Needle protective device for subcutaneous sensors

• US 9,295,786 B2
• Filed: 05/28/2008
• Issued: 03/29/2016
• Est. Priority Date: 05/28/2008
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Gottlieb, Rebecca K., Shah, Rajiv, Wolfe, Katherine T., Larson, Eric Allan
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): BLOCH, MICHAEL RYAN
• Application Number:
  US12/154,935
• Publication Number:
  US 20090299301A1
• Time in Patent Office: 2,862 Days
• Field of Search: 600/345, 600/391
• US Class Current: 1/1
• 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
• 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 configured to insert a sensor into a patient, the introducer comprising:

a housing detachably connectable to a sensor hub containing a sensor, wherein the sensor hub contains the sensor prior to connection to the housing, the housing having a top side and a base and including a needle cover, wherein the needle cover is an internal compartment of the housing;

a needle that is moveable with respect to the needle cover and is extendable out of, and retractable into, the housing;

a needle holder connected to the needle and contained within the housing, wherein the needle holder has a top portion having an upper surface and an undersurface; and

a spring having a top end and a bottom end, wherein the undersurface of the needle holder'"'"'s top portion rests on the spring'"'"'s top end at all times, and wherein the spring'"'"'s bottom end rests on the housing'"'"'s base at all times,

wherein the introducer is configured such that, 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 to insert the sensor into the patient, and disconnection of the housing from the sensor hub causes the needle holder to move in the housing to a needle covered position such that the needle is covered by the needle cover inside the housing and the sensor remains inserted in the patient;

wherein said needle holder and spring are configured such that, when the housing is connected to the sensor hub, said spring is in a compressed position, and such that disconnection of the housing from the sensor hub causes said spring to expand, thereby moving the needle holder towards the needle covered position and retracting the needle into the housing to be covered by said needle cover;

wherein the housing includes a mating component to mate with the sensor hub and hold said spring in a compressed position when the housing is connected to the sensor hub;

wherein the mating component includes a lock that locks the needle holder into the needle extended position when the housing is connected to the sensor hub; and

wherein said upper surface of the needle holder'"'"'s top portion abuts said top side of the housing when the needle holder is in the needle covered position.

2. The introducer of claim 1, wherein the needle holder is slidably coupled to the housing.

3. The introducer of claim 1, wherein the housing and the mating component are configured such that disconnection of the housing from the sensor hub causes the mating component to release the needle holder such that the needle holder may move into the needle covered position.

4. The introducer of claim 1, wherein the needle holder'"'"'s top portion defines an indentation therein, said indentation extending radially inwards from a periphery of said top portion, and wherein, when the housing is connected to the sensor hub, said lock extends into, and engages with, said indentation on the needle holder'"'"'s top portion, thereby locking the needle holder in the needle extended position.

5. The introducer of claim 4, wherein disconnection of the housing from the sensor hub disengages said lock from said indentation on the needle holder'"'"'s top portion, thereby allowing the spring to expand and move the needle holder towards the needle covered position.

6. The introducer of claim 4, wherein said lock is fixedly attached to said mating component.

7. The introducer of claim 4, wherein said indentation extends vertically to and through said upper surface of the needle holder'"'"'s top portion.

8. The introducer of claim 1, wherein the mating component is held in a locking position by friction when the housing is connected to the sensor hub.

9. The introducer of claim 1, 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.

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

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

12. 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 configured to insert the sensor into a patient, the introducer including;

a housing detachably connectable to the sensor hub, wherein the sensor hub contains the sensor prior to connection to the housing, the housing having a top side and a base and including a needle cover, wherein the needle cover is an internal compartment of the housing;

a needle that is moveable with respect to the needle cover and is extendable out of, and retractable into, the housing;

a needle holder connected to the needle and contained within the housing, wherein the needle holder has a top portion having an upper surface and an undersurface; and

a spring having a top end and a bottom end, wherein the undersurface of the needle holder'"'"'s top portion rests on the spring'"'"'s top end at all times, and wherein the spring'"'"'s bottom end rests on the housing'"'"'s base at all times,

wherein the introducer is configured such that, 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 to insert the sensor into the patient, and disconnection of the housing from the sensor hub causes the needle holder to move in the housing to a needle covered position such that the needle is covered by the needle cover inside the housing and the sensor remains inserted in the patient;

wherein said needle holder and spring are configured such that, when the housing is connected to the sensor hub, said spring is in a compressed position, and such that disconnection of the housing from the sensor hub causes said spring to expand, thereby moving the needle holder towards the needle covered position and retracting the needle into the housing to be covered by said needle cover;

wherein the housing includes a mating component to mate with the sensor hub and hold said spring in a compressed position when the housing is connected to the sensor hub;

wherein the mating component includes a lock that locks the needle holder into the needle extended position when the housing is connected to the sensor hub; and

wherein said upper surface of the needle holder'"'"'s top portion abuts said top side of the housing when the needle holder is in the needle covered position.

13. The sensor set of claim 12, further including:

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

14. The sensor set of claim 13, 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.

15. The sensor set of claim 13, 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.

16. The sensor set of claim 13, wherein the reusable adhesive is selected from the group consisting of silicone, rubber, natural rubber and acrylic adhesives.

17. The sensor set of claim 13, wherein the mounting base is flexible.

18. The sensor set of claim 13, further comprising an adhesive layer on the second side of the mounting base, the adhesive layer being operable to adhere to the skin of the patient.

19. The sensor set of claim 13, 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.

20. The sensor set of claim 12, 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.

21. The sensor set of claim 12, wherein the sensor hub includes:

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

wherein said sensor is carried in the sensor carrier and extends into the carrier pocket, and

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

22. The sensor set of claim 12, wherein the sensor is a thin film electrochemical sensor for measuring glucose.

23. The sensor set of claim 12, wherein the housing and the mating component are configured such that disconnection of the housing from the sensor hub causes the mating component to release the needle holder such that the needle holder may move into the needle covered position.

24. The sensor set of claim 12, wherein the needle holder'"'"'s top portion defines an indentation therein, said indentation extending radially inwards from a periphery of said top portion, and wherein, when the housing is connected to the sensor hub, said lock extends into, and engages with, said indentation on the needle holder'"'"'s top portion, thereby locking the needle holder in the needle extended position.

25. The sensor set of claim 24, wherein said lock is fixedly attached to said mating component.

26. The sensor set of claim 24, wherein said indentation extends vertically to and through said upper surface of the needle holder'"'"'s top portion.

27. The sensor set of claim 24, wherein disconnection of the housing from the sensor hub disengages said lock from said indentation on the needle holder'"'"'s top portion, thereby allowing the spring to expand and move the needle holder towards the needle covered position.

28. An introducer configured to insert a sensor into a patient, the introducer comprising:

a housing detachably connectable to a sensor hub containing a sensor, wherein the sensor hub contains the sensor prior to connection to the housing, the housing having a top side and a base and including a needle cover, wherein the needle cover is an internal compartment of the housing;

a needle that is moveable with respect to the needle cover and is extendable out of, and retractable into, the housing;

a needle holder connected to the needle and contained within the housing, wherein the needle holder has a top portion having an upper surface and an undersurface; and

a spring having a top end and a bottom end, wherein the undersurface of the needle holder'"'"'s top portion rests on the spring'"'"'s top end at all times, and wherein the spring'"'"'s bottom end rests on the housing'"'"'s base at all times,

wherein the introducer is configured such that, 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 to insert the sensor into the patient, and disconnection of the housing from the sensor hub causes the needle holder to move in the housing to a needle covered position such that the needle is covered by the needle cover inside the housing and the sensor remains inserted in the patient;

wherein the needle holder'"'"'s top portion defines two indentations therein, wherein the housing includes two mating components, each said mating component including a respective lock, and wherein, when the housing is connected to the sensor hub, each said lock extends into, and engages with, a respective one of said indentations, thereby locking the needle holder in the needle extended position; and

wherein said upper surface of the needle holder'"'"'s top portion abuts said top side of the housing when the needle holder is in the needle covered position.

29. The introducer of claim 28, wherein disconnection of the housing from the sensor hub disengages each said lock from each said respective indentation on the needle holder'"'"'s top portion, thereby releasing the needle holder to move towards the needle covered position.

30. The introducer of claim 29, wherein each said mating component includes an arm, and wherein the arms are moveable towards, and away from, each other.

31. The introducer of claim 30, wherein, when the arms are moved towards one another, each said lock extends into, and engages with, a respective one of said indentations on the needle holder'"'"'s top portion, and when the arms are moved away from one another, each said lock disengages from each said respective indentation.

32. The introducer of claim 28, wherein each said indentation extends vertically to and through said upper surface of the needle holder'"'"'s top portion.

33. The introducer of claim 32, wherein each said mating component is fixedly attached to each said respective lock.

34. 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 configured to insert the sensor into a patient, the introducer including;

a housing detachably connectable to the sensor hub, wherein the sensor hub contains the sensor prior to connection to the housing, the housing having a top side and a base and including a needle cover, wherein the needle cover is an internal compartment of the housing;

a needle that is moveable with respect to the needle cover and is extendable out of, and retractable into, the housing;

a needle holder connected to the needle and contained within the housing, wherein the needle holder has a top portion having an upper surface and an undersurface; and

a spring having a top end and a bottom end, wherein the undersurface of the needle holder'"'"'s top portion rests on the spring'"'"'s top end at all times, and wherein the spring'"'"'s bottom end rests on the housing'"'"'s base at all times,

wherein the introducer is configured such that, 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 to insert the sensor into the patient, and disconnection of the housing from the sensor hub causes the needle holder to move in the housing to a needle covered position such that the needle is covered by the needle cover inside the housing and the sensor remains inserted in the patient;

wherein the needle holder'"'"'s top portion defines two indentations therein, wherein the housing includes two mating components, each said mating component including a respective lock, and wherein, when the housing is connected to the sensor hub, each said lock extends into, and engages with, a respective one of said indentations, thereby locking the needle holder in the needle extended position; and

wherein said upper surface of the needle holder'"'"'s top portion abuts said top side of the housing when the needle holder is in the needle covered position.

35. The sensor set of claim 34, wherein disconnection of the housing from the sensor hub disengages each said lock from each said respective indentation on the needle holder'"'"'s top portion, thereby releasing the needle holder to move towards the needle covered position.

36. The sensor set of claim 35, wherein each said mating component includes an arm, and wherein the arms are moveable towards, and away from, each other.

37. The sensor set of claim 36, wherein, when the arms are moved towards one another, each said lock extends into, and engages with, a respective one of said indentations on the needle holder'"'"'s top portion, and when the arms are moved away from one another, each said lock disengages from each said respective indentation.

38. The sensor set of claim 34, wherein each said indentation extends vertically to and through said upper surface of the needle holder'"'"'s top portion.

39. The sensor set of claim 38, wherein each said mating component is fixedly attached to each said respective lock.