Sensor Inserter Having Introducer

• US 20110190603A1
• Filed: 09/29/2010
• Published: 08/04/2011
• Est. Priority Date: 09/29/2009
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Stafford, Gary A.
• Application Number:
  US12/893,974
• Publication Number:
  US 20110190603A1
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A sensor inserter assembly having an introducer configured with one or more holding members to releasably retain a sensor and/or a compressible member.

Claims

1. An introducer comprising:

a body portion having a proximal end and a distal end; and

a shaft portion comprising a channel and a distal end, the shaft portion extending downwardly from an edge of the body portion, the shaft portion including a holding member disposed along a length of the channel, the holding member configured to substantially releasably retain a sensor.

2. The introducer of claim 1, wherein the holding member comprises one or more rolling members disposed along a length of the shaft portion, the rolling members configured to contact and releasably retain the sensor.

3. The introducer of claim 2, wherein the rolling members are configured to rotate.

4. The introducer of claim 3, wherein a sensor retained by the shaft portion may be displaced from the shaft portion upon rotation of the rolling members.

5. The introducer of claim 2, wherein the one or more rolling members are disposed within the channel.

6. The introducer of claim 5, wherein the one or more rolling members are disposed within a sidewall of the channel.

7. The introducer of claim 1, wherein the holding member comprises a sheath disposed coaxially about the shaft portion.

8. The introducer of claim 7, wherein the sheath comprises one or more perforations along a perforation line disposed along a length of the sheath.

9. The introducer of claim 8, wherein the sheath is a tear away member.

10. The introducer of claim 7, wherein the sheath comprises a polymer film.

11. The introducer of claim 10, wherein the polymer film is attached an outer surface of the shaft portion.

12. The introducer of claim 1, wherein the shaft portion comprises a magnet, and further wherein a sensor releasably retained in the shaft includes a magnetic metal.

13. The introducer of claim 12, wherein the magnetic metal comprises stainless steel.

14. The introducer of claim 12, wherein the sensor is doped with a magnetic metal.

15. The introducer of claim 12, wherein the magnet is disposed along the channel of the shaft portion.

16. The introducer of claim 1, wherein the shaft portion includes one or more windings configured to releasably retain the sensor.

17. The introducer of claim 16, wherein the sensor is capable of being displaced from the shaft portion by unwinding the one or more windings.

18. The introducer of claim 16, wherein the windings comprises wound rolls of polymer film.

19. The introducer of claim 1, wherein the shaft portion includes an aperture formed in the channel, and further wherein the sensor includes a flange extending from an edge of the sensor, the flange disposed in the aperture formed in the channel.

20. The introducer of claim 19, wherein the aperture includes a section configured to be wider than the width of a sensor flange such that the sensor may be displaced from the shaft.

21. The introducer of claim 1, wherein the holding member comprises a sponge material disposed along the channel of the shaft portion, the sponge material configured to provide a soft interference fit with a sensor disposed in the shaft portion.

22. The introducer of claim 1 wherein the shaft portion is substantially hollow.

23. The introducer of claim 1 wherein the shaft portion is configured to retain at least a portion of the sensor substantially subcutaneously when the shaft portion is removed from a skin layer.

24. The introducer of claim 1 wherein the distal end includes a tapered end configured to pierce the skin layer, and further, wherein at least a portion of the sensor is substantially retained within the shaft portion while the tapered end is piercing through the skin layer.

25. The introducer of claim 24 wherein when the tapered end of the shaft portion is transcutaneously introduced to the skin layer, the sensor is substantially contemporaneously transcutaneously introduced through the skin layer.

26. The introducer of claim 1 wherein the sensor includes an analyte sensor.

27. The introducer of claim 26 wherein the analyte sensor is a glucose sensor.

28. The introducer of claim 26 wherein the introducer is configured to position an analyte sensor in fluid contact with the user'"'"'s analyte.

29. The introducer of claim 1, further including a compressible member having a distal end, the compressible member attached to a lateral side of the shaft portion, wherein the distal end of the compressible member is distal to the distal end of the shaft portion.

30. The introducer of claim 29, wherein the compressible member is configured to retract to allow the sharp to penetrate skin of a user.

31. An introducer comprising

a body portion having a proximal end and a distal end;

a shaft portion comprising a channel and a distal end, the shaft portion extending downwardly from an edge of the body portion, and

a compressible member having a distal end, the compressible member attached to a lateral side of the shaft portion, wherein the distal end of the compressible member is distal to the distal end of the shaft portion.

32. The introducer of claim 31, wherein the compressible member includes a first section and a second section.

33. The introducer of claim 32, wherein the first section includes a compressible body.

34. The introducer of claim 33, wherein the compressible body includes a spring.

35. The introducer of claim 34, wherein the spring is disposed within a housing.

36. The introducer of claim 32, wherein the second section is non-compressible.

37. The introducer of claim 32, wherein the first section is configured to receive the second section.

38. The introducer of claim 37, wherein the second section is retractable within the first portion.

39. The introducer of claim 38, wherein the first and second sections have a telescoping relationship.

40. A sensor inserter assembly comprising

a housing;

a shuttle movably connected to the housing, the shuttle movable in an insertion direction and a retraction direction;

a first spring means for urging the shuttle in the insertion direction;

a second spring means for urging the shuttle in the retraction direction;

a sensor;

an introducer attached to the shuttle, the sensor introducer configured to releasably receive the sensor;

an actuator having a depressible body, the actuator configured for releasing the shuttle and allowing the first spring means to urge the shuttle and introducer in the insertion direction, wherein the depressible body includes a safety member to impede the actuator.

41. The sensor insertion assembly of claim 40, wherein the safety member is disposed in one or more apertures formed in the depressible body of the actuator.

42. The sensor insertion assembly of claim 41, wherein the disposition of the safety member impedes depression of the actuator.

43. The sensor insertion assembly of claim 42, wherein the safety member comprises a grenade pin.

44. The sensor insertion assembly of claim 43, wherein the grenade pin includes a pull tab.

45. The sensor insertion assembly of claim 42, wherein the safety member comprises a plug disposed in an aperture formed in the depressible body of the actuator.

46. The sensor insertion assembly of claim 45, wherein the plug includes a pullable cap disposed at and end of the plug.

47. The sensor insertion assembly of claim 40, wherein the safety member has a body including a first end and a second end, and further wherein the first and second ends form an L-shaped body.

48. The sensor insertion assembly of claim 47, wherein at least one of the first or second ends is disposed in an aperture formed in the actuator.

49. The sensor insertion assembly of claim 48, wherein the other of the first or second ends forms a pull tab for deactivation of the safety.

50. The sensor insertion assembly of claim 40, wherein the safety member includes a D-ring.

51. The sensor insertion assembly of claim 50, wherein the actuator includes a slot to slidably receive the D-ring.

52. The sensor insertion assembly of claim 40, wherein the safety member includes a press clip configured to be received in one or more aperture formed on the actuator.

53. The sensor insertion assembly of claim 52, wherein the press clip includes a first leg and a second leg.

54. The sensor insertion assembly of claim 53, wherein the first leg is disposed in an aperture formed in a first side of the actuator depressible body, and the second leg is disposed in an aperture formed in a second opposite side of the actuator depressible body.

55. The sensor insertion assembly of claim 40, wherein the safety member is formed from a molded thermoplastic material.

56. The sensor insertion assembly of claim 55, wherein the thermoplastic material has a shore hardness of about 40 to 50.

57. A method of arming a sensor inserter assembly comprising a shuttle movable in an insertion direction and a retraction direction, a first spring means for urging the shuttle in the insertion direction, a second spring means for urging the shuttle in an opposite retraction direction, an introducer having a sensor disposed therein, the introducer attached to the shuttle, an actuator configured for releasing the shuttle and allowing the first spring means to urge the shuttle and introducer in the insertion direction, and an arming pin disposed on the method comprising:

contacting the distal end of the arming pin on a surface until the actuator moves to an upward position; and

pulling pin from the sensor inserter assembly to remove the pin.

58. The method of claim 57, wherein the method includes contacting the distal end of the arming pin with a surface until the actuator clicks.

59. The method of claim 57, wherein no safety member is required.