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;
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; and
a user interface coupled to a 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.
4 Assignments
0 Petitions
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.
244 Citations
36 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; 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; and a user interface coupled to a 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A lancing device 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 associated with the device and at least partially surrounding an impact location of the penetrating member on the tissue; and a user interface coupled to a 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.
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18. A lancing device 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 associated with the device and at least partially surrounding an impact location of the penetrating member on the tissue; and a human interface coupled to a 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.
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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; a position sensor used to determine a position of the penetrating member during actuation. 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; a user interface coupled to a 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.
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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; a position sensor used to determine a position of the penetrating member during actuation, 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; and a human interface coupled to a 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.
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21. 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; 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; a user interface coupled to a 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.
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22. 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; 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; and a human interface coupled to a 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.
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23. A body fluid sampling system for use on a tissue site, the system comprising:
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a voice coil drive force generator; a plurality of modules each containing a penetrating member, each of said modules coupled together to define a flexible array; a transport device for moving each of said modules into a launch position operatively coupling said penetrating member to the force generator, 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; a user interface coupled to a 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.
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24. A body fluid sampling system for use on a tissue site, the system comprising:
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a voice coil drive force generator; a plurality of modules each containing a penetrating member, each of said modules coupled together to define a flexible array; a transport device for moving each of said modules into a launch position operatively coupling said penetrating member to the force generator, 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; and a human interface coupled to a 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.
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25. 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, 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; a user interface coupled to a 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.
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26. 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; 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; and a human interface coupled to a 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.
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27. 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; 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; a user interface coupled to a 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.
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28. 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; 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; and a human interface coupled to a 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.
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29. 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 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; a user interface coupled to a 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.
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30. 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 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; and a human interface coupled to a 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.
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31. 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 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; a user interface coupled to a 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.
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32. 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 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; and a human interface coupled to a 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.
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33. 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 user interface coupled to a 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.
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34. 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; and a human interface coupled to a processor and relaying to the drive force generator at least one lancing penetration parameter selected from at least one oft 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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35. 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 advancable between a first position and a second position; a user interface coupled to a 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.
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36. 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 advancable between a first position and a second position; and a human interface coupled to a 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.
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Specification