Analytical device with lancet and test element
First Claim
1. Analytical device containing i) a lancet comprising a lancet needle with a tip and a lancet body which completely surrounds the lancet needle at least in the area of the tip, the lancet needle being movable relative to the lancet body and the lancet body being composed, at least in the area of the tip of the lancet needle, of an elastic material in which the tip of the lancet needle is embedded and ii) an analytical test element, the analytical test element being permanently connected to the lancet body.
4 Assignments
0 Petitions
Accused Products
Abstract
The invention concerns an analytical device containing a lancet comprising a lancet needle and a lancet body, the lancet needle being movable relative to the lancet body and the lancet body being composed, at least in the area of the tip of the lancet needle, of an elastic material in which the tip of the lancet needle is embedded, and an analytical test element which is permanently connected to the lancet body. In addition the invention concerns an analytical device containing a lancet comprising a lancet needle and a lancet body which is in the form of a hollow body in the area of the tip of the lancet needle and surrounds the tip of the lancet needle, the lancet needle being movable relative to the lancet body and the hollow body being composed at least partially of an elastic material, and an analytical test element which is permanently connected to the lancet body. Finally the invention concerns a process for manufacturing such an analytical device.
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Citations
341 Claims
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1. Analytical device containing
i) a lancet comprising a lancet needle with a tip and a lancet body which completely surrounds the lancet needle at least in the area of the tip, the lancet needle being movable relative to the lancet body and the lancet body being composed, at least in the area of the tip of the lancet needle, of an elastic material in which the tip of the lancet needle is embedded and ii) an analytical test element, the analytical test element being permanently connected to the lancet body.
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2. Analytical device containing
i) a lancet comprising a lancet needle with a tip and a lancet body which is in the form of a hollow body in the area of the tip of the lancet needle and which surrounds the tip of the lancet needle, the lancet needle being movable relative to the lancet body and the hollow body being composed at least partially of an elastic material that can be pierced by the tip of the lancet needle during the lancing process and which optionally reseals after the tip of the lancet needle has been retracted into the hollow body and ii) an analytical test element, the analytical test element being permanently connected to the lancet body.
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9. Use of an elastic material as a component of an analytical device containing a lancet and an analytical test element to maintain the sterility of at least the tip of a lancet needle in the unused state.
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10. A lancet module, comprising
a module body portion comprising a lancet channel with a plurality of lancet bearing guides disposed within the lancet channel; - and
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the lancet channel and lancet bearing guides with the lancet bearing guides configured to confine a lancet to substantially linear axial movement. - View Dependent Claims (11, 12, 13, 14)
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15. A lancet module, comprising
a module body portion comprising a lancet channel having at least one flow stop chamber disposed within a distal end portion of the lancet channel that has a transverse dimension that is significantly larger than a transverse dimension of a distally adjacent portion of the lancet channel and a rapid transition in transverse dimension that will interrupt capillary action from a distal end of the lancet channel; - and
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the lancet channel. - View Dependent Claims (16, 17, 18, 19)
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20. A sampling module, comprising
a module body portion comprising a lancet channel with a plurality of lancet bearing guides disposed within the lancet channel; -
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the lancet channel and lancet bearing guides with the lancet bearing guides configured to confine a lancet to substantially linear axial movement; and
a sample reservoir in fluid communication with a sample input port of the module body portion. - View Dependent Claims (21, 22, 23, 24)
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25. A sampling module, comprising:
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a module body portion comprising a lancet channel having at least one flow stop chamber disposed within a distal end portion of the lancet channel that has a transverse dimension that is significantly larger than a transverse dimension of a distally adjacent portion of the lancet channel and a rapid transition in transverse dimension that will interrupt capillary action from a distal end of the lancet channel;
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the lancet channel; and
a sample reservoir in fluid communication with a sample input port of the module body portion. - View Dependent Claims (26, 27, 28, 29)
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30. A sampling module, comprising:
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a module body portion comprising a lancet channel;
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the lancet channel of the module body portion;
a sample reservoir having an input end and a terminal end, the sample reservoir being in fluid communication with a sample input port of the module body portion; and
a vent disposed between and in fluid communication with the terminal end of the sample reservoir and the lancet channel. - View Dependent Claims (31, 32, 33, 34, 35, 36)
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37. A sampling module comprising:
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a module body portion having a sampling site adjacent a lancet exit port where the sharpened distal tip of the lancet exits a distal end of the module body portion that includes a sample cavity in a distal end surface of the module body portion;
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the module body portion and extendable from the lancet exit port; and
a sample reservoir in fluid communication with a sample cavity of the module body portion. - View Dependent Claims (38, 39)
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40. A sampling module, comprising:
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a module body portion configured to be mechanically registered and secured adjacent a lancet driver;
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the module body portion; and
a sample reservoir in fluid communication with a sample input port of the module body portion that has a fill detector for determining when the sample reservoir is full of a sample. - View Dependent Claims (41, 42, 43)
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44. A sampling module, comprising:
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a module body portion comprising a lancet channel;
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the lancet channel of the module body portion;
a first sample reservoir having an input end and a terminal end, the input end of the sample reservoir being in fluid communication with a sample input port of the module body portion; and
a second sample reservoir having an input end in fluid communication with the terminal end of the first sample reservoir and having a cross sectional area that is substantially smaller than a cross sectional area of the first sample reservoir such that a sample flowing from the sample input port into the first sample reservoir will fill the first sample reservoir and then rapidly fill the second sample reservoir by capillary action. - View Dependent Claims (45, 46, 47, 48)
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49. A lancet module comprising
a module body portion configured to be mechanically registered and secured adjacent a lancet driver; - and
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the module body portion. - View Dependent Claims (50, 51, 52, 53, 54, 55)
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- 56. A lancet module comprising a module body portion having a lancet channel and a lancet slidably disposed within the lancet channel and a cover sheet disposed over the lancet and lancet channel capturing the lancet shaft in the lancet channel.
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61. A sampling module comprising:
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a module body portion configured to be mechanically registered and secured adjacent a lancet driver;
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the module body portion; and
a sample reservoir in fluid communication with a sampling site of the module body portion. - View Dependent Claims (62, 63, 64, 65, 66, 67, 68)
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69. A sampling module comprising:
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a module body portion;
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within a lancet channel of the module body portion; and
a sample reservoir which has an analytical region with sample sensors disposed within the analytical region the sample reservoir being in fluid communication with a sampling site of the module body portion.
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- 70. A sampling module comprising a module body portion having a lancet channel, a lancet slidably disposed within the lancet channel, a cover sheet disposed over the lancet and lancet channel capturing the lancet shaft in the lancet channel, and a sample reservoir for collection of a sample obtained by lancing a patient with the lancet.
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80. A sampling device comprising:
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a lancet for obtaining a blood sample from a user, said lancet having a distal end and a proximal end;
a reservoir for collecting the blood sample adjacent to the distal end of said lancet;
a lancet driver attached to the proximal end of said lancet; and
a sensor on said sampling device for detecting said user and initiating a lancing cycle. - View Dependent Claims (81, 82, 83, 84, 85)
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86. A method of sampling comprising:
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providing a sampling module having a lancet disposed within a lancet channel, a sample reservoir and an orifice on a surface of the sampling module in fluid communication with the sample reservoir;
coupling the lancet of the sampling module to a lancet driver;
activating a lancing cycle by having a patient place target tissue over a sensor which detects the target tissue and initiates the lancing cycle;
lancing the target tissue to obtain a sample of blood;
collecting said sample of blood through the orifice. - View Dependent Claims (87)
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88. A method of sampling comprising:
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loading a disposable sampling module into a lancing device with a lancet disposal within a lancet channel which has an orifice on a surface of said sampling module;
initiating a lancing cycle by prompting a user sensor on said lancing device;
activating said lancing cycle by having a patient place a finger over an ergonomically contoured area located on said surface such that said finger overlaps with said orifice;
lancing the finger to obtain a sample of blood;
collecting said sample of blood through said orifice; and
informing said user to remove said finger from the ergonomically contoured active sampling area. - View Dependent Claims (89)
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90. A method of sampling comprising:
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loading a disposable sampling module having a lancet into a lancing device;
initiating a lancing cycle and activating a user sensor on said lancing device by placing a piece of skin on a surface of said sampling module;
lancing said skin to obtain a blood sample; and
collecting said blood sample. - View Dependent Claims (91)
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92. A method of sampling comprising:
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loading a disposable sampling module having a lancet into a lancing device;
initiating a lancing cycle and activating a user sensor on said lancing device by placing a piece of skin on a surface of said sampling module;
lancing said skin to obtain a blood sample;
collecting said blood sample; and
. - View Dependent Claims (93, 94)
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95. A tissue penetration sampling device for collecting blood from the skin of a patient, the device comprising:
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a sampling module having a sampling site, the sampling site having a sample input port, a sample reservoir in fluid communication with the sample input port, a lancet maintained within the sampling module, the lancet having a lancet tip adjacent the sample input port, and a lancet driver coupled to the lancet to drive the lancet tip through the opening to lance the skin when the lancet driver is actuated, the device being configured to allow actuation of the lancet driver, lancing of the skin, collection of the blood, and movement of the blood to the sample reservoir seamlessly by forming a substantially airtight seal at the opening when the skin is firmly pressed against the sampling site. - View Dependent Claims (96)
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97. A sampling module for use in collecting blood from the skin of a patient, comprising
a body portion, a sampling site on the body portion defining a sample input port, the sampling site shaped to conform to the skin and to form a substantially airtight seal with the skin, a lancet disposed in the body portion, the lancet having a lancet tip adjacent the sample input port, wherein the lancet is operable to send the lancet tip through the opening to lance the skin of the patient, and a reservoir in fluid communication with the sample input port, the sampling acquisition module configured to allow seamless sampling of the blood, and integrated lancing of the skin, collection of the blood through the sample input port, and movement of the blood to the sample reservoir.
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98. A method of collecting blood from the skin of a patient, the method comprising:
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a) contacting the skin of the patient with a blood sampling device, and b) performing a single initiating act resulting in the blood sampling device lancing the skin, collecting blood from the skin, and moving blood to a reservoir within the sampling device. - View Dependent Claims (99, 100, 101)
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- 102. A sampling module belt comprising a plurality of sampling modules having a module body portion with a lancet channel and a lancet slidably disposed within the lancet channel and a cover sheet disposed over the lancet and lancet channel capturing the lancet shaft in the lancet channel with the plurality of sampling modules interconnected in a linear array by a flexible belt member.
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105. A lancet belt cartridge comprising:
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(a) a lancet belt comprising a plurality of lancets releasably secured to a flexible belt tape substantially orthogonal to a longitudinal axis of the belt tape; and
(b) a supply canister disposed about an unused portion of the lancet belt. - View Dependent Claims (106)
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107. A lancet module cartridge, comprising a plurality of lancet modules interconnected in an array and configured for sequential use.
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108. A lancet module cartridge comprising:
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(a) a lancet module belt comprising a plurality of lancet modules interconnected in an array by a flexible member; and
(b) a supply canister that is disposed about an unused portion of the lancet module belt. - View Dependent Claims (109)
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110. A lancet module cartridge comprising:
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(a) a lancet module belt comprising a plurality of lancet modules having a module body portion with a lancet channel and a lancet slidably disposed within the lancet channel and a cover sheet disposed over the lancet and lancet channel capturing the lancet shaft in the lancet channel with the plurality of lancet modules interconnected in a linear array by a flexible belt member. (b) a supply canister that is disposed about an unused portion of the lancet module belt; and
(c) a receptacle canister that is configured to store a used portion of the lancet module belt.
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- 111. A sampling module cartridge comprising a plurality of sampling modules interconnected in an array and configured for sequential use.
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113. A sampling module cartridge comprising:
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(a) a plurality of sampling modules interconnected in an array by a flexible member; and
(b) a supply canister that is disposed about an unused portion of the sampling module belt. - View Dependent Claims (114, 115)
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116. A sampling module cartridge comprising:
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(a) a sampling module belt comprising a plurality of sampling modules having a module body portion with a lancet channel, a lancet slidably disposed within the lancet channel, a cover sheet disposed over the lancet and lancet channel capturing the lancet shaft in the lancet channel, and a sample reservoir for collection of a sample obtained by lancing a patient with the lancet with the plurality of sampling modules interconnected in a linear array by a flexible belt member;
(b) a supply canister that is disposed about an unused portion of the sampling module belt; and
(c) a receptacle canister that is configured to store a used portion of the sampling module belt.
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117. An apparatus for collecting blood from a patient'"'"'s skin, the apparatus comprising a cartridge including a plurality of sampling modules, each sampling module comprising a sampling input port,
a lancet having a tip, the tip adjacent the sampling input port, the lancet maintained within the cartridge and operable to extend the lancet tip through the sampling input port to pierce the patient'"'"'s skin positioned adjacent the sampling input port, and an analytical region in fluid communication with the sampling input port, the analytical region associated with sample sensors.
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120. A method of collecting and testing a series of blood samples, the method comprising:
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a) providing a sampling module cartridge and a reader device, the sampling module cartridge including a plurality of sampling modules, each sampling module adapted to perform a single blood sampling cycle of lancing, collection of a blood sample, and testing of the blood sample;
b) coupling the sampling module cartridge to the reader device;
c) initiating the blood sampling cycle and obtaining a first blood sample;
d) testing the first blood sample obtained;
e) advancing the sampling cartridge to bring another sampling module online;
f) initiating another blood sampling cycle and obtaining a second blood sample; and
g) testing the second blood sample. - View Dependent Claims (121, 122, 123, 124, 125)
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126. A tissue penetration sampling device comprising a controllable lancet driver operatively coupled to a cartridge of sampling modules.
- 127. A sampling module cartridge comprising a plurality of sampling modules disposed within a cartridge housing and configured for serial use by a lancet driver.
- 130. A cartridge for use in sampling, comprising a sampling cartridge body having a plurality of sampling module portions, a lancet cartridge body having a plurality of lancet module portions with the sampling cartridge body and lancet cartridge body being disposed adjacent each other in an operative configuration such that each lancet module portion can be readily aligned in a functional arrangement with each sampling module portion.
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147. A skin penetrating system, comprising:
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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, each analyte detecting member including a sample chamber and an opening for transport of a body fluid into the 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 user interface configured to relay at least one of, skin penetrating performance or a skin penetrating setting.
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148. A skin penetrating system, comprising:
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a housing member;
a plurality of penetrating members positioned in the housing member, a penetrating member driver coupled to the plurality of penetrating members;
a plurality of analyte detecting members each associated with a penetrating member, each analyte detecting member including a sample chamber and an opening for transport of a body fluid into the 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 human interface providing at least one output.
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149. A tissue penetrating system, comprising:
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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 sample chamber; and
a user interface configured to relay at least one of, skin penetrating performance or a skin penetrating setting.
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150. A tissue penetrating system, comprising:
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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 sample chamber; and
a human interface providing at least one output. - View Dependent Claims (151, 152, 153, 154)
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155. A skin penetrating system, comprising:
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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. - View Dependent Claims (156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169)
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170. A skin penetrating system, comprising:
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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.
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171. A tissue penetrating system, comprising:
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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.
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172. A tissue penetrating system, comprising:
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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. - View Dependent Claims (173, 174, 175, 176)
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177. A tissue penetrating system, comprising:
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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.
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178. A method of penetrating a target tissue, comprising:
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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; and
receiving no more than 1 μ
L of a body fluid in the sample chamber.
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179. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
wherein said penetrating member is an elongate member without a molded attachment;
a coupler on said force generator configured to engage at least a portion of said elongate portion of the penetrating member and drive said member along a path into a tissue site and withdrawn from a tissue site;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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180. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
wherein said penetrating member is an elongate member without a molded attachment;
a coupler on said force generator configured to engage at least a portion of said elongate portion of the penetrating member and drive said member along a path into a tissue site and withdrawn from a tissue site;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and
a human interface providing at least one output.
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181. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;
a sterility enclosure covering at least a tip of said penetrating member, said sterility enclosure removed from said penetrating member prior to actuation of the member and positioned so that the penetrating member will not contact said enclosure during actuation;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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182. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;
a sterility enclosure covering at least a tip of said penetrating member, said sterility enclosure removed from said penetrating member prior to actuation of the member and positioned so that the penetrating member will not contact said enclosure during actuation;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and
a human interface providing at least one output.
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183. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;
a sterility enclosure creating a sterile environment around at least a tip of said penetrating member, said penetrating member breaching said sterile enviromnent during actuation;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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184. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;
a sterility enclosure creating a sterile environment around at least a tip of said penetrating member, said penetrating member breaching said sterile environment during actuation;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and
a human interface providing at least one output.
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185. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having said a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
a skin stabilizer device suitable for stretching a surface of a tissue site, said skin stabilizer at least partially surrounding the penetrating member exit;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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186. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having said a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
a skin stabilizer device suitable for stretching a surface of a tissue site, said skin stabilizer at least partially surrounding the penetrating member exit;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and
a human interface providing at least one output.
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187. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having said a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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188. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having said a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and
a human interface providing at least one output.
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189. A device for use with penetrating member driver to penetrate tissue, the device comprising:
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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. - View Dependent Claims (190, 191, 192, 193, 194)
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195. A device for use with a penetrating member driver to penetrate tissue, the device comprising:
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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. - View Dependent Claims (196, 197, 198, 199, 200, 201, 202, 203)
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204. A device for use with a penetrating member driver to penetrate tissue, the device comprising:
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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. - View Dependent Claims (205, 206, 207, 208)
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209. A device for use with a penetrating member driver to penetrate tissue, the device comprising:
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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.
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210. A lancing system for use with a penetrating member driver, said system comprising:
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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.
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211. 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. - View Dependent Claims (212, 213, 214)
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215. 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.
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216. 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.
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217. A device for use with a 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 optical analyte sensors coupled to said single cartridge;
a sterility barrier covering said openings. - View Dependent Claims (218, 219, 220, 221)
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222. 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 optical analyte sensors coupled to said single cartridge, said sensors receiving body fluid entering said cavities. - View Dependent Claims (223, 224, 225, 226, 227, 228, 229, 230)
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231. 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. - View Dependent Claims (232, 233, 234, 235, 236)
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237. 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.
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238. A lancing system for use with a penetrating member driver, said system comprising:
-
means for housing a plurality of penetrating members and optical 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 optical analyte sensors receives body fluid from a wound created in said tissue by one of said penetrating members.
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239. A body fluid sampling system for use on a tissue site, the system comprising:
-
a single drive force generator;
a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site; and
a flexible support member coupling said penetrating members to define a linear array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator. - View Dependent Claims (240, 241, 242, 243, 244, 245, 246, 247, 248)
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249. A body fluid sampling system for use on a tissue site, the system comprising:
-
a drive force generator;
a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
a flexible support member coupling said penetrating members to define a linear array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator; and
an analyte detection member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid.
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250. A body fluid sampling system for use on a tissue site, the system comprising:
-
a drive force generator;
a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;
a sterility enclosure creating a sterile environment around at least a tip of said penetrating member, said penetrating member breaching said sterile environment during actuation;
a skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site;
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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251. A body fluid sampling system for use on a tissue site, the system comprising:
-
a drive force generator;
a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;
a sterility enclosure creating a sterile environment around at least a tip of said penetrating member, said penetrating member breaching said sterile environment during actuation;
a skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site; and
a human interface providing at least one output.
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252. A body fluid sampling system for use on a tissue site, the system comprising:
-
a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
wherein said penetrating member is an elongate member without a molded attachment;
a coupler on said force generator configured to engage at least a portion of said elongate portion of the penetrating member and drive said member along a path into a tissue site and withdrawn from a tissue site;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid.
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253. A body fluid sampling system for use on a tissue site, the system comprising:
-
a drive force generator;
a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;
a sterility enclosure covering at least a tip of said penetrating member, said sterility enclosure removed from said penetrating member prior to actuation of the member and positioned so that the penetrating member will not contact said enclosure during actuation;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid.
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254. A body fluid sampling system for use on a tissue site, the system comprising:
-
a drive force generator;
a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;
a sterility enclosure creating a sterile environment around at least a tip of said penetrating member, said penetrating member breaching said sterile environment during actuation;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid.
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255. 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. - View Dependent Claims (256, 257, 258, 259, 260, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 271, 272, 273)
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274. 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.
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275. 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.
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276. 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.
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277. A body fluid sampling system for use on a tissue site, the system comprising:
-
a drive force generator;
a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;
a sterility enclosure creating a sterile environment around at least a tip of said penetrating member, said penetrating member breaching said sterile environment during actuation; and
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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278. A body fluid sampling system for use on a tissue site, the system comprising:
-
a drive force generator;
a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;
a sterility enclosure creating a sterile environment around at least a tip of said penetrating member, said penetrating member breaching said sterile environment during actuation; and
a human interface providing at least one output.
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279. A body fluid sampling system for use on a tissue site, the system comprising:
-
a drive force generator;
a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;
a sterility enclosure covering at least a tip of said penetrating member, said sterility enclosure removed from said penetrating member prior to actuation of the member and positioned so that the penetrating member will not contact said enclosure during actuation.
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280. A body fluid sampling system for use on a tissue site, the system comprising:
-
a drive force generator;
a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;
a sterility enclosure creating a sterile environment around at least a tip of said penetrating member, said penetrating member breaching said sterile environment during actuation.
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281. 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;
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; and
a user interface configured to relay at least one of, skin penetrating performance or a skin penetrating setting.
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282. 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;
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; and
a human interface coupled providing at least one output. - View Dependent Claims (283)
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284. A body fluid sampling system for use on a tissue site, the system comprising:
-
a drive force generator;
a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;
a sterility enclosure covering at least a tip of said penetrating member, said sterility enclosure removed from said penetrating member prior to actuation of the member and positioned so that the penetrating member will not contact said enclosure during actuation; and
a tissue stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site.
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285. A body fluid sampling system for use on a tissue site, the system comprising:
-
a drive force generator;
a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;
a sterility enclosure creating a sterile environment around at least a tip of said penetrating member, said penetrating member breaching said sterile environment during actuation; and
a tissue stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site.
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286. A body fluid sampling system for use on a tissue site, the system comprising:
-
a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
an analyte detection member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and
a tissue stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site.
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287. A device for use with a penetrating member driver to penetrate tissue, the device comprising:
-
a single cartridge having a plurality of penetrating members;
a plurality of analyte detecting members, said analyte detecting members positioned to receive body fluid from a wound in the tissue created by the penetrating member.
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288. A device for use with a 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 optical analyte detecting members coupled to said single cartridge;
a sterility barrier covering said openings. - View Dependent Claims (289, 290, 291, 292)
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293. 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 optical analyte detecting members coupled to said single cartridge, said analyte detecting members receiving body fluid entering said cavities. - View Dependent Claims (294, 295, 296, 297, 298, 299, 300, 301)
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302. 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 analyte detecting members attached to a substrate, said substrate couplable to said single cartridge in manner positioning at least one of said analyte detecting members with each of said plurality of cavities. - View Dependent Claims (303, 304, 305, 306, 307, 308)
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309. 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 analyte detecting members on a layer of material couplable to said single cartridge wherein at least two of said cavities each has at least one analyte detecting member in fluid communication with one of said cavities, said analyte detecting members positioned on the cartridge to receive body fluid from a wound in the tissue created by the penetrating member.
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310. 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 optical analyte detecting members by coupling a analyte detecting member layer to the cartridge. - View Dependent Claims (311, 312, 313, 314)
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315. 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 member slidably coupled to the cartridge, each of said penetrating members at least partially housed in one of said cavities and being moveable relative to the other ones of the penetrating members along a path out of the cartridge and into tissue;
a sterility barrier covering a plurality of openings on said cartridge and creating a sterile environment in the plurality of cavities.
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316. A device comprising:
-
a cartridge defining a plurality of cavities; and
a plurality of penetrating members at least partially contained in said cavities of the single cartridge wherein the penetrating members are slidably movable to extend outward from said cartridge to penetrate tissue, said cavities each having a longitudinal opening providing access to an elongate portion of the penetrating member;
a sterility barrier coupled to said cartridge, said sterility barrier covering a plurality of the longitudinal openings.
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317. A device comprising:
-
a cartridge defining a plurality of cavities; and
a plurality of penetrating members at least partially contained in said cavities of the single cartridge wherein the penetrating members are slidably movable to extend outward from lateral openings on said cartridge to penetrate tissue;
a sterility barrier coupled to said cartridge, said sterility barrier covering a plurality of said lateral openings.
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318. A manufacturing method comprising:
-
providing a cartridge having a plurality of cavities for holding penetrating members;
sealing a plurality of cavities with a seal layer;
providing a plurality of analyte analyte detecting members by coupling a analyte detecting member layer to the cartridge.
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319. A device for use in penetrating tissue to obtain a body fluid sample, comprising:
-
a cartridge; and
a plurality of penetrating members slidably coupled to the cartridge, each of said penetrating members having a distal end sufficiently sharp to pierce tissue and each of said penetrating members being moveable relative to the other ones of the penetrating members, so that the distal end of the respective penetrating member is movable to penetrate tissue;
wherein each of said penetrating member is a bare lancet does not penetrate an outer sterility barrier during actuation.
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320. A device comprising:
-
a cartridge having a plurality of cavities; and
a plurality of penetrating members at least partially contained in said cavities of the single cartridge wherein the penetrating members are slidably movable to extend outward from lateral openings on said cartridge to penetrate tissue;
a sterility barrier coupled to said cartridge, said sterility barrier covering a plurality of said lateral openings, wherein the sterility barrier covering the lateral openings is configured to be moved so that a penetrating member exits the lateral opening without contacting the barrier.
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321. A method comprising:
-
providing a cartridge having a plurality of cavities;
inserting a plurality of penetrating members at least partially contained in said cavities of the cartridge wherein the penetrating members are slidably movable to extend outward from lateral openings on said cartridge to penetrate tissue;
adding a sterility barrier to said cartridge, said sterility barrier covering a plurality of said lateral openings.
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322. A manufacturing method comprising:
-
providing a cartridge having a plurality of cavities for holding penetrating members;
sterilizing said cartridge while each of said cavities is in a sealed condition and the cartridge contains a plurality of penetrating members;
using a planar sheet of sterility barrier material to cover a plurality of said cavities to create a sterile environment inside each of said cavities.
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323. A method comprising:
-
providing a cartridge having a plurality of bare lancets;
moving at least a portion of a sterility barrier such that an active one of said bare lancets exits the cartridge to penetrate tissue without contacting said sterility barrier;
retracting said active one of said bare lancets back into the cartridge after penetrating tissue.
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324. A device for use with a 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 analyte detecting members coupled to said single cartridge;
a sterility barrier covering said openings.
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325. 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 analyte detecting members coupled to said single cartridge, said analyte detecting members receiving body fluid entering said cavities.
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326. 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 analyte detecting members attached to a substrate, said substrate couplable to said single cartridge in manner positioning at least one of said analyte detecting members with each of said plurality of cavities.
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327. 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 analyte detecting members on a layer of material couplable to said single cartridge wherein at least two of said cavities each has at least one analyte detecting member in fluid communication with one of said cavities, said analyte detecting members positioned on the cartridge to receive body fluid from a wound in the tissue created by the penetrating member.
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328. 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 analyte detecting members by coupling a analyte detecting member layer to the cartridge.
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329. A body fluid sampling system for use on a tissue site, the system comprising:
-
a drive force generator;
a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;
a sterility enclosure covering at least a tip of said penetrating member, said sterility enclosure removed from said penetrating member prior to actuation of the member and positioned so that the penetrating member will not contact said enclosure during actuation;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member. - View Dependent Claims (330)
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331. A body fluid sampling system for use on a tissue site, the system comprising:
-
a drive force generator;
a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;
a sterility enclosure creating a sterile environment around at least a tip of said penetrating member, said penetrating member breaching said sterile environment during actuation;
an analyte detecting member positioned to receive fluid from a wound created by said penetrating member. - View Dependent Claims (332, 333, 334)
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335. A body fluid sampling system for use on a tissue site, the system comprising:
-
a drive force generator;
a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
a flexible support member coupling said penetrating members to define a linear array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator;
an analyte detection member positioned to receive fluid from a wound created by said penetrating member. - View Dependent Claims (336)
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337. A skin penetrating system, comprising:
-
a housing member;
a penetrating member positioned in the housing member, and a tissue pressure applicator coupled to the housing member. - View Dependent Claims (340, 341)
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338. 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.
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339. A tissue penetrating system, comprising:
-
a housing a penetrating member positioned in the housing;
a seal coupled to the penetrating member to maintain the penetrating member in a sterile environment.
-
Specification