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 plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members 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 each of a penetrating member at least partially positioned adjacent to an analyte sensor in a sample chamber, each sample chamber configured to receive body fluid from a wound in tissue created by a penetrating member, and each analyte sensor configured to determine analyte levels using a body fluid sample of less than about 1 microliter;
a flexible support member coupling said penetrating members [to define a linear array], said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator. said drive force generator configured to be controlled to follow a predetermined velocity trajectory into the tissue and out of said tissue.
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Accused Products
Abstract
A body fluid sampling system for use on a tissue site includes a single drive force generator. A plurality of penetrating members are operatively coupled to the force generator. The force generator moves each of the members 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. A flexible support member couples the penetrating members to define a linear array. The support member is movable and configured to move each of the penetrating members to a launch position associated with the force generator.
239 Citations
63 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 plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members 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 each of a penetrating member at least partially positioned adjacent to an analyte sensor in a sample chamber, each sample chamber configured to receive body fluid from a wound in tissue created by a penetrating member, and each analyte sensor configured to determine analyte levels using a body fluid sample of less than about 1 microliter;
a flexible support member coupling said penetrating members [to define a linear array], said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator. said drive force generator configured to be controlled to follow a predetermined velocity trajectory into the tissue and out of said tissue. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 61, 63)
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53. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members 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, each of a penetrating member at least partially positioned adjacent to an analyte sensor in a sample chamber, each sample chamber configured to receive body fluid from a wound in tissue created by a penetrating member, and each analyte sensor configured to determine analyte levels using a body fluid sample of less than about 1 microliter;
a flexible support member coupling said penetrating members to define a linear array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator. a position sensor configured to provide an indication of a position of the penetrating member during actuation.
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54. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members 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, each of a penetrating member at least partially positioned adjacent to an analyte sensor in a sample chamber, each sample chamber configured to receive body fluid from a wound in tissue created by a penetrating member, and each analyte sensor configured to determine analyte levels using a body fluid sample of less than about 1 microliter;
a flexible support member coupling said penetrating members to define a linear array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator. 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.
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55. 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 plurality of cartridges each containing a penetrating member, each of said cartridges coupled together to define a flexible array;
a transport device for moving each of said cartridges into a launch position operatively coupling said penetrating member to the force generator. a flexible support member coupling said cartridges to define a linear array, said support member being movable and configured to move each of said cartridges to said launch position associated with said force generator.
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56. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members 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, each of a penetrating member at least partially positioned adjacent to an analyte sensor in a sample chamber, each sample chamber configured to receive body fluid from a wound in tissue created by a penetrating member, and each analyte sensor configured to determine analyte levels using a body fluid sample of less than about 1 microliter;
a flexible support member coupling said penetrating members to define a linear array, said support member being movable and configured to move each of said penetrating members to a launch position associated with 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.
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57. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members 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, each of a penetrating member at least partially positioned adjacent to an analyte sensor in a sample chamber, each sample chamber configured to receive body fluid from a wound in tissue created by a penetrating member, and each analyte sensor configured to determine analyte levels using a body fluid sample of less than about 1 microliter;
a flexible support member coupling said penetrating members to define a linear array, said support member being movable and configured to move each of said penetrating members to a launch position associated with 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.
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58. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members 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, each of a penetrating member at least partially positioned adjacent to an analyte sensor in a sample chamber, each sample chamber configured to receive body fluid from a wound in tissue created by a penetrating member, and each analyte sensor configured to determine analyte levels using a body fluid sample of less than about 1 microliter;
a flexible support member coupling said penetrating members to define a linear array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator;
a skin stabilizer device suitable for stretching a surface of a tissue site, said skin stabilizer at least partially surrounding the penetrating member exit.
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59. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members 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, each of a penetrating member at least partially positioned adjacent to an analyte sensor in a sample chamber, each sample chamber configured to receive body fluid from a wound in tissue created by a penetrating member, and each analyte sensor configured to determine analyte levels using a body fluid sample of less than about 1 microliter;
a flexible support member coupling said penetrating members to define a linear array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator;
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 microliter of the fluid.
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60. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator;
a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members 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, each of a penetrating member at least partially positioned adjacent to an analyte sensor in a sample chamber, each sample chamber configured to receive body fluid from a wound in tissue created by a penetrating member, and each analyte sensor configured to determine analyte levels using a body fluid sample of less than about 1 microliter, a flexible support member coupling said penetrating members to define a linear array, said support member being movable and configured to move each of said penetrating members to a launch position associated with said force generator;
a spool in contact with at least one portion of the flexible support member, said spool configured to hold unused portions of the support member in a roll configuration.
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Specification