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:
Techniques disclosed herein relate to determining a calibrated measurement value indicative of a physiological condition of a patient using sensor calibration data determined based on fabrication measurements. In some embodiments, the techniques involve obtaining one or more electrical signals from a sensing element of a sensing arrangement, where the one or more electrical signals are influenced by a physiological condition in a body of a patient; obtaining calibration data associated with the sensing element, where the calibration data is based on fabrication process measurement data for the sensing element and a calibration model for a certain physiological condition; and determining, using the one or more electrical signals and the calibration data associated with the sensing element, a calibrated output value indicative of the physiological condition.
Abstract:
Medical devices, systems and methods are provided. One method involves obtaining fabrication process measurement data for a plurality of instances of a sensing element, obtaining reference output measurement data from the plurality of instances in response to a reference stimulus, determining a predictive model for a measurement output of the sensing element as a function of fabrication process measurement variables based on the relationship between the fabrication process measurement data and the reference output measurement data, generating a simulated output measurement distribution across a range of the fabrication process measurement variables using the predictive model, identifying performance thresholds for the measurement output based on the simulated output measurement distribution, obtaining output measurement data from the instance of the sensing element in response to the reference stimulus, and verifying the output measurement data satisfies the performance threshold prior to calibrating a subsequent instance of the sensing element.
Abstract:
Techniques disclosed herein relate to determining a calibrated measurement value indicative of a physiological condition of a patient using sensor calibration data and a performance model. In some embodiments, the techniques involve obtaining one or more electrical signals from a sensing element of a sensing arrangement, where the one or more electrical signals are influenced by a physiological condition in a body of a patient. The techniques also involve obtaining calibration data associated with the sensing element from a data storage element of the sensing arrangement, converting the one or more electrical signals into one or more calibrated measurement parameters using the calibration data, obtaining a performance model associated with the sensing element, obtaining personal data associated with the patient, and determining, using the performance model and based on the personal data and the one or more calibrated measurement parameters, a calibrated output value indicative of the physiological condition.
Abstract:
Techniques disclosed herein relate to determining a calibrated measurement value indicative of a physiological condition of a patient using sensor calibration data and a performance model. In some embodiments, the techniques involve obtaining one or more electrical signals from a sensing element of a sensing arrangement, where the one or more electrical signals are influenced by a physiological condition in a body of a patient. The techniques also involve obtaining calibration data associated with the sensing element from a data storage element of the sensing arrangement, converting the one or more electrical signals into one or more calibrated measurement parameters using the calibration data, obtaining a performance model associated with the sensing element, obtaining personal data associated with the patient, and determining, using the performance model and based on the personal data and the one or more calibrated measurement parameters, a calibrated output value indicative of the physiological condition.
Abstract:
Medical devices, systems and methods are provided. One method involves obtaining fabrication process measurement data for a plurality of instances of a sensing element, obtaining reference output measurement data from the plurality of instances in response to a reference stimulus, determining a predictive model for a measurement output of the sensing element as a function of fabrication process measurement variables based on the relationship between the fabrication process measurement data and the reference output measurement data, generating a simulated output measurement distribution across a range of the fabrication process measurement variables using the predictive model, identifying performance thresholds for the measurement output based on the simulated output measurement distribution, obtaining output measurement data from the instance of the sensing element in response to the reference stimulus, and verifying the output measurement data satisfies the performance threshold prior to calibrating a subsequent instance of the sensing element.