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

• US 20030199893A1
• Filed: 12/18/2002
• Published: 10/23/2003
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Freeman, Dominique M.
• Granted Patent: US 7,198,606 B2
• Time in Patent Office: Days
• US Class Current: 606/181
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150916 : by blocking components, e.g. piston, driving device or fluid passageway
• CPC Class Codes: A61B 5/151 : Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/15113 : Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 : comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15123 : comprising magnets or solenoids
• CPC Class Codes: A61B 5/1513 : comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15146 : Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15151 : Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15153 : Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15161 : Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/15163 : Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/15169 : Characterized by a rolled strip
• CPC Class Codes: A61B 5/15171 : Characterized by propelling the piercing element perpendicular to the direction of movement of the strip
• CPC Class Codes: A61B 5/15178 : Stocking means comprising separate compartments or units for new and for used piercing elements separate compartments for used piercing elements in piercing devices A61B5/15184
• CPC Class Codes: A61B 5/15182 : Means for keeping track or checking of the total number of piercing elements already used or the number of piercing elements still remaining in the stocking, e.g. by check window, counter, display
• CPC Class Codes: A61B 5/15184 : Piercing device comprising a separate compartment or unit for used piercing elements separate compartments for used piercing elements in stocking means A61B5/15178
• CPC Class Codes: A61B 5/15186 : Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 37/0015 : by using microneedles

Abstract

A device for use with a penetrating member driver to penetrate tissue is provided. A plurality of penetrating members are coupled to a single cartridge and are operatively couplable to the penetrating member driver. The penetrating members are movable to extend radially outward from the cartridge to penetrate tissue. A plurality of analyte sensors are coupled to the single cartridge and are positioned on the cartridge to receive body fluid from a wound in the tissue created by the penetrating member.

Claims

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.

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

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

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

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

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

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

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

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

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.

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.

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

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

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.

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

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

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

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.

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.

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.

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.

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

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

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.

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.

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

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.

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

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

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

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

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

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.

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.

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

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

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

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

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.

40. The device of claim 39 wherein said substrate comprises a material selected from:

polymer, metallic foil, or paper.

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.

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

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

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.

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.

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.

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.

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

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.

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.

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.

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

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.

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.

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.

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.

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

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

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.

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

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.

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.

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.

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.

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.

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.

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

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

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

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.

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

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

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.

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.

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.

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..

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

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

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

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

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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

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

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

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

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.

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.

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.

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.

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.

103. The system of claim 98, further comprising:

a data exchange device for coupling a penetrating member driver to support equipment.

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.

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.

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.

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.

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

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

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.

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.

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

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

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.

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

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

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

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.

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.

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

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

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.

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

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.

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.

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.

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.

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

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

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

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.

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

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

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

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.

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

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

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

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

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.

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.

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.

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.

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.

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.

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.