Biopsy systems and methods

Abstract

A system and method for examining a volume of tissue and sampling therefrom is described. The system comprises at least first and second radiation detection modules spaced apart from one another to define a receiving region therebetween for receiving a volume of tissue to be examined; each detection module comprises a detector system in communication with a data module, the data module, in use, being configured to receive radiation from the volume of tissue to be examined, determine spatial registration information in respect of the received radiation, and construct spatially registered data in respect of structure and / or function of the volume of tissue from the spatial registration information; wherein one of the detection modules further comprises a biopsy tool, and the detector system of the one detection module comprises a detection region defining and at least partially surrounding an open portion through which the biopsy tool is configured to be movable so as to enter and exit the receiving region. A method of operating based on such a system is also disclosed.

Description

Technical Field

[0001] This invention relates to a biopsy system for extracting tissue samples from a subject, simultaneously examining and, for example, imaging the volume from which the tissue sample is taken during extraction to improve sampling accuracy. Particularly, this invention relates to a biopsy system combining a biopsy tool with a nuclear medicine imaging system, whereby the tool can extract tissue samples from a subject guided by an image of the volume from which the tissue sample is taken, generated by the nuclear medicine imaging system. Suitable nuclear medicine imaging systems include single-photon emission computed tomography (SPECT). A method for extracting tissue samples from a subject while simultaneously imaging the volume from which the tissue sample is taken is also described.

[0002] Applications include scenarios where the target sample is a biopsy sample of human or other animal tissue, particularly human breast tissue, and scenarios where nuclear medicine imaging systems or methods are used for molecular breast imaging. Background Technology

[0003] Various systems and methods are known for obtaining image data from a portion of a subject's body volume for medical and related purposes, and particularly for imaging human breast tissue.

[0004] Examples include nuclear medicine imaging systems and methods in which radiation from a radioactive isotope source is directed to a portion of the body of a subject under investigation containing a region of interest, and in which spatial registration information of the radiation received at a remote detector is used to obtain information about the structure and / or real-time physiological function of that portion of the patient's anatomy, and, for example, to construct an image of that structure and / or physiological function.

[0005] An example of a well-established nuclear medicine imaging technique is single-photon emission computed tomography (SPECT), a nuclear medicine computed tomography technique that uses gamma rays. This technique requires the delivery of a radioactive isotope that emits gamma rays into the patient's body, for example, via the bloodstream. In typical applications, the radioactive isotope binds to a specific ligand, enabling it to be carried and bound to the region of interest within the body of the subject being examined.

[0006] Radioactive isotopes emit gamma rays that penetrate the tissues of the subjects being investigated and can be detected at suitable detectors, such as gamma cameras. SPECT imaging with a gamma camera acquires multiple two-dimensional images, which are then constructed into a three-dimensional dataset using appropriate tomographic reconstruction techniques.

[0007] Positron emission tomography (PET) uses a similar principle. In this case, the radioactive isotope that emits positrons is typically introduced into the body as part of a radioactive ligand. The emitted positrons then undergo local annihilation, and the system detects the gamma-ray pairs indirectly emitted by this annihilation event.

[0008] These two technologies are particularly powerful, allowing not only imaging of relevant parts of the body, but also active functional imaging of biological processes.

[0009] Another known technique for imaging breast tissue, such as for detecting abnormalities that may lead to early detection of breast cancer, is mammography. Standard mammography uses X-rays to create images. These images are then analyzed for abnormal findings, particularly characteristic dense masses that may indicate an underlying tumor. These patients are then referred for further, often more invasive, examinations. Therefore, standard mammography is a widely adopted first-stage screening technique.

[0010] However, the response of normal but relatively dense breast tissue to low-energy X-rays may resemble that of a mass that could indicate the potential development of many common tumors, thus reducing the technique's ability to differentiate in patients with a higher proportion of high-density breast tissue. Therefore, molecular breast imaging (MBI) is a developed nuclear medicine imaging technique that utilizes many of the principles of the aforementioned SPECT-type techniques. A radioactive isotope source, typically bound to a suitable ligand to localize it within the breast tissue, is introduced into the subject. A suitable system using a small semiconductor-based gamma camera, constructed typically corresponding to the construction of a more conventional mammogram, is used to detect the radiation originating from the source after it has penetrated the breast tissue. This technique can be particularly effective in detecting early-stage tumors because it can differentiate between structural and physiological activity.

[0011] To investigate suspicious areas of body tissue (such as breast tissue) to determine specific pathology, it is usually necessary to extract tissue samples for testing, such as histological examination. Such samples can be extracted using controlled biopsy tools. Accurate guidance of these tools is crucial for their effective use and for minimizing harm or discomfort to the subject.

[0012] For example, when attempting to biopsy a suspicious breast lesion, using nuclear medicine images of the breast (such as MBI images) or other indicators of the lesion's location to guide the biopsy tool can be valuable. Typically, lesions are detected using three-dimensional imaging techniques. Therefore, the location and depth of the lesion can be determined from the images. For example, the depth of the lesion can help guide the biopsy needle during the extraction of a sample for pathological examination.

[0013] A typical general-purpose MBI device may be as described in US5519221. In the embodiments described therein, the breast is typically fixed and slightly compressed between two compression plates, one above and one below, and two associated camera heads including gamma detectors record multiple image views to reconstruct a tomographic synthetic image.

[0014] However, performing a biopsy in such a system requires proximity to the breast. In the example system, this is accomplished by removing the top camera head unit or tilting one or both camera heads to approach the breast via a top compression plate. This plate is responsible for compressing the breast and holding it in place. Some arrangement is then needed to align the biopsy needle with the removed camera. For example, the system could have a grid structure that allows needle insertion. Using reconstructed MBI images, the grid cell above the biopsy site is determined. An additional plastic insert with smaller holes can be inserted into this cell, and one of those smaller holes is used to insert the biopsy needle and perform the procedure.

[0015] In an example operation of the existing technology system, the depth of the lesion is determined using the ratio between the count rates detected by the top and bottom camera heads. After the needle with the sample is removed, the biopsy holder is removed, the top camera is moved back to its position, and a post-procedure MBI scan is performed. A successful biopsy procedure requires a visible decrease in the count rate from the lesion. If this is not observed, the biopsy is repeated.

[0016] Because the top camera head is removed from its position for biopsy in this system, the technique relies on previous images to guide the biopsy needle. Therefore, simultaneous images from a single camera may have lower clinical value. Guiding the biopsy needle is more difficult, and the likelihood of the needle missing the lesion increases.

[0017] In addition, it is necessary to verify that the biopsy procedure has extracted tissue samples from the intended location. Images of the breast and the needle within the field of view after the biopsy must be taken; these images must show the size of the lesion area and the decrease in total activity, and detect the activity emitted by the extracted tissue sample from the needle. If the biopsy was not successfully targeted, it needs to be repeated. Therefore, a large number of samples may have to be extracted, causing pain and discomfort to the patient.

[0018] Therefore, there is a general need for a biopsy system and method for extracting tissue samples from subjects that allows for more accurate simultaneous imaging of the volume from which the tissue sample is taken, thereby improving sampling target accuracy and / or reducing the number of samples that may need to be extracted. A system that enables easier acquisition of post-biopsy verification images is also desired.

[0019] There is a particular need for a biopsy system and method for extracting human breast tissue samples that allows for more accurate simultaneous generation of MBI images of the breast volume from which tissue samples are extracted, in order to improve the accuracy of the sampling target and / or reduce the number of samples that may have to be extracted. Summary of the Invention

[0020] According to a first aspect of the present invention, a system for examining tissue volume and sampling therefrom comprises: At least the first and second radiation detection modules are spaced apart from each other to define a receiving area therebetween for receiving the volume of tissue to be examined; Each detection module includes a detector system that communicates with a data module, which is configured in use to receive radiation from the tissue volume to be examined, determine spatial registration information about the received radiation, and construct spatial registration data about the structure and / or function of the tissue volume, such as imaging data, from the spatial registration information. One of the detection modules further includes a biopsy tool, and the detector system of the detection module includes a detection area defining and at least partially surrounding the opening, the biopsy tool being configured to move through the opening to enter and exit the receiving area.

[0021] The system requires at least two radiation detection modules spaced apart from each other to define a receiving area therebetween for receiving the volume of tissue to be examined. In embodiments, the system may include pairs of detection modules spaced apart from each other, for example, configured at the top and bottom or side by side. A greater number of detection modules may be provided, for example, in alternative suitable geometries. Each radiation detection module may include a sub-module that can be operated independently. The discussion herein considers, in particular, by way of example a detector geometry in which paired detection modules are configured as top and bottom opposing imaging heads, but the principles of the invention are not necessarily limited to any particular geometry.

[0022] The basic structure of at least two spaced-apart and, for example, generally opposing detection modules for receiving and, for example, imaging a volume of tissue to be examined. In use, the tissue volume, typically a part of a human or animal body, and, for example, a part of a living human or animal body, is positioned in the receiving area. It can be held therein by pressure applied by the respective detection modules, for example, by opposing imaging heads constructed at the top and bottom or side by side, with pressure plates for this purpose.

[0023] Then, for example, suitable imaging methods are used to obtain information about the structure, such as images of at least the tissue, as is well known. Such methods are, for example, nuclear medicine imaging methods, particularly in which radiation from a radioactive isotope source is directed to a portion of the human or animal body of the subject under investigation that contains the region of interest. The spatial registration information of the radiation received at the detector is thus used to obtain information about the structure and / or real-time physiological function of that portion and to construct images of its structure and / or its real-time physiological function.

[0024] This system is not only an examination / imaging device, but also a biopsy device capable of extracting a target sample from a tissue volume from a target area identified by the examination. For this purpose, one of the tools and detection modules is arranged in a co-correlated manner. Contrary to existing technologies, it is arranged such that a specific detection module positioned to work in conjunction with the biopsy tool is adapted to work in two ways. First, the detector system of said detection module includes a detection area defining and at least partially surrounding an opening, and the biopsy tool is configured to move through this opening. Second, to facilitate this, the detection module preferably includes a through-hole aligned with the opening, and the biopsy tool is configured to move through this through-hole to enter and exit the receiving area. Thus, it is not necessary to move the detector module out of position to approach the tissue volume in the receiving area and extract the tissue sample from the target area.

[0025] This results in many potential advantages, which are discussed in detail below, including the potential for more accurate targeting of the target area, the ability to continue imaging the target area simultaneously from the paired detector system in real time when useful, and the ability to maintain more accurate registration between the biopsy tool and the target area as the biopsy tool moves into and out of the tissue volume while the tissue is always held between the two detection modules.

[0026] According to the present invention, a detector system including a detection module of a biopsy tool includes a detection region defining and at least partially surrounding an opening. The detection region need not completely surround or close the opening. At least some functionality can be achieved as long as detection capability is provided at at least two spaced-apart portions of the detection region with the opening located between them. In a preferred embodiment, the detection region may substantially surround the opening, for example, extending beyond a conceptually complete 180 degrees around the perforated portion, although useful effects can also be obtained in other embodiments where the detector region extends less than 180 degrees. In a preferred embodiment, the detection region may substantially completely surround the opening, for example, extending approximately a complete 360 ​​degrees around the perforated portion. In a preferred embodiment, the detection region may close the opening to define a closed aperture therein.

[0027] This adaptation can be applied to any suitable detection system, especially any suitable imaging system, where the principle is to use nuclear medicine imaging methods to identify the target area of ​​the biopsy and deploy a pair of stationary detector heads to generate spatial registration data, such as spatial registration image data, and thereby construct a three-dimensional (3D construct) of the structure and / or function of the examined tissue volume containing the target area.

[0028] Each detector system must be adapted to detect and allow the resolution of spatial registration information of radiation received at the detector system. This invention can be applied to detector systems comprising multiple discrete detector configurations, and / or a single detector configuration defining multiple discrete detection regions, and / or a single detector configuration defining a single continuous detection region, which is virtually subdivided into individually addressed sub-regions. Multiple responses required to obtain spatial registration information of radiation received at the detector system can be received from multiple detector configurations, and / or from a single detector configuration defining multiple discrete detection regions, and / or from a single detector configuration defining a single continuous detection region, which is virtually subdivided into individually addressed sub-regions.

[0029] Preferably, the detector system includes at least a detection module for a biopsy tool, and optionally, two detector systems include a plurality of discrete detector configurations.

[0030] In particular, in some embodiments, a detector system that includes at least a detection module for a biopsy tool may include a plurality of discrete detector configurations arranged to at least partially surround and define an opening, and the biopsy tool is configured to move through the opening. In a preferred embodiment, the plurality of discrete detector configurations may be configured to substantially or completely surround the opening. In a preferred embodiment, the plurality of discrete detector configurations may be configured to close the opening to define a closed aperture therein.

[0031] Each detector system can be subdivided into discrete regions such as pixels or voxels. In some embodiments, each detector system may include multiple discrete detector configurations. Additionally or alternatively, each detector system may include multiple discrete detector layers. Additionally or alternatively, each detector system may be subdivided into discrete regions such as pixels or voxels by suitable signal processing electronics. Additionally or alternatively, each detector system may include materials that inherently exhibit the ability to localize radiative interactions and thereby provide spatial registration information. Combinations of such systems will be familiar.

[0032] In some embodiments, each detection module may include a substantially or completely planar detector system. That is, the detection surfaces of the detector system or its components may lie mostly or completely in the same plane, which can be considered as the detection plane of the detector system. The corresponding planar detector system of the corresponding detection module may be configured to unfold face-to-face in use.

[0033] Such an arrangement is generally preferred. However, it should be understood that the principles of the invention do not require, or even necessarily make, a strictly planar detector system ideal. The detector system can be generally planar but deviate from strict planarity. For example, when the detector system comprises multiple discrete detector configurations, some of these configurations may be angled from the general plane of the detector. Additionally or alternatively, non-planar surfaces may be provided. Even in such an arrangement, the surfaces of the detector system or its elements may lie primarily in a single plane comprising the general plane of the detector.

[0034] In some embodiments, each planar detector system may include an array of detector elements. In this case, preferably, the detector system of the detection module associated with the biopsy tool includes an array of planar detector elements arranged around an opening and defining, for example, a central aperture, and the biopsy tool is configured to move through the opening and, for example, through the central aperture, to enter and exit the receiving area to extract a tissue sample. Preferably, the system is a planar detector system, where each element of the element array has a planar detection surface, and said surface is positioned in a single detection plane.

[0035] In a typical embodiment, each detection module is adapted to detect radiation, such as high-energy photons, like X-rays or gamma rays, emitted from a tissue volume located in the receiving region. Each detector system preferably includes a detector for high-energy photons, such as X-rays or gamma rays.

[0036] Each detection module is, for example, an imaging camera. Each detection module is, for example, a gamma camera.

[0037] In typical usage, radiation will be generated in the tissue using a suitable radioactive tracer source, such as one of the techniques described above regarding the prior art. For example, this technique could be SPECT, PET, or MBI.

[0038] Each detection module is adapted to operate statically in a typical usage mode, thereby receiving spatial registration information about radiation, constructing spatial registration data about the structure and / or function of tissue volume, such as imaging data, while the tissue volume is maintained between the detection modules.

[0039] Each detection module may be adapted to statically hold the tissue volume in the receiving area and, for example, apply a holding pressure thereto. For example, each detection module may include a holding surface to statically hold the tissue volume in the receiving area.

[0040] Typically, the tissue volume maintained in this way can be part of the body, such as a human breast.

[0041] Suitable detectors can be those familiar to those skilled in the art and can include scintillator detectors and semiconductor detectors. In a preferred embodiment, the detector system or its detector configuration includes a semiconductor detector.

[0042] In an example embodiment, the detector system or its detector configuration includes a bulk cadmium telluride-type solid-state semiconductor detector. The materials constituting the semiconductor detector are selected from, for example, cadmium telluride, cadmium zinc telluride (CZT), cadmium manganese telluride (CMT), and alloys thereof, and include, for example, crystalline Cd. 1-(a+b) Mn a Zn b Te, where a+b<1, and a and / or b can be zero. Bulk single-crystal detectors may be particularly preferred.

[0043] One potential advantage of cadmium telluride-based solid-state semiconductor detectors is that this material inherently allows for the extraction of interaction depth information. The possible uses of this will be discussed in more detail below.

[0044] Preferably, the biopsy tool includes a registration system to fix the registration of the tool relative to its associated detection module before use, making it operable to a predetermined orientation and / or depth in the receiving area to extract a tissue sample from the tissue volume. The registration system is operable to determine such predetermined orientation and / or depth from constructed spatial registration data relating to the structure and / or function of the tissue volume.

[0045] For example, a biopsy tool includes a positioning device for positioning the tool in the x and y directions relative to the detection module, such as defined by the detection plane of its detector system; and a driving device for moving the tool through the opening in the z direction; and a registration system determines these from the constructed spatial registration data of the structure and / or function of the tissue volume prior to use.

[0046] Additionally or alternatively, a biopsy tool guide may be provided, configured to be selected from constructed spatial registration data of the structure and / or function of the tissue volume to guide the biopsy tool through the opening in the detector system. For example, the guide may include a guide plate with a two-dimensional array of holes, juxtaposed with the opening, such that one of the selected holes guides the direction of the biopsy tool during use. This guide plate has the added advantage of maintaining positioning pressure on the tissue volume in the receiving area. This guide plate may be removable. Interchangeable guide plates may be provided.

[0047] This system is adapted, at least in possible operating modes, to simultaneously examine and sample tissue volumes. That is, the system is adapted such that each detection module is configured in use to receive radiation from the tissue volume to be examined, determine spatial registration information regarding the received radiation, and construct spatial registration data, such as imaging data, about the structure and / or function of the tissue volume from the spatial registration information; simultaneously, the biopsy tool is moved into and out of the receiving area. Notably, unlike prior art systems, the detection module associated with the biopsy tool is not required and, in this case, is not moved away from the area to be examined; therefore, two detector systems can be used to generate images to guide the tool.

[0048] Specifically, a control device is provided, operable to move the biopsy tool into and out of the receiving area according to the orientation and depth determined from simultaneously generated spatial registration information.

[0049] In some embodiments, the detector system includes means for locating interactions within the detector to each of the x and y directions and the z direction in a plane substantially perpendicular to the incident radiation direction, the z direction including the depth within the detector substantially orthogonal to the x, y plane.

[0050] For example, a detector system includes a detection surface divided into multiple individually addressable detection portions, which are positionally defined across the detection surface in two orthogonal directions (hereinafter referred to as the x-direction and y-direction), whereby the interaction of incident radiation particles from the source at the detection module can positionally locate the detection portion; and in a third orthogonal direction (hereinafter referred to as the z-direction), the radiation detector is configured such that the interaction of incident radiation particles from the source at the detection module can further positionally locate the depth in the z-direction.

[0051] Therefore, the detector system is configured to determine the interaction depth (i.e., the dimension in the z-direction) at which each photon interaction occurs. This can be achieved through any suitable combination of materials, structural features, and processing electronics.

[0052] For example, the detector system can be made of a material that inherently allows for the extraction of interaction depth information, such as a bulk crystalline cadmium telluride-type solid-state semiconductor detector as described above. Additionally or alternatively, the detector may comprise multiple discrete layers of suitable detector material in the z-direction. For example, a multilayer scintillator detector may be suitable.

[0053] The use of such detectors allows for interaction depth effects, as embodied in systems described in WO2021 / 176232A1 and WO2022 / 090722A1, the disclosures and contents of which are incorporated herein by reference. These systems utilize a combination of a detector with nontrivial depth and a porous collimator (e.g., a pinhole collimator) with a nontrivial extension angle for outgoing radiation. This combination allows the detector to localize a continuous response to a continuous interaction with incident radiation occurring within the detector in three dimensions, including two area dimensions and a depth dimension. The porous collimator introduces complexity into the outgoing radiation pattern through divergence and overlap to infer additional information about the radiation pattern from the target object.

[0054] For example, in an embodiment of the system of the present invention, at least one and optionally each detection module includes a collimator associated with each detector, wherein the collimator has a plurality of apertures having an extension angle for outgoing radiation, configured such that radiation emitted from the target object passes through the respective collimator and is incident on the respective detector.

[0055] In some embodiments, the collimator comprises a one-dimensional or two-dimensional array of at least partially diverging apertures. The apertures may, for example, have an expansion angle of at least 15 degrees.

[0056] In some embodiments, the collimator includes one or more pinholes. In some embodiments, the collimator includes a one-dimensional or two-dimensional array of pinholes. In some embodiments, the collimator includes diverging pinholes, and for example, a one-dimensional or two-dimensional array of diverging pinholes.

[0057] Collimators based on pinhole or similar structure arrays act as multiplexing filters, which differentially pass only a portion of the incident radiation on the basis of directional registration to create a pattern that is at least partly a function of the x, y coordinate position, to create some kind of registration between the x, y in the radiation emitted by the source and the x, y at the detector, but do not produce a substantially one-to-one x, y registration.

[0058] By using a multiplexer that intentionally adds some complexity to the radiation pattern in three dimensions, and by purposefully detecting and reconstructing this three-dimensional complexity at the detector, information about the object / body under test can be reconstructed from this more complex data, while the inherent source-level radioactivity is much lower, and thus the radiation dose to the patient's tissue is lower, for example, in the case of medical imaging.

[0059] This arrangement, particularly using diverging pinhole or similar array structures, provides additional capabilities for imaging beyond the standard field of view (FOV) of conventional detectors, such as conventional imaging cameras. In parallel-aperture collimation systems, the FOV is limited to the area directly above a single detector array or directly between pairs of detector arrays. Therefore, portions of the object outside this area cannot be imaged. In the non-parallel-aperture collimation system used in this invention, data from the detectors is collected within a certain angular receiving range. The portion of the angular receiving range beyond the FOV defined by the detector area provides an additional area that can be imaged without extending the detector coverage directly above it. This arrangement also provides the ability to utilize reduction, which can further improve the flexibility / usefulness of the imaging information obtainable from the region of interest.

[0060] This can be used to extend the field of view of a planar detector beyond the direct field of view defined perpendicular to the detection plane, thereby mitigating aperture-related data loss in detection systems that might otherwise be associated with biopsy tools, making perforated arrangements more practical.

[0061] According to a second aspect of the present invention, a method for preparing a sample by examining tissue volume is provided, comprising: At least first and second radiation detection modules are spaced apart from each other, each detection module including a detector system that communicates with a data module to define a receiving area therebetween; The volume of tissue to be examined is received in the receiving area; This causes radiation to be emitted from the tissue volume; Each detector system receives radiation from the tissue volume, and The detector module determines spatial registration information about the received radiation and constructs spatial registration data about the structure and / or function of tissue volume, such as imaging data, from the spatial registration information. One of the detection modules further includes a biopsy tool, the detector system of the detection module including a detection region defining and at least partially surrounding the opening, the biopsy tool being configured to move through the opening to enter and exit the receiving region, and the method further includes: Use spatial registration data on the structure and / or function of the tissue volume to determine the target tissue region within the tissue volume; Set up the biopsy tool to move through the opening and thus into the target area.

[0062] In a more complete aspect, a method for examining tissue volume and sampling therefrom includes the second aspect of the method and the further steps of manipulating a biopsy tool to move through an opening and thereby into a target area to extract a tissue sample therefrom.

[0063] According to this method, a tissue volume, typically part of a human or animal body, and for example, part of a living or active animal body, is positioned in the receiving area. It can be held therein by pressure applied by a corresponding detection module, for example, by a relative imaging head configured to have a pressure plate for this purpose.

[0064] Then, for example, a suitable imaging method is used to obtain information about the structure, such as at least an image of the tissue, as is well known. Such a method is, for example, a nuclear medicine imaging method, in particular in which radiation from a radioactive isotope source is directed to a portion of the human or animal body of the subject under investigation that contains the region of interest, thereby spatial registration information of the radiation received at the detector is used to obtain information about the structure and / or real-time physiological function of that portion, and to construct an image of its structure and / or its real-time physiological function.

[0065] This method identifies and pre-configures biopsy tools to extract biopsies from tissue volumes of target samples from target regions identified as targets during the examination phase, and operates the tools in a more complete manner to extract biopsies.

[0066] Compared to existing technologies, the biopsy tool and its associated detection module work together, with the biopsy tool moving as needed through openings in its detector system and co-positioned apertures in the detector module structure to enter and exit the receiving area. This eliminates the need to move the detector module out of position to approach the tissue volume in the receiving area and remove the tissue sample from the target region.

[0067] Therefore, in the preferred case, both of these methods are the operating methods of the first aspect of the system, and by analogy with the discussion of other aspects, the preferred features of each aspect will be understood.

[0068] Each detector system must be adapted to detect and allow resolution of spatial registration information of the radiation received at the detector system. Multiple responses required to obtain spatial registration information of the radiation received at the detector system can be received from multiple detector configurations, and / or from a single detector configuration defining multiple discrete detection regions, and / or from a single detector configuration defining a single continuous detection region, which is virtually subdivided into individually addressed sub-regions.

[0069] In some embodiments, each detection module may include a planar detector system. The corresponding planar detector system of the corresponding detection module may be configured to unfold face-to-face in use.

[0070] In some embodiments, each planar detector system may include an array of detector elements. In this case, preferably, the detector system of the detection module associated with the biopsy tool includes an array of planar detector elements surrounding and defining an opening and, for example, closing a central aperture, and the biopsy tool is configured to move through the opening and, for example, the central aperture, to enter and exit a receiving area to extract a tissue sample. Preferably, the system is a planar detector system in which each element of the element array has a planar detection surface, and said surface is positioned in a single detection plane.

[0071] The method includes detecting radiation emitted from a tissue volume located in a receiving region, such as high-energy photons, like X-rays or gamma rays.

[0072] In a preferred embodiment of the method, radiation is generated in the tissue.

[0073] For example, radiation is generated by using a suitable radiation source, and the method includes first introducing such a source into the tissue volume.

[0074] Therefore, this method involves generating radiation using nuclear medicine imaging techniques, determining spatial registration information about the radiation, and constructing spatial registration data. Suitable techniques include those described above regarding existing technologies. For example, the techniques are SPECT, PET, or MBI.

[0075] Preferably, spatial registration data is constructed in a static operating mode and, for example, an image is generated, thereby receiving spatial registration information about radiation, constructing spatial registration data about the structure and / or function of tissue volume, such as imaging data, while the tissue volume is statically held between detection modules.

[0076] Each detection module may be adapted to statically hold the tissue volume in the receiving area and, for example, apply a holding pressure to it. The method may include applying such a holding pressure to statically hold the tissue volume in the receiving area.

[0077] Typically, the tissue volume maintained in this way can be part of the body, such as a human breast.

[0078] In a preferred embodiment, the detector system or its detector configuration includes a semiconductor detector as described above.

[0079] The use of such detectors allows for interaction depth effects, as exemplified by the systems described in WO2021 / 176232A1 and WO2022 / 090722A1, such as generating further information in three dimensions by additionally utilizing a multiplexed collimator, which can then be processed to generate further data for locating structures within tissues.

[0080] Therefore, the method may include: A collimator is used to apply a multiplexing transformation to the radiation from the source to create three-dimensional complexity in the radiation pattern from the source. It receives multiple responses, each of which is a response to the interaction of incident radiation occurring within the detector; For each of the plurality of responses, characteristics of the interaction are determined, wherein the characteristics include at least the three-dimensional location of the interaction within the detector; The multiple responses are processed based on the determined three-dimensional location of each interaction within the detector, and information about the radiation pattern from the source is inferred from there.

[0081] This method identifies and pre-configures biopsy tools to extract biopsies from tissue volumes of target samples from target regions identified as targets during the examination phase, and operates the tools in a more complete manner to extract biopsies.

[0082] Preferably, the method includes a registration step to fix the tool relative to its associated detection module before use, making it operable to a predetermined orientation and / or depth in the receiving area to extract tissue samples from the tissue volume.

[0083] For example, the tool may have a programmable control device, and the method may include a programming step in which a series of instructions for operating the biopsy tool are created using predetermined operating directions and / or depths determined from constructed spatial registration data relating to the structure and / or function of the tissue volume. The second aspect of the method then includes operating the tool according to this series of instructions.

[0084] A biopsy tool guide may be provided, configured to be selected from constructed spatial registration data of structure and / or function regarding tissue volume, to guide the direction of the biopsy tool through an opening in a detector system, the method comprising selecting such a guide.

[0085] In a preferred embodiment of a more complete aspect of the method, the method includes simultaneously examining the tissue volume according to the method of the second aspect of the invention while manipulating a biopsy tool through an opening and thereby into a target area to extract a tissue sample therefrom.

[0086] Therefore, this method continues to acquire radiation from the tissue volume to be examined, determine spatial registration information about the received radiation, and construct spatial registration data about the structure and / or function of the tissue volume, such as imaging data, from the spatial registration information, while the biopsy tool moves in and out of the receiving area. The data acquired simultaneously can be used for dynamically guided tools.

[0087] Therefore, the method includes moving the biopsy tool into and out of the receiving area according to the orientation and depth determined from the simultaneously generated spatial registration information.

[0088] Alternatively, the steps of examining the tissue volume to determine the target area and manipulating the biopsy tool through the opening and thus into the target area can be performed sequentially.

[0089] Preferably, the step of obtaining spatial registration information about the radiation includes locating each radiation interaction to each of the x and y directions and the z direction in a plane substantially perpendicular to the direction of incident radiation, the z direction including the depth within the detector substantially orthogonal to the x, y plane.

[0090] Therefore, this method can determine the interaction depth (i.e., the dimension in the z-direction) at which each photon interaction occurs. This can be achieved through any suitable combination of materials, structural features, and processing electronics.

[0091] For example, the detector system can be made of materials that inherently allow the extraction of depth information of interactions, such as bulk cadmium telluride type solid-state semiconductor detectors as described above.

[0092] This can be used, as described above, to extend the field of view of a planar detector beyond the direct field of view defined perpendicular to the detection plane, thereby mitigating data loss associated with openings in the detection system that might otherwise be associated with biopsy tools, making perforated arrangements more practical.

[0093] Therefore, the method may include, at least with respect to, a detector system having an opening: A detector system is provided, having area and depth, and configured to produce a continuous response to continuous interactions with incident radiation occurring within the detector in such a way that the location of each interaction is determined in three dimensions comprising two area dimensions and one depth dimension; It receives multiple responses, each of which is a response to the interaction of incident radiation occurring within the detector system; For each of the plurality of responses, determine the location of each interaction within the detector, which is in three dimensions including two area dimensions and a depth dimension; By simultaneously processing the location data and processing the multiple responses in such a manner, information about the portion of the target object within the main field of view and further information about the portion of the target object extending beyond the main field of view in the opening region can be obtained.

[0094] In one embodiment, in actual implementation, the method includes: The radiation detector system and collimator are positioned relative to the region of interest of the target object, such that the distance between the radiation detector system and the collimator is smaller than the distance between the collimator and the region of interest of the tissue volume.

[0095] A particular advantage of this invention can arise in nuclear medicine imaging embodying techniques such as SPECT, PET, or MBI. In a preferred embodiment, the method includes a method for generating nuclear medicine images, for example using such SPECT, PET, or MBI, performed on a target object containing biological tissue. The biological tissue may include a sample or may include a portion of the body of a living organism. In particular, the method can allow for the examination of processes within the organism. Suitable organisms include human and non-human objects, and the invention can be performed on human or tissue, non-human animal body or tissue, or non-animal body or tissue. The method can provide images for subsequent review stages, such as for determining whether further testing or intervention is needed, or for making or contributing to subsequent diagnostic steps. The method can provide images as part of a diagnostic approach to determine the state therefrom.

[0096] A suitable radioactive source can be introduced and diffused through the tissue, at least in the vicinity of the region of interest.

[0097] The method may include, in a first step, introducing such a radioactive source, for example, via the subject's bloodstream. The source may be, for example, a radioactive isotope that emits gamma rays. The source may also be, for example, a radioactive isotope that emits positrons.

[0098] In typical applications, radioactive isotopes bind to specific ligands, enabling them to be carried and bound to regions of interest within the body of the organism under investigation.

[0099] In some embodiments, the method further includes generating an image and optionally further displaying the image. The system may also include an image generation module and an image display for generating the image. The method may also include generating a continuous image as a tomographic reconstruction. The system may also include a tomographic reconstruction module for achieving the same purpose.

[0100] In some embodiments, the image is a tomographic image, and the image generation module includes a tomographic image reconstruction module for generating a continuous image as a tomographic reconstruction, for example, using the 3D location of the detected event to interpret uncertainties in the origin of radioactivity. Optionally, this can be done directly in the reconstruction or as a prior processing step. Optionally, a hybrid approach can be employed, such as the hybrid approach discussed below.

[0101] Other preferred features of the second aspect of the method will be understood by analogy through the discussion of the first aspect system, and vice versa. Attached Figure Description

[0102] Figure 1 is a view of a system with bimolecular breast imaging and biopsy capabilities; Figure 2 This is a further view of a system with bimolecular breast imaging and biopsy capabilities that embodies the principles of the present invention; Figure 3A A possible modified detector array embodying the principles of the present invention is shown, which is suitable to be included as part of an imaging head combined with a biopsy tool in a bimolecular breast imaging and biopsy device. Figure 3B Some possible alternative geometries for the modified detector array that embody the principles of the present invention are shown; Figure 4 The extended field of view principle that can be utilized in possible embodiments of the invention is illustrated. Detailed Implementation

[0103] An MBI biopsy system in Figure 1A The image is shown in perspective, and in each of the following sections: Figure 1B and Figure 1C The figures are shown in side and front views. These views do not show the adaptation of the invention and therefore can generally represent both prior art and embodiments of the invention.

[0104] The system includes a support 1 and a camera system 3. Camera system 3 includes a top camera head 5 and a bottom camera head 7. During imaging, the breast is held between the two camera heads 5 and 7, typically under at least slight pressure. For access to the breast for biopsy, the typical operating pattern involves moving the top camera head 5 backward to expose the breast from the top side. This... Figure 2 The close-up perspective view shows this shifted position.

[0105] Below the top camera is a plastic plate used to compress the breast and hold it in place. At the top of this plate, as... Figure 2 An alternative view shows an aligned plastic grid 9. This grid has grid cells of approximately 1 cm. The grid cells above the biopsy site were determined using the reconstructed MBI image. Finally, a plastic insert with a 3x3 array of smaller holes was placed into this grid cell (see [link to image]). Figure 2 One of the nine holes in the 3x3 array will be used to insert a biopsy needle and perform the procedure. The top camera head 5 can be moved backward to expose the breast for biopsy.

[0106] The depth of the suspected tumor is determined using the ratio between the count rates of the tumor area detected by the top and bottom camera heads. The extracted tissue sample is approximately 20 mm long, therefore the depth coordinates of the tumor location do not need to be accurate to more than a few millimeters. After the needle with the sample is removed, the biopsy holder is removed, the top camera is moved back to its position, and a post-procedure MBI scan is performed. A successful biopsy procedure requires a visible decrease in the count rate from the suspected tumor area. If this is not observed, the biopsy is repeated.

[0107] This discussion is presented only as an example of Figure 1 and Figure 2 An embodiment of the present invention with modifications to the device.

[0108] The principles of this invention encompass a biopsy tool configured in a co-associative manner with one of the camera heads. In contrast to existing technologies, it is arranged such that a specific head arranged to work in conjunction with the biopsy tool has a detector array including an opening portion, such that the head defines a through-hole, and the biopsy tool is configured to move through this hole to enter and exit a breast or other tissue volume to perform a biopsy. It is not necessary to move the camera head out of position to approach a tissue volume in the receiving area and extract a tissue sample from the target region.

[0109] Examples of such detector arrays, and their possible uses in modifying prior art systems to include exemplary embodiments of the present invention by providing a modified detector system for an imaging head combined with a biopsy tool, are shown and discussed by way of example in Figure 3. Various possible arrangements are shown, each including multiple detector elements. Typically, the array is a planar detector system, with each element of the array having a planar detection surface, and said surface being positioned in a single detection plane.

[0110] Those skilled in the art will understand that this invention is not limited to this system, or more generally not limited to the SPECT MBI system, and is not limited to modifications of existing designs, whether aftermarket or as original manufacturing. Rather, this invention potentially covers all scenarios within the scope of the claims, where there is a need for a system and method that requires the ability to construct spatial registration data of the structure and / or function of tissue volume and, for example, to construct a combination of imaging data from the spatial registration information, and to use it to guide biopsy procedures using integrated biopsy tools, and particularly in scenarios where it is desirable to image simultaneously with the biopsy procedure and to use image control tools and more accurately position the tools.

[0111] Existing technology systems use SPECT systems that generate reconstructed 3D images using two stationary camera heads. Moving one of the camera heads to one side makes image reconstruction virtually impossible. The resulting images will have very poor quality.

[0112] The applicant's proposed solution, based on the modified detector array in Figure 3 and other corresponding modifications discussed below, provides a solution capable of reconstructing 3D images in the volume surrounding a suspected tumor.

[0113] In a possible embodiment, at least four detectors can be as follows: Figure 3A The array shown is arranged with a square hole in the center for the biopsy needle to pass through. This additional detector array (“biopsy insert”) will be made into a tethered head that can be positioned manually or mechanically using an electric clamp.

[0114] exist Figure 3AIn this embodiment, four detectors create a detection region that surrounds, closes, and defines a closed aperture within themselves, through which a biopsy tool can pass. According to the invention, the detector system only needs to provide an opening, and the detector array needs to create a detection region that defines and at least partially surrounds that opening. The detection region does not necessarily completely surround or close the open region. At least some functionality can be achieved as long as detection capability is provided at at least two spaced-apart portions of the detection region and the opening is located between them. Figure 3B Alternative geometries were proposed.

[0115] In further possible modifications to the existing technical system to incorporate the principles of this invention, Figure 2 The plastic mesh can be replaced, for example, by a flat plastic plate that holds the breast in place and has mechanical clamps for positioning the biopsy insert on top of it.

[0116] A potential design implementation could be as follows: Manual positioning — Figure 2 The plastic mesh shown will be replaced by an alternative design with a matching structure at the bottom of the biopsy insert. This will allow the insert to be positioned with a precision comparable to that achievable with the current design. The radiographer will obtain the tumor coordinates from the reconstructed 3D image, very similar to how it is currently done.

[0117] Mechanical positioning — Figure 2 The plastic mesh will be replaced by a fixture consisting of a set of motorized stages that will move the biopsy insert to the desired location by pointing it, for example, at the desired location on a reconstructed image on a computer screen. The biopsy insert can be integrated into the positioning fixture or can be a separate unit that enters a dedicated position within the fixture. The motorized version will provide more precise positioning because the insert position is not limited by the fixed position of the alignment fixture unit as in the manual option.

[0118] Imaging data from biopsy inserts with the detector array shown in Figure 3 will allow for better reconstruction of 3D images within the volume containing the tumor. The imaging process can be performed during the biopsy, providing virtually real-time visualization of the procedure and monitoring the possibility of partial tumor resection required for a successful biopsy. This will significantly improve the procedure, making it faster and eliminating the potential need for a second insertion needle.

[0119] The preferred detector material is a cadmium telluride semiconductor detector. This detector has an inherent ability to resolve the depth of interaction with incident photons. If this detector, or any other detector capable of resolving spatial registration information in the z-direction, is used in conjunction with suitable depth and processing electronics, as well as a diverging pinhole collimator, this depth information can be used to extend the effective field of view of the aperture detector and mitigate the effects of the aperture, according to the principles embodied in UK Application No. 2304760.8 and WO2024 / 201081 A1.

[0120] This principle is Figure 4 The diagram shows a bulk semiconductor detector array using cadmium zinc telluride (CZT). This detector array inherently allows for the determination of the depth of photon interaction in the z-direction and the position within a specific pixel in the x and y directions. However, the invention is not limited to this detector. This semiconductor detector can be replaced by any "depth sensing" or "3D position sensing" detector structure, including, for example, a scintillator detector module made of several layers to provide some form of depth sensing.

[0121] Figure 4 The use of a pinhole collimator to project an image from a source onto a detection plane is illustrated. This principle is generally described, for example, in WO2021 / 176232A1. In the case of this invention, the source is part of the biological system under investigation, in which radioactive material has been introduced and allowed to diffuse. This reference describes the use of a porous collimator having a nontrivial expansion angle for the emitted radiation, such as a pinhole collimator, which introduces complexity into the emitted radiation pattern through divergence and overlap. Figure 4 The collimator used in this process utilizes the same principle.

[0122] In parallel-aperture collimated MBI systems, the field of view (FOV) is limited to the area directly above the detector array. Therefore, tissues outside this area cannot be imaged.

[0123] In the description and Figure 4 In a hypothetical collimation system with a diverging pinhole, data from the detectors is collected within a certain angular receiving range around the detector array. The portion of the angular receiving range beyond the main field of view conventionally defined by the detector area provides an additional region that can be imaged without extending the detector coverage directly above it.

[0124] As can be seen in the illustrated embodiment, the distance between each detector array and its corresponding collimator will be less than the distance between the collimator and the extended FOV (region of interest) (ROI) of the imaged object. Therefore, this method typically involves downscaling rather than upscaling as in known methods.

[0125] Therefore, two principles are utilized to provide additional functionality: the portion of the angular receiving range beyond the main field of view can be imaged without extending the detector coverage directly above it, and the generation of reduced-size images can be used in conjunction with this to collect more information from the target object and present it in tomographic or other images at any given process and illumination level. In embodiments as MBI systems, this can offer particular advantages in providing improved physiologically relevant images of the patient's breast.

[0126] Figure 4 The effective field of view extension outside the detection plane is shown and discussed in UK application number 2304760.8, but the same principle can also be additionally applied to the array of Figure 3 to extend the effective field of view into the aperture region.

Claims

1. A system for examining tissue volume and sampling therefrom, comprising: At least first and second radiation detection modules, spaced apart from each other to define a receiving area therebetween for receiving the volume of tissue to be examined; Each detection module includes a detector system that communicates with a data module, which is configured in use to receive radiation from the tissue volume to be examined, determine spatial registration information about the received radiation, and construct spatial registration data about the structure and / or function of the tissue volume from the spatial registration information. One of the detection modules further includes a biopsy tool, and the detector system of the detection module includes a detection area defining and at least partially surrounding the opening, the biopsy tool being configured to move through the opening to enter and exit the receiving area.

2. The system of claim 1, wherein the detector system includes at least a detection module for a biopsy tool and optionally two detector systems comprising a plurality of discrete detector configurations.

3. The system of claim 2, wherein the detector system of the detection module of the biopsy tool includes an array of detector elements surrounding and defining the opening portion.

4. The system of claim 3, wherein the plurality of discrete detectors are configured to substantially surround the opening portion.

5. The system of claim 4, wherein the plurality of discrete detector configurations are configured to close the open region to define a closed aperture therein.

6. The system according to any of the preceding claims, wherein each detector system is subdivided into discrete regions of pixels or voxels.

7. The system according to any of the preceding claims, wherein each detection module includes a planar detector system, and the respective planar detector system of the respective detection module is configured in use to be deployed face-to-face in parallel.

8. The system according to any of the preceding claims, wherein each detection module is adapted to detect high-energy photons, such as X-rays or gamma rays, emitted from a tissue volume located in the receiving region.

9. The system according to any of the preceding claims, wherein each detection module includes a gamma camera.

10. The system according to any of the preceding claims, wherein each detection module is adapted to operate at rest, thereby receiving spatial registration information about radiation while the tissue volume is held between the detection modules, and constructing spatial registration data about the structure and / or function of the tissue volume.

11. The system according to any of the preceding claims, wherein each detection module is adapted to statically hold the tissue volume in a receiving area, including a holding surface operable to apply holding pressure and statically hold the tissue volume in the receiving area.

12. The system according to any of the preceding claims, wherein the detector system comprises a solid-state semiconductor detector.

13. The system of claim 12, wherein the material constituting the semiconductor detector is selected from cadmium telluride, cadmium zinc telluride (CZT), cadmium manganese telluride (CMT), and alloys thereof, and includes, for example, crystalline Cd. 1-(a+b) Mn a Zn b Te, where a+b<1, and a and / or b can be zero.

14. The system according to any one of claims 1 to 11, wherein the detector is a scintillator detector comprising a scintillator material coupled to an optical sensor such as a SiPM or a photodiode.

15. The system according to any of the preceding claims, wherein at least one and optionally each detection module includes a collimator associated with each detector, wherein the collimator has a plurality of apertures having an extension angle for outgoing radiation, configured such that radiation emitted from the target object passes through the respective collimator and is incident on the respective detector.

16. The system of claim 15, wherein the collimator comprises a one-dimensional or two-dimensional array of at least a portion of the diverging apertures.

17. The system of claim 15 or claim 16, wherein the hole has an expansion angle of at least 15 degrees.

18. The system according to any one of claims 15 to 17, wherein the collimator comprises a one-dimensional array or a two-dimensional array of pinholes.

19. The system according to any preceding claim, wherein the biopsy tool includes a registration system for fixing the registration of the tool relative to its associated detection module prior to use, making it operable to a predetermined orientation and / or depth in the receiving area to extract a tissue sample from the tissue volume, said registration system being operable to determine such predetermined orientation and / or depth from constructed spatial registration data relating to the structure and / or function of the tissue volume.

20. The system of claim 19, wherein the biopsy tool includes a positioning device for positioning the tool in the x and y directions relative to the detection module, for example, defining the detection plane relative to its detector system; and a driving device for moving the tool through the opening in the z direction; and a registration system determines these from constructed spatial registration data relating to the structure and / or function of the tissue volume.

21. The system according to any of the preceding claims is adapted, at least in possible operating modes, to simultaneously examine tissue volume and sample therefrom.

22. A method for preparing a sample by examining tissue volume, comprising: At least first and second radiation detection modules are spaced apart from each other to define a receiving area therebetween, each detection module including a detector system that communicates with a data module; The volume of tissue to be examined is received in the receiving area; This causes radiation to be emitted from the tissue volume; Each detector system receives radiation from the tissue volume, and The detector module determines spatial registration information about the received radiation and constructs spatial registration data about the structure and / or function of the tissue volume from the spatial registration information. One of the detection modules further includes a biopsy tool, the detector system of the detection module including a detection region defining and at least partially surrounding the opening, the biopsy tool being configured to move through the opening to enter and exit the receiving region, and the method further includes: Use spatial registration data on the structure and / or function of the tissue volume to determine the target tissue region within the tissue volume; Set up the biopsy tool to move through the opening and thus into the target area.

23. The method of claim 22, wherein the detector system of the detection module of the biopsy tool includes an array of detector elements surrounding and defining an opening, and the method includes positioning the biopsy tool to move through the opening and thereby enter a target area.

24. The method of claim 22 or 23, wherein each detection module includes a planar detector system, and the method includes unfolding the detector systems of the respective detection modules face-to-face in parallel.

25. The method according to any one of claims 22 to 24, comprising positioning a portion of a human or animal body in a receiving area and holding said portion of the human or animal body in the receiving area under applied pressure from a corresponding detection module.

26. The method according to any one of claims 22 to 25, comprising detecting radiation emitted from a tissue volume located in a receiving region, and, for example, high-energy photons such as X-rays or gamma rays.

27. The method according to any one of claims 22 to 26, wherein radiation is generated in the tissue by using a suitable radiation source, and the method includes first introducing such a source into the tissue volume.

28. The method according to any one of claims 22 to 27, wherein spatial registration data is constructed in a static operating mode, thereby receiving spatial registration information about radiation while the tissue volume is statically held between detection modules, and constructing spatial registration data about the structure and / or function of the tissue volume.

29. The method according to any one of claims 22 to 28, further comprising a registration step to fix the registration of the tool relative to its associated detection module before use, making it operable to a predetermined orientation and / or depth in the receiving area to extract a tissue sample from the tissue volume.

30. The method of claim 29, wherein the tool includes a programmable control device, and the method includes a programming step wherein a series of instructions for operating the biopsy tool are created using predetermined operating directions and / or depths determined from constructed spatial registration data relating to the structure and / or function of the tissue volume.

31. The method according to any one of claims 22 to 30, further comprising generating a continuous image constructed from spatial registration data as a fault reconstruction.

32. The method according to any one of claims 22 to 31, further comprising the step of subsequently manipulating a biopsy tool to pass through the opening and thereby into the target area to extract a tissue sample therefrom.

33. The method of claim 22, further comprising simultaneously examining the tissue volume according to any one of claims 22 to 30 while manipulating the biopsy tool through the opening and thereby into the target area to extract a tissue sample therefrom.

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