The present invention provides a package for and method of packaging a sterilizable calibratable medical device including a hydratable sensor component. The device is maintained in a sterile environment during storage and in a clean environment during the calibration procedure. The package includes a manifold connected to the sensor component by plumbing. The plumbing establishes fluid communication between the manifold and the sensor component and/or between the sensor component and the ambient environment of the plumbing. The manifold, plumbing and medical device are sealed in a wrap including a gas-permeable surface. The wrap and its contents, including the interior surfaces of the components, are sterilizable by exposing the wrap to a gaseous sterilization solution and appropriately adjusting the plumbing. The medical device is hydratable by directing the hydration solution to the sensor component by means of the plumbing. In order to store the package over an extended period of time, a gas-impermeable chamber is defined which includes the ambient environment of the plumbing. The gaseous environment of the medical device is thereby controllable. In this manner, the device is prepared for calibration and is storable in the sterile environment. By connecting a reservoir including calibration solution to the plumbing, the calibration solution is directed to the sensor component without removing the medical device from its clean environment. The temperature of the sensor component and the solution are controlled throughout the calibration process in order to ensure that the device is calibrated in accordance with its intended use. The present invention further discloses a solution for preparing the medical device for use. The solution is chemically compatible with the intended use of the device.
This is a divisional of the prior application Ser. No. 07/224,425, filed July 25, 1988, and now U.S. Pat. No. 4,063,016 the benefit of the filing date of which is hereby claimed under 35 U.S.C. 120.
A precalibrated sensing system for determining a blood parameter such as the partial pressures of oxygen (pO.sub.2) and carbon dioxide (pCO.sub.2), and the negative logarithm of hydrogen ion activity (pH). A dry sensor is provided which may be calibrated in the factory, packaged, sterilized and stored, without requiring recalibration prior to use.
A method for assembling a package for an active medical device which comprises making an opening in a wall of a recess shaped to receive the device, placing a gasket against the wall and about a band mounted through a flat portion of the wall, inserting the band through the opening so the gasket is flush against the wall, installing an outer part about the band to hold the gasket against the wall to form a sterile barrier, and placing a lid over the recess to contain the device within a sterile field.
A calibration system and method for calibrating a medical sensor (16) that monitors chemical blood gases. A calibrator (12) is used in connection with a tray (14) in which the medical sensor is stored in a sterile environment, both before and during the calibration process. The medical sensor is immersed in a liquid (30) in a tonometry chamber (28) defined in the tray and covered by a membrane (120/122) that is permeable to gas, but impermeable to bacteria. During the calibration process, the tray is inserted into the calibrator, bringing a heated platen (26) into contact with the tonometry chamber, so that the liquid can be heated to a calibration temperature substantially equal to the temperature at which the medical sensor will subsequently be used. A first calibration gas is then bubbled through the liquid until a saturated condition is achieved. Once the temperature of the liquid is increased to the desired calibration temperature, as determined by a temperature sensor on the medical sensor, data for a first calibration point is taken. A second calibration gas is then bubbled through the liquid until saturation is achieved, yielding data for a second calibration point, for each of the chemical blood gas parameters. The calibration data is processed to determine calibration coefficients that will be applied to the medical sensor.
Reagents for detecting an analyte are described. A reagent comprises (a) an enzyme selected from the group consisting of a flavoprotein, a quinoprotein, and a combination thereof; and (b) a mediator selected from the group consisting of a phenothiazine, a phenoxazine, and a combination thereof. In addition, reagents having good stability to radiation sterilization are described. Electrochemical sensors and sampling devices comprising such reagents, methods of producing a sterilized device including such reagents, and methods for detecting an analyte which utilize such reagents are described as well.
A package for a drug-device combination product includes an outer package including a first gas impermeable sheet and a second gas impermeable sheet hermetically sealed there to on three sides. A gas permeable header is attached to an unsealed side of the first sheet and sealed to the second sheet on two sides. The first and second gas impermeable sheets and the header form an interior and an opening communicating with the interior. A gas permeable inner package is disposed within the outer package. A product is sealed within the inner package. The inner package is placed within the outer package and a top end of the header is sealed to the second sheet. The outer package is then sealed by sealing the first gas impermeable sheet to the second gas impermeable sheet at a seal point below the point where the header attaches to the first sheet.
