Method and apparatus for penetrating tissue
First Claim
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1. A body fluid sampling system for use on a tissue site, the system comprising:
- a single drive force generator;
a housing including a plurality of analyte sensors and a plurality of sample chambers, each of an analyte sensor being associated with a sample chamber;
each analyte sensor and associated sample chamber positioned and sized to receive body fluid from a wound in tissue created by a penetrating member;
a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members along a path out of the housing into the tissue site, stopping in the tissue site, and withdrawing out of said tissue site;
a flexible support member coupling the penetrating members at the flexible support member to form an array of penetrating members and positioned to move each of said penetrating members to a launch position associated with said force generator;
each of a penetrating member at least partially positioned adjacent to an analyte sensor in a sample chamber that does not exceed 1 μ
L, each sample chamber positioned to receive body fluid from a wound in tissue created by a penetrating member, and each analyte sensor interacting with the body fluid to determine analyte levels; and
a penetrating member sensor positioned to monitor a penetrating member coupled to said force generator, the penetrating member sensor in communication with a processor providing information relative to a depth of penetration of a penetrating member through a skin surface;
wherein the penetrating member sensor and the processor providing an indication of velocity of a penetrating member.
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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.
1729 Citations
23 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 single drive force generator; a housing including a plurality of analyte sensors and a plurality of sample chambers, each of an analyte sensor being associated with a sample chamber;
each analyte sensor and associated sample chamber positioned and sized to receive body fluid from a wound in tissue created by a penetrating member;a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members along a path out of the housing into the tissue site, stopping in the tissue site, and withdrawing out of said tissue site; a flexible support member coupling the penetrating members at the flexible support member to form an array of penetrating members and positioned to move each of said penetrating members to a launch position associated with said force generator; each of a penetrating member at least partially positioned adjacent to an analyte sensor in a sample chamber that does not exceed 1 μ
L, each sample chamber positioned to receive body fluid from a wound in tissue created by a penetrating member, and each analyte sensor interacting with the body fluid to determine analyte levels; anda penetrating member sensor positioned to monitor a penetrating member coupled to said force generator, the penetrating member sensor in communication with a processor providing information relative to a depth of penetration of a penetrating member through a skin surface;
wherein the penetrating member sensor and the processor providing an indication of velocity of a penetrating member. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A body fluid sampling system for use on a tissue site, the system comprising:
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a single drive force generator; a housing including a plurality of analyte sensors and a plurality of sample chambers, each of an analyte sensor being associated with a sample chamber that does not exceed 1 μ
L, each analyte sensor and sample chamber positioned and sized to receive body fluid from a wound in tissue created by a penetrating member;a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members along a path out of the housing into the tissue site, stopping in the tissue site, and withdrawing out of said tissue site; a flexible support member coupling the penetrating members at the flexible support member to form an array of penetrating members and positioned to move each of said penetrating members to a launch position associated with said force generator; and each of a penetrating member at least partially positioned adjacent to an analyte sensor in a sample chamber, each sample chamber positioned to receive body fluid from a wound in tissue created by a penetrating member, and each analyte sensor interacting with the body fluid to determine analyte levels; and a penetrating member sensor positioned to monitor a penetrating member coupled to said force generator, the penetrating member sensor in communication with a processor providing information relative to a depth of penetration of a penetrating member through a skin surface, the penetrating member sensor being coupled to a processor with control instructions for the single drive force generator, the processor being utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction. - View Dependent Claims (9, 10)
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11. A body fluid sampling system for use on a tissue site, the system comprising:
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a single drive force generator; a housing including a plurality of analyte sensors and a plurality of sample chambers, each of an analyte sensor being associated with a sample chamber that does not exceed 1 μ
L;
each analyte sensor and sample chamber positioned and sized to receive body fluid from a wound in tissue created by a penetrating member;a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members along a path out of the housing into the tissue site, stopping in the tissue site, and withdrawing out of said tissue site; a flexible support member coupling the penetrating members at the flexible support member o form an array of penetrating members and positioned to move each of said penetrating members to a launch position associated with said force generator; and each of a penetrating member at least partially positioned adjacent to an analyte sensor in a sample chamber, each sample chamber positioned to receive body fluid from a wound in tissue created by a penetrating member, and each analyte sensor interacting with the body fluid to determine analyte levels; and a penetrating member sensor positioned to monitor a penetrating member coupled to said force generator, the penetrating member sensor and a processor providing information relative to a depth of penetration of a penetrating member through a skin surface, the penetrating member sensor being coupled to a processor with control instructions for the single drive force generator, the processor being utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction toward a target tissue, wherein the application of a launching force to the penetrating member is controlled based on position and speed of the penetrating member. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. A body fluid sampling system for use on a tissue site, the system comprising:
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a single drive force generator; a housing including a plurality of analyte sensors and a plurality of sample chambers, each of an analyte sensor being associated with a sample chamber that does not exceed 1 μ
L;
each analyte sensor and associated sample chamber positioned and sized to receive body fluid from a wound in tissue created by a penetrating member;a plurality of penetrating members operatively coupled to said force generator, said force generator moving each of said members along a path out of the housing into the tissue site, stopping in the tissue site, and withdrawing out of said tissue site; a flexible support member coupling the penetrating members at the flexible support member to form an array of penetrating members and positioned to move each of said penetrating members to a launch position associated with said force generator; and each of a penetrating member at least partially positioned adjacent to an analyte sensor in a sample chamber, each sample chamber positioned to receive body fluid from a wound in tissue created by a penetrating member, and each analyte sensor interacting with the body fluid to determining analyte levels; and a penetrating member sensor positioned to monitor a penetrating member coupled to said force generator, the penetrating member sensor in communication with a processor providing information relative to a depth of penetration of a penetrating member through a skin surface, the penetrating member sensor being coupled to a processor with control instructions for the single drive force generator, the processor being utilized to monitor position and speed of a penetrating member as the penetrating member moves in the first direction toward a target tissue and control a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from the target tissue, wherein the application of a launching force to the penetrating member is controlled based on position and speed of the penetrating member; and wherein the average velocity of the penetrating member during a tissue penetration stroke in a first direction is about 100 to about 1000 times greater than the average velocity of the penetrating member during a withdrawal stroke in a second direction.
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Specification
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Current AssigneeSanofi-Aventis Deutschland GmbH (Sanofi )
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Original AssigneePelikan Technologies, Inc.
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InventorsBoecker, Dirk, Alden, Don, Freeman, Dominique M.
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Primary Examiner(s)HOEKSTRA, JEFFREY GERBEN
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Application NumberUS10/335,073Publication NumberTime in Patent Office2,310 DaysField of Search600/573, 600/583, 600/575, 600/576, 600/584, 600/172, 600/181, 600/182, 600/183, 606/167, 606/172, 606181-183US Class Current600/583CPC Class CodesA61B 17/32093 for skin incisionsA61B 5/14532 for measuring glucose, e.g....A61B 5/14546 for measuring analytes not ...A61B 5/150022 for capillary blood or inte...A61B 5/150068 by tissue compression, e.g....A61B 5/150099 by negative pressure, other...A61B 5/150152 by an adequate mechanical i...A61B 5/150167 Adjustable piercing speed o...A61B 5/150175 Adjustment of penetration d...A61B 5/150213 Venting meansA61B 5/150251 Collection chamber divided ...A61B 5/150358 Strips for collecting blood...A61B 5/150435 Specific design of proximal...A61B 5/150503 Single-ended needles hollow...A61B 5/150572 Pierceable protectors, e.g....A61B 5/150809 by audible feedbackA61B 5/150816 by tactile feedback, e.g. v...A61B 5/150824 by visual feedbackA61B 5/15087 short range, e.g. between c...A61B 5/151 Devices specially adapted f...View All
