84 (wired link) or a wireless link, so that movement data, measured by the accelerometer 72, is obtained by the processor 80, either by pushing data to the processor 80, or the processor 80 pulling data from the accelerometer 72.

The processor 80 obtains the movement data from the accelerometer 72, for example, by the accelerometer 72 either sending signals indicative of measured movement, to the processor 80, either continuously or at various time intervals including randomly, and, either automatically, or when triggered by the processor 80. Alternately, the processor 80 monitors the accelerometer 72, for example, monitoring the data of measured movement, which is outputted by the accelerometer 72, or obtained by the processor 80 polling the accelerometer 72. The aforementioned monitoring, triggering and/or polling is, for example, continuous, and may be constant or in intervals, equally spaced apart in time, or random.

FIG. 4 is a flow diagram of an example process performed by the processor 80 that schematically illustrates a method for using patch 68 and series of “test” pulses, to determine suitable, including optimal, locations on the body for body surface electrode 68 placement, for example, for a “full” IRE procedure. The process is, for example, performed automatically and in real time, and may include manual subprocesses. The process may be performed as long as desired.

The process begins at a START block 400, where, for example, the IRE system 20 is in place and ready for use with a patient 28. At block 402, the process begins, as the body surface electrode 68 is placed at a location on the body 28, such as a first location. At block 404, which may be contemporaneous or simultaneous with, or interchanged with block 402, the controller 86 determines a sequence or protocol of “test” pulses, including the number of pulses, the intensity and the frequency of the pulses.

A series or sequence of “test” pulses, as part of a protocol, is generated by the IRE Generator 38, at block 406. At block 408, the accelerometer 72 detects body movements, which may be, for example, muscle movements in the form of muscle contractions and/or muscle spasms, resulting from the “test” pulses traveling through the body, from the delivery electrode 250 to the electrode 66 on the body surface electrode 68. The data associated with the body movements, as detected by the accelerometer 72, at the location (which may also include locations on the body proximate to the location of the body surface electrode 68) of the body 28, is obtained from the accelerometer 72 by the processor 80, as detailed above.

The obtained accelerometer data (body movement data for the location of the body surface electrode 68 subject to the “test” pulses) is recorded, and typically stored, at block 410. The storage is in a database, for example, associated with the processor 80, and which may be in the controller 86.

The process moves to block 412, where it is determined whether more data is needed, for example, data from at least two locations of the body surface electrode 68 on the body, as points of comparison. However, data from a single body surface electrode location on the body 28 may be sufficient, should a threshold value or score for acceptable body movement be programmed into the processor 80 or controller 86. Should more movement data be needed from subsequent locations of the body surface electrode, after data from a first location of the body surface electrode on the body has been obtained, the process moves to block 414.

At block 414, the body surface electrode 68, now removed from the previous location, or a new body surface electrode (with the previous body surface electrode removed from the body), is placed at a subsequent location on the body, for example, different than any previous location on the body 28 where the body surface electrode 68 was placed (positioned). From block 414, the process moves to block 404, from where it resumes, in accordance with that detailed above.

Returning to block 412, should more movement data from more locations of the body surface electrode on the body not be needed, the process moves to block 416. At block 416, movement data from the locations of the body surface electrodes is analyzed. The analysis determines whether there are suitable locations (zero or more) for the body surface electrode for a “full” IRE procedure. In the case of zero suitable locations, although movement data was obtained for the locations of the body surface electrode on the body, the movement exceeded a predetermined movement threshold or score, programmed into the processor 80 or controller 86, such that zero or none of the locations were sufficient for a body surface electrode for a “full” and subsequent (after the test IRE procedure using the “test” pulses) IRE procedure.

The process moves to block 418. At block 418, should the analysis have determined zero or no suitable locations on the body for a body surface electrode for a “full” IRE procedure, the process returns to block 400, from where it resumes, as described above.

However, at block 418, should there be one or more suitable locations determined, the process moves to block 420, where at least one optimal location on the patient's body for the body surface electrode for the “full” IRE procedure is indicated to the operator. The optimal location is selected from one or more locations of the patch electrode 68 with the least amount of body movement (from the g-sensor 72 on the patch electrode adhered to the body) when the test IRE pulse is applied. That is, at each location on the body, the system stores the movement data at each application of the test IRE pulses and indicates to the operator a location with the least amount of body movements during the IRE test pulses.

Alternatively, the system may utilize a predetermined movement threshold and when the movement of the patch electrode 68 at an operator selected location is greater than the predetermined threshold at step 412, the method indicates to the user to begin a test sequence at a different location. A location of the body patch 68 is selected when the body movement (via g-sensor 72) during the test IRE pulses is less than the predetermined threshold. At this point, the system would inform the operator via the display or audio output of system 24 that this selected location is “optimal” for IRE ablation therapy. At this determination step 420 of the optimal location, the process moves to block 422 where it ends. The process of determining an optimal location may be repeated for as long as desired.

Typically, the processor 80 comprises a general-purpose computer, which is programmed in software to carry out the functions described herein. The software may be downloaded to the computer in electronic form, over a network, for example, or it may, alternatively or additionally, be provided and/or stored on non-transitory tangible media, such as magnetic, optical, or electronic memory.

Example 1

A system (20) for determining placement of a body surface electrode (