elastomer nodules adapted to provide grip during handling.

50. The on-body device of claim 1, wherein the cover is unitary, soft and flexible.

51. The on-body device of claim 1, wherein the cover is unitary and comprises a plurality of rounded extensions around the perimeter of the on-body device.

52. The on-body device of claim 1, wherein the cover has a substantially pinwheel shape.

53. The on-body device of claim 1, wherein the cover is adapted to receive a stabilizer having telescoping pins.

54. The on-body device of claim 1, wherein the cover is adapted to receive a stabilizer having a rotating sleeve adapted to enable the cover to rotate with respect to the stabilizer during needle insertion.

55. The on-body device of claim 1, wherein the cover comprises a hinged handle and a pull cord adapted to be pulled to separate the on-body device from a user after use.

56. The on-body device of claim 1, wherein the cover has a profile of substantially 8 millimeters.

57. The on-body device of claim 1, wherein the cover has a profile of substantially 10 millimeters.

58. The on-body device of claim 1, further comprising a flange.

59. The on-body device of claim 58, wherein the flange slopes down from the cover to an outer perimeter of the flange.

60. The on-body device of claim 58, wherein the flange is substantially triangular.

61. The on-body device of claim 58, further comprising a handle, and wherein the handle can be broken off and separated from the cover and stowed in a recess between the cover and the flange.

62. The on-body device of claim 58, further comprising a recess formed between the cover and the flange, wherein the recess provides a handle portion.

63. The on-body device of claim 58, further comprising a rotatable handle portion rotatable respect to the flange.

64. The on-body device of claim 58, wherein the flange comprises a compound curved-shaped flange.

65. The on-body device of claim 58, wherein the flange comprises a convex flange or a concave flange.

66. The on-body device of claim 58, wherein the flange comprises a pinwheel-shaped flange.

67. The on-body device of claim 58, wherein the flange has a slightly asymmetrical shape and comprises a removal tape on a bottom surface of the flange.

68. The on-body device of claim 58, wherein the flange has a slightly higher profile than the cover.

69. The on-body device of claim 58, wherein the flange is slightly elongated and stop, and wherein the cover is square-shaped.

70. The on-body device of claim 58, wherein a top surface of the flange comprises elastomeric bumps.

71. A method for applying an on-body device for sensing an analyte in a living body, the on-body device comprising:

a cover at least partially containing a continuous glucose monitoring sensor;

a surface of the cover comprising a release paper over an adhesive layer;

a hinged handle; and

a needle,

and the method comprising;

removing the on-body device from a package using the handle;

removing the release paper to expose the adhesive layer;

folding down the handle;

pressing down on the cover until the needle until the needle has been inserted and the cover has been secured to skin of a user via the adhesive layer.

72. A method for removing an on-body device for sensing an analyte in a living body, the on-body device comprising:

a housing having a cover material on a top surface, wherein the housing at least partially containing a continuous glucose monitoring sensor;

at least one tab integral with the cover material; and

a handle, and the method comprising;

pulling on the at least one tab to release the cover material from the top surface of the housing;

pulling the handle to release the housing from a user; and

peeling a foam layer away from the user.