Method and apparatus for penetrating tissue

• US 20030199790A1
• Filed: 12/31/2002
• 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, Alden, Don, Freeman, Dominique M.
• Granted Patent: US 7,410,468 B2
• Time in Patent Office: Days
• US Class Current: 600/576
• CPC Class Codes: A61B 17/32093 for skin incisions
• 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 5/150022 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 5/150427 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• 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 5/15123 comprising magnets or solenoids
• 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 5/15153 Multiple piercing elements stocked in a single compartment
• 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 5/15184 : 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 2005/004 : Magazines with multiple needles directly inserted into an injection or infusion device, e.g. revolver-like magazines
• CPC Class Codes: B01L 2200/10 : Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0663 : Whole sensors
• CPC Class Codes: B01L 2300/18 : Means for temperature control
• CPC Class Codes: B01L 3/5027 : by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: G01N 33/4905 : Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54
• CPC Class Codes: G01N 33/557 : using kinetic measurement, i.e. time rate of progress of an antigen-antibody interaction

Abstract

A skin penetrating system includes a housing member and a penetrating member positioned in the housing member. An analyte detecting member is coupled to a sample chamber. The analyte detecting member is 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 tip of the penetrating member is configured to extend through an opening of the sample chamber.

Claims

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 μ

L 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.

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 μ

L of a body fluid disposed in the sample chamber.

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.

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

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

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

8. The system of claim 4, further comprising:

a second penetrating member sensor configured to provide an indication of velocity of a penetrating member.

9. The system of claim 4, further comprising:

a feedback loop coupled to the penetrating member sensor.

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

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

28. The system of claim 1, further comprising:

a plurality of cartridges integrated in a cassette.

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

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

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

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

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

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

L of the body fluid.

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

L of the body fluid.

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

L of the body fluid.

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

L of the body fluid.

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 μ

L of a body fluid disposed in the sample chamber.

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 μ

L of a body fluid disposed in the sample chamber.

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 μ

L of a body fluid disposed in the sample chamber.

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 μ

L of a body fluid disposed in the sample chamber.

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 cm³/penetrating member.

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 cm³/penetrating member.

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 cm³/penetrating member.

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 cm³/penetrating member.

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 cm³/penetrating member.

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 cm³.

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 cm³.

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 cm³.

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 cm³.

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 cm³.

52. The system of claim 1, further comprising:

a tissue stabilizer device coupled to the housing.

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

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

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

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

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.

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

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.

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.

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

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.

63. The system of claim 1, further comprising,

a belt for holding the penetrating members in an array configuration.

64. The system of claim 1, further comprising:

a tape device configured to hold the penetrating members in an array configuration.

65. The system of claim 1, further comprising:

a support channel configured to hold the penetrating members in an array configuration.

66. The system of claim 1, further comprising:

a cog configured to hold the penetrating members in an array configuration.

67. The system of claim 1, further comprising:

a plurality of connectors between penetrating members for holding the penetrating members in an array configuration.

68. The system of claim 1, further comprising:

a support structure for receiving the penetrating members.

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

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

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

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.

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

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

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

77. The system of claim 73, further comprising:

a second penetrating member sensor configured to provide an indication-of velocity of a penetrating member.

78. The system of claim 73, further comprising:

a feedback loop coupled to the penetrating member sensor.

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

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

97. The system of claim 1, further comprising:

a plurality of cartridges integrated in a cassette.

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

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

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

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

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

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

L of the body fluid.

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

L of the body fluid.

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

L of the body fluid.

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

L of the body fluid.

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 μ

L of a body fluid disposed in the sample chamber.

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 μ

L of a body fluid disposed in the sample chamber.

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 μ

L of a body fluid disposed in the sample chamber.

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 μ

L of a body fluid disposed in the sample chamber.

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 cm³/penetrating member.

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 cm³/penetrating member.

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 cm³/penetrating member.

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 cm³/penetrating member.

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 cm³/penetrating member.

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.

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

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.

132. The system of claim 1, further comprising,

a belt for holding the penetrating members in an array configuration.

133. The system of claim 1, further comprising:

a tape device configured to hold the penetrating members in an array configuration.

134. The system of claim 1, further comprising:

a support channel configured to hold the penetrating members in an array configuration.

135. The system of claim 1, further comprising:

a cog configured to hold the penetrating members in an array configuration.

136. The system of claim 1, further comprising:

a plurality of connectors between penetrating members for holding the penetrating members in an array configuration.

137. The system of claim 1, further comprising:

a support structure for receiving the penetrating members.

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

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

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

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 μ

L 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.

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 μ

L 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.

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 cm³.

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 cm³.

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 cm³.

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 cm³.

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 cm³.

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

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

124. The system of claim 1, further comprising:

a tissue stabilizer device coupled to the housing.

124-1. The system of claim 121, wherein the tissue stabilizer device includes a plurality of protrusions.

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

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.

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

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.

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 μ

L 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.

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 μ

L of a body fluid disposed in the sample chamber.

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 μ

L of a body fluid disposed in the sample chamber.

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 μ

L of a body fluid disposed in the sample chamber.

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 μ

L of a body fluid disposed in the sample chamber.

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.

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.

148. The system of claim 141, further comprising:

a human interface providing at least one output.

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 μ

L 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

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 μ

L of a body fluid disposed in the sample chamber.

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 μ

L of a body fluid disposed in the sample chamber.

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 μ

L of a body fluid disposed in the sample chamber.

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 μ

L of a body fluid disposed in the sample chamber.

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.

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.

156. The system of claim 149, further comprising:

a human interface providing at least one output.

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 μ

L of a body fluid disposed in the sample chamber.

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 μ

L of a body fluid disposed in the sample chamber.

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 μ

L of a body fluid disposed in the sample chamber.

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 μ

L of a body fluid disposed in the sample chamber.

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 μ

L of a body fluid disposed in the sample chamber.

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.

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.

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.

165. The system of claim 157, further comprising:

a human interface providing at least one output.

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 μ

L 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.

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 μ

L of a body fluid disposed in the sample chamber.

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 μ

L of a body fluid disposed in the sample chamber.

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 μ

L of a body fluid disposed in the sample chamber.

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 μ

L of a body fluid disposed in the sample chamber.

171. The system of claim 167, further comprising:

a plurality of penetrating members each coupled to a cartridge.

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.

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.

174. The system of claim 166, further comprising:

a human interface providing at least one output.

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 μ

L of a body fluid in the sample chamber.

176. The method of claim 175, wherein no more than 0.5 μ

L of the body fluid is received in the sample chamber.

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.

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.

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.

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.

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.