Abstract:
Interelectrode impedance or electric field potential measurements are used to determine the relative orientation of one lead to other leads in the spinal column or other body/tissue location. Interelectrode impedance is determined by measuring impedance vectors. The value of the impedance vector is due primarily to the electrode-electrolyte interface, and the bulk impedance between the electrodes. The bulk impedance between the electrodes is, in turn, made up of (1) the impedance of the tissue adjacent to the electrodes, and (2) the impedance of the tissue between the electrodes. In one embodiment, the present invention makes both monopolar and bipolar impedance measurements, and then corrects the bipolar impedance measurements using the monopolar measurements to eliminate the effect of the impedance of the tissue adjacent the electrodes. The orientation and position of the leads may be inferred from the relative minima of the corrected bipolar impedance values. These corrected impedance values may also be mapped and stored to facilitate a comparison with subsequent corrected impedance measurement values. Such comparison allows a determination to be made as to whether the lead position and/or orientation has changed appreciably over time. In another embodiment, one or more electrodes are stimulated and the resulting electric field potential on the non-stimulated electrodes is measured. Such field potential measurements provide an indication of the relative orientation of the electrodes. Once known, the relative orientation may be used to track lead migration, to setup stimulation configurations and parameters for nominal stimulation and/or navigation. Also, such measurements allow automatic adjustment of stimulation energy to a previously-defined optimal potential field in the case of lead migration or postural changes.
Abstract:
A system and method for rapidly switching stimulation parameters of a Spinal Cord Stimulation (SCS) system increases the number of stimulation parameter sets that may be tested during a fitting procedure, or alternatively, reduces the time required for the fitting procedure. The switching method comprises selecting a new stimulation parameter set, and setting the initial stimulation levels to levels at or just below an estimated perception threshold of the patient. The estimated perception level is based on previous stimulation results. The stimulation level is then increased to determine a minimum stimulation level for effective stimulation, and/or an optimal stimulation level, and/or a maximum stimulation level, based on patient perception.
Abstract:
The present invention includes a body implantable lead having a multipolar proximal connector, at least a first conductor coupled to at least one stimulating electrode, a sensor for sensing at least one physiologic parameter of the body, and a second and a third conductor coupled to the sensor. The sensor is hermetically sealed in a D-shaped housing. Sensor components are mounted onto a microelectronic substrate which is advantageously placed on an inner flat portion of the D-shaped housing. End caps having sealing rings, either glass frit or metal, are used to seal the ends of the shell. A hermetic seal is easily achieved by heating the sealing material until they re-flow between the end caps and the shell. Advantageously, the sensor terminals are sized to fit snugly within a narrow bore of the end cap which is then circumferentially welded closed. The D-shaped sensor is placed on a carrier having at least two lumens. At least the first and second conductors pass through the lumens for connection with the stimulating electrode and the distal end of the sensor. Advantageously, the D-shaped housing reduces the area that needs to be hermetically sealed by more than half, and thus reduces the overall diameter of the lead. Advantageously, the conductors coupled to the sensor function independently from the stimulation conductors so that interference with basic operation of the pacemaker is prevented.
Abstract:
An implantable programmable pacemaker includes a sensor for measuring SO.sub.2 levels in blood on a periodic basis, e.g., every 15 seconds, while the pacemaker is operating in its programmed mode of operation. The energy of stimulation pulses generated by the pacemaker is automatically adjusted, as required, in order to maintain a prescribed level of SO.sub.2 in the blood. At least a minimum level of SO.sub.2 is presumed when the stimulation pulses are of sufficient energy to effectuate capture. Hence, the SO.sub.2 level is monitored to provide an indication of whether capture has been lost, and if so, to increase the stimulation energy. In one embodiment, the stimulation energy is increased by first increasing the pulse width of the stimulation pulse a prescribed amount. After the pulse width has been increased a maximum amount, and if capture is still lost, the stimulation energy is further increased by increasing the pulse amplitude a prescribed amount. After the pulse amplitude has been increased a maximum amount, and if capture is still lost, the operating mode of the pacemaker is changed, and the stimulation energy is reset to an appropriate value.