Conformable ultrasound scanning and imaging methods and apparatus and related techniques

Abstract

Described herein is a patch, comprising: a honeycomb structure comprised of two or more cells, wherein each of the two or more cells include a window and one or more first attachment means; and a tracker comprised of a sensor and one or more second attachment means configured to mate with the first attachment means to arrange the sensor in the window, wherein the tracker is moved to different ones of the cells to traverse a path along the patch. In some embodiments, the two or more cells have a regular or irregular shape. In embodiments, there are two or more first attachment means and two or more second attachment means that mate to form a first position and a second position, wherein the tracker is configured move between the first position and the second position.

Description

CONFORMABLE ULTRASOUND SCANNING AND IMAGING METHODS ANDAPPARATUS AND RELATED TECHNIQUESCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit under 35 U.S.C. §119 of U.S. Provisional Patent Application No. 63 / 515,873 filed on July 27, 2023, which is hereby incorporated by reference herein in its entirety.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

[0002] This invention was made with government support under ECCS02044688 awarded by the National Science Foundation. The government has certain rights in the invention.BACKGROUND

[0003] In large-area deep tissue imaging, the human body presents a particular challenge, as its geometry and deformability are highly variable not only between subjects, but also at different times and ages within a given subject. Ultrasound imaging plays an important role in the diagnosis and treatment of various cancers (e.g., breast cancer) because it can be used to extract meaningful images from dissimilar tissue presentations. While harnessing technologies and materials in pursuit of more effective ultrasound technologies is crucial, imaging biological regions introduces complex mechanical challenges.

[0004] Take, for example, breast cancer, there are notable technical gaps to overcome for ultrasound to become a reliable option for breast screening. In conventional ultrasound breast imaging technologies, handheld ultrasonography (HHUS) and automated breast ultrasound (ABUS) are preferred methods. However, HHUS relies heavily on the expertise and training of the technician to manually scan the whole breast by applying a strong compression. Meanwhile, ABUS can scan the whole breast at once, but suffers poor skin contact due to using a liquid media between the tissue and stationary, bulky machines in a hospital setting.SUMMARY OF DISCLOSED EMBODIMENTS

[0005] Disclosed herein is a conformable ultrasound breast patch (which may be referred to herein as a cUSBr-Patch) consisting of a one-dimensional (1 D) phased array and an easily-operable nature-inspired patch design. The patch offers large-area, deep tissue scanning and multi-angle, repeatable imaging, while avoiding the drawbacks of conventional ultrasound imaging technologies. With the design and implementation of a scanning trace, the patch physically guides the transducer positioning, with 360 degree rotation capabilities at each position, along the patch. Accordingly, the 1 D array can fully cover the entire organism’s surface and obtain a multi-angle image reconstruction from different views, thus overcoming fundamental issues that characterize present ultrasound technologies for large-area screening, namely imaging artifacts due to poor positioning or lack of contact.

[0006] In one aspect, the present disclosure is directed towards a patch. The patch comprises a honeycomb structure comprised of two or more cells, wherein each of the two or more cells include a window and one or more first attachment means; and a tracker comprised of a sensor and one or more second attachment means configured to mate with the first attachment means to arrange the sensor in the window. In embodiments, the tracker is moved to different ones of the cells to traverse a path along the patch.

[0007] In embodiments, the two or more cells have a regular or irregular shape, including but not limited to a hexagon shape, a pentagon shape, a circular shape, a triangular shape, or a square shape. In embodiments, the two or more cells each have different shapes. In embodiments, there are two or more first attachment means and two or more second attachment means that mate to form a first position and a second position. In embodiments, the tracker is configured move between the first position and the second position. In embodiments, the first attachment means and the second attachment means are magnets. In embodiments, the sensor is an ultrasound sensor, a blood oxygen sensor, a heart rate sensor, an electrocardiogram sensor, a temperature sensor, an accelerometer, a humidity sensor, a modulus sensor, a pressure sensor, a touch sensor, a capacitive sensor, a proximity sensor, a chemical sensor, a flow and level sensor, a light sensor, a color sensor, or a gyroscope. In embodiments, thesensor is a one-dimensional phased array, a two-dimensional phased array, a three-dimensional phased array, or a composite of array types. In embodiments, the sensor is a piezoelectric transducer comprised of a piezoelectric crystal, polymer, or composite having morphotropic phase boundaries.

[0008] According to a further aspect of the disclosure, an apparatus comprises a fabric having a first attachment means; and a patch having a second attachment means, wherein the first and second attachment means cooperate to removably attach the patch to a fixed location on the fabric. In embodiments, the patch comprises a honeycomb structure comprised of two or more cells, wherein each of the two or more cells include a window and one or more third attachment means; and a tracker comprised of a sensor and one or more fourth attachment means configured to mate with the third attachment means to arrange the sensor in the window, wherein the tracker may be moved to different ones of the cells to traverse a path along the patch. In embodiments, the fabric is conformable to a shape of an organism to orient the sensor to enable measurements of the organism.

[0009] In embodiments, the fabric is a garment fitted for the organism and the sensor is disposed in one or more windows in the fabric. In embodiments, the first attachment means and the second attachment means comprise one or more of magnets, hooks, latches, snap buttons, or a mechanical fixture for attachment purposes. In embodiments, the two or more cells have a regular or irregular shape, including but not limited to a hexagon shape, a pentagon shape, a circular shape, a triangular shape, or a square shape. In embodiments, there are two or more third attachment means and two or more fourth attachment means that mate to form a first position and a second position, wherein the tracker is configured move between the first position and the second position. In embodiments, the third attachment means and the fourth attachment means are magnets. In embodiments, the sensor is an ultrasound sensor, a blood oxygen sensor, a heart rate sensor, an electrocardiogram sensor, a temperature sensor, an accelerometer, a humidity sensor, a modulus sensor, a pressure sensor, a touch sensor, a capacitive sensor, a proximity sensor, a chemical sensor, a flow and level sensor, a light sensor, a color sensor, or a gyroscope. In embodiments, thesensor is a one-dimensional phased array, a two-dimensional phased array, or a three-dimensional phased array.

[0010] According to a further aspect of the disclosure, a method for taking measurements of an organism comprises providing a fabric having a first attachment means; and providing a patch having a second attachment means, wherein the first and second attachment means cooperate to removably attach the patch to a fixed location on the fabric. In embodiments, providing the patch comprises providing a honeycomb structure comprised of two or more cells, wherein each of the two or more cells include a window and one or more third attachment means; providing a tracker comprised of a sensor and one or more fourth attachment means configured to mate with the third attachment means to arrange the sensor in the window; and moving the tracker to different ones of the cells to traverse a path along the patch. In embodiments, the fabric is conformable to a shape of the organism to orient the sensor to enable the measurements of the organism.

[0011] In embodiments, the two or more cells have a regular or irregular shape, including but not limited to a hexagon shape, a pentagon shape, a circular shape, a triangular shape, or a square shape. In embodiments, there are two or more third attachment means and two or more fourth attachment means that mate to form a first position and a second position, wherein moving the tracker further comprises moving the tracker between the first position and the second position. In embodiments, the sensor is an ultrasound sensor, a blood oxygen sensor, a heart rate sensor, an electrocardiogram sensor, a temperature sensor, an accelerometer, a humidity sensor, a modulus sensor, a pressure sensor, a touch sensor, a capacitive sensor, a proximity sensor, a chemical sensor, a flow and level sensor, a light sensor, a color sensor, or a gyroscope.DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0012] The manner and process of making and using the disclosed embodiments may be appreciated by reference to the figures of the accompanying drawings. It should be appreciated that the components and structures illustrated in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principals of the concepts described herein. Like reference numeralsdesignate corresponding parts throughout the different views. Furthermore, embodiments are illustrated by way of example and not limitation in the figures, in which:

[0013] FIG. 1 is a perspective view of a patch;

[0014] FIG. 2A is a perspective view of a patch, such as the patch of FIG. 1 , disposed on a fabric and an organism;

[0015] FIG. 2B is a perspective view of a fabric disposed on an organism, such as the fabric and organism of FIG. 2A;

[0016] FIG. 3 is a side view of a patch, such as the patch of FIG. 1 , disposed on a fabric and an organism;

[0017] FIG. 4 is a front view of a patch, such as the patch of FIG. 1 , illustrating a path along the patch;

[0018] FIG. 5A is a first perspective view of a front side a tracker portion;

[0019] FIG. 5B is a second perspective view of a back side of the tracker portion of FIG. 5A;

[0020] FIG. 5C is a side view of a tracker portion, including a tracker;

[0021] FIG. 6 is a perspective view of a tracker;

[0022] FIG. 7A-7C are perspective views of a tracker in a patch, such as the patch of FIG. 1 , illustrating the rotation of the tracker;

[0023] FIG. 8 is a perspective view of a one-dimensional (1 D) array;

[0024] FIG. 9 is an exploded view of sensor;

[0025] FIG. 10 is a schematic diagram of dicing orientations for five sample crystals;

[0026] FIG. 1 1 is an in vivo study on breast tissue, illustrating ultrasound scanning along a designated path (or trace) along a patch, such as the patch of FIG. 1 ; and

[0027] FIG. 12 is an in vivo study on breast tissue, illustrating ultrasound scanning by rotating a sensor (or array), such as a sensor in the patch of FIG. 1 , to various positions.DETAILED DESCRI PTION

[0028] FIG. 1 is a perspective view of a patch 100 including a honeycomb structure 110 comprised of two or more cells 120a, 120b, 120c, 120d, 120e, 120f,generally denoted 120 (or more simply cells 120). Each of the cells 120 include a window 122a, 122b, 122c, 122d, 122e, 122f, generally denoted 122 (or more simply windows 122), and one or more first attachment means 124a, 124b, 124c, 124d, 124e, 124f , generally denoted 124 (or more simply first attachment means 124). The patch 100 includes a tracker 130 comprised of a sensor 140 and one or more second attachment means configured to mate with the first attachment means 124 to arrange the sensor 140 in the windows 122. The tracker 130 is moved to different ones of the cells 120 to traverse a path along the patch 100. The patch 100 secures the tracker 130, enabling standard and reproducible measurements from the sensor 140 over curvilinear areas.

[0029] The cells 120 are formed from a plurality of interconnected members that form the sides of the cell 120 that surround the windows 122. The cells 120 have a regular or irregular shape, including but not limited to a hexagon shape, a pentagon shape, a circular shape, a triangular shape, or a square shape. The cells 120 may each have different shapes. The cells 120 may each have a different shape or some or all of the cells may have the same shape.

[0030] The first attachment means 124 are disposed on the members around the windows 122. A first cell 120a includes a first window 122a and one or more first attachment means 124a. A second cell 120b includes a second window 122b and one or more second attachment means 124b. A third cell 120c includes a third window 122c and one or more third attachment means 124c. A fourth cell 120d includes a fourth window 122d and one or more fourth attachment means 124d. A fifth cell 120e includes a fifth window 122e and one or more fifth attachment means 124e. A sixth cell 120f includes a sixth window 122f and one or more sixth attachment means 124f .

[0031] In an embodiment, such as the embodiment disclosed in FIG. 1 , there are two or more first attachment means 124 and two or more second attachment means that mate to form a first position 160 and a second position 162. The tracker 130 is configured move between the first position 160 and the second position 162. The first position 160 is formed from a first attachment mean 126a, a second attachment mean 126b, and a third attachment mean 126c along the fourth cell 120d and a first, second, and third attachment means along the tracker 130. The second position 162 is formed from a first attachment mean 126d, asecond attachment mean 126e, and a third attachment mean 126f along the fourth cell 120d and a first, second, and third attachment means along the tracker 130.

[0032] The sensor 140 on the tracker 130 may be oriented by the tracker 130 and may take measurements in the first position 160 and the second position 162. This movement enables further and improved measurement. The sensor 140 may be an ultrasound sensor, a blood oxygen sensor, a heart rate sensor, an electrocardiogram sensor, a temperature sensor, an accelerometer, a humidity sensor, a modulus sensor, a pressure sensor, a touch sensor, a capacitive sensor, a proximity sensor, a chemical sensor, a flow and level sensor, a light sensor, a color sensor, or a gyroscope. The sensor 140 may be a onedimensional phased array, a two-dimensional phased array, a three-dimensional phased array, or a composite of array types. The sensor 140 may be a piezoelectric transducer comprised of a piezoelectric crystal, polymer, or composite having morphotropic phase boundaries. Morphotropic phase boundary (MPB) compositions referring to a single crystal, i.e. , Pb(Mgi / 3Nb2 / 3)O3- PbTiO3(PMN-PT).

[0033] The honeycomb structure 110 may be formed from one or more polylactic acid (PLA) layers 150 and one more thermoplastic polyurethane (TPU) layers 180. The PLA layers 150 may be marble colored. The TPU layers 180 may be white colored. One or more attachment mechanisms may be disposed between the layers 150, 180 to secure the attachment, for example superglue may be used.

[0034] The first attachment means 124 may be disposed on the honeycomb structure 110. The first attachment means 124 may be formed in the layers of the honeycomb structure 110. The honeycomb structure 110 may have circular notches to hold the first attachment means 124, such that the first attachment means 124 may be press-fit into the honeycomb structure 110. One or more attachment mechanisms may be disposed between the first attachment means 124 and the honeycomb structure 110 to secure the attachment, for example superglue may be used.

[0035] The first attachment means 124 and the second attachment means may be magnets. The magnets may be oriented such that they have the samedirection of polarity. The honeycomb structure 110 may have a cable or cable path provided therein, for example a cable path 180 intercepts the sixth cell 120f.

[0036] One or more second attachment means 170 are disposed on the patch 100. The second attachment means 170 may comprise one or more of magnets, hooks, latches, snap buttons, or a mechanical fixture for attachment purposes. The patch 100 may contain a tab with two or more circular openings. The second attachment means 170 maybe superglued to the exterior of the patch on the ears of the tab. The second attachment means 170 may be rectangular magnets (with a size of 12 mm x 5 mm x 3 mm) that are attached, for example through superglue, to the outside of the patch on ears of the tab.

[0037] FIG. 2A is a perspective view of a patch 210, which may be similar to or the same as the patch 100 of FIG. 1 , disposed on a fabric 202 and an organism 200 (the organism may be referred to herein as a user). The organism 200 may be a person. The fabric 202 is disposed on the organism 200. The fabric 202 is conformable to a shape of the organism 200 to orient and secure the sensor in the patch 210 to enable measurements of the organism 200.

[0038] The fabric may be a garment fitted for the organism 200. The fabric 202 has enough elasticity to secure the fabric 202 to a surface of the organism 200. The fabric 202 may be designed to arrange the patch in a specific location, such as a specific body part, above a certain organ, or against the surface, such as on the skin of the organism 200.

[0039] The patch 210 may be sized to fit over any portion of the organism. The fabric 202 may be a clothing item that can fit onto a person to arrange the patch 210 over a specific location. Forexample, if the organism is a person, the patch 210 may be designed to fit an breast, arm, leg, torso, etc. In an embodiment where the patch is designed to fit a breast, patch may have a cup shape designed to fit the breast. For example, as disclosed in FIG. 2A, the fabric 202 is a bra and the patch 210 is affixed over the breast of the organism 200.

[0040] FIG. 2B is a perspective view of a fabric 222 disposed on an organism 220, which may be similar to or the same as fabric 202 and organism 200 from FIG. 2A. The fabric 222 includes a window 224a, 224b, 224c, 224d, 224e, 224f, generally denoted 224 (or more simply windows 224). The windows 224 are disposed along the organism 220 to enable access to the surface of the organism 220 (e.g., theskin of the organism 220). A first window 224a, a second window 224b, a third window 224c, a fourth window 224d, and fifth window 224e, a sixth window 224f are arranged along the fabric 222. A patch, such as the patch 100 in FIG. 1 , may be arranged on the fabric 222. The patch is oriented on the fabric 222 and organism 220 such that the sensor is disposed in one of the windows 224. For example, as disclosed in FIG. 2B, the fabric 222 is a bra and the windows 224 enable access to the breast of the organism 200.

[0041] The fabric 222 includes a first attachment means 226a, 226b, 226c, generally denoted 226 (or more simply first attachment means 226). The first attachment means 226 and second attachment means of the patch (such as the second attachment means 170 of patch 100 in FIG. 1A) cooperate to removably attach the patch to a fixed location on the fabric 222. A first attachment means 226a is disposed adjacent to the first window 226a and the fourth window 224d. A second attachment means 226b is disposed adjacent to the third window 224c. A third attachment means 226c is disposed adjacent to the sixth window 224f. The first attachment means 226 comprise one or more of magnets, hooks, latches, snap buttons, or a mechanical fixture for attachment purposes.

[0042] FIG. 3 is a side view of a patch 300, which may be similar to or the same as patch 100 of FIG. 1 , disposed on a fabric 304 and an organism 302, which may be similar to or the same as fabric 202 and organism 200 in FIG. 2A. The fabric 304 is a garment fitted for the organism 302. For example, as disclosed in FIG. 3, the fabric 304 is a bra fitted over the breast of the organism 302 to enable scanning of a tumor 306 in the organism 302. The fabric 304 includes a window 308, which may be similar to or the same as windows 224 in FIG. 2B.

[0043] The patch 300 includes a honeycomb structure 312, which may be similar to or the same as a honeycomb structure 110 in FIG. 1 , and a tracker 314. The tracker 314 includes a sensor 316, in FIG. 3 the sensor 316 is an array. The sensor 316 is disposed in the window 308 in the fabric 304. A cable 318 is disposed adjacent to the honeycomb structure 312 and the organism 302 and is coupled to the sensor 316.

[0044] FIG. 4 is a front view of a patch 400, which may be similar to or the same as patch 100 of FIG. 1 , illustrating a path 440 formed along the patch 400. The patch 100 includes cells 420, 422, 424, 428, 430, which may be similar to orthe same as cells 120 from FIG. 1 , disposed along a length 406 and a width 408 of the patch 400. The length 406 extends from a top side 402a to a bottom side 402b of the patch 400. The width 408 ends from a first side 404a to a second side 404b of the patch 400. The tracker of the patch 400 may be moved to different ones of the cells to traverse the path 440 along the patch 400.

[0045] A first cell 420 is disposed along the top side 402a of the patch 400, by the second side 404b. A second cell 422 is disposed adjacent to the first cell 420 along the top side 402a, but across the width 408 towards the first side 404a. A third cell 424 is disposed adjacent to the second cell 422, but across the length 406 towards the bottom side 402b. A fourth cell 426 is disposed adjacent to the third cell 424, but across the width 408 towards the second side 404b. A fifth cell 428 is disposed adjacent to the fourth cell 426, but across the length 406 towards the bottom side 402b. A sixth cell 430 is disposed adjacent to the fifth cell 428, but across the width 408 towards the first side 404a. The path 440 is disposed similarly to the cell locations across the patch 400.

[0046] The arrangement of the cells 420, 422, 424, 428, 430 may in part determine the path 440. However, the path 440 is an example of one possible path across the patch 400. Other variations of the path 440 are possible. The path is selected to ensure the sensor on the patch 400 fully accesses the organism by orienting the tracker at each cell. However, if only the desired sensor data is wanted for a portion of the organism, the path may extend to a portion of the cells. For example, two, three, four, or five of the cells may be apart of the path.

[0047] FIG. 5A is a first perspective view of a front side of a tracker portion 500. The tracker portion 500 is apart of the support structure which supports and holds the tracker, which may be similar to or the same as the tracker 130 of FIG. 1 . The tracker portion 500 includes a tracker cable 510, which may be similar to or the same as cable 318 in FIG. 3. The tracker cable 510 may be an anisotropic conductive film (ACF) cable. The tracker portion 500 includes a matching layer 520. A second transparent matching layer is disposed on the matching layer 520. FIG. 5B is a second perspective view of a back side of the tracker portion 500 of FIG. 5A. The tracker portion 500 includes a backing layer 530. FIG. 5C is a side view of a tracker portion 540, which may be similar to or the same as tracker portion 500 from FIGS. 5A-5B, including a backing layer 550, which may be similar to or thesame as the backing layer 530 from FIG. 5B. Tracker 540 further includes a tracker 560, which may be similar to or the same as the tracker 130 from FIG. 1 .

[0048] FIG. 6 is a perspective view of a tracker 600, which may be similar to or the same as the tracker 130 from FIG. 1 . The tracker 600 includes a tracker base 610, upon which a tracker body 620 and a tracker head 640 are disposed. The tracker head 640 is disposed on the tracker body 620. A sensor, such as the sensor 140 from FIG. 1 , is disposed on the tracker head 640. The tracker base 620 includes one or more tracker arms 622, 624, 626 with attachment means 632, 634, 636. A first attachment mean 632 is disposed on a first tracker arm 622. A second attachment mean 634 is disposed on a second tracker arm 624. A third attachment mean 636 is disposed on a third tracker arm 626. The number of arms, in the case of tracker 600 three 622, 624, 626, was selected to maintain planar stability while both minimizing the material needed for the tracker 600 and reducing the manufacturing complexity.

[0049] The attachment means 632, 634, 636 may be magnets. The magnets may be circular with a diameter of 2 mm and a thickness of 1 mm. The attachment means on the tracker align with the attachment means on the patch, as each may have the same specific distance from the center and 60° apart.

[0050] The tracker 600 may comprise a acrylonitrile butadiene styrene (ABS) like photopolymer resin material. The tracker 600 may be three dimensional (3D) printed at a 45 degree angle in a resin printer. The tracker 600 may be cured for strength with a ultraviolet (UV) cure box, such that the tracker is strong enough to withstand the torsion forces experienced during the carrying and rotating of the sensor.

[0051] FIG. 7A-7C are perspective views of a tracker in a patch, such as the patch 100 of FIG. 1 , illustrating the rotation of the tracker. In FIG. 7A, the tracker is disposed at a first position 710, which is designated to be at 0 degrees. In FIG. 7B, the tracker rotates to a second position 720, which is at a 60 degree angle compared to the first position 710. In FIG. 7C, the tracker rotates to a third position 730, which is at a 120 degree angle compared to the first position 710.

[0052] FIG. 8 is a perspective view of a one-dimensional (1 D) array 800, which may be used in a sensor in a patch, such as the sensor 140 in patch 100 in FIG. 1A. 1 D array 800 includes a bottom electrode 810, with a conductive epoxy812 disposed on the bottom electrode 810. A conductive backing layer 820a, 820b is disposed on opposing ends of the bottom electrode 810. A spacer 830 is disposed adjacent to a first conductive backing layer portion 820a on the bottom electrode 810.

[0053] A plurality of elements 840a, 840b, 840c, 840d, 840e, 840f, 840g, 840h are disposed on the bottom electrode 810 adjacent to the spacer 830 and a second conductive backing layer portion 820b. The elements 840a, 840b, 840c, 840d, 840e, 840f, 840g, 840h are formed from a piezoelectric material. A first top element 840a is disposed adjacent to the spacer 830 and a second element 840b. A third element 840c is disposed adjacent to the second element 840b. A fourth element 840d is disposed adjacent to the third element 840c. A fifth element 840e is disposed adjacent to a sixth element 840f. A seventh element 840g is disposed adjacent to an eighth element 840h. The eighth element 840h is disposed adjacent to the second conductive backing layer portion 820b. The space 842 between the fourth element 840d and the fifth element 840e illustrates space for further elements, which are not shown for ease of reference. The array 800 includes 64 elements. While 64 elements are referenced, more or less are possible.

[0054] A coordinate system 850 is disclosed for reference, with the 1 D array disposed along an x-axis 852, a y-axis 854, and a z-axis 856. The elements 840a, 840b, 840c, 840d, 840e, 840f, 840g, 840h have a transducer aperture 860 across the elements 840a, 840b, 840c, 840d, 840e, 840f, 840g, 840h along the x-axis 852 of the 1 D array 800. Each element has a thickness (T) 880 along the z-axis 856, a width 896 along the x-axis 852, and an elevation height 870 along the y-axis 854. A pitch value 894 and a kerf 892 describe the distance between the midpoint of two elements and a distance between the elements respectively. A top electrode 814 is disposed on the elements 840a, 840b, 840c, 840d, 840e, 840f, 840g, 840h, spacer 830, and conductive backing layer 820a, 820b.

[0055] Utilized in the disclosed 1 D array 800 is an extended, conductive backing layer 820a, 820b for an electrical connection for the top and bottom electrodes. The conductive backing layer 820a, 820b extends to the side (labeled “Connected to the bottom electrode” in FIG. 8), so that the top electrode 814 and bottom electrode 810 connections can be on the same plane (i.e., a top plane). This decreases electrical cross talk in between the top and bottom electrodes 810, 814,given the two are on the same plane, compared to being separated between the bottom plane (for the bottom electrode) and the top plane (for the top electrode). In comparison, conventionally a straight backing layer is used for standard ultrasound devices.

[0056] The conventional transducer frequency for imaging breast tumors ranges from 5 to 12 MHz. The 1 D phased array 800 was designed on a transducer three-port network, which includes the active piezoelectric element, backing layer, and two matching layers. FIG. 8 depicts the geometry of the 1 D phased array with its main components. The 1 D phased array 800 includes 64 elements and a working frequency of 7.0 MHz and the wavelength (A) of 220 pm, which were selected to strike a balance between the demands for depth and spatial resolution. This working frequency, wavelength, and number of elements may find effective applications in breast scanning and imaging.

[0057] The pitch value 894 is 125 pm (0.56A), which is slightly above the phased array requirement of 0.5A, to achieve wide angle imaging and reduce grating lobes. The element width 896 is 95 pm and the kerf 892 is 30 pm, which is determined by the thickness and vibration of the dicing blade. The element length is chosen to be 8 mm (which is 64 times the pitch value 894) to achieve a minimally dispersed acoustic beam within the intended imaging depth.

[0058] To fabricate the 1 D array 800, three steps were involved: first, the creation of a 64-element 1 D array; second, electrode deposition and patterning, followed by cable bonding; and third, the creation of matching and backing layers. The dice-and-fill method was used to fabricate the 1 D phased array. A dicing machine with a 15 pm-thick synthetic diamond blade was used to achieve 65 dicing lines on the sample.

[0059] To increase the crystal footprint and minimize damage from blade vibration, the appropriate specifications were specified to custom manufacture the ultra-thin dicing blade. Accordingly, the dicing pitch, kerf, and actual width of each element were 125 pm, 30 pm, and 95 pm, respectively. To avoid any mechanical harm on the elements, the dicing speed was fixed at 0.25 mm / s. The dicing depth was roughly 350 pm, which was greater than the final desired thickness to allow for polishing. The epoxy was used to fill the kerf and eliminate the transverse vibration in the ceramic by vacuum degassing and was cured at 65 degrees Celsius for 2hours. After lapping the top surface to expose ceramic elements, the conductive epoxy strip was added on both sides to connect the bottom electrode to the top surface. Next, the entire array was polished to the designed thickness and encapsulated by the epoxy again in a round mold.

[0060] Next, 10nm of chromium (Cr) and 300 nm of gold (Au) were deposited on the upper surface of the array by e-beam evaporation (DENTON electron beam deposition). A layer of photoresist was spin-coated onto the electrode at a speed of 3,000 rpm for 60 seconds and then baked at 65 degrees Celsius for 10 minutes. Then the array was exposed to ultraviolet (UV) for 10 seconds under a mask aligner, developed for 60 seconds in a developer, and then wet etched by Au and Cr etchant solution for 120 seconds and 20 seconds, respectively. After stripping with acetone, I PA, and deionized (DI) water, the final electrode pattern on the top surface is completed, including 64 traces of electrodes and two wide traces on strips of E- SOLDER 3022. Next, layers of 10 nm of Cr and 300 nm of Au were deposited on the bottom surface of the array by e-beam evaporation. The bottom electrode fully covered all elements and strips of E-SOLDER 3022. The ACF cable was bonded to the array and the printed circuit board (PCB) interface under a microscope. The bonding area was applied with strong pressure and cured in the oven at 65 degrees Celsius for 1 hour.

[0061] The final array was obtained by adding the matching layer and the backing layer. For the matching layer preparation, Zirconia Oxide (ZrOs) powder (5 pm, 99%) was selected as the filler and the epoxy was used as the matrix. The ZrO2 powder and epoxy solution were first mixed with the ratio of 3:1 to obtain a homogenous mixture, poured into the mold, centrifuged at 2000 rpm for 10 minutes, and then cured at 65 degrees Celsius for 2 hours in the oven. After polishing the 1 st matching layer to the designed thickness, the epoxy solution was cast on the surface of the 1 st matching layer and polished to achieve the 2nd matching layer. For backing layer preparation, Tungsten (W) powder (APS 1-5 micron, 99.9%) was selected as the filler and the epoxy was used as the matrix. The W powder and epoxy solution were first mixed with a ratio of 4:1 to obtain a homogenous mixture, which was poured into the mold, centrifuged at 2500 rpm for 10 minutes, and then cured at 65 degrees Celsius for 2 hours in the oven. The final backing layer was obtained by polishing the surface to the designed thickness. Finally, the matchingand backing layers were bonded onto the array by the epoxy solution. Firm pressure was applied to the bonding area, which was then cured in the oven at 65 degrees Celsius for 1 hour.

[0062] Once the epoxy under high-temperature pressure has firmly bonded all of the components, the resulting components have a consistent thickness. After bonding with matching layers, backing layer, and the anisotropic conductive film (ACF) cable, the thickness of the entire device is still less than about 3 mm (+ / - 0.5 mm). The resonance and anti-resonance frequencies are 5.9 MHz and 8.1 MHz, respectively, resulting in a large effective electromechanical coupling coefficient (keff = 0.68). The array also showed a -6 dB bandwidth of 70% with the center frequency around 7.1 MHz, which is slightly smaller than the simulation results (of 79%) by the Krimholtz-Leedom-Mattaei (KLM) model due to the fabrication processing, flexible cable, or unmatched electric circuit.

[0063] FIG. 9 is an exploded view of a sensor 900, which may be used as a sensor in a patch, such as the sensor 140 in patch 100 in FIG. 1A. A first cable 910 is disposed on the top side 902 of the sensor 900. A backing layer 920 is disposed next to the cable 910 and a second cable 930. A top electrode 940 is disposed next to the second cable 930 and elements 950. A bottom electrode 960 is disposed adjacent to the elements 950 and a first matching layer 970. The first matching layer 970, which may be similar to or the same as matching layer 520 of FIG. 5A, is disposed adjacent to a second matching layer 980. The first and second matching layers 970, 980 are embedded in an epoxy matrix 990. The epoxy matrix 990 is disposed on a bottom side 904 of the sensor. The bottom side 904 is disposed or otherwise attached to the organism, while the top side 902 is positioned away from the organism towards air.

[0064] FIG. 10 is a schematic diagram of dicing orientations 1000 for five sample crystals 1010, 1020, 1030, 1040, 1050 that may be used as piezoelectric transducer elements, such as elements 840a, 840b, 840c, 840d, 840e, 840f, 840g, 840h in FIG. 8. The samples are from Yb / Bi-PIN-PMN-PT crystals. The dicing orientation 1000 are shown along the poling directions

[0100] 1002,

[0001] 1004, and

[0010] 1006. A poling direction 1008 is along the

[0001] 1004 crystal direction for all five samples 1010, 1020, 1030, 1040, 1050. A first crystal 1010 has the dimensions 2.0 x 2.0 x 8.0. A second crystal 1020 has the dimensions 5.0 x 0.5 x 5.0. A thirdcrystal 1030 has the dimensions 5.0 x 5.0 x 0.5. A fourth crystal 1040 has the dimensions 15.0 x 3.0 x 0.7. A fifth crystal 1050 has the dimensions 10.0 x 3.0 x 0.7.

[0065] FIG. 11 is an in vivo study 1100 on breast tissue, illustrating ultrasound scanning along a designated path (or trace) along a patch, for example the path 440 in FIG. 4. The box designated A illustrates a photo of the clISBr-Patch on the left breast of a female subject. For the box designated A, the scale bar is 2 cm. The box designated B illustrates a schematic of the scanning trace on the breast which may be placed at any of the six different positions of the honeycomb patch. The boxes designated C-H illustrate ultrasound images at position 1 to 6 on the patch in box B. For box C-H, the scale bar is 1 cm. The path enables scanning along the entirety of the patch and organism, in this case the breast. Thanks to the reasonable maximum image depth and axial / lateral resolution, various breast tissue can be clearly observed from different positions (boxes C-H). At position 4, a cyst with the diameter of 1 cm can be detected, which appears as well circumscribed and hypoechoic due to the lower acoustic impedance from the surrounding tissues.

[0066] FIG. 12 is an in vivo study 1200 on breast tissue, illustrating ultrasound scanning by rotating a sensor (or array) in a tracker to various positions, such as those rotations disclosed in FIGS. 7A-7C. The study 1200 illustrates the effect of rotating the sensor at the position 4 (along the patch as shown in FIG. 11) and the resulting muti-view ultrasound images. The box designated I is a schematic of the array rotation by the tracker. The boxes designated J-L illustrate ultrasound images by the array when it is rotated clockwise at different angles (0°, 60°, and 120°) at the position 4 of the patch in box B of FIG. 11. To better define the lesion shape, the array at position 1-4 was rotated by manipulation of the tracker from its initial 0° orientation to 60° and 120°, respectively (boxes l-L). The cyst is identified as a roughly spherical shape via all three ultrasound images at various angles.

[0067] The boxes designated M-0 illustrate multi-angle image reconstruction at position 4 of the patch in box B of FIG. 11 with different view angles (-15°, center view, and +15°). The dashed circle indicates the hypoechoic lesion. For box J-O, the scale bar is 1 cm. The multi-angle reconstructed images and video based on the rotation images are shown in boxes M-O. Accordingly, the patch can preciselyand observe these lesions and has the potential reliable capability to detect early stage breast tumors.

[0068] Disclosed herein is a wearable, nature-inspired honeycomb-shaped patch combined with a phased array guided by an easy-to-operate tracker that provides for large-area, deep scanning and multi-angle imaging capability. The conformable patch (cUSBr-Patch) uses a nature-inspired honeycomb design to hold the array in place, such that the array can be easily rotated and moved to different positions along the patch to enable the observation of tissue in a more streamlined and standardized manner. The cUSBr-Patch enables standardized and reproducible image acquisition over an entire organism with less reliance on operator training and applied transducer compression. The cUSBr-Patch additionally circumvents the need for a three-dimensional scanner or complex beamforming algorithm by using a high frequency phased array transducer with a fixed element pitch.

[0069] The nature-inspired honeycomb patch design provides several advancements including: first, the ability to traverse through a path of 15 imaged sections, which makes the scanning straightforward for localizing the lesion location outside of the conventional four-quadrant designation; second, mechanical support and stability for the array, with a tracker to achieve images at different angles via rotation; third, the elimination of the requirement for an operator to constantly hold the device, which is especially critical for freeing up the operator’s hands during future home-based screening; and fourth, great repeatability positions, demonstrating reliable and comparable tissue screening for long-term monitoring. For use in practical applications, additional advantages prevail, such as reusability, ease of operation, and increased feasibility for at- home continuous monitoring of abnormalities.

[0070] When tested on a breast, the cUSBr-Patch’s ability to discernibly image cysts with diameters of about 0.3 cm (+ / - 0.01 cm) makes it suitable for early breast cancer screening. For large-area imaging, individual users can move the array to different positions along the honeycomb-shaped patch to obtain an all- encompassing representation, while a hospital can employ more arrays simultaneously to achieve spatiotemporally accurate imagery by multi-angle image reconstruction.

[0071] The clinical trials reveal that the array using a piezoelectric crystal (Yb / Bi-PIN-PMN-PT) exhibits a sufficient contrast resolution (about 3 dB + / - 0.1 dB) and axial / lateral resolutions of 0.25 / 1.0 mm at 30 mm depth, allowing the observation of small cysts (about 0.3 cm + / - 0.1 cm) in the breast. Accordingly, disclosed herein is a first-of-its-kind ultrasound technology for breast tissue scanning and imaging which offers a non-invasive method for tracking real-time dynamic changes of soft tissue.

[0072] The 1 D array’s integration with a nature-inspired patch, together with superior electromechanical performance of Yb / Bi PIN-PMN-PT crystal (d33 = 2800 pC / N, £33 / EO = 7000, Tc= 160 °C, Tr-t= 109 °C, and Ec= 5.3 kV / cm), offer high- performance image production with i) deep image depth (about 80 mm + / - 5 mm), ii) sufficient contrast sensitivity (about 3 dB (+ / - 0.1 dB) at 30 mm depth), iii) desired axial / lateral resolution (0.25 / 1.0 mm), and iv) a larger field of view for breast tissue imaging, which is cross validated with a commercial ultrasound probe.

[0073] Various embodiments of the concepts, systems, devices, structures and techniques sought to be protected are described herein with reference to the related drawings. Alternative embodiments can be devised without departing from the scope of the concepts, systems, devices, structures and techniques described herein. It is noted that various connections and positional relationships (e.g., over, below, adjacent, etc.) are set forth between elements in the following description and in the drawings. These connections and / or positional relationships, unless specified otherwise, can be direct or indirect, and the described concepts, systems, devices, structures and techniques are not intended to be limiting in this respect. Accordingly, a coupling of entities can refer to either a direct or an indirect coupling, and a positional relationship between entities can be a direct or indirect positional relationship.

[0074] As an example of an indirect positional relationship, references in the present description to forming layer "A" over layer "B" include situations in which one or more intermediate layers (e.g., layer "C") is between layer "A" and layer "B" as long as the relevant characteristics and functionalities of layer "A" and layer "B" are not substantially changed by the intermediate layer(s).The following definitions and abbreviations are to be used for the interpretation of the claims and thespecification. As used herein, the terms "comprises," "comprising, "includes," "including," "has," "having," "contains" or "containing," or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a composition, a mixture, process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but can include other elements not expressly listed or inherent to such composition, mixture, process, method, article, or apparatus.

[0075] The terms "one or more" and "one or more" are understood to include any integer number greater than or equal to one, i.e. one, two, three, four, etc. The terms "a plurality" are understood to include any integer number greater than or equal to two, i.e. two, three, four, five, etc. The term "connection" can include an indirect "connection" and a direct "connection".

[0076] References in the specification to "one embodiment, "an embodiment," "an example embodiment," etc., indicate that the embodiment described can include a particular feature, structure, or characteristic, but every embodiment can include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described.

[0077] For purposes of the description hereinafter, the terms "upper," "lower," "right," "left," "vertical," "horizontal, "top," "bottom," and derivatives thereof shall relate to the described structures and methods, as oriented in the drawing figures. The terms "overlying," "atop," "on top, "positioned on" or "positioned atop" mean that a first element, such as a first structure, is present on a second element, such as a second structure, where intervening elements such as an interface structure can be present between the first element and the second element. The term "direct contact" means that a first element, such as a first structure, and a second element, such as a second structure, are connected without any intermediary conducting, insulating or semiconductor layers at the interface of the two elements. It should be noted that the term "selective to, "such as, for example, "afirst element selective to a second element," means that the first element can be etched and the second element can act as an etch stop.

[0078] Use of ordinal terms such as “first,” “second,” “third,” etc., in the claims to modify a claim element does not by itself connote any priority, precedence, or order of one claim element over another or the temporal order in which acts of a method are performed, but are used merely as labels to distinguish one claim element having a certain name from another element having a same name (but for use of the ordinal term) to distinguish the claim elements.

[0079] The terms “approximately” and “about” may be used to mean within ±20% of a target value in some embodiments, within ±10% of a target value in some embodiments, within ±5% of a target value in some embodiments, and yet within ±2% of a target value in some embodiments. The terms “approximately” and “about” may include the target value.

[0080] It is to be understood that the disclosed subject matter is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The disclosed subject matter is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. As such, those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for the designing of other structures, methods, and systems for carrying out the several purposes of the disclosed subject matter. Therefore, the claims should be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the disclosed subject matter.

[0081] Although the disclosed subject matter has been described and illustrated in the foregoing exemplary embodiments, it is understood that the present disclosure has been made only by way of example, and that numerous changes in the details of implementation of the disclosed subject matter may be made without departing from the spirit and scope of the disclosed subject matter.

Claims

What is claimed is:

1. A patch, comprising: a honeycomb structure comprised of two or more cells, wherein each of the two or more cells include a window and one or more first attachment means; and a tracker comprised of a sensor and one or more second attachment means configured to mate with the first attachment means to arrange the sensor in the window, wherein the tracker is moved to different ones of the cells to traverse a path along the patch.

2. The patch of claim 1 , wherein the two or more cells have a regular or irregular shape, including but not limited to a hexagon shape, a pentagon shape, a circular shape, a triangular shape, or a square shape.

3. The patch of claim 2, wherein the two or more cells each have different shapes.

4. The patch of claim 1 , wherein there are two or more first attachment means and two or more second attachment means that mate to form a first position and a second position, wherein the tracker is configured move between the first position and the second position.

5. The patch of claim 1 , wherein the first attachment means and the second attachment means are magnets.

6. The patch of claim 1 , wherein the sensor is an ultrasound sensor, a blood oxygen sensor, a heart rate sensor, an electrocardiogram sensor, a temperature sensor, an accelerometer, a humidity sensor, a modulus sensor, a pressure sensor, a touch sensor, a capacitive sensor, a proximity sensor, a chemical sensor, a flow and level sensor, a light sensor, a color sensor, or a gyroscope.

7. The patch of claim 1 , wherein the sensor is a one-dimensional phased array, a two-dimensional phased array, a three-dimensional phased array, or a composite of array types.

8. The patch of claim 1 , wherein the sensor is a piezoelectric transducer comprised of a piezoelectric crystal, polymer, or composite having morphotropic phase boundaries.

9. An apparatus, comprising: a fabric having a first attachment means; and a patch having a second attachment means, wherein the first and second attachment means cooperate to removably attach the patch to a fixed location on the fabric, the patch comprising: a honeycomb structure comprised of two or more cells, wherein each of the two or more cells include a window and one or more third attachment means; and a tracker comprised of a sensor and one or more fourth attachment means configured to mate with the third attachment means to arrange the sensor in the window, wherein the tracker may be moved to different ones of the cells to traverse a path along the patch, wherein the fabric is conformable to a shape of an organism to orient the sensor to enable measurements of the organism.

10. The apparatus of claim 9, wherein the fabric is a garment fitted for the organism and the sensor is disposed in one or more windows in the fabric.

11. The apparatus of claim 9, wherein the first attachment means and the second attachment means comprise one or more of magnets, hooks, latches, snap buttons, or a mechanical fixture for attachment purposes.

12. The apparatus of claim 9, wherein the two or more cells have a regular or irregular shape, including but not limited to a hexagon shape, a pentagon shape, a circular shape, a triangular shape, or a square shape.

13. The apparatus of claim 9, wherein there are two or more third attachment means and two or more fourth attachment means that mate to form a first position and a second position, wherein the tracker is configured move between the first position and the second position.

14. The apparatus of claim 13, wherein the third attachment means and the fourth attachment means are magnets.

15. The apparatus of claim 9, wherein the sensor is an ultrasound sensor, a blood oxygen sensor, a heart rate sensor, an electrocardiogram sensor, a temperature sensor, an accelerometer, a humidity sensor, a modulus sensor, a pressure sensor, a touch sensor, a capacitive sensor, a proximity sensor, a chemical sensor, a flow and level sensor, a light sensor, a color sensor, or a gyroscope.

16. The apparatus of claim 9, wherein the sensor is a one-dimensional phased array, a two-dimensional phased array, or a three-dimensional phased array.

17. A method for taking measurements of an organism, comprising: providing a fabric having a first attachment means; and providing a patch having a second attachment means, wherein the first and second attachment means cooperate to removably attach the patch to a fixed location on the fabric, providing the patch comprising: providing a honeycomb structure comprised of two or more cells, wherein each of the two or more cells include a window and one or more third attachment means; providing a tracker comprised of a sensor and one or more fourth attachment means configured to mate with the third attachment means to arrange the sensor in the window; andmoving the tracker to different ones of the cells to traverse a path along the patch, wherein the fabric is conformable to a shape of the organism to orient the sensor to enable the measurements of the organism.

18. The method of claim 17, wherein the two or more cells have a regular or irregular shape, including but not limited to a hexagon shape, a pentagon shape, a circular shape, a triangular shape, or a square shape.

19. The method of claim 17, wherein there are two or more third attachment means and two or more fourth attachment means that mate to form a first position and a second position, wherein moving the tracker further comprises moving the tracker between the first position and the second position.

20. The method of claim 17, wherein the sensor is an ultrasound sensor, a blood oxygen sensor, a heart rate sensor, an electrocardiogram sensor, a temperature sensor, an accelerometer, a humidity sensor, a modulus sensor, a pressure sensor, a touch sensor, a capacitive sensor, a proximity sensor, a chemical sensor, a flow and level sensor, a light sensor, a color sensor, or a gyroscope.

Images