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 predeteremined velocity trajectory into the tissue and out of said tissue;
a skin stabilizing member associated with the device and at least partially surrounding an impact location of the penetrating member on said skin;
a user interface configured to relay at least one of,,penetrating member performance or a penetrating member setting.
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Accused Products
Abstract
These and other objects of the present invention are achieved in a body fluid sampling system for use on a tissue site that includes a drive force generator and a penetrating member operatively coupled to the force generator. The force generator moves the member along a path out of a housing with a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. The drive force generator is configured to be controlled to follow a predetermined velocity trajectory into the tissue and out of the tissue. A tissue stabilizing member is associated with the device and at least partially surrounds an impact location of the penetrating member on the tissue site. A user interface is configured to relay at least one of, penetrating member performance or a penetrating member setting.
276 Citations
53 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 predeteremined velocity trajectory into the tissue and out of said tissue;
a skin stabilizing member associated with the device and at least partially surrounding an impact location of the penetrating member on said skin;
a user interface configured to relay at least one of,,penetrating member performance or a penetrating member setting. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 10, 11, 12, 13, 14, 15, 16, 17, 33)
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9. The system of claim 55, wherein the processor is configured to assist in an adjustment of force applied to the penetrating member driver in response to a target tissue parameter.
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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 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 skin stabilizing member associated with the device and at least partially surrounding an impact location of the penetrating member on said skin; and
a human interface providing at least one output. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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34. 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 skin stabilizing member associated with the device and at least partially surrounding an impact location of the penetrating member on the skin; and
a user interface configured to relay at least one of, skin penetrating performance or a skin penetrating setting.
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35. 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 skin stabilizing member associated with the device and at least partially surrounding an impact location of the penetrating member on the skin; and
a human interface providing at least one output.
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36. 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 skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site;
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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37. 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 skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site; and
a human interface providing at least one output.
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38. 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 skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site;
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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39. 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 skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site; and
a human interface providing at least one output.
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40. 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 skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site;
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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41. 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 skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site; and
a human interface providing at least one output.
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42. 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 skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site;
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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43. 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 skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site; and
a human interface providing at least one output.
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44. 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 skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site;
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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45. 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 skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site; and
a human interface providing at least one output.
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46. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having said a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
a skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site;
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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47. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having'"'"'said a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;
a skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site; and
a human interface providing at least one output.
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48. 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 mL of the fluid;
a skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site;
a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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49. 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 mL of the fluid;
a skin stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site; and
a human interface providing at least one output.
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50. 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 configured to relay at least one of, penetrating member performance or a penetrating member setting.
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51. 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 providing at least one output.
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52. 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 configured to relay at least one of, penetrating member performance or a penetrating member setting.
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53. 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 providing at least one output.
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Specification