US-20260123979-A1 - APPARATUS AND METHOD FOR OPTIMIZING AND ADAPTING TREATMENT OF MULTIPLE TUMORS IN PATIENTS WITH METASTATIC DISEASE BY ELECTRIC FIELD

Abstract

A method of delivering tumor treating electric fields to a patient after tumor remission using predictive data in a preventive therapy, which includes the steps of: reviewing a scan of the body; identifying remissive tumor-filled areas on the scan; determining a spatial relationship between remissive tumor-filled areas and predicted locations of tumors; arranging an array of insulated electrode elements on the body, the array of electrode elements being coupled to an electric field generator, a control device configured to send a signal to the generator causing the generator to deliver tumor-preventative electric fields to the electrode elements; determining at least two subarray firing configurations for the array of electrode elements for targeting the remissive tumor-filled areas, the subarray firing configurations depending at least in part upon the spatial relationship between the two remissive tumor-filled areas; and delivering the tumor-treating fields to the remissive tumor-filled areas using the subarray firing configurations.

Inventors

• Peter F. Travers
• Richard Rotondo
• Scott Krywick
• Nathaniel R. Travers
• Ken Watkins

Assignees

• LIFEBRIDGE INNOVATIONS, PBC

Dates

Publication Date

20260507

Application Date

20250701

Claims (20)

1. 1 . A method of delivering tumor treating electric fields to a body of a patient after tumor remission in the patient, comprising: using predictive data as an input to a preventive therapy regimen, the preventive therapy regime including the steps of: reviewing a scan of the body of the patient; predicting areas of tumor occurrence using the predictive data to arrive at locations of predicted tumors; identifying at least two remissive tumor-filled areas on the scan, each remissive tumor-filled area having at least one remissive tumor therein; determining a spatial relationship between the remissive tumor-filled areas and the locations of predicted tumors; arranging an array of insulated electrode elements on the body of the patient, the array of insulated electrode elements being coupled to an electric field generator, a control device being configured to send a signal to the electric field generator causing the electric field generator to deliver tumor-preventative electric fields to the insulated electrode elements; determining at least two subarray firing configurations for the array of insulated electrode elements for targeting the remissive tumor-filled areas and/or the locations of predicted tumors, the at least two subarray firing configurations depending at least in part upon the spatial relationship between the areas and locations; and delivering the tumor-treating fields to at least two of the areas and/or locations using the at least two subarray firing configurations.
2. 2 . The method of claim 1 , further including assigning a respective group of insulated electrode elements of the array of insulated electrode elements to each subarray firing configuration.
3. 3 . The method of claim 2 , wherein the respective groups of insulated electrode elements share some common insulated electrode elements of the array of insulated electrode elements.
4. 4 . The method of claim 2 , wherein the respective groups of insulated electrode elements do not share any common insulated electrode elements of the array of insulated electrode elements.
5. 5 . The method of claim 1 , wherein each subarray firing configuration of the array of insulated electrode elements is implemented simultaneously such that at least two of the areas and/or locations are simultaneously treated.
6. 6 . The method of claim 1 , wherein each subarray firing configuration of the array of insulated electrode elements is implemented sequentially such that the at least two of the areas and/or the locations are sequentially treated.
7. 7 . The method of claim 1 , further including determining the at least two subarray firing configurations depending upon one or more of a triage strategy, a duty cycle of each insulated electrode element, a sensed temperature of each insulated electrode element, a peak power consumption of the array of insulated electrode elements, and a total power consumption of the array of insulated electrode elements.
8. 8 . The method of claim 1 , further comprising the step of triaging the areas and locations to obtain a triage strategy.
9. 9 . The method of claim 8 , wherein triaging includes assigning a priority value to the areas and/or locations.
10. 10 . The method of claim 9 , further including optimizing one or more of a total amount of treatment time dedicated to the remissive tumor and/or the locations of predicted tumors, a duration of a field intensity, and a number of angles of electric field delivery depending upon the assigned priority values of the areas and locations.
11. 11 . The method of claim 9 , wherein implementing the at least two subarray firing configurations includes altering the at least two subarray firing configurations depending upon one or more of the priority value of the at least one remissive tumor in each of the areas and the locations.
12. 12 . The method of claim 9 , further including re-triaging the tumors in the remissive tumor-filled areas to obtain an updated triage strategy.
13. 13 . The method of claim 8 , further including determining the at least two subarray firing configurations depending upon one or more of a duty cycle of each insulated electrode element, a sensed temperature of each insulated electrode element, a peak power consumption of the array of insulated electrode elements, and a total power consumption of the array of insulated electrode elements.
14. 14 . A method of delivering tumor treating electric fields to a body of a patient, comprising: verifying data from a scan of the body of the patient for identifying remissive tumor-filled areas, each remissive tumor-filled area having at least one remissive tumor therein; predicting locations of predicted tumors; determining a spatial relationship in between the areas and locations; arranging an array of insulated electrode elements on the body of the patient, the array of insulated electrode elements being coupled to a control device; determining at least two subarray firing configurations for the array of insulated electrode elements depending at least in part upon the spatial relationship between the areas and/or the locations, each subarray firing configuration being configured for treating a respective remissive tumor-filled area and/or the locations of predicted tumors; determining if the at least two subarray firing configurations are simultaneously implementable or sequentially implementable; and simultaneously implementing or sequentially implementing the at least two subarray firing configurations for treating the at least two remissive tumor-filled areas and/or the locations of predicted tumors.
15. 15 . The method of claim 14 , wherein determining if the at least two subarray firing configurations are simultaneously implementable or sequentially implementable depends upon one or more of an interaction of electric fields of the at least two subarray firing configurations, a power availability of the insulated electrode system, a duty cycle of each insulated electrode element, a sensed temperature of each insulated electrode element, a triage strategy, a peak power consumption of the array of insulated electrode elements, a total power consumption of the array of insulated electrode elements, and a time constraint to maintain optimal therapeutic effect.
16. 16 . The method of claim 15 , further including triaging the remissive tumors in the remissive tumor-filled areas and the locations of predicted tumors to obtain a triage strategy, wherein the remissive tumors and/or the locations of predicted tumors are of equal threat, wherein the method further includes conducting an adaptive optimization process by determining if a subarray firing configuration can be terminated so that another subarray firing configuration will optimize treatment of a corresponding one of the areas and/or the locations.
17. 17 . The method of claim 15 , further including triaging the remissive tumors in the at least two remissive tumor-filled areas and/or the locations of predicted tumors to obtain a triage strategy, wherein the remissive tumors in the areas and/or locations are of an unequal threat, wherein the method further includes conducting an adaptive optimization process by determining if a subarray firing configuration can be terminated based upon the priority value of the remissive tumor areas and/or the locations of predicted tumors.
18. 18 . A method of delivering tumor treating electric fields to a body of a patient, comprising: reviewing a scan of the body of the patient for identifying remissive tumor-filled areas, each remissive tumor-filled area having at least one remissive tumor therein; predicting locations of predicted tumors; arranging an array of insulated electrode elements on the body of the patient, the array of insulated electrode elements being coupled to a control device; implementing at least one initial subarray firing configuration for the array of insulated electrode elements to treat the at least one remissive tumor-filled area; sensing temperatures of the insulated electrode elements of the array of insulated electrode elements; and implementing at least one alternative subarray firing configuration for the array of insulated electrode elements depending upon the sensed temperatures to treat the remissive tumor-filled areas and/or the locations of predicted tumors.
19. 19 . The method of claim 18 , further including identifying at least one overheated insulated electrode element which is used in the at least one initial subarray firing configuration.
20. 20 . The method of claim 19 , wherein the at least one overheated insulated electrode element is not used in the at least one alternative subarray firing configuration such that the at least one overheated insulated electrode element can cool down.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This is a divisional application based on non-provisional application Ser. No. 17/111,204, filed on Dec. 3, 2020. Application Ser. No. 17/111,204 was based upon U.S. provisional patent application Ser. No. 62/948,600, entitled “APPARATUS AND METHOD FOR OPTIMIZING AND ADAPTING TREATMENT OF MULTIPLE TUMORS IN PATIENTS WITH METASTATIC DISEASE BY ELECTRIC FIELD”, filed Dec. 16, 2019, which is incorporated herein by reference. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to the selective destruction of multiple solid tumors in large areas encompassing the entire torso of metastatic cancer patients. More particularly, the present invention relates to an apparatus and method for optimizing the destruction of multiple tumors while not damaging normal cells, and further adapting the optimization of the destruction of multiple tumors over time as changes in size, a number of, and location of multiple tumors occur within a metastatic patient. 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 tubulins 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. The following is an explanation of how electric fields selectively kill cancer cells. The basic physics of using electric fields to trigger an immunogenic response to selectively kill cancer cells involves commonly known attributes of charged particles. That is, like charges repel and opposite charges attract. Key protein(s) essential to mitosis have high dipole moments. That is, they are negative on one side and positive on the other. In a constant field charged particles will migrate towards opposite charges. Under exposure to an alternating electric field, dipole proteins essential to mitosis rotate back and forth with the alternating charge of the field. Electric fields that lead to cancer cell death are those created through solid tumors at frequencies between 100 hKz and 300 hKz, depending on the size of the cancer cells. The question to answer first is what within the cancer cell is the electric field interactive with to disrupt tumor growth. A key protein complex involved in mitosis is Septin, which has a very high dipole moment. Septins have many functions and are involved in cell structural support. In the presence of an alternating electric field, at the optimal frequency, the localization of Septin needed to carry out its functions is diminished. The result of electric field exposure during mitosis does not prevent tumor daughter cells from being formed but does cause them to be malformed. The foreign nature of daughter cells developed under the optimal electric field is such that an immune response is triggered. Immunogenic cell death occurs, resulting in diminished tumors. The above mechanism of action using Septin can be further validated by the fact that patients under electric field therapy for glioblastoma who have compromised immune systems (CD8 cell count<144 cells/mm2, CD4/CD8 ratio<1.09) do not respond to electric field therapy as compared to those with healthy immune systems. Such patients with compromised immune states may receive no benefit from receiving therapy. Of course, the results of therapy may depend on a properly tuned electric field which may penetrate the cell wall. Whether an electric field can penetrate a cancer cell wall is dependent on the relationship of the frequency of the field to the size of a cell. There is an inverse relationship between the effective electric field frequency and the size of the cancer cell. The larger the cancer cell the lower the frequency needed to penetrate its cell wall. The smaller the cancer cell the higher the frequency needed to push through the cell wall. I