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:
Thrombolytic and/or anticoagulation therapy of the present invention includes implantation of the discharge portion(s) of a catheter and, optionally, one or more electrodes on a lead, adjacent tissue(s) to be stimulated. Stimulation pulses, i.e., drug infusion pulses and optional electrical pulses, are supplied by a stimulator implanted remotely, and through the catheter or lead, which is tunneled subcutaneously between the stimulator and stimulation site. Stimulation sites include the coronary arteries, coronary veins, cerebral arteries, other blood vessels, chambers of the heart, mesenteric vessels, deep vessels of the leg, and other locations. Disclosed treatments include drugs used for chronic treatment and/or prevention of thromboembolic disease, for acute treatment of thromboembolic disease, for acute treatment of thrombosis, and combinations of these. The invention reduces or eliminates the incidence of thromboembolic disease and related morbidities, improve symptoms resulting from thromboembolic disease, and improve patient quality of life.
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.
Abstract:
A method for determining whether the relative position of electrodes used by a neurostimulation system has changed within a patient comprises determining the amplitude of a field potential at each of at least one of the electrodes, determining if a change in each of the determined electric field amplitudes has occurred, and analyzing the change in each of the determined electric field amplitudes to determine whether a change in the relative position of the electrodes has occurred. Another method comprises measuring a first monopolar impedance between a first electrode and a reference electrode, measuring a second monopolar impedance between second electrode and the reference electrode, measuring a bipolar impedance between the first and second electrodes, and estimating an amplitude of a field potential at the second electrode based on the first and second monopolar impedances and the bipolar impedance.
Abstract:
An implantable medical device system, external programmer, and method of indicating the status of a power source in a medical device implanted within a patient. An actual status of the power source is maintained at the medical device. A status indicator of an external programmer indicates an estimated status of the power source, which can be reconciled with the actual status of the power source when the external programmer is placed in telecommunicative contact with the implantable medical device.
Abstract:
Systems and methods for detecting intrathecal penetration are disclosed. A method in accordance with one embodiment includes detecting a value corresponding to an impedance of an electrical circuit that in turn includes an electrical contact located within the patient, and patient tissue adjacent to the electrical contact. The method further includes comparing the detected value to a predetermined criterion, and, if the detected value meets the predetermined criterion, identifying penetration of the patient's dura based at least in part on the detected value.
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.
Abstract:
An implantable lead having at least one electrode contact at or near its distal end prevents undesirable movement of the electrode contact from its initial implant location. One embodiment relates to a spinal cord stimulation (SCS) lead. A first injectable material is injected into the dura space to mechanically position the electrode array with respect to the spinal cord. Conjunctively for use with adhesives, or alternatively for use instead of the adhesives, a balloon may be positioned on the electrode lead array. The balloon is filled with air, liquid or a compliant material. When inflated, the balloon stabilizes the lead with respect to the spinal cord and holds the lead in place. An elastic aspect of the balloon serves as an internal contained relief valve to limit the pressure the balloon may place on the surrounding tissues when the epidural space is constrained.
Abstract:
Selective high-frequency spinal chord modulation for inhibiting pain with reduced side affects and associated systems and methods are disclosed. In particular embodiments, high-frequency modulation in the range of from about 1.5 KHz to about 50 KHz may be applied to the patient's spinal chord region to address low back pain without creating unwanted sensory and/or motor side affects. In other embodiments, modulation in accordance with similar parameters can be applied to other spinal or peripheral locations to address other indications.