TRANSDUCER APPARATUSES FOR DELIVERING TUMOR TREATING FIELDS TO A SUBJECT'S BODY
20220305276 · 2022-09-29
Assignee
Inventors
Cpc classification
A61N1/0476
HUMAN NECESSITIES
A61N1/40
HUMAN NECESSITIES
International classification
Abstract
A transducer apparatus for delivering tumor treating fields to a subject's body, the transducer apparatus including: an array of electrode elements comprising all electrode elements present on the transducer apparatus, the array configured to be positioned over the subject's body with a face thereof facing the subject's body; when viewed from a direction perpendicular to the face, a number of electrode elements of the array are peripheral electrode elements defining an outer perimeter, the peripheral electrode elements substantially surrounding all other electrode elements; for each pair of adjacent peripheral electrode elements, a distance between the pair is not more than 25% greater than a distance between any other pair of adjacent peripheral electrode elements; and for each peripheral electrode element, an angle formed between the peripheral electrode element and its two adjacent peripheral electrode elements is greater than 90 and less than 180 degrees and facing interior to the array.
Claims
1. A transducer apparatus for delivering tumor treating fields to a subject's body, the transducer apparatus comprising: an array of electrode elements, the array comprising all electrode elements present on the transducer apparatus, the array configured to be positioned over the subject's body with a face of the array facing the subject's body; wherein, when viewed from a direction perpendicular to the face of the array, a number of the electrode elements of the array are peripheral electrode elements defining an outer perimeter of the array, the peripheral electrode elements substantially surrounding all other electrode elements of the array; for each pair of adjacent peripheral electrode elements along the outer perimeter, a distance between the pair of adjacent peripheral electrode elements is not more than 25% greater than a distance between any other pair of adjacent peripheral electrode elements; and for each peripheral electrode element, an angle formed between the peripheral electrode element and its two adjacent peripheral electrode elements along the outer perimeter is greater than 90 degrees and less than 180 degrees, the angle facing interior to the array.
2. The transducer apparatus of claim 1, wherein the outer perimeter either extends through, or touches the outermost edge of, each of the peripheral electrode elements.
3. The transducer apparatus of claim 1, wherein at least 50% of a total number of electrode elements in the array are peripheral electrode elements.
4. The transducer apparatus of claim 1, wherein the array comprises at least five peripheral electrode elements.
5. The transducer apparatus of claim 1, wherein, for each pair of adjacent peripheral electrode elements along the outer perimeter, a distance between the pair of adjacent peripheral electrode elements is not more than 10% greater than a distance between any other pair of adjacent peripheral electrode elements.
6. The transducer apparatus of claim 1, wherein, for each distance between the pair of adjacent peripheral elements along the outer perimeter, the distance is from a centroid of a first peripheral electrode element to a centroid of a second adjacent peripheral electrode element.
7. The transducer apparatus of claim 1, wherein, for each distance between a pair of adjacent peripheral elements along the outer perimeter, the distance is a shortest distance from an edge of a first peripheral electrode element to an edge of a second adjacent peripheral electrode element.
8. The transducer apparatus of claim 1, wherein the angle formed between at least one peripheral electrode element and its two adjacent peripheral electrode elements along the outer perimeter is between 108 degrees and 162 degrees.
9. The transducer apparatus of claim 1, wherein for each peripheral electrode element, the angle is measured between a first line connecting a centroid of the peripheral electrode element to a centroid of a first adjacent peripheral electrode element and a second line connecting the centroid of the peripheral electrode element to a centroid of a second adjacent peripheral electrode element.
10. The transducer apparatus of claim 1, wherein each of the electrode elements in the array, individually, has a shape selected from: disk-shaped or substantially disk-shaped; square, rectangular or hexagonal shape; substantially square, rectangular or hexagonal shape with one or more rounded corners; triangular shape; substantially triangular shape with rounded corners; truncated triangular shape; substantially truncated triangular shape with rounded corners; wedge shape; substantially wedge shape with rounded corners; truncated wedge shape; or substantially truncated wedge shape with rounded corners.
11. The transducer apparatus of claim 1, wherein each electrode element in the array comprises a ceramic disk.
12. The transducer apparatus of claim 1, wherein the outer perimeter extends through at least a majority of the peripheral electrode elements or is disposed along and touches an outermost edge of at least a majority of the peripheral electrode elements.
13. A transducer apparatus for delivering tumor treating fields to a subject's body, the transducer apparatus comprising: an array of electrode elements, the array comprising all electrode elements present on the transducer apparatus, the array configured to be positioned over the subject's body with a face of the array facing the subject's body; wherein, when viewed from a direction perpendicular to the face of the array, an outer perimeter substantially surrounding the array of electrode elements is entirely convex in shape; the outer perimeter either extends through, or touches the outermost edge of, at least five of the electrode elements of the array, the at least five electrode elements extended through or touched by the outer perimeter being peripheral electrode elements of the array; and the peripheral electrode elements of the array are spaced from each other along the perimeter with a variation in the spacing between adjacent peripheral electrode elements of less than 25%.
14. The transducer apparatus of claim 13, wherein the array does not have three or more peripheral electrode elements disposed adjacent each other and aligned with each other such that a straight line passes through the centroid of each of the three or more peripheral electrode elements.
15. The transducer apparatus of claim 13, wherein the convex outer perimeter is substantially circular, oval, ovaloid, ovoid, or elliptical.
16. The transducer apparatus of claim 13, wherein the convex outer perimeter has a regular polygon shape, a substantially regular polygonal shape with rounded or curved vertices, an irregular polygon shape, or an irregular polygonal shape with rounded or curved vertices.
17. A transducer apparatus for delivering tumor treating fields to a subject's body, the transducer apparatus comprising: an array of electrode elements, the array comprising all electrode elements present on the transducer apparatus, the array configured to be positioned over the subject's body with a face of the array facing the subject's body; wherein, when viewed from a direction perpendicular to the face of the array, an outer perimeter of the array circumscribes the array of electrode elements; an X-axis and a Y-axis of the array are perpendicular to each other and intersect each other at a centroid of the array and in a plane of the array; a first electrode element in the array is located at a first point of intersection between the X-axis and the outer perimeter; a second electrode element in the array is located at a second point of intersection between the X-axis and the outer perimeter; a third electrode element in the array is located at a first point of intersection between the Y-axis and the outer perimeter; and a fourth electrode element in the array is located at a second point of intersection between the Y-axis and the outer perimeter.
18. The transducer apparatus of claim 17, wherein the Y-axis is aligned with a largest dimension of the array measured along a straight line passing through the centroid of the array and intersecting the outer perimeter in two locations.
19. The transducer apparatus of claim 17, wherein the outer perimeter of the array is symmetrical with respect to the X-axis and/or symmetrical with respect to the Y-axis.
20. The transducer apparatus of claim 17, wherein at least four additional electrode elements other than the first, second, third, and fourth electrode elements touch the outer perimeter.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0005]
[0006]
[0007]
[0008]
[0009]
[0010]
[0011]
[0012]
DESCRIPTION OF EMBODIMENTS
[0013] This application describes exemplary transducer apparatuses for delivering TTFields to a subject's body and used to treat one or more cancers located in the subject's body.
[0014] When TTFields are applied to a subject's body, the temperature at the subject's body may increase proportionally to the induced electric field. Regulations limit the amount of current that can be driven through a transducer to an amount that keeps the measured temperature at locations on the subject's body below a threshold. Typically, the temperature at the location of the transducers on the subject's body is controlled to be below the threshold by reducing operational current driven by the transducer. This in turn becomes an over-riding limitation on the TTFields strength that can be used to treat the tumor. Thus, there is a need to safely access higher TTField strengths without exceeding the temperature threshold at the subject's skin.
[0015] The inventors discovered that, on a transducer having an array of electrode elements, electrode elements located along the edge of the array have a lower resistance to current flowing therethrough compared to electrode elements located toward the middle of the array. This can lead to higher concentrations of electric charge at points on the edge of the array in general. Further, an electrode element located at a corner or sharp bend in the array's edge will have a higher concentration than other electrode elements along the edge and in the center of the array. The tendency of a transducer to drive higher amounts of current through electrode elements at the edge (and particularly the corners) of the array is referred to herein as the “edge effect.”
[0016] An uneven distribution of current through the array of a transducer due to the edge effect can lead to higher temperature zones (or “hot spots”) forming at distant corners and along edges of the array. These hot spots are locations that reach the threshold temperature first and thus control the requirement to reduce the current. The generation of such hot spots limits the maximum operational current that may be driven by a transducer, and resulting TTField strength.
[0017] The inventors have now recognized that a need exists for transducers having electrode element array layouts that reduce or minimize the edge effect and allow the application of higher operating currents to the transducers. Transducers operated with increased current can induce stronger TTFields in the subject's body, leading to better patient outcomes. Transducers disclosed herein have arrays of electrode elements that reduce or minimize the edge effect.
[0018]
[0019]
[0020] The structure of the transducers may take many forms. In
[0021] The transducers 300A and 300B may comprise arrays of substantially flat electrode elements 302A and 302B, respectively. In one example, the electrode elements 302A and 302B are ceramic disks. In another example, the electrode elements 302A and 302B are ceramic elements that are not disk-shaped. In another example, the electrode elements 302A and 302B are non-ceramic dielectric materials positioned over a plurality of flat conductors such as, for example, polymer films disposed over pads on a printed circuit board or over flat pieces of metal.
[0022]
[0023]
[0024] As depicted in
[0025] In
[0026] In each electrode element layout described herein (e.g., in
[0027] In each electrode element layout described herein (e.g., in
[0028]
[0029] In
[0030] In
[0031] In
[0032] In
[0033] In
[0034] In
[0035] In
[0036] An outer perimeter of the array of electrode elements may be defined in other ways as well. In
[0037] As depicted in
[0038] In
[0039] In an example, as depicted in
[0040] As depicted in
[0041] As depicted in
[0042] In
[0043] The array of electrode elements may have symmetry with respect to one or more axes. For example, in
[0044] The Y-axis (622, 822) may be aligned with a largest dimension (e.g., horizontal in
[0045] The invention includes other illustrative embodiments (“Embodiments”) as follows.
[0046] Embodiment 1: A transducer apparatus for delivering tumor treating fields to a subject's body, the transducer apparatus comprising: an array of electrode elements, the array comprising all electrode elements present on the transducer apparatus, the array configured to be positioned over the subject's body with a face of the array facing the subject's body; wherein, when viewed from a direction perpendicular to the face of the array, a number of the electrode elements of the array are peripheral electrode elements defining an outer perimeter of the array, the peripheral electrode elements substantially surrounding all other electrode elements of the array; for each pair of adjacent peripheral electrode elements along the outer perimeter, a distance between the pair of adjacent peripheral electrode elements is not more than 25% greater than a distance between any other pair of adjacent peripheral electrode elements; and for each peripheral electrode element, an angle formed between the peripheral electrode element and its two adjacent peripheral electrode elements along the outer perimeter is greater than 90 degrees and less than 180 degrees, the angle facing interior to the array.
[0047] Embodiment 2: The transducer apparatus of Embodiment 1, wherein the outer perimeter either extends through, or touches the outermost edge of, each of the peripheral electrode elements.
[0048] Embodiment 3: The transducer apparatus of Embodiment 1, wherein at least 50% of a total number of electrode elements in the array are peripheral electrode elements.
[0049] Embodiment 4: The transducer apparatus of Embodiment 1, wherein at least 80% of a total number of electrode elements in the array are peripheral electrode elements.
[0050] Embodiment 5: The transducer apparatus of Embodiment 1, wherein no more than 50% of a total number of electrode elements in the array are peripheral electrode elements.
[0051] Embodiment 6: The transducer apparatus of Embodiment 1, wherein the array comprises at least five peripheral electrode elements.
[0052] Embodiment 7: The transducer apparatus of Embodiment 1, wherein, for each pair of adjacent peripheral electrode elements along the outer perimeter, a distance between the pair of adjacent peripheral electrode elements is not more than 10% greater than a distance between any other pair of adjacent peripheral electrode elements.
[0053] Embodiment 8: The transducer apparatus of Embodiment 1, wherein, for each distance between the pair of adjacent peripheral elements, the distance is from a centroid of a first peripheral electrode element to a centroid of a second adjacent peripheral electrode element.
[0054] Embodiment 9: The transducer apparatus of Embodiment 1, wherein, for each distance between the pair of adjacent peripheral elements, the distance is a shortest distance from an edge of one peripheral electrode element to an edge of an adjacent peripheral element.
[0055] Embodiment 10: The transducer apparatus of Embodiment 1, wherein the angle formed between at least one peripheral electrode element and its two adjacent peripheral electrode elements along the outer perimeter is between 108 degrees and 162 degrees.
[0056] Embodiment 11: The transducer apparatus of Embodiment 1, wherein for each peripheral electrode element, the angle is measured between a first line connecting a centroid of the electrode element to a centroid of a first adjacent peripheral element and a second line connecting the centroid of the electrode element to a centroid of a second adjacent peripheral electrode element.
[0057] Embodiment 12: The transducer apparatus of claim 1, wherein each of the electrode elements in the array, individually, has a shape selected from: disk-shaped or substantially disk-shaped; square, rectangular or hexagonal shape; substantially square, rectangular or hexagonal shape with one or more rounded corners; triangular shape; substantially triangular shape with rounded corners; truncated triangular shape; substantially truncated triangular shape with rounded corners; wedge shape; substantially wedge shape with rounded corners; truncated wedge shape; or substantially truncated wedge shape with rounded corners.
[0058] Embodiment 13: The transducer apparatus of Embodiment 1, wherein each electrode element in the array comprises a ceramic disk.
[0059] Embodiment 14: The transducer apparatus of Embodiment 1, wherein the outer perimeter extends through at least a majority of the peripheral electrode elements.
[0060] Embodiment 15: The transducer apparatus of Embodiment 1, wherein the outer perimeter is disposed along and touches an outermost edge of at least a majority of the peripheral electrode elements.
[0061] Embodiment 16: A transducer apparatus for delivering tumor treating fields to a subject's body, the transducer apparatus comprising: an array of electrode elements, the array comprising all electrode elements present on the transducer apparatus, the array configured to be positioned over the subject's body with a face of the array facing the subject's body; wherein, when viewed from a direction perpendicular to the face of the array, an outer perimeter substantially surrounding the array of electrode elements is entirely convex in shape; the outer perimeter either extends through, or touches the outermost edge of, at least five of the electrode elements of the array, the at least five electrode elements extended through or touched by the outer perimeter being peripheral electrode elements of the array; and the peripheral electrode elements of the array are spaced from each other along the perimeter with a variation in the spacing between adjacent peripheral electrode elements of less than 25%.
[0062] Embodiment 17: The transducer apparatus of Embodiment 16, wherein the array does not have three or more peripheral electrode elements disposed adjacent each other and aligned with each other such that a straight line passes through the centroid of each of the three or more peripheral electrode elements.
[0063] Embodiment 18: The transducer apparatus of Embodiment 16, wherein the convex outer perimeter is substantially circular, oval, ovaloid, ovoid, or elliptical.
[0064] Embodiment 19: The transducer apparatus of Embodiment 16, wherein the outer perimeter has a regular polygon shape or substantially regular polygonal shape with rounded or curved vertices.
[0065] Embodiment 20: The transducer apparatus of Embodiment 16, wherein the convex outer perimeter has an irregular polygon shape or an irregular polygonal shape with rounded or curved vertices.
[0066] Embodiment 21: A transducer apparatus for delivering tumor treating fields to a subject's body, the transducer apparatus comprising: an array of electrode elements, the array comprising all electrode elements present on the transducer apparatus, the array configured to be positioned over the subject's body with a face of the array facing the subject's body; wherein, when viewed from a direction perpendicular to the face of the array, the array has a convex outer perimeter substantially tracing the array of electrode elements, the convex outer perimeter being continuously rounded and without a straight line portion; and among peripheral electrode elements of the array which are touching the convex outer perimeter, a spacing between adjacent peripheral electrode elements along the convex outer perimeter has a variation of less than 25%.
[0067] Embodiment 22: The transducer apparatus of Embodiment 21, wherein the electrode elements of the array are each substantially disk-shaped.
[0068] Embodiment 23: The transducer apparatus of Embodiment 21, wherein the electrode elements of the array each comprise a ceramic disk.
[0069] Embodiment 24: The transducer apparatus of Embodiment 21, wherein the electrode elements of the array are each a square, rectangular or hexagonal shape or a substantially square, rectangular or hexagonal shape with one or more rounded corners.
[0070] Embodiment 25: The transducer apparatus of Embodiment 21, wherein the electrode elements of the array are each a triangular shape, a substantially triangular shape with rounded corners, a truncated triangular shape, a substantially truncated triangular shape with rounded corners, a wedge shape, a substantially wedge shape with rounded corners, a truncated wedge shape, or a substantially truncated wedge shape with rounded corners.
[0071] Embodiment 26: A transducer apparatus for delivering tumor treating fields to a subject's body, the transducer apparatus comprising: an array of electrode elements, the array comprising all electrode elements present on the transducer apparatus, the array configured to be positioned over the subject's body with a face of the array facing the subject's body; wherein, when viewed from a direction perpendicular to the face of the array, an outer perimeter of the array circumscribes the array of electrode elements; an X-axis and a Y-axis of the array are perpendicular to each other and intersect each other at a centroid of the array and in a plane of the array; a first electrode element in the array is located at a first point of intersection between the X-axis and the perimeter; a second electrode element in the array is located at a second point of intersection between the X-axis and the perimeter; a third electrode element in the array is located at a first point of intersection between the Y-axis and the perimeter; and a fourth electrode element in the array is located at a second point of intersection between the Y-axis and the perimeter.
[0072] Embodiment 27: The transducer apparatus of Embodiment 26, wherein the Y-axis is aligned with a largest dimension of the array measured along a straight line passing through the centroid of the array and intersecting the outer perimeter in two locations.
[0073] Embodiment 28: The transducer apparatus of Embodiment 26, wherein the outer perimeter of the array is symmetrical with respect to the X-axis.
[0074] Embodiment 29: The transducer apparatus of Embodiment 28, wherein the outer perimeter of the array is symmetrical with respect to the Y-axis.
[0075] Embodiment 30: The transducer apparatus of Embodiment 26, wherein at least four additional electrode elements touch the outer perimeter.
[0076] Embodiments illustrated under any heading or in any portion of the disclosure may be combined with embodiments illustrated under the same or any other heading or other portion of the disclosure unless otherwise indicated herein or otherwise clearly contradicted by context.
[0077] Modifications, alterations, and changes to the described embodiments are possible without departing from the scope of the present invention defined in the claims. The present invention has the full scope defined by the language of the claims, and equivalents thereof