Method and apparatus for penetrating tissue

A body fluid sampling system for use on a tissue site, the system comprising:

• an electrically powered 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;
• a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;
• and
• a human interface providing at least one output.

A body fluid sampling system for use on a tissue site, the system comprising:

• an electrically powered 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;
• a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;
• and
• a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.

A body fluid sampling system for use on a tissue site, the system comprising:

• an electrically powered 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;
• a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;
• and
• a human interface providing at least one output.

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;
• said drive force generator configured to be controlled to follow a predetermined velocity trajectory into the tissue and out of said tissue;
• a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;
• and
• a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.

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;
• said drive force generator configured to be controlled to follow a predetermined velocity trajectory into the tissue and out of said tissue;
• a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;
• and
• a human interface providing at least one output.

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;
• a position sensor positioned to provide an indication of a position of the penetrating member during actuation;
• a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;
• and
• a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.

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;
• a position sensor positioned to provide an indication of a position of the penetrating member during actuation;
• a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;
• and
• a human interface providing at least one output.

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;
• a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;
• and
• a user interface configured to relay at least one of penetrating member performance or a penetrating member setting.

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;
• a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;
• and
• a human interface providing at least one output.

A body fluid sampling system for use on a tissue site, the system comprising:

• a drive force generator;
• a plurality of cartridges each containing a penetrating member, each of said cartridges coupled together to define a flexible array;
• a transport device for moving each of said cartridges into a launch position operatively coupling said penetrating member to the force generator;
• each cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;
• and
• a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.

A body fluid sampling system for use on a tissue site, the system comprising:

• a drive force generator;
• a plurality of cartridges each containing a penetrating member, each of said cartridges coupled together to define a flexible array;
• a transport device for moving each of said cartridges into a launch position operatively coupling said penetrating member to the force generator;
• each cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;
• and
• a human interface providing at least one output.

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 user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.

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 human interface providing at least one output.

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.

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.

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 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;
• a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;
• and
• a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.

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 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;
• a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;
• and
• a human interface providing at least one output.

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 said a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
• a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;
• and
• a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.

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 said a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
• a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;
• and
• a human interface providing at least one output.

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;
• a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;
• and
• a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.

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;
• a cartridge housing said penetrating member, said cartridge having a first and a second seal coupled to said penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation;
• and
• a human interface providing at least one output.