US20030199790A1 — Method and apparatus for penetrating tissue

Claim 1

Independent Claim 80 words

1 . A skin penetrating system, comprising: a housing member; a penetrating member positioned in the housing member, and an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μL of a body fluid disposed in the sample chamber, wherein a tip of the penetrating member is configured to extend through an opening of the sample chamber.

Claim 2

Dependent Claim 80 words

1 . A skin penetrating system, comprising: a housing member; a penetrating member positioned in the housing member, and an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μL of a body fluid disposed in the sample chamber, wherein a tip of the penetrating member is configured to extend through an opening of the sample chamber.

Claim 3

Dependent Claim 43 words

2 . The system of claim 1 , wherein the analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample of less than 0.5 μL of a body fluid disposed in the sample chamber.

Claim 4

Dependent Claim 89 words

3 . A skin penetrating system, comprising: a housing member; a plurality of penetrating members positioned in the housing member, and a plurality of analyte detecting members each associated with a penetrating member and a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μL of a body fluid disposed in the sample chamber, wherein a tip of the penetrating member is configured to extend through an opening of a sample chamber.

Claim 5

Dependent Claim 89 words

3 . A skin penetrating system, comprising: a housing member; a plurality of penetrating members positioned in the housing member, and a plurality of analyte detecting members each associated with a penetrating member and a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μL of a body fluid disposed in the sample chamber, wherein a tip of the penetrating member is configured to extend through an opening of a sample chamber.

Claim 6

Dependent Claim 43 words

4 . The system of claim 1 , further comprising: a penetrating member sensor coupled to the plurality of penetrating members, the penetrating member sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

Claim 7

Dependent Claim 18 words

5 . The system of claim 4 , wherein the depth of penetration is 100 to 2500 microns.

Claim 8

Dependent Claim 18 words

6 . The system of claim 4 , wherein the depth of penetration is 500 to 750 microns.

Claim 9

Dependent Claim 26 words

7 . The system of claim 4 , wherein the penetrating member sensor is further configured to provide an indication of velocity of a penetrating member.

Claim 10

Dependent Claim 26 words

8 . The system of claim 4 , further comprising: a second penetrating member sensor configured to provide an indication of velocity of a penetrating member.

Claim 11

Dependent Claim 19 words

9 . The system of claim 4 , further comprising: a feedback loop coupled to the penetrating member sensor.

Claim 12

Dependent Claim 19 words

10 . The system of claim 4 , wherein the penetrating member driver is an electric drive force member.

Claim 13

Dependent Claim 20 words

11 . The system of claim 4 , wherein the penetrating member driver is a voice coil drive force generator.

Claim 14

Dependent Claim 26 words

12 . The system of claim 4 , wherein the penetrating member sensor is coupled to a processor with control instructions for the penetrating member driver.

Claim 15

Dependent Claim 31 words

13 . The system of claim 12 , wherein the processor includes a memory for storage and retrieval of a set of penetrating member profiles utilized with the penetrating member driver.

Claim 16

Dependent Claim 31 words

14 . The system of claim 12 , wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction.

Claim 17

Dependent Claim 31 words

15 . The system of claim 12 ,,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 18

Dependent Claim 46 words

16 . The system of claim 12 , 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 19

Dependent Claim 57 words

17 . The system of claim 12 , 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 20

Dependent Claim 36 words

18 . The system of claim 17 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 21

Dependent Claim 41 words

19 . The system of claim 18 , 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 22

Dependent Claim 41 words

20 . The system of claim 18 , 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 23

Dependent Claim 27 words

21 . The system of claim 17 , wherein a speed of a penetrating member in the first direction is the range of 0.05 to 60 m/sec.

Claim 24

Dependent Claim 27 words

22 . The system of claim 17 , wherein a speed of a penetrating member in the first direction is the range of 0.1 to 20.0 m/sec.

Claim 25

Dependent Claim 27 words

23 . The system of claim 17 , wherein a speed of a penetrating member in the first direction is the range of 1.0 to 10.0 m/sec.

Claim 26

Dependent Claim 27 words

24 . The system of claim 17 , wherein a speed of a penetrating member in the first direction is the range of 3.0 to 8.0 m/sec.

Claim 27

Dependent Claim 34 words

25 . The system of claim 17 , wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 1 microsecond to 2 seconds.

Claim 28

Dependent Claim 34 words

26 . The system of claim 4 , wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 500 milliseconds to 1.5 second.

Claim 29

Dependent Claim 34 words

27 . The system of claim 4 , wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 100 milliseconds to 1 second.

Claim 30

Dependent Claim 18 words

28 . The system of claim 1 , further comprising: a plurality of cartridges integrated in a cassette.

Claim 31

Dependent Claim 26 words

29 . The system of claim 28 , wherein each cartridge has an exit port, and upon launch each penetrating member exists from the exit port.

Claim 32

Dependent Claim 18 words

30 . The system of claim 4 , wherein the penetrating member sensor includes a capacitive incremental encoder.

Claim 33

Dependent Claim 17 words

31 . The system of claim 4 , wherein the penetrating member sensor includes an incremental encoder.

Claim 34

Dependent Claim 17 words

32 . The system of claim 4 , wherein the penetrating member sensor includes an optical encoder.

Claim 35

Dependent Claim 17 words

33 . The system of claim 4 , wherein the penetrating member sensor includes an interference encoder.

Claim 36

Dependent Claim 25 words

34 . The system of claim 1 , wherein each sample chamber is sized to receive no more than 0.75 μL of the body fluid.

Claim 37

Dependent Claim 25 words

35 . The system of claim 1 , wherein each sample chamber is sized to receive no more than 0.5 μL of the body fluid.

Claim 38

Dependent Claim 25 words

36 . The system of claim 1 , wherein each sample chamber is sized to receive no more than 0.25 μL of the body fluid.

Claim 39

Dependent Claim 25 words

37 . The system of claim 1 , wherein each sample chamber is sized to receive no more than 0.1 μL of the body fluid.

Claim 40

Dependent Claim 47 words

38 . The system of claim 1 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.75 μL of a body fluid disposed in the sample chamber.

Claim 41

Dependent Claim 47 words

39 . The system of claim 1 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.5 μL of a body fluid disposed in the sample chamber.

Claim 42

Dependent Claim 47 words

40 . The system of claim 1 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.25 μL of a body fluid disposed in the sample chamber.

Claim 43

Dependent Claim 47 words

41 . The system of claim 1 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.1 μL of a body fluid disposed in the sample chamber.

Claim 44

Dependent Claim 32 words

42 . The system of claim 1 , wherein each of a penetrating of the plurality of penetrating members has a packing density of no more than 1.0 cm 3 /penetrating member.

Claim 45

Dependent Claim 33 words

43 . The system of claim 1 , wherein each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.75 cm 3 /penetrating member.

Claim 46

Dependent Claim 34 words

44 . The system of claim 1 , wherein the each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.5 cm 3 /penetrating member.

Claim 47

Dependent Claim 33 words

45 . The system of claim 1 , wherein each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.25 cm 3 /penetrating member.

Claim 48

Dependent Claim 33 words

46 . The system of claim 1 , wherein each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.1 cm 3 /penetrating member.

Claim 49

Dependent Claim 31 words

47 . The system of claim 1 wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 1.0 cm 3 .

Claim 50

Dependent Claim 32 words

48 . The system of claim 1 , wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.75 cm 3 .

Claim 51

Dependent Claim 32 words

49 . The system of claim 1 , wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.5 cm 3 .

Claim 52

Dependent Claim 32 words

50 . The system of claim 1 , wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.25 cm 3 .

Claim 53

Dependent Claim 32 words

51 . The system of claim 1 , wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.1 cm 3 .

Claim 54

Dependent Claim 18 words

52 . The system of claim 1 , further comprising: a tissue stabilizer device coupled to the housing.

Claim 55

Dependent Claim 23 words

53 . The system of claim 52 , wherein the tissue stabilizer device is configured to enhance fluid flow from a target tissue.

Claim 56

Dependent Claim 20 words

54 . The system of claim 52 , wherein the tissue stabilizer device creates a stretching of a skin surface.

Claim 57

Dependent Claim 18 words

55 . The system of claim 52 , wherein the tissue stabilizer device includes a plurality of protrusions.

Claim 58

Dependent Claim 20 words

56 . The system of claim 52 , wherein the tissue stabilizer device applies a vacuum to a target tissue.

Claim 59

Dependent Claim 39 words

57 . The system of claim 52 , wherein the tissue stabilizer device is configured to apply a force to a target tissue and cause the target tissue to press in an inward direction relative to the housing member.

Claim 60

Dependent Claim 20 words

58 . The system of claim 52 , wherein the tissue stabilizing member applies a stimulation to a target tissue.

Claim 61

Dependent Claim 42 words

59 . The system of claim 1 , further comprising: a seal formed by a fracturable material between the penetrating member and a cartridge, the seal being positioned at least one of a distal port or a proximal port of the cartridge.

Claim 62

Dependent Claim 27 words

60 . The system of claim 52 , further comprising a second fracturable seal located at least one of the distal port or proximal port of cartridge.

Claim 63

Dependent Claim 19 words

61 . The system of claim 1 , wherein each penetrating member is an elongated member without molded attachments.

Claim 64

Dependent Claim 31 words

62 . The system of claim 1 , further comprising: a penetrating member transport device for moving each of a penetrating member into a position aligned with the penetrating member driver.

Claim 65

Dependent Claim 21 words

63 . The system of claim 1 , further comprising, a belt for holding the penetrating members in an array configuration.

Claim 66

Dependent Claim 23 words

64 . The system of claim 1 , further comprising: a tape device configured to hold the penetrating members in an array configuration.

Claim 67

Dependent Claim 23 words

65 . The system of claim 1 , further comprising: a support channel configured to hold the penetrating members in an array configuration.

Claim 68

Dependent Claim 22 words

66 . The system of claim 1 , further comprising: a cog configured to hold the penetrating members in an array configuration.

Claim 69

Dependent Claim 26 words

67 . The system of claim 1 , further comprising: a plurality of connectors between penetrating members for holding the penetrating members in an array configuration.

Claim 70

Dependent Claim 18 words

68 . The system of claim 1 , further comprising: a support structure for receiving the penetrating members.

Claim 71

Dependent Claim 14 words

69 . The system of claim 68 wherein the support structure is a bandolier.

Claim 72

Dependent Claim 15 words

70 . The system of claim 68 , wherein the support structure is a drum.

Claim 73

Dependent Claim 15 words

71 . The system of claim 68 , wherein the support structure is a disc.

Claim 74

Dependent Claim 108 words

72 . A tissue penetrating system, comprising: a penetrating member driver; a cartridge with a distal port and a proximal port and coupled to the penetrating member driver; an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μL of a body fluid disposed in the sample chamber; and a penetrating member with a sharpened distal tip and shaft portion that is slidably disposed within the cartridge, wherein a tip of the penetrating member is configured to extend through the opening of the sample chamber.

Claim 75

Dependent Claim 108 words

72 . A tissue penetrating system, comprising: a penetrating member driver; a cartridge with a distal port and a proximal port and coupled to the penetrating member driver; an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μL of a body fluid disposed in the sample chamber; and a penetrating member with a sharpened distal tip and shaft portion that is slidably disposed within the cartridge, wherein a tip of the penetrating member is configured to extend through the opening of the sample chamber.

Claim 76

Dependent Claim 43 words

73 . The system of claim 1 , further comprising: a penetrating member sensor coupled to the plurality of penetrating members, the penetrating member sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

Claim 77

Dependent Claim 18 words

74 . The system of claim 73 , wherein the depth of penetration is 100 to 2500 microns.

Claim 78

Dependent Claim 18 words

75 . The system of claim 73 , wherein the depth of penetration is 500 to 750 microns.

Claim 79

Dependent Claim 26 words

76 . The system of claim 73 , wherein the penetrating member sensor is further configured to provide an indication of velocity of a penetrating member.

Claim 80

Dependent Claim 25 words

77 . The system of claim 73 , further comprising: a second penetrating member sensor configured to provide an indication-of velocity of a penetrating member.

Claim 81

Dependent Claim 19 words

78 . The system of claim 73 , further comprising: a feedback loop coupled to the penetrating member sensor.

Claim 82

Dependent Claim 19 words

79 . The system of claim 73 , wherein the penetrating member driver is an electric drive force member.

Claim 83

Dependent Claim 20 words

80 . The system of claim 73 , wherein the penetrating member driver is a voice coil drive force generator.

Claim 84

Dependent Claim 26 words

81 . The system of claim 73 , wherein the penetrating member sensor is coupled to a processor with control instructions for the penetrating member driver.

Claim 85

Dependent Claim 31 words

82 . The system of claim 81 , wherein the processor includes a memory for storage and retrieval of a set of penetrating member profiles utilized with the penetrating member driver.

Claim 86

Dependent Claim 31 words

83 . The system of claim 81 , wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction.

Claim 87

Dependent Claim 32 words

84 . The system of claim 81 , 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 88

Dependent Claim 46 words

85 . The system of claim 81 , 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 89

Dependent Claim 57 words

86 . The system of claim 81 , 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 90

Dependent Claim 37 words

87 . The system of claim 86 , 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 91

Dependent Claim 41 words

88 . The system of claim 87 , 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 92

Dependent Claim 41 words

89 . The system of claim 87 , 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 93

Dependent Claim 27 words

90 . The system of claim 86 , wherein a speed of a penetrating member in the first direction is the range of 0.05 to 60 m/sec.

Claim 94

Dependent Claim 27 words

91 . The system of claim 86 , wherein a speed of a penetrating member in the first direction is the range of 0.1 to 20.0 m/sec.

Claim 95

Dependent Claim 27 words

92 . The system of claim 86 , wherein a speed of a penetrating member in the first direction is the range of 1.0 to 10.0 n/sec.

Claim 96

Dependent Claim 27 words

93 . The system of claim 86 , wherein a speed of a penetrating member in the first direction is the range of 3.0 to 8.0 m/sec.

Claim 97

Dependent Claim 34 words

94 . The system of claim 86 , wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 1 microsecond to 2 seconds.

Claim 98

Dependent Claim 34 words

95 . The system of claim 2 , wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 500 milliseconds to 1.5 second.

Claim 99

Dependent Claim 34 words

96 . The system of claim 2 , wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 100 milliseconds to 1 second.

Claim 100

Dependent Claim 18 words

97 . The system of claim 1 , further comprising: a plurality of cartridges integrated in a cassette.

Claim 101

Dependent Claim 26 words

98 . The system of claim 97 , wherein each cartridge has an exit port, and upon launch each penetrating member exists from the exit port.

Claim 102

Dependent Claim 18 words

99 . The system of claim 73 , wherein the penetrating member sensor includes a capacitive incremental encoder.

Claim 103

Dependent Claim 17 words

100 . The system of claim 73 , wherein the penetrating member sensor includes an incremental encoder.

Claim 104

Dependent Claim 17 words

101 . The system of claim 73 , wherein the penetrating member sensor includes an optical encoder.

Claim 105

Dependent Claim 17 words

102 . The system of claim 73 , wherein the penetrating member sensor includes an interference encoder.

Claim 106

Dependent Claim 25 words

103 . The system of claim 1 , wherein each sample chamber is sized to receive no more than 0.75 μL of the body fluid.

Claim 107

Dependent Claim 25 words

104 . The system of claim 1 , wherein each sample chamber is sized to receive no more than 0.5 μL of the body fluid.

Claim 108

Dependent Claim 25 words

105 . The system of claim 1 , wherein each sample chamber is sized to receive no more than 0.25 μL of the body fluid.

Claim 109

Dependent Claim 25 words

106 . The system of claim 1 , wherein each sample chamber is sized to receive no more than 0.1 μL of the body fluid.

Claim 110

Dependent Claim 47 words

107 . The system of claim 1 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.75 μL of a body fluid disposed in the sample chamber.

Claim 111

Dependent Claim 47 words

108 . The system of claim 1 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.5 μL of a body fluid disposed in the sample chamber.

Claim 112

Dependent Claim 47 words

109 . The system of claim 1 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.25 μL of a body fluid disposed in the sample chamber.

Claim 113

Dependent Claim 47 words

110 . The system of claim 1 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.1 μL of a body fluid disposed in the sample chamber.

Claim 114

Dependent Claim 32 words

111 . The system of claim 1 , wherein each of a penetrating of the plurality of penetrating members has a packing density of no more than 1.0 cm 3 /penetrating member.

Claim 115

Dependent Claim 33 words

112 . The system of claim 1 , wherein each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.75 cm 3 /penetrating member.

Claim 116

Dependent Claim 34 words

113 . The system of claim 1 , wherein the each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.5 cm 3 /penetrating member.

Claim 117

Dependent Claim 33 words

114 . The system of claim 1 , wherein each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.25 cm 3 /penetrating member.

Claim 118

Dependent Claim 33 words

115 . The system of claim 1 , wherein each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.1 cm 3 /penetrating member.

Claim 119

Dependent Claim 32 words

116 . The system of claim 72 , wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 1.0 cm 3 .

Claim 120

Dependent Claim 32 words

117 . The system of claim 72 , wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.75 cm 3 .

Claim 121

Dependent Claim 32 words

118 . The system of claim 72 , wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.5 cm 3 .

Claim 122

Dependent Claim 32 words

119 . The system of claim 72 , wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.25 cm 3 .

Claim 123

Dependent Claim 32 words

120 . The system of claim 72 , wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.1 cm 3 .

Claim 124

Dependent Claim 18 words

124 . The system of claim 1 , further comprising: a tissue stabilizer device coupled to the housing.

Claim 125

Dependent Claim 23 words

122 . The system of claim 121 , wherein the tissue stabilizer device is configured to enhance fluid flow from a target tissue.

Claim 126

Dependent Claim 20 words

123 . The system of claim 121 , wherein the tissue stabilizer device creates a stretching of a skin surface.

Claim 127

Dependent Claim 18 words

124 . The system of claim 121 , wherein the tissue stabilizer device includes a plurality of protrusions.

Claim 128

Dependent Claim 20 words

125 . The system of claim 121 , wherein the tissue stabilizer device applies a vacuum to a target tissue.

Claim 129

Dependent Claim 39 words

126 . The system of claim 121 , wherein the tissue stabilizer device is configured to apply a force to a target tissue and cause the target tissue to press in an inward direction relative to the housing member.

Claim 130

Dependent Claim 20 words

127 . The system of claim 121 , wherein the tissue stabilizing member applies a stimulation to a target tissue.

Claim 131

Dependent Claim 42 words

128 . The system of claim 1 , further comprising: a seal formed by a fracturable material between the penetrating member and the cartridge, the seal being positioned at least one of a distal port or a proximal port of the cartridge.

Claim 132

Dependent Claim 27 words

129 . The system of claim 121 , further comprising a second fracturable seal located at least one of the distal port or proximal port of cartridge.

Claim 133

Dependent Claim 19 words

130 . The system of claim 1 , wherein each penetrating member is an elongated member without molded attachments.

Claim 134

Dependent Claim 31 words

131 . The system of claim 1 , further comprising: a penetrating member transport device for moving each of a penetrating member into a position aligned with the penetrating member driver.

Claim 135

Dependent Claim 21 words

132 . The system of claim 1 , further comprising, a belt for holding the penetrating members in an array configuration.

Claim 136

Dependent Claim 23 words

133 . The system of claim 1 , further comprising: a tape device configured to hold the penetrating members in an array configuration.

Claim 137

Dependent Claim 23 words

134 . The system of claim 1 , further comprising: a support channel configured to hold the penetrating members in an array configuration.

Claim 138

Dependent Claim 22 words

135 . The system of claim 1 , further comprising: a cog configured to hold the penetrating members in an array configuration.

Claim 139

Dependent Claim 26 words

136 . The system of claim 1 , further comprising: a plurality of connectors between penetrating members for holding the penetrating members in an array configuration.

Claim 140

Dependent Claim 18 words

137 . The system of claim 1 , further comprising: a support structure for receiving the penetrating members.

Claim 141

Dependent Claim 15 words

138 . The system of claim 137 , wherein the support structure is a bandolier.

Claim 142

Dependent Claim 15 words

139 . The system of claim 137 , wherein the support structure is a drum.

Claim 143

Dependent Claim 15 words

140 . The system of claim 137 , wherein the support structure is a disc.

Claim 144

Dependent Claim 156 words

141 . A tissue penetrating system, comprising: a penetrating member driver; a cartridge with a distal port and a proximal port and coupled to the penetrating member driver; an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μL of a body fluid disposed in the sample chamber; a penetrating member with a sharpened distal tip and shaft portion that is slidably disposed within the cartridge, wherein a tip of the penetrating member is configured to extend through the opening of the analyte detecting member; and a first seal formed at the distal port and a second seal formed at the proximal port, wherein the first seal and second seal maintain the distal tip of the penetrating member and the sample chamber in a sterile environment prior to launch of the penetrating member.

Claim 145

Dependent Claim 156 words

141 . A tissue penetrating system, comprising: a penetrating member driver; a cartridge with a distal port and a proximal port and coupled to the penetrating member driver; an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μL of a body fluid disposed in the sample chamber; a penetrating member with a sharpened distal tip and shaft portion that is slidably disposed within the cartridge, wherein a tip of the penetrating member is configured to extend through the opening of the analyte detecting member; and a first seal formed at the distal port and a second seal formed at the proximal port, wherein the first seal and second seal maintain the distal tip of the penetrating member and the sample chamber in a sterile environment prior to launch of the penetrating member.

Claim 146

Dependent Claim 47 words

142 . The system of claim 141 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.75 μL of a body fluid disposed in the sample chamber.

Claim 147

Dependent Claim 47 words

143 . The system of claim 141 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.5 μL of a body fluid disposed in the sample chamber.

Claim 148

Dependent Claim 47 words

144 . The system of claim 141 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.25 μL of a body fluid disposed in the sample chamber.

Claim 149

Dependent Claim 47 words

145 . The system of claim 141 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.1 μL of a body fluid disposed in the sample chamber.

Claim 150

Dependent Claim 40 words

146 . The system of claim 141 , further comprising: a penetrating member sensor coupled to penetrating member, the penetrating member sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

Claim 151

Dependent Claim 28 words

147 . The system of claim 141 , further comprising: a user interface configured to relay at least one of, skin penetrating performance or a skin penetrating setting.

Claim 152

Dependent Claim 18 words

148 . The system of claim 141 , further comprising: a human interface providing at least one output.

Claim 153

Dependent Claim 96 words

149 . A tissue penetrating system, comprising: a cartridge with a distal port and a proximal port, each cartridge including an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μL of a body fluid disposed in the sample chamber; a penetrating member with a sharpened distal tip and shaft portion that is slidably disposed within the cartridge; a first seal covering the distal port; and a second seal covering the proximal port

Claim 154

Dependent Claim 96 words

149 . A tissue penetrating system, comprising: a cartridge with a distal port and a proximal port, each cartridge including an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μL of a body fluid disposed in the sample chamber; a penetrating member with a sharpened distal tip and shaft portion that is slidably disposed within the cartridge; a first seal covering the distal port; and a second seal covering the proximal port

Claim 155

Dependent Claim 47 words

150 . The system of claim 149 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.75 μL of a body fluid disposed in the sample chamber.

Claim 156

Dependent Claim 47 words

151 . The system of claim 149 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.5 μL of a body fluid disposed in the sample chamber.

Claim 157

Dependent Claim 47 words

152 . The system of claim 149 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.25 μL of a body fluid disposed in the sample chamber.

Claim 158

Dependent Claim 47 words

153 . The system of claim 149 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.1 μL of a body fluid disposed in the sample chamber.

Claim 159

Dependent Claim 40 words

154 . The system of claim 149 , further comprising: a penetrating member sensor coupled to penetrating member, the penetrating member sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

Claim 160

Dependent Claim 28 words

155 . The system of claim 149 , further comprising: a user interface configured to relay at least one of, skin penetrating performance or a skin penetrating setting.

Claim 161

Dependent Claim 18 words

156 . The system of claim 149 , further comprising: a human interface providing at least one output.

Claim 162

Dependent Claim 100 words

157 . A tissue penetrating system, comprising: a plurality of penetrating members each having a sharpened distal tip; a penetrating member driver coupled to the plurality of penetrating members; and a plurality of cartridges each housing a penetrating member and configured so that the penetrating member driver engages each of the penetrating members sequentially, each cartridge including an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μL of a body fluid disposed in the sample chamber.

Claim 163

Dependent Claim 100 words

157 . A tissue penetrating system, comprising: a plurality of penetrating members each having a sharpened distal tip; a penetrating member driver coupled to the plurality of penetrating members; and a plurality of cartridges each housing a penetrating member and configured so that the penetrating member driver engages each of the penetrating members sequentially, each cartridge including an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μL of a body fluid disposed in the sample chamber.

Claim 164

Dependent Claim 47 words

158 . The system of claim 157 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.75 μL of a body fluid disposed in the sample chamber.

Claim 165

Dependent Claim 47 words

159 . The system of claim 157 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.5 μL of a body fluid disposed in the sample chamber.

Claim 166

Dependent Claim 47 words

160 . The system of claim 157 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.25 μL of a body fluid disposed in the sample chamber.

Claim 167

Dependent Claim 47 words

161 . The system of claim 157 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.1 μL of a body fluid disposed in the sample chamber.

Claim 168

Dependent Claim 43 words

162 . The system of claim 157 , wherein each cartridge has a plurality of seals positioned so that the sharpened distal tip remains in a sterile environment before launch of a penetrating member, the plurality of modules coupled together in an array.

Claim 169

Dependent Claim 43 words

163 . The system of claim 157 , further comprising: a penetrating member sensor coupled to the plurality of penetrating members, the penetrating member sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

Claim 170

Dependent Claim 28 words

164 . The system of claim 157 , further comprising: a user interface configured to relay at least one of, skin penetrating performance or a skin penetrating setting.

Claim 171

Dependent Claim 18 words

165 . The system of claim 157 , further comprising: a human interface providing at least one output.

Claim 172

Dependent Claim 93 words

166 . A tissue penetrating system, comprising: a plurality of cartridges, each cartridge including an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μL of a body fluid disposed in the sample chamber; and each of the cartridges having a plurality of seals positioned so that the sample chamber remains in a sterile environment before launch of a penetrating member, the plurality of modules coupled together in an array.

Claim 173

Dependent Claim 93 words

166 . A tissue penetrating system, comprising: a plurality of cartridges, each cartridge including an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μL of a body fluid disposed in the sample chamber; and each of the cartridges having a plurality of seals positioned so that the sample chamber remains in a sterile environment before launch of a penetrating member, the plurality of modules coupled together in an array.

Claim 174

Dependent Claim 47 words

167 . The system of claim 166 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.75 μL of a body fluid disposed in the sample chamber.

Claim 175

Dependent Claim 47 words

168 . The system of claim 166 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.5 μL of a body fluid disposed in the sample chamber.

Claim 176

Dependent Claim 47 words

169 . The system of claim 166 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.25 μL of a body fluid disposed in the sample chamber.

Claim 177

Dependent Claim 47 words

170 . The system of claim 166 , wherein each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.1 μL of a body fluid disposed in the sample chamber.

Claim 178

Dependent Claim 20 words

171 . The system of claim 167 , further comprising: a plurality of penetrating members each coupled to a cartridge.

Claim 179

Dependent Claim 40 words

172 . The system of claim 171 , further comprising: a penetrating member sensor coupled to penetrating member, the penetrating member sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

Claim 180

Dependent Claim 28 words

173 . The system of claim 166 , further comprising: a user interface configured to relay at least one of, skin penetrating performance or a skin penetrating setting.

Claim 181

Dependent Claim 18 words

174 . The system of claim 166 , further comprising: a human interface providing at least one output.

Claim 182

Dependent Claim 59 words

175 . A method of penetrating a target tissue, comprising: providing a tissue penetrating system with a penetrating member and an analyte detecting member coupled to a sample chamber,; advancing a penetrating member through the target tissue; withdrawing the penetrating member from the target tissue. receiving no more than 1 μL of a body fluid in the sample chamber.

Claim 183

Dependent Claim 59 words

175 . A method of penetrating a target tissue, comprising: providing a tissue penetrating system with a penetrating member and an analyte detecting member coupled to a sample chamber,; advancing a penetrating member through the target tissue; withdrawing the penetrating member from the target tissue. receiving no more than 1 μL of a body fluid in the sample chamber.

Claim 184

Dependent Claim 24 words

176 . The method of claim 175 , wherein no more than 0.5 μL of the body fluid is received in the sample chamber.

Claim 185

Dependent Claim 31 words

177 . The method of claim 175 , further comprising: monitoring position and speed of the penetrating member as the penetrating member moves in the first direction toward the target tissue.

Claim 186

Dependent Claim 28 words

178 . The method of claim 175 , further comprising: adjusting an application of force to the penetrating member to achieve a desired speed of the penetrating member.

Claim 187

Dependent Claim 42 words

179 . The method of claim 175 , further comprising: adjusting an application of force to the penetrating member when the penetrating member contacts the skin surface so that the penetrating member penetrates the skin surface within a desired range of speed.

Claim 188

Dependent Claim 53 words

180 . The method of claim 175 , further comprising: monitoring position and speed of the penetrating member as the penetrating member moves in a first direction toward the 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 189

Dependent Claim 33 words

181 . The method of claim 180 , further comprising: controlling a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from the target tissue.

Method and apparatus for penetrating tissue

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