Analytical device with lancet and test element
First Claim
1. An analytical device comprising:
- i) a lancet comprisinga lancet needle with a tip anda lancet body which completely surrounds the lancet needle at least in the area of the tip,the lancet needle being movable relative to the lancet body and the lancet body comprising, at least in the area of the tip of the lancet needle, an elastic material in which the tip of the lancet needle is embedded therein without a hollow space remaining, both before and after the tip penetrates the elastic material to form an incision in tissue, wherein the elastic material is an injection moldable material, andii) an analytical test element, the analytical test element being permanently connected to the lancet body.
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Accused Products
Abstract
The invention concerns an analytical device containing a lancet comprising a lancet needle and a lancet body, the lancet needle being movable relative to the lancet body and the lancet body being composed, at least in the area of the tip of the lancet needle, of an elastic material in which the tip of the lancet needle is embedded, and an analytical test element which is permanently connected to the lancet body. In addition the invention concerns an analytical device containing a lancet comprising a lancet needle and a lancet body which is in the form of a hollow body in the area of the tip of the lancet needle and surrounds the tip of the lancet needle, the lancet needle being movable relative to the lancet body and the hollow body being composed at least partially of an elastic material, and an analytical test element which is permanently connected to the lancet body. Finally the invention concerns a process for manufacturing such an analytical device.
233 Citations
19 Claims
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1. An analytical device comprising:
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i) a lancet comprising a lancet needle with a tip and a lancet body which completely surrounds the lancet needle at least in the area of the tip, the lancet needle being movable relative to the lancet body and the lancet body comprising, at least in the area of the tip of the lancet needle, an elastic material in which the tip of the lancet needle is embedded therein without a hollow space remaining, both before and after the tip penetrates the elastic material to form an incision in tissue, wherein the elastic material is an injection moldable material, and ii) an analytical test element, the analytical test element being permanently connected to the lancet body. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A tissue penetrating system, comprising:
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a plurality of penetrating members each having a sharpened distal tip; a penetrating member driver coupled to the plurality of penetrating members; and a plurality of cartridges each housing a penetrating member and configured so that the penetrating member driver engages each of the penetrating members sequentially, the cartridge including an injection moldable material, said sharpened distal tip embedded in said injection moldable material of said cartridge without a hollow space remaining, said sharpened distal tip being configured to pierce through said cartridge to form an incision in tissue when said penetrating member driver is actuated, said cartridge further configured to seal said sharpened distal tip therein after said distal tip forms the incision in tissue, each cartridge defines a capillary chamber, each cartridge including an analyte detecting member coupled to said capillary chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μ
L of a body fluid disposed in the capillary chamber. - View Dependent Claims (8, 9, 10, 11)
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12. 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 with a penetrating member tip, said 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 penetrating member body including an injection moldable material which completely surrounds and contacts said penetrating member tip without a hollow space remaining, said penetrating member body further defining a capillary gap configured to collect fluid from a wound created by said penetrating member tip; a skin stabilizer device suitable for stretching a surface of a tissue site, said skin stabilizer device at least partially surrounding the penetrating member exit; an analyte detecting member positioned to receive fluid from a wound created by said penetrating member tip and delivered by said capillary gap, said analyte detecting member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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13. 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 a penetrating member tip, said 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 penetrating member body including an injection moldable material which completely surrounds and contacts the penetrating member tip without a hollow space remaining, said penetrating member body further defining a capillary gap configured to collect fluid from a wound created by said penetrating member tip; a skin stabilizer device suitable for stretching a surface of a tissue site, said skin stabilizer device at least partially surrounding the penetrating member exit; an analyte detecting member positioned to receive fluid from a wound delivered by said capillary gap, said analyte detecting member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and a human interface providing at least one output.
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14. 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 a penetrating member tip, said 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 penetrating member body including an injection moldable material which completely embeds the penetrating member tip therein without a hollow space remaining, said penetrating member body further defining a capillary gap configured to collect fluid from a wound created by said penetrating member tip; an analyte detecting member positioned to receive fluid from a wound delivered by said capillary gap, said analyte detecting member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 mL of the fluid; and a user interface configured to relay at least one of, penetrating member performance or a penetrating member setting.
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15. 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 the penetrating members having a penetrating member tip; a plurality of penetrating member bodies that cover said plurality of penetrating member tips, each of said penetrating member bodies includes an injection moldable material that completely surrounds and contacts a corresponding one of said penetrating member tips without a hollow space remaining, each of said penetrating member bodies further defining a capillary channel configured to collect fluid from a wound created by said penetrating member tip; 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; and an analyte detection member positioned to receive fluid from said capillary channel, 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.
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16. 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 a penetrating member tip, said 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 penetrating member body configured to store the penetrating member, said penetrating member body including an injection moldable material that embeds said penetrating member tip therein without a hollow space remaining, said penetrating member body further defining a capillary channel configured to collect fluid from a wound created by said penetrating member; an analyte detection member positioned to receive fluid from the capillary channel, 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; and 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.
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17. 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, wherein each of said plurality of penetrating members has a penetrating member tip; a plurality of penetrating member bodies configured to store said plurality of penetrating members, each of said plurality of penetrating member bodies includes an injection moldable material that embeds said plurality of penetrating member tips therein without a hollow space remaining, each of said penetrating member bodies further defining a capillary channel configured to collect fluid from a wound created by said penetrating member; 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; and an analyte detection member positioned to receive fluid from said capillary channel. - View Dependent Claims (18)
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19. A skin penetrating system, comprising:
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a housing member having an injection moldable material; a penetrating member having a penetrating tip, the penetrating tip being embedded in the injection moldable material before use without a hollow space remaining, the penetrating tip being configured to pierce through the injection moldable material to form an incision in tissue, the injection moldable material configured to embed the penetrating tip therein after the penetrating tip has formed the incision in tissue; and an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample of less than 1 μ
L of a body fluid disposed in the sample chamber.
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Specification