Method and apparatus for a multi-use body fluid sampling device with optical analyte sensing
First Claim
Patent Images
1. A device for use with a penetrating member driver to penetrate tissue, the device comprising:
- a single cartridge;
a plurality of penetrating members coupled to said single cartridge and operatively couplable to the penetrating member driver, said penetrating members movable to extend radially outward from the cartridge to penetrate tissue;
a plurality of optical analyte sensors coupled to said single cartridge, said sensors positioned on the cartridge to receive body fluid from a wound in the tissue created by the penetrating member.
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Accused Products
Abstract
A device for use with a penetrating member driver to penetrate tissue is provided. The device includes a single cartridge coupled to a plurality of penetrating members and operatively couplable to the penetrating member driver. The penetrating members are movable to extend radially outward from the cartridge to penetrate tissue; A plurality of optical analyte sensors are coupled to the single cartridge and positioned to receive body fluid from a wound in the tissue created by the penetrating member.
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Citations
144 Claims
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1. A device for use with a penetrating member driver to penetrate tissue, the device comprising:
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a single cartridge;
a plurality of penetrating members coupled to said single cartridge and operatively couplable to the penetrating member driver, said penetrating members movable to extend radially outward from the cartridge to penetrate tissue;
a plurality of optical analyte sensors coupled to said single cartridge, said sensors positioned on the cartridge to receive body fluid from a wound in the tissue created by the penetrating member. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. A device for use with a penetrating member driver to penetrate tissue, the device comprising:
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a single cartridge having a plurality of openings;
a plurality of penetrating members having a sharpened tips movable to penetrate tissue;
a plurality of optical analyte sensors coupled to said single cartridge;
a sterility barrier covering said openings. - View Dependent Claims (19, 20, 21, 22, 23, 24)
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25. A device for use with a penetrating member driver to penetrate tissue, the device comprising:
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a single cartridge having a plurality of cavities;
a plurality of penetrating members coupled to said single cartridge and couplable to the penetrating member driver, said penetrating members movable to extend outward to penetrate tissue;
a plurality of optical analyte sensors coupled to said single cartridge, said sensors receiving body fluid entering said cavities. - View Dependent Claims (26, 27, 28, 29, 30, 31, 32, 33, 34, 35)
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36. A device for use with a penetrating member driver to penetrate tissue, the device comprising:
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a single cartridge having a plurality of openings and a plurality of penetrating member cavities;
a plurality of penetrating members at least partially contained in said cavities;
a plurality of sensors attached to a substrate, said substrate couplable to said single cartridge in manner positioning at least one of said sensors with each of said plurality of cavities. - View Dependent Claims (37, 38, 39, 40, 41, 42, 43)
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44. A device for use with a penetrating member driver to penetrate tissue, the device comprising:
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a single cartridge having a plurality of openings and a plurality of cavities;
a plurality of penetrating members with at least one penetrating members in at least one of said cavities;
a plurality of sensors on a layer of material couplable to said single cartridge wherein at least two of said cavities each has at least one sensor in fluid communication with one of said cavities, said sensors positioned on the cartridge to receive body fluid from a wound in the tissue created by the penetrating member.
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45. A device comprising:
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a single cartridge;
at least 50 penetrating members coupled to and at least partially housed in said single cartridge wherein said cartridge has a diameter no greater than about 5 inches;
at least 50 optical analyte sensors, each associated with one of said penetrating members;
said penetrating members movable in an outward direction from the cartridge to penetrate tissue when actuated by said penetrating member driver. - View Dependent Claims (46, 47, 48)
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49. A device comprising:
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a single cartridge;
at least 100 penetrating members coupled to and at least partially housed in said single cartridge wherein said cartridge has a diameter no greater than 6 inches;
at least 100 optical analyte sensors, each associated with one of said penetrating members;
said penetrating members movable in an outward direction from the cartridge to penetrate tissue when actuated by said penetrating member driver. - View Dependent Claims (50, 51, 52)
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53. A method comprising:
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providing a cartridge having a plurality of penetrating members and a plurality of optical analyte sensors;
using a penetrating member driver to actuate said penetrating members to penetrate tissue and wherein used penetrating members and sensors remain coupled to said cartridge;
wherein said cartridge containing said used penetrating members and used sensors, is disposable;
replacing the entire cartridge by inserting a new cartridge having penetrating members and sensors into the penetrating member driver.
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54. A lancing system comprising:
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a penetrating member driver;
a plurality of penetrating members in a disc-shaped housing;
a penetrating member release device releasing the penetrating member for a sterile environment prior to use and moving said penetrating member into position to be operatively coupled to said penetrating member driver;
a plurality of sampling modules, wherein each of said modules is coupled to one of said penetrating members and housed in said disc-shaped housing. - View Dependent Claims (55, 56, 57, 58, 59)
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60. A lancing system for use with a penetrating member driver, said system comprising:
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means for housing a plurality of penetrating members and optical analyte sensors;
means for releasing one of said penetrating member from a sealed enclosure on said housing means;
means for operatively coupling one of said penetrating member to said penetrating member driver;
wherein one of said optical analyte sensors receives body fluid from a wound created in said tissue by one of said penetrating members.
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61. A body fluid sampling system comprising:
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a cartridge;
a plurality of penetrating members coupled to said cartridge and selectively actuatable to penetrate tissue, said penetrating members extending radially outward to penetrate tissue;
a plurality of optical analyte sensors coupled to said cartridge;
an electrically powered drive force generator configured to drive one of said penetrating members in a launch position into a tissue site. - View Dependent Claims (62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118)
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119. A device for use in penetrating tissue to obtain a body fluid sample, comprising:
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a cartridge having a plurality of cavities; and
a plurality of penetrating members having sharpened tips and slidably coupled to the cartridge, each of said penetrating members being moveable relative to the other ones of the penetrating members along a path out of the cartridge to penetrate tissue;
a plurality of optical analyte sensors wherein at least one of said sensors is positioned to receive body fluid when one of said penetrating members creates a wound in said tissue;
said penetrating members arranged with said sharpened tips pointing radially outward;
wherein each of said cavities is defined in part by a deflectable portion, wherein said deflectable portion in a first position prevents said penetrating member from exiting the cartridge and said deflectable portion is movable to a second position creating an opening that allows said lancet to extend outward from the cartridge. - View Dependent Claims (120, 121, 122, 123, 124, 125, 126)
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127. A manufacturing method comprising:
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providing a cartridge having a plurality of cavities for holding penetrating members;
sealing a plurality of cavities with a sterility barrier;
providing said cartridge with a plurality of optical analyte sensors by coupling a sensor layer to the cartridge. - View Dependent Claims (128, 129, 130, 131)
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132. A manufacturing method comprising:
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providing a cartridge having a plurality of cavities at least partially holding a plurality of penetrating members;
sterilizing said cartridge while each of said cavities is in a sealed condition;
adding sensors to the cavities by opening cavities in a sterile environment and coupling a sensor layer to the cartridge that provides the sensors and resealing the cavities to maintain a sterile environment. - View Dependent Claims (133, 134, 135, 136)
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137. A method of driving a penetrating member into a tissue site to obtain a body fluid sample, said method comprising:
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providing a single cartridge having a plurality of penetrating members and a plurality of optical analyte sensors;
expressing fluid from a wound tract created by advancing one of said penetrating members radially outward from the cartridge into a tissue site;
drawing fluid into said single cartridge which exposes at least one of said optical analyte sensors to said fluid. - View Dependent Claims (138, 139, 140, 141, 142, 143, 144)
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Specification