KR20240045288A - A transducer device with electrode element spacing to reduce edge effects when delivering a tumor treatment field to the subject's body. - Google Patents

Abstract

A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: a plurality of electrode elements; the plurality of electrode elements include a first electrode element and a second electrode element, the first electrode element and the second electrode element being substantially located in a plane of the transducer device; When viewed in a direction perpendicular to the plane, the first electrode element and the second electrode element have edges adjacent to each other with no other electrodes between them, and the edges of the first electrode element and the second electrode element have their lengths. extend parallel to each other.

Description

A transducer device with electrode element spacing to reduce edge effects when delivering a tumor treatment field to the subject's body.

This application is filed under Taiwan Patent Application No. 111130476, U.S. Patent Application No. 17/886,319 filed on August 12, 2022, U.S. Patent Application No. 17/698,457 filed on August 11, 2022, and U.S. Patent Application No. 17/698,457 filed on March 18, 2022. Patent Application No. 63/232,329, filed Aug. 12, 2021, claims priority to U.S. Patent Application No. 63/232,229, all of which are incorporated herein by reference.

Tumor treatment fields are low-intensity (e.g., 1-4 V/cm) within the mid-frequency range (e.g., 50 kHz to 1 MHz, etc.) that can be used for tumor treatment as described in U.S. Pat. No. 7,565,205. ) alternating electric field, as described in U.S. Patent No. 7,565,205. Oncology field therapy is approved as a monotherapy for relapsed glioblastoma (GBM) and in combination with chemotherapy for patients with newly diagnosed GBM. The tumor treatment field can also be used to treat tumors in other parts of the subject's body (e.g., lung, ovary, pancreas). For example, oncological field therapy has been approved in combination with chemotherapy for malignant pleural mesothelioma (MPM). The tumor treatment field is guided non-invasively to the area of interest (e.g. using the Novocure Optune™ system) through transducers (e.g. an array of capacitively coupled electrode elements) placed directly on the patient's body and applying an alternating voltage between the transducers. do.

Conventional transducers used to create a tumor treatment field include multiple ceramic disks. One side of each ceramic disk is in close contact with the patient's skin, and the other side of each disk has a conductive support. An electrical signal is applied to this conductive support, which is electrostatically coupled to the patient's body via a ceramic disk. Conventional transducer designs involve a rectangular array of ceramic disks aligned with each other in straight rows and columns (e.g., a 3×3 array).

Figure 1 shows an example of a transducer placed on a subject's head.
Figure 2 shows an example of a transducer located on the torso of a subject.
Figures 3A and 3B show example cross-sectional views of various transducer structures.
Figure 3C shows a thermal image of a rectangular electrode array.
Figure 4 shows an example layout of an electrode element arrangement in a transducer device.
Figure 5 shows another example layout of an electrode element arrangement in a transducer device.
Figures 6a and 6b show another example layout of an electrode element arrangement in a transducer device.
Figure 7 shows another example layout of an electrode element arrangement in a transducer device.
Figure 8 shows another example layout of electrode element arrangement in a transducer device.
Figure 9 shows another example layout of electrode element arrangement in a transducer device.
Figure 10 shows another example layout of electrode element arrangement in a transducer device.
Figure 11 shows another example layout of electrode element arrangement in a transducer device.
Various embodiments are described in detail below with reference to the accompanying drawings, where like reference numerals represent like elements.

This application describes an exemplary transducer device used to deliver a tumor treatment field to a subject's body and treat one or more cancers located in the subject's body.

Applying a tumor treatment field to a subject's body may cause the subject's body temperature to rise in proportion to the induced electric field. Regulations limit the amount of current that can be driven through a transducer to that amount that keeps the temperature measured at the subject's body location below a temperature threshold. As practiced in the industry, the temperature at the transducer location on the subject's body is controlled to be below a temperature threshold by reducing the operating current driven by the transducer and reducing the intensity of the resulting tumor treatment field. This ultimately becomes an overriding limitation on the tumor treatment field strength that can be used for tumor treatment. Accordingly, there is a need for those skilled in the art to find a way to safely access higher tumor treatment field intensities without exceeding the temperature threshold of the subject's skin.

The inventors discovered that in a transducer including an array of electrode elements, electrode elements located along the edges of the array have lower resistance to current flowing compared to electrode elements located in the center of the array. This can result in higher charge concentrations at points that are typically at the edges (e.g. outer boundary) of the array. Additionally, electrode elements located at the edge corners of the array or similar sharp bends have higher concentrations than other electrode elements at the edges and in the center of the array. The tendency for transducers to drive larger amounts of current through electrode elements located at the edges of the array, especially corners, is referred to herein as the “edge effect.”

Edge effects can cause uneven distribution of current through a transducer array, causing hot areas (or "hot spots") to form at the far corners and edges of the array. These hot spots are the first to reach critical temperatures and therefore control the requirement to reduce current. Therefore, the creation of hot spots due to edge effects limits the maximum operating current that the transducer can drive and the strength of the resulting tumor treatment field.

Inventors have now recognized the need for transducers with electrode element array layouts that reduce or minimize edge effects and allow higher operating currents to be applied to the transducer. Transducers operating at higher currents can induce stronger tumor treatment fields into the subject's body, ultimately leading to better patient outcomes. Each disclosed transducer device has an array of electrode elements arranged in a layout in a shape that reduces or minimizes edge effects.

The present invention can be more easily understood by referring to the following detailed description, examples, drawings, and claims, as well as the preceding and following descriptions. However, it should be understood that the present invention is not limited to the specific apparatus, apparatus, system and/or method disclosed unless otherwise specified, and therefore may naturally vary.

Headings are provided for convenience only and should not be construed to limit the invention in any way. Embodiments illustrated in any title or portion of this disclosure may be combined with embodiments illustrated in the same or a different title or portion of this disclosure.

Unless otherwise specified herein or otherwise clearly contradicted by context, all possible combinations of variations of the elements described herein are considered to be encompassed by the invention.

As used in the specification and the appended claims, the singular forms "a", "an" and "the" include plural references unless the context clearly dictates otherwise.

Figure 1 shows a transducer 100 placed on the head of a subject's body. 1 shows an example of a subject's head with transducers 100 positioned in various positions and/or orientations. Placing such a transducer 100 on the subject's head allows application of a tumor treatment field to a tumor in the subject's brain region. It should be noted that a variety of different positions and/or orientations of the subject's head may be selected for transducer placement.

Each transducer 100 may deploy an array of electrode elements as described herein. Each transducer 100 may be placed on the subject's head so that the side of the electrode element array faces the subject's head. The transducer 100 may be placed on the subject's head so that the surface of the electrode element array matches the external shape of the head.

2 shows transducers 200, 202, 204, and 206 attached to a subject's body for applying a tumor treatment field to the subject's torso. In one embodiment, two electric fields are applied alternately between two pairs of transducers. Each transducer pair corresponds to a channel for generating a tumor treatment field in the subject's body. In the example shown in Figure 2, transducer 200 is attached to the front of the subject's right chest, transducer 202 is attached to the front of the subject's right thigh, and transducer 204 is attached to the back of the subject's left chest. Attached, the transducer 206 is attached to the back of the subject's left thigh. For a transducer pair, transducer 200 and transducer 206 may form a first transducer pair, and transducer 202 and transducer 204 may form a second transducer pair. there is.

Figure 2 is a diagram showing transducers 200, 202, 204, and 206 attached to the subject's body. For example, transducers 200, 202, 204, and 206 may be attached to the subject's body by applying a medically appropriate adhesive to the surface of each transducer. In other embodiments, transducers 200, 202, 204, and 206 may be placed in other locations on the body. In other embodiments, transducers 200, 202, 204, and 206 may be attached to one or more garments (not shown), such as shirts and pants, for example. In one example, transducers 200, 202, 204, and 206 can be attached to clothing using adhesive. In another example, transducers 200, 202, 204, and 206 may be attached to clothing by integrating transducers 200, 202, 204, and 206 within the clothing. In instances where the transducer is placed at a location on the subject's head, the transducer may be integrated into other types of clothing (eg, a hat).

Each transducer 200, 202, 204, and 206 can deploy an array of electrode elements as described herein. Each transducer 200, 202, 204, and 206 may be placed on the subject's body with the side of the array of electrode elements facing the subject's body. The transducers 200, 202, 204, and 206 may be placed on the subject's body such that the surface of the electrode element array matches the external shape of the subject's body.

An array of electrode elements may include a number of different layouts and/or electrode element geometries disclosed herein that reduce or minimize edge effects during operation of the transducer. For example, the layout may include adjacent first and second electrode elements having parallel edges, adjacent first and second electrode elements being non-circular and having varying distances between adjacent edges, and two groups of electrodes in an arrangement of electrode elements. Separation between elements, electrode elements having first and second edges extending radially outward from the central portion of the array and/or electrode elements having a larger area located closer to the outer edge of the array than the central portion of the array. may include.

3A and 3B show exemplary cross-sectional views of transducer structures. For example, as shown in Figure 3A, transducer 300A includes a plurality of electrode elements 302A and a substrate 304A. The substrate 304A is configured to attach the transducer 300A to the subject's body. Suitable materials for substrate 304A include fabric, foam, and flexible plastic, for example. In one example, substrate 304A includes a conductive medical gel having a thickness of at least about 0.5 mm. In a more specific example, substrate 304A is a hydrogel layer with a minimum thickness of 0.5 mm. In this situation, transducer 300A is attached to the subject's body via substrate 304A.

A plurality of electrode elements 302A are disposed on the substrate 304A. Each electrode element may have a conductive plate with a dielectric layer disposed toward the substrate 304A. Optionally, one or more sensors may be disposed beneath each electrode element 302A in a manner similar to a conventional arrangement used in the Novocure Optune system. In one example, the one or more sensors are temperature sensors (eg, thermistors).

FIG. 3B shows a cross-sectional view of another example of the structure of the transducer 300B. In this example, transducer 300B includes a plurality of electrode elements 302B. The plurality of electrode elements 302B are electrically and mechanically connected to each other without a substrate. Electrode elements 302B may be connected via conductive wire 304B.

As shown in FIGS. 3A and 3B, transducers 300A and 300B include arrays of substantially planar electrode elements 302A and 302B, respectively. 3A and 3B, the array of electrode elements can be capacitively coupled. In some embodiments, electrode elements 302A and 302B are non-ceramic dielectric materials disposed over a plurality of planar conductors. Examples of non-ceramic dielectric materials disposed over flat conductors include pads of printed circuit boards or polymer films disposed over substantially planar pieces of metal. In another embodiment, electrode elements 302A and 302B are ceramic elements.

Transducers using an array of electrode elements that are not capacitively coupled may also be used. In this situation, each electrode element 302A and 302B may be implemented using a region of conductive material configured to be placed on the subject's body without an insulating dielectric layer between the conductive element and the body.

Other alternative structures for implementing transducers for use with embodiments of the invention may also be used as long as they (a) can deliver a tumor treatment field to the subject's body and (b) can be placed at a location on the subject's body. .

3A and 3B show transducers 300A and 300B in a direction perpendicular to the Y-Z plane defined by the three-dimensional coordinate axis shown in the figure. As shown, the electrode elements 302A and 302B are distributed along a direction parallel to the Y axis. Additionally, the electrode elements 302A and 302B may be distributed along a direction parallel to the X axis. As such, transducers 300A and 300B may each include an array of electrode elements 302A and 302B distributed along a plane of the array and located in a plane substantially parallel to the X-Y plane. The plane of the array (parallel to the X-Y plane) is configured to face the subject's body when the transducer is positioned over the subject's body. Similar three-dimensional coordinate axes are drawn in the remaining figures.

Figure 3c shows a heat map of a 9-electrode transducer array (3 x 3 rectangular electrode array) in use, showing the presence of high temperature areas, or 'hot spots', at the edges, particularly the corners of the array. As described above, the creation of hotspots due to edge effects limits the maximum operating current that the transducer can drive and the strength of the resulting tumor treatment field.

4-11 each show example layouts of electrode elements on a transducer according to disclosed embodiments. In each example layout of electrode elements described herein (e.g., Figures 4-11), the layout is visible in a direction perpendicular to the plane of the electrode element array (i.e., perpendicular to the X-Y plane). The array of electrode elements is configured to be placed over the subject's body with this side of the array facing the subject's body. In the example layout described herein, an “array of electrode elements” may include all electrode elements (e.g., 402A-402H in FIG. 4) present in a transducer device (e.g., 400 in FIG. 4).

As shown in FIGS. 4 to 11 , the transducer (eg, 400 in FIG. 4 ) may include a substrate (eg, 404 in FIG. 4 ) on which electrode elements are disposed. In some embodiments (e.g., Figures 4 and 5), the substrate may have cuts, slits, or perforations formed therein to facilitate placement of the substrate on the rounded edges of the subject's body. As discussed above, other embodiments of the transducer may not include a substrate. The disclosed electrode element layout can be equally applied to transducers with a substrate and transducers without a substrate.

In certain transducers, for example as shown in Figures 6A-11, at least one of the electrode elements of the array extends from a central portion of the array toward the outer periphery of the array. For example, as shown in Figures 4-9, in a particular transducer each electrode element of the array may have approximately the same surface area. In certain transducers described herein, there are embodiments in which each electrode element in the array may have approximately the same size and/or shape. In other embodiments, one or more electrode elements of the array may have a different size and/or shape than the other electrode elements.

In the following description of Figures 4-11, reference is made to individual electrode elements having one or more edges. As used herein, the term “edge” refers to at least a portion of the outer boundary of an electrode element when viewed in a direction perpendicular to the X-Y plane. “Edges” have length. Therefore, an 'edge' is not simply a point on the outer boundary of an electrode element.

Each electrode element layout described herein (e.g., Figures 4-11) is designed to reduce or minimize edge effects and reduce the presence or intensity of hot spots formed by the array of electrode elements. This can be achieved by manipulating the shape and/or arrangement of the electrode elements of the array, particularly the spacing between the electrode elements of the array to promote substantially uniform shielding between them. The term 'shielding' means increased resistance to current flow through an electrode element due to the presence of one or more adjacent electrode elements. Promoting uniform shielding between all electrode elements in the array balances the current output from the electrodes, allowing the current to remain relatively constant throughout the array. Through this, the current supplied to the transducer can be increased while maintaining the subject's body temperature below the critical temperature.

4 shows a transducer 400 with an example layout of electrode elements 402 that may be placed on a substrate 404. As shown, the electrode elements 402 of the transducer 400 may be electrically coupled to each other. In Figure 4, the transducer's array of electrode elements includes eight electrode elements 402A-402H. 5 shows transducer 500 with another example layout of electrode elements 402. The layout of Figure 5 includes similar features to the layout of Figure 4 as described herein.

Figures 4 and 5 show the stacked structure of transducers 400 and 500. As shown, transducers 400 and 500 may include a printed circuit board (PCB) layer 405 between electrode elements 402 and substrate 404. PCB layer 405 may include conductive paths that electrically couple electrode elements 402.

The specific shape of the individual electrode elements 402 can help balance the current through the array. As an example, at least one of the electrode elements 402 in the array may have a square, rectangular, or hexagonal shape or a substantially square, rectangular, or hexagonal shape with one or more rounded corners. 4 and 5 show each electrode element 402 having a substantially rectangular shape with four rounded corners. As shown with respect to electrode element 402A, one or more electrode elements 402 have a first edge 406, a second edge 408, and a first edge 406 at an end of electrode element 402A. It may include at least one rounded corner (eg, rounded corners 410A and 410B) connecting to second edge 408. As shown, the first edge 406 and second edge 408 of electrode element 402A are substantially parallel (eg, within ±5 degrees).

As previously discussed, controlling the spacing between individual electrode elements 402 can help balance the current through the array. In one example, a first electrode element (e.g., 402A) and a second electrode element (e.g., 402B) each have edges located adjacent to each other with no other electrodes between them. For example, first edge 406 of electrode element 402A is located adjacent edge 412 of electrode element 402B. As shown, first edge 406 may be a substantially straight edge portion of electrode element 402A located between two rounded corners 410B and 410C of electrode element 402A. Similarly, second edge 412 may be a substantially straight edge portion of electrode element 402B located between two rounded corners of electrode element 402B. As shown, the edge 406 of the first electrode element 402A and the edge 412 of the second electrode element 402B extend parallel to each other along their length. Accordingly, electrode elements 402A and 402B have a uniform distance 414 therebetween along the length of opposite edges 406 and 412. Having a uniform distance 414 between the two electrodes can help maintain current balance between the electrode elements 402 to reduce edge effects on the transducer.

As shown, the edge 406 of electrode element 402A may have a length greater than 5% of the total circumference of electrode element 402A. More specifically, edge 406 may have a length greater than 10% of the circumference, greater than 20% of the circumference, or greater than 25% of the circumference of electrode element 402A. Similarly, edge 412 of electrode element 402B may have a length greater than 5% of the circumference of electrode element 402B. More specifically, edge 412 may have a length greater than 10%, greater than 20%, or greater than 25% of the circumference of electrode element 402B. This facilitates mutual shielding of electrode elements 402A and 402B along sufficiently large portions of the electrode elements.

As shown, an electrode element (e.g., 402A) may have a plurality of edges each parallel to another adjacent electrode element (e.g., 402B and 402C). For example, in FIGS. 4 and 5 , electrode element 402A has another substantially straight edge located parallel to and at a uniform distance 416 from a substantially straight edge of electrode element 402C. In the example shown in FIG. 4 , the distance 416 between the edges of electrode elements 402A and 402C is equal to or may be substantially equal to the distance 414 between the edges of electrode elements 402A and 402B. You can. In another example shown in Figure 5, distance 414 and distance 416 are different.

The arrangement of the electrode elements 402 on the transducer 400/500 shown in FIGS. 4 and 5 can also contribute to improving the current distribution between the electrode elements 402. As illustrated, transducers 400 and 500 each include an array of eight electrode elements 402. Among the eight electrode elements 402, the array consists of a first group 418A of four electrode elements 402A-402D arranged in a 2x2 grid pattern and a first group 418A of four electrode elements 402E- arranged in a 2x2 grid pattern. 402H) may include a second group (418B). As shown, each 2x2 grid pattern includes first and second electrode elements (e.g., 402A and 402B), third and fourth electrode elements (e.g., 402C and 402D) are aligned with each other in a direction parallel to the Y axis, first and third electrode elements (e.g., 402A and 402C) are aligned with each other in a direction parallel to the X axis, and second and fourth electrode elements (e.g., 402A and 402C) are aligned with each other in a direction parallel to the For example, 402B and 402D) may be aligned with each other in a direction parallel to the X axis. The distance 414 between the first and second electrode elements (eg, 402A and 402B) may be equal to the distance between the third and fourth electrode elements (eg, 402C and 402D). Additionally, the distance 416 between the first and third electrode elements (eg, 402A and 402C) may be equal to the distance between the second and fourth electrode elements (eg, 402B and 402D). Groups 418A and 418B may all have the same size and arrangement of the four electrode elements therein.

As shown, the first group 418A of four electrode elements 402A-402D is separated by a distance 420 from the second group 418B of four electrode elements 402E-402H. The distance 420 is greater than the spacing between any two of the four electrode elements 402A-402D of the first group 418A and any two of the four electrode elements 402E-402H of the second group 418B. is greater than the gap between two That is, distance 420 is greater than distance 414 and greater than distance 416 in the first group 418A of four electrode elements 402A-402D. Likewise, distance 420 is greater than the corresponding distance in second group 418B of four electrode elements 402E-402H. Ensuring greater spacing between the two groups of electrode elements (418A and 418B) than between individual electrode elements within the group can help balance the current flowing through the array as follows: Separating the more centrally placed electrode elements (402B, 402D, 402E, and 402G) from each other and leaving a larger space in the center of the array increases the amount of shielding experienced by the more centrally placed electrode elements (402B, 402D, 402E, and 402G). Decrease these electrode elements to behave like edge electrode elements (e.g. 402A, 402C, 402F, 402H). Accordingly, the current passing through the central portion of the array of electrode elements can be increased or maximized, and the current passing through the entire array can be balanced to reduce edge effects.

As shown, the distance 420 between the two groups of electrodes 418A and 418B is in the direction of the longest dimension of the transducer 400/500 (e.g., parallel to the Y axis as shown in the figure). It can be located in . In embodiments where the electrode elements 402 are rectangular or substantially rectangular with one or more rounded corners, as shown, each electrode element 402 has its longest dimension equal to the distance 420 between groups 418A and 418B. It may be oriented in a direction substantially perpendicular to the orientation. This arrangement may further balance the current output through the arrangement of electrode elements 402 on the transducers 400/500.

As an example, as shown in Figure 5, the first group 418A of electrode elements 402A-402D may include two pairs of electrode elements 502A and 502B, and two pairs of electrode elements 502A and 502B) include electrode elements 502A and 502B spaced apart from each other (spaced by a distance 416) in a second direction (parallel to the X axis as shown in the figure). . The second group 418B of electrode elements 402E-402H may similarly include two pairs of electrode elements 502C and 502D, where the two pairs of electrode elements 502C and 502D are spaced apart from each other in a second direction. (by distance 416).

Any number of electrode elements 402 within the array can have substantially similar shapes. For example, in Figures 4 and 5, all electrode elements 402A-402H have substantially similar shapes as described above. In other embodiments, one or more electrode elements within the array may have substantially different shapes from one another. As shown in Figures 4 and 5, each electrode element 402A-402H within the array can have approximately the same surface area, further balancing the current output from the individual electrode elements.

PCB layer 405 may include electrical connector portions 422 that provide points for connecting leads to transducers 400/500. 4, electrical connector portion 422 may be placed in the center of transducer 400 in the space provided by the increased distance 420 between two groups of electrode elements 418A and 418B. 5, at least a portion of the electrical connector portion 422 is between two pairs of electrode elements (e.g., 502A and 502B) in one of a group (e.g., 418A) of four electrode elements (e.g., 402A-402D). It can be located in an array. The position of the electrical connector portion 422 in FIGS. 4 and 5 helps avoid breaking the symmetry of the layout of the electrode element array.

6A and 6B show transducer 600 with an example layout of electrode elements 602A-602H that may be placed on substrate 604. The layout of electrode elements 602 is the same in both FIGS. 6A and 6B. 7 and 8 show transducers 700 and 800 having the same type of electrode elements 602A-602H, but with different shapes and arrangements. As shown in FIGS. 6A-8, transducers 600, 700, and 800 may each include a PCB layer 605 between electrode elements 602 and a substrate 604. PCB layer 605 may include conductive paths that electrically couple electrode elements 602. PCB layer 605 may include electrical connector portions 622 that provide points for connecting leads to transducers 600/700/800. As shown, the electrical connector portion 622 may be disposed at the center 611 of the transducer 600/700/800 surrounded by the array of electrode elements 602. Other embodiments of the transducer may feature electrical connectors located elsewhere on the transducer.

The specific shape of the individual electrode elements 602 can help balance the current through the array. As an example, at least one of the electrode elements 602 in the array has 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, and a substantially triangular shape with rounded corners. It may have a wedge shape, a truncated wedge shape, or a substantially truncated wedge shape with rounded edges. 6A-8 show each electrode element 602 having a substantially wedge shape with rounded corners and rounded corners pointing radially outward. As shown, electrode element 602 is non-circular.

As shown with respect to electrode element 602C, one or more electrode elements 602 have a first edge 606, a second edge 608, and a first edge 606 at an end of electrode element 602C. It may include at least one rounded edge 610 connecting the second edge 608. 6A-8, the first edge 606 and second edge 608 of electrode element 602C are not substantially parallel. Rather, the first edge 606 extends radially outward with respect to the center 611 of the array, and the second edge 608 extends radially outward with respect to the center 611 of the array. The rounded edge 610 connecting the first edge 606 to the second edge 608 is located at the end of the electrode element radially away from the center 611 of the array. As shown, rounded corners 612 may connect first edge 606 to second edge 608 at opposite ends of the electrode element positioned radially toward center 611 . The radius of curvature of the rounded corner 610 may be larger than the radius of curvature of the rounded corner 612. As shown, rounded corner 614 may connect first corner 606 to rounded corner 610, and rounded corner 616 may connect second corner 608 to rounded corner 610.

As shown in Figures 6A and 8, the first electrode element (eg, 602A) and the second electrode element (eg, 602H) each have edges located adjacent to each other without other electrodes between them. For example, edge 618 of electrode element 602A is located adjacent edge 620 of electrode element 602H. Both edges 618 and 620 may be substantially straight edges located between two rounded corners of each electrode element 602A and 602H. As shown, edges 618 and 620 extend parallel to each other along their length. Accordingly, electrode elements 602A and 602H have a uniform distance 624 therebetween along the length of their opposite edges 618 and 620.

Edge 618 may have a length greater than 5% of the total circumference of electrode element 602A. More specifically, edge 618 may have a length greater than 10%, greater than 20%, or greater than 25% of the circumference of electrode element 602A. Similarly, edge 620 may have a length greater than 5% of the perimeter of electrode element 602H. More specifically, edge 620 may have a length greater than 10%, greater than 20%, or greater than 25% of the circumference of electrode element 602H.

As shown, an electrode element (e.g., 602A) may have a plurality of edges each parallel to another adjacent electrode element (e.g., 602H and 602B). For example, in FIGS. 6A, 6B, and 8, electrode element 602A has another substantially straight edge located parallel and at a uniform distance from a substantially straight edge of electrode element 602B. In the illustrated example, the distance between the edges of electrode elements 602A and 602B may be equal to the distance 624 between the edges of electrode elements 602A and 602H. In other examples the distance may be different.

As shown in FIGS. 6A-8 , multiple electrode elements 602 may be disposed peripherally with respect to the center 611 of the array. At least one of the electrode elements 602 in the array may extend from the center 611 of the array toward the outer periphery of the array. For example, in Figures 6A-8, all electrode elements 602A-602H extend from the center 611 toward the outer periphery of the array. The peripheral arrangement of electrode elements 602 may provide additional balance between current output through electrode elements 602.

FIG. 6B shows transducer 600 with a plurality of electrode elements 602A-602H and shows transducer 600 with two example boundaries 626 and 628 drawn over transducer 600. First boundary 626 is defined by tracing the outer perimeter of transducer 600. The outer perimeter of the transducer 600 may be defined as either the peripheral edge of the PCB layer 605, the peripheral edge of the substrate 604, or the outer edge of each electrode element 602, as shown. The second boundary 628 is defined by continuously tracing the midpoint between the center 630 of the transducer 600 and the outer perimeter of the transducer at all locations surrounding the center 630. For at least one of the electrode elements (e.g., 602A) in the array, a first portion 632 of the electrode element 602A is located inside the first boundary 626 and outside the second boundary 628, wherein the electrode element ( The second part 634 of 602A is located inside the second boundary 628, and the area of the first part 632 is larger than the area of the second part 634. Accordingly, the largest surface area portion of electrode element 602A is located closer to the peripheral or outer edge of the electrode element array, and the smaller surface area portion of electrode element 602A is located closer to the center 630 of the array. In the illustrated embodiment, all electrode elements 602 of the array have a larger surface area at the peripheral edges and a smaller surface area toward the center 630. 7 and 8 also have similar spatial configurations of the electrode elements 602.

This spatial configuration of electrode elements 602 relative to transducer 600 can improve the balance of heat output in the array. Heat output by electrode element 602 is a function of current concentration divided by surface area. A higher concentration of current travels through the peripheral portion 632 of the electrode element 602 than the interior portion 634 due to edge effects of the array and shielding from other electrode elements. Accordingly, configuring the electrode element 602 to have an interior portion 634 with a relatively small surface area and a peripheral portion 632 with a relatively large surface area reduces the amount of heat output from different portions of the electrode element 602. It helps to balance things out.

7 shows another example of transducer 700 with an example layout of electrode elements 602A-602H that may be placed on substrate 604. In transducer 700, the distance between the edges of adjacent electrode elements varies depending on the length of the edges. For example, a first electrode element (e.g., 602D) and a second electrode element (e.g., 602E) each have edges located adjacent to each other with no other electrodes between them. For example, edge 702 of electrode element 602D is located adjacent edge 704 of electrode element 602E. Both edges 702 and 704 may be substantially straight edges located between two rounded corners of each electrode element 602D and 602E. The distance from the first edge 702 to the second edge 704 varies along the length of the first and second edges 702 and 704. Accordingly, electrode elements 602D and 602E do not have a uniform distance between them along the edge.

For example, when the bisector 706 is drawn between the first edge 702 and the second edge 704, the distance from the first edge 702 to the bisector 706 is measured in a direction perpendicular to the bisector 706. The distance 708 may be equal to the distance 710 from the second edge 704 to the bisector 706 measured in a direction perpendicular to the bisector 706 along the length of the first and second edges 702 and 704. In the example of Figure 7, first edges 702, 704 and second edges 706 are both linear. Accordingly, the distance between the first edge 702 and the second edge 704 may have a constant rate of change along the lengths of the edges 702 and 704. The first edge and second edge may be non-linear in other embodiments.

As shown in FIG. 7, the distance from the first edge 702 to the second edge 704 is from the central portion 611 along the length of the first and second edges 702 and 704 to the outside of the transducer 700. It may decrease towards the periphery. This is a balance between the heat output of the electrode elements 602 because as the distance between the electrode elements 602 increases towards the center, the surface area of the inner portion of the electrode elements 602 decreases, increasing the heat output in this low current region. can be improved.

8 shows that the electrode elements 602A-602H are divided into two groups, the electrical connector portion 622 is aligned in a direction parallel to the X-axis, and the largest dimension of the transducer 800 is in a direction parallel to the Y-axis ( Shows an example of the transducer 800 on the axis shown in the figure. 8, transducer 800 includes a first group 802A of electrode elements 602A, 602B, 602G, and 602H and a second group 802B of electrode elements 602C, 602D, 602E, and 602F. As shown, the first group 802A of electrode elements is separated from the second group 802B of electrode elements by a distance 804. The distance 804 may be greater than the spacing between two adjacent electrode elements 602A, 602B, 602G, and 602H in the first group 802A, and between two adjacent electrode elements 602C, 602D, 602E in the second group 802B. and 602F). That is, distance 804 may be greater than distance 624 and greater than the distance between adjacent electrode elements 602 in one of groups 802A or 802B. The location of the electrode elements 602 and the electrical connector portion 622 of the PCB layer 605 in FIG. 8 can help improve current or heat balancing between the electrodes without breaking the symmetry of the electrode layout. .

9 shows another example of a transducer 900 with an example layout of electrode elements 902 that may be placed on a substrate 904. Transducer 900 may include six electrode elements 902A-902F. In the transducer 900, the shape, size and overall layout of the electrode elements 902 are similar to Figure 7, but the distance between the edges of adjacent electrode elements 902 varies in opposite directions along the length of the edges. For example, in Figure 9, edge 906 of electrode element 902B is located adjacent edge 908 of electrode element 902C. The distance from the first edge 906 to the second edge 908 varies along the length of the first and second edges 906, 908. Accordingly, electrode element 902B and electrode element 902C do not have a uniform distance therebetween along the edge. For example, when the bisector 912 is drawn between the first edge 906 and the second edge 908, the distance from the first edge 906 to the bisector 912 is measured in a direction perpendicular to the bisector 912. The distance 914 is the distance 916 from the second edge 908 to the bisector 912 measured in a direction perpendicular to the bisector 912 along the length of the first and second edges 906, 908. It's the same. In the example of Figure 9, the first and second edges 906 and 908 are both linear. Accordingly, the distance between the first edge 906 and the second edge 908 may have a constant rate of change depending on the lengths of the edges 906 and 908. 9, the distance from the first edge 906 to the second edge 908 extends from the central portion 910 along the length of the first and second edges 906, 908 toward the outer periphery of the transducer 900. It can increase. This may improve the balance between heat output from electrode elements 902 in certain embodiments. The spacing between adjacent electrode elements of the transducers described herein can be adjusted to meet the desired current distribution or heat distribution.

10 shows another example of transducer 1000 with an example layout of electrode elements 1002 that may be placed on substrate 1004. Transducer 1000 may include nine electrode elements 1002A-1002I, eight of which are peripheral electrode elements 1002A-1002H surrounding one non-peripheral electrode element 1002I. In transducer 1000, the shape of peripheral electrode elements 1002A-1002H is similar to that of electrode elements 602A-602H in Figures 6A-8. Transducer 1000 may include a PCB layer 1005 between electrode elements 1002 and a substrate 1004.

As shown in FIG. 10 , transducer 1000 includes at least one pair of electrode elements (e.g., 1002A and 1002H) with adjacent edges 1006 and 1008 parallel to each other (equal distance 1010). Transducer 1000 may also include at least one pair of electrode elements (e.g., 1002A and 1002B) having adjacent edges that are not parallel to each other but instead have varying distances between them. They may or may not all have the same size and/or shape. As shown in Figure 10, transducer 1000 may include an array of electrode elements 1002 that are not all the same size or shape. For example, non-peripheral electrode element 1002I has a substantially rectangular shape with rounded corners, while each peripheral electrode element 1002A-1002H has a substantially truncated wedge shape with rounded corners and rounded peripheral corners. .

11 shows a transducer 1100 with an example layout of electrode elements 1102 that may be placed on a substrate 1104. In Figure 11, the array of electrode elements includes six electrode elements 1102A-1102F. In one example, at least one of the electrode elements 1102 in the array may have an irregular shape. Figure 11 shows each of the electrode elements 1102 having an irregular shape with one or more edges. As shown with reference to electrode element 1102A, one or more electrode elements 1102 have a first edge 1106, a second edge 1108, and a first edge 1106 at an end of electrode element 1102A. It may include at least one rounded edge 1110 connecting the second edge 1108. In Figure 11, first edge 1106 and second edge 1108 are not substantially parallel. The first edge 1106 and the second edge 1108 both extend radially outward with respect to the center of the array, and the rounded edge 1110 extends with the first edge 1106 at the end of the electrode element radially away from the center of the array. ) is connected to the second edge (1108).

In one example, first edge 1106 of electrode element 1102A is located adjacent edge 1112 of electrode element 1102B. As shown, first edge 1106 may include a curved portion of electrode element 1102A. Similarly, edge 1112 of second electrode element 1102B may include a curved portion of electrode element 1102B. As shown, the edge 1106 of the first electrode element 1102A and the edge 1112 of the second electrode element 1102B extend parallel to each other along their length. That is, electrode elements 1102A and 1102B have a uniform distance 1114 therebetween along the length of their opposing edges 1106 and 1112. 11 shows edges 1106 and 1112 each having a curved portion, in other embodiments edges 1106 and 1112 are positioned at corners while remaining equidistant from each other (i.e., substantially parallel along their length). It should be noted that it may have partial, zigzag, or other non-linear directions.

As shown, the edge 1106 of electrode element 1102A may have a length greater than 5% of the total circumference of electrode element 1102A. More specifically, edge 1106 may have a length greater than 10%, greater than 20%, or greater than 25% of the circumference of electrode element 1102A. Similarly, edge 1112 of electrode element 1102B may have a length greater than 5% of the circumference of electrode element 1102B. More specifically, edge 1112 may have a length greater than 10%, greater than 20%, or greater than 25% of the circumference of electrode element 1102B.

In Figure 11, an electrode element (eg, 1102A) and an adjacent electrode element (eg, 1102F) each have edges located close to each other. For example, edge 1108 of electrode element 1102A (hereinafter referred to as “first edge”) is adjacent to edge 1116 (hereinafter referred to as “second edge”) of electrode element 1102F. Located. Edge 1108 and edge 1116 may both be curved edges. The distance from the first edge 1108 to the second edge 1116 varies depending on the length of the edge. Accordingly, electrode elements 1102A and 1102F do not have a uniform distance between them along the edge.

As shown, when the bisector 1118 is drawn between the first edge 1108 and the second edge 1116, the distance 1120 measured from the first edge 1108 in a direction perpendicular to the bisector 1118 ) is equal to the distance from the distance 1122 to the second edge 1116 measured in a direction perpendicular to the bisector 1118 along the lengths of the first and second edges 1108 and 1116. In Figure 11, the first edges 1108 and 1116 and the second edges 1108 and 1116 are both non-linear, so the distance between the first edge 1108 and the second edge 1116 does not have a constant rate of change. As shown in Figure 11, the distance from the first edge 1108 to the second edge 1116 extends from the center along the length of the first and second edges 1108, 1116 to the outer periphery of the transducer 1100. can increase towards. In other embodiments, the distance between two curved edges may decrease from the center toward the outer periphery of the transducer.

The present invention includes other items as follows.

Item 1. A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: a plurality of electrode elements; The plurality of electrode elements includes a first electrode element and a second electrode element, the first electrode element and the second electrode element being substantially located in a plane of the transducer device and viewed in a direction perpendicular to the plane. When the first electrode element and the second electrode element have adjacent edges with no other electrodes between them, the edges of the first electrode element and the second electrode element extend parallel to each other along their length.

Item 2. The transducer device of item 1, wherein the first electrode element has: a second edge; and an edge of the first electrode element and at least one rounded edge connected to the second edge at an end of the first electrode element.

Item 3. The transducer device of item 2, wherein the edge of the first electrode element and the second edge are not substantially parallel.

Item 4. The transducer device of item 1, wherein at least one of the electrode elements of the array extends from a central portion of the array toward the outer periphery of the array.

Item 5. The transducer device of item 1, wherein at least one of the electrode elements of the array has an irregular shape.

Item 6. The transducer device of item 1, wherein the electrode element comprises a polymer film disposed on a pad of a printed circuit board or a substantially planar metal.

Item 7. A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: a first electrode element having a first edge; a second electrode element electrically coupled to the first electrode element, the second electrode element having a second edge; wherein the first electrode element and the second electrode element are located substantially in the plane of the transducer device, and when viewed in a direction perpendicular to the plane, the first edge is located close to the second edge; The distance from the first edge to the second edge varies along the length of the first and second edges, where the first and second electrode elements are non-circular.

Item 8. The transducer of item 7 is such that when a bisector is drawn between a first edge and a second edge, the distance from the first edge to the bisector, measured in a direction perpendicular to the bisector, is measured in a direction perpendicular to the bisector. The distance from the second edge to the bisector is equal along the lengths of the first and second edges.

Item 9. The transducer of item 7 is a transducer in which at least one of the first edge and the second edge is nonlinear.

Item 10. A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: an array of eight electrode elements, the array configured to be disposed on the subject's body, the face of the array having: When viewed in a direction perpendicular to the plane of the array, facing the subject's body, each electrode element is substantially square, rectangular, or hexagonal in shape or substantially square, rectangular, or hexagonal with rounded corners, and the eight electrode elements are arranged in a 2x2 grid. comprising a first group of four electrode elements arranged in a pattern and a second group of four electrode elements arranged in a 2x2 grid pattern; The first group of four electrode elements is greater than the gap between any two of the four electrode elements of the first group from the second group of four electrode elements, and They are separated by a distance greater than the gap between any two.

Item 11. The transducer device of item 10, wherein, when viewed in a direction perpendicular to the plane of the array: a first group of electrode elements are separated from a second group of fourth electrode elements in the first direction; The first electrode element group includes two pairs of second electrode elements, the two pairs being spaced apart from each other in a second direction perpendicular to the first direction; and the second group of fourth electrode elements includes two pairs of electrode elements spaced apart from each other in the second direction.

Item 12. A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: an array of a plurality of electrode elements, the array configured to be positioned over the subject's body, wherein a side of the array is positioned above the subject's body. facing the body of; When viewed in a direction perpendicular to the plane of the array, at least one electrode element is located proximate to the center of the array, and wherein the at least one electrode element includes: A transducer device for treating: a first edge extending in a radially outward direction with respect to the center of the array; a second edge extending radially outward with respect to the center of the array; and a rounded edge connecting the first edge and the second edge at an end of the electrode element radially away from the center of the array.

Item 13. A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: a plurality of electrode elements, wherein the plurality of electrode elements comprises a first electrode element located substantially in the plane of the transducer device. a transducer device, wherein, when viewed in a direction perpendicular to the plane, the first boundary is defined by tracing an outer perimeter of the transducer device; a second boundary defined by continuously tracing midpoints between the center of the transducer device and the outer perimeter of the transducer device at all locations surrounding the center; a first portion of the first electrode element is located inside the first boundary and outside the second boundary; a second portion of the first electrode element is located within the second boundary; The area of the first part is larger than the area of the second part.

Item 14. The transducer device of item 9, wherein the plurality of electrode elements further comprises a second electrode element, wherein the first electrode element and the second electrode element have edges adjacent to each other without another electrode between them, and wherein the first electrode element The edges of the electrode element and the second electrode element extend parallel to each other along their length.

Item 15. The transducer device of item 9, wherein the first electrode element comprises: a first edge extending in a radially outward direction about the center; a second edge extending radially outward about the center; and a rounded edge connecting the first edge and the second edge at the end of the electrode element radially away from the center.

Clause 16. A transducer device according to clauses 1, 7, 10, 12 or 13 wherein the surface areas of each electrode element are approximately equal.

Clause 17. The transducer device according to clause 10, further comprising an electrical connector coupled to the array of eight electrode elements, wherein the electrical connector is between a first group of four electrode elements and a second group of four electrode elements. It is located in the array of

Item 18. The transducer device according to item 11, further comprising an electrical connector coupled to an array of eight electrode elements, wherein at least a portion of the electrical connector is an array between two pairs of electrode elements in a first group of electrode elements. It is located in

Item 19. The transducer device according to item 12, further comprising an electrical connector coupled to the array of electrode elements, the electrical connector being located in a central portion of the array.

Item 20. The transducer device according to item 12, wherein the plurality of electrode elements comprises a first group of electrode elements and a second group of electrode elements, wherein the first group of electrode elements when viewed in a direction perpendicular to the plane of the array. , is separated from the second group of electrode elements by a distance that is greater than the spacing between any two adjacent electrode elements in the first group and is greater than the spacing between any two adjacent electrode elements in the second group.

In each embodiment disclosed herein, the edge of the first electrode element may have a length greater than 5% of the total circumference of the first electrode element, and in particular, the edge of the first electrode element may have a length greater than 5% of the total circumference of the first electrode element. may have a length greater than %, a length greater than 20%, or a length greater than 25%; And, the edge of the second electrode element may have a length greater than 5% of the circumference of the second electrode element, and in particular, the edge of the second electrode element may have a length greater than 10%, or more than 20%, of the circumference of the second electrode element. It may have a large length or a length greater than 25%.

Although the present invention has been disclosed with reference to specific embodiments, numerous modifications, changes and alterations are possible to the described embodiments without departing from the scope and scope of the invention as defined in the appended claims. Accordingly, the present invention is not intended to be limited to the described embodiments, but is to have the full scope defined by the language of the following claims and equivalents thereto.

Claims (15)

A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising:
a plurality of electrode elements;
the plurality of electrode elements include a first electrode element and a second electrode element, the first electrode element and the second electrode element being substantially located in a plane of the transducer device;
When viewed in a direction perpendicular to the plane,
The first electrode element and the second electrode element have adjacent edges with no other electrodes between them, and the edges of the first electrode element and the second electrode element extend parallel to each other along their lengths. . According to paragraph 1,
Each of the edges is
A transducer device that is a substantially straight edge portion located between two curved edges of corresponding said electrode elements. According to paragraph 1,
Each of the edges is:
having curved, edged, or zigzag parts;
The transducer device of claim 1 , wherein the curved, corner, or zigzag portion of the edges are non-linear, and the edges are equally spaced from each other along the length of the curved, corner, or zigzag portion. According to claim 1, 2 or 3,
The edge of the first electrode element is
Having a length greater than 5% of the outer circumference of the first electrode element,
The edge of the second electrode element is
A transducer device having a length greater than 5% of the outer circumference of the second electrode element. According to any one of claims 1 to 4,
at least one of the electrode elements in the array has a square, rectangular or hexagonal shape or a substantially square, rectangular or hexagonal shape with one or more rounded corners;
At least one of the electrode elements in the array has 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 rounded shape. A transducer device having a substantially truncated wedge shape at the edges. According to any one of claims 1 to 5,
The first electrode element is:
second edge; and
having at least one rounded edge connecting the edge of the first electrode element to a distal second edge of the first electrode element,
Optionally, the edge of the first electrode element and the second edge are substantially parallel. According to any one of claims 1 to 6,
A transducer device wherein the electrode elements of the array are capacitively coupled. According to any one of claims 1 to 6,
A transducer device wherein the array of electrode elements is not capacitively coupled. A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising:
a first electrode element having a first edge;
a second electrode element electrically coupled to the first electrode element, the second electrode element having a second edge;
The first electrode element and the second electrode element are located substantially in the plane of the transducer device;
When viewed in a direction perpendicular to the plane,
the first edge is located proximate to the second edge;
The distance from the first edge to the second edge varies along the length of the first and second edges, wherein the first and second electrode elements are non-circular. According to clause 9,
The transducer device of claim 1, wherein the first edge and the second edge are both linear. According to claim 9 or 10,
each of the first edge and the second edge extends from a central portion of the transducer device toward the outer periphery of the transducer device;
A transducer device wherein the distance from the first edge to the second edge decreases along the length of the first and second edges from a central portion of the transducer device toward the outer periphery of the transducer device. According to claim 9 or 10,
each of the first edge and the second edge extends from a central portion of the transducer device toward the outer periphery of the transducer device;
A transducer device wherein the distance from the first edge to the second edge increases along the length of the first and second edges from a central portion of the transducer device toward the outer periphery of the transducer device. A transducer device for delivering a tumor treatment field to a subject's body, the transducer device comprising: an array of a plurality of electrode elements, configured to be positioned on the subject's body with a side of the array facing the subject's body; ;
When viewed in a direction perpendicular to the plane of the array,
At least one electrode element is located proximate to the center of the array, wherein the at least one electrode element:
a first edge extending radially outward with respect to the center of the array;
a second edge extending radially outward with respect to the center of the array; and
A transducer device comprising a rounded edge connecting a first edge and a second edge at an end of an electrode element radially away from the center of the array. According to clause 13,
The transducer device wherein the plurality of electrode elements are disposed peripherally with respect to the central portion of the array. According to claim 13 or 14,
The distance from the first edge to the second edge is
A transducer device that decreases toward the outside of the array or increases toward the outer periphery of the array.