EP-4434573-B1 - APPARATUS FOR TREATING MULTIPLE TUMORS IN PATIENTS WITH METASTATIC DISEASE BY ELECTRIC FIELDS

EP4434573B1EP 4434573 B1EP4434573 B1EP 4434573B1EP-4434573-B1

Inventors

TRAVERS, Peter, F.
WATKINS, Ken
KRYWICK, SCOTT
TRAVERS, MATTHEW

Dates

Publication Date: 20260513
Application Date: 20190809

Claims (13)

An apparatus for delivering a plurality of tumor treating electromagnetic fields to a body of an individual, comprising: a plurality of independently programmable electrode elements (706) for locating on the body of the individual; a control device; a field generator (1102) generating electrical signals in a frequency range, the electrical signals being directed to at least two of the plurality of electrode elements; and a flexible rack (704) configured to hold the electrode elements for application to the body of the individual; characterised in that the control device is configured to detect temperatures of the plurality of electrode elements and dynamically program the frequency range, a firing configuration and a firing sequence for the plurality of electrode elements thereby reducing temperatures of the plurality of electrode elements.
The apparatus of claim 1, wherein the plurality of electrode elements include both master and slave electrode elements.
The apparatus of claim 1, wherein the control device is configured to individually control each electrode element for optimizing a duty cycle of each electrode element.
The apparatus of claim 1, further including a plurality of heat sensors coupled with the plurality of electrode elements, each heat sensor being configured to sense a temperature of a respective electrode element.
The apparatus of claim 4, wherein the control device is configured to receive, from the plurality of heat sensors, the sensed temperatures of the plurality of electrode elements to detect the temperatures of the plurality of electrode elements, the control device is further configured to determine alternate firing sequences of the plurality of electrode elements in response to the sensed temperatures of the plurality of electrode elements.
The apparatus of claim 1, wherein the control device is configured to monitor the firing sequences and select the firing sequences that provide optimal field intensities with optimal duty cycles on the plurality of electrode elements.
The apparatus of claim 1, further including a stretchable shirt configured for holding the plurality of electrode elements relative to the body of the individual.
The apparatus of claim 2 wherein each of the master electrode elements is connected to at least one of the slave electrode elements, optionally wherein the master electrode elements are each connected to a differing set of the slave electrode elements by way of wires from each of the master electrode elements to the corresponding set of the slave electrode elements.
The apparatus of claim 8 wherein each of the master electrode elements directly control each of the slave electrode elements connected to the master electrode element.
The apparatus of claim 8 or 9 wherein a microprocessor is present only on master electrode elements.
The apparatus of any preceding claim wherein the electrode elements comprise a conductive adhesive on a body facing side of the electrode elements.
The apparatus of any preceding claim wherein the control device is configured to turn on or off an individual electrode element while maintaining other electrode elements.
The apparatus according to any preceding claim wherein the control device is configured to detect current leakage of the electrode elements, optionally wherein an electrode element is turned off when current leakage is detected.

Description

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to tumor and cancer cell treatment and more specifically to treatments involving the application of electromagnetic fields. 2. Description of the Related Art Alternating Electric Fields, also referred to as Tumor Treating Fields (TTF's), can be employed as a type of cancer treatment therapy by using low-intensity electromagnetic fields. These low-intensity fields rapidly change direction, thousands of times per second. Since the TTF's are electric fields, they do not cause muscle twitching or severe adverse side effects on other electrically activated tissues. The growth rate of metastatic diseases is typically greater than the growth rate of normal, healthy cells. Alternating Electric Fields therapy takes advantage of this high growth-rate characteristic. TTF's act to disrupt a cancer cell's mitotic process and cytokinesis by manipulating the cell's polarizable intracellular constituents, namely tublins that form mitotic spindles that pull the genetic material in the nucleus into two sister cells. TTF's interrupt mitotic spindle microtubule assembly thereby preventing cell division. The metastatic disease cells treated using TTF's will go into programmed cell death usually within 4 to 5 hours. The result is a significant reduction in tumor size and potential for full elimination of solid tumors. TTF's are tuned to treat specific cancer cells and thereby do not damage normal cells. TTF therapy can be used as a sole treatment method, or it can be combined with conventional drug delivery mechanisms. TTF's are applied to patients using insulated electrodes adhered to the skin by a variety of methods including the use of medical adhesives, articles of clothing, etc. There are multiple configurations of insulated electrodes, but all have an insulated material with a high dielectric constant on one side and a thin metal coating on the other, usually silver. Insulated electrodes used to generate TTF's always come in pairs with both sides being similar, but not necessarily the same. What is needed in the art, is a TTF system that enables the dynamic reassignment of array elements to thereby define any array needed and to apply the field from selected electrode elements. What is needed in the art is a modular system for adding and removing array elements. What is needed in the art is a current monitoring sensor that sends a shut off signal to the control device if fluctuations in current, which may be caused by current leakage to the skin or the detachment of the electrode, is detected. What is needed in the art is adhering array elements to a material while also reducing the temperature of the array elements. WO 2016/014264 discloses an insulated electrode system for delivering a plurality of tumor treating electromagnetic fields including an array of electrode elements for location on the body of a patient, each electrode having an insulation layer and each electrode element being independently electrically accessible and configured to be dynamically assigned to emanate an electromagnetic field relative to at least one other of said electrode elements. SUMMARY OF THE INVENTION The invention is defined by the appended claims. The present disclosure provides an improved cancer and tumor treatment regime. The disclosure in one form is directed to an electronic device for delivering a plurality of tumor treating electromagnetic fields to a patient including a plurality of electrode elements each being independently programmable, a control device and a field generator. The control device is configured to dynamically program a frequency range, a firing configuration and a firing sequence for the plurality of electrode elements. The field generator generates electrical signals in the frequency range, the electrical signals being directed to at least two of the plurality of electrode elements. The plurality of electrode elements including both master and slave electrode elements. The disclosure in another form is directed to a non-claimed method of using an electrode array to deliver tumor treating electric fields to a patient including the steps of: placing a plurality of electrode elements in optimized locations on the patient, each of the electrode elements being independently programmable; dynamically programming a control device with a frequency range, a firing configuration and a firing sequence for the plurality of electrode elements; and generating electrical signals with a field generator in the frequency range, the electrical signals being directed to at least two of the plurality of electrode elements, the plurality of electrode elements including both master and slave electrode elements. An advantage of the present disclosure is that connected sets of master and slave electrode elements are used to deliver programed electric signals to selected electrodes attached to the patient. The arrangement of which reduces the cost of the