US20030199893A1 — Method and apparatus for a multi-use body fluid s…

Claim 1

Independent Claim 83 words

1 . A device for use with a penetrating member driver to penetrate tissue, the device comprising: a single cartridge; a plurality of penetrating members coupled to said single cartridge and operatively couplable to the penetrating member driver, said penetrating members movable to extend radially outward from the cartridge to penetrate tissue; a plurality of analyte sensors coupled to said single cartridge, said sensors positioned on the cartridge to receive body fluid from a wound in the tissue created by the penetrating member.

Claim 2

Dependent Claim 83 words

1 . A device for use with a penetrating member driver to penetrate tissue, the device comprising: a single cartridge; a plurality of penetrating members coupled to said single cartridge and operatively couplable to the penetrating member driver, said penetrating members movable to extend radially outward from the cartridge to penetrate tissue; a plurality of analyte sensors coupled to said single cartridge, said sensors positioned on the cartridge to receive body fluid from a wound in the tissue created by the penetrating member.

Claim 3

Dependent Claim 17 words

2 . The device of claim 1 wherein said penetrating members are slidably coupled to said cartridge.

Claim 4

Dependent Claim 23 words

3 . The device of claim 1 wherein at least one analyte sensor is associated with at least one of said penetrating members.

Claim 5

Dependent Claim 15 words

4 . The device of claim 1 wherein said cartridge is a flat radial disc.

Claim 6

Dependent Claim 18 words

5 . The device of claim 1 wherein said cartridge has a diameter of less than 6 cm.

Claim 7

Dependent Claim 14 words

6 . The device of claim 1 wherein said cartridge is a unitary body.

Claim 8

Dependent Claim 21 words

7 . The device of claim 1 wherein said penetrating members are not attached by a resilient member to the cartridge.

Claim 9

Dependent Claim 14 words

8 . The device of claim 1 wherein said analyte sensors are electrochemical sensors.

Claim 10

Dependent Claim 14 words

9 . The device of claim 1 wherein said analyte sensor are potentiometric sensors.

Claim 11

Dependent Claim 28 words

10 . The device of claim 1 wherein said analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 1 microliter.

Claim 12

Dependent Claim 28 words

11 . The device of claim 1 wherein said analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 300 nanoliters.

Claim 13

Dependent Claim 16 words

12 . The device of claim 1 wherein said analyte sensors are mounted on said cartridge.

Claim 14

Dependent Claim 18 words

13 . The device of claim 1 wherein each of said analyte sensors comprises an array of sensors.

Claim 15

Dependent Claim 31 words

14 . The device of claim 1 wherein each of said analyte sensors comprises an array of sensors wherein a plurality of said array sensors have different ranges of analyte sensitivity.

Claim 16

Dependent Claim 21 words

15 . The device of claim 1 wherein each of said analyte sensors comprises an array of sensors formed from nanowires.

Claim 17

Dependent Claim 19 words

16 . The device of claim 1 wherein each of said penetrating members are elongate members without molded attachments.

Claim 18

Dependent Claim 20 words

17 . The device of claim 1 wherein each of said penetrating members are elongate wires of substantially constant diameter.

Claim 19

Dependent Claim 29 words

18 . The device of claim 1 wherein each of said penetrating members is made of only one material selected from the following: a metal or a metal alloy.

Claim 20

Dependent Claim 53 words

19 . A device for use with penetrating member driver to penetrate tissue, the device comprising: a single cartridge having a plurality of openings; a plurality of penetrating members having a sharpened tips movable to penetrate tissue; a plurality of analyte sensors coupled to said single cartridge; a sterility barrier covering said openings.

Claim 21

Dependent Claim 53 words

19 . A device for use with penetrating member driver to penetrate tissue, the device comprising: a single cartridge having a plurality of openings; a plurality of penetrating members having a sharpened tips movable to penetrate tissue; a plurality of analyte sensors coupled to said single cartridge; a sterility barrier covering said openings.

Claim 22

Dependent Claim 31 words

20 . The device of claim 19 wherein said penetrating members with sharpened distal ends and are arranged in a radial pattern pointing each of said sharpened distal ends radially outward.

Claim 23

Dependent Claim 31 words

21 . The device of claim 19 wherein said analyte sensors are positioned on the cartridge to receive body fluid from a wound in the tissue created by a penetrating member.

Claim 24

Dependent Claim 14 words

22 . The device of claim 19 wherein said analyte sensors are electrochemical sensors.

Claim 25

Dependent Claim 14 words

23 . The device of claim 19 wherein said analyte sensor are potentiometric sensors.

Claim 26

Dependent Claim 28 words

24 . The device of claim 19 wherein said analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 1 microliter.

Claim 27

Dependent Claim 28 words

25 . The device of claim 19 wherein said analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 300 nanoliters.

Claim 28

Dependent Claim 22 words

26 . The device of claim 19 wherein said sterility barrier, prior to being breached, maintains a sterile environment inside said openings.

Claim 29

Dependent Claim 70 words

27 . A device for use with a penetrating member driver to penetrate tissue, the device comprising: a single cartridge having a plurality of cavities; a plurality of penetrating members coupled to said single cartridge and couplable to the penetrating member driver, said penetrating members movable to extend outward to penetrate tissue; a plurality of analyte sensors coupled to said single cartridge, said sensors receiving body fluid entering said cavities.

Claim 30

Dependent Claim 70 words

27 . A device for use with a penetrating member driver to penetrate tissue, the device comprising: a single cartridge having a plurality of cavities; a plurality of penetrating members coupled to said single cartridge and couplable to the penetrating member driver, said penetrating members movable to extend outward to penetrate tissue; a plurality of analyte sensors coupled to said single cartridge, said sensors receiving body fluid entering said cavities.

Claim 31

Dependent Claim 16 words

28 . The device of claim 27 wherein said sensors define a portion of said cavities.

Claim 32

Dependent Claim 15 words

29 . The device of claim 27 wherein said sensors are mounted in said cavities.

Claim 33

Dependent Claim 15 words

30 . The device of claim 27 further comprising a sterility barrier covering said cavities.

Claim 34

Dependent Claim 14 words

31 . The device of claim 27 wherein said analyte sensors are electrochemical sensors.

Claim 35

Dependent Claim 14 words

32 . The device of claim 27 wherein said analyte sensor are potentiometric sensors.

Claim 36

Dependent Claim 28 words

33 . The device of claim 27 wherein said analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 1 microliter.

Claim 37

Dependent Claim 28 words

34 . The device of claim 27 wherein said analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 300 nanoliters.

Claim 38

Dependent Claim 24 words

35 . The device of claim 27 wherein at least some of said analyte sensors are positioned on a bottom surface of said cavities.

Claim 39

Dependent Claim 24 words

36 . The device of claim 27 wherein at least some of said analyte sensors are positioned on a side surface of said cavities.

Claim 40

Dependent Claim 24 words

37 . The device of claim 27 wherein at least some of said analyte sensors are positioned on a top surface of said cavities.

Claim 41

Dependent Claim 24 words

38 . The device of claim 27 wherein at least some of said analyte sensors are positioned on a curved surface of said cavities.

Claim 42

Dependent Claim 75 words

39 . A device for use with a penetrating member driver to penetrate tissue, the device comprising: a single cartridge having a plurality of openings and a plurality of penetrating member cavities; a plurality of penetrating members at least partially contained in said cavities; a plurality of sensors attached to a substrate, said substrate couplable to said single cartridge in manner positioning at least one of said sensors with each of said plurality of cavities.

Claim 43

Dependent Claim 75 words

39 . A device for use with a penetrating member driver to penetrate tissue, the device comprising: a single cartridge having a plurality of openings and a plurality of penetrating member cavities; a plurality of penetrating members at least partially contained in said cavities; a plurality of sensors attached to a substrate, said substrate couplable to said single cartridge in manner positioning at least one of said sensors with each of said plurality of cavities.

Claim 44

Dependent Claim 20 words

40 . The device of claim 39 wherein said substrate comprises a material selected from: polymer, metallic foil, or paper.

Claim 45

Dependent Claim 26 words

41 . The device of claim 39 wherein said substrate comprises a laminate made from combinations of any of the following: polymer, metallic foil, or paper.

Claim 46

Dependent Claim 16 words

42 . The device of claim 39 wherein said sensors define a portion of said cavities.

Claim 47

Dependent Claim 18 words

43 . The device of claim 39 further comprising a sterility barrier covering a plurality of said openings.

Claim 48

Dependent Claim 28 words

44 . The device of claim 39 wherein said analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 1 microliter.

Claim 49

Dependent Claim 28 words

45 . The device of claim 39 wherein said analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 300 nanoliters.

Claim 50

Dependent Claim 104 words

46 . A device for use with a penetrating member driver to penetrate tissue, the device comprising: a single cartridge having a plurality of openings and a plurality of cavities; a plurality of penetrating members with at least one penetrating members in at least one of said cavities; a plurality of sensors on a layer of material couplable to said single cartridge wherein at least two of said cavities each has at least one sensor in fluid communication with one of said cavities, said sensors positioned on the cartridge to receive body fluid from a wound in the tissue created by the penetrating member.

Claim 51

Dependent Claim 104 words

46 . A device for use with a penetrating member driver to penetrate tissue, the device comprising: a single cartridge having a plurality of openings and a plurality of cavities; a plurality of penetrating members with at least one penetrating members in at least one of said cavities; a plurality of sensors on a layer of material couplable to said single cartridge wherein at least two of said cavities each has at least one sensor in fluid communication with one of said cavities, said sensors positioned on the cartridge to receive body fluid from a wound in the tissue created by the penetrating member.

Claim 52

Dependent Claim 70 words

47 . A device comprising: a single cartridge; at least 50 penetrating members coupled to and at least partially housed in said single cartridge wherein said cartridge has a diameter no greater than about 5 inches; at least 50 analyte sensors, each associated with one of said penetrating members; said penetrating members movable in an outward direction from the cartridge to penetrate tissue when actuated by said penetrating member driver.

Claim 53

Dependent Claim 70 words

47 . A device comprising: a single cartridge; at least 50 penetrating members coupled to and at least partially housed in said single cartridge wherein said cartridge has a diameter no greater than about 5 inches; at least 50 analyte sensors, each associated with one of said penetrating members; said penetrating members movable in an outward direction from the cartridge to penetrate tissue when actuated by said penetrating member driver.

Claim 54

Dependent Claim 18 words

48 . The system of claim 47 , wherein the diameter is no great than about 5 cm.

Claim 55

Dependent Claim 30 words

49 . The system of claim 47 , wherein a volume of the cartridge does not exceed a packing density of about 0.5 cm3 per penetrating member and analyte sensor.

Claim 56

Dependent Claim 30 words

50 . The system of claim 47 , wherein a volume of the cartridge does not exceed a packing density of about 0.1 cm3 per penetrating member and analyte sensor.

Claim 57

Dependent Claim 69 words

51 . A device comprising: a single cartridge; at least 100 penetrating members coupled to and at least partially housed in said single cartridge wherein said cartridge has a diameter no greater than 6 inches; at least 100 analyte sensors, each associated with one of said penetrating members; said penetrating members movable in an outward direction from the cartridge to penetrate tissue when actuated by said penetrating member driver.

Claim 58

Dependent Claim 69 words

51 . A device comprising: a single cartridge; at least 100 penetrating members coupled to and at least partially housed in said single cartridge wherein said cartridge has a diameter no greater than 6 inches; at least 100 analyte sensors, each associated with one of said penetrating members; said penetrating members movable in an outward direction from the cartridge to penetrate tissue when actuated by said penetrating member driver.

Claim 59

Dependent Claim 18 words

52 . The system of claim 51 , wherein the diameter is no great than about 5 cm.

Claim 60

Dependent Claim 30 words

53 . The system of claim 51 , wherein a volume of the cartridge does not exceed a packing density of about 0.5 cm3 per penetrating member and analyte sensor.

Claim 61

Dependent Claim 29 words

54 . The system of claim 51 , wherein a volume of the cartridge does not exceed a packing density of about 0.1 cm3 penetrating member and analyte sensor.

Claim 62

Dependent Claim 77 words

55 . A method comprising: providing a cartridge having a plurality of penetrating members and a plurality of analyte sensors; using a penetrating member driver to actuate said penetrating members to penetrate tissue and wherein used penetrating members and sensors remain coupled to said cartridge; wherein said cartridge containing said used penetrating members and used sensors, is disposable; replacing the entire cartridge by inserting a new cartridge having penetrating members and sensors into the penetrating member driver.

Claim 63

Dependent Claim 77 words

55 . A method comprising: providing a cartridge having a plurality of penetrating members and a plurality of analyte sensors; using a penetrating member driver to actuate said penetrating members to penetrate tissue and wherein used penetrating members and sensors remain coupled to said cartridge; wherein said cartridge containing said used penetrating members and used sensors, is disposable; replacing the entire cartridge by inserting a new cartridge having penetrating members and sensors into the penetrating member driver.

Claim 64

Dependent Claim 75 words

56 . A lancing system comprising: a penetrating member driver; a plurality of penetrating members in a disc-shaped housing; a penetrating member release device releasing the penetrating member for a sterile environment prior to use and moving said penetrating member into position to be operatively coupled to said penetrating member driver; a plurality of sampling modules, wherein each of said modules is coupled to one of said penetrating members and housed in said disc-shaped housing.

Claim 65

Dependent Claim 75 words

56 . A lancing system comprising: a penetrating member driver; a plurality of penetrating members in a disc-shaped housing; a penetrating member release device releasing the penetrating member for a sterile environment prior to use and moving said penetrating member into position to be operatively coupled to said penetrating member driver; a plurality of sampling modules, wherein each of said modules is coupled to one of said penetrating members and housed in said disc-shaped housing.

Claim 66

Dependent Claim 17 words

57 . The system of claim 56 wherein said penetrating member driver is an electric powered driver.

Claim 67

Dependent Claim 22 words

58 . The system of claim 56 wherein said release device comprises a movable member sufficient to pierce a penetrating member enclosure.

Claim 68

Dependent Claim 45 words

59 . The system of claim 56 further comprising a penetrating member coupler suitable for engaging one of the penetrating members and independently advancing one of the penetrating members along a path outward from the housing, into a target tissue, and back into the housing.

Claim 69

Dependent Claim 21 words

60 . The system of claim 56 wherein said sample module has a sample chamber volume of less than 1 microliter.

Claim 70

Dependent Claim 56 words

61 . The system of claim 56 further comprising a penetrating member coupler suitable for engaging one of the modules and advancing one of the modules and one of the penetrating members such that said one of the lances advances along a path outward from the housing, into a target tissue, and back into the housing.

Claim 71

Dependent Claim 78 words

62 . A lancing system for use with a penetrating member driver, said system comprising: means for housing a plurality of penetrating members and analyte sensors; means for releasing one of said penetrating member from a sealed enclosure on said housing means; means for operatively coupling one of said penetrating member to said penetrating member driver; wherein one of said analyte sensors receives body fluid from a wound created in said tissue by one of said penetrating members.

Claim 72

Dependent Claim 78 words

62 . A lancing system for use with a penetrating member driver, said system comprising: means for housing a plurality of penetrating members and analyte sensors; means for releasing one of said penetrating member from a sealed enclosure on said housing means; means for operatively coupling one of said penetrating member to said penetrating member driver; wherein one of said analyte sensors receives body fluid from a wound created in said tissue by one of said penetrating members.

Claim 73

Dependent Claim 65 words

63 . A body fluid sampling system comprising: a cartridge; a plurality of penetrating members coupled to said cartridge and selectively actuatable to penetrate tissue, said penetrating members extending radially outward to penetrate tissue; a plurality of analyte sensors coupled to said cartridge; an electrically powered drive force generator configured to drive one of said penetrating members in a launch position into a tissue site.

Claim 74

Dependent Claim 65 words

63 . A body fluid sampling system comprising: a cartridge; a plurality of penetrating members coupled to said cartridge and selectively actuatable to penetrate tissue, said penetrating members extending radially outward to penetrate tissue; a plurality of analyte sensors coupled to said cartridge; an electrically powered drive force generator configured to drive one of said penetrating members in a launch position into a tissue site.

Claim 75

Dependent Claim 40 words

64 . A system as in claim 63 wherein said drive force generator is configured to sequentially drive said penetrating members, each of said members moved from said launch position along a path into and out of the tissue site.

Claim 76

Dependent Claim 37 words

65 . A system as in claim 63 further comprising a penetrating member coupler attached the drive force generator, the coupler configured to establish a frictional coupling with one of said penetrating members in the launch position.

Claim 77

Dependent Claim 27 words

66 . A system as in claim 63 further comprising means for moving said a penetrating member into contact with a coupler of said drive force generator.

Claim 78

Dependent Claim 16 words

67 . A system as in claim 63 wherein said penetrating member coupler is vertically movable.

Claim 79

Dependent Claim 17 words

68 . A system as in claim 63 further comprising an actuator for rotating said radial cartridge.

Claim 80

Dependent Claim 22 words

69 . A system as in claim 63 further comprising means for coupling the force generator with one of said penetrating members.

Claim 81

Dependent Claim 47 words

70 . A system as in claim 63 further comprising a penetrating member sensor positioned to monitor a penetrating member coupled to said force generator, the penetrating member sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

Claim 82

Dependent Claim 19 words

71 . The system of claim 70 , wherein the depth of penetration is about 100 to 2500 microns.

Claim 83

Dependent Claim 18 words

72 . The system of claim 70 , wherein the depth of penetration is 500 to 750 microns.

Claim 84

Dependent Claim 29 words

73 . The system of claim 70 , wherein the depth of penetration is no more than about 1000 microns beyond a stratum corneum thickness of a skin surface.

Claim 85

Dependent Claim 29 words

74 . The system of claim 70 , wherein the depth of penetration is no more than about 500 microns beyond a stratum corneum thickness of a skin surface.

Claim 86

Dependent Claim 29 words

75 . The system of claim 70 , wherein the depth of penetration is no more than about 300 microns beyond a stratum corneum thickness of a skin surface.

Claim 87

Dependent Claim 30 words

76 . The system of claim 70 , wherein the depth of penetration is less than a sum of a stratum corneum thickness of a skin surface and 400 microns..

Claim 88

Dependent Claim 23 words

77 . The system of claim 70 , wherein the penetrating member sensor is further configured to control velocity of a penetrating member.

Claim 89

Dependent Claim 22 words

78 . The system of claim 63 , wherein the active penetrating member moves along a substantially linear path into the tissue.

Claim 90

Dependent Claim 24 words

79 . The system of claim 63 , wherein the active penetrating member moves along an at least partially curved path into the tissue.

Claim 91

Dependent Claim 18 words

80 . The system of claim 63 , wherein the driver is a voice coil drive force generator.

Claim 92

Dependent Claim 19 words

81 . The system of claim 63 , wherein the driver is a rotary voice coil drive force generator.

Claim 93

Dependent Claim 26 words

82 . The system of claim 70 , wherein the penetrating member sensor is coupled to a processor with control instructions for the penetrating member driver.

Claim 94

Dependent Claim 31 words

83 . The system of claim 82 , wherein the processor includes a memory for storage and retrieval of a set of penetrating member profiles utilized with the penetrating member driver.

Claim 95

Dependent Claim 31 words

84 . The system of claim 82 , wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction.

Claim 96

Dependent Claim 32 words

85 . The system of claim 82 , wherein the processor is utilized to adjust an application of force to a penetrating member to achieve a desired speed of the penetrating member.

Claim 97

Dependent Claim 46 words

86 . The system of claim 82 , wherein the processor is utilized to adjust an application of force to a penetrating member when the penetrating member contacts a target tissue so that the penetrating member penetrates the target tissue within a desired range of speed.

Claim 98

Dependent Claim 57 words

87 . The system of claim 82 , wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in the first direction toward a target tissue, wherein the application of a launching force to the penetrating member is controlled based on position and speed of the penetrating member.

Claim 99

Dependent Claim 37 words

88 . The system of claim 87 , wherein the processor is utilized to control a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from the target tissue.

Claim 100

Dependent Claim 41 words

89 . The system of claim 88 , wherein in the first direction the penetrating member moves toward the target tissue at a speed that is different than a speed at which the penetrating member moves away from the target tissue.

Claim 101

Dependent Claim 41 words

90 . The system of claim 88 , wherein in the first direction the penetrating member moves toward the target tissue at a speed that is greater than a speed at which the penetrating member moves away from the target tissue.

Claim 102

Dependent Claim 28 words

91 . The system of claim 87 , wherein a speed of a penetrating member in the first direction is the range of about 2.0 to 10.0 m/sec.

Claim 103

Dependent Claim 49 words

92 . The system of claim 88 , wherein the average velocity of the penetrating member during a tissue penetration stroke in the first direction is about 100 to about 1000 times greater than the average velocity of the penetrating member during a withdrawal stroke in a second direction.

Claim 104

Dependent Claim 18 words

93 . The system of claim 70 , wherein the penetrating member sensor includes a capacitive incremental encoder.

Claim 105

Dependent Claim 17 words

94 . The system of claim 70 , wherein the penetrating member sensor includes an incremental encoder.

Claim 106

Dependent Claim 17 words

95 . The system of claim 70 , wherein the penetrating member sensor includes an optical encoder.

Claim 107

Dependent Claim 17 words

96 . The system of claim 70 , wherein the penetrating member sensor includes an interference encoder.

Claim 108

Dependent Claim 24 words

97 . The system of claim 63 wherein said penetrating member is advanced along a path at a velocity following a lancing velocity profile.

Claim 109

Dependent Claim 27 words

98 . The system of claim 63 further comprising a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.

Claim 110

Dependent Claim 78 words

99 . The system of claim 98 , wherein the user interface is configured to provide a user with at least one input selected from, depth of a penetrating member penetration, velocity of a penetrating member, a desired velocity profile, a velocity of a penetrating member into the target tissue, velocity of the penetrating member out of the target tissue, dwell time of the penetrating member in the target tissue; tent and hold characteristic of the penetrating member.

Claim 111

Dependent Claim 96 words

100 . The system of claim 98 , wherein the user interface provides at least one output to the user selected from, number of penetrating members available, number of penetrating members used, actual depth of penetrating member penetration on a target tissue penetrating cycle, stratum corneum thickness, force delivered on a target tissue penetrating cycle, energy used by a penetrating member driver to drive a penetrating member into the target tissue, dwell time of the penetrating member, battery status, system status, consumed energy, and speed profile of the penetrating member during a target tissue penetrating cycle.

Claim 112

Dependent Claim 33 words

101 . The system of claim 98 , wherein the user interface is selected from at least one of, a visual display selected from: an LCD, LED, TFT, and a backlit LCD display.

Claim 113

Dependent Claim 29 words

102 . The system of claim 98 , wherein the user interface includes an input device selected from a button, a touch pad, and a touch sensitive visual display.

Claim 114

Dependent Claim 23 words

103 . The system of claim 98 , further comprising: a data exchange device for coupling a penetrating member driver to support equipment.

Claim 115

Dependent Claim 28 words

104 . The system of claim 103 , wherein the support equipment is selected from at least one of a personal computer, modem, PDA, and a computer network.

Claim 116

Dependent Claim 27 words

105 . The system of claim 98 , further comprising a data interface configured to couple the skin penetrating system to support equipment with a data interface.

Claim 117

Dependent Claim 50 words

106 . The system of claim 105 , wherein the data interface is selected from at least one of, Serial RS-232, modem-interface, USB, HPNA, Ethernet, optical interface, IRDA, RF interface, Bluetooth interface, cellular telephone interface, 2 way pager interface, parallel port interface standard, near field magnetic coupling, and RF transceiver.

Claim 118

Dependent Claim 37 words

107 . The system of claim 98 , wherein the user interface includes a real time clock and one or more alarms to provide a user with a reminder of a next target penetrating event is needed.

Claim 119

Dependent Claim 14 words

108 . The system of claim 63 wherein said analyte sensors are electrochemical sensors.

Claim 120

Dependent Claim 14 words

109 . The system of claim 63 wherein said analyte sensor are potentiometric sensors.

Claim 121

Dependent Claim 28 words

110 . The system of claim 63 wherein said analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 1 microliter.

Claim 122

Dependent Claim 28 words

111 . The system of claim 63 wherein said analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 300 nanoliters.

Claim 123

Dependent Claim 16 words

112 . The system of claim 63 wherein said analyte sensors are mounted on said cartridge.

Claim 124

Dependent Claim 18 words

113 . The system of claim 63 wherein each of said analyte sensors comprises an array of sensors.

Claim 125

Dependent Claim 31 words

114 . The system of claim 63 wherein each of said analyte sensors comprises an array of sensors wherein a plurality of said array sensors have different ranges of analyte sensitivity.

Claim 126

Dependent Claim 21 words

115 . The system of claim 63 wherein each of said analyte sensors comprises an array of sensors formed from nanowires.

Claim 127

Dependent Claim 19 words

116 . The system of claim 63 wherein each of said penetrating members are elongate members without molded attachments.

Claim 128

Dependent Claim 20 words

117 . The system of claim 63 wherein each of said penetrating members are elongate wires of substantially constant diameter.

Claim 129

Dependent Claim 29 words

118 . The system of claim 63 wherein each of said penetrating members is made of only one material selected from the following: a metal or a metal alloy.

Claim 130

Dependent Claim 157 words

119 . A device for use in penetrating tissue to obtain a body fluid sample, comprising: a cartridge having a plurality of cavities; and a plurality of penetrating members having sharpened tips and slidably coupled to the cartridge, each of said penetrating members being moveable relative to the other ones of the penetrating members along a path out of the cartridge to penetrate tissue; a plurality of analyte sensors wherein at least one of said sensors is positioned to receive body fluid when one of said penetrating members creates a wound in said tissue; said penetrating members arranged with said sharpened tips pointing radially outward; wherein each of said cavities is defined in part by a deflectable portion, wherein said deflectable portion in a first position prevents said penetrating member from exiting the cartridge and said deflectable portion is movable to a second position creating an opening that allows said lancet to extend outward from the cartridge.

Claim 131

Dependent Claim 157 words

119 . A device for use in penetrating tissue to obtain a body fluid sample, comprising: a cartridge having a plurality of cavities; and a plurality of penetrating members having sharpened tips and slidably coupled to the cartridge, each of said penetrating members being moveable relative to the other ones of the penetrating members along a path out of the cartridge to penetrate tissue; a plurality of analyte sensors wherein at least one of said sensors is positioned to receive body fluid when one of said penetrating members creates a wound in said tissue; said penetrating members arranged with said sharpened tips pointing radially outward; wherein each of said cavities is defined in part by a deflectable portion, wherein said deflectable portion in a first position prevents said penetrating member from exiting the cartridge and said deflectable portion is movable to a second position creating an opening that allows said lancet to extend outward from the cartridge.

Claim 132

Dependent Claim 13 words

120 . The device of claim 119 wherein said portion is vertically deflectable.

Claim 133

Dependent Claim 13 words

121 . The device of claim 119 wherein said portion is horizontally deflectable.

Claim 134

Dependent Claim 28 words

122 . The device of claim 119 further comprising a sterility barrier over a planar surface of the cartridge covering a plurality of longitudinal openings on the surface.

Claim 135

Dependent Claim 25 words

123 . The device of claim 119 wherein each deflectable portion includes a penetrable wall for receiving a sharpened tip of a used penetrating member.

Claim 136

Dependent Claim 27 words

124 . The device of claim 119 further comprising a module mounted about one of said penetrating member and having at least one of said analyte sensors.

Claim 137

Dependent Claim 39 words

125 . The device of claim 119 further comprising a module slidably mounted about one of said penetrating member and having at least one of said analyte sensors, said module movable to be adjacent said wound in the tissue.

Claim 138

Dependent Claim 44 words

126 . A manufacturing method comprising: providing a cartridge having a plurality of cavities for holding penetrating members; sealing a plurality of cavities with a sterility barrier; providing said cartridge with a plurality of analyte sensors by coupling a sensor layer to the cartridge.

Claim 139

Dependent Claim 44 words

126 . A manufacturing method comprising: providing a cartridge having a plurality of cavities for holding penetrating members; sealing a plurality of cavities with a sterility barrier; providing said cartridge with a plurality of analyte sensors by coupling a sensor layer to the cartridge.

Claim 140

Dependent Claim 27 words

127 . The method of claim 126 wherein said sensor layer comprises said analyte sensors secured to a material selected from the following: polymer, foil, or paper.

Claim 141

Dependent Claim 13 words

128 . The method of claim 126 wherein said sensors are electrochemical sensors.

Claim 142

Dependent Claim 16 words

129 . The method of claim 126 wherein sealing creates a sterile environment in said cavities.

Claim 143

Dependent Claim 17 words

130 . The method of claim 126 further comprising applying a second sterility barrier to said cartridge.

Claim 144

Dependent Claim 69 words

131 . A manufacturing method comprising: providing a cartridge having a plurality of cavities at least partially holding a plurality of penetrating members; sterilizing said cartridge while each of said cavities is in a sealed condition; adding sensors to the cavities by opening cavities in a sterile environment and coupling a sensor layer to the cartridge that provides the sensors and resealing the cavities to maintain a sterile environment.

Claim 145

Dependent Claim 69 words

131 . A manufacturing method comprising: providing a cartridge having a plurality of cavities at least partially holding a plurality of penetrating members; sterilizing said cartridge while each of said cavities is in a sealed condition; adding sensors to the cavities by opening cavities in a sterile environment and coupling a sensor layer to the cartridge that provides the sensors and resealing the cavities to maintain a sterile environment.

Claim 146

Dependent Claim 16 words

132 . The method of claim 131 further comprising adding a sterility barrier to said cartridge.

Claim 147

Dependent Claim 23 words

133 . The method of claim 131 wherein said providing for step comprises adding a sterility barrier covering said cavities prior to sterilizing.

Claim 148

Dependent Claim 20 words

134 . The method of claim 131 wherein said sensors include components that cannot withstand a penetrating member sterilization process.

Claim 149

Dependent Claim 79 words

135 . A method of driving a penetrating member into a tissue site to obtain a body fluid sample, said method comprising: providing a single cartridge having a plurality of penetrating members and a plurality of analyte sensors; expressing fluid from a wound tract created by advancing one of said penetrating members radially outward from the cartridge into a tissue site; drawing fluid into said single cartridge which exposes at least one of said analyte sensors to said fluid.

Claim 150

Dependent Claim 79 words

135 . A method of driving a penetrating member into a tissue site to obtain a body fluid sample, said method comprising: providing a single cartridge having a plurality of penetrating members and a plurality of analyte sensors; expressing fluid from a wound tract created by advancing one of said penetrating members radially outward from the cartridge into a tissue site; drawing fluid into said single cartridge which exposes at least one of said analyte sensors to said fluid.

Claim 151

Dependent Claim 21 words

136 . The method of claim 135 further comprising using an electric powered drive force generator for advancing the penetrating member.

Claim 152

Dependent Claim 14 words

137 . The method of claim 135 wherein said cartridge has a disc-shaped configuration.

Claim 153

Dependent Claim 19 words

138 . The method of claim 135 wherein each of said penetrating members are elongate members without molded attachments.

Claim 154

Dependent Claim 20 words

139 . The method of claim 135 wherein each of said penetrating members are elongate wires of substantially constant diameter.

Claim 155

Dependent Claim 29 words

140 . The method of claim 135 wherein each of said penetrating members is made of only one material selected from the following: a metal or a metal alloy.

Claim 156

Dependent Claim 32 words

141 . The method of claim 135 wherein said cartridge has a radial configuration and is rotated to bring an unused penetrating member into a launch position for a drive force generator.

Claim 157

Dependent Claim 56 words

142 . A method for determining a concentration of an analyte in body fluid, comprising: collecting a sample of body fluid of about 500 nL or less; filling a measurement zone of an electrochemical sensor with at least a portion of the sample; determining the concentration of the analyte in the sample using a potentiometric technique.

Claim 158

Dependent Claim 56 words

142 . A method for determining a concentration of an analyte in body fluid, comprising: collecting a sample of body fluid of about 500 nL or less; filling a measurement zone of an electrochemical sensor with at least a portion of the sample; determining the concentration of the analyte in the sample using a potentiometric technique.

Claim 159

Dependent Claim 68 words

143 . A method comprising: creating an unassisted flow of a body fluid from the patient; transporting a portion of the body fluid into an analyte sensor configured and arranged to determine the concentration of the analyte from 500 nL or less of body fluid; and determining the concentration of the analyte in the body fluid from the portion of the body fluid transported into the analyte sensor.

Claim 160

Dependent Claim 68 words

143 . A method comprising: creating an unassisted flow of a body fluid from the patient; transporting a portion of the body fluid into an analyte sensor configured and arranged to determine the concentration of the analyte from 500 nL or less of body fluid; and determining the concentration of the analyte in the body fluid from the portion of the body fluid transported into the analyte sensor.

Claim 161

Dependent Claim 39 words

144 . A device comprising: a plurality of analyte sensors defining an array; wherein at least two of said sensors have different sensitivity ranges enhancing the overall range of sensitivity of the array when used on a sample fluid.

Claim 162

Dependent Claim 39 words

144 . A device comprising: a plurality of analyte sensors defining an array; wherein at least two of said sensors have different sensitivity ranges enhancing the overall range of sensitivity of the array when used on a sample fluid.

Claim 163

Dependent Claim 46 words

145 . A system comprising: a cartridge housing a plurality of penetrating members; a punch for penetrating a sterility barrier on the cartridge; a cam for sequencing the punch to penetrate the barrier to release at least one of the penetrating members from a sterile environment.

Claim 164

Dependent Claim 46 words

145 . A system comprising: a cartridge housing a plurality of penetrating members; a punch for penetrating a sterility barrier on the cartridge; a cam for sequencing the punch to penetrate the barrier to release at least one of the penetrating members from a sterile environment.

Claim 165

Dependent Claim 72 words

146 . A system comprising: a cartridge housing a plurality of penetrating members; a punch for penetrating a sterility barrier on the cartridge; a cam for sequencing the punch to penetrate the barrier to release at least one of the penetrating members from a sterile environment; a penetrating member gripper coupled to a penetrating member driver, wherein the penetrating member gripper is elastically movable to apply frictional force to the penetrating member.

Claim 166

Dependent Claim 72 words

146 . A system comprising: a cartridge housing a plurality of penetrating members; a punch for penetrating a sterility barrier on the cartridge; a cam for sequencing the punch to penetrate the barrier to release at least one of the penetrating members from a sterile environment; a penetrating member gripper coupled to a penetrating member driver, wherein the penetrating member gripper is elastically movable to apply frictional force to the penetrating member.

Method and apparatus for a multi-use body fluid sampling device with analyte sensing

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