Granted Patent B2

US 12,415,086 · App. 18/624,048 · Granted Sep 16, 2025

Inventor: Vivek K. Sharma (San Ramon, CA)

Assignee: Asha Medical, Inc.

A61N2/004A61K45/06A61N2/002A61N2/02A61B5/055A61B6/032A61B6/037A61B6/50A61N5/10

Abstract

Claims (67)

1. A system for treating cancer cells in a body of a patient by modifying a cancer microenvironment (TME) comprising:

an alternating polarity (AP) magnetic field generator;

one or more AP electromagnetic coils coupled to the AP magnetic field generator and adapted to be coupled to a first portion of the patient's body and energized by an electrical signal from the AP magnetic field generator to generate and apply to the first portion of the patient's body an AP magnetic field having at least a first frequency of 5-500 kHz and a field strength of 0.2-5 mT;

a controller adapted to control the AP magnetic field generator, the one or more AP electromagnetic coils, and at least one of the first frequency and the field strength;

wherein the AP magnetic field is adapted to modify a cancer microenvironment (TME) surrounding the cancer cells by at least one of:

increasing a number of M 1 macrophages in the TME surrounding the cancer cells;

decreasing a number of M 2 macrophages in the TME surrounding the cancer cells; and

decreasing one of a number or a concentration of myeloid-derived suppressor cells (MDSCs) in the TME surrounding the cancer cells.

2. The system of claim 1 , wherein the AP magnetic field is further adapted to modify a cancer microenvironment (TME) surrounding the cancer cells by at least one of:

increasing a number of CD8+ lymphocytes in the TME surrounding the cancer cells;

increasing a ratio of CD8+ to total lymphocytes in the TME surrounding the cancer cells;

increasing a number of CD4+ lymphocytes surrounding the cancer cells;

increasing a ratio of CD4+ to total lymphocytes in the TME surrounding the cancer cells;

increasing a number of tumor infiltrating lymphocytes (TILs) in the TME surrounding the cancer cells;

increasing a number of antigen presenting cells (APCs) in the TME surrounding the cancer cells;

increasing a concentration of tumor-suppressive cytokines in the TME surrounding the cancer cells;

decreasing a concentration of tumor-promoting cytokines in the TME surrounding the cancer cells; and

increasing one of a number or a concentration of natural killer (NK) cells in the TME surrounding the cancer cells.

3. The system of claim 1 , wherein the AP magnetic field is configured to achieve at least one of damaging the cancer cells, inhibiting growth of the cancer cells, reducing tumor size, reducing metastasis of the cancer cells, and inhibiting angiogenesis for the cancer cells, while leaving non-cancer cells substantially unharmed.

4. The system of claim 1 , further comprising:

a retaining element for retaining the one or more AP electromagnetic coils in a desired position relative to the first portion of the patient's body during the application of the AP magnetic field, and wherein the retaining element is selected from a garment and a bandage.

5. The system of claim 4 , wherein the one or more AP electromagnetic coils, the retaining element, and the controller are each wearable by a user, and wherein the system comprises an ambulatory treatment system capable of treating the cancer cells while the patient is non-stationary.

6. The system of claim 5 , wherein the one or more AP electromagnetic coils comprises a plurality of AP electromagnetic coils, and the retaining element is selected from a hat, a cap, a bra, a shirt, and a vest, and is adapted to maintain the plurality of AP electromagnetic coils in a desired position relative to the first portion of the patient's body.

7. The system of claim 1 , wherein the controller comprises:

a timing control module to perform at least one of:

applying the AP magnetic field continuously to the first portion of the patient's body for a first treatment period;

applying the AP magnetic field intermittently for a second treatment period in alternating on time periods in which the AP magnetic field is applied to the first portion of the patient's body, followed by off time periods in which the AP magnetic field is not applied to the first portion of the patient's body;

applying the AP magnetic field intermittently for one or more circadian treatment periods based on circadian rhythms of the patient; and

applying the AP magnetic field intermittently for one or more third treatment periods at defined times of day.

8. The system of claim 1 , wherein the controller comprises:

a frequency control module to perform at least one of:

applying an AP magnetic field having a single frequency of 5-500 kHz to the first portion of the patient's body;

applying an AP magnetic field having a frequency of 5-500 kHz that varies in a defined pattern.

9. The system of claim 8 wherein the frequency control module further controls the AP magnetic field generator and the one or more AP electromagnetic coils to apply an AP magnetic field having at least one of:

a frequency of 5-500 kHz that varies randomly;

a frequency that varies in a Gaussian distribution in one or more ranges within the range of 5-500 kHz;

a frequency that varies in a non-Gaussian distribution in one or more ranges within the range of 5-500 kHz.

10. The system of claim 1 , wherein the controller is adapted to control the AP magnetic field generator and the one or more AP electromagnetic coils to generate and apply to the first portion of the patient's body an AP magnetic field having a frequency of 5-300 kHz and a field strength of 0.4-3 mT.

11. The system of claim 1 , wherein the controller is adapted to control the AP magnetic field generator and the one or more AP electromagnetic coils to generate and apply to the first portion of the patient's body an AP magnetic field having a frequency of 5-200 kHz and a field strength of 0.5-2 mT.

12. The system of claim 1 , wherein the controller is adapted to control the AP magnetic field generator and the one or more AP electromagnetic coils to generate and apply to the first portion of the patient's body an AP magnetic field having a frequency of 5-150 kHz and a field strength of 0.2-1.6 mT.

13. The system of claim 1 , wherein the controller is adapted to control the AP magnetic field generator and the one or more AP electromagnetic coils to generate and apply to the first portion of the patient's body an AP magnetic field having a frequency of 10.0-100 kHz and a field strength of 0.3-5 mT.

14. The system of claim 1 , further comprising one or more drugs selected from a chemotherapy drug, an immunotherapy drug, a hormone therapy drug, a targeted therapy drug, and an angiogenesis drug, wherein the each of the one or more drugs is adapted to be administered to the patient one of before, during, or after coupling the one or more AP electromagnetic coils to the first portion of the patient's body, wherein the controller controls the AP magnetic field generator based at least in part on a dosage of the one or more drugs, and wherein the AP magnetic field is adapted to modify the cancer microenvironment (TME) by increasing an efficacy of the one or more drugs.

15. The system of claim 1 , wherein the controller is adapted to control the AP magnetic field generator and the one or more AP electromagnetic coils to generate and apply to the first portion of the patient's body an AP magnetic field comprising a series of pulse bursts, wherein each pulse in each pulse burst comprises a predefined number of AP magnetic waveforms having a frequency of 5-500 kHz and a field strength of 0.2-5 mT, and each pulse burst in the series of pulse bursts comprises a series of pulses applied at a pulse frequency of 0.01-1000 Hz and a pulse duration of 0.1-5000 msec.

16. The system of claim 1 wherein the AP magnetic field is adapted to modify the cancer microenvironment (TME) of a brain cancer in a brain of the patient, wherein the brain cancer comprises one of cancerous brain tissue and a cancer metastasized to the brain from another region of the patient's body.

17. A system for treating cancer cells in a first portion of the patient's body by modifying a cancer microenvironment (TME), comprising:

an alternating polarity (AP) magnetic field generator adapted to provide an electrical signal to cause an AP magnetic field to be generated;

one or more AP electromagnetic coils coupled to the AP magnetic field generator and adapted to be coupled to the first portion of the patient's body and energized by the electrical signal from the AP magnetic field generator to generate an AP magnetic field having at least a first frequency of 5-500 kHz and a first field strength of 0.2-5 mT, wherein the AP magnetic field is adapted to modify the cancer microenvironment (TME) by modulating immune cell signaling molecules proximate to the cancer cells; and

a controller adapted to control the AP magnetic field generator and the one or more AP electromagnetic coils to cause the one or more AP electromagnetic coils to generate and apply to the first portion of the patient's body the AP magnetic field.

18. The system of claim 17 , wherein the AP magnetic field is further adapted to modify the cancer microenvironment (TME) by at least one of:

modulating blood vessels surrounding the cancer cells;

modulating fibroblasts proximate to the cancer cells;

modulating an extracellular matrix surrounding the cancer cells;

modulating resident host cells;

modulating infiltrating host cells;

modulating secreted factors proximate to the cancer cells;

modulating proteins surrounding the cancer cells;

modulating a concentration of pericycles proximate to the cancer cells; and

modulating a concentration of adipocytes proximate to the cancer cells.

19. The system of claim 17 , wherein the cancer cells are brain cancer cells selected from astrocytomas, glioblastoma multiforme, meningioma, and pituitary tumors, the system further comprising:

a retaining element comprising a head covering selected from a hat, a helmet, and a garment head covering for retaining the one or more AP electromagnetic coils in a desired position relative to the first portion of the patient's body during the application of the AP magnetic field.

20. A method for treating cancer cells in a first portion of the patient's body by modifying a cancer microenvironment (TME) using a system comprising an alternating polarity (AP) magnetic field generator, one or more AP electromagnetic coils coupled to the AP magnetic field generator and adapted to receive electrical signals from the AP magnetic field generator to generate an AP magnetic field, and a controller adapted to control the AP magnetic field generator and the one or more AP electromagnetic coils, the method comprising:

coupling the one or more AP electromagnetic coils to the first portion of the patient's body;

using the controller to cause the alternating polarity (AP) magnetic field generator to provide the electrical signals to the one or more AP electromagnetic coils cause the AP electromagnetic coils to generate an AP magnetic field having a first frequency of 5-500 kHz and a first field strength of 0.2-5 mT, wherein the AP magnetic field is adapted to modify the cancer microenvironment (TME) surrounding the cancer cells by at least one of:

increasing a number of M 1 macrophages in the TME surrounding the cancer cells;

decreasing a number of M 2 macrophages in the TME surrounding the cancer cells;

decreasing one of a number or a concentration of myeloid-derived suppressor cells (MDSCs) in the TME surrounding the cancer cells; and

modulating immune cell signaling molecules proximate to the cancer cells.

Assignments (1)

Continuity (9)

References Cited (133)