Implantable biosensor system, apparatus and method
First Claim
1. An implantable needle-type biosensor wherein an electric signal is produced between first and second electrical contacts responsive to an electrochemical reaction in a body, said biosensor comprising:
- an elongate core comprising a plurality of axially oriented fibers, said elongate core having a distal end and a proximal end, said distal end being spaced apart in an axial direction from said proximal end;
a working electrode associated with said distal end;
a reference electrode spaced apart from said working electrode;
structure adapted to resist direct physical contact between said working electrode and said reference electrode;
a first electrically conductive path between said working electrode and said first electrical contact; and
a second electrically conductive path between said reference electrode and said second electrical contact.
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Accused Products
Abstract
An implantable biosensor assembly and system includes an enzymatic sensor probe from which subcutaneous and interstitial glucose levels may be inferred. The assembly may be associated by direct percutaneous connection with electronics, such as for signal amplification, sensor polarization, and data download, manipulation, display, and storage. The biosensor comprises a miniature probe characterized by lateral flexibility and tensile strength and has a large electrode surface area for increased sensitivity. Irritation of tissues surrounding the probe is minimized due to ease of flexibility and small cross section of the sensor. Foreign body reaction is diminished due to a microscopically rough porous probe surface.
266 Citations
19 Claims
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1. An implantable needle-type biosensor wherein an electric signal is produced between first and second electrical contacts responsive to an electrochemical reaction in a body, said biosensor comprising:
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an elongate core comprising a plurality of axially oriented fibers, said elongate core having a distal end and a proximal end, said distal end being spaced apart in an axial direction from said proximal end;
a working electrode associated with said distal end;
a reference electrode spaced apart from said working electrode;
structure adapted to resist direct physical contact between said working electrode and said reference electrode;
a first electrically conductive path between said working electrode and said first electrical contact; and
a second electrically conductive path between said reference electrode and said second electrical contact. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. An implantable biosensor, comprising:
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an introducer cannula with a lumen extending axially between proximal and distal ends, said proximal end carrying affixing structure adapted to resist motion of said proximal end relative to a skin surface of a subject and further carrying holding structure configured to receive a probe;
said probe structured for sliding installation of a distal probe end through said lumen, said probe comprising an elongate core having a distal end spaced apart axially from a proximal end, a proximal end of said probe being associated with a hub adapted for attachment to said holding structure;
a first electrode associated with said distal end of said probe; and
a second electrode associated with said distal end of said cannula, said cannula and said probe being cooperatively structured on assembly to resist direct physical contact between said first electrode and said second electrode. - View Dependent Claims (17)
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18. A method for manufacturing an implantable, needle-type biosensor probe with a transversely flexible first electrode effective to resist irritation at a site of implantation in a subject, the method comprising:
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providing a core comprising a first nonconductive material;
disposing a first electrode in a reinforcing path about said core;
disposing structure forming a first electrical conductor between said first electrode and a hub associated with a proximal end of said probe; and
disposing structure forming a second electrical conductor between a second electrode and said hub. - View Dependent Claims (19)
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Specification