Device and method for determining analyte levels
AssigneeDexCom, Inc.
InventorsMark C. Shults, Stuart J. Updike, Rathbun K. Rhodes
Life of this patent
Estimating the term…
Abstract
Devices and methods for determining analyte levels are described. The devices and methods allow for the implantation of analyte-monitoring devices, such as glucose monitoring devices, that result in the delivery of a dependable flow of blood to deliver sample to the implanted device. The devices comprise a unique microarchitectural arrangement in the sensor region that allows accurate data to be obtained over long periods of time.
Claims320
A device for measuring glucose in a biological fluid, comprising:
- a) a housing comprising an electronic circuit and at least two electrodes operatively connected to said electronic circuit;
- and
- b) a sensor operably connected to said electrodes of said housing, said sensor comprising an apparatus for determining the amount of glucose in a biological sample, said glucose determining apparatus operably associated with said electrodes and comprising a membrane impregnated with an oxidase, a bioprotective membrane substantially impermeable to macrophages, said bioprotective membrane positioned more distal to said housing than said oxidase impregnated membrane, and an angiogenic layer, said angiogenic layer positioned more distal to said housing than said bioprotective membrane, wherein said sensor protrudes from said housing.
A wholly implantable glucose monitoring device, comprising:
- a) a housing of size and configuration for whole implantation into a host;
- and
- b) a sensor supported by said housing for communication with tissue of said host, said sensor comprising (i) a member for determining the amount of glucose in biological fluid of said host, and (ii) a bioprotective member disposed more distal to said housing than said glucose determining member and comprising a bioprotective membrane that is substantially impermeable to macrophages and permeable to glucose and oxygen;
- and
- c) a member for securing the device to biological tissue of said host, said securing member cooperatively associated with said housing, and wherein said securing member comprises poly(ethylene terephthalate).
An implantable glucose monitoring device of claim 48, said housing comprising a cavity contained therewithin.
A biological fluid measuring device, comprising:
- (a) a housing comprising an electronic circuit and at least two electrodes operably connected to said electronic circuit;
- and
- (b) a sensor operably connected to said electrodes of said housing, said sensor comprising (i) a bioprotective membrane, and (ii) an angiogenic layer said angiogenic layer positioned more distal to said housing than said bioprotective membrane, wherein said angiogenic layer comprises polytetrafluoroethylene.
A device for measuring glucose in a tissue of a host comprising:
- a wholly implantable device comprising a sensor having an interface tip for communicating with the tissue of said host, said tip comprising a fixation domain adapted for substantial fixation of said tip in a foreign bode capsule, wherein said sensor tip fixation domain comprises a capsular attachment layer on said sensor, and wherein said sensor tip fixation domain further comprises an angiogenic layer on said sensor.
The device of claim 106, wherein said bioprotective membrane comprises polytetrafluoroethylene.
An implantable device for subcutaneous monitoring of glucose levels, comprising a housing and a sensor comprising an angiogenic layer for promoting adequate microcirculatory delivery of glucose and oxygen to said sensor, wherein said sensor further comprises a capsular attachment layer.
A device for measuring glucose in a biological fluid, comprising:
- a) a housing comprising an electronic circuit and at least two electrodes operatively connected to said electronic circuit;
- and
- b) a sensor operably connected to said electrodes of said housing, said sensor comprising an apparatus for determining the amount of glucose in a biological sample, said glucose determining apparatus operably associated with said electrodes and comprising a membrane impregnated with an oxidase, a bioprotective membrane substantially impermeable to macrophages, said bioprotective membrane positioned more distal to said housing than said oxidase impregnated membrane, and an angiogenic layer positioned more distal to said housing than said bioprotective membrane, wherein the sensor further comprises a sensor interface dome.
A device for measuring glucose in a biological fluid, comprising:
- a) a housing comprising an electronic circuit and at least two electrodes operatively connected to said electronic circuit;
- and
- b) a sensor operably connected to said electrodes of said housing, said sensor comprising an apparatus for determining the amount of glucose in a biological sample, said glucose determining apparatus operably associated with said electrodes and comprising a membrane impregnated with an oxidase, a bioprotective membrane substantially impermeable to macrophages, said bioprotective membrane positioned more distal to said housing than said oxidase impregnated membrane, and an angiogenic layer positioned more distal to said housing than said bioprotective membrane, wherein said membrane impregnated with oxidase comprises a resistance layer, and enzyme layer, an interference layer and an electrolyte layer.
A device for measuring glucose in a biological fluid, comprising:
- a) a housing comprising an electronic circuit and at least two electrodes operatively connected to said electronic circuit;
- b) a sensor operably connected to said electrodes of said housing, said sensor comprising an apparatus for determining the amount of glucose in a biological sample, said glucose determining apparatus operably associated with said electrodes and comprising a membrane impregnated with an oxidase, a bioprotective membrane substantially impermeable to macrophages, said bioprotective membrane positioned more distal to said housing than said oxidase impregnated membrane, and an angiogenic layer positioned more distal to said housing than said bioprotective membrane,
- c) a securing element for securing said device to biological tissue, said securing element composed of a material selected from the group consisting of polyester, polypropylene cloth, polytetrafluoroethylene felts and expanded polytetrafluoroethylene.
A biological fluid measuring device, comprising:
- a) a housing comprising an electronic circuit and at least two electrodes operably connected to said electronic circuit;
- and
- b) a sensor operably connected to said electrodes of said housing, said sensor comprising (i) a bioprotective membrane, and (ii) an angiogenic layer, said angiogenic layer positioned more distal to said housing than said bioprotective membrane;
- and
- c) a member for securing said device to biological tissue, and securing member associated with said housing.
A device for measuring glucose in a tissue of a host comprising a wholly implantable device comprising a sensor comprising an interface tip for communicating with the tissue of said host, said tip comprising a fixation domain adapted for substantial fixation of said tip in a foreign body capsule, wherein said sensor tip fixation domain further comprises a capsular attachment layer made from surgical grade polyester velour on said sensor.
Dependencies are inferred from the claim text.