Testing sterile packaged components of an implantable medical device prior to chronic implantation

摘要

Apparatus, systems and methods for coupling components of an implantable medical device that are contained within separate sterile packages together and testing operation thereof prior to chronic implantation are disclosed. In particular, testing of the integrity of the lead conductors and other electrical components coupled therewith and the testing and calibration of an implantable sensor, e.g., an implantable pressure sensor, coupled to a programmable, implantable hemodynamic monitor (IHM) or implantable pulse generator (IPG) while in respective sterile packages are disclosed. The lead and IPG/IHM sterile packages are provided with package connectors that couple the terminals of the IPG/IHM and lead to external package connector arrays. The package connector arrays are coupled together, and a programmer is employed to downlink telemetered commands to the IPG or IHM to test the sensor and/or lead conductors and uplink via telemetery the results to the programmer for display. When a lead borne pressure sensor is under test, the uplink telemetered pressure readings are compared to a reference pressure reading. A correction factor is determined if the uplink telemetered and reference pressure readings differ, and the correction factor is downlink telemetered from the programmer into memory of the IPG or IHM for use in adjusting the sensor pressure readings. The pressure test may be conducted both at atmospheric pressure and at elevated pressures correlated to typical systolic blood pressures, and the correction factor may be derived from all tests.