IP Library Granted Patent US 10,980,452
Granted Patent B2
US 10,980,452 · App. 17/088,396 · Granted Apr 20, 2021

Analyte sensor

Inventors: Peter C. Simpson (Cardiff, CA); James H. Brauker (Coldwater, MI); Mark C. Brister (Encinitas, CA); Paul V. Goode, Jr. (Round Rock, TX); Apurv Ullas Kamath (San Diego, CA); Steve Masterson (Encinitas, CA); Aarthi Mahalingam (San Diego, CA); John Nolting (San Diego, CA); James R. Petisce (San Diego, CA); Jack Pryor (Ladera Ranch, CA); Sean Saint (San Diego, CA); Vance Swanson (San Diego, CA); Matthew D. Wightlin (San Diego, CA)
Assignee: DexCom, Inc.
A61B5/14532A61B5/0002A61B5/0004A61B5/05A61B5/1411A61B5/1473A61B5/1486A61B5/1495A61B5/14503A61B5/14507A61B5/14514A61B5/14546A61B5/14735A61B5/14865A61B5/6801A61B5/6833A61B5/6848A61B5/6849A61B5/68335A61B5/72A61B17/3468A61B5/14A61B5/145A61B5/1468A61B5/150022A61B2017/3492A61B2560/0223A61B2560/045A61B2562/18A61M5/14244A61M5/1723A61M2005/1585Y02A90/10
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Quick Facts
Patent No.
US 10,980,452
App. No.
17/088,396
Granted
Apr 20, 2021
Kind
B2
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 (138)

1. A system for measuring an analyte concentration in a host, the system comprising:

a transcutaneous analyte sensor;

sensor electronics configured to operatively connect to the transcutaneous analyte sensor;

an electrical contact comprising a first material, wherein the first material is associated with a first durometer hardness, wherein the electrical contact is configured to operably connect the transcutaneous analyte sensor to the sensor electronics;

a sealing member comprising a second material, wherein the second material is associated with a second durometer hardness, wherein the sealing member at least partially surrounds the electrical contact and at least a portion of the transcutaneous analyte sensor when the transcutaneous analyte sensor is operably connected to the sensor electronics, wherein the sealing member substantially seals at least a portion of the electrical contact from moisture;

a contact holder over which the sealing member and the transcutaneous analyte sensor are at least partially located; and

wherein the first durometer hardness is higher than the second durometer hardness.

2. The system of claim 1 , wherein the first durometer hardness is from about 5 Shore A to about 80 Shore A.

3. The system of claim 2 , wherein the second durometer hardness is from about 5 Shore A to about 80 Shore A.

4. The system of claim 2 , wherein the second durometer hardness is from about 20 Shore A to about 50 shore A.

5. The system of claim 1 , wherein the first durometer hardness is from about 5 Shore A to about 80 Shore A and the second durometer hardness is from about 5 Shore A to about 80 Shore A.

6. The system of claim 1 , wherein the first durometer hardness is from about 5 Shore A to about 80 Shore A and the second durometer hardness is from about 10 Shore A to about 50 Shore A.

7. The system of claim 1 , wherein the contact holder is connected to a mounting unit.

8. The system of claim 1 , wherein the contact holder comprises means for maintaining the sealing member on the contact holder.

9. The system of claim 1 , wherein the contact holder and sealing member comprises means for maintaining the sealing member substantially in place on the contact holder.

10. The system of claim 1 , wherein the sealing member is held at least in part on the contact holder by mating male-female mechanical structures on the contact holder and on the sealing member.

11. The system of claim 1 , wherein the sealing member comprises a raised ridge to improve a seal around the electrical contact.

12. The system of claim 1 , wherein the sealing member is held on the contact holder at least in part by protrusions on the contact holder that are configured to mate with recesses on the sealing member.

13. The system of claim 1 , wherein the sealing member is held on the contact holder at least in part by a chemical to maintain the sealing member substantially stationary without substantial translation or deformation during sensor insertion.

14. The system of claim 1 , wherein the sealing member comprises an upper portion and a lower portion, wherein an ex vivo portion of the transcutaneous analyte sensor is sandwiched between the upper portion and the lower portion.

15. The assembly of claim 14 , wherein the upper portion is connected to the lower portion.

16. The system of claim 1 , wherein the sealing member comprises an upper portion and a lower portion, wherein the upper portion comprises an inner face and an outer face, wherein the lower portion comprises an inner face and an outer face, wherein an ex vivo portion of the transcutaneous analyte sensor is positioned between the inner face of the upper portion and the inner face of the lower portion.

17. The assembly of claim 16 , wherein the upper portion is connected to the lower portion.

18. The system of claim 1 , further comprising a memory storing calibration information for the transcutaneous analyte sensor, wherein the calibration information is derived at least in part from a predictive relationship between in vitro sensor sensitivity to the analyte and in vivo sensor sensitivity to the analyte.

19. A system for measuring a glucose concentration in a host, the system comprising:

a transcutaneous glucose sensor;

sensor electronics configured to operably connect to the transcutaneous glucose sensor;

an electrical contact configured to operably connect the transcutaneous glucose sensor to the sensor electronics;

a sealing member comprising a sealing member upper portion and a sealing member lower portion, wherein the sealing member at least partially surrounds the electrical contact and at least a portion of the transcutaneous glucose sensor when the transcutaneous glucose sensor is operably connected to the sensor electronics, wherein the sealing member substantially seals at least a portion of the electrical contact from moisture, and wherein an ex vivo portion of the transcutaneous glucose sensor is sandwiched between the sealing member upper portion and the sealing member lower portion; and

a contact holder over which the sealing member and the transcutaneous glucose sensor are at least partially located.

20. The system of claim 19 , wherein the electrical contact is formed from a material associated with a durometer hardness of from about 5 Shore A to about 80 Shore A.

21. The system of claim 20 , wherein the sealing member is formed from a material associated with a durometer hardness of from about 5 Shore A to about 80 Shore A.

22. The system of claim 20 , wherein the sealing member is formed from a material associated with a durometer hardness of from about 20 Shore A to about 50 shore A.

23. The system of claim 19 , wherein the contact holder is connected to a mounting unit.

24. The system of claim 19 , wherein the contact holder comprises means for maintaining the sealing member on the contact holder.

25. The system of claim 19 , wherein the contact holder and sealing member comprises means for maintaining the sealing member substantially in place on the contact holder.

26. The system of claim 19 , wherein the sealing member is held at least in part on the contact holder by mating male-female mechanical structures on the contact holder and on the sealing member.

27. The system of claim 19 , wherein the sealing member comprises a raised ridge to improve a seal around the electrical contact.

28. The system of claim 19 , wherein the sealing member is held on the contact holder at least in part by protrusions on the contact holder that are configured to mate with recesses on the sealing member.

29. The system of claim 19 , wherein the sealing member is held on the contact holder at least in part by a chemical to maintain the sealing member substantially stationary without substantial translation or deformation during sensor insertion.

30. A system for measuring a glucose concentration in a host, the system comprising:

a transcutaneous glucose sensor;

sensor electronics configured to operably connect to the transcutaneous glucose sensor;

an electrical contact configured to operably connect the transcutaneous glucose sensor to the sensor electronics;

a sealing member comprising a sealing member upper portion and a sealing member lower portion;

wherein the sealing member upper portion comprises an inner face and an outer face, wherein the sealing member lower portion comprises an inner face and an outer face;

wherein the sealing member at least partially surrounds the electrical contact and at least a portion of the transcutaneous glucose sensor when the transcutaneous glucose sensor is operably connected to the sensor electronics;

wherein the sealing member substantially seals at least a portion of the electrical contact from moisture;

wherein an ex vivo portion of the transcutaneous glucose sensor is positioned between the sealing member upper portion inner face and the sealing member lower portion inner face; and

a contact holder over which the sealing member and the transcutaneous glucose sensor are at least partially located.

31. The system of claim 30 , wherein the electrical contact is formed from a material associated with a durometer hardness of from about 5 Shore A to about 80 Shore A.

32. The system of claim 31 , wherein the sealing member is formed from a material associated with a durometer hardness of from about 5 Shore A to about 80 Shore A.

33. The system of claim 31 , wherein the sealing member is formed from a material associated with a durometer hardness of from about 20 Shore A to about 50 shore A.

34. The system of claim 30 , wherein the contact holder is connected to a mounting unit.

35. The system of claim 30 , wherein the contact holder comprises means for maintaining the sealing member on the contact holder.

36. The system of claim 30 , wherein the contact holder and sealing member comprises means for maintaining the sealing member substantially in place on the contact holder.

37. The system of claim 30 , wherein the sealing member is held at least in part on the contact holder by mating male-female mechanical structures on the contact holder and on the sealing member.

38. The system of claim 30 , wherein the sealing member comprises a raised ridge to improve a seal around the electrical contact.

39. The system of claim 30 , wherein the sealing member is held on the contact holder at least in part by protrusions on the contact holder that are configured to mate with recesses on the sealing member.

40. The system of claim 30 , wherein the sealing member is held on the contact holder at least in part by a chemical to maintain the sealing member substantially stationary without substantial translation or deformation during sensor insertion.

41. A system for measuring a glucose concentration in a host, the system comprising:

a transcutaneous glucose sensor;

sensor electronics configured to operably connect to the transcutaneous glucose sensor;

an electrical contact configured to operably connect the transcutaneous glucose sensor to the sensor electronics;

a sealing member comprising a sealing member upper portion and a sealing member lower portion;

wherein the sealing member upper portion comprises an inner face and an outer face, wherein the sealing member lower portion comprises an inner face and an outer face;

wherein the sealing member upper portion comprises one or more holes therethrough, wherein each of the one or more holes extends from a respective opening in the outer face of the sealing member upper portion to a respective opening in the inner face of the sealing member upper portion;

wherein the sealing member at least partially surrounds the electrical contact and at least a portion of the transcutaneous glucose sensor when the transcutaneous glucose sensor is operably connected to the sensor electronics;

wherein the sealing member substantially seals at least a portion of the electrical contact from moisture;

wherein an ex vivo portion of the transcutaneous glucose sensor is positioned between the sealing member upper portion inner face and the sealing member lower portion inner face;

wherein the electrical contact is exposed for connection to the sensor electronics by the opening in the outer face of the sealing member upper portion;

wherein the electrical contact is exposed to the transcutaneous glucose sensor by the opening in the inner face of the sealing member upper portion; and

a contact holder over which the sealing member and the transcutaneous glucose sensor are at least partially located.

42. The system of claim 41 , wherein the electrical contact is formed from a material associated with a durometer hardness of from about 5 Shore A to about 80 Shore A.

43. The system of claim 42 , wherein the sealing member is formed from a material associated with a durometer hardness of from about 5 Shore A to about 80 Shore A.

44. The system of claim 42 , wherein the sealing member is formed from a material associated with a durometer hardness of from about 20 Shore A to about 50 shore A.

45. The system of claim 41 , wherein the contact holder is connected to a mounting unit.

46. The system of claim 41 , wherein the contact holder comprises means for maintaining the sealing member on the contact holder.

47. The system of claim 41 , wherein the contact holder and sealing member comprises means for maintaining the sealing member substantially in place on the contact holder.

48. The system of claim 41 , wherein the sealing member is held at least in part on the contact holder by mating male-female mechanical structures on the contact holder and on the sealing member.

49. The system of claim 41 , wherein the sealing member comprises a raised ridge to improve a seal around the electrical contact.

50. The system of claim 41 , wherein the sealing member is held on the contact holder at least in part by protrusions on the contact holder that are configured to mate with recesses on the sealing member.

51. The system of claim 41 , wherein the sealing member is held on the contact holder at least in part by a chemical to maintain the sealing member substantially stationary without substantial translation or deformation during sensor insertion.

52. An assembly for glucose monitoring in a host, the assembly comprising:

a transcutaneous glucose sensor having an in vivo portion and an ex vivo portion, wherein the transcutaneous glucose sensor is operably connectable to sensor electronics configured for detecting a signal from the transcutaneous glucose sensor, wherein the signal is indicative of a glucose concentration in the host;

at least one electrical contact configured to operably connect the ex vivo portion of the sensor to the sensor electronics;

a base configured for placement over the host's skin;

an elastomeric sealing member in contact with the ex vivo portion of the sensor and at least partially surrounding the at least one electrical contact, wherein the elastomeric sealing member is configured to seal the at least one electrical contact from moisture, wherein the elastomeric sealing member is located over the base by mating mechanical structures on the base and on the elastomeric sealing member.

53. The assembly of claim 52 , wherein the base comprises at least one protrusion, and wherein the mating mechanical structures comprise the at least one protrusion.

54. The assembly of claim 52 , wherein the elastomeric sealing member comprises at least one recess, and wherein the mating mechanical structures comprise the at least one recess.

55. The assembly of claim 52 , wherein the base comprises at least one protrusion, wherein the sealing member comprises at least one recess, and wherein the at least one protrusion and the at least one recess mate with one another.

56. The assembly of claim 52 , wherein the base comprises reinforcing mechanical supports configured to hold the sealing member.

57. An assembly for glucose monitoring in a host, the assembly comprising:

a transcutaneous glucose sensor having an in vivo portion and an ex vivo portion, wherein the transcutaneous glucose e sensor is operably connectable to sensor electronics configured for detecting a signal from the transcutaneous glucose sensor, wherein the signal is indicative of a glucose concentration in the host;

at least one electrical contact configured to operably connect the ex vivo portion of the sensor to the sensor electronics;

a base configured for placement over the host's skin;

an elastomeric sealing member in contact with the ex vivo portion of the sensor and to at least partially surrounding the at least one electrical contact, wherein the elastomeric sealing member is configured to seal the at least one electrical contact from moisture, wherein the elastomeric sealing member is held over the base by mechanical structures and/or chemical adhesives without substantial translation or deformation during sensor insertion.

58. The assembly of claim 57 , wherein the base comprises at least one protrusion, and wherein the mechanical structures comprise the at least one protrusion.

59. The assembly of claim 57 , wherein the sealing member comprises at least one recess, and wherein the mechanical structures comprise the at least one recess.

60. The assembly of claim 57 , wherein the base comprises at least one protrusion, wherein the sealing member comprises at least one recess, and wherein the at least one protrusion and the at least one recess mate with one another.

61. The assembly of claim 57 , wherein the base comprises reinforcing mechanical supports configured to hold the sealing member.

62. An assembly for glucose monitoring in a host, the assembly comprising:

a transcutaneous glucose sensor having an in vivo portion and an ex vivo portion, wherein the transcutaneous glucose sensor is operably connectable to sensor electronics configured for detecting a signal from the transcutaneous glucose sensor, wherein the signal is indicative of a glucose concentration in the host;

an electrical contact configured to operably connect the ex vivo portion of the transcutaneous glucose sensor to the sensor electronics;

a contact holder configured for placement over a skin of the host;

an elastomeric sealing member at least partially located over the contact holder, wherein the elastomeric sealing member is in contact with the ex vivo portion of the transcutaneous glucose sensor, wherein the elastomeric sealing member at least partially surrounds the electrical contact, wherein the elastomeric sealing member is configured to substantially seal at least a portion of the electrical contact from moisture, wherein the elastomeric sealing member is held on the contact holder by mating male-female mechanical structures on the contact holder and on the elastomeric sealing member.

63. The assembly of claim 62 , wherein a durometer of the electrical contact is higher than a durometer hardness of the elastomeric sealing member.

64. The assembly of claim 62 , wherein the electrical contact is formed from a material associated with a durometer hardness of from about 5 Shore A to about 80 Shore A.

65. The assembly of claim 64 , wherein the elastomeric sealing member is formed from a material associated with a durometer hardness of from about 5 Shore A to about 80 Shore A.

66. The assembly of claim 64 , wherein the elastomeric sealing member is formed from a material associated with a durometer hardness of from about 20 Shore A to about 50 shore A.

67. The assembly of claim 62 , wherein the contact holder is connected to a mounting unit.

68. The assembly of claim 62 , wherein the elastomeric sealing member comprises an upper portion and a lower portion, wherein the ex vivo portion of the transcutaneous glucose sensor is sandwiched between the upper portion and the lower portion.

69. The assembly of claim 62 , wherein the elastomeric sealing member comprises an upper portion and a lower portion, wherein the upper portion comprises an inner face and an outer face, wherein the lower portion comprises an inner face and an outer face, wherein the ex vivo portion of the transcutaneous glucose sensor is positioned between the inner face of the upper portion and the inner face of the lower portion.

70. The assembly of claim 62 , wherein the elastomeric sealing member comprises an upper portion and a lower portion, wherein the upper portion comprises an inner face and an outer face, wherein the lower portion comprises an inner face and an outer face, wherein the upper portion comprises one or more holes therethrough, wherein each of the one or more holes extends from a respective opening in the outer face of the upper portion to a respective opening in the inner face of the upper portion, wherein the ex vivo portion of the transcutaneous glucose sensor is positioned between the inner face of the upper portion and the inner face of the lower portion.

71. The assembly of claim 68 , wherein the upper portion is connected to the lower portion.

72. The assembly of claim 69 , wherein the upper portion is connected to the lower portion.

73. The assembly of claim 70 , wherein the upper portion is connected to the lower portion.

74. An assembly for glucose monitoring in a host, the assembly comprising:

a transcutaneous glucose sensor having an in vivo portion and an ex vivo portion, wherein the transcutaneous glucose sensor is operably connectable to sensor electronics configured for detecting a signal from the transcutaneous glucose sensor, wherein the signal is indicative of a glucose concentration in the host;

an electrical contact configured to operably connect the ex vivo portion of the transcutaneous glucose sensor to the sensor electronics;

a contact holder configured for placement over the skin of the host;

an elastomeric sealing member at least partially located over the contact holder, wherein the elastomeric sealing member is in contact with the ex vivo portion of the transcutaneous glucose sensor, wherein the elastomeric sealing member at least partially surrounds the electrical contact, wherein the elastomeric sealing member is configured to substantially seal at least a portion of the electrical contact from moisture, wherein the elastomeric sealing member is held on the contact holder by protrusions on the contact holder that are configured to mate with recesses on the elastomeric sealing member.

75. The assembly of claim 74 , wherein a durometer of the electrical contact is higher than a durometer hardness of the elastomeric sealing member.

76. The assembly of claim 74 , wherein the electrical contact is formed from a material associated with a durometer hardness of from about 5 Shore A to about 80 Shore A.

77. The assembly of claim 76 , wherein the elastomeric sealing member is formed from a material associated with a durometer hardness of from about 5 Shore A to about 80 Shore A.

78. The assembly of claim 76 , wherein the elastomeric sealing member is formed from a material associated with a durometer hardness of from about 20 Shore A to about 50 shore A.

79. The assembly of claim 74 , wherein the contact holder is connected to a mounting unit.

80. The assembly of claim 74 , wherein the elastomeric sealing member comprises an upper portion and a lower portion, wherein the ex vivo portion of the transcutaneous analyte sensor is sandwiched between the upper portion and the lower portion.

81. The assembly of claim 74 , wherein the elastomeric sealing member comprises an upper portion and a lower portion, wherein the upper portion comprises an inner face and an outer face, wherein the lower portion comprises an inner face and an outer face, wherein the ex vivo portion of the transcutaneous analyte sensor is positioned between the inner face of the upper portion and the inner face of the lower portion.

82. The assembly of claim 74 , wherein the elastomeric sealing member comprises an upper portion and a lower portion, wherein the upper portion comprises an inner face and an outer face, wherein the lower portion comprises an inner face and an outer face, wherein the upper portion comprises one or more holes therethrough, wherein each of the one or more holes extends from a respective opening in the outer face of the upper portion to a respective opening in the inner face of the upper portion, wherein the ex vivo portion of the transcutaneous analyte sensor is positioned between the inner face of the upper portion and the inner face of the lower portion.

83. The assembly of claim 80 , wherein the upper portion is connected to the lower portion.

84. The assembly of claim 81 , wherein the upper portion is connected to the lower portion.

85. The assembly of claim 82 , wherein the upper portion is connected to the lower portion.

86. An assembly for glucose monitoring in a host, the assembly comprising:

a transcutaneous glucose sensor having an in vivo portion and an ex vivo portion, wherein the transcutaneous glucose sensor is operably connectable to sensor electronics configured for detecting a signal from the transcutaneous glucose sensor, wherein the signal is indicative of a glucose concentration in the host;

an electrical contact configured to operably connect the ex vivo portion of the sensor to the sensor electronics;

a contact holder configured for placement over a skin of the host;

an elastomeric sealing member in contact with the ex vivo portion of the sensor and at least partially surrounding the electrical contact, wherein the elastomeric sealing member is configured to seal the electrical contact from moisture, wherein the elastomeric sealing member is held on the contact holder by a chemical implemented to maintain the elastomeric sealing member substantially stationary without substantial translation or deformation during sensor insertion.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 4, 2021
From: PETISCE, JAMES R.; SAINT, SEAN; NOLTING, JOHN
To: DEXCOM, INC.
Reel/Frame 055500/0023 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 4, 2021
From: MASTERSON, STEVE; SWANSON, VANCE
To: DEXCOM, INC.
Reel/Frame 055500/0108 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 3, 2021
From: MASTERSON, STEVE; SIMPSON, PETER; WIGHTLIN, MATTHEW D.; PRYOR, JACK; SWANSON, VANCE
To: DEXCOM, INC.
Reel/Frame 055126/0580 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 3, 2021
From: GOODE, PAUL V., JR.; KAMATH, APURV ULLAS; MAHALINGAM, AARTHI; BRAUKER, JAMES H.
To: DEXCOM, INC.
Reel/Frame 055126/0684 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 3, 2021
From: BRISTER, MARK; PETISCE, JAMES R.; WOO, KUM MING; SAINT, SEAN; NOLTING, JOHN
To: DEXCOM, INC.
Reel/Frame 055126/0773 →
Continuity (8)
Continuation 16924117 · Jul 8, 2020
Continuation 16691358 · Nov 21, 2019
Continuation 16674610 · Nov 5, 2019
Continuation 16392521 · Apr 23, 2019
Continuation 14590483 · Jan 6, 2015
Continuation 13909962 · Jun 4, 2013
Continuation 11360262 · Feb 22, 2006
Related Publication 20210068726A1 · Mar 11, 2021
Cited By (8)
US 1,130,751 US 12,279,865 US 12,453,494 US 12,458,257 US 12,458,258 US 12,502,132 US 12,666,543 US 12,690,787