Patent Application
20180132944
This disclosure relates to medical imaging and more particularly to systems and methods that provide feedback during a biopsy procedure.
In image-guided biopsy procedures, physicians rely on real-time imaging to guide an insertion of a biopsy gun to targets, which may be visible directly in a live image, or may be transferred from a prior image and superimposed on the live image using image fusion. Most biopsy guns have a spring-loaded mechanism that, when fired, shoots forward to obtain a tissue sample from a location that is offset from a needle tip by a fixed distance (i.e., the “throw” of the needle). Operators need to estimate that distance and position the biopsy needle proximal to the intended target, offset by the “throw”, and with the needle trajectory intersecting the target. When the operator considers the needle to be positioned correctly, the biopsy gun is “fired” to obtain the tissue sample. If the distance to the target or the trajectory of the biopsy needle is not estimated correctly, the target will not be sampled accurately.
In addition, by using hardware tracking technology and fusing pre-procedural diagnostic images with intra-procedural live imaging, e.g., ultrasound, pre-identified targets from diagnostic images can be mapped to the space of live imaging. An example of such system is the Philips® UroNav™ system, which is used for image fusion guided prostate cancer biopsy. In this system, magnetic resonance (MR) images are fused with the transrectal ultrasound (TRUS) images in real time. The suspicious prostate cancer lesions are identified as biopsy targets by radiologists on MR images. Those targets are usually not visible from TRUS images. During a prostate biopsy procedure, MR images are fused with TRUS images via electromagnetic (EM) tracking. In this way, the MR targets can be mapped to the TRUS images and thus can be superimposed over TRUS images when they are in view. With such guidance, users can aim for a target in TRUS with a biopsy gun.
However, even with the targets displayed over TRUS, there is no guarantee that a user can hit the target accurately with the biopsy needle for several reasons. For example, a biopsy needle is usually spring loaded, and the core-taking part will be fired out when a button is released. The user has to insert the needle to a certain depth but stay proximal to the target, accounting for the throw of the needle when fired. This mental estimation of the insertion depth may be error prone, and inaccurate insertion depth estimation may result in the sampled location being either too deep or too shallow and thus missing the target. Another cause for missing a target is due to the biopsy guide bending and/or shifting. When this happens, the needle will deviate from a biopsy guide line displayed on a screen. Thus, when a user uses the displayed guide line to aim for the target, the actual sample will be taken from an area other than the targeted area. Yet another factor can be the motion due to either patient movement or TRUS probe movement. During needle firing, if there is such motion, the needle may be directed away from the target.
In accordance with the present principles, a feedback system for instrument guidance includes a feedback guidance module configured to detect an instrument in a real-time image and generate feedback under a detected event for aligning or guiding the instrument. An image generation module is configured to generate a projected guideline in the image. The feedback guidance module is configured to generate at least one of audio and visual feedback to provide guidance to a user in positioning the instrument in the area of interest relative to the projected guideline in real-time.
Another feedback system for instrument guidance includes an imaging system configured to capture real-time images for a region of interest, the region of interest including a biopsy needle having a core taking portion extendable from the needle. A workstation includes a processor and memory. A feedback guidance module is stored in the memory and configured to detect the biopsy needle in the real-time image and generate feedback under a detected event for aligning or guiding the needle. An image generation module is configured to generate a projected guideline in the image for directing the biopsy needle. The feedback guidance module is configured to generate at least one of audio and visual feedback to provide guidance to a user in positioning the needle in the area of interest relative to the projected guideline in real-time.
A method for instrument guidance includes detecting an instrument in a real-time image; generating a projected guideline in the image to indicate a path for the instrument in a subject; and generating feedback for aligning or guiding the instrument in accordance with a detected event, wherein the feedback includes at least one of audio and visual feedback to provide guidance to a user in positioning the instrument in the area of interest relative to the projected guideline in real-time.
These and other objects, features and advantages of the present disclosure will become apparent from the following detailed description of illustrative embodiments thereof, which is to be read in connection with the accompanying drawings.
This disclosure will present in detail the following description of preferred embodiments with reference to the following figures wherein:
In accordance with the present principles, systems and methods are provided that produce feedback to a user before and after a biopsy gun firing by determining a spatial relationship between the biopsy needle and a target. Users will be able to take corresponding actions when needed to improve the accuracy and in turn achieve higher success rates. In one embodiment, a system in accordance with the present principles uses image processing and analysis methods to detect a needle in real-time imaging. The system can provide visual feedback superimposed on images to show a desired position of biopsy gun before firing. This can also be used together with hardware-based device tracking (e.g., electromagnetic (EM) tracking, optical shape sensing (OSS), etc.).
Under such settings, a detected needle can be mapped into a same space with pre-identified targets. Thus, the spatial relationship between the needle and the target can be computed, based on which specific visual or auditory feedback is provided to the users both before and after needle firing. The present system and method provide intra-procedural-accuracy feedback to users immediately before and after the biopsy gun firing. With the feedback, a user can either adjust the needle to be in a better position for firing or take another sample if the target has already been missed. The feedback can be visual, auditory, or other feedback signals may be employed.
It should be understood that the present invention will be described in terms of medical instruments; however, the teachings of the present invention are much broader and are applicable to any image based technology that involve alignment or activities. In some embodiments, the present principles are employed in tracking or analyzing complex biological or mechanical systems. In particular, the present principles are applicable to internal tracking procedures of biological systems and procedures in all areas of the body such as the lungs, gastro-intestinal tract, excretory organs, blood vessels, etc. The elements depicted in the FIGS. may be implemented in various combinations of hardware and software and provide functions which may be combined in a single element or multiple elements.
The functions of the various elements shown in the FIGS. can be provided through the use of dedicated hardware as well as hardware capable of executing software in association with appropriate software. When provided by a processor, the functions can be provided by a single dedicated processor, by a single shared processor, or by a plurality of individual processors, some of which can be shared. Moreover, explicit use of the term “processor” or “controller” should not be construed to refer exclusively to hardware capable of executing software, and can implicitly include, without limitation, digital signal processor (“DSP”) hardware, read-only memory (“ROM”) for storing software, random access memory (“RAM”), non-volatile storage, etc.
Moreover, all statements herein reciting principles, aspects, and embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (i.e., any elements developed that perform the same function, regardless of structure). Thus, for example, it will be appreciated by those skilled in the art that the block diagrams presented herein represent conceptual views of illustrative system components and/or circuitry embodying the principles of the invention. Similarly, it will be appreciated that any flow charts, flow diagrams and the like represent various processes which may be substantially represented in computer readable storage media and so executed by a computer or processor, whether or not such computer or processor is explicitly shown.
Furthermore, embodiments of the present invention can take the form of a computer program product accessible from a computer-usable or computer-readable storage medium providing program code for use by or in connection with a computer or any instruction execution system. For the purposes of this description, a computer-usable or computer readable storage medium can be any apparatus that may include, store, communicate, propagate, or transport the program for use by or in connection with the instruction execution system, apparatus, or device. The medium can be an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system (or apparatus or device) or a propagation medium. Examples of a computer-readable medium include a semiconductor or solid state memory, magnetic tape, a removable computer diskette, a random access memory (RAM), a read-only memory (ROM), a rigid magnetic disk and an optical disk. Current examples of optical disks include compact disk-read only memory (CD-ROM), compact disk-read/write (CD-R/W), Blu-Ray™ and DVD.
Reference in the specification to “one embodiment” or “an embodiment” of the present principles, as well as other variations thereof, means that a particular feature, structure, characteristic, and so forth described in connection with the embodiment is included in at least one embodiment of the present principles. Thus, the appearances of the phrase “in one embodiment” or “in an embodiment”, as well any other variations, appearing in various places throughout the specification are not necessarily all referring to the same embodiment.
It is to be appreciated that the use of any of the following “/”, “and/or”, and “at least one of”, for example, in the cases of “A/B”, “A and/or B” and “at least one of A and B”, is intended to encompass the selection of the first listed option (A) only, or the selection of the second listed option (B) only, or the selection of both options (A and B). As a further example, in the cases of “A, B, and/or C” and “at least one of A, B, and C”, such phrasing is intended to encompass the selection of the first listed option (A) only, or the selection of the second listed option (B) only, or the selection of the third listed option (C) only, or the selection of the first and the second listed options (A and B) only, or the selection of the first and third listed options (A and C) only, or the selection of the second and third listed options (B and C) only, or the selection of all three options (A and B and C). This may be extended, as readily apparent by one of ordinary skill in this and related arts, for as many items listed.
It will also be understood that when an element such as a layer, image, region or material is referred to as being “on” or “over” another element, it can be directly on the other element or intervening elements may also be present. In contrast, when an element is referred to as being “directly on” or “directly over” another element, there are no intervening elements present. It will also be understood that when an element is referred to as being “connected” or “coupled” to another element, it can be directly connected or coupled to the other element or intervening elements may be present. In contrast, when an element is referred to as being “directly connected” or “directly coupled” to another element, there are no intervening elements present.
Referring now to the drawings in which like numerals represent the same or similar elements and initially to
Memory 116 may store a feedback guidance application or module 122 configured to identify and track objects in an image. The feedback guidance application 122 can be run to detect an instrument 102 in an image, e.g., to assist in needle insertion and needle firing using live imaging. The feedback guidance application 122 includes a detection module or algorithm 136 configured to determine a position and orientation of the instrument 102 within an image. The live imaging may be collected using the imaging device or system 110. The imaging system 110 may include an ultrasound system, although other imaging modalities may be employed, e.g., fluoroscopy, etc.
The feedback guidance application 122 provides for live imaging only guided procedures and well as procedures with fused images (e.g., live images with stored static/preoperative images). The feedback guidance application 122 provides visual or audible signal warnings if the instrument 102 is deviating from a guideline (path determined for a biopsy needle or the like) or other stored criteria. In one example, the instrument 102 may include a biopsy gun. Before firing the biopsy gun, a display 118 can display a projected location of a biopsy core-taking portion based on a current position and orientation of a biopsy needle attached to the gun. The feedback guidance application 122 generates an actual tissue sample-taking area graphic before and/or after needle firing that can be displayed in an image shown on the display 118. Such graphics are employed as feedback for the proper alignment or positioning of the instrument 102 and/or the realignment or repositioning for a next task.
For image fusion guided procedures, a device tracking system 124 (with a sensor 125 (e.g., EM sensor, optical shape sensor, etc.) and an image registration module 126 may be employed to spatially map the detected instrument 102 (e.g., a needle) in 3D space (images 144). The feedback guidance application 122 computes the distance between a biopsy core location and a target according to the detected instrument 102. The feedback guidance application 122 provides signals for visual or audible feedback to users based on the distances between the biopsy core and the target. In the example of a biopsy, before firing, feedback on whether the target is on the needle insertion path and whether the needle is inserted to the correct depth to sample the target is provided. After firing, feedback on whether the biopsy core was actually taken from the targeted area is provided.
The instrument 102 may include a fired biopsy needle, other needles, a catheter, a guidewire, a probe, an endoscope, a robot, an electrode, a balloon device or other medical component, etc.
In one embodiment, an image generation module 148 is configured to generate objects to assist in the planning of a biopsy. The image generation module 148 generates overlays on displayed images to provide visual feedback to the user. In one embodiment, a biopsy guideline is generated by the image generation module 148 and projected in a real-time image, which is displayed on display 118.
The feedback guidance application 122 may use the geometric dimensions of the biopsy needle (specifically the distance between the needle tip and the biopsy-core taking part of the needle), and the estimate position and trajectory of a needle to determine a location of a core taken after a biopsy needle has fired. These features may be generated by the image generation module 148 and projected in the real-time image as feedback for the user. In another embodiment, acoustic information may be generated instead of or in addition to the visual feedback. A speaker or speakers 146 may be provided that receive audio signals from the feedback guidance application 122 to provide different forms of audio feedback. For example, the amplitude of an audio signal or its tone may be employed to indicate that a throw region is being approached or that the throw region has been exceeded. In another embodiment, textual information (on display 118) or audio commands (on speakers 146) may provide the same function by informing the user of the position based on measurements, etc. performed by the feedback guidance application 122.
Workstation 112 includes the display 118 for viewing internal images of a subject (patient) or volume 130 and may include images as an overlay or other rendering as generated by the image generation module 148. Display 118 may also permit a user to interact with the workstation 112 and its components and functions, or any other element within the system 100. This is further facilitated by an interface 120 which may include a keyboard, mouse, a joystick, a haptic device, or any other peripheral or control to permit user feedback from and interaction with the workstation 112.
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In block 208, the system (100) checks whether the target falls on the pointing direction of the detected needle. Feedback is provided to the user, e.g., visual or audio feedback can be provided. For example, the biopsy guide line can be turned into a highlighted color when the current target falls on the line, or a sound can be played to confirm that user is pointing the needle in the right direction.
In block 210, once the needle is in the right direction, the system will continue to check whether the core taking part of the needle will cover the biopsy target once being fired. The 3D position of the core taking part, which is usually in the shape of a cylinder, is computed based on the anatomy of the needle, the needle tip location, and also the needle pointing direction. This is illustratively depicted in
In block 212, when the user inserts the needle to the desired location, the needle can be fired to acquire a tissue sample. In block 214, the needle firing can be automatically detected or manually indicated. Automatic detection can be achieved by looking for the sudden increase of the needle length, since the firing is very fast, which can be captured by 1 to 3 frames of the live imaging depending on the frame rate of the system. With the firing detected, the distance between the actual biopsy core and the target can be computed in the same way as described above. If the system detects that the biopsy core is actually away from target but not covering it, a warning signal may be displayed on a screen or a warning sound may be played. Then, the user will have a chance to check the biopsy and redo it if the user determines that is necessary.
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In block 404, a projected guideline is generated in the image to indicate a path for the instrument in a subject. In block 406, the instrument is advanced further or aimed in the subject, if needed, to attempt to follow the guideline. The instrument may be partially or completely inserted in block 402. If partially inserted, the instrument may be further advanced here.
In block 408, feedback for aligning or guiding the instrument is generated in accordance with a detected event. The feedback may include audio and/or visual feedback to provide guidance to a user in positioning the instrument in the area of interest relative to the projected guideline in real-time. The audio and visual feedback may include, e.g., an alert on a display, a sound, a change in frequency of a sound, a change in the projected guideline, etc. The detected event may include misalignment of the instrument from a projected path, proximity to a target, a display of a projected core taking region in the area of interest and/or a display of a region of an actual core taken from the area of interest after firing a biopsy needle.
In block 410, a trajectory of the instrument is altered in accordance with the feedback. The feedback and altering the trajectory continues until alignment is achieved.
In block 411, procedure specific projections are generated in the image. For example, the instrument may include a biopsy needle having a throw for a core taking portion. In block 412, a projected region is generated representing the throw in the displayed image as visual feedback). In block 414, the projected region is positioned in the image.
In block 416, an instrument event is performed. For example, the needle is fired to collect a sample.
In block 417, post event projections are generated. In block 418, a core projection region is generated representing a core taken from the subject. In block 420, the core projection region is positioned on the target in the image.
In block 422, a decision as to the adequacy of the procedure (e.g., core taken) is determined. If adequate, stop; otherwise return to block 404.
As described, before firing the needle, the (un-fired) needle tip is detected and the throw is added to estimate the location of the biopsy core if the needle were fired at that moment. Feedback is provided on whether the needle is positioned correctly to sample the target. After firing, the (fired) needle tip is detected and a dead zone (between core-taking portion and needle tip) is subtracted to estimate where the tissue was actually sampled. Feedback is provided on whether the target was correctly sampled, or whether it may need re-sampling.
In interpreting the appended claims, it should be understood that:
Having described preferred embodiments for intra-procedural accuracy feedback for image-guided biopsy (which are intended to be illustrative and not limiting), it is noted that modifications and variations can be made by persons skilled in the art in light of the above teachings. It is therefore to be understood that changes may be made in the particular embodiments of the disclosure disclosed which are within the scope of the embodiments disclosed herein as outlined by the appended claims. Having thus described the details and particularity required by the patent laws, what is claimed and desired protected by Letters Patent is set forth in the appended claims.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2016/060545 | 5/11/2016 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62162848 | May 2015 | US |
