Three-dimensional ultrasound imaging device, related systems, reference elements, and methods

Abstract

A three-dimensional ultrasound imaging device is provided, the three-dimensional ultrasound imaging device comprising a processing unit and an interface. The processing unit is configured to acquire scan data indicative of a tissue sample and a reference feature from an ultrasound scanning machine via the interface. The processing unit is configured to acquire image data based on the scan data, the image data indicative of the tissue sample and the reference feature. The processing unit is configured to determine a tissue sample representation based on the image data.

Description

[Technical field]

[0001] The present disclosure relates to the fields of ultrasound imaging devices, ultrasound imaging systems, reference elements, and related methods. [Background technology]

[0002] The goal in surgical oncology is to remove malignant tumors and at the same time preserve as much healthy tissue as possible. However, during surgery it can be difficult to ascertain tumor margins and increase the chances of a curative operation, and different perioperative techniques can be used. Currently, many hospitals use biopsies from the tumor margins, which are sent to the pathology department for urgent frozen section examination. The subsequent progress of the surgery depends on the evaluation of a surgical pathologist. This procedure is time-consuming, increases the time of general anesthesia, and has high costs. One of the limitations of frozen sections is that only some margins can be examined, and subsequent microscopic examination of formalin-fixed specimens can change the surgical outcome to be non-curative. Summary of the Invention [Problem to be solved by the invention]

[0003] Ultrasound is a portable and inexpensive imaging technique that can be used perioperatively, intraoperatively, and postoperatively to provide high-resolution visualization of surgical specimens. However, implementing ultrasound imaging techniques and achieving satisfactory accuracy when using ultrasound imaging devices can be difficult.

[0004] Therefore, there is a need for three-dimensional ultrasound imaging devices, systems, and methods for characterizing tissue samples and reference elements that may mitigate, alleviate, or address existing shortcomings and provide improved ultrasound imaging with improved visualization and improved accuracy. [Means for solving the problem]

[0005] A three-dimensional ultrasound imaging device is provided, the three-dimensional ultrasound imaging device comprising a processing unit and an interface. The processing unit is configured to acquire scanning data indicative of a tissue sample and a reference feature from an ultrasound scanning machine via the interface. The processing unit is configured to acquire image data based on the scanning data, the image data indicative of the tissue sample and the reference feature. The processing unit is configured to determine a tissue sample representation based on the image data.

[0006] Further disclosed is a three-dimensional ultrasound imaging system. The three-dimensional ultrasound imaging system comprises an ultrasound scanning machine comprising an ultrasound scanning probe. The three-dimensional ultrasound imaging system comprises a three-dimensional ultrasound imaging device comprising a processing unit and an interface. The three-dimensional ultrasound imaging system comprises a reference element. The processing unit is configured to acquire scan data indicative of the tissue sample and the reference element from the ultrasound scanning machine via the interface. The processing unit is configured to acquire image data based on the scan data, the image data indicative of the tissue sample and the reference element. The processing unit is configured to determine a tissue sample representation based on the image data.

[0007] Further disclosed is a method implemented by a three-dimensional ultrasound imaging device for characterizing a tissue sample and a reference feature. The method includes acquiring positioning data for the reference feature based on image data. The method includes acquiring image data based on the scan data, the image data being indicative of the tissue sample and the reference feature. The method includes determining a tissue sample representation based on the image data.

[0008] The disclosed imaging devices, reference elements, related methods, and systems may provide improved ultrasound imaging, such as improved three-dimensional ultrasound imaging, with improved visualization and improved accuracy. The present disclosure may provide improved tissue sample representations with improved accuracy, which in turn may provide improved accuracy of assessment of resection margins of tissue samples. For example, by providing a tissue sample representation, such as a three-dimensional tissue sample representation, the present disclosure may improve visualization of ex-vivo tissue samples, such as three-dimensional visualization. Thus, the tissue sample representation may provide a user (such as a surgeon) with information regarding, for example, the resection margins of a tissue sample during a surgical procedure. In turn, the present disclosure may provide a surgeon with faster feedback during a surgical procedure, for example, when removing a tissue sample containing a malignant tumor, avoiding the wait time to analyze the tissue sample by a pathology department before having information regarding the removed tissue sample.

[0009] For example, the present disclosure may provide accurate information of a tissue sample (such as a surgical specimen) after formalin fixation. In other words, in a second step after formalin fixation of the tissue sample, volume rendering of the tissue sample and / or calculating the tumor dimensions and / or margins by using scan data may provide a pathologist with rapid and functional prior knowledge before the tissue sample slicing procedure. Furthermore, the present disclosure may eliminate extra cuts, for example, when a pathologist would slice a tissue sample to analyze the cells of each slice. The pathologist may be provided with knowledge of the structure of the tissue sample prior to slicing, which may reduce the number of cuts, for example, in healthy tissue.

[0010] It can be appreciated that the present disclosure provides point-of-care imaging that can be used in an operating room and / or in a pathology laboratory. Thus, the present disclosure provides a less cumbersome, faster, and simpler tissue sample representation. This can, for example, reduce surgery time and improve accuracy in assessing resection margins and removing tumors. Additionally, the present disclosure can improve assessment of tissue sample slicing direction and tissue sample slicing location. From the tissue sample representation, it can be possible to determine the tissue sample slicing direction and tissue sample slicing location.

[0011] Additionally, an advantage of the present disclosure is that the imaging device is more versatile and may be used with any available ultrasound scanning machine, such as an ultrasound scanning machine available in an operating room, etc. For example, no add-ons to the ultrasound scanning machine may be required and no changes in the setup of the ultrasound scanning machine may be required.

[0012] Further disclosed is a reference element for a three-dimensional ultrasound scanning system. In other words, the reference element is for the three-dimensional ultrasound scanning system disclosed herein. The reference element includes a three-dimensional geometric structure. Optionally, the reference element includes a three-dimensional grid structure. The grid structure is configured to be used as a reference when performing three-dimensional ultrasound imaging.

[0013] An advantage of the present reference element is that it makes it possible to improve the accuracy of the determination of the tissue sample representation when performing three-dimensional ultrasound imaging.

[0014] The above and other features and advantages of the present disclosure will become readily apparent to those skilled in the art from the following detailed description of illustrative examples thereof, which proceeds with reference to the accompanying drawings. [Brief description of the drawings]

[0015] [Figure 1] 1 is a schematic diagram of an exemplary three-dimensional imaging system according to the present disclosure, comprising a three-dimensional imaging device, an ultrasound scanning machine, and a reference element according to the present disclosure. [Figure 2A] 1 is a flow diagram of an exemplary method according to the present disclosure. [Figure 2B] 1 is a flow diagram of an exemplary method according to the present disclosure. [Diagram 3] FIG. 1 illustrates an exemplary 3D ultrasound imaging scenario in which the techniques disclosed herein can be applied. [Figure 4] FIG. 1 illustrates an exemplary 3D ultrasound imaging scenario in which the techniques disclosed herein can be applied. [Diagram 5] FIG. 2 illustrates an exemplary reference element according to the present disclosure. [Figure 6] FIG. 1 shows photographs of exemplary tissue samples. [Figure 7] FIG. 1 is a schematic diagram illustrating an exemplary three-dimensional imaging system according to the present disclosure, viewed from above. [Figure 8]FIG. 1 is a schematic diagram illustrating a perspective view of an exemplary three-dimensional imaging system according to the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] Various examples and details are described below with reference to the figures when relevant. It should be noted that the figures may or may not be drawn to scale, and that elements of similar structure or function are represented by similar reference numerals throughout the figures. It should also be noted that the figures are merely for facilitating the description of the examples. They are not intended as an exhaustive description of the disclosure or as limitations on the scope of the disclosure. Furthermore, the examples shown do not necessarily have to have all aspects or advantages shown. An aspect or advantage described with respect to a particular example is not necessarily limited to that example, and may be practiced in any other example, even if not so shown or not so explicitly described.

[0017] The figures are schematic and simplified for clarity, and the figures only show details that aid in understanding the disclosure, while other details are omitted. The same reference numbers are used throughout for like or corresponding parts.

[0018] A three-dimensional (3D) ultrasound imaging device is disclosed. The three-dimensional ultrasound imaging device may be considered as a device configured to provide a three-dimensional (3D) ultrasound image, such as a three-dimensional representation of a sample, such as a tissue sample, and / or a reference element. The three-dimensional ultrasound imaging device may be considered as an electronic device, such as a computer device and / or a server device. In other words, the three-dimensional ultrasound imaging device may be considered as an electronic device for three-dimensional ultrasound imaging.

[0019] The three-dimensional ultrasound imaging device comprises a processing unit and an interface.

[0020] The processing unit is configured to obtain, via the interface, from the ultrasound scanning machine, scan data indicative of, e.g. representative of, the tissue sample and the reference element. Obtaining the scan data may include retrieving and / or receiving the scan data from the ultrasound scanning machine. In other words, the processing unit is configured to obtain, via the interface, from the ultrasound scanning machine, scan data of the tissue sample and the reference element scanned by the ultrasound scanning machine. The scan data may be indicative of a portion of the tissue sample and / or a portion of the reference element. The three-dimensional ultrasound imaging device may be connected to the ultrasound scanning machine either directly, e.g., via a cable, and / or via a network, e.g., a local network and / or a public network, such as the Internet. The interface of the imaging device may comprise a wireless and / or wired interface for connection with the ultrasound scanning machine. The ultrasound scanning machine may comprise an ultrasound scanning probe for scanning a tissue sample, e.g., human tissue or animal tissue, by using ultrasound. The scan data may be considered as data of an ultrasound scan performed with the ultrasound scanning machine. The scan data may comprise an ultrasound signal output generated by the ultrasound scanning machine. The scan data may be considered as raw ultrasound scan data generated by an ultrasound scanning machine, and the scan data indicative of the tissue sample and the reference element may be considered as scan data including data representative of the tissue sample and the reference element scanned by the ultrasound scanning machine.

[0021] A reference element may be considered as an element configured to provide one or more reference dimensions when performing three-dimensional ultrasound imaging, in other words, a reference element may be considered as a marker.

[0022] The reference element may be scanned with the tissue sample using an ultrasound scanning machine. The reference element may be positioned next to, such as in the vicinity of, the tissue sample when performing a scan of the tissue sample. The reference element may be positioned substantially anywhere within the field of view when performing a scan with the ultrasound scanning machine. The reference element may include one or more known dimensions, such as one or more dimensions known at the imaging device and / or stored at the imaging device, such as stored in a memory of the imaging device. The reference element may include one or more known dimensions in different planes, such as in the x-plane, y-plane, and / or z-plane. The reference element may also be referred to as a reference device. The reference element may include two-dimensional and / or three-dimensional structures.

[0023] The tissue sample may also be referred to as a tissue specimen, such as a surgical specimen. The tissue sample may be considered as a tissue sample from a human or an animal, such as a sample of human tissue or a sample of animal tissue. The tissue sample may include, for example, a tissue sample removed (e.g., excised) from a human patient by a surgeon, e.g., a surgeon performing surgical oncology. The tissue sample may be considered as an ex vivo tissue sample from a patient. The tissue sample may be disposed in a liquid and / or material configured to transmit ultrasound and / or used in an ultrasound imaging modality. For example, the tissue sample may be disposed in a buffer bath (e.g., a water bath) when being scanned with ultrasound.

[0024] The processing unit is configured to acquire image data based on the scan data, the image data being indicative of the tissue sample and the reference element. In other words, the image data may represent, at least in part, the tissue sample and / or the reference element. Acquiring the image data may include determining, retrieving, and / or receiving the image data. For example, acquiring the image data based on the scan data may include determining the image data based on the scan data. Acquiring the image data may include converting the scan data into image data. Acquiring the image data may include recording video data (such as including multiple image frames over time) based on the scan data, such as based on ultrasound output from an ultrasound scanning machine. The image data may include raw video data based on the scan data. The image data may include multiple image frames. In other words, acquiring the image data may include acquiring one or more image frames based on the scan data. Acquiring the image data may include acquiring one or more image frames based on a frame rate of the image data, such as a frame rate of the raw video data. In other words, the image data may be separated into multiple image frames. Each image frame of the image data may be associated with a timestamp. The image data may include one or more image frames of the tissue sample and / or the reference element. Each image frame may include a slice of the tissue sample. The processing unit may be configured to identify the image frame representative of the tissue sample. The processing unit may be configured to extract a portion of the image data representative of the tissue sample. In other words, the processing unit may be configured to extract a region of interest representative of the tissue sample from the image data.

[0025] In one or more exemplary imaging devices, the imaging device comprises an image data acquisition device. In one or more exemplary imaging devices, the processing unit is configured to acquire scan data from an ultrasound scanning machine via the image acquisition device. In other words, acquiring the image data may include recording video data using the image acquisition device based on the scan data, such as based on an ultrasound output from the ultrasound scanning machine. The image acquisition device may be configured to convert the scan data into image data. In other words, the image acquisition device may be considered as a video grabber configured to convert an ultrasound scan signal from the ultrasound scanning machine into image data. The image acquisition device may be configured to acquire one or more image frames based on the scan data. The image acquisition device may be configured to associate a timestamp with the image frames of the image data, such as associating a timestamp for each image frame of the image data.

[0026] In one or more exemplary imaging devices, the processing unit is configured to acquire positioning data of the reference element based on the image data. In other words, acquiring the image data may include acquiring positioning data of the reference element. In other words, acquiring the image data may include determining positioning data of the reference element. The positioning data may include one or more positions of the reference element. In other words, acquiring the positioning data may include acquiring, such as determining, one or more positions, such as position coordinates, of the reference element based on the image data. Acquiring the positioning data may include determining one or more position coordinates of the reference element based on one or more known dimensions of the reference element. The positioning data may be considered as a positioning reference, such as a positioning reference for the image data. In other words, the positioning data may be considered as a positioning reference for an image frame of the image data.

[0027] In one or more exemplary imaging devices, the processing unit is configured to determine a reference coordinate system based on the positioning data. In other words, the reference coordinate system may include a three-dimensional coordinate system. The processing unit may be configured to determine the reference coordinate system based on one or more position coordinates of a reference element. The reference coordinate system may be considered as a global coordinate system.

[0028] The processing unit may be configured to determine a tissue sample representation based on the image data. In other words, the processing unit may be configured to determine a three-dimensional (3D) tissue sample representation based on the image data. The tissue sample representation may include a graphical representation, such as a graphical visualization, of the tissue sample. The tissue sample representation may include a portion or all of the scanned tissue sample. The imaging device may be configured to output a user interface including a plurality of user interface objects, such as via a display interface of the imaging device and / or a separate display interface of a separate electronic device. The imaging device, such as a processing unit, may be configured to output the tissue sample representation. In other words, the imaging device, such as a processing unit, may be configured to output, such as display, a user interface including the tissue sample representation. The tissue sample representation may include a representation of the tissue sample and / or a representation of the reference element. In other words, the determination of the tissue sample representation may be based on image data associated with (e.g., representing) the tissue sample and / or the reference element. The tissue sample representation may include a graphical representation, such as a three-dimensional graphical representation, in a reference coordinate system. The tissue sample representation may be based on a plurality of image frames. In other words, determining the tissue sample representation may be based on one or more image frames of the plurality of image frames. The tissue sample representation may include one or more dimensions of the tissue sample. In other words, the processing unit may be configured to determine one or more dimensions of the tissue sample. For example, the processing unit may be configured to output, such as display, the one or more dimensions to a user of the imaging device via an interface. The one or more dimensions may indicate a size of the first portion (such as a size of a tumor), a size of the second portion, a size of a resection margin, and / or a size of a reference element.

[0029] The processing unit may be configured to extract a portion of the image data representative of the tissue sample and to determine a tissue sample representation based on the extracted portion of the image data, in other words, the processing unit may be configured to determine, from the image data, the tissue sample representation, a region of interest representative of the tissue sample.

[0030] The processing unit may be configured to determine a tissue sample representation based on an image frame, such as a voxel frame, of voxels. Determining the tissue sample representation may include determining one or more dimensions of the tissue sample based on the image data, such as based on positions of reference elements and / or known dimensions of reference elements.

[0031] In one or more exemplary imaging devices, the processing unit is configured to determine, for each image frame of the plurality of image frames, a position associated with the image frame based on a reference coordinate system (e.g., based on the positioning data) to provide a set of positions for the plurality of image frames. In other words, the processing unit may be configured to determine one or more position coordinates associated with the image frame. In one or more exemplary imaging devices, the processing unit is configured to determine, for one or more image frames of the plurality of image frames, a position associated with each of the one or more image frames based on a reference coordinate system to provide a set of positions for the one or more image frames. In one or more exemplary imaging devices, the processing unit is configured to determine, for each image frame of the image frames representing the tissue sample, a position associated with the image frame based on a reference coordinate system to provide a set of positions for the image frames representing the tissue sample. In other words, the processing unit may be configured to position each image frame of the plurality of image frames such that the position of each image frame corresponds to a true position of the image frame. For example, the processing unit may be configured to determine, for each voxel (e.g., a voxel frame) of the plurality of voxels, a position associated with the voxel based on a reference coordinate system to provide a set of positions for the plurality of voxels. In one or more exemplary imaging devices, the processing unit is configured to determine a distance between image frames, such as a distance between two image frames, based on the positioning data and / or the reference coordinate system.

[0032] The processing unit may be configured to determine a first position (e.g., a first position coordinate) for a first image frame of the plurality of image frames, a second position (e.g., a second position coordinate) for a second image frame of the plurality of image frames, a third position (e.g., a third position coordinate) for a third image frame of the plurality of image frames, etc.

[0033] The processing unit may be configured to calibrate the positioning of the image frames, such as calibrating the positioning of each image frame based on a reference coordinate system. For example, the processing unit may be configured to calibrate the positioning of the image frames based on an interpolation, such as a spline interpolation, and based on the positioning data of the reference element and / or the reference coordinate system. For example, the processing unit may be configured to perform an interpolation of a set of positions based on the positioning data of the reference element and / or the reference coordinate system.

[0034] In one or more exemplary imaging devices, determining the tissue sample representation is based on the set of locations. In other words, the tissue sample representation may include a graphical representation, such as a three-dimensional graphical representation, in a reference coordinate system. Determining the tissue sample representation may include, for example, determining one or more dimensions of the tissue sample based on the set of locations. Determining the tissue sample representation may include, for example, determining one or more dimensions of the tissue sample for each image frame of the plurality of image frames based on the set of locations. For example, determining the tissue sample representation may include performing volumetric segmentation based on the image data, such as based on each image frame of the plurality of image frames.

[0035] In one or more exemplary imaging devices, determining the tissue sample representation includes determining a first portion of the tissue sample associated with a first type of tissue based on the image data and / or based on the scan data. In other words, the processing unit may be configured to determine the first portion of the tissue sample associated with a first type of tissue based on the image data. For example, the processing unit may be configured to determine a first type of tissue of the first portion based on the image data. In other words, the processing unit may be configured to determine that the first portion of the tissue sample has a first property. For example, the processing unit may be configured to determine that the first portion of the tissue sample has a first volumetric weight based on the scan data, such as, for example, based on an ultrasound signal. For example, different tissue types may have different acoustic impedances. Thus, ultrasound waves striking different tissue types and returning echoes will have different characteristics. For example, a first portion of a first tissue type (such as tumor tissue) and a second portion of a second tissue type (such as healthy tissue) may have different intensities and textures in the tissue sample representation. Thus, it may be possible to determine which portions of a tissue sample are a first portion of a first type of tissue (such as tumor tissue) and which portions are a second portion of a second type of tissue (such as healthy tissue).

[0036] For example, determining the tissue sample representation may include defining a first portion and / or a second portion. For example, determining the tissue sample representation volume may include labeling a portion associated with the first portion with a first label and / or labeling a portion associated with the second portion with a second label. Determining the tissue sample representation may include providing a three-dimensional matrix associated with the first portion (e.g., tumor tissue) and / or the second portion (e.g., healthy tissue).

[0037] For example, the processing unit may be configured to determine that a first portion of the tissue sample has a volume weight that is different from a volume weight of a remaining portion of the tissue sample, such as a second portion. The first type of tissue of the first portion may include a tissue type that is a tumor, such as, for example, a tumor type. In other words, the first portion may be a tumor portion of the tissue sample. The first type of tissue of the first portion may include a tissue type that is a malignant tissue, such as, for example, a malignant type, such as, for example, a malignant tumor. In other words, the first portion may be a malignant tissue portion of the tissue sample. The first type of tissue of the first portion may include a tissue type that is a benign tissue, such as, for example, a benign type, such as, for example, a benign tumor. In other words, the first portion may be a benign tissue portion of the tissue sample.

[0038] In one or more exemplary imaging devices, determining the tissue sample representation includes determining a second portion of the tissue sample associated with a second type of tissue based on the image data. In other words, the processing unit may be configured to determine a second portion of the tissue sample associated with the second type of tissue based on the image data.

[0039] In other words, the processing unit may be configured to determine, based on the image data, a second portion of the tissue sample associated with a second type of tissue. For example, the processing unit may be configured to determine, based on the image data, a second type of tissue of the second portion. In other words, the processing unit may be configured to determine that the second portion of the tissue sample has a second property. For example, the processing unit may be configured to determine, based on the scan data, such as, for example, based on an ultrasound signal, that the second portion of the tissue sample has a second volume weight. For example, the processing unit may be configured to determine that the second portion of the tissue sample has a volume weight that is different from the volume weight of the remainder of the tissue sample, such as the first portion. The second type of tissue of the second portion may include a tissue type that is healthy, such as, for example, a healthy type. In other words, the second portion may be a healthy portion of the tissue sample, such as a healthy tissue portion.

[0040] In one or more exemplary imaging devices, the determination of the tissue sample representation is based on a first portion of the tissue sample and / or a second portion of the tissue sample, in other words, the tissue sample representation includes a representation of the first portion and / or a representation of the second portion.

[0041] In the one or more exemplary imaging devices, the processing unit is configured to determine a volume of the tissue sample based on the set of positions.

[0042] In one or more exemplary imaging devices, the processing unit is configured to determine a first volume of the first portion and / or a second volume of the second portion based on the set of locations. Determining the first volume of the first portion may include determining one or more first dimensions of the first portion. Determining the second volume of the second portion may include determining one or more second dimensions of the second portion. In one or more exemplary imaging devices, the processing unit is configured to determine the first volume and / or the second volume based on a volume weight of the first portion and / or a volume weight of the second portion, such as a volume weight of a first type of tissue and / or a volume weight of a second type of tissue. For example, the processing unit may be configured to determine a first volume of the first portion that is a tumor. The first volume and / or the second volume may be expressed in liters (L). The first volume may be considered a first size and the second volume may be considered a second size.

[0043] Determining the first volume and / or the second volume may include determining an area of ​​the tissue sample for each image frame of the plurality of image frames. Determining the first volume and / or the second volume may include determining an area of ​​the first portion and / or an area of ​​the second portion for each image frame of the plurality of image frames. Determining the first volume and / or the second volume may include summing areas of the plurality of frames over the range of the tissue sample. In other words, determining the first volume and / or the second volume may include summing areas representing the tissue sample for all image frames (such as slices) representing the tissue sample. For example, determining the first volume and / or the second volume may include summing areas representing the tissue sample from a first image frame representing the tissue sample to a last image frame representing the tissue sample. For example, determining the first volume and / or the second volume may include defining the first portion and / or the second portion. For example, the determination of the first volume and / or the second volume may include labeling a portion associated with the first portion with a first label and / or labeling a portion associated with the second portion with a second label. The determination of the first volume and / or the second volume may include providing a three-dimensional matrix associated with the first portion (such as tumor tissue) and / or the second portion (such as healthy tissue). For example, the determination of the first volume and / or the second volume may include performing a three-dimensional integration based on the three-dimensional matrix. Alternatively and / or additionally, the determination of the first volume and / or the second volume may include determining an area on a sample of image frames and then estimating the entire volume based on the sample of image frames. This may provide for faster determination of the first volume and / or the second volume.

[0044] In one or more exemplary imaging devices, the determination of the tissue sample representation is based on a first volume of the first portion and / or a second volume of the second portion.

[0045] In one or more exemplary imaging devices, the processing unit is configured to determine a resection margin of the tissue sample based on the tissue sample representation. The processor circuit may be configured to determine a resection margin of the tissue sample based on the first volume and / or the second volume. For example, the resection margin may be determined by subtracting the first volume from the second volume. The resection margin may be a resection margin of the first portion and / or the second portion. The resection margin itself may be formed by the second portion. Determining the resection margin may include determining whether a resection margin exists, such as whether there is a resection margin. The processor circuit may be configured to determine a distance from an outer surface of the second portion of the tissue sample to an outer surface of the first portion of the tissue sample. In other words, the processing unit may be configured to determine whether a resection margin of the tissue sample exists. The processing unit may be configured to determine whether the second portion (e.g., a second portion of a second type of tissue) encapsulates (e.g., encircles and / or surrounds) the first portion (e.g., a first portion of a first type of tissue). When it is determined that the second portion encapsulates (e.g., surrounds) the first portion, a resection margin is determined to be present. When it is determined that the second portion does not encapsulate (e.g., does not surround) the first portion, a resection margin is determined to be absent, or at least does not encapsulate the entire first portion.

[0046] The resection margin of a tissue sample may be considered as the margin in the tissue sample of a second type of tissue around the first type of tissue, in other words, the resection margin may be considered as a second layer of the second type of tissue, such as a layer of healthy tissue, surrounding a first layer and / or core of the first type of tissue, such as a layer and / or core of tumor tissue.

[0047] The resection margin of a tissue sample may vary depending on the location on the tissue sample where the resection margin is determined. When performing a resection of a tissue sample from a subject, it may be desirable to have a margin (also called a resection) of healthy tissue all around the tumor, such as surrounding the tumor. This is to ensure that the entire tumor has been removed and that the tumor has not spread to additional tissue. In other words, it may be desirable to have a second portion (resection margin) of a second type of tissue (healthy tissue) all around a first portion of a first type of tissue (tumor). Determining the resection margin may include determining a type of resection margin, such as a safe resection margin (e.g., greater than 1 cm), a close margin (e.g., in the range 1 cm to 0.5 cm), and / or a positive margin (e.g., less than 0.5 cm).

[0048] In one or more exemplary imaging devices, the reference elements include three-dimensional geometric structures, such as a three-dimensional grid structure. The reference elements may include three-dimensional geometric structures with known dimensions that are to be used as a reference when scanning. The three-dimensional geometric structures may include patterns of geometric structures that are easy to identify and have a recognizable pattern.

[0049] In one or more exemplary imaging devices, the reference element includes a three-dimensional grid structure. In other words, the reference element may include a three-dimensional array structure, such as an array of substantially equal sized rectangles. The imaging device may have one or more dimensions of the three-dimensional grid structure stored, such as one or more dimensions of the three-dimensional grid structure known by the imaging device. The three-dimensional grid structure may comprise, for example, an overall width, a rectangular side length of the grid, an overall length, and / or a depth and / or height. The three-dimensional grid structure may be used as the reference element. By using the three-dimensional grid structure as the reference element, it may be easier for the processing unit to determine positioning data. The three-dimensional grid structure may provide a simpler identification of the reference element by the processing unit. By having a three-dimensional grid structure, it may be possible to determine and / or obtain known dimensions (such as true dimensions) of the reference element in three dimensions, such as in three directions. The reference element may be a three-dimensional (3D) printed reference element.

[0050] In one or more exemplary imaging devices, the tissue sample is configured to be supported on the support element. In other words, the tissue sample may be supported by the support element when performing an ultrasound scan of the tissue sample. In one or more exemplary imaging devices, the support element includes a reference element. In other words, the reference element may be integrated and / or incorporated into the support element. The support element may be considered a support for the tissue sample, such as a support on which the tissue sample is attached or placed when performing an ultrasound scan of the tissue sample. In other words, the reference element may be placed below and / or beneath the tissue sample. An advantage of the tissue sample being supported on the support element when the support element includes a reference element may be that less scan data may have to be acquired, since a smaller area has to be scanned. The processing unit may be configured to acquire image data representing the reference element through the tissue sample placed above the reference element based on the scan data.

[0051] A three-dimensional ultrasound imaging system is disclosed. The three-dimensional ultrasound imaging system comprises an ultrasound scanning machine comprising an ultrasound scanning probe. The three-dimensional ultrasound imaging system comprises a three-dimensional ultrasound imaging device, such as a three-dimensional ultrasound imaging device disclosed herein, comprising a processing unit and an interface. The three-dimensional ultrasound imaging system comprises a reference element, such as a reference element disclosed herein.

[0052] The processing unit is configured to acquire, via the interface, scan data indicative of the tissue sample and the reference element from the ultrasound scanning machine.

[0053] The processing unit is configured to acquire image data based on the scan data, the image data being indicative of the tissue sample and / or the reference feature. The processing unit is configured to determine a tissue sample representation based on the image data.

[0054] In the one or more exemplary imaging systems, the processing unit is configured to determine positioning data of the reference element based on the image data. In the one or more exemplary imaging systems, the processing unit is configured to determine a reference coordinate system based on the positioning data.

[0055] In one or more exemplary imaging systems, the image data includes a plurality of image frames, and the processing unit is configured to determine, for each image frame of the plurality of image frames, a position associated with the image frame based on a reference coordinate system to provide a set of positions for the plurality of image frames. In one or more exemplary systems, the determination of the tissue sample representation is based on the set of positions.

[0056] In one or more exemplary imaging systems, determining the tissue sample representation includes determining a first portion of the tissue sample associated with a first type of tissue based on the image data. In one or more exemplary imaging systems, determining the tissue sample representation includes determining a second portion of the tissue sample associated with a second type of tissue based on the image data.

[0057] In the one or more exemplary imaging systems, the processing unit is configured to determine a first volume of the first portion and / or a second volume of the second portion based on the set of positions.

[0058] In one or more exemplary imaging systems, the system includes a gripping element for mounting the ultrasound scanning probe. The gripping element may be considered a grabber. In other words, the scanning machine may include a gripping element for mounting the scanning probe. In one or more exemplary imaging systems, the ultrasound scanning machine includes a slider element for moving the ultrasound scanning probe. In other words, the scanning machine may include a slider element for moving the scanning probe. The ultrasound scanning probe may be mounted directly to the slider without a gripping element. In one or more exemplary imaging systems, the system includes an arm, such as a robotic arm. The arm may include a gripping element and / or a slider element. The system, such as the scanning machine, may include a motor configured to move the slider element and thereby the scanning probe. The motor may be configured to move the slider at a constant speed.

[0059] In one or more exemplary imaging systems, the processing unit is configured to control a slider element. In other words, the processing unit may be configured to control a motor of the system, such as a motor of a scanning machine. The processing unit may be configured to control a slider, such as a motor, in one or more dimensions, such as one dimension, two dimensions, and / or three dimensions.

[0060] In one or more exemplary imaging systems, the reference elements include a three-dimensional grid structure.

[0061] In one or more exemplary imaging systems, the tissue sample is configured to be supported on the support element. In one or more exemplary imaging systems, the support element includes a reference element. In one or more exemplary imaging systems, the reference element may comprise an empty area, such as a sample area, configured to receive a tissue sample. The empty area or sample area may be considered an area where the reference element does not have a reference pattern, e.g., a planar surface on which a tissue sample may be placed. In one or more exemplary imaging systems, the sample area may be implemented as an opening in the reference element, e.g., a hole in the reference element, where the reference element does not comprise material. The sample area may be shaped as a rectangle. An advantage of having a reference element with an opening may be that the tissue sample may be scanned without a background. The reference element may be used to support, such as a cork, and / or to gravity clamp the tissue samples, e.g., to ensure that they are covered with saline.

[0062] A reference element for a three-dimensional ultrasound scanning system is disclosed. The reference element includes a three-dimensional grid structure. The grid structure is configured to be used as a reference when performing three-dimensional ultrasound imaging. In other words, the reference element can be for a three-dimensional ultrasound scanning system as disclosed herein.

[0063] The use of reference elements according to the present disclosure for three-dimensional ultrasound scanning systems is disclosed.

[0064] A method is disclosed for characterizing a tissue sample and a reference feature, the method including obtaining scan data from an ultrasound scanning machine indicative of the tissue sample and the reference feature, obtaining image data based on the scan data, the image data indicative of the tissue sample and the reference feature, and determining a tissue sample representation based on the image data.

[0065] It should be understood that a description of a feature related to the imaging device(s) is also applicable to corresponding features in the imaging system(s), reference element(s), and / or method(s).

[0066] 1 illustrates a schematic diagram of an exemplary system, such as a three-dimensional imaging system 2, according to the present disclosure. The system 2 includes an ultrasound scanning machine 20 including an ultrasound scanning probe 20A. The three-dimensional ultrasound imaging system 2 includes a three-dimensional ultrasound imaging device 10, such as a three-dimensional ultrasound imaging device, according to the present disclosure, including a processing unit 10C and an interface 10B (such as one or more interfaces). The three-dimensional ultrasound imaging system 2 includes a reference element (not shown), such as a reference element, according to the present disclosure. Optionally, the imaging device 10 includes a memory 10A. Optionally, the scanning machine 20 includes one or more interfaces 20B.

[0067] The processing unit 10C is configured to acquire 14 scan data indicative of the tissue sample and the reference features from an ultrasound scanning machine 20 via an interface 10B.

[0068] The processing unit 10C is configured to acquire image data based on the scan data, the image data being indicative of the tissue sample and the reference element.

[0069] The processing unit 10C is configured to determine a tissue sample representation based on the image data.

[0070] Optionally, imaging device 10 may be configured to output 6 a user interface (e.g., user output) including a plurality of user interface objects to a user 1 of the imaging device, such as via a display interface of imaging device 10 and / or a separate display interface of a separate electronic device. Imaging device 10, such as processing unit 10C, may be configured to output 6 a tissue sample representation to user 1, such as via interface 10A. In other words, imaging device 10, such as processing unit 10C, may be configured to output 6 a user interface including the tissue sample representation to user 1, such as displaying it.

[0071] Optionally, user 1 may provide input 4 (e.g., user input) to imaging device 10, such as via interface 10A. Determination of the tissue sample representation may be based on input 4 from the user. User 1 may, for example, select a region of interest of the tissue sample to be represented. User 1 may, for example, provide input 4 including one or more dimensions of a reference element.

[0072] For example, the processing unit may be configured to output, e.g., display, the one or more dimensions to a user of the imaging device via the interface. The one or more dimensions may indicate a size of the first portion (e.g., a size of a tumor), a size of the second portion, a size of a resection margin, and / or a size of a reference element.

[0073] In one or more exemplary imaging devices, the processing unit 10C is configured to obtain positioning data of the reference element based on the image data. In one or more exemplary imaging systems and / or imaging devices, the processing unit 10C is configured to determine a reference coordinate system based on the positioning data.

[0074] In one or more exemplary imaging systems and / or imaging devices, the image data includes a plurality of image frames, and the processing unit 10C is configured to determine, for each image frame of the plurality of image frames, a position associated with the image frame based on a reference coordinate system to provide a set of positions for the plurality of image frames. In one or more exemplary imaging devices, the determination of the tissue sample representation is based on the set of positions.

[0075] In one or more of the exemplary imaging systems and / or imaging devices, the processing unit 10C is configured to determine a first portion of the tissue sample associated with a first type of tissue based on the image data, and in one or more of the exemplary imaging devices, the processing unit 10C is configured to determine a second portion of the tissue sample associated with a second type of tissue based on the image data.

[0076] In one or more exemplary imaging systems and / or imaging devices, the processing unit 10C is configured to determine a first volume of the first portion and / or a second volume of the second portion based on the set of positions.

[0077] In one or more exemplary imaging systems and / or imaging devices, the processing unit 10C is configured to determine a resection margin of the tissue sample based on the tissue sample representation.

[0078] In one or more of the exemplary imaging systems and / or imaging devices, the imaging device 10 includes an image data acquisition device 10D. In one or more of the exemplary imaging systems and / or imaging devices, the processing unit 10C is configured to acquire 14 scan data from an ultrasound scanning machine 20 via the image acquisition device 10D.

[0079] In one or more exemplary imaging systems and / or imaging systems, the system 2 includes a gripping element 20C for mounting the ultrasound scanning probe 20A. The gripping element 20C may be considered as a grabber. In other words, the scanning machine 20 may include a gripping element 20C for mounting the scanning probe 20A. In one or more exemplary imaging systems, the ultrasound scanning machine includes a slider element 20D for moving the ultrasound scanning probe 20A.

[0080] In one or more exemplary imaging systems and / or imaging systems, the processing unit 10C may be configured to control 12 (e.g., send one or more signals and / or commands to) the slider element 20D. In other words, the processing unit 10C may be configured to control 12 a motor of the system 2, such as a motor of the scanning machine 20.

[0081] The electronic device 10 may be configured to perform any of the methods disclosed in Figures 2A, 2B.

[0082] The processing unit 10C is optionally configured to perform any of the operations disclosed in FIG. 2A-2B (such as any one or more of S102A, S106, S108, S110, S112A, S112B, S114). The operations of the imaging device may be embodied in the form of executable logic routines (e.g., lines of code, software programs, etc.) stored in a non-transitory computer-readable medium (e.g., memory 10A) and executed by the processing unit 10C). Furthermore, the operations of the imaging device 10 may be considered as methods that the imaging device 10 is configured to perform. Also, while the functions and operations described may be implemented in software, such functionality may also be performed via dedicated hardware or firmware, or any combination of hardware, firmware and / or software.

[0083] Memory 10A may be one or more of a buffer, flash memory, hard drive, removable media, volatile memory, non-volatile memory, random access memory (RAM), or other suitable device. In a typical arrangement, memory 10A may include non-volatile memory for long-term data storage and volatile memory that serves as system memory for processing unit 10C. Memory 10A may exchange data with processing unit 10C over a data bus. There may also be control lines and address buses between memory 10B and processing unit 10C (not shown in FIG. 1). Memory 10B is considered a non-transitory computer-readable medium.

[0084] The memory 10B may be configured to store information, such as scan data, image data, and / or tissue sample(s) representations in portions of the memory.

[0085] 2A and 2B show flow diagrams of an exemplary method, such as method 100. Method 100 is disclosed that is implemented by a three-dimensional ultrasound imaging device for characterizing a tissue sample and a reference feature. Method 100 includes acquiring S102 scan data indicative of the tissue sample and the reference feature from an ultrasound scanning machine. Method 100 includes acquiring S104 image data based on the scan data, the image data indicative of the tissue sample and the reference feature. Method 100 includes determining S112 a tissue sample representation based on the image data.

[0086] In one or more exemplary methods, the method 100 includes obtaining S106 positioning data of the reference feature based on the image data.

[0087] In one or more exemplary methods, the method 100 includes determining S108 a reference coordinate system based on the positioning data.

[0088] In one or more exemplary methods, the image data includes a plurality of image frames, and the method 100 includes determining S110, for each image frame of the plurality of image frames, a position associated with the image frame based on a reference coordinate system to provide a set of positions for the plurality of image frames.

[0089] In one or more exemplary methods, determining S112 the tissue sample representation is based on a set of locations.

[0090] In one or more exemplary methods, determining S112 the tissue sample representation includes determining S112A a first portion of the tissue sample associated with a first type of tissue based on the image data.

[0091] In one or more exemplary methods, the method 100 includes determining S112A a second portion of the tissue sample associated with a second type of tissue based on the image data.

[0092] In one or more example methods, the method 100 includes determining S112B a first volume of the first portion and / or a second volume of the second portion based on the set of locations.

[0093] In one or more exemplary methods, the method 100 includes determining S114 a resection margin for the tissue sample based on the tissue sample representation.

[0094] In one or more exemplary methods, the method 100 includes acquiring S102A scan data from an ultrasound scanning machine via an image acquisition device.

[0095] FIG. 3 illustrates an exemplary three-dimensional ultrasound imaging scenario in which the techniques disclosed herein are applied. FIG. 3 illustrates an exemplary scenario in which a three-dimensional ultrasound imaging device according to the present disclosure is used. A processing unit (such as processing unit 10C in FIG. 1) acquires scan data indicative of a tissue sample 200 and a reference element 300 from an ultrasound scanning machine via an interface. The processing unit (such as processing unit 10C in FIG. 1) acquires image data based on the scan data, the image data indicative of the tissue sample 200 and the reference element 300. The processing unit (such as processing unit 10C in FIG. 1) determines a tissue sample representation 250 based on the image data. In FIG. 3, the tissue sample representation 250 is a three-dimensional tissue sample representation, such as a three-dimensional visualization of the tissue sample 200.

[0096] Optionally, a processing unit (such as processing unit 10C in FIG. 1 ) obtained positioning data of the reference element 300 based on the image data, and determined the reference coordinate system 260 based on the positioning data. The reference coordinate system 260 can be regarded as a three-dimensional reference coordinate system having an X-axis, a Y-axis, and a Z-axis on FIG.

[0097] Optionally, determining the tissue sample representation includes determining, based on the image data, a first portion 210 of the tissue sample 200 associated with a first type of tissue and a second portion 220 of the tissue sample 200 associated with a second type of tissue.

[0098] Optionally, a processing unit (such as processing unit 10C in FIG. 1) is configured to determine a first volume of the first portion 210 and a second volume of the second portion 220 based on the set of positions.

[0099] Optionally, the processing unit (such as processing unit 10C of FIG. 1) is configured to determine a resection margin 230 of the tissue sample 200 based on the tissue sample representation 250.

[0100] Optionally, the reference element 300 includes a three-dimensional grid structure.

[0101] Optionally, the tissue sample 200 is configured to be supported on a support element, the support element including a reference element 300. In Figure 3, the tissue sample 200 was supported on the reference element 300 when the tissue sample 200 was scanned with ultrasound.

[0102] 4 illustrates an example three-dimensional ultrasound imaging scenario in which a three-dimensional ultrasound imaging device, such as imaging device 10 according to the present disclosure, is used to provide a tissue sample representation, such as the tissue sample representation of FIG.

[0103] Optionally, the image data includes multiple image frames. For example, the image data includes a first image frame 240 (e.g., a first image plane), a second image frame 242 (e.g., a second image plane), and / or a third image frame 244 (e.g., a third image plane). In FIG. 4, the image data includes 13 image frames.

[0104] A processing unit, such as processing unit 10C, may be configured to determine, for each image frame of the plurality of image frames, a position associated with the image frame based on the reference coordinate system 260 to provide a set of positions for the plurality of image frames. Optionally, the determination of the tissue sample representation 250 is based on the set of positions.

[0105] In one or more exemplary imaging devices, a processing unit (such as processing unit 10C of FIG. 1 ) is configured to determine, for one or more image frames of the plurality of image frames, a position associated with each of the one or more image frames based on the reference coordinate system 260 to provide a set of positions for the one or more image frames. For example, the processing unit may be configured to determine a first position of the first image frame 240, a second position of the second image frame 242, and / or a third position of the third image frame 244. In one or more exemplary imaging devices, a processing unit (such as processing unit 10C of FIG. 1 ) is configured to determine, for each image frame of the image frames representing the tissue sample 200, a position associated with the image frame based on the reference coordinate system 260 to provide a set of positions for the image frames representing the tissue sample 200. In other words, the processing unit may be configured to position each image frame of the plurality of image frames such that the position of each image frame corresponds to a true position of the image frame, e.g., a true position when scanning the tissue sample 200. For example, the processing unit may be configured to determine, for each voxel (e.g., a voxel frame) of the plurality of voxels, a position associated with the voxel based on the reference coordinate system 260 to provide a set of positions for the plurality of voxels. In one or more exemplary imaging devices, the processing unit is configured to determine a distance between image frames, such as a distance between two image frames, such as between a first image frame 240 and a second image frame 242, based on the positioning data and / or the reference coordinate system 260.

[0106] The processing unit may be configured to determine a first position (e.g., a first position coordinate) for a first image frame 240 of the plurality of image frames, a second position (e.g., a second position coordinate) for a second image frame 242 of the plurality of image frames, a third position (e.g., a third position coordinate) for a third image frame 244 of the plurality of image frames, etc.

[0107] The processing unit may be configured to calibrate the positioning of the image frames, such as calibrating the positioning of each image frame based on the reference coordinate system 260. For example, the processing unit may be configured to calibrate the positioning of the image frames based on an interpolation, such as a spline interpolation, and based on the positioning data of the reference element 300 and / or the reference coordinate system 260. For example, the processing unit may be configured to perform an interpolation of a set of positions based on the positioning data of the reference element 300 and / or the reference coordinate system 260.

[0108] Determining the tissue sample representation 250 may include, for example, determining one or more dimensions of the tissue sample 200 for each image frame of the plurality of image frames based on the set of locations. For example, determining the tissue sample representation 250 may include performing volume segmentation based on the image data, such as based on each image frame of the plurality of image frames.

[0109] Determining the first volume and / or the second volume may include determining an area of ​​the tissue sample for each image frame of the plurality of image frames. Determining the first volume and / or the second volume may include determining an area of ​​the first portion 210 and / or an area of ​​the second portion 220 for each image frame of the plurality of image frames. Determining the first volume and / or the second volume may include summing areas of the plurality of frames across the range of the tissue sample 200. In other words, determining the first volume and / or the second volume may include summing areas representing the tissue sample 200 for all image frames (e.g., slices) representing the tissue sample 200. For example, determining the first volume and / or the second volume may include summing areas representing the tissue sample 200 from a first image frame 240 representing the tissue sample to a last image frame 270 representing the tissue sample 200. For example, the determination of the first volume and / or the second volume may include defining the first portion 210 and / or the second portion 220. For example, the determination of the first volume and / or the second volume may include labeling a portion associated with the first portion 210 with a first label and / or labeling a portion associated with the second portion 220 with a second label. The determination of the first volume and / or the second volume may include providing a three-dimensional matrix associated with the first portion 210 (such as tumor tissue) and / or the second portion 220 (such as healthy tissue). For example, the determination of the first volume and / or the second volume may include performing a three-dimensional integration based on the three-dimensional matrix. Alternatively and / or additionally, the determination of the first volume and / or the second volume may include determining an area on a sample of the image frame and then estimating the entire volume based on the sample of the image frame. This may provide for faster determination of the first volume and / or the second volume.

[0110] Figure 5 illustrates an exemplary reference element according to the present disclosure, such as the reference element 300 of Figures 3-4. The reference element 300 may be considered an element configured to provide one or more reference dimensions when performing three-dimensional ultrasound imaging, such as using the imaging device 10 of Figure 1. In other words, the reference element 300 may be considered a marker.

[0111] The reference element 300 may be scanned with a tissue sample, such as the tissue sample 200 of Figs. 3-4, using an ultrasound scanning machine. The reference element 300 may be positioned next to, such as in the vicinity of, the tissue sample when performing a scan of the tissue sample. The reference element 300 may be positioned substantially anywhere within the field of view when performing a scan with the ultrasound scanning machine. The reference element 300 may include one or more known dimensions, such as one or more dimensions known at the imaging device and / or stored at the imaging device, such as stored in a memory of the imaging device. The reference element 300 may include one or more known dimensions in different planes, such as in the x-plane, y-plane, and / or z-plane. The reference element 300 may also be referred to as a reference device. The reference element 300 may include two-dimensional and / or three-dimensional structures. In Fig. 5, the reference element 300 includes a three-dimensional grid structure, which is configured to be used as a reference when performing three-dimensional ultrasound imaging. The reference element 300 includes a three-dimensional array structure, such as an array of rectangles of substantially the same size. The imaging device may have stored one or more dimensions of the three-dimensional grid structure, such as one or more dimensions of the three-dimensional grid structure known by the imaging device. The three-dimensional grid structure may comprise, for example, an overall width, a rectangular side length of the grid, an overall length, and / or a depth and / or height. The three-dimensional grid structure may be used as the reference element 300. By using the three-dimensional grid structure as a reference element, it may be easier for the processing unit to determine positioning data. The three-dimensional grid structure may provide a simpler identification of the reference element by the processing unit. By having a three-dimensional grid structure, it may be possible to determine and / or obtain known dimensions (such as true dimensions) of the reference element in three dimensions, such as in three directions.

[0112] FIG. 6 shows a photograph of an exemplary tissue sample, such as tissue sample 200 of FIGS. 3-4. Tissue sample 200 is an animal tissue sample. Tissue sample 200 has been sliced, and thus the photograph shows a cross-section of tissue sample 200. Tissue sample 200 includes a first portion 210 associated with a first type of tissue (such as tumor tissue), and tissue sample 200 includes a second portion 220 associated with a second type of tissue. FIGS. 3-4 may include tissue sample representations of tissue sample 200 of FIG. 6.

[0113] 7-8 show schematic illustrations of three-dimensional imaging systems according to the present disclosure, such as imaging system 2. In FIG. 7, the exemplary three-dimensional imaging system is seen from above, and FIG. 8 shows a perspective view of the exemplary three-dimensional imaging system. It can be appreciated that an ultrasound scanning machine with an ultrasound scanning probe and a three-dimensional ultrasound imaging device with a processing unit and interface are not shown in the figures. The imaging system shown in FIG. 7-8 comprises a cabinet, which may be closed on all sides. For illustration purposes, the top cover and the side cover of the cabinet are not shown. The cabinet may be configured to be connected to a ventilation system, for example, to prevent cross-contamination and / or outgassing from tissue samples, and to ensure that the mechanical movement system does not contaminate the air in the surgical volume, such as the operating theater. The cabinet may further serve as a safety net for the operator, for example, to prevent pinching, clamping, burns, and access may be controlled by a monitored door, which ensures that all movements are stopped if the door is opened during scanning. The imaging system 2 may be connected to an external computer, such as a laptop, configured to act as a processing unit.

[0114] The imaging system 2 comprises a reference element 300, such as a reference element disclosed herein. As can be seen in Figs. 7-8, the reference element 300 is placed in the carrier element 22. It can be appreciated that the reference element 300 can have an empty area, a sample area 26, configured to receive a tissue sample. The empty area or sample area 26 can be considered as an area where the reference element does not have a reference pattern, e.g., a planar surface on which a tissue sample can be placed. In one or more exemplary imaging systems, the sample area 26 can be implemented as an aperture in the reference element 300. An advantage of having a reference element with an aperture can be that the tissue sample can be scanned without background. The reference element 300 can be used to support, such as a cork, and / or to gravity clamp the tissue samples, for example to ensure that they are covered with saline. As can be seen on Figs. 7-8, the sample area 26 is here rectangular. In one or more exemplary imaging systems, the sample area 26 may be configured to receive a support element, such as a piece of cork. In other words, the tissue sample may be pinned to the piece of cork in the sample area 26. In one or more exemplary imaging systems, the support element may include the reference element 300, or vice versa. The carrier element 22 may comprise a container in which the reference element 300 and the tissue sample are placed. The container may then be filled to the brim with a saline solution to cover the tissue sample. Preferably, the tissue sample is covered with saline solution such that there is at least 5 mm of saline solution above the highest point of the tissue sample, e.g., at least 10 mm above, at least 20 mm above, or at least 50 mm above. Optionally, the imaging system 2 may comprise a thermometer for measuring the temperature of the saline solution. Since the dimensions acquired using an ultrasound scan are temperature dependent (sound propagation varies with temperature), the temperature of the saline bath in which the tissue sample is placed may be measured while performing the scan. The acquired temperatures may then be logged together with the scan data, for example by a processing unit.In the example of Figures 7-8, the reference element 300 comprises a three-dimensional grid structure.The grid structure is configured to be used as a reference when performing three-dimensional ultrasound imaging, such as a geometric reference. In this example, the reference element includes a grid structure around the sample area 26. Optionally, the reference element 300 includes auxiliary reference structures at the corners of the reference element 300, such as at the corners of the grid structure. The auxiliary reference structures may be used for optional geometric calibration. The auxiliary reference structures may have a different encapsulation than the remaining reference structures and may be automatically identified and used for global alignment.

[0115] In one or more exemplary imaging systems, the system 2 includes a gripping element 20C for mounting an ultrasound scanning probe (not shown). The gripping element 20C may be considered a grabber. In one or more exemplary imaging systems, the imaging system 2 includes a slider element 20D for moving the ultrasound scanning probe. The ultrasound scanning probe may be mounted directly to the slider element 20D without the gripping element 20C. It may be appreciated that the system 2 may include multiple slider elements 20D, such as a first slider element, a second slider element, a third slider element, and / or a fourth slider element. For example, the system 2 may include two slider elements 20D on each side of the gripping element 20C, such as a first slider element 20D1 and a second slider element 20D2, for enabling movement / movement on an X-axis of the system, such as an X-axis of a cabinet. Additionally or alternatively, system 2 may include a slider element 20D, such as a third slider element 20D3, to enable movement / translation on a Y-axis of the system, such as the Y-axis of the cabinet. For example, gripping element 20C may be mounted on third slider element 20D3. In one or more exemplary imaging systems, system 2 includes a beam 24 connecting two slider elements 20D, 20D1, 20D2 on each side of the cabinet. In one or more exemplary imaging systems, gripping element 20C may be mounted on beam 24.

[0116] The system 2 may comprise one or more motors configured to move the slider element(s) 20D and thereby the scanning probe, for example, to move the gripping element 20C. The motors may be configured to move the slider at a constant speed. The system 2 is thereby configured to move the scanning probe in the XY plane. For example, each slider element 20D may comprise a motor. In one or more exemplary imaging systems, the system 2 is configured to rotate the scanning probe about a system Z-axis, such as the Z-axis of the cabinet. In other words, the gripping element 20C and / or the third slider element 20D3 may comprise a motor, for example, to enable rotation about the Z-axis. In one or more exemplary imaging systems, the carrier element 22 is mounted on a slider element, such as the fourth slider element 20D4. The fourth slider element 20D4 may allow movement / translation of the carrier element 22, such as the movement of the tissue sample, on the Z-axis of the system, such as the Z-axis of the cabinet. It may thereby be appreciated that the system 2 may provide four degrees of freedom of movement in a Cartesian coordinate system. With these degrees of freedom, the system 2 may be able to align the scanning probe with respect to the tissue sample, in principle allowing scanning along any trajectory in a plane, for example with a scanner array oriented perpendicular to the trajectory of the scanning direction. It may be appreciated that the scanning probe may comprise a scanner array, for example, within an array of elements, aligned with the width of the probe. When scanning, the scanning direction may have to be perpendicular to the array. In one or more exemplary imaging systems, the system 2 may be configured to scan the sample separately along both the X-axis and the Y-axis, for example, to improve geometric shape recognition and feature recognition. By having a system that allows movement in 3D, the scanning probe may be positioned perpendicular to the trajectory of the scanning direction.For example, when a tissue sample is scanned in the X direction and then scanned in the Y direction, it requires that the scanning probe be able to be rotated 90 degrees about the Z axis.

[0117] Examples of imaging devices, systems, reference elements, and methods according to the present disclosure are presented in the following sections. Item 1. a processing unit; - Interface and A three-dimensional ultrasound imaging device comprising: - The processing unit - acquiring scan data indicative of the tissue sample and the reference element from an ultrasound scanning machine via an interface; - acquiring image data based on the scan data, the image data being indicative of the tissue sample and the reference element; and - determining a tissue sample representation based on the image data; A three-dimensional ultrasound imaging device configured to perform Item 2. An imaging device as described in Item 1, wherein the processing unit is configured to obtain positioning data of a reference element based on the image data, and to determine a reference coordinate system based on the positioning data. Item 3. The imaging device of item 2, wherein the image data includes a plurality of image frames, and the processing unit is configured to determine, for each image frame of the plurality of image frames, a position associated with the image frame based on a reference coordinate system to provide a set of positions for the plurality of image frames, and wherein determining the tissue sample representation is based on the set of positions. Item 4. The imaging device of any one of items 1 to 3, wherein determining the tissue sample representation includes determining a first portion of the tissue sample associated with a first type of tissue and a second portion of the tissue sample associated with a second type of tissue based on the image data. Item 5. The imaging device of Item 4, wherein the processing unit is configured to determine a first volume of the first portion and a second volume of the second portion based on the set of positions. Item 6. The imaging device according to any one of items 1 to 5, wherein the processing unit is configured to determine a resection margin of the tissue sample based on the tissue sample representation. Item 7. The imaging device of any one of items 1 to 6, wherein the reference element comprises a three-dimensional grid structure. Item 8. The imaging device of any one of items 1 to 7, wherein the tissue sample is configured to be supported on a support element, the support element including a reference element. Item 9. An imaging device according to any one of items 1 to 8, wherein the imaging device comprises an image data collection device, and the processing unit is configured to acquire scan data from an ultrasound scanning machine via the image collection device. Item 10. - an ultrasound scanning machine having an ultrasound scanning probe; - a 3D ultrasound imaging device comprising a processing unit and an interface; - Criteria elements and A three-dimensional ultrasound imaging system comprising: - The processing unit - acquiring scan data indicative of the tissue sample and the reference element from an ultrasound scanning machine via an interface; - acquiring image data based on the scan data, the image data being indicative of the tissue sample and the reference element; and determining a tissue sample representation based on the image data. A three-dimensional ultrasound imaging system configured to perform Item 11. The system of item 10, wherein the processing unit is configured to determine positioning data of the reference element based on the image data, and to determine a reference coordinate system based on the positioning data. Item 12. The system of item 11, wherein the image data includes a plurality of image frames, and the processing unit is configured to determine, for each image frame of the plurality of image frames, a position associated with the image frame based on a reference coordinate system to provide a set of positions for the plurality of image frames, and the determination of the tissue sample representation is based on the set of positions. Item 13. The system of any one of items 10 to 12, wherein determining the tissue sample representation includes determining a first portion of the tissue sample associated with a first type of tissue and a second portion of the tissue sample associated with a second type of tissue based on the image data. Item 14. The system of item 13, wherein the processing unit is configured to determine a first volume of the first portion and a second volume of the second portion based on the set of positions. Item 15. The system of any one of items 10 to 14, wherein the system comprises a gripping element for mounting the ultrasound scanning probe and the ultrasound scanning machine comprises a slider element for moving the ultrasound scanning probe. Item 16. The system of item 15, wherein the processing unit is configured to control the slider element. Item 17. The system of any one of items 10 to 16, wherein the reference element includes a three-dimensional grid structure. Item 18. The system of any one of items 10 to 17, wherein the tissue sample is configured to be supported on a support element, the support element including a reference element. Item 19. A reference element for a three-dimensional ultrasound scanning system, the reference element including a three-dimensional grid structure, the grid structure configured to be used as a reference when performing three-dimensional ultrasound imaging. Item 20. A method for characterizing a tissue sample and a reference element, the method being performed by a three-dimensional ultrasound imaging device, the method comprising: - acquiring scan data indicative of the tissue sample and the reference element from an ultrasound scanning machine (S102); - acquiring (S104) image data based on the scan data, the image data being indicative of the tissue sample and the reference element; - determining (S118) a tissue sample representation based on the image data; A method comprising: Item 21. The method is - obtaining positioning data of the reference element based on the image data (S106); determining a reference coordinate system based on the positioning data (S108); 21. The method according to item 20, comprising: Item 22. The image data includes a plurality of image frames, and the method comprises: - determining, for each image frame of the plurality of image frames, a position associated with the image frame based on a reference coordinate system to provide a set of positions for the plurality of image frames (S110). Including, 22. The method according to claim 21, wherein determining the tissue sample representation (S118) is based on a set of positions. Item 23. The method is - determining (S112) a first portion of the tissue sample associated with a first type of tissue and a second portion of the tissue sample associated with a second type of tissue based on the image data. 23. The method according to any one of items 20 to 22, comprising: Item 24. The method is - determining (S114) a first volume of the first portion and a second volume of the second portion based on the set of positions; 24. The method according to item 23, comprising: Item 25. The method is - determining a resection margin for the tissue sample based on the tissue sample representation (S120); 25. The method according to any one of items 20 to 24, comprising: Item 26. The method is - acquiring scan data from the ultrasound scanning machine via an image acquisition device (S116); 26. The method according to any one of items 20 to 25, comprising:

[0118] The use of the terms "first", "second", "third", and "fourth", "primary", "secondary", "tertiary", etc. does not imply a particular order, but is included to identify individual elements. Moreover, the use of the terms "first", "second", "third", and "fourth", "primary", "secondary", "tertiary", etc. does not indicate an order or importance, but rather, the use of the terms "first", "second", "third", and "fourth", "primary", "secondary", "tertiary", etc. is used to distinguish one element from another. It should be noted that the words "first", "second", "third", and "fourth", "primary", "secondary", "tertiary", etc. are used here and elsewhere for labeling purposes only, and do not indicate a particular spatial or temporal ordering. Moreover, the labeling of a first element does not imply the presence of a second element, and vice versa.

[0119] It may be appreciated that the figures include some circuits or operations shown with solid lines and some circuits, components, features, or operations shown with dashed lines. The circuits or operations included in the solid lines are the circuits, components, features, or operations included in the broadest examples. The circuits, components, features, or operations included in the dashed lines are examples that may be included in, or may be part of, additional circuits, components, features, or operations that may be required in addition to the circuits, components, features, or operations of the solid line examples. It should be appreciated that these operations do not have to be performed in the order presented. Furthermore, it should be appreciated that not all of the operations need to be performed. The example operations may be performed in any order and in any combination. It should be appreciated that these operations do not have to be performed in the order presented. The circuits, components, features, or operations included in the dashed lines may be considered optional.

[0120] Other operations not described herein may be incorporated into the example operations, for example, one or more additional operations may be performed before, after, simultaneously with, or during any of the described operations.

[0121] Some features described above as separate implementations may also be implemented in combination as a single implementation. Conversely, features described as a single implementation may also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as working in several combinations, one or more features from a claimed combination may in some cases be deleted from the combination, and the combination may be claimed as any subcombination or a variation of any subcombination.

[0122] It should be noticed that the word "comprising" does not necessarily exclude the presence of other elements or steps than those listed.

[0123] It should be noted that the word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements.

[0124] It should further be noted that the reference signs do not limit the scope of the claims, and that the examples may be implemented at least in part by both hardware and software, and that several "means," "units" or "devices" may be represented by the same item of hardware.

[0125] As used herein, degree phrases such as "approximately," "about," "generally," and "substantially" still refer to values, amounts, or characteristics that are close to the stated value, amount, or characteristic that performs a desired function or achieves a desired result. For example, the terms "approximately," "about," "generally," and "substantially" can refer to an amount that is within 10% or less, within 5% or less, within 1% or less, within 0.1% or less, and within 0.01% or less of the stated amount. When the stated amount is zero (e.g., none, having no), the recited range above is a specific range and may not be within a specific % of the value. For example, within 10 wt. / vol.% or less, within 5 wt. / vol.% or less, within 1 wt. / vol.% or less, within 0.1 wt. / vol.% or less, and within 0.01 wt. / vol.% or less of the stated amount.

[0126] While features have been shown and described, it is understood that they are not limitations of the claimed disclosure, and it will be apparent to one skilled in the art that various changes and modifications may be made without departing from the scope of the claimed disclosure. Accordingly, the specification and drawings are to be considered in an illustrative rather than a restrictive sense. The claimed disclosure is intended to cover all alternatives, modifications, and equivalents. [Explanation of symbols]

[0127] 1 User 2. Imaging System 4 Input 6. Tissue sample representation, output 10 Imaging Devices 10A One or more interfaces 10B Memory 10C Processing Unit 10D Image Acquisition Device 12 Control, Send 14. Get 20 Scanning Machine 20A Scan Probe 20B One or more interfaces 20C gripping element 20D, 20D1, 20D2, 20D3, 20D4 Slider elements 22 Career Elements 23 Carrier Element Mover 24 beams / robot arm 26 Sample Area 200 tissue samples 210 First Part 220 Second Part 230 Resection Margins 240 First Image Frame 242 Second Image Frame 244 Third Image Frame 250 tissue sample representation 260 Reference Coordinate System 270 Last Image Frame 300 Reference Elements 100 Method for characterizing tissue samples and reference elements S102 Get scan data Acquire scan data from ultrasound scanning machines via the S102A image acquisition device S104 Acquire image data S106 Acquire positioning data of reference element S108 Determine the reference coordinate system based on the positioning data S110: Determining positions associated with the image frames to provide a set of positions for the plurality of image frames. S112 Determine tissue sample representation S112A Determining a first portion of the tissue sample and a second portion of the tissue sample S112B Determine a first volume of the first portion and a second volume of the second portion. S114 Determine resection margins for tissue samples

Claims

1. a processing unit, - Interface and A three-dimensional ultrasound imaging device comprising: said processing unit - acquiring scan data indicative of the tissue sample and the reference features from an ultrasound scanning machine via said interface; - acquiring image data based on said scan data, said image data being indicative of said tissue sample and said reference element; determining a tissue sample representation based on said image data; A three-dimensional ultrasound imaging device configured to perform the following:

2. The imaging device of claim 1 , wherein the processing unit is configured to obtain positioning data of the reference element based on the image data, and to determine a reference coordinate system based on the positioning data.

3. 3. The imaging device of claim 2, wherein the image data includes a plurality of image frames, and the processing unit is configured to determine, for each image frame of the plurality of image frames, a position associated with the image frame based on the reference coordinate system to provide a set of positions for the plurality of image frames, and the determination of the tissue sample representation is based on the set of positions.

4. 4. The imaging device of claim 1, wherein the determining of the tissue sample representation comprises determining, based on the image data, a first portion of the tissue sample associated with a first type of tissue and a second portion of the tissue sample associated with a second type of tissue.

5. The imaging device of claim 4 , wherein the processing unit is configured to determine a first volume of the first portion and a second volume of the second portion based on the set of locations.

6. The imaging device of claim 1 , wherein the processing unit is configured to determine a resection margin of the tissue sample based on the tissue sample representation.

7. The imaging device of claim 1 , wherein the reference element comprises a three-dimensional grid structure.

8. 8. An imaging device according to claim 1, wherein the tissue sample is configured to be supported on a support element, the support element including the reference element.

9. 9. The imaging device of claim 1, wherein the imaging device comprises an image data acquisition device, and the processing unit is configured to acquire the scan data from the ultrasound scanning machine via the image acquisition device.

10. an ultrasound scanning machine comprising an ultrasound scanning probe; a three-dimensional ultrasound imaging device comprising a processing unit and an interface; - Reference elements and 1. A three-dimensional ultrasound imaging system comprising: said processing unit - acquiring scan data indicative of the tissue sample and the reference element from the ultrasound scanning machine via the interface; acquiring image data based on the scan data, the image data being indicative of the tissue sample and the reference element; and determining a tissue sample representation based on the image data. A three-dimensional ultrasound imaging system configured to:

11. The system of claim 10 , wherein the processing unit is configured to determine positioning data of the reference element based on the image data, and to determine a reference coordinate system based on the positioning data.

12. 12. The system of claim 11, wherein the image data includes a plurality of image frames, and the processing unit is configured to determine, for each image frame of the plurality of image frames, a position associated with the image frame based on the reference coordinate system to provide a set of positions for the plurality of image frames, and the determination of the tissue sample representation is based on the set of positions.

13. 13. The system of claim 10, wherein the determining of the tissue sample representation comprises determining, based on the image data, a first portion of the tissue sample associated with a first type of tissue and a second portion of the tissue sample associated with a second type of tissue.

14. The system of claim 13 , wherein the processing unit is configured to determine a first volume of the first portion and a second volume of the second portion based on the set of locations.

15. 15. The system according to claim 10, wherein the system comprises a gripping element for mounting the ultrasound scanning probe and the ultrasound scanning machine comprises a slider element for moving the ultrasound scanning probe.

16. The system of claim 15 , wherein the processing unit is configured to control the slider element.

17. The system of claim 10 , wherein the reference element comprises a three-dimensional grid structure.

18. 18. The system of claim 10, wherein the tissue sample is configured to be supported on a support element, the support element including the reference element.

19. The system of claim 10 , wherein the reference element comprises an opening configured to receive the tissue sample.

20. 1. A reference element for a three-dimensional ultrasound scanning system, the reference element including a three-dimensional grid structure, the grid structure configured to be used as a reference when performing three-dimensional ultrasound imaging.

21. 1. A method for characterizing a tissue sample and a reference element, the method being implemented by a three-dimensional ultrasound imaging device, the method comprising: - acquiring scan data indicative of said tissue sample and said reference element from an ultrasound scanning machine; - acquiring image data based on said scan data, said image data being indicative of said tissue sample and said reference element; determining a tissue sample representation based on said image data; A method comprising:

22. The method further comprising: obtaining (S106) positioning data of said reference elements based on said image data; and determining a reference coordinate system based on said positioning data (S108); and 22. The method of claim 21 , comprising:

23. The image data includes a plurality of image frames, the method comprising: determining (S110), for each image frame of said plurality of image frames, a position associated with said image frame based on said reference coordinate system to provide a set of positions for said plurality of image frames; Including, The method according to claim 22, wherein said determining (S118) of said tissue sample representation is based on said set of locations.

24. The method further comprising: - determining (S112) a first portion of the tissue sample associated with a first type of tissue and a second portion of the tissue sample associated with a second type of tissue based on the image data; 24. The method of any one of claims 21 to 23, comprising:

25. The method further comprising: - determining (S114) a first volume of said first portion and a second volume of said second portion based on said set of locations; 25. The method of claim 24, comprising:

26. The method further comprising: - determining (S120) a resection margin for said tissue sample based on said tissue sample representation; 26. The method of any one of claims 21 to 25, comprising:

27. The method further comprising: - acquiring said scan data from an ultrasound scanning machine via an image acquisition device (S116); 27. The method of any one of claims 21 to 26, comprising:

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