Subcutaneous multi-electrode sensing system

A - Human Necessities – 61 – B

Patent

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A61B 5/0402 (2006.01) A61N 1/36 (2006.01) A61N 1/362 (2006.01) A61N 1/375 (2006.01)

Patent

CA 2106378

2106378 9217240 PCTABS00016 A method and apparatus for providing an enhanced capability of detecting and gathering electrical cardiac signals via an array of relatively closely spaced subcutaneous electrodes (located on the body of an implanted device) which may be employed with suitable switching circuits, signal processors, and memory to process the electrical cardiac signals between any selected pair or pairs of the electrode array in order to provide a leadless, orientation insensitive means for receiving the electrical signal from the heart. This far-field EGM may be used to provide storage and analysis of arrhythmic events and to provide control signals for the delivery of various therapies including pacing, cardioversion and defibrillation therapies as well as the delivery of antiarrhythmic drugs, and, in the pacing context, to effect capture detection and automatic stimulation threshold adaptation, recording of PMT episodes, measurement of refractory periods in order to set timing windows for antitachy pacing therapies, and as a control signal for use in adjusting pacing rate to physiologic demand. The housing or case of the subcutaneously implanted medical device is modified to provide an array of electrodes which may be selectively or sequentially coupled in one or more pairs to the terminals of one or more sense amplifiers to pick up, amplify and process the electrical cardiac signals across each electrode pair. In one embodiment, the signals from the selected electrode pairs may be stored and compared to one another in order to determine the sensing vector which provides the largest cardiac signal (in a test mode). Following completion of the test mode, the system may employ the selected subcutaneous ECG signal vector for a number of applications. The implanted device possesses analog-to-digital conversion circuitry for sampling and converting the selected subcutaneous ECG signal to digital data which is stored in a recirculating buffer, the contents of which are transferred to RAM for later data retrieval either periodically or upon the occurrence of an event of interest. In another embodiment, the selected subcutaneous ECG signal is used to confirm capture in conjunction with an algorithm for determining the stimulation threshold of the heart and set stimulation pulse energy at a level exceeding the threshold by a desired safety margin. Further embodiments include replacing the switching approach with parallel linear and nonlinear combinational processing of the signals from the orthogonal electrode pairs of the electrode array, to develop and employ continuous signals insensitive to the orientation variations of the electrode array. These linear and nonlinear embodiments would be used for improving the data storage and autocapture embodiments by providing an optimal signal at all times, while avoiding the switching process.

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