Embodiments of the invention relate generally to medical biopsy procedures, and more specifically, to a system and method for management of a biopsy apparatus during a biopsy procedure.
Many medical biopsy procedures concern obtaining a biopsy sample, i.e., a tissue sample, from a body part of a patient suspected as being cancerous, and then testing the biopsy sample for indications that the body part contains cancer cells. In many breast biopsy procedures, a needle is inserted into the breast via a biopsy apparatus. In such procedures, the biopsy apparatus typically guides the needle to a suspect region, i.e., a target biopsy site, within the breast via an x-ray imaging system, e.g., a digital tomosynthesis imaging system. The patient's breast is usually positioned on a breast support located between the detector and the ray source, and then held/compressed in place against the breast support by a compression plate.
Many breast biopsy procedures use needles of predetermined lengths, e.g., short, medium, and/or long, with the size of the compressed breast and location of the biopsy site determining the length of the needle used. In other words, the distance between the biopsy site and the border of the breast, i.e., the surface, when in a compressed state, determines which size needle is used. Many traditional imaging systems, however, have fields of view (“FOV”) which are too small to accurately depict the border of the breast in combination with the biopsy site. Additionally, the biopsy site is often not visible to a radiologist performing the biopsy. Thus, it is often difficult for a radiologist to accurately calculate the distance from the breast border to the biopsy site. Accordingly, many radiologists often use the longest needle available to improve the odds of reaching the biopsy site. Use of long needles, however, may increase the risk of the needle deflecting and/or decrease the accuracy of correctly guiding the needle to the biopsy site.
Further, in certain circumstances, e.g., a breast larger than the compression plate and/or an unusual positioning of the breast between the breast support and the compression plate, some of the breast tissue may remain uncompressed. In such circumstances, the distance between the biopsy site and the breast border may be different than expected, which, in turn, may result in the needle penetrating the breast sooner than expected by both the physician and/or the patient, and/or with part of the biopsy apparatus contacting the breast in an unexpected manner such that the needle may miss the biopsy site.
What is needed, therefore, is an improved system and method for management of a biopsy apparatus during a biopsy procedure.
In an embodiment, a system for management of a biopsy apparatus is provided. The system includes an imaging device and a controller. The imaging device is operative to obtain one or more images of an object to be biopsied by the biopsy apparatus. The controller is in electronic communication with the imaging device and operative to receive the one or more images; and to generate a contour of the object based at least in part on the one or more images. The controller is further operative to determine, based at least in part on the contour, if the biopsy apparatus will contact the object during biopsy of the object; and to generate an indicator upon determining that the biopsy apparatus will contact the object.
In another embodiment, a method for management of a biopsy apparatus is provided. The method includes obtaining one or more images of an object to be biopsied by the biopsy apparatus; and receiving the one or more images at a controller. The method further includes generating, via the controller, a contour of the object based at least in part on the one or more images; determining, via the controller, if the biopsy apparatus will contact the object during biopsy of the object based at least in part on the contour; and generating, via the controller, a contact indicator upon determining that the biopsy apparatus will contact the object.
In yet another embodiment, a non-transitory computer readable medium storing instructions is provided. The stored instructions adapt a controller to receive one or more images of an object to be biopsied by a biopsy apparatus; and to generate a contour of the object based at least in part on the one or more images. The stored instructions further adapt the controller to determine, based at least in part on the contour, if the biopsy apparatus will contact the object during biopsy of the object; and to generate a contact indicator upon determining that the biopsy apparatus will contact the object.
The present invention will be better understood from reading the following description of non-limiting embodiments, with reference to the attached drawings, wherein below:
Reference will be made below in detail to exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference characters used throughout the drawings refer to the same or like parts, without duplicative description.
As used herein, the terms “substantially,” “generally,” and “about” indicate conditions within reasonably achievable manufacturing and assembly tolerances, relative to ideal desired conditions suitable for achieving the functional purpose of a component or assembly. As used herein, “electrically coupled”, “electrically connected”, and “electrical communication” mean that the referenced elements are directly or indirectly connected such that an electrical current may flow from one to the other. The connection may include a direct conductive connection, i.e., without an intervening capacitive, inductive or active element, an inductive connection, a capacitive connection, and/or any other suitable electrical connection. Intervening components may be present. Additionally, the terms “collide” and/or “collision”, as used herein with respect to a biopsy apparatus and an object to be biopsied, refer to a situation/scenario/event where a part of the biopsy apparatus is compressing the object. The terms “compress” and/or “compressing”, as used herein with respect to a biopsy apparatus and an object to be biopsied, mean to distort the matter/tissue of the object in an unexpected and/or undesirable manner. The terms “contact” and “contacting”, as used herein with respect to a biopsy apparatus and an object to be biopsied, refers to a situation/scenario/event where the biopsy apparatus touches the matter/tissue of the object in an unexpected and/or undesirable manner.
Further, while the embodiments disclosed herein are described with respect to a breast biopsy system and procedure, it is to be understood that embodiments of the present invention may be applicable to other types of biopsy procedures. Further still, as will be appreciated, embodiments of the present invention related imaging systems may be used to analyze tissue generally and are not limited to human tissue.
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In embodiments, the controller 16 may be a workstation having at least one processor 78 and a memory device 80. In other embodiments, the controller 16 may be embedded/integrated into one or more of the various components of the imaging system 10 disclosed above. In embodiments, the controller 16 may be in electrical communication with the radiation source 42, radiation detector 44, the paddles 72 and 74, and/or the biopsy apparatus 12 via link 34. As will be appreciated, in embodiments, the connection 34 may be a wireless connection. In embodiments, the controller 16 may include a radiation shield 82 that protects an operator of the system 10 from the radiation rays 46 emitted by the radiation source 42. The controller 16 may further include a display 84, a keyboard 86, mouse 88, and/or other appropriate user input devices, that facilitate control of the system 10 via a user interface 90.
Referring briefly to
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As will be understood, in embodiments, the controller 16 may generate the contour 36 prior to any attempt to biopsy the object 32 with the biopsy apparatus 12. As such,
For example, as shown in
Accordingly, upon determining that the biopsy apparatus 12 will likely contact the object 32 during a biopsy attempt, as stated above, the controller 16 may generate a visual indicator/cue 38 (
In embodiments, the controller 16 may continuously monitor the insertion of the probe 94 into the object 32 and generate the indicator 38/40 when a portion of the body 92 comes within a predetermined margin, e.g., one (1) cm of the contour 36. In other embodiments, the controller 16 may allow the object 32 to be compressed and/or contacted by the biopsy apparatus 12 by a margin, e.g., one (1) cm prior to generating the indicator 38/40.
Additionally, as shown in
Finally, it is also to be understood that the system 10 may include the necessary electronics, software, memory, storage, databases, firmware, logic/state machines, microprocessors, communication links, displays or other visual or audio user interfaces, printing devices, and any other input/output interfaces to perform the functions described herein and/or to achieve the results described herein. For example, as previously mentioned, the system may include at least one processor and system memory/data storage structures, which may include random access memory (RAM) and read-only memory (ROM). The at least one processor of the system 10 may include one or more conventional microprocessors and one or more supplementary co-processors such as math co-processors or the like. The data storage structures discussed herein may include an appropriate combination of magnetic, optical and/or semiconductor memory, and may include, for example, RAM, ROM, flash drive, an optical disc such as a compact disc and/or a hard disk or drive.
Additionally, a software application that adapts the controller to perform the methods disclosed herein may be read into a main memory of the at least one processor from a computer-readable medium. The term “computer-readable medium”, as used herein, refers to any medium that provides or participates in providing instructions to the at least one processor of the system 10 (or any other processor of a device described herein) for execution. Such a medium may take many forms, including but not limited to, non-volatile media and volatile media. Non-volatile media include, for example, optical, magnetic, or opto-magnetic disks, such as memory. Volatile media include dynamic random access memory (DRAM), which typically constitutes the main memory. Common forms of computer-readable media include, for example, a floppy disk, a flexible disk, hard disk, magnetic tape, any other magnetic medium, a CD-ROM, DVD, any other optical medium, a RAM, a PROM, an EPROM or EEPROM (electronically erasable programmable read-only memory), a FLASH-EEPROM, any other memory chip or cartridge, or any other medium from which a computer can read.
While in embodiments, the execution of sequences of instructions in the software application causes at least one processor to perform the methods/processes described herein, hard-wired circuitry may be used in place of, or in combination with, software instructions for implementation of the methods/processes of the present invention. Therefore, embodiments of the present invention are not limited to any specific combination of hardware and/or software.
It is further to be understood that the above description is intended to be illustrative, and not restrictive. For example, the above-described embodiments (and/or aspects thereof) may be used in combination with each other. Additionally, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from its scope.
For example, in an embodiment, a system for management of a biopsy apparatus is provided. The system includes an imaging device and a controller. The imaging device is operative to obtain one or more images of an object to be biopsied by the biopsy apparatus. The controller is in electronic communication with the imaging device and operative to receive the one or more images; and to generate a contour of the object based at least in part on the one or more images. The controller is further operative to determine, based at least in part on the contour, if the biopsy apparatus will contact the object during biopsy of the object; and to generate an indicator upon determining that the biopsy apparatus will contact the object. In certain embodiments, the indicator is at least one of an audio indicator and a visual indicator. In certain embodiments, the controller is further operative to restrict biopsy of the object by the biopsy apparatus upon determining that the biopsy apparatus will contact the object. In certain embodiments, the contour is a two-dimensional (2D) contour. In certain embodiments, the contour is a three-dimensional (3D) contour. In certain embodiments, the controller determines that the biopsy apparatus will contact the object during biopsy of the object if a portion of a body of the biopsy apparatus will penetrate the contour before a probe guided by the biopsy apparatus would reach a target site within the object. In certain embodiments, each of the one or more images forms part of a two-dimensional (2D) pair of images of the object. In certain embodiments, the one or more images are scout images. In certain embodiments, the one or more images are acquired in accordance with a three-dimensional (3D) tomosynthesis image acquisition. In certain embodiments, the controller is further operative to generate a trajectory for the biopsy apparatus to follow for biopsy of the object. In certain embodiments, the object is a breast and the imaging system is a mammography imaging system.
Other embodiments provide for a method for management of a biopsy apparatus. The method includes obtaining one or more images of an object to be biopsied by the biopsy apparatus; and receiving the one or more images at a controller. The method further includes generating, via the controller, a contour of the object based at least in part on the one or more images; determining, via the controller, if the biopsy apparatus will contact the object during biopsy of the object based at least in part on the contour; and generating, via the controller, a contact indicator upon determining that the biopsy apparatus will contact the object. In certain embodiments, generating, via the controller, the contact indicator includes sounding an audio indicator. In certain embodiments, generating, via the controller, the contact indicator includes displaying an audio indicator. In certain embodiments, the method further includes restricting, via the controller, biopsy of the object via the biopsy apparatus upon determining that the biopsy apparatus will contact the object. In certain embodiments, each of the one or more images are scout images. In certain embodiments, obtaining one or more images of an object to be biopsied by the biopsy apparatus is accomplished via a tomosynthesis image acquisition.
Yet still other embodiments provide for a non-transitory computer readable medium storing instructions. The stored instructions adapt a controller to receive one or more images of an object to be biopsied by a biopsy apparatus; and to generate a contour of the object based at least in part on the one or more images. The stored instructions further adapt the controller to determine, based at least in part on the contour, if the biopsy apparatus will contact the object during biopsy of the object; and to generate a contact indicator upon determining that the biopsy apparatus will contact the object. In certain embodiments, each of the one or more images forms part of a two-dimensional (2D) pair of images of the object. In certain embodiments, the one or more images are scout images.
Accordingly, as will be appreciated, by determining that a biopsy apparatus will likely contact an object, i.e., compression of the object via a biopsy apparatus, during a biopsy attempt of the object, some embodiments of the present invention reduce the likelihood that a biopsy attempt will be unsuccessful, which in turn, improves the patient throughput of the encompassing imaging/biopsy system, and/or reduces patient discomfort.
Further, by generating a trajectory for a biopsy apparatus, based at least in part on a model of the object as described herein, some embodiments of the present invention reduce the risks associated with biopsy of the object by reducing the amount of distance a probe has to travel within the object in order to reach the target site.
Additionally, while the dimensions and types of materials described herein are intended to define the parameters of the invention, they are by no means limiting and are exemplary embodiments. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Moreover, in the following claims, terms such as “first,” “second,” “third,” “upper,” “lower,” “bottom,” “top,” etc. are used merely as labels, and are not intended to impose numerical or positional requirements on their objects. Further, the limitations of the following claims are not written in means-plus-function format are not intended to be interpreted as such, unless and until such claim limitations expressly use the phrase “means for” followed by a statement of function void of further structure.
This written description uses examples to disclose several embodiments of the invention, including the best mode, and also to enable one of ordinary skill in the art to practice the embodiments of invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims, and may include other examples that occur to one of ordinary skill in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims.
As used herein, an element or step recited in the singular and proceeded with the word “a” or “an” should be understood as not excluding plural of said elements or steps, unless such exclusion is explicitly stated. Furthermore, references to “one embodiment” of the present invention are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features. Moreover, unless explicitly stated to the contrary, embodiments “comprising,” “including,” or “having” an element or a plurality of elements having a particular property may include additional such elements not having that property.
Since certain changes may be made in the above-described invention, without departing from the spirit and scope of the invention herein involved, it is intended that all of the subject matter of the above description shown in the accompanying drawings shall be interpreted merely as examples illustrating the inventive concept herein and shall not be construed as limiting the invention.