Method and apparatus for penetrating tissue
First Claim
1. 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 in a lancing cycle to provide for a flow of blood into a sample chamber of the system;
said drive force generator configured to be controlled to follow a predetermined velocity trajectory into the tissue and out of said tissue;
a tissue stabilizing member associated with the device and at least partially surrounding an impact location of the penetrating member on said tissue site;
a processor configured to construct a database for a user, the processor using the database to calculate user profile traits depending on user input information to customize a user profile for subsequent lancing cycles;
wherein the user profile traits include a degree of painlessness, success rate, and blood volume; and
a human interface specific for use by humans and having at least one output, wherein the human interface is coupled to the processor and relays to the drive force generator at least one lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction of the penetrating member, the processor having resources to deliver one or more signals to the drive force generator to initiate movement of a penetrating member, achieve acceleration of the penetrating member, keep track of a velocity of the penetrating member, determine if a distal tip of the penetrating member has made contact at the tissue site, and when to brake and retract the penetrating member.
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Accused Products
Abstract
A skin penetrating system is provided with a drive force generator and a disposable housing member. A plurality of penetrating members are positioned in the disposable housing member. Each penetrating member is coupled to the drive force generator. A plurality of analyte detecting members are each associated with a penetrating member and are positioned in the disposable housing member. Each analyte detecting member is positioned in a sample chamber with a volume of less than 1 μL, The sample chambers have openings for transport of a body fluid into the sample chamber. Each analyte detecting member is configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μL of a body fluid disposed in the sample chamber. A user interface is configured to relay at least one of, skin penetrating performance or a skin penetrating setting.
2957 Citations
24 Claims
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1. 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 in a lancing cycle to provide for a flow of blood into a sample chamber of the system;said drive force generator configured to be controlled to follow a predetermined velocity trajectory into the tissue and out of said tissue; a tissue stabilizing member associated with the device and at least partially surrounding an impact location of the penetrating member on said tissue site; a processor configured to construct a database for a user, the processor using the database to calculate user profile traits depending on user input information to customize a user profile for subsequent lancing cycles;
wherein the user profile traits include a degree of painlessness, success rate, and blood volume; anda human interface specific for use by humans and having at least one output, wherein the human interface is coupled to the processor and relays to the drive force generator at least one lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction of the penetrating member, the processor having resources to deliver one or more signals to the drive force generator to initiate movement of a penetrating member, achieve acceleration of the penetrating member, keep track of a velocity of the penetrating member, determine if a distal tip of the penetrating member has made contact at the tissue site, and when to brake and retract the penetrating member. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A body fluid sampling system for use on a tissue site, the system comprising:
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an electrically powered drive force generator; a penetrating member operatively coupled to the force generator, the force generator moving the member along a path out of a housing having a penetrating member exit, into the tissue site, stopping in the tissue site, and withdrawing out of the tissue site; a penetrating member sensor coupled to the penetrating member and configured to provide information relative to a depth of penetration of the penetrating member within the tissue site; a processor configured to construct a database for a user, the processor using the database to calculate user profile traits depending on user input information to customize a user profile for subsequent lancing cycles;
wherein the user profile traits include a degree of painlessness, success rate, and blood volume; anda user interface including a data interface coupled to the processor and relaying to the drive force generator at least one lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction of the penetrating member, the processor having resources to deliver one or more signals to the drive force generator to initiate movement of a penetrating member, achieve acceleration of the penetrating member, keep track of a velocity of the penetrating member, determine if a distal tip of the penetrating member has made contact at the tissue site, and when to brake and retract the penetrating member, the processor providing instructions to the drive force generator to provide for an entrance velocity of the penetrating member into the tissue site being different than a retraction velocity out of the tissue site.
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17. A body fluid sampling system for use on a tissue site, the system comprising:
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an electrically powered drive force generator; a penetrating member operatively coupled to the force generator, the force generator moving the member along a path out of a housing having a penetrating member exit, into the tissue site, stopping in the tissue site, and withdrawing out of the tissue site; a tissue stabilizing member member associated with the device and at least partially surrounding an impact location of the penetrating member on the tissue; a penetrating member sensor coupled to the penetrating member and configured to provide information relative to a depth of penetration of the penetrating member within the tissue site; a processor configured to construct a database for a user, the processor using the database to calculate user profile traits depending on user input information to customize a user profile for subsequent lancing cycles;
wherein the user profile traits include a degree of painlessness, success rate, and blood volume; anda human interface specific for use by humans and is coupled to the processor and relays to the drive force generator at least one lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction of the penetrating member, the processor having resources to deliver one or more signals to the drive force generator to initiate movement of a penetrating member, achieve acceleration of the penetrating member, keep track of a velocity of the penetrating member, determine if a distal tip of the penetrating member has made contact at the tissue site, and when to brake and retract the penetrating member, the processor providing instructions to the drive force generator to provide for an entrance velocity of the penetrating member into the tissue site being different than a retraction velocity out of the tissue site.
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18. 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 the force generator, the force generator moving the member along a path out of a housing having a penetrating member exit, into the tissue site, stopping in the tissue site, and withdrawing out of the tissue site; a penetrating member sensor coupled to the penetrating member and configured to provide information relative to a depth of penetration of the penetrating member within the tissue site; a processor configured to construct a database for a user, the processor using the database to calculate user profile traits depending on user input information to customize a user profile for subsequent lancing cycles;
wherein the user profile traits include a degree of painlessness, success rate, and blood volume; anda user interface including a data interface coupled to the processor and relaying to the drive force generator at least one lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction of the penetrating member, the processor having resources to deliver one or more signals to the drive force generator to initiate movement of a penetrating member, achieve acceleration of the penetrating member, keep track of a velocity of the penetrating member, determine if a distal tip of the penetrating member has made contact at the tissue site, and when to brake and retract the penetrating member, the processor providing instructions to the drive force generator to provide for an entrance velocity of the penetrating member into the tissue site being different than a retraction velocity out of the tissue site.
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19. 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; 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 μ
L of the fluid;a penetrating member sensor coupled to the penetrating member and configured to provide information relative to a depth of penetration of the penetrating member within the tissue site; a processor configured to construct a database for a user, the processor using the database to calculate user profile traits depending on user input information to customize a user profile for subsequent lancing cycles;
wherein the user profile traits include a degree of painlessness, success rate, and blood volume; anda user interface including a data interface coupled to the processor and relaying to the drive force generator at least one lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction of the penetrating member, the processor having resources to deliver one or more signals to the drive force generator to initiate movement of a penetrating member, achieve acceleration of the penetrating member, keep track of a velocity of the penetrating member, determine if a distal tip of the penetrating member has made contact at the tissue site, and when to brake and retract the penetrating member, the processor providing instructions to the drive force generator to provide for an entrance velocity of the penetrating member into the tissue site being different than a retraction velocity out of the tissue site.
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20. 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; 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 μ
L of the fluid;a penetrating member sensor coupled to the penetrating member and configured to provide information relative to a depth of penetration of the penetrating member within the tissue site; a processor configured to construct a database for a user, the processor using the database to calculate user profile traits depending on user input information to customize a user profile for subsequent lancing cycles;
wherein the user profile traits include a degree of painlessness, success rate, and blood volume; anda human interface specific for use by humans and is coupled to the processor and relays to the drive force generator at least one lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction of the penetrating member, the processor having resources to deliver one or more signals to the drive force generator to initiate movement of a penetrating member, achieve acceleration of the penetrating member, keep track of a velocity of the penetrating member, determine if a distal tip of the penetrating member has made contact at the tissue site, and when to brake and retract the penetrating member, the processor providing instructions to the drive force generator to provide for an entrance velocity of the penetrating member into the tissue site being different than a retraction velocity out of the tissue site.
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21. A body fluid sampling system for use on a tissue site, the system comprising:
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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 vacuum source associated with said device for creating a lower atmosphere environment to draw fluid from a wound created by said penetrating member; a processor configured to construct a database for a user, the processor using the database to calculate user profile traits depending on user input information to customize a user profile for subsequent lancing cycles;
wherein the user profile traits include a degree of painlessness, success rate, and blood volume; anda user interface including a data interface coupled to the processor and relaying to the drive force generator at least one lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction of the penetrating member, the processor having resources to deliver one or more signals to the drive force generator to initiate movement of a penetrating member, achieve acceleration of the penetrating member, keep track of a velocity of the penetrating member, determine if a distal tip of the penetrating member has made contact at the tissue site, and when to brake and retract the penetrating member, the processor providing instructions to the drive force generator to provide for an entrance velocity of the penetrating member into the tissue site being different than a retraction velocity out of the tissue site.
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22. 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 vacuum source associated with said device for creating a lower atmosphere environment to draw fluid from a wound created by said penetrating member; a processor configured to construct a database for a user, the processor using the database to calculate user profile traits depending on user input information to customize a user profile for subsequent lancing cycles;
wherein the user profile traits include a degree of painlessness, success rate, and blood volume; anda human interface specific for use by humans and is coupled to the processor and relays to the drive force generator at least one lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction of the penetrating member, the processor having resources to deliver one or more signals to the drive force generator to initiate movement of a penetrating member, achieve acceleration of the penetrating member, keep track of a velocity of the penetrating member, determine if a distal tip of the penetrating member has made contact at the tissue site, and when to brake and retract the penetrating member, the processor providing instructions to the drive force generator to provide for an entrance velocity of the penetrating member into the tissue site being different than a retraction velocity out of the tissue site.
- an electrically powered drive force generator;
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23. A body fluid sampling system for use on a tissue site, the system comprising:
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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 movable capillary tube advanceable between a first position and a second position; a processor configured to construct a database for a user, the processor using the database to calculate user profile traits depending on user input information to customize a user profile for subsequent lancing cycles;
wherein the user profile traits include a degree of painlessness, success rate, and blood volume; anda user interface including a data interface coupled to the processor and relaying to the drive force generator at least one lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction of the penetrating member, the processor having resources to deliver one or more signals to the drive force generator to initiate movement of a penetrating member, achieve acceleration of the penetrating member, keep track of a velocity of the penetrating member, determine if a distal tip of the penetrating member has made contact at the tissue site, and when to brake and retract the penetrating member, the processor providing instructions to the drive force generator to provide for an entrance velocity of the penetrating member into the tissue site being different than a retraction velocity out of the tissue site.
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24. A body fluid sampling system for use on a tissue site, the system comprising:
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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 movable capillary tube advanceable between a first position and a second position; a processor configured to construct a database for a user, the processor using the database to calculate user profile traits depending on user input information to customize a user profile for subsequent lancing cycles;
wherein the user profile traits include a degree of painlessness, success rate, and blood volume; anda human interface coupled to the processor and relaying to the drive force generator at least one lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction of the penetrating member, the processor having resources to deliver one or more signals to the drive force generator to initiate movement of a penetrating member, achieve acceleration of the penetrating member, keep track of a velocity of the penetrating member, determine if a distal tip of the penetrating member has made contact at the tissue site, and when to brake and retract the penetrating member, the processor providing instructions to the drive force generator to provide for an entrance velocity of the penetrating member into the tissue site being different than a retraction velocity out of the tissue site.
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Specification