TRANSCUTANEOUS ANALYTE SENSOR

• US 20100179404A1
• Filed: 03/23/2010
• Published: 07/15/2010
• Est. Priority Date: 07/13/2004
• Status: Abandoned Application

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Dobbles, J. Michael, Kamath, Apurv Ullas, Brauker, James
• Application Number:
  US12/730,072
• Publication Number:
  US 20100179404A1
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 2562/18 Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/14 Devices for taking samples of blood hypodermic syringes A61M5/00; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood measuring of blood pressure A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• 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 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1473 : invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14735 : comprising an immobilised reagent
• CPC Class Codes: A61B 5/1486 : using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 : invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 : Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/150022 : for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/6801 : specially adapted to be attached to or worn on the body surface
• 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
• CPC Class Codes: A61B 5/6849 : in combination with a needle set
• CPC Class Codes: A61B 5/72 : Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61M 2005/1585 : Needle inserters
• CPC Class Codes: A61M 5/14244 : adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Claims

1. A transcutaneous analyte sensor assembly, the assembly comprising:

a housing adapted for mounting on a skin of a host, wherein the housing comprises a first portion and a second portion configured to articulate relative to each other between a first position and a second position; and

a sensor configured to measure a level of an analyte in the host, wherein the sensor extends from the housing and is adapted to be inserted through the skin of the host.

2. The assembly of claim 1, wherein the housing is configured to guide insertion of the sensor into the host when the housing is in the first position.

3. The assembly of claim 2, wherein the first portion and the second portion are configured to pivot to an angle of insertion adapted for insertion of the sensor into the host when the housing is in the first position.

4. The assembly of claim 3, wherein the angle of insertion is adjustable.

5. The assembly of claim 1, wherein the sensor is configured to measure the level of the analyte in the host when the housing is in the second position.

6. The assembly of claim 1, further comprising a mechanical joint for securing the first portion and the second portion of the housing in the second position.

7. The assembly of claim 1, wherein the first portion and the second portion comprise a hinge configured to allow articulation of the housing between the first position and the second position.

8. The assembly of claim 1, wherein the sensor is configured to bend during articulation of the housing between the first position and the second position.

9. The assembly of claim 8, wherein the sensor is configured to absorb movement when the sensor is bent.

10. A transcutaneous analyte sensor assembly, the assembly comprising:

a housing adapted for mounting on a skin of a host;

an electronics unit configured to releasably mate with the housing; and

a sensor configured to measure a level of an analyte in the host, wherein the sensor is operably connected to the electronics unit when the electronics unit is mated to the housing.

11. The assembly of claim 10, wherein the electronics unit is configured to releasably mate to the housing by a mechanical fit selected from the group consisting of a slide fit, a snap fit, a press fit, and an interference fit.

12. The assembly of claim 11, wherein the electronics unit comprises a tab extending therefrom and the mounting assembly comprises a tab extending therefrom, wherein the tabs are configured to guide mating of the electronics unit with the housing.

13. The assembly of claim 10, wherein the housing comprises at least one electrical contact configured to operably connect the sensor to the electronics unit when releasably mated thereto.

14. The assembly of claim 13, wherein the electronics unit comprises at least one electrical contact configured to engage with the electrical contact of the housing when releasably mated thereto.

15. The assembly of claim 13, wherein the housing comprises at least two electrical contacts.

16. The assembly of claim 15, wherein the electrical contacts are aligned with the sensor.

17. The assembly of claim 13, wherein the electrical contact of the housing comprises a conductive elastomer.

18. The assembly of claim 13, wherein the sensor is disposed adjacent to the electrical contact of the housing or within the electrical contact of the housing.

19. The assembly of claim 18, wherein the sensor is configured to extend through the electrical contact.

20. The assembly of claim 10, further comprising at least one release latch configured to release the electronics unit from the housing releasably mated thereto.

21. The assembly of claim 20, wherein the release latch is located on the housing and is configured to manually release the electronics unit from the housing releasably mated thereto.

23. The sensor system of claim 21, wherein the mounting unit comprises a base adapted for fastening to the skin of the host, wherein the base at least partially comprises the flexible material.

26. The sensor system of claim 23, wherein the flexible material is configured to seal at least one of the needle and the sensor at the opening.

22. A sensor system comprising:

an analyte sensor adapted for transcutaneous placement through a skin of a host;

a mounting unit adapted for placement adjacent to the skin of the host, wherein the mounting unit comprises a flexible material, and wherein the sensor is configured to extend through the mounting unit and into the host; and

an adhesive material configured to adhere the mounting unit to the skin of the host.

24. The sensor system of claim 22, wherein the flexible material is elastomeric.

25. The sensor system of claim 24, wherein the flexible material comprises silicone.

27. The sensor system of claim 22, wherein the mounting unit comprises an opening through which the sensor and the needle are configured to extend, and wherein the flexible material comprises a sealing material configured to seal at least one of the needle and the sensor at the opening.

28. The sensor system of claim 27, wherein the sealing material is integral with the mounting unit.

29. The sensor system of claim 27, wherein the sealing material is integral with the adhesive material.

30. The sensor system of claim 27, wherein the sealing material is attached to the mounting unit.

31. The sensor system of claim 27, wherein the sealing material extends through the opening.

32. The sensor system of claim 27, wherein the sealing material comprises a bioactive agent incorporated therein.

33. The sensor system of claim 27, wherein the sealing material comprises a material selected from the group consisting of a malleable material, an elastomer, a gel, a grease, and combinations thereof.

34. The sensor system of claim 22, wherein the mounting unit comprises an opening through which the sensor and the needle are configured to extend, and wherein the opening is configured to provide ventilation between the sensor and an exit site.

35. The sensor system of claim 22, wherein the adhesive material comprises an opening for needle entry.

36. The sensor system of claim 22, wherein the adhesive material comprises a bioactive agent.

37. The sensor system of claim 22, further comprising a covering configured to be placed over at least a portion of the mounting unit.

38. The sensor system of claim 37, wherein the covering comprises an adhesive material.

39. The sensor system of claim 37, wherein the covering is configured to provide a seal around at least a portion of the mounting unit.

40. The sensor system of claim 39, wherein the seal includes a watertight seal.

41. The sensor system of claim 22, wherein the mounting unit comprises a base portion and a sealing portion, wherein the sealing portion comprises the flexible material.

42. The sensor system of claim 41, wherein the flexible material comprises a watertight sealing member.

43. The sensor system of claim 42, wherein the sealing member comprises an elastomeric material.

44. The sensor system of claim 42, wherein the sealing member comprises silicone.

45. The sensor system of claim 42, wherein the sealing member is configured to seal at least one of the needle and the sensor at the opening.

46. The sensor system of claim 22, wherein the flexible material comprises a flexible plastic.

47. The sensor system of claim 22, wherein the sensor is flexible.

48. The sensor system of claim 22, wherein the mounting unit comprises a portion configured to guide needle entry.

49. The sensor system of claim 22, wherein the sensor is an electrochemical sensor.

50. The sensor system of claim 22, wherein the sensor is a glucose sensor.

51. A sensor system comprising:

a glucose sensor adapted for transcutaneous placement through a skin of a host; and

a flexible mounting unit adapted for placement adjacent to the skin of the host, wherein the sensor is configured to extend through an area of the mounting unit and into the host, and wherein the area is configured to seal around the sensor.

52. The system of claim 51, further comprising an adhesive material configured to adhere the mounting unit to the skin of the host.

53. The sensor system of claim 51, wherein the flexible mounting unit comprises a base adapted for fastening to the skin of the host, wherein the base is at least partially formed from the flexible material.

54. The sensor system of claim 51, further comprising a covering configured to be placed over at least a portion of the mounting unit.

55. The sensor system of claim 51, wherein the flexible mounting unit comprises a flexible plastic.

56. The sensor system of claim 51, wherein the sensor is flexible.