Patent Grant
11684429
The systems and methods disclosed herein relate generally to computer systems facilitating medical device guidance through tissue by a medical practitioner.
Various medical device systems are available to aid a healthcare provider to guide a medical device in a patient. The medical device systems can provide various image guidance cues to aid the healthcare provider, and can also provide views of images of an imaged area and of virtual medical devices corresponding to physical medical devices.
Implementations disclosed herein provide systems, methods, and apparatus for generating images facilitating medical device insertion into tissue by an operator. Certain embodiments pertain to a free-hand medical device guidance system. The system can provide the healthcare provider manual control over the medical device, while making the spatial relationships between the target, medical device and U/S image more intuitive via a visual display. Using this visual feedback, the operator can adjust the medical device's position, orientation, or trajectory. Certain of the contemplated embodiments can be used in conjunction with systems described in greater detail in U.S. patent application Ser. No. 13/014,587, filed Jan. 26, 2011, entitled SYSTEMS, METHODS, APPARATUSES, AND COMPUTER-READABLE MEDIA FOR IMAGE MANAGEMENT IN IMAGE-GUIDED MEDICAL PROCEDURES and U.S. patent application Ser. No. 13/753,274, filed Jan. 29, 2013, entitled MULTIPLE MEDICAL DEVICE GUIDANCE (the '274 application), and U.S. patent application Ser. No. 14/212,933, filed Mar. 14, 2014, entitled MEDICAL DEVICE GUIDANCE, each of which is hereby incorporated by reference in its entirety.
The system can aid the healthcare provider in guiding one or more medical devices through the tissue of the patient and/or placing the medical devices, and can be used for treatment of tumors, fibroids or cysts, with bipolar radiofrequency medical device ablation, multiple microwave medical devices, electroporation, and/or electrochemotherapy systems. It can also be used for nerve or muscle stimulation or sensing (electrodes in the spine, brain). The system can be used during open surgery, laparoscopic surgery, endoscopic procedures, biopsies, and/or interventional radiology procedures.
The system can be used in conjunction with live intraoperative ultrasound (U/S), pre-operative CT, or any cross-sectional medical imaging modality (e.g. MRI, OCT, etc.). In addition, the system can use a variety of techniques to determine the position and/or orientation of one or more medical devices. For example, the system can use the NDI Aurora magnetic system, NDI Polaris optical system, etc. In some embodiments, a position sensor can be embedded inside, or affixed to each medical device, at the tip, along the shaft, and/or on the handle. Sensors can be built into the medical devices or attached after manufacturing, as described in greater detail in U.S. application Ser. No. 14/212,184, filed Mar. 14, 2014, entitled SENSOR MOUNT, incorporated herein in its entirety.
Each medical device can be associated with one or more sensors, which can continually, or repeatedly, report position and/or orientation, or a single sensor can be used for all the medical devices. In embodiments where one sensor is used, the healthcare provider can attach the sensor to the particular medical device that she is intentionally repositioning, and then, once she has placed that medical device, she can remove the sensor and attach it to the next medical device she is repositioning. In some embodiments, the medical devices can be manipulated by the healthcare provider. In certain embodiments, the system can be used with a robotic manipulator, where the robot controls the medical devices.
In some embodiments, the handles of medical devices can have push-button switches, to allow the user to select a medical device, indicate a tissue target, etc. The handle can also have an indicator light to indicate to the users which medical device is selected. Finally, the handle can have an encoder to detect how much length of electrode has been exposed by the user, and report this information to the guidance system and therapeutic generator
Although only two surgical instruments 145 and 155 are shown in
Information about and from multiple surgical systems 149 and attached surgical instruments 145 (and additional surgical instruments not shown) can be processed by image guidance unit 130 and shown on display 120. These and other possible embodiments are discussed in more detail below. It will be understood that any combination of the display objects, image guidance cues, etc., described herein can be displayed concurrently, or simultaneously. Further, reference to displaying objects “concurrently” and/or “simultaneously” is to be interpreted broadly and may refer to displaying objects in such a way that to a human observer the objects are visible at the same time.
Imaging unit 150 can be coupled to image guidance unit 130. In some embodiments, imaging unit 150 can be coupled to a second display unit (not shown). The second display unit can display imaging data from imaging unit 150. The imaging data displayed on display unit 120 and displayed on second display unit can be the same or different. In some embodiments, the imaging unit 150 is an ultrasound machine 150, the movable imaging device 155 is an ultrasound transducer 155 or ultrasound probe 155, and the second display unit is a display associated with the ultrasound machine 150 that displays the ultrasound images from the ultrasound machine 150. In some embodiments, a movable imaging unit 155 can be connected to image guidance unit 130. The movable imaging unit 155 can be useful for allowing a user to indicate what portions of a first set of imaging data are to be displayed. For example, the movable imaging unit 155 can be an ultrasound transducer 155, a needle or other medical device, for example, and can be used by a user to indicate what portions of imaging data, such as a pre-operative CT scan, to show on a display unit 120 as image 125. Further, in some embodiments, there can be a third set of pre-operative imaging data that can be displayed with the first set of imaging data.
In some embodiments, system 100 comprises a display unit 120 and a position sensing unit 140 communicatively coupled to image guidance unit 130. In some embodiments, position sensing unit 140, display unit 120, and image guidance unit 130 are coupled to the stand 170. Image guidance unit 130 can be used to produce images 125 that are displayed on display unit 120. The images 125 produced on display unit 120 by the image guidance unit 130 can be determined based on ultrasound or other visual images from the first surgical instrument 145 and second surgical instrument 155. In the illustrated embodiment, the images 125 includes a 2D viewing area and a 3D viewing area. The 2D viewing area includes a 2D view of each of an ultrasound slice 121, a virtual medical device 122 corresponding to the first surgical instrument 145, a virtual imaging device 123 corresponding to the second surgical instrument 155, surface display regions 124a, 124b, intersection indicator 126, and trajectory and other image guidance cues 127. In the illustrated embodiment, the 3D viewing area includes perspective views of each of the image slice 121, the virtual medical device 122, a displayed affected region 129 including the surface display regions 124a, 124b, the virtual imaging device 123, intersection indicator 126, trajectory and other image guidance cues 127, and a patient orientation indicator 128. It will be understood that any combination of the aforementioned display objects can be displayed in the 2D view and/or 3D view as desired.
As a non-limiting example, if the first surgical instrument 145 is an ablation needle 145 and the second surgical instrument 155 is an ultrasound probe 155, then images 125 produced on display 120 can include the images, or video, from the ultrasound probe 155 (e.g., image slice 121) combined with other medical display objects and image guidance cues, such as projected medical device drive (e.g., trajectory indicators 127) or projected ablation volume (e.g., displayed affected region 129), determined based on the emplacement of ablation needle 145. If the first surgical instrument 145 is an ultrasound probe 145 and the second surgical instrument 155 is a laparoscopic camera 155, then images 125 produced on display 120 can include the video from the laparoscopic camera 155 combined with ultrasound data superimposed on the laparoscopic image. More surgical instruments can be added to the system. For example, the system can include an ultrasound probe, ablation needle, laparoscopic camera, stapler, cauterizer, scalpel and/or any other surgical instrument or medical device. The system can also process and/or display collected data, such as preoperative CT scans, X-Rays, MRIs, laser scanned 3D surfaces etc.
The term “emplacement” as used herein is a broad term and may refer to, without limitation, position and/or orientation or any other appropriate location information. The term “pose” as used herein is a broad term encompassing its plain and ordinary meaning and may refer to, without limitation, position and orientation or any other appropriate location information. In some embodiments, the imaging data obtained from one or both of surgical instruments 145 and 155 can include other modalities such as a CT scan, MRI, open-magnet MRI, optical coherence tomography (“OCT”), positron emission tomography (“PET”) scans, fluoroscopy, ultrasound, or other preoperative, or intraoperative 2D or 3D anatomical imaging data. In some embodiments, surgical instruments 145 and 155 can also be scalpels, implantable hardware, or any other device used in surgery. Any appropriate surgical system 149 or imaging unit 150 can be attached to the corresponding medical instruments 145 and 155.
As noted above, images 125 produced can also be generated based on live, intraoperative, or real-time data obtained using the second surgical instrument 155, which is coupled to second imaging unit 150. The term “real time” as used herein is a broad term and has its ordinary and customary meaning, including without limitation instantaneously or nearly instantaneously. The use of the term real time can also mean that actions are performed or data is obtained with the intention to be used immediately, upon the next cycle of a system or control loop, or any other appropriate meaning. Additionally, as used herein, real-time data can be data that is obtained at a frequency that would allow a healthcare provider to meaningfully interact with the data during surgery. For example, in some embodiments, real-time data can be a medical image of a patient that is updated one time per second. In some embodiments, real-time data can be ultrasound data that is updated multiple times per second.
The surgical instruments 145, 155 can be communicatively coupled to the position sensing unit 140 (e.g., sensors embedded or coupled to the surgical instruments 145, 155 can be communicatively coupled with the position sensing unit 140). The position sensing unit 140 can be part of imaging unit 150 or it can be separate. The position sensing unit 140 can be used to determine the emplacement of first surgical instrument 145 and/or the second surgical instrument 155. In some embodiments, the position sensing unit 140 can include a magnetic tracker and/or one or more magnetic coils can be coupled to surgical instruments 145 and/or 155. In some embodiments, the position sensing unit 140 can include an optical tracker and/or one or more visually-detectable fiducials can be coupled to surgical instruments 145 and/or 155. In some embodiments, the position sensing unit 140 can be located below the patient. In such embodiments, the position sensing unit 140 can be located on or below the table 180. For example, in embodiments where the position sensing unit 140 is a magnetic tracker, it can be mounted below the surgical table 180. Such an arrangement can be useful when the tracking volume of the position sensing unit 140 is dependent on the location of the position sensing unit 140, as with many magnetic trackers. In some embodiments, magnetic tracking coils can be mounted in or on the medical devices 145 and 155.
In some embodiments, the position sensing unit 140 can be an electromagnetic measurement system (e.g., NDI Aurora system) using sensor coils for tracking units attached to the first and/or second surgical devices 145 and 155. In some embodiments, the second position sensing unit 140 can be an optical 3D tracking system using fiducials. Such optical 3D tracking systems can include the NDI Polaris Spectra, Vicra, Certus, PhaseSpace IMPULSE, Vicon MX, InterSense IS-900, NaturalPoint OptiTrack, Polhemus FastTrak, IsoTrak, or Claron MicronTracker2. In some embodiments, the position sensing unit 140 can each be an inertial 3D tracking system comprising a compass, accelerometer, tilt sensor, and/or gyro, such as the InterSense InertiaCube or the Nintendo Wii controller. In some embodiments, the position sensing unit 140 can be attached to or affixed on the corresponding surgical device 145 and 155.
In some embodiments, the position sensing units 140, can include sensing devices such as the HiBall tracking system, a GPS device, or signal emitting device that would allow for tracking of the position and/or orientation (e.g., emplacement) of the tracking unit (also referred to as an emplacement sensor). In some embodiments, a position sensing unit 140 can be affixed to either or both of the surgical devices 145 and 155. The surgical devices 145 or 155 can be tracked by the position sensing unit 140. A room coordinate system reference, such as the display 120 can also be tracked by the position sensing unit 140 in order to determine the emplacements of the surgical devices 145 and 155 with respect to the room coordinate system. Devices 145 and 155 can also include or have coupled thereto one or more accelerometers, which can be used to estimate movement, position, and location of the devices.
In some embodiments, the position sensing unit 140 can be an Ascension Flock of Birds, Nest of Birds, driveBAY, medSAFE, trakSTAR, miniBIRD, MotionSTAR, pciBIRD, or Calypso 2D Localization System and tracking units attached to the first and/or second medical devices 145 and 155 can be magnetic tracking coils.
The term “tracking unit” (also referred to as an emplacement sensor), as used herein, is a broad term encompassing its plain and ordinary meaning and includes without limitation all types of magnetic coils or other magnetic field sensing devices for use with magnetic trackers, fiducials or other optically detectable markers for use with optical trackers, such as those discussed above and below. In some embodiments, the tracking units can be implemented using optical position sensing devices, such as the HiBall tracking system and the position sensing unit 140 can form part of the HiBall tracking system. Tracking units can also include a GPS device or signal emitting device that allows for tracking of the position and/or orientation of the tracking unit. In some embodiments, a signal emitting device might include a radio-frequency identifier (RFID). In such embodiments, the position sensing unit 140 can use the GPS coordinates of the tracking units or can, for example, triangulate the radio frequency signal being emitted by the RFID associated with tracking units. The tracking systems can also include one or more 3D mice.
Images 125 can be produced based on intraoperative or real-time data obtained using first surgical instrument 145, which is coupled to first surgical system 149. In the illustrated embodiment of
In some embodiments, the display unit 120 displays 3D images to a user, such as a healthcare provider. Stereoscopic 3D displays separate the imagery shown to each of the user's eyes. This can be accomplished by a stereoscopic display, a lenticular auto-stereoscopic display, or any other appropriate type of display. The display 120 can be an alternating row or alternating column display. Example alternating row displays include the Miracube G240S, as well as Zalman Trimon Monitors. Alternating column displays include devices manufactured by Sharp, as well as many “auto-stereoscopic” displays (e.g., Philips). In some embodiments, Sony Panasonic 3D passive displays and LG, Samsung, and/or Vizio 3D TVs can be used as well. Display 120 can also be a cathode ray tube. Cathode Ray Tube (CRT) based devices, can use temporal sequencing, showing imagery for the left and right eye in temporal sequential alternation. This method can also be used projection-based devices, as well as by liquid crystal display (LCD) devices, light emitting diode (LED) devices, and/or organic LED (OLED) devices.
In certain embodiments, the display unit 120 can be a head mounted display worn by the user in order to receive 3D images from the image guidance unit 130. In such embodiments, a separate display, such as the pictured display unit 120, can be omitted. The 3D graphics can be produced using underlying data models, stored in the image guidance unit 130 and projected onto one or more 2D planes in order to create left and right eye images for a head mount, lenticular, or other 3D display. The underlying 3D model can be updated based on the relative emplacements of the various devices 145 and 155, as determined by the position sensing unit(s) 140, and/or based on new data associated with the devices 145 and 155. For example, if the second medical device 155 is an ultrasound probe, then the underlying data model can be updated to reflect the most recent ultrasound image. If the first medical device 145 is an ablation needle, then the underlying model can be updated to reflect any changes related to the needle, such as power or duration information. Any appropriate 3D graphics processing can be used for rendering including processing based on OpenGL, Direct3D, Java 3D, etc. Whole, partial, or modified 3D graphics packages can also be used, such packages including 3DS Max, SolidWorks, Maya, Form Z, Cybermotion 3D, VTK, Slicer, or any others. In some embodiments, various parts of the needed rendering can occur on traditional or specialized graphics hardware. The rendering can also occur on the general CPU, on programmable hardware, on a separate processor, be distributed over multiple processors, over multiple dedicated graphics cards, or using any other appropriate combination of hardware or technique.
One or more components, units, devices, or elements of various embodiments can be packaged and/or distributed as part of a kit. For example, in one embodiment, an ablation needle, one or more tracking units, 3D viewing glasses, and/or a portion of an ultrasound wand can form a kit. Other embodiments can have different elements or combinations of elements grouped and/or packaged together. Kits can be sold or distributed separately from or with the other portions of the system.
One will readily recognize that there are numerous other examples of image guidance systems which can use, incorporate, support, or provide for the techniques, methods, processes, and systems described herein.
It can often be difficult to discern the content of a 3D scene from a 2D depiction of it, or even from a 3D depiction of it. Therefore, various embodiments herein provide image guidance that can help the healthcare provider better understand the scene, relative emplacements or poses of object in the scene and thereby provide improved image guidance.
Although only one virtual surgical instrument 202 is displayed, it will be understood that multiple medical devices can be tracked and displayed concurrently, or simultaneously, on screen 220, as described in greater detail in the '274 application, previously incorporated by reference. For example, a virtual rendering of the medical imaging device 222 can be displayed.
The virtual surgical instrument 202 can be displayed in a virtual 3D space with the screen 220 acting as a window into the virtual 3D space. Thus, as the surgical instrument 242 is moved to the right with respect to a point-of-view location (e.g., the location of the point-of-view for viewing the 3D space), the virtual surgical instrument 202 also moves to the right. Similarly, if the surgical instrument 242 is rotated 90 degrees so that the tip of the surgical instrument is pointing away from the point-of-view location (e.g., at the screen 220), the virtual surgical instrument 201 will likewise show the change in orientation, and show the tip of the virtual surgical instrument 202 in the background and the other end of the virtual surgical instrument 202 in the foreground. In some embodiments, as described in greater detail in U.S. application Ser. No. 14/212,933, incorporated herein by reference in its entirety, the point-of-view location can be a fixed location, such as a predetermined distance/angle from the screen 220 or stand 170 and or a location configured by the user; or the point-of-view location can by dynamic. For example, the system can track a user in real-time and determine the point-of-view location based at least in part on the tracked location of the user.
Some models of medical devices have markings such as bands around the shaft (to indicate distance along the shaft), and a colored region 203 near the tip to indicate from where the radio frequency or microwave energy is emitted in the case of an ablation probe. Healthcare providers performing medical device procedures are often familiar with these markings and can use them to help understand the spatial relationship between the medical device and anatomy. In some embodiments, the make and model of the medical device 242 is known to the image guidance system and the virtual medical device 202 displayed in display 220 can resemble medical device 242. The features of medical devices that can be rendered in the scene include the overall shape (diameter, cross sectional shape, curvature, etc.), color, distance markers, visuals or echogenic fiduciary markers, the state of deployable elements such as tines, paddles, anchors, resection loops, stiffening or steerable sleeves, temperature, radiation, light or magnetic field sensors, lens, waveguides, fluid transfer channels, and the like.
The type of medical device being used can be input into the image guidance system 100, can be a system default, can be detected by a camera or other device, can be received as data from an attached medical device, such as surgical system 149 in
Consider an embodiment in which the virtual surgical instrument 202 in the display 220 is an ablation needle depicting the portion of the needle that will perform the ablation, for example, the portion that emits the radio or microwave energy. If the display 220 also includes ultrasound data, then the doctor can be able to find the tumor 212 she wishes to ablate by moving the ultrasound probe around until she spots the tumor 212. In various embodiments, she will be able to see the displayed ultrasound data and its location relative to the displayed medical device with the markings. She can then drive the medical device until she sees, on display 220, that the emitter-portion of the medical device encompasses the tumor in the ultrasound, also seen on display 220. When she activates the ablation, she can then be much more certain that she has ablated the correct portion of the tissue. Various embodiments of this are discussed below.
As another example, consider the physical markings that can be on the instruments themselves. These markings can help orient a healthcare provider during use of the instrument. In some embodiments, the image guidance unit can represent these markings in the images displayed in the display. For example, certain ultrasound transducers are built with an orientation mark (e.g., a small bump) on one side of the transducing array. That mark can also be shown in the ultrasound image on the scanner's display, to help the healthcare provider understand where the scanned anatomical structures shown on screen are located under the transducer, inside the patient. In some embodiments, the image guidance system can display a symbolic 3D representation of the orientation mark both next to the motion-tracked ultrasound slice (e.g., moving with the displayed ultrasound slice) and next to the 2D view of the ultrasound slice also displayed by the system. An example of this is displayed in
It will be understood that an image slice can correspond to image data received from an imaging device, such as an ultrasound transponder. In some embodiments, the image data can correspond to a cross-section of tissue having a certain thickness. In some instances, the imaging device can compact the image data, and/or treat the image data as 2D data, such that there is no perceived thickness. In certain embodiments, when the image slice is displayed in a 3D view, the system can treat the image slice as a 2D or quasi 2D object. In such embodiments, the system can cause the image slice to have little to no perceptible thickness. Accordingly, in certain embodiments, when the image slice is oriented orthogonally or perpendicularly with respect to the point-of-view location, the system can cause the display to display nothing or a line having a relatively small thickness, such as a few pixels, etc. In some cases, the number of pixels used to display the relatively small thickness of the image slice can correspond to the size of the display. For example, more pixels can be used for a larger display and fewer pixels can be used for a smaller display, etc.
Other embodiments can track and display other types of instruments and their features. For example, a healthcare provider may want to track one or more of a scalpel, a biopsy, a cauterizer (including an electrocauterizer and Bovies), forceps, cutting loops on hysteroscopes, harmonic sheers, lasers (including CO2 lasers), etc. For example, in various embodiments, the following devices can be tracked and various aspects of their design displayed on display 220: Olympus™ OES Pro Hystero-Resectoscope, SonoSurg Ultrasonic Surgical System Olympus™ GF-UC 160 Endoscope Wallus™ Embryo Transfer Catheter AngioDynamics® NanoKnife™, VenaCure™ laser, StarBurst, Uniblade, Habib® Resector Bovie™ Electrodes, Covidien Evident™, Cool-tip™ Ablation Antennas, Opti4™ Electrodes Microsulis MEA (microwave endometrial ablation), Acculis Halt™ Medical System Optimed BigLumen Aspiration Catheter Optimed Optipure Stent Central venous catheterization introducer medical device (such as those made by Bard and Arrow).
Once tracked, a healthcare provider is able to see image guidance data on display 220 that will allow her to know the relative pose, location, or emplacement of the tracked instrument(s) with respect to one another or with respect to imaging data and will be able to see, on display 220, the features of the instrument rendered in the scene.
In certain procedures, the system can provide image prediction information related to the surgical instruments as image guidance cues. In the context of scalpel movement, this can be the location that the scalpel will hit if a healthcare provider continues to move the scalpel in a particular direction. In the context of ablation or biopsies, this can be the projected medical device placement if it is driven along its central axis, which is also referred to herein as a longitudinal axis.
In some embodiments, to implement the trajectory indicators 208, the image guidance system can draw a number of rings about the axis of the medical device shaft, extrapolated beyond its tip, as depicted in
The rings can, in some embodiments, be spaced at regular (e.g., 0.5, 1, or 2 cm) intervals to provide the healthcare provider with visual or guidance cues regarding the distance from the medical device tip to the targeted anatomy. In some embodiments, the spacing of the rings can indicate other aspects of the data, such as the drive speed of the medical device, the density of the tissue, the distance to a landmark, such as the ultrasound data, or any other appropriate guidance data or property. In some embodiments, the rings or other trajectory indicators can extend beyond the medical device tip, by a distance equal to the length of the medical device-shaft. This way, the user knows if the medical device is long enough to reach the target—even before the tip enters the patient. That is, in some embodiments, if the rings do not reach the target with the tip still outside the body, then the tip will not reach the target even when the entire length shaft is inserted into the body.
Other display markers can be used to show trajectory, such as a dashed, dotted, or solid line, transparent medical device shaft, point cloud, wire frame, etc. In some embodiments, three-dimensional rings can be used and provide depth cues and obscure little of the ultrasound image. Virtual rings or other virtual markers can be displayed semi-transparently, so that they obscure less of the ultrasound image than an opaque marker would.
Other prediction information can also be displayed as image guidance cues. For example, if a scalpel is being tracked by the image guidance system, then a cutting plane corresponding to the scalpel can be displayed (not pictured). Such a cutting plan can be coplanar with the blade of the scalpel and can project from the blade of the scalpel. For example, the projected cutting plane can show where the scalpel would cut if the doctor were to advance the scalpel. Similar prediction information can be estimable or determinable for cauterizers, lasers, and numerous other surgical instruments.
Furthermore, the data from two or more devices can be combined and displayed based on their relative emplacements or poses. For example, the system 100 can determine the emplacement of an image plane based on the emplacement information of the ultrasound probe 222. Further, the rendered ultrasound image 204 can be displayed on the image plane with respect to the virtual medical device 202 on the display 220 in a manner that estimates the relative emplacements or poses of an ultrasound probe 222 and the medical device 242. As illustrated in
In addition, the display 220 can include another image guidance cue in the form of an intersection indicator 210 that indicates where the virtual ablation medical device 202 (and/or its trajectory) intersects the ultrasound image 204. In some embodiments, the intersection indicator 210 can be displayed before the medical device is inserted, thereby allowing the healthcare provider to see where the medical device will intersect the image, or imaged area.
In the illustrated embodiment, a tumor 212 appears in the ultrasound image, or rendered ultrasound image 204, and the virtual ablation needle 202 is shown driven through the tumor 212. As will be described in greater detail below, the displayed affected region (or affected region indicator) 206 can indicate what region or volume would be affected when the medical device 242 is operated. In the illustrated embodiment, the displayed affected region 206 can estimate where ablation would occur if the tissue were ablated at that time. As can be seen, in the illustrated embodiment, the displayed affected region 206 appears to cover the tumor displayed in the ultrasound image.
Various embodiments can include any combinations of the graphics described above and/or other graphics or image guidance cues. For example, in some embodiments, data related to a single surgical instrument (such as an ablation needle, ultrasound probe, etc.) can be presented in more than one manner on a single display. Consider an embodiment in which device 242 is an ablation needle and device 222 is an ultrasound transducer. As mentioned previously, as the medical devices are displayed in a virtual 3D space, with the screen 220 acting as a window into the virtual 3D space, if a healthcare provider orients ultrasound transducer 222 such that it is perpendicular to the point-of-view or point-of-view location (e.g., perpendicular to the screen), the perspective view of the ultrasound image 204 would show only the edge and the contents of the ultrasound image 204 would not be visible. In some embodiments, the image guidance system can track the healthcare provider's head using an emplacement sensor and/or a position sensing unit. In some embodiments, such as, when the head of a user is tracked, the healthcare provider can then move her head to the side, so that she sees the ultrasound image from a different point of view location.
In some embodiments, the image guidance system can constantly display an additional 2D view 205 of the ultrasound image, simultaneous to the 3D depiction 204, so that the ultrasound image is always visible, regardless of the emplacement in which the healthcare provider holds the transducer 222. The 2D view 205 of the ultrasound data can be similar to what a healthcare provider is accustomed to seeing with traditional ultrasound displays. This can be useful to provide the healthcare provider with imaging to which she is accustomed and allows a healthcare provider to see the ultrasound data regardless of the then-current emplacement of the ultrasound probe with respect to the user.
In some embodiments, the 2D view 205 of an ultrasound image is depicted in the upper right corner of the monitor (though it can be placed in any location). In some embodiments, the guidance system can automatically (and continually) choose a corner in which to render the 2D view 205 of the ultrasound image, based on the 3D position of the surgical instruments in the rendered scene. For example, in
In some embodiments, the system attempts to avoid having the 2D view 205 of the ultrasound image quickly moving among corners of the display in order to avoid overlapping with graphics and data in the display. For example, a function f can be used to determine which corner is most suitable for the 2D ultrasound image to be drawn in. The inputs to f can include the locations, in the screen coordinate system, of the displayed medical device tip, the corners of the 3D view of the ultrasound image, etc. In some embodiments, f's output for any given point in time is independent of f's output in the previous frames, which can cause the ultrasound image to move among corners of the display rapidly. In some embodiments, the image guidance system will filter f's output over time. For example, the output of a filter g, for any given frame, could be the corner, which has been output by f the most number of times over the last n frames, possibly weighting the most recent values for f most heavily. The output of the filter g can be used to determine in which corner of display 220 to display the 2D ultrasound image and the temporal filtering provided by g can allow the 2D view 205 of the ultrasound image display to move more smoothly among the corners of the display 220.
In some embodiments, other appropriate virtual information and/or image guidance cues can be overlaid on the 2D view 205 of the ultrasound image as well as the 3D view 204. Examples include: orientation indicator 214, an indication of the distance between the medical device's tip and the point in the plane of the ultrasound image that is closest to the medical device tip; the cross section or outline of the ablation volume that intersects with the ultrasound slice; and/or the intersection point, box, outline, etc. between the medical device's axis and the ultrasound image plane.
Furthermore, it will be understood that other image guidance cues can be generated and displayed on the display as described in greater detail in the '274 application, previously incorporated herein by reference. For example, the system 100 can generate and/or display graphical indicators that help indicate the spatial relationship between a medical device and an ultrasound image plane (e.g., graphical image plane indicators) or other plane (e.g., graphical plane indicators), indicators to indicate the relative positions of the medical device(s) and ultrasound image, features of interest, annotations, foundational plane indicators, foundational plane intersection indicators, other graphical indicators, approximate medical device location indicators, etc. As described in greater detail above and in the '274 application, the various image guidance cues can be generated based at least in part on the emplacement information of the medical devices used with the system 100.
Embodiments of the system can include image guidance cues as part of the image guidance data to depict information related to the region or regions that will be affected by the use of surgical instruments. For example, in some embodiments, an image guidance cue displayed by the image guidance system can include affected region information. The illustrated embodiment of
In some embodiments, the system can use the operating parameters of the medical device 242 and/or measured parameters to determine the affected region (and display the displayed affected region 206). For example, in some cases, the affected region's approximate size (e.g., girth and length) can be either specified by the healthcare provider, or automatically computed by the guidance system based on or more operating parameters, such as, but not limited to, the medical device make and model, power and duration settings of the medical device (e.g., microwave or radio frequency generator for ablation needles, etc.), and the like. Similarly, the system can use measured parameters to determine the affected region, such as, but not limited to, measured or estimated temperature, impedance of surrounding tissue. In some embodiments, the measured parameters can be received in real-time as real-time data. In either case, the system can use one or more a formulas, a look-up-tables, fixed or default values, or any other appropriate available information, etc. to determine the affected region.
In addition, the system can determine affected regions prior to operating the medical device and/or during operation of the medical device. For example, prior to operating the medical device, the system can determine one or more predicted affected regions and/or during operation of the medical device, the system can determine one or more dynamic affected regions. In some embodiments, the predicted affected regions can be static during operation of the medical device and the dynamic affected regions can change over time. In certain embodiments, the system may rely more on operating parameters of the medical device to determine the predicted affected regions and measured parameters to determine the dynamic affected regions. However, it will be understood that operating parameters and/or measured parameters can be used to determine the predicted affected regions and/or the dynamic affected regions
In some circumstances, the operating parameters, measured parameters, formulas, a look-up-tables, fixed or default values, or other information used to determine the affected regions may include some amount of error or variance. The variance may be due to uncertainty regarding the tissue that will be presented for ablation, a manufacturers indication that impedance, temperature, power, etc., can vary between tissue and/or medical devices, etc.
As such, it can be difficult to determine the affected region with certainty. Thus, the operating parameters or other data can include one or more variance parameters indicating the amount of variance that a healthcare provider can expect when using a particular medical device. The variance parameter may account for all possible outcomes or a significant portion of possible outcomes (non-limiting examples: 95% or 99%). For example, the variance parameter can indicate that a medical device operates within a certain range, or that a healthcare provider can expect a certain volume to be affected with a particular standard deviation and/or +/− some percent. For example, the variance parameter may indicate that, when operating for a particular amount of time, an ablation needle will ablate a certain range of tissue, or that a certain amount of tissue will be ablated with a particular standard deviation and/or +/− some percent.
Accordingly, in such scenarios, the system can determine multiple affected regions based at least in part on the variance parameter. For example, the system can determine two affected regions using the extrema of the variance parameter. In some cases, such as when the variance parameter includes a lower threshold and a higher threshold, the system can determine two affected regions using the lower threshold and the higher threshold, respectively. The affected regions can be predicted affected regions and/or dynamic affected regions depending on when and how the system determines them. In some cases, a third affected regions can be determined. The third affected region can be determined using a third point in the range, such as the midpoint, average, or other point.
The system can also determine the emplacement of the affected region. In some cases, the emplacement of the affected region can be based at least in part on the emplacement of some or all of the corresponding medical device (or virtual medical device), such as medical device 242 in
As yet another example, if the medical device is an ablation needle and the affected region is an ablation volume, the emplacement of the ablation volume can be based at least in part on the emplacement of the ablation needle (or its rendered version) or at least a portion of it, such as the location on the ablation needle where the ablation energy will be emitted. Specifically, in some embodiments, the affected region can be centered at a location on the medical device, such as the location on the medical device that affects the surrounding tissue (non-limiting examples: microwave emitter, laser source output, etc.). Similarly, if multiple medical devices are used, the posed can be based at least in part on the emplacement of the medical devices.
The system can display the affected region in a variety of ways. Furthermore, although the illustrated embodiment of
For some medical devices, the expected volume of ablated tissue is neither spherical nor centered at the tip of the medical device. Accordingly, in such embodiments, the affected regions can match expected volumes. For example, a Covidien surgical microwave medical device has an ellipsoidal ablation volume; a Covidien Evident transcutaneous microwave medical device has a teardrop-like ablation volume; RFA Medical's bipolar ablation system uses two medical devices simultaneously, where each medical device has paddles that deploy after the medical device is inserted inside the tissue (which one can equate to a canoe's oar). In some embodiments, the affected region for such a medical device corresponds to a volume that lies directly between the paddles of the two medical devices.
Although the illustrated embodiment of
As non-limiting examples and with reference to
When displaying a portion of a volume, the system can display the portions of the volume that are located in front of the image slice with respect to the point-of-view location (or display them differently than portions that are behind the image slice), alternating bands or tiles of the affected region, portions of the affected region that are co-located with or intersect the medical device and/or the image slice. In addition, when multiple affected regions are determined, the system can display them in any combination as described above. Further, in some embodiments, such as when the system determines a second affected region that includes a first affected region, the displayed affected region can include the portions of the second affected region that are unique second affected region with respect to the first affected region only, or in combination with other portions. In certain embodiments, such as when the system determines that portions of a second affected region and a first affected region overlap, the system can display the overlapping portions only, or in combination with other portions.
Furthermore, the system can display the affected regions and other displayed features differently. For example, in some embodiments, the system can vary the characteristics of the affected regions (non-limiting examples: portions closer to the outline or edge of the affected regions can be more/less opaque, bright or focused, distal portions of the affected regions can be more/less opaque, bright or focused). Similarly, the system can vary the characteristics of the other displayed features. In some embodiments, the system can use different display settings for different portions of an image slice. For example, the system can display portions of the image slice within a first affected region using a first setting, portions of the image slice within a second affected region using a second setting, and portions of the image slice outside the first and second affected regions using a third setting. The different settings can correspond to different opacity levels, brightness levels, contrast levels, and/or focus levels, etc. In some embodiments, portions of the image slice outside the first and second affected regions can be darkened, blurred, or otherwise adjusted to provide the healthcare provider with additional insight regarding the portions of the image slice that are within the affected region(s).
The surface display regions can correspond to predicted affected regions and/or dynamic affected regions, as desired. Accordingly, if the first and/or second affected regions are dynamic affected regions, the associated surface display regions can move, or grow, during operation of the medical device associated with the virtual medical device 401, 501.
In addition, the surface display regions can correspond to affected regions that are co-located with the medical display object or only portions thereof, or the medical display object's trajectory. Accordingly, in some embodiments, the surface display region can be displayed as a volume, area, or line depending on which portions of the affected region and medical display object are used to determine the surface display region.
In some embodiments, to determine whether a portion of the affected region and a portion of the medical display object are co-located or level, the system 100 can compare the coordinates of the portion of the affected region with the portion of the medical display object. If the coordinates (e.g., the x, y, z coordinates) match (e.g., are equal) or satisfy a distance threshold, the system can determine that the portion of the medical display object and the portion of the affected region are co-located. In certain embodiments, the system 100 can determine that the portion of the affected region and the portion of the medical display object are co-located if the portion of the affected region and the portion of the medical display object can be mapped to the same pixel in a video or image output data buffer.
The distance threshold can be a predefined distance, such as one or more bits, one or more pixels, etc. In some embodiments, the distance threshold can be based at least in part on whether the distance between the coordinates is perceptible to a user, which may be based at least in part on the size of the display, the size of the display relative to the image and/or imaged area, and/or the distance between the point-of-view location and the display, etc. For example, in some cases, the distance threshold can be smaller for larger displays (or larger display:image ratios) and larger for smaller displays (or smaller display:image ratios), or vice versa. In certain cases, the distance threshold can be larger for larger distances between the point-of-view location and the display and smaller for smaller distances between the point-of-view location and the display, or vice versa. In certain embodiments, the distance threshold can be different for each coordinate.
In certain embodiments, the system 100 can perform the comparison for each location of the medical display objects and/or each location of the affected regions. In some cases, the system can determine that the portion of the medical display object and the portion of the affected region are co-located if the portion of the medical display object and the portion of the affected region are level and have the same depth.
Any coordinate system can be used to compare the coordinates of the portion of the affected region with the medical display object and/or to determine whether the portion of the affected region is co-located with the medical display object. For example, the coordinate system of the display and/or the coordinate system of device in the system 100 that is used to determine the emplacement of the medical devices can be used, as desired.
In some embodiments, the coordinate system of the display is used. The coordinate system of the display can be any emplacement as desired. In certain embodiments, the coordinates of the display are that the x-axis is the width of the display, the y-axis is the height of the display, and the z-axis is the depth (e.g., into and out of) the display. In such embodiments, the system 100 can determine that the portion of the affected region satisfies the location threshold and/or is level with the medical display object, based at least in part on the x and y coordinates of the affected region and the x and y coordinates of the medical display object. For example, if the x and y coordinates of the affected region and the x and y coordinates of the medical display object match (or satisfy a distance threshold); the system 100 can determine that the portion of the affected region satisfies the location threshold.
Although reference is made to the x and y coordinates, it will be understood that the coordinates used to determine whether the portion of the affected region satisfies the location threshold and/or is co-located with the medical display object can be based at least in part on the coordinate system used. For example, in some embodiments, the coordinate system used can include the x-axis as the depth (e.g., forward/backward), the y-axis as lateral movement (e.g., side-to-side), and the z-axis as elevation (e.g., up/down). In such embodiments, the system 100 can determine that portion of the affected region satisfies the location threshold if the y and z coordinates of the affected region match (or satisfy a distance threshold) the y and z coordinates of the medical display object.
In some embodiments, for each location on the display, the system can query whether a portion of the medical display object and/or a portion of the affected region have been (or will be) mapped to that location. If the system 100 determines that a portion of the medical display object and a portion of the affected region have been (or will be) mapped to that location, the system 100 can determine that the portion of the medical display object and the portion of the affected region are co-located.
In certain embodiments, the system 100 can determine that the portion of the affected region satisfies the location threshold, intersects, and/or is co-located with the medical display object if the portion of the affected region and the medical display object (or portion of the image corresponding to the medical display object) are co-located when mapped to a 2D plane. In some embodiments, the 2D plane can be based at least in part on the point-of-view location. For example, the 2D plane can be orthogonal to the point-of-view location. In certain embodiments, the system 100 can determine that the portion of the affected region satisfies the location threshold (or corresponding virtual affected region) if the portion of the affected region overlaps with the medical display object (or portion of the image corresponding to the medical display object) in a virtual image (e.g., one is directly in front of or behind the other in the virtual image). In certain embodiments, the system 100 can determine that the portion of the affected region satisfies the location threshold if the portion of the affected region and the medical display object (or portion of the image corresponding to the medical display object) map to the same location on a display, such as the same pixel or same array of pixels.
With continued reference to
It will be understood that any of the aforementioned embodiments from
At block 602, the system 100 receives operating parameters of a medical device. As described in greater detail above, the operating parameters can include information regarding make and model, power and duration settings of the medical device, and/or variance parameters, etc. The operating parameters can be stored in a non-transitory, computer-readable medium associated with the system 100 and/or can be stored in the medical device.
At block 604, the system 100 determines a first affected region. As described previously, affected regions can correspond to predicted affected regions and/or a dynamic affected regions. In some embodiments, the system determines the first affected region based at least in part on the operating parameters and/or measured parameters. In certain embodiments, the system 100 determines the first affected region based at least in part on a variance parameter of the medical device.
At block 606, the system 100 causes one or more displays to display at least a portion of the first affected region, or first displayed affected region. As described previously, the first displayed affected region can be displayed in a 2D view or 3D view and/or as a perspective view.
In addition, as described in greater detail above, the displayed affected region can be displayed as a volume, area, and/or line. The displayed affected region can be wire-framed, transparent, semi-transparent, have varied opacity, brightness, and/or focus, include alternating bands/tiles, be textured, include solid or dashed lines, include spikes, etc. In certain embodiments, the at least a portion of the first affected region corresponds to portions of the first affected region that are unique to it, with respect to other affected regions. In some embodiments, the displayed affected region corresponds to at least a portion of the first affected region that is co-located with at least a portion of a medical display object (non-limiting examples: a virtual medical device, image slice, etc.) or its trajectory, also referred to as the surface display region.
It will be understood that fewer, more, or different blocks can be used as part of the routine 600. For example, any combination of blocks 608, 610, 612, and 614 can be included as part of routine 600.
At block 608, the system 100 determines a second affected region. The second affected region can be determined in a manner similar to the first affected region. As described in greater detail above, in some embodiments, the variance parameter can be used to determine the first and second affected regions. For example, a first variance threshold can be used to determine the first affected region and a second variance threshold can be used to determine the second affected region. In certain cases, the first variance threshold can be less than the second variance threshold. In such embodiments, the second affected region can be larger than, and in some cases include, the first affected region.
At block 610, the system 100 causes one or more displays to display at least a portion of the second affected region, or second displayed affected region. The system 100 can cause the one or more displays to display the second displayed affected region similar to the first displayed affected region. In some embodiments, the second displayed affected region can be displayed differently, such as by using a different color, transparency level, focus setting, shape, texture, etc. Furthermore, in some embodiments, the system can omit causing the display of the first displayed affected region in favor of the second displayed affected region. In such embodiments, the second displayed affected region can, in some instances, correspond to the portions of the second affected region that are unique to the second affected region, with respect to the first affected region.
In some instances the first affected region can be a predicted affected region and the second affected region can be a dynamic affected region. As such, in certain embodiments, during operation of the medical device, the second displayed affected region can change and/or grow with respect to the first displayed affected region.
At block 612, the system 100 determines a third affected region. For example, in some embodiments, the first and second affected regions can be first and second predicted affected regions and the third affected region can be a dynamic affected region. However, in certain embodiments the three affected regions can be dynamic affected regions, predicted affected regions, or any combination thereof.
At block 614, the system 100 causes one or more displays to display at least a portion of the third affected region, or third displayed affected region. The system 100 can cause the one or more displays to display the third displayed affected region similar to the first and second displayed affected regions. In some embodiments, the third displayed affected region can be displayed differently, such as by using a different color, transparency level, focus setting, shape, texture, etc. In embodiments, where the third affected region is a dynamic affected region and the first and second affected regions are predicted affected regions, the third displayed affected region can move with respect to the first and second displayed affected regions.
With continued reference to
At block 702, the system 100 determines the emplacement of a virtual medical device. In some embodiments, as described above, the system 100 can determine the emplacement of the virtual medical device based at least in part on emplacement data corresponding to a medical device, such as medical device 242. As described previously, the emplacement data can be received from one or more emplacement sensors associated with the medical device.
At block 704, the system 100 obtains operating parameters of the medical device, as described in greater detail above with reference to block 602 of
At block 710, the system 100 can determine the emplacement of the first and second affected regions. At block 712, the system 100 can cause one or more displays to display at least a portion of the virtual medical device, at least a portion of the first affected region (second displayed affected region), and at least a portion of the second affected region (second displayed affected region). As described previously, the displayed affected regions can, in some embodiments, correspond to surface display regions. In some embodiments, the system 100 can cause the one or more displays to display at least a portion of the first and second affected regions similar to blocks 606 and 610 of
It will be understood that fewer, more, or different blocks can be used as part of the routine 700. For example, any combination of blocks 714, 716, 718, and 720 can be included as part of routine 700.
At block 714, the system 100 can determine a third affected region, and at block 716, the system 100 can cause the one or more displays to display at least a portion of the third affected region. In some embodiments, the system 100 can determine the third affected region and display a third displayed affected region similar to the first and second displayed affected regions as described in greater detail above with reference to blocks 612 and 616 of
At block 718, the system 100 can determine an emplacement of an image slice, and at block 720, the system 100 can cause the one or more displays to display at least a portion of the image slice and/or perspective view thereof, as described in greater detail above.
With continued reference to
Those having skill in the art will further appreciate that the various illustrative logical blocks, modules, circuits, and process steps described in connection with the implementations disclosed herein can be implemented as electronic hardware, computer software, or combinations of both. To clearly illustrate this interchangeability of hardware and software, various illustrative components, blocks, modules, circuits, and steps have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system. Skilled artisans can implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the present invention. One skilled in the art will recognize that a portion, or a part, can comprise something less than, or equal to, a whole. For example, a portion of a collection of pixels can refer to a sub-collection of those pixels.
The various illustrative logical blocks, modules, and circuits described in connection with the implementations disclosed herein can be implemented or performed with a processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A processor can be a microprocessor, but in the alternative, the processor can be any conventional processor, controller, or microcontroller. A processor can also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.
The steps of a method or process described in connection with the implementations disclosed herein can be embodied directly in hardware, in a software module executed by a processor, or in a combination of the two. A software module can be stored in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, a CD-ROM, or any other form of non-transitory computer-readable medium known in the art, as computer-executable instructions. An exemplary computer-readable storage medium is coupled to the processor such the processor can read information and/or computer-executable instructions from, and write information to, the computer-readable storage medium. In the alternative, the storage medium can be integral to the processor. The processor and the storage medium can reside in an ASIC. The ASIC can reside in a user terminal, camera, or other device. In the alternative, the processor and the storage medium can reside as discrete components in a user terminal, camera, or other device.
Headings are included herein for reference and to aid in locating various sections. These headings are not intended to limit the scope of the concepts described with respect thereto. Such concepts can have applicability throughout the entire specification.
Conditional language such as, among others, “can,” “could,” “might” or “may,” unless specifically stated otherwise, are otherwise understood within the context as used in general to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment.
Language such as the phrase “at least one of X, Y and Z,” and “at least one of X, Y or Z,” unless specifically stated otherwise, is understood with the context as used in general to convey that an item, term, etc. may be either X, Y or Z, or any combination thereof. Thus, such language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y and at least one of Z to each be present or exclusively X or exclusively Y or exclusively Z.
Unless otherwise explicitly stated, articles such as ‘a’ or ‘an’ should generally be interpreted to include one or more described items. Accordingly, phrases such as “a device configured to” are intended to include one or more recited devices. Such one or more recited devices can also be collectively configured to carry out the stated recitations. For example, “a processor configured to carry out recitations A, B and C” can include a first processor configured to carry out recitation A working in conjunction with a second processor configured to carry out recitations B and C.
The previous description of the disclosed implementations is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these implementations will be readily apparent to those skilled in the art, and the generic principles defined herein can be applied to other implementations without departing from the spirit or scope of the invention. Furthermore, although described above with reference to medical devices and procedures, it will be understood that the embodiments described herein can be applied to other systems in which objects are tracked and virtual representations are displayed on a display and/or systems in which multiple objects are displayed on a display within a virtual space, such as within a virtual 3D space. Thus, the present invention is not intended to be limited to the implementations shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
The present application is a continuation of U.S. patent application Ser. No. 15/882,709, filed Jan. 29, 2018, entitled AFFECTED REGION DISPLAY BASED ON A VARIANCE PARAMETER ASSOCIATED WITH A MEDICAL DEVICE, which is a continuation of U.S. patent application Ser. No. 14/872,930, filed Oct. 1, 2015, entitled AFFECTED REGION DISPLAY ASSOCIATED WITH A MEDICAL DEVICE, which claims priority benefit to U.S. Provisional Application No. 62/059,077, filed Oct. 2, 2014, entitled ABLATION AREA VISUALIZATIONS, each of which is hereby incorporated herein by reference in its entirety. Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are incorporated by reference under 37 CFR 1.57 and made a part of this specification.
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| Number | Date | Country | |
|---|---|---|---|
| 20210161601 A1 | Jun 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62059077 | Oct 2014 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15882709 | Jan 2018 | US |
| Child | 17071459 | US | |
| Parent | 14872930 | Oct 2015 | US |
| Child | 15882709 | US |
