Method and apparatus for penetrating tissue

• US 20030199901A1
• 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 7,229,458 B2
• Time in Patent Office: Days
• US Class Current: 606/181
• 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 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• 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 5/150435 Specific design of proximal end
• 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 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150816 by tactile feedback, e.g. vibration
• 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 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• 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 5/15151 : 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 5/15163 : 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 5/15186 : 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 tissue penetrating system includes a plurality of cartridges each with a distal port and a proximal port. A plurality of penetrating members are provided, each coupled to a cartridge and having a sharpened distal tip and a shaft portion slidably disposed within the cartridge. A seal is formed by a fracturable material between the penetrating member and the cartridge. The seal is positioned at one or both of a distal port or a proximal port of the cartridge.

Claims

1. A tissue penetrating system, comprising:

a plurality of cartridges each with a distal port and a proximal port;

a plurality of penetrating members each coupled to a cartridge, each penetrating member having a sharpened distal tip and a shaft portion slidably disposed within the cartridge; and

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.

2. 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.

3. The system of claim 2, wherein the depth of penetration is 100 to 2500 microns.

4. The system of claim 2, wherein the depth of penetration is 500 to 750 microns.

5. The system of claim 2, wherein the penetrating member sensor is further configured to provide an indication of velocity of a penetrating member.

6. The system of claim 2, further comprising:

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

7. The system of claim 2, further comprising:

a feedback loop coupled to the penetrating member sensor.

8. The system of claim 2, wherein the penetrating member driver is an electric drive force member.

9. The system of claim 2, wherein the penetrating member driver is a voice coil drive force generator.

10. The system of claim 2, wherein the penetrating member sensor is coupled to a processor with control instructions for the penetrating member driver.

11. The system of claim 10, wherein the processor includes a memory for storage and retrieval of a set of penetrating member profiles utilized with the penetrating member driver.

12. The system of claim 10, wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction.

13. The system of claim 10, wherein the processor is utilized to adjust an application of force to a penetrating member to achieve a desired speed of the penetrating member.

14. The system of claim 10, 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.

15. The system of claim 10, 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.

16. The system of claim 15, 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.

17. The system of claim 16, 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.

18. The system of claim 16, 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.

19. The system of claim 15, wherein a speed of a penetrating member in the first direction is the range of 0.05 to 60 m/sec.

20. The system of claim 15, wherein a speed of a penetrating member in the first direction is the range of 0.1 to 20.0 m/sec.

21. The system of claim 15, wherein a speed of a penetrating member in the first direction is the range of 1.0 to 10.0 m/sec.

22. The system of claim 15, wherein a speed of a penetrating member in the first direction is the range of 3.0 to 8.0 m/sec.

23. The system of claim 15, 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.

24. 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.

25. 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.

26. The system of claim 1, further comprising:

a plurality of cartridges integrated in a cassette.

27. The system of claim 26, wherein each cartridge has an exit port, and upon launch each penetrating member exists from the exit port.

28. The system of claim 2, wherein the penetrating member sensor includes a capacitive incremental encoder.

29. The system of claim 2, wherein the penetrating member sensor includes an incremental encoder.

30. The system of claim 2, wherein the penetrating member sensor includes an optical encoder.

31. The system of claim 2, wherein the penetrating member sensor includes an interference encoder.

32. The system of claim 1, further comprising:

an analyte detecting member.

33. The system of claim 1, further comprising:

a plurality of analyte detecting members each coupled to a penetrating member.

34. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 1.0 μ

L of the body fluid.

35. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.75 μ

L of the body fluid.

36. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.5 μ

L of the body fluid.

37. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.25 μ

L of the body fluid.

38. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.1 μ

L of the body fluid.

39. The system of claim 1, further comprising:

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 that does not exceed a volume of 1 μ

L of a body fluid disposed in the sample chamber.

40. The system of claim 1, further comprising:

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 that does not exceed a volume of 0.75 μ

L of a body fluid disposed in the sample chamber.

41. The system of claim 1, further comprising:

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 that does not exceed a volume of 0.5 μ

L of a body fluid disposed in the sample chamber.

42. The system of claim 1, further comprising:

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 that does not exceed a volume of 0.25 μ

L of a body fluid disposed in the sample chamber.

43. The system of claim 1, further comprising:

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 that does not exceed a volume of 0.1 μ

L of a body fluid disposed in the sample chamber.

44. 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.

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 0.75 cm³/penetrating member.

46. 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.

47. 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.

48. 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.

49. The system of claim 34, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 1.0 cm³.

50. The system of claim 34, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.75 cm³.

51. The system of claim 34, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.5 cm³.

52. The system of claim 34, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.25 cm³.

53. The system of claim 34, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.1 cm³

54. The system of claim 1, further comprising:

a tissue stabilizer device coupled to the housing.

55. The system of claim 54, wherein the tissue stabilizer device is configured to enhance fluid flow from a target tissue.

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

57. The system of claim 54, wherein the tissue stabilizer device includes a plurality of protrusions.

58. The system of claim 54, wherein the tissue stabilizer device applies a vacuum to a target tissue.

59. The system of claim 54, 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.

60. The system of claim 54, wherein the tissue stabilizing member applies a stimulation to a target tissue.

61. The system of claim 1, further comprising

a second fracturable seal located at least one of the distal port or proximal port of cartridge.

62. The system of claim 1, wherein each penetrating member each penetrating members is an elongate member without molded attachments.

63. 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.

64. The system of claim 1, further comprising,

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

65. The system of claim 1, further comprising:

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

66. The system of claim 1, further comprising:

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

67. The system of claim 1, further comprising:

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

68. The system of claim 1, further comprising:

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

69. The system of claim 1, further comprising:

a support structure for receiving the penetrating members.

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

71. The system of claim 69, wherein the support structure is a drum.

72. The system of claim 69, wherein the support structure is a disc.

73. A tissue penetrating system, comprising:

a cartridge with a distal port and a proximal port;

a plurality of penetrating members each with a sharpened distal tip and a shaft portion slidably disposed within the cartridge; and

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.

74. A tissue penetrating system, comprising:

a cartridge with a distal port and a proximal port;

a sample chamber;

a plurality of penetrating members each with a sharpened distal tip and a shaft portion slidably disposed within the cartridge; and

a first seal formed at the distal port and a second seal formed at the proximal port, wherein prior to lancing the first seal and second seal maintain the distal tip of a penetrating member and the sample chamber in a sterile environment.

75. A tissue penetrating system, comprising:

a cartridge with a distal port and a proximal port;

a plurality of sample chambers;

a plurality of penetrating members each with a sharpened distal tip and a shaft portion slidably disposed within the cartridge, each penetrating member being associated with a sample chamber;

a first seal formed at the distal port and a second seal formed at the proximal port, wherein prior to lancing the first seal and second seal maintain the distal tip of a penetrating member and the sample chamber in a sterile environment.

76. The system of claim 75, 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.

77. The system of claim 76, wherein the depth of penetration is 100 to 2500 microns.

78. The system of claim 76, wherein the depth of penetration is 500 to 750 microns.

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

80. The system of claim 76, further comprising:

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

81. The system of claim 76, further comprising:

a feedback loop coupled to the penetrating member sensor.

82. The system of claim 76, wherein the penetrating member driver is an electric drive force member.

83. The system of claim 76, wherein the penetrating member driver is a voice coil drive force generator.

84. The system of claim 76, wherein the penetrating member sensor is coupled to a processor with control instructions for the penetrating member driver.

98. The system of claim 76, 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.

99. The system of claim 76, 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.

100. The system of claim 75, further comprising:

a plurality of cartridges integrated in a cassette.

101. The system of claim 100, wherein each cartridge has an exit port, and upon launch each penetrating member exists from the exit port.

102. The system of claim 76, wherein the penetrating member sensor includes a capacitive incremental encoder.

103. The system of claim 76, wherein the penetrating member sensor includes an incremental encoder.

104. The system of claim 76, wherein the penetrating member sensor includes an optical encoder.

105. The system of claim 76, wherein the penetrating member sensor includes an interference encoder.

106. The system of claim 76, further comprising:

an analyte detecting member.

107. The system of claim 75, further comprising:

a plurality of analyte detecting members each coupled to a penetrating member.

108. The system of claim 75, wherein each sample chamber is sized to receive no more than 1.0 μ

L of the body fluid.

109. The system of claim 75, wherein each sample chamber is sized to receive no more than 0.75 μ

L of the body fluid.

110. The system of claim 75, wherein each sample chamber is sized to receive no more than 0.5 μ

L of the body fluid.

111. The system of claim 75, wherein each sample chamber is sized to receive no more than 0.25 μ

L of the body fluid.

112. The system of claim 75, wherein each sample chamber is sized to receive no more than 0.1 μ

L of the body fluid.

113. The system of claim 75, further comprising:

an analyte detecting member coupled to each sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 1 μ

L of a body fluid disposed in the sample chamber.

114. The system of claim 75, further comprising:

an analyte detecting member couple to each sample chamber, the analyte detecting member being 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.

115. The system of claim 75, further comprising:

an analyte detecting member coupled to each sample chamber, the analyte detecting member being 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.

116. The system of claim 75, further comprising:

an analyte detecting member coupled to each sample chamber, the analyte detecting member being 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.

117. The system of claim 75, further comprising:

an analyte detecting member coupled to each sample chamber, the analyte detecting member being 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.

118. The system of claim 75, wherein each of a penetrating of the plurality of penetrating members has a packing density of no more than 1.0 cm³/penetrating member.

119. The system of claim 75, 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.

120. The system of claim 75, 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.

121. The system of claim 75, 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.

122. The system of claim 75, 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.

123. The system of claim 108, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 1.0 cm³.

124. The system of claim 108, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.75 cm³.

125. The system of claim 108, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.5 cm³.

126. The system of claim 108, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.25 cm³.

127. The system of claim 108, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.1 cm³

128. The system of claim 75, further comprising:

a tissue stabilizer device coupled to the housing.

129. The system of claim 128, wherein the tissue stabilizer device is configured to enhance fluid flow from a target tissue.

130. The system of claim 128, wherein the tissue stabilizer device creates a stretching of a skin surface.

131. The system of claim 128, wherein the tissue stabilizer device includes a plurality of protrusions.

132. The system of claim 128, wherein the tissue stabilizer device applies a vacuum to a target tissue.

133. The system of claim 128, 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.

134. The system of claim 128, wherein the tissue stabilizing member applies a stimulation to a target tissue.

135. The system of claim 75, further comprising

a second fracturable seal located at least one of the distal port or proximal port of cartridge.

136. The system of claim 75, wherein each penetrating member each penetrating member is an elongated member without molded attachments.

137. The system of claim 75, further comprising:

a penetrating member transport device for moving each of a penetrating member into a position aligned with the penetrating member driver.

138. The system of claim 75, further comprising,

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

139. The system of claim 75, further comprising:

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

140. The system of claim 75, further comprising:

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

141. The system of claim 75, further comprising:

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

142. The system of claim 75, further comprising:

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

143. The system of claim 75, further comprising:

a support structure for receiving the penetrating members.

144. The system of claim 143, wherein the support structure is a bandolier.

145. The system of claim 143, wherein the support structure is a drum.

146. The system of claim 143, wherein the support structure is a disc.

85. The system of claim 85, wherein the processor includes a memory for storage and retrieval of a set of penetrating member profiles utilized with the penetrating member driver.

86. The system of claim 85, wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction.

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

88. The system of claim 85, 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.

89. The system of claim 85, 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.

90. The system of claim 89, 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.

91. The system of claim 90, 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.

92. The system of claim 90, 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.

93. The system of claim 89, wherein a speed of a penetrating member in the first direction is the range of 0.05 to 60 m/sec.

94. The system of claim 89, wherein a speed of a penetrating member in the first direction is the range of 0.1 to 20.0 m/sec.

95. The system of claim 89, wherein a speed of a penetrating member in the first direction is the range of 1.0 to 10.0 m/sec.

96. The system of claim 89, wherein a speed of a penetrating member in the first direction is the range of 3.0 to 8.0 m/sec.

97. The system of claim 89, 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.

147. A tissue penetrating system, comprising:

a cartridge with a distal port and a proximal port;

a plurality of sample chambers;

a plurality of penetrating members each with a sharpened distal tip and a shaft portion slidably disposed within the cartridge, each penetrating member being associated with a sample chamber; and

a first seal formed at the distal port and a second seal formed at the proximal port, wherein prior to lancing the first seal and second seal maintain the distal tip of a penetrating member and the sample chamber in a sterile environment.

148. A tissue penetrating system, comprising:

a cartridge having a distal port and a proximal port;

a plurality of penetrating members;

a plurality of lumens between the distal port and the proximal port for slidably receiving a penetrating member;

a sample chamber defined by the cartridge having an opening;

a first seal covering the distal port; and

a second seal covering the proximal port.

149. The system of claim 148, further comprising:

a plurality of sample chambers each associated with a penetrating member.

151. The system of claim 149, wherein the plurality of cartridges is arranged as a bandolier.

152. The system of claim 149, wherein the array is a stack.

154. The system of claim 152, wherein the plurality of cartridges is arranged as a bandolier.

155. The system of claim 152, wherein each of the cartridges has one of the seals located at a proximal port and another of the seals located at a distal port.

156. The system of claim 152, further comprising:

a belt for holding the cartridges in the array.

157. The system of claim 152, further comprising:

a tape for holding the cartridges in the array.

158. The system of claim 152, further comprising:

a support channel for holding the cartridges in the array.

159. The system of claim 152, further comprising:

a cog for holding the cartridges in the array.

150. A tissue penetrating system, comprising:

a plurality of cartridges;

a penetrating member driver;

a plurality of penetrating members coupled to the penetrating member driver, each of a penetrating member associated with a cartridge;

a plurality of gas-tightly sealed enclosures coupled in an array, each of the enclosures fully containing at least one of the plurality of cartridges;

the sealed enclosures configured to be advanceable on a transport device that individually releases the cartridges from the sacks and loads them individually onto the penetrating member driver.

153. A tissue penetrating system, comprising:

a plurality of penetrating members each having a sharpened distal tip;

a penetrating member driver; and

a plurality of cartridges coupled in an array and each housing a penetrating member, each cartridge configured to permit the penetrating member driver to engage each of the penetrating members sequentially, each cartridge having a plurality of seals positioned to provide that the sharpened distal tip remains in a sterile environment before penetrating a target site, each penetrating being launched without breaking a seal.

160. A tissue penetrating system, comprising:

a plurality of cartridges each with a distal port and a proximal port;

a plurality of penetrating members each associated with a cartridge, each penetrating member having a sharpened distal tip and a shaft portion slidably disposed within the cartridge;

a seal formed by a fracturable material between the penetrating member and each cartridge, the seal being positioned at least one of a distal port or a proximal port of the cartridge; and

a cartridge transport device for moving each of the cartridges to a position that aligns the penetrating member with the penetrating member driver so that the penetrating member can be driven along a path into a target tissue.

162. The method of claim 160, wherein no more than 1 μ

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

163. The method of claim 160, wherein no more than 0.5 μ

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

164. The method of claim 160, further comprising:

monitoring position and speed of the penetrating member as the penetrating member moves in the first direction toward the target tissue.

165. The method of claim 160, further comprising:

adjusting an application of force to the penetrating member to achieve a desired speed of the penetrating member.

166. The method of claim 160, 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.

167. The method of claim 160, 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.

168. The method of claim 166, 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.

161. A method of penetrating a tissue site, comprising:

providing a tissue penetrating system that includes a cartridge, a sample chamber, a penetrating member and at least one seal that maintains the penetrating member in a sterile condition prior to launch of the penetrating member;

fracturing at least a portion of the seal prior to launch of the penetrating member;

launching the penetrating member to a target tissue; and

receiving a body fluid in the sample chamber of the tissue penetrating system.