Abstract: A new biostable glucose permeable polymer has been developed which is useful, for example, in implantable glucose sensors. This biostable glucose permeable polymer has a number of advantageous characteristics and, for example, does not undergo hydrolytic cleavage and degradation, thereby providing a composition that facilitates long term sensor stability in vivo. The versatile characteristics of this polymer allow it to be used in a variety of contexts, for example to form the body of an implantable glucose sensor. The invention includes the polymer composition, sensor systems formed from this polymer composition, and methods for making and using such sensor systems.

Abstract: A continuous glucose monitoring system may include a hand-held monitor, a transmitter, an insulin pump, and an orthogonally redundant glucose sensor, which may comprise an optical glucose sensor and a non-optical glucose sensor. The former may be a fiber optical sensor, including a competitive glucose binding affinity assay with a glucose analog and a fluorophore-labeled glucose receptor, which is interrogated by an optical interrogating system, e.g., a stacked planar integrated optical system. The non-optical sensor may be an electrochemical sensor having a plurality of electrodes distributed along the length thereof. Proximal portions of the optical and electrochemical sensors may be housed inside the transmitter and operationally coupled with instrumentation for, e.g., receiving signals from the sensors, converting to respective glucose values, and communicating the glucose values.

Abstract: A new biostable glucose permeable polymer has been developed which is useful, for example, in implantable glucose sensors. This biostable glucose permeable polymer has a number of advantageous characteristics and, for example, does not undergo hydrolytic cleavage and degradation, thereby providing a composition that facilitates long term sensor stability in vivo. The versatile characteristics of this polymer allow it to be used in a variety of contexts, for example to form the body of an implantable glucose sensor. The invention includes the polymer composition, sensor systems formed from this polymer composition, and methods for making and using such sensor systems.

Abstract: A continuous glucose monitoring system may include a hand-held monitor, a transmitter, an insulin pump, and an orthogonally redundant glucose sensor, which may comprise an optical glucose sensor and a non-optical glucose sensor. The former may be a fiber optical sensor, including a competitive glucose binding affinity assay with a glucose analog and a fluorophore-labeled glucose receptor, which is interrogated by an optical interrogating system, e.g., a stacked planar integrated optical system. The non-optical sensor may be an electrochemical sensor having a plurality of electrodes distributed along the length thereof. Proximal portions of the optical and electrochemical sensors may be housed inside the transmitter and operationally coupled with instrumentation for, e.g., receiving signals from the sensors, converting to respective glucose values, and communicating the glucose values.

Abstract: An injection apparatus for making an injection at a predetermined depth in skin comprises: a skin positioning member, an injection needle (610), and means guiding the injection needle for movement from a parking position above the skin beside said skin positioning member to slide beneath said skin positioning member to an injection position; wherein: the tip (620) of the injection needle is closer to the longitudinal axis of the shaft portion (650) than is the outside of the shaft portion (650) and/or the length of the lumen opening (625) of the needle is in a range from 5 to 15 times the diameter of the shaft (650) of the needle. An injection needle wherein the length of the lumen opening (625) of the needle is in a range from 5 to 15 times the diameter of the shaft (650) of the needle.

Abstract: Medical devices are typically sterilized in processes used to manufacture such products and their sterilization by exposure to radiation is a common practice. Radiation has a number of advantages over other sterilization processes including a high penetrating ability, relatively low chemical reactivity, and instantaneous effects without the need to control temperature, pressure, vacuum, or humidity. Unfortunately, radiation sterilization can compromise the function of certain components of medical devices. For example, radiation sterilization can lead to loss of protein activity and/or lead to bleaching of various dye compounds. Embodiments of the invention provide methods and materials that can be used to protect medical devices from unwanted effects of radiation sterilization.

Abstract: Medical devices are typically sterilized in processes used to manufacture such products and their sterilization by exposure to radiation is a common practice. Radiation has a number of advantages over other sterilization processes including a high penetrating ability, relatively low chemical reactivity, and instantaneous effects without the need to control temperature, pressure, vacuum, or humidity. Unfortunately, radiation sterilization can compromise the function of certain components of medical devices. For example, radiation sterilization can lead to loss of protein activity and/or lead to bleaching of various dye compounds. Embodiments of the invention provide methods and materials that can be used to protect medical devices from unwanted effects of radiation sterilization.

Abstract: A device for detection or measurement of a carbohydrate analyte in fluid comprises: an optical sensor comprising components of an assay for carbohydrate analyte, the readout of which is a detectable or measurable optical signal, and a light guide having a distal portion optically coupled to the assay components and a proximal portion; and a reader for interrogating the optical sensor, the reader comprising an assay interrogating system including a lens; and an interface portion forming part of at least one of the optical sensor and the reader, the interface portion being capable of removably constraining the proximal portion of the light guide and the lens of the assay interrogating system in an optically coupled arrangement. The device may be combined with an insulin-infusion system.

Abstract: Medical devices are typically sterilized in processes used to manufacture such products and their sterilization by exposure to radiation is a common practice. Radiation has a number of advantages over other sterilization processes including a high penetrating ability, relatively low chemical reactivity, and instantaneous effects without the need to control temperature, pressure, vacuum, or humidity. Unfortunately, radiation sterilization can compromise the function of certain components of medical devices. For example, radiation sterilization can lead to loss of protein activity and/or lead to bleaching of various dye compounds. Embodiments of the invention provide methods and materials that can be used to protect medical devices from unwanted effects of radiation sterilization.

Abstract: Solid pharmaceutical compositions for parenteral injection comprising a binder and at least one therapeutic agent. The pharmaceutical composition has the strength to be injected directly with the need of using cannulas or the like.

Abstract: An injection apparatus for making an injection at a predetermined depth in skin comprises: a first skin positioning member, a second skin positioning member, wherein the first and second skin positioning members lie or are moveable to lie in an injection arrangement; an injection needle; and an injection needle movement guide to guide the injection needle for movement from a parking position above the skin, through the lower surface of the second skin positioning member to slide beneath the first skin positioning member to an injection position. A further injection apparatus comprises: an injection needle; a plunger within the injection needle; and a retractor to retract the injection needle such that material to be injected is expelled from the injection needle by the plunger.

Abstract: A continuous glucose monitoring system may include a hand-held monitor, a transmitter, an insulin pump, and an orthogonally redundant glucose sensor, which may comprise an optical glucose sensor and a non-optical glucose sensor. The former may be a fiber optical sensor, including a competitive glucose binding affinity assay with a glucose analog and a fluorophore-labeled glucose receptor, which is interrogated by an optical interrogating system, e.g., a stacked planar integrated optical system. The non-optical sensor may be an electrochemical sensor having a plurality of electrodes distributed along the length thereof. Proximal portions of the optical and electrochemical sensors may be housed inside the transmitter and operationally coupled with instrumentation for, e.g., receiving signals from the sensors, converting to respective glucose values, and communicating the glucose values.

Abstract: An optical glucose sensor may include an optical fiber and a glucose-permeable membrane having a hollow interior and being coupled to the optical fiber's distal end. The membrane's hollow interior provides a compartment to house a competitive glucose binding affinity assay. The assay may include a glucose analog that may be labeled with a dye, and a glucose receptor that may be labeled with a fluorophore. The optical fiber may include a compound parabolic concentrator tip, and the compartment may additionally house a reflector disposed so as to face the optical fiber's tip. A fluorophore-labeled assay may be interrogated by an optical interrogating system including a light source and a filter substrate having one or more coatings to effect, e.g., an excitation filter and/or an emission filter. The interrogating system may be manufactured as a stacked planar integrated optical system and diced into smaller units.

Abstract: In apparatus for the production and detection of fluorescence at a sample surface, the height of the apparatus above the sample surface is reduced, and loss of the emitted fluorescence due to reflection loss and light scattering is minimized. The apparatus comprises a three-dimensionally curved light reflecting surface (40) that directs light from a light source (32) transversely to its original path and focuses the light on to an illumination zone (30) at or below the sample surface. The reflecting surface (40) also collects, directs and at least partially collimates emitted fluorescence transversely to its original path and towards a detector (46).

Abstract: Solid pharmaceutical compositions for parenteral injection comprising a binder and at least one therapeutic agent. The pharmaceutical composition has the strength to be injected directly with the need of using cannulas or the like.

Abstract: Solid pharmaceutical compositions and methods of making and administering for parenteral injection comprising a binder and at least one therapeutic agent. The pharmaceutical composition has the strength to be injected directly with the need of using cannulas or the like.

Abstract: A first light source emits a light signal along a measurement optical path that includes a sample and a second light source emits a light signal along a dummy measurement optical path. A measurement circuit receives the light signals and provides outputs separated in time which are indicative of the phase of the respective light signals. A phase shift is induced in light in the measurement optical path by the sample. A reference circuit receives a signal indicative of the phase of the light signals emitted by the first and second light sources. Circuitry compares the phases of light output from the two circuits to provide output indicative of a first measured phase difference during operation of the first light source. Correction is applied to this measurement by taking a similar phase difference measurement during operation of the second light source and comparing the two phase differences.

Abstract: An injection apparatus for making an injection at a predetermined depth in skin comprises: a skin positioning member, an injection needle (610), and means guiding the injection needle for movement from a parking position above the skin beside said skin positioning member to slide beneath said skin positioning member to an injection position; wherein: the tip (620) of the injection needle is closer to the longitudinal axis of the shaft portion (650) than is the outside of the shaft portion (650) and/or the length of the lumen opening (625) of the needle is in a range from 5 to 15 times the diameter of the shaft (650) of the needle. An injection needle wherein the length of the lumen opening (625) of the needle is in a range from 5 to 15 times the diameter of the shaft (650) of the needle.

Abstract: A first light source emits a light signal along a measurement optical path that includes a sample and a second light source emits a light signal along a dummy measurement optical path. A measurement circuit receives the light signals and provides outputs separated in time which are indicative of the phase of the respective light signals. A phase shift is induced in light in the measurement optical path by the sample. A reference circuit receives a signal indicative of the phase of the light signals emitted by the first and second light sources. Circuitry compares the phases of light output from the two circuits to provide output indicative of a first measured phase difference during operation of the first light source. Correction is applied to this measurement by taking a similar phase difference measurement during operation of the second light source and comparing the two phase differences.

Abstract: In apparatus for the production and detection of fluorescence at a sample surface, the height of the apparatus above the sample surface is reduced, and loss of the emitted fluorescence due to reflection loss and light scattering is minimized. The apparatus comprises a three-dimensionally curved light reflecting surface (40) that directs light from a light source (32) transversely to its original path and focuses the light on to an illumination zone (30) at or below the sample surface. The reflecting surface (40) also collects, directs and at least partially collimates emitted fluorescence transversely to its original path and towards a detector (46).