Abstract: An electrode array for use in an electrochemical device is provided. The electrode array includes at least one electrode material and at least one insulating material arranged in a spiral configuration. The electrode array is manufactured by forming a composite stack of the at least one electrode material and the at least one insulating material, such that the insulating material(s) surrounds the electrode material(s) after which the stack is rolled into a spiral roll. The spiral roll can be cut, sliced, and/or dissected in numerous ways to form the electrode array of the preferred embodiments. Optionally, the sections can be further processed by machining, polishing, etching, or the like, to produce a curvature or stepped configuration.

Abstract: Systems and methods for minimizing or eliminating transient non-glucose related signal noise due to non-glucose rate limiting phenomenon such as ischemia, pH changes, temperatures changes, and the like. The system monitors a data stream from a glucose sensor and detects signal artifacts that have higher amplitude than electronic or diffusion-related system noise. The system replaces some or the entire data stream continually or intermittently including signal estimation methods that particularly address transient signal artifacts. The system is also capable of detecting the severity of the signal artifacts and selectively applying one or more signal estimation algorithm factors responsive to the severity of the signal artifacts, which includes selectively applying distinct sets of parameters to a signal estimation algorithm or selectively applying distinct signal estimation algorithms.

Abstract: A biointerface membrane for an implantable device including a nonresorbable solid portion with a plurality of interconnected cavities therein adapted to support tissue ingrowth in vivo, and a bioactive agent incorporated into the biointerface membrane and adapted to modify the tissue response is provided. The bioactive agents can be chosen to induce vascularization and/or prevent barrier cell layer formation in vivo, and are advantageous when used with implantable devices wherein solutes are transported across the device-tissue interface.

Abstract: An implantable analyte-measuring device including a membrane adapted to promote vascularization and/or interfere with barrier cell layer formation. The membrane includes any combination of materials, architecture, and bioactive agents that facilitate analyte transport to provide long-term in vivo performance of the implantable analyte-measuring device.

Abstract: Systems and methods for processing sensor analyte data, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. During initial calibration, the analyte sensor data is evaluated over a period of time to determine stability of the sensor. The sensor may be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. The calibration may be updated after evaluating the calibration set for best calibration based on inclusion criteria with newly received reference analyte data. Fail-safe mechanisms are provided based on clinical acceptability of reference and analyte data and quality of sensor calibration. Algorithms provide for optimized prospective and retrospective analysis of estimated blood analyte data from an analyte sensor.

Abstract: Systems and methods for processing sensor analyte data, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. During initial calibration, the analyte sensor data is evaluated over a period of time to determine stability of the sensor. The sensor may be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. The calibration may be updated after evaluating the calibration set for best calibration based on inclusion criteria with newly received reference analyte data. Fail-safe mechanisms are provided based on clinical acceptability of reference and analyte data and quality of sensor calibration. Algorithms provide for optimized prospective and retrospective analysis of estimated blood analyte data from an analyte sensor.

Abstract: Systems and methods for processing sensor analyte data, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. During initial calibration, the analyte sensor data is evaluated over a period of time to determine stability of the sensor. The sensor may be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. The calibration may be updated after evaluating the calibration set for best calibration based on inclusion criteria with newly received reference analyte data. Fail-safe mechanisms are provided based on clinical acceptability of reference and analyte data and quality of sensor calibration. Algorithms provide for optimized prospective and retrospective analysis of estimated blood analyte data from an analyte sensor.

Abstract: Systems and methods for processing sensor analyte data, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. During initial calibration, the analyte sensor data is evaluated over a period of time to determine stability of the sensor. The sensor may be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. The calibration may be updated after evaluating the calibration set for best calibration based on inclusion criteria with newly received reference analyte data. Fail-safe mechanisms are provided based on clinical acceptability of reference and analyte data and quality of sensor calibration. Algorithms provide for optimized prospective and retrospective analysis of estimated blood analyte data from an analyte sensor.

Abstract: A porous three dimensional structure for implantation in a host animal capable of producing an inflammatory foreign body response. The structure includes first and second layers spaced by a plurality of posts having a predetermined length connecting the first and second layers. Each of the layers has a plurality of openings of a predetermined size permitting fluids and inflammatory cells of the animal to pass through the openings and migrate into an interior volume defined by the first and second layers. The size of the openings and length of the posts promote a non-flattened morphology of the cells. The structure promotes vascularization adjacent to the structure when implanted into the animal.

Abstract: An implant assembly and methods for loading implant devices which avoids the accidental deposition of transplanted material or other contaminates on the exterior of the device during transportation, storage, and handling are disclosed. The implant assembly of the invention may be used with a large variety of implant devices for implanting a variety of materials such as cells, tissue or other materials into a host. The implant assembly includes an implant device having an elongated port and a first chamber for holding material for implantation and a container with a second chamber for holding the implant device. The container functions to maintain the sterility and protect the physical integrity of the implant device during loading, storage, cryopreservation and transportation and is removed immediately prior to implantation of the device. The container may optionally include liquid media for cellular growth, maintenance, cryostorage, or transportation purposes.

Abstract: A method and apparatus for implanting cells in a host is provided. In an embodiment, an implant assembly for a host tissue is provided comprising wall means defining a chamber for holding cells for implantation, the wall means including means for forming a porous boundary between the host tissue and the implanted cells in the chamber, the pore size of the boundary being sufficient to isolate the implanted cells from the immune response of the host tissue, and port means for providing selective access to the chamber.

Abstract: A method for implanting cells into a host tissue is provided. The method comprises the steps of: creating an implant assembly for holding cells including wall means for forming a porous boundary between the host tissue and the implanted cells in the device, the pore size of the boundary being sufficient to isolate the implanted cells from the immune response; implanting the assembly without the cells into a host tissue; and accessing an interior of the assembly to add the cells thereto.

Abstract: A method and apparatus for implanting cells in a host is provided. In an embodiment, an implant assembly for a host tissue is provided comprising wall means defining a chamber for holding cells for implantation, the wall means including means for foxing a porous boundary between the host tissue and the implanted cells in the chamber, the pore size of the boundary being sufficient to isolate the implanted cells from the immune response of the host tissue, and port means for providing selective access to the chamber.