Abstract: 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.

Abstract: 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.

Abstract: An acoustic monitoring system that is able to verify the success or failure of the positional adjustment of a valve without the need for additional energy during non-invasive reprogramming is provided. The acoustic monitoring system includes a programmer for generating a sequence of commands to adjust the valve mechanism, and for receiving acoustic signals for analysis, a transmitter to implement the command and adjust the valve, and a sensor for detecting an acoustic signal generated from the valve during execution of the commands. A method for using the acoustic monitoring system is also provided.

Abstract: A shunt has a housing and a base. The base has a first set of electrodes extending across the base. A catheter is connected to the housing. The catheter has a longitudinal length, a proximal end, and a distal end. The catheter has a second set of electrodes extending along the longitudinal length of the catheter. At least two of the electrodes of said first set are electrically connected to two of the electrodes of the second set. The housing including a self sealing, needle penetrable outer housing wall. The system includes a probe assembly that is selectively penetratable through an outer housing wall.

Abstract: An acoustic monitoring system that is able to verify the success or failure of the positional adjustment of a valve without the need for additional energy during non-invasive reprogramming is provided. The acoustic monitoring system includes a programmer for generating a sequence of commands to adjust the valve mechanism, and for receiving acoustic signals for analysis, a transmitter to implement the command and adjust the valve, and a sensor for detecting an acoustic signal generated from the valve during execution of the commands. A method for using the acoustic monitoring system is also provided.

Abstract: A locking assembly is provided to simply and effectively prevent any unintentional adjustment of the adjustable valve mechanism in a fluid flow control device, without compromising the function of the device. The locking assembly generally includes at least one gripping arm for frictionally engaging at least a portion of the adjustable valve mechanism, and an actuating mechanism for controlling the deployment and release of the gripping arm. The locking assembly prevents unintentional adjustments that can adversely affect the pressure settings of the fluid flow control device. In particular, the locking assembly prevents unintentional adjustment, such as may be caused by the presence of a strong external magnetic field. The locking assembly can be easily disengaged, such as through the application or removal of an external mechanical force, to allow a clinician to adjust the pressure settings of the fluid flow control device as necessary.