Needle protective device for subcutaneous sensors

• US 20090299301A1
• Filed: 05/28/2008
• Published: 12/03/2009
• Est. Priority Date: 05/28/2008
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Shah, Rajiv, Gottlieb, Rebecca K., Larson, Eric Allan, Wolfe, Katherine T.
• Granted Patent: US 9,295,786 B2
• Time in Patent Office: Days
• US Class Current: 604/263
• CPC Class Codes: A61B 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 2560/0406 specially shaped apparatus housings
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 2562/0217 Electrolyte containing
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 2562/247 Hygienic covers, i.e. for covering the sensor or apparatus during use
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 25/0612 Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/3243 being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel devices for protecting guide needles in combination with catheters A61M25/0612

Abstract

An introducer is provided for introducing a sensor into the body of a patient. The introducer connects to a sensor hub. When the sensor hub and introducer are connected, the introducer needle is exposed. When the sensor hub and introducer are disconnected, a needle cover and the needle move with respect to each other so that the needle cover substantially covers the needle, protecting a user from being injured by the needle.

Claims

1. An introducer comprising:

a housing detachably connectable to a sensor hub containing a sensor, the housing including a needle cover; and

a needle contained in and extending out of the housing,

wherein the needle cover is operable to move in relation to the needle such that the needle cover covers the needle when the housing is detached from the sensor hub.

2. The introducer of claim 1, wherein the needle cover is an internal compartment of the housing.

3. The introducer of claim 2, further comprising a needle holder connected to the needle and contained within the housing, wherein when the housing is connected to the sensor hub, the needle holder is in a needle extended position and the needle extends out of the housing, and when the housing is disconnected from the sensor hub, the needle holder moves in the housing to a needle covered position such that the needle is covered by the needle cover.

4. The introducer of claim 3, wherein the needle holder is slidably coupled to the housing.

5. The introducer of claim 3, further including a spring connected to the needle holder, wherein when the housing is connected to the sensor hub, the spring is in a compressed position, and when the housing is disconnected from the sensor hub, the spring expands to move the needle holder in the housing such that the needle is covered by the housing.

6. The introducer of claim 5, wherein the housing includes a mating component to mate with the sensor hub and hold the spring in a compressed position when the housing is connected to the sensor hub.

7. The introducer of claim 6, wherein when the housing is disconnected from the sensor hub, the mating component releases the needle holder such that the needle holder may move into the needle covered position.

8. The introducer of claim 6, wherein the mating component includes one or more locks that lock the needle holder into the needle extended position when the housing is connected to the sensor hub.

9. The introducer of claim 8, wherein the one or more locks release the needle holder when the housing is disconnected from the sensor hub.

10. The introducer of claim 6, wherein the mating component is held in a locking position by friction when the housing is connected to the sensor hub.

11. The introducer of claim 6, wherein the mating component includes a catch that catches on the sensor hub when the housing is connected to the sensor hub, whereby the mating component is held in a locking position by the catch.

12. The introducer of claim 1, wherein the needle is permanently covered by the needle cover after the housing is disconnected from the sensor hub.

13. The introducer of claim 1, wherein the housing is composed of a substantially rigid plastic.

14. The introducer of claim 1, wherein the needle cover is contained at least partially within the housing and extendable over the needle and out of the housing.

15. The introducer of claim 14, wherein when the housing is connected to the sensor hub, the needle cover is substantially contained within the housing, and when the housing is disconnected from the sensor hub, the needle cover extends over the needle, whereby the needle is covered by the needle cover.

16. The introducer of claim 14, wherein the needle cover includes a needle cover catch operable to catch onto the sensor hub and extend the needle cover out of the housing when the sensor hub is separated from the housing.

17. The introducer of claim 16, wherein the needle cover includes a locking element operable to lock the needle cover catch onto the sensor hub until the needle cover is substantially fully extended out of the housing.

18. The introducer of claim 17, wherein the locking element moves in the opposite direction from the sensor hub when the needle cover is substantially fully extended out of the housing, allowing the needle cover catch to uncatch from the sensor hub.

19. The introducer of claim 17, wherein the housing includes an internal locking ledge and the locking element includes a locking element catch that catches on the internal locking ledge when the needle cover is substantially fully extended out of the housing, causing the locking element to move in the opposite direction from the sensor hub.

20. The introducer of claim 14, wherein the needle cover includes one or more cover locks operable to lock the needle cover in an extended position.

21. The introducer of claim 20, wherein the housing includes a locking opening and the one or more cover locks interact with the locking opening such that the needle cover is locked in an extended position.

22. A sensor set comprising:

a sensor hub including a sensor;

a sensor electronics hub connectable to the sensor and including sensor electronics operable to receive signals from the sensor; and

an introducer including

a housing detachably connectable to the sensor hub, the housing including a needle cover;

a needle contained in and extending out of the housing,

wherein the needle cover is operable to move in relation to the needle such that the needle cover covers the needle when the housing is detached from the sensor hub.

23. The sensor set of claim 22, wherein the needle cover is an internal compartment of the housing.

24. The sensor set of claim 23, further comprising a needle holder connected to the needle and contained within the housing, wherein when the housing is connected to the sensor hub, the needle holder is in a needle extended position and the needle extends out of the housing, and when the housing is disconnected from the sensor hub, the needle holder moves in the housing to a needle covered position such that the needle is covered by the needle cover.

25. The sensor set of claim 24, further including a spring connected to the needle holder, wherein when the housing is connected to the sensor hub, the spring is in a compressed position, and when the housing is disconnected from the sensor hub, the spring expands to move the needle holder in the housing such that the needle is covered by the housing.

26. The sensor set of claim 25, wherein the housing includes a mating component to mate with the sensor hub and hold the spring in a compressed position when the housing is connected to the sensor hub.

27. The sensor set of claim 22, wherein the needle cover is at least partially contained within the housing and extendable over the needle and out of the housing.

28. The sensor set of claim 27, wherein when the housing is connected to the sensor hub, the needle cover is substantially contained within the housing, and when the housing is disconnected from the sensor hub, the needle cover extends over the needle, whereby the needle is covered by the needle cover.

29. The sensor set of claim 28, wherein the needle cover includes a needle cover catch operable to catch onto the sensor hub and extend the needle cover out of the housing when the sensor hub is separated from the housing.

30. The sensor set of claim 28, wherein the needle cover includes a locking element operable to lock the needle cover catch onto the sensor hub until the needle cover is substantially fully extended out of the housing.

31. The sensor set of claim 30, wherein the locking element moves in the opposite direction from the sensor hub when the needle cover is substantially fully extended out of the housing, allowing the needle cover catch to uncatch from the sensor hub.

32. The sensor set of claim 30, wherein the housing includes an internal locking ledge and the locking element includes a locking element catch that catches on the internal locking ledge when the needle cover is substantially fully extended out of the housing, causing the locking element to move in the opposite direction from the sensor hub.

33. The sensor set of claim 27, wherein the needle cover includes one or more cover locks operable to lock the needle cover in an extended position.

34. The sensor set of claim 22, further including:

a mounting base containing a first side and a second side, wherein the first side is attached at a first base portion to the sensor hub and is operable to mate with the sensor electronics hub at a second base portion; and

a reusable adhesive attached to the second base portion on the first side of the mounting base, wherein the reusable adhesive is operable to removably adhere to the sensor electronics hub when the sensor electronics hub mates with the second base portion.

35. The sensor set of claim 34, wherein the sensor electronics hub has a top and a bottom and the second base portion includes a mounting extension configured to extend to the top of the sensor electronics hub, and wherein the reusable adhesive is attached to the second base portion at the mounting extension.

36. The sensor set of claim 34, wherein when the sensor electronics hub is adhered to the reusable adhesive, the sensor electronics hub is substantially stationary with respect to the second base portion.

37. The sensor set of claim 34, wherein the reusable adhesive is selected from the group consisting of silicone, rubber, natural rubber and acrylic adhesives.

38. The sensor set of claim 34, wherein the sensor electronics hub includes a wireless transmitter.

39. The sensor set of claim 34, wherein the mounting base is flexible.

40. The sensor set of claim 34, further comprising an adhesive layer on the second side of the mounting base, the adhesive layer being operable to adhere to the skin of a patient.

41. The sensor set of claim 34, wherein the mounting base is shaped to be of substantially the same shape as the bottom of the sensor hub and sensor electronics hub when the sensor hub is connected to the sensor electronics hub.

42. The sensor set of claim 22, wherein when the introducer is connected to the sensor hub in a pre-insertion position, the needle is hidden in the sensor hub, and when the introducer is connected to the sensor hub in an insertion position, the needle extends out of the sensor hub.

43. The sensor set of claim 22, wherein a the sensor hub includes:

a sensor hub housing including a sensor carrier and a sensor hub base, the sensor hub base having a pocket; and

a sensor carried in the sensor carrier and extending into the carrier pocket,

wherein the sensor carrier is operable to move into the pocket such that the sensor extends out of the pocket and sensor hub base.

44. The sensor set of claim 22, wherein the sensor is a thin film electrochemical sensor for measuring glucose.

45. A method of covering an introducer needle comprising:

providing a sensor hub including a sensor and an introducer, the introducer including

a housing detachably connectable to the sensor hub, the housing including a needle cover; and

a needle contained in and extending out of the housing,

wherein the needle cover is operable to move in relation to the needle; and

disconnecting the housing from the sensor hub, whereby the needle cover covers the needle when the housing is detached from the sensor hub.

46. The method of claim 45, wherein the needle cover is an internal compartment of the housing.

47. The method of claim 46, wherein the introducer further includes a needle holder connected to the needle and contained in the housing.

48. The method of claim 47, wherein when the housing is disconnected from the sensor hub, the needle holder moves in the housing such that the needle is covered by the needle cover.

49. The method of claim 48, wherein the housing further includes a spring connected to the needle cover, wherein when the housing is connected to the sensor hub, the spring is in a compressed position, and when the housing is disconnected from the sensor hub, the spring expands to move the needle holder in the housing such that the needle is covered by the needle cover.

50. The method of claim 49, wherein the housing further includes a mating component to mate with the sensor hub and hold the spring in a compressed position when the housing is connected to the sensor hub.

51. The method of claim 45, wherein the needle cover is at least partially contained within the housing and extendable over the needle and out of the housing.

52. The method of claim 51, wherein when the housing is connected to the sensor hub, the needle cover is substantially contained within the housing, and when the housing is disconnected from the sensor hub, the needle cover extends over the needle, whereby the needle is covered by the needle cover.

53. The method of claim 52, wherein the needle cover includes a needle cover catch and the method further comprises:

prior to disconnecting the housing from the sensor hub, pulling the housing away from the sensor hub, whereby the needle cover catch catches onto the sensor hub and the needle cover extends out of the housing.

54. The method of claim 51, wherein the needle cover includes a locking slide and the locking slide locks the needle cover catch onto the sensor hub when the housing is pulled away from the sensor hub, until the needle cover is substantially fully extended out of the housing.

55. A sensor set comprising:

a sensor hub including a sensor;

a sensor electronics hub connectable to the sensor and including sensor electronics operable to receive signals from the sensor;

a mounting base containing a first side and a second side, wherein the first side is attached at a first base portion to the sensor hub and is operable to mate with the sensor electronics hub at a second base portion; and

a reusable adhesive attached to the second base portion on the first side of the mounting base, wherein the reusable adhesive is operable to removably adhere to the sensor electronics hub when the sensor electronics hub mates with the second base portion.

56. The sensor set of claim 55, wherein the sensor electronics hub has a top and a bottom and the second base portion includes a mounting extension that can extend to the top of the sensor electronics hub, and wherein the reusable adhesive is attached to the second base portion at the mounting extension.

57. The sensor set of claim 56, wherein when the sensor electronics hub is adhered to the reusable adhesive, the sensor electronics hub is substantially stationary with respect to the second base portion.

58. The sensor set of claim 56, wherein the adhesive is selected from the group consisting of silicone, rubber, natural rubber and acrylic adhesives.

59. The sensor set of claim 56, wherein the sensor electronics hub includes a wireless transmitter.

60. A sensor hub comprising:

a housing including a sensor carrier and a base, the base having a pocket;

a sensor carried in the sensor carrier and extending into the carrier pocket;

wherein the sensor carrier is operable to slide into the pocket such that the sensor extends out of the pocket and base.

61. The sensor hub of claim 60, further comprising a guide to guide the sensor carrier into the pocket.

62. A sensor set comprising:

a sensor hub including;

a sensor carrier housing including a sensor carrier and a base, the base having a pocket, and

a sensor carried in the sensor carrier and extending into the carrier pocket; and

an introducer including;

a housing, and

a needle connected to and extending out of the housing,

wherein the introducer is connected to the sensor hub at the sensor carrier such that the needle extends into the carrier pocket at least partially past the sensor, and wherein the sensor carrier is operable to move into the pocket such that the needle and sensor extend out of the pocket and base.

63. An introducer comprising:

a housing detachably connectable to a cannula hub containing a cannula for infusion of a medication, the housing including a needle cover; and

a needle contained in and extending out of the housing,

wherein the needle cover is operable to move in relation to the needle such that the needle cover covers the needle when the housing is detached from the cannula hub.

64. The introducer of claim 63, wherein the housing is detachably connectable to a cannula hub containing a cannula for infusion of insulin.