Abstract: Receiver apparatus for use with an analyte sensor, and methods of operation and manufacturing. In one embodiment, the analyte sensor is an implanted/implantable blood glucose sensor, including oxygen-based detector elements. The receiver apparatus is a wireless-enabled small form-factor device with limited functionality that can be easily worn or kept with the user on a continual basis, thereby obviating the need for a more fully featured receiver or smartphone for extended periods of time (e.g., one week). The exemplary oxygen based analyte sensor, with high degree of stability over time, enables the user to divorce themselves from the more fully functioned receiver or smartphone, since no external calibration of the sensor is required during the extended period. In one variant, the device is a lightweight wristband. Other variants include e.g., pendants, finger-worn rings, arm or head bands, skin patches, and even dental, subcutaneous, or prosthetic implants.

Abstract: Implantable sensor and associated receiver apparatus, and methods of manufacturing, implantation, and use. In one embodiment, the sensor apparatus is a heterogeneous glucose sensor, including hydrogen peroxide-based detector elements and oxygen-based detector elements. The sensor apparatus utilizes one (type) of the detector elements to confirm the accuracy of, and/or calibrate, the second (type of) detector element, so as to among other things enable the second type of detector to operate more robustly, and/or for a longer period without external calibration and/or explants. In one variant, the heterogeneous detector types are contained within a common biocompatible implantable housing. In another variant, the first type of detector (e.g., oxygen based) is disposed within a separable module that can operate independently of (or mechanically and/or electrically interface with) the second type of detector.

Abstract: Biocompatible implantable sensor apparatus and methods of implantation and use. In one embodiment, the sensor apparatus is an oxygen-based glucose sensor having biocompatibility features that mitigate the host tissue response. In one variant, these features include use of a non-enzymatic membrane over each of the individual analyte detectors so as to preclude contact of the surrounding tissue with the underlying enzyme or other matrix, and mitigate vascularization, and insulation of the various electrodes and associated electrolytic processes of the sensor from the surrounding tissue. In one implementation, the sensor region of the implanted apparatus is configured to interlock or imprint the surrounding tissue so as to promote a high degree of glucose molecule diffusion into the individual detectors, and a constant and predictable sensor to blood vessel interface, yet preclude the tissue from bonding to the sensor, especially over extended periods of implant.

Abstract: Enzymatic and non-enzymatic detectors and associated membrane apparatus, and methods of use, such as within a fully implantable sensor apparatus. In one embodiment, detector performance is controlled through selective use of membrane configurations and enzyme region shapes, which enable accurate detection of blood glucose level within the solid tissue of the living host for extended periods of time. Isolation between the host's tissue and the underlying enzymes and reaction byproducts used in the detectors is also advantageously maintained in one embodiment via use of a non-enzyme containing permeable membrane formed of e.g., a biocompatible crosslinked protein-based material. Control of response range and/or rate in some embodiments also permits customization of sensor elements. In one variant, heterogeneous detector elements are used to, e.g., accommodate a wider range of blood glucose concentration within the host.

Abstract: Implantable sensor apparatus and methods of implantation. In one embodiment, a fully implantable, biocompatible sensor is disposed within a cavity or pocket formed within a living being, such that the sensor remains in a desired orientation and placement so as to enhance the performance of the sensor, and mitigate the effects of one or more factors potentially deleterious to the operation of the sensor and the host being. In one implementation, the sensor comprises an implantable biocompatible oxygen-based glucose sensor which is implanted deep within the being's torso tissue proximate the extant fascia, and oriented such that an active detector aspect of the device faces away from the being's skin surface. In one variant, the deep placement, orientation, and construction of the sensor itself cooperate to enhance the performance of the sensor, especially over extended periods of time, with little need for external calibration.

Abstract: A tissue-implantable sensor for measurement of solutes in fluids and gases, such as oxygen and glucose, is provided. The sensor includes a multiplicity of detectors, constructed and arranged to improve the probability that one or more detectors will have access to a vascular source at points in time sufficient to permit accurate measurements to be taken. Means and methods for calculating solute levels using the sensor device of the invention are also provided.

Abstract: A protective, biocompatible coating or encapsulation material protects and insulates a component or device intended to be implanted in living tissue. The coating or encapsulation material comprises a thin layer or layers of alumina, zerconia, or other ceramic, less than 25 microns thick, e.g., 5-10 microns thick. The alumina layer(s) may be applied at relatively low temperature. Once applied, the layer provides excellent hermeticity, and prevents electrical leakage. Even though very thin, the alumina layer retains excellent insulating characteristics. In one embodiment, an alumina layer less than about 6 microns thick provides an insulative coating that exhibits less than 10 pA of leakage current over an area 75 mils by 25 mils area while soaking in a saline solution at temperatures up to 80° C. over a three month period.

Abstract: A protective, biocompatible coating or encapsulation material protects and insulates a component or device intended to be implanted in living tissue. The coating or encapsulation material comprises a thin layer or layers of alumina, zerconia, or other ceramic, less than 25 microns thick, e.g., 5-10 microns thick. The alumina layer(s) may be applied at relatively low temperature. Once applied, the layer provides excellent hermeticity, and prevents electrical leakage. Even though very thin, the alumina layer retains excellent insulating characteristics. In one embodiment, an alumina layer less than about 6 microns thick provides an insulative coating that exhibits less than 10 pA of leakage current over an area 75 mils by 25 mils area while soaking in a saline solution at temperatures up to 80° C. over a three month period.

Abstract: A tissue-implantable sensor for measurement of solutes in fluids and gases, such as oxygen and glucose, is provided. The sensor includes a multiplicity of detectors, constructed and arranged to improve the probability that one or more detectors will have access to a vascular source at points in time sufficient to permit accurate measurements to be taken. Means and methods for calculating solute levels using the sensor device of the invention are also provided.