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 drive force generator, said drive force generator moving said penetrating 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 sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μL and including an analyte detecting member, the sample chamber being positioned to receive fluid from a wound created by said penetrating member, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;
• a human interface providing at least one output, and
• a position sensor coupled to a processor and the electrically powered drive force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

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 drive force generator, said drive force generator moving said penetrating 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 site and out of said tissue site;
• a sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μL and including electrodes, the sample chamber being positioned to receive fluid from a wound created by said penetrating member and determine a concentration of an analyte in the fluid using a sample of less than 1 μL of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;
• a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting, and
• a position sensor coupled to a processor and the electrically powered drive force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

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 site and out of said tissue site;
• a sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber including electrodes and having a volume no greater than 1 μL, the sample chamber being positioned to receive fluid from a wound created by said penetrating member and determine a concentration of an analyte in the fluid using a sample of less than 1 μL of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;
• a human interface providing at least one output, and
• a position sensor coupled to a processor and the electrically powered drive force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

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 sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μL and including an analyte detecting member, the sample chamber being positioned to receive fluid from a wound created by said penetrating member and determine a concentration of an analyte in the fluid using a sample of less than 1 μL of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;
• a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting;
• and
• a position sensor coupled to a processor and the electrically powered drive force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

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 sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μL and including an analyte detecting member, the sample chamber being positioned to receive fluid from a wound created by said penetrating member and determine a concentration of an analyte in the fluid using a sample of less than 1 μL of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;
• a human interface providing at least one output;
• and
• a position sensor coupled to a processor and the electrically powered drive force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

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 sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μL and including an analyte detecting member, the sample chamber being positioned to receive fluid from a wound created by said penetrating member and determine a concentration of an analyte in the fluid using a sample of less than 1 μL of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;
• a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting;
• and
• a position sensor coupled to a processor and the electrically powered drive force generator the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

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 sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μL and including an analyte detecting member, the sample chamber being positioned to receive fluid from a wound created by said penetrating member and determine a concentration of an analyte in the fluid using a sample of less than 1 μL of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;
• a human interface providing at least one output;
• and
• a position sensor coupled to a processor and the electrically powered drive force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

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 sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μL and including an analyte detecting member, the sample chamber being positioned to receive fluid from a wound created by said penetrating member and determine a concentration of an analyte in the fluid using a sample of less than 1 μL of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;
• a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting;
• and
• a position sensor coupled to a processor and the electrically powered drive force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

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 sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μL and including an analyte detecting member, the sample chamber being positioned to receive fluid from a wound created by said penetrating member and determine a concentration of an analyte in the fluid using a sample of less than 1 μL of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;
• a human interface providing at least one output;
• and
• a position sensor coupled to a processor and the electrically powered drive force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

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 sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μL and including an analyte detecting member, the sample chamber being positioned to receive fluid from a wound created by said penetrating member and determine a concentration of an analyte in the fluid using a sample of less than 1 μL of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;
• a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting and
• a position sensor coupled to a processor and the electrically powered drives force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement is used to drive the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.

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 sample chamber positioned to receive fluid from a wound created by said penetrating member, the sample chamber having a volume no greater than 1 μL and including an analyte detecting member, the sample chamber being positioned to receive fluid from a wound created by said penetrating member and determine a concentration of an analyte in the fluid using a sample of less than 1 μL of the fluid, the penetrating member and sample chamber being integrated in a single device, the penetrating member and sample chamber having a combined packing density of no more than 5.0 cm3;
• a human interface providing at least one output;
• and
• a position sensor coupled to a processor and the electrically powered drive force generator, the processor having a control algorithm that provides an input to the drive force generator of a real time measurement of a penetrating member depth of penetration in the tissue site, wherein the real time measurement drives the penetrating member to a numerical depth that has been set through a feedback control system in response to a tissue site cutting parameter selected from at least one of, velocity of the penetrating member into or out of the tissue site, a desired velocity profile of the penetrating, dwell time of the penetrating member into tissue site, a force delivered on the tissue site by the penetrating member, information relative to contact of the penetrating member with the tissue site before penetration by the penetrating member, and information relative to a change of velocity of the penetrating member as in travels in and through the tissue site.