System and method for ablating a tissue site by electroporation with real-time monitoring of treatment progress

Abstract

A medical system for ablating a tissue site with real-time monitoring during an electroporation treatment procedure. A pulse generator generates a pre-treatment (PT) test signal prior to the treatment procedure and intra-treatment (IT) test signals during the treatment procedure. A treatment control module determines impedance values from the PT test signal and IT test signals and determines a progress of electroporation and an end point of treatment in real-time based on the determined impedance values while the treatment progresses.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]The present application claims priority to and is a Continuation application of U.S. application Ser. No. 14 / 940,863, filed on Nov. 13, 2015, which published as U.S. Patent Application Publication No. 2016 / 0066977 on Mar. 10, 2016. The '863 application claims priority to and the benefit of the filing date of U.S. Provisional Application No. 62 / 079,061 filed on Nov. 13, 2014, and U.S. Provisional Application No. 62 / 173,538 filed on Jun. 10, 2015. The '863 application is also a Continuation-in-Part (CIP) application of parent application U.S. application Ser. No. 14 / 012,832, filed on Aug. 28, 2013, which published as U.S. Patent Application Publication No. 2013 / 0345697 on Dec. 26, 2013 and issued as U.S. Pat. No. 9,283,051 on Mar. 15, 2016. The '832 application is a Continuation-in-Part (CIP) application of U.S. application Ser. No. 12 / 491,151, filed on Jun. 24, 2009, which published as U.S. Patent Application Publication No. 2010 / 0030211 o...

AI Technical Summary

Benefits of technology

The patent text explains that using a specific baseline value for a patient can help in monitoring their progress and determining when treatment is complete in real-time. This can improve the delivery of treatment and increase the likelihood of successful outcome.

Problems solved by technology

As can be appreciated, the electroporation therapy treatment plans selected by the physician are limited to using a retrospective dimension data approach, where a pre-determined pulse parameter protocol is delivered between each electrode pair in an array and the pulse parameters are selected from previously existing ablation data.

However, this approach ignores the specifics of the actual case, which will vary both in terms of initial tissue properties and tissue response to the electroporation pulses for each patient.

Specifically, there is no way to monitor the progress of the treatment procedure or alter the settings other than to stop the procedure manually.

Thus, even when the procedure completes normally, there was no assurance that there were clinically sufficient electroporation of the targeted region due to the unpredictable nature of patient environments and living tissue.

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