Patent Description:
Substantial progress has been made towards increasing the effectiveness of medical treatment while reducing trauma and risks to the patient. Many procedures that once required open surgery now may be done with less invasive techniques, thus providing for less recovery time and risks of infection for the patient. Certain procedures requiring biopsy, electro-stimulation, tissue ablation, or removal of native or foreign bodies may be performed through minimally-invasive surgery.

In the field of urology, for example, renal calculi or kidney stones can accumulate in the urinary tract and become lodged in the kidney. Kidney stones are deposits of materials from the urine, typically minerals and acid salts. While smaller stones may pass from the body naturally, larger stones can require surgical intervention for removal. While open surgery was once the standard treatment for the removal of stones, other less invasive techniques, such as ureteroscopy and percutaneous nephrolithotomy/nephrolithotripsy (PCNL), have emerged as safer, effective alternatives. Additionally, advances in imaging technology have improved a medical professional's ability to identify and locate stones before and during procedures. Nevertheless, medical professionals still must analyze images to determine the location of stones and whether any stones are present. Moreover, the images are often in grayscale, blurry, and otherwise difficult to evaluate, making the medical professional's task of discerning the presence of any stones challenging.

The systems, devices, and non-claimed methods of the current disclosure may rectify some of the deficiencies described above, and/or address other aspects of the prior art.

Document <CIT> describes systems and methods in which local tissue diagnostic measurements are correlated with archival local tissue diagnostic data from prior tissue analyses to supplement diagnostic measurements with tissue analysis data from prior tissue analyses having similar local tissue diagnostic data. The tissue analysis data may include information such as pathology data, outcome data, and diagnosis data. The archived local tissue diagnostic data and the tissue analysis data may be stored in a database, and employed for a wide variety of methods, involving preoperative, intraoperative, and/or postoperative phases of a medical procedure. Methods and systems are also provided for displaying, on a medical image shown in a user interface, hyperlinked reference markers associated with tissue analyses, where the reference markers are shown at locations corresponding to local tissue analyses, and where associated diagnostic data and/or tissue analysis may be viewed by selecting a given reference marker.

Document <CIT> describes a method for guiding resection of local tissue from a patient which includes generating at least one image of the patient, automatically determining a plurality of surgical guidance cues indicating three-dimensional spatial properties associated with the local tissue, and generating a visualization of the surgical guidance cues relative to the surface. A system for generating surgical guidance cues for resection of a local tissue from a patient includes a location module for processing at least one image of the patient to determine three-dimensional spatial properties of the local tissue, and a surgical cue generator for generating the surgical guidance cues based upon the three-dimensional spatial properties. A patient-specific locator form for guiding resection of local tissue from a patient includes a locator form surface matching surface of the patient, and a plurality of features indicating a plurality of surgical guidance cues, respectively.

Document <CIT> describes a method for characterizing tissue of a patient, including receiving acoustic data derived from the interaction between the tissue and the acoustic waves irradiating the tissue; generating a morphology rendering of the tissue from the acoustic data, in which the rendering represents at least one biomechanical property of the tissue; determining a prognostic parameter for a region of interest in the rendering, in which the prognostic parameter incorporates the biomechanical property; and analyzing the prognostic parameter to characterize the region of interest. The method may further include introducing a contrast agent into the tissue; generating a set of enhanced morphology renderings of the tissue after introducing the contrast agent; determining an enhanced prognostic parameter from the enhanced morphology renderings; and analyzing the enhanced prognostic parameter.

Document <CIT> describes surgery-assistance apparatus that sets a margin region with respect to a target region of excision in an organ including a diseased part to be removed, and the margin region being removed together with the target region. A dominance region in an organ dominated by a part of a structure is determined as a target-region, and a region in the organ other than the target-region is determined as a non-target-region. The part extends from a predetermined position in a structure region toward a part of the organ including a diseased part. A margin-region is set based on a distance from predetermined position to each position on a boundary surface between the target-region and the non-target-region. The width of the margin-region gradually increases from zero to a predetermined value in a range in which the distance is less than or equal to a predetermined threshold value, and the width of the margin-region is substantially constant in a range in which the distance is greater than the predetermined threshold value.

Document <CIT> discloses an endoscope system that includes: a memory portion that stores preoperative multi-slice image data; an image processing portion that constructs three-dimensional data based on the preoperative multi-slice image data and extracts a predetermined luminal organ; a position detection that acquires position information of an image pickup portion; a position alignment portion that makes position information of the image pickup portion correspond to coordinates of the three-dimensional data; and a determination portion that determines whether or not the image pickup portion passes through a lumen in the three-dimensional data of the predetermined luminal organ. The image processing portion creates an image in which determination information that was determined by the determination portion is superimposed on the three-dimensional data of the predetermined luminal organ.

Examples of the present disclosure relate to, among other things, medical systems and non-claimed methods. Each of the examples disclosed herein may include one or more of the features described in connection with any of the other disclosed examples.

In accordance with the invention, a system for identifying material to be removed from a patient comprises an imaging device configured to obtain image data, a display configured to display images, an insertion device, and a control unit. The control unit is configured to receive a first set of image data from the imaging device, analyze the first set of image data based on at least one of a darkness, a contrast, or a saturation, and generate a coded image identifying the material to be removed from the patient to be displayed on the display. The insertion device includes a deflectable delivery shaft having at least one lumen extending through the delivery shaft, and the delivery shaft includes at least a camera and a light source positioned at a distal end of the delivery shaft. The display includes at least two screens, and a first screen displays the coded image and a second screen may displays images from the camera. The control unit includes a processing unit and a memory unit. The control unit is configured to signal the imaging device to obtain a second set of image data, and the control unit is further configured to compare the second set of image data with the coded image generated based on the first set of image data.

The system may further include one or more of the following features. The system may further include at least one of a retrieval device or a laser source. The control unit may be further configured to control the imaging device or the display. Based on the comparison of the second set of image data with the coded image generated based on the first set of image data, the control unit may be further configured to indicate progress during a material removal procedure. Based on the comparison of the second set of image data with the coded image generated based on the first set of image data, the control unit may be further configured to indicate whether a material removal procedure is complete.

The obtained image data may be grayscale or monochrome, and the coded image may identify the material to be removed from the patient with a different color, pattern, or shape than an area that is free of the material to be removed. The identification of material to be removed from the patient in the coded image may further be based on at least one of size, density, and location. The coded image may indicate the location of the material relative to an organ of the patient. The coded image may indicate the size of the material and whether the material may be removed from the patient with a retrieval device. The imaging device may be a rotatable C-arm X-ray machine including an X-ray tube and an X-ray detector configured to be positioned on opposing sides of the patient. The control unit may be integrally incorporated within a handle of the insertion device.

In another example, a non-claimed method for identifying material to be removed from a patient using an imaging device, a display, a control unit, and an insertion device may include obtaining a first set of image data from the imaging device, sending the first set of image data to the control unit from the imaging device, analyzing the first set of image data based on at least one of a darkness, a contrast, or a saturation, generating a coded image identifying the material to be removed from the patient to be displayed on the display, displaying the coded image on a first screen of the display, and indicating the material to be removed with the insertion device based on the displayed coded image.

The non-claimed method may further include one or more of the following features. The method may further include removing at least a portion of the material from the patient with the insertion device, and removing the material from the patient may include deflecting a delivery shaft of the insertion device, viewing an interior organ of the patient with at least a camera and a light source positioned at a distal end of the delivery shaft, and displaying images obtained from the camera on a second screen of the display. The method may further include obtaining a second set of image data from the imaging device and comparing the second set of image data with the coded image generated based on the first set of image data. Based on the comparison of the second set of image data with the generated coded image and the first set of image data, the method may include indicating progress of a material removal procedure. The obtained image data may be grayscale or monochrome, and the method may further include identifying the material to be removed from the patient with a different color, pattern, or shape than an area that is free of the material to be removed.

The non-claimed method may further include indicating the location of the material relative to an organ of the patient, identifying the material to be removed from the patient based on density, and indicating the size of the material and whether the material may be removed from the patient with a retrieval device. Obtaining the first set of image data from the imaging device may include using a rotatable C-arm X-ray machine including an X-ray tube and an X-ray detector configured to be positioned on opposing sides of the patient, and the control unit may be integrally incorporated within a handle of the insertion device.

In an example according to the invention, a system for identifying material to be removed from a patient includes an imaging device configured to obtain image data, a display configured to display images, an insertion device, and a control unit. The control unit is configured to receive a first set of image data from the imaging device, analyze the first set of image data based on at least one of a darkness, a contrast, or a saturation, and generate a coded image identifying the material to be removed from the patient to be displayed on the display.

The insertion device includes a deflectable delivery shaft having at least one lumen extending through the delivery shaft. The delivery shaft includes at least a camera and a light source positioned at a distal end of the delivery shaft. The display includes at least two screens, and a first screen displays the coded image and a second screen displays images from the camera. The control unit includes a processing unit and a memory unit. The control unit is configured to signal the imaging device to obtain a second set of image data, and the control unit is further configured to compare the second set of image data with the coded image generated based on the first set of image data. Based on the comparison of the second set of image data with the coded image generated based on the first set of image data, the control unit may be further configured to indicate progress during a material removal procedure.

The obtained image data may be grayscale or monochrome, and the coded image may identify the material to be removed from the patient with a different color, pattern, or shape than an area that is free of the material to be removed. The coded image may indicate the location of the material relative to an organ of the patient, identify the material to be removed from the patient based on density, and indicate the size of the material and whether the material may be removed from the patient with a retrieval device. The imaging device may be a rotatable C-arm X-ray machine including an X-ray tube and an X-ray detector configured to be positioned on opposing sides of the patient, and the control unit may be is integrally incorporated within a handle of the insertion device.

In another example, a non-transitory computer-readable medium for identifying material to be removed from a patient may include instructions stored thereon, that when executed on a processor, perform the steps of receiving a first set of image data, analyzing the first set of image data based on at least one of a darkness, a contrast, or a saturation, and generating a coded image identifying the material to be removed from the patient displayable on a display, and sending the coded image to the display.

The non-transitory computer-readable medium may further include one or more of the following features. The non-transitory computer-readable medium may further include instructions, that when executed on a processor, further perform the step of displaying images obtained from a camera on a second display. The non-transitory computer-readable medium may further include instructions, that when executed on a processor, further perform the step of comparing a second set of image data with the coded image generated based on the first set of image data. The non-transitory computer-readable medium may further include instructions, that when executed on a processor, further include the step of, based on the comparison of the second set of image data with the generated coded image and the first set of image data, indicating progress of a material removal procedure. The step of generating the coded image identifying the material to be removed from the patient may include indicating the location of the material relative to an organ of the patient, identifying the material to be removed from the patient with a different color, pattern, or shape than an area that is free of the material to be removed, and indicating the size and/or density of the material and whether the material may be removed from the patient with a retrieval device. The step of receiving the first set of image data may include receiving image data from a rotatable C-arm X-ray machine including an X-ray tube and an X-ray detector configured to be positioned on opposing sides of the patient, and the step of analyzing the first set of image data may be performed by a processing unit integrally incorporated within a handle of an insertion device.

Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features, as claimed. As used herein, the terms "comprises," "comprising," or other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such a process, method, article, or apparatus. Additionally, the term "exemplary" is used herein in the sense of "example," rather than "ideal. " As used herein, the terms "about," "substantially," and "approximately," indicate a range of values within +/- <NUM>% of a stated value.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and together with the description, serve to explain the principles of the disclosure.

Examples of the present disclosure include systems and non-claimed methods to facilitate, and improve the efficacy and safety of minimally-invasive surgeries. For example, aspects of the present disclosure may provide a user (e.g., a physician, medical technician, or other medical service provider) with the ability to more easily identify and, thus, remove kidney stones or other material from a patient's kidney or other organ. In some embodiments, for example, the present disclosure may be used in planning and/or performing a flexible ureteroscope procedure, with or without laser lithotripsy.

Reference will now be made in detail to examples of the present disclosure described above and illustrated in the accompanying drawings.

The terms "proximal" and "distal" are used herein to refer to the relative positions of the components of an exemplary medical device or insertion device. When used herein, "proximal" refers to a position relatively closer to the exterior of the body or closer to an operator using the medical device or insertion device. In contrast, "distal" refers to a position relatively further away from the operator using the medical device or insertion device, or closer to the interior of the body.

<FIG> illustrates a medical system <NUM> that includes a medical device <NUM>, an imaging device <NUM>, a display <NUM>, and a patient support <NUM> for a patient <NUM>. Medical device <NUM> may be wire connected (as shown), wirelessly connected, or otherwise coupled to a control unit <NUM>. The imaging device <NUM> and/or the display <NUM> may also be wire connected, wirelessly connected, or otherwise coupled to control unit <NUM>. Images and other patient information may be displayed on display <NUM> and/or a monitor <NUM> coupled to control unit <NUM>.

As shown in <FIG>, medical device <NUM> is an insertion device such as, for example, a ureteroscope (e.g., Lithovue™ Single-Use Digital Flexible Ureteroscope by Boston Scientific Corp. Medical device <NUM> may include a handle <NUM> with at least one port <NUM> and a deflection lever <NUM>. Port <NUM> may be threaded and may include a T-connector as shown in <FIG>, a Y-connector, or another appropriate connector. Medical device <NUM> includes a delivery shaft <NUM> terminating distally in a distal opening <NUM>. The delivery shaft <NUM> includes at least one lumen or a plurality of lumens, and the at least one port <NUM> may connect to a proximal end of the delivery shaft <NUM> through a lumen (not shown) in handle <NUM>.

Various instruments or devices may be inserted through port <NUM> to be delivered to and/or out of distal opening <NUM> of delivery shaft <NUM>, such as, for example, an energy device, such as a laser device for lithotripsy, and/or a retrieval basket. The distal end of delivery shaft <NUM> may be manipulated by action on the deflection lever <NUM>. Handle <NUM> may also be connected to display <NUM> and/or control unit <NUM> via a communication and/or power conduit <NUM>. For example, though not shown, medical device <NUM> includes an integral camera and light at the distal end of delivery shaft <NUM> that is/are connected to display <NUM> and/or monitor <NUM> of control unit <NUM> via the communication and power conduit <NUM>. With medical device <NUM> positioned within patient <NUM>, for example, through the patient's urethra to a patient's kidney, a retrieval device (not shown) may be inserted through port <NUM> and delivery shaft <NUM> and, using the integral camera and/or light and deflection lever <NUM>, a user may manipulate the distal end of delivery shaft <NUM> and extend the retrieval device to retrieve and remove material such as, for example, a kidney stone, with or without using laser lithotripsy.

Imaging device <NUM> may be any medical imaging device used to collect patient data. For example, imaging device <NUM> may include an X-ray, Magnetic Resonance Imaging, Computerized Tomography Scan, rotational angiography, ultrasound, or another appropriate internal imaging device. For some imaging procedures, a contrast agent may be used to assist in identifying anatomical features in the images. For example, a contrast agent may be introduced into the patient (e.g., iodine, barium, or another appropriate contrast agent may be introduced via the patient's urinary tract via the ureter) prior to imaging to assist in visualization of the kidneys and urinary system.

In one example, imaging device <NUM> is a mobile C-arm device useful for collecting X-ray images of the patient <NUM> in preparation for and/or during a ureteroscopic procedure, according to some aspects of the present disclosure. As shown, the "C-arm" <NUM> of the imaging device <NUM> includes an X-ray tube <NUM> aligned with a detector <NUM> positioned on the opposite side of the patient <NUM>. The C-arm <NUM> may be rotatable relative to the patient <NUM> in one or more planes (e.g., about an axis parallel and/or an axis perpendicular to the patient <NUM>) to allow for the collection of images in different orientations, without moving the patient <NUM>. The images may be displayed and analyzed in real time on a monitor or display, for example, monitor <NUM> and/or display <NUM>. The images may also be stored locally or remotely for later viewing and analysis. For example, as discussed in more detail below, the C-arm device <NUM> may be used to collect patient images before a ureteroscopic procedure to locate and identify any stones or material to be removed. The user may consult the images for guidance on proper insertion and positioning of the ureteroscope and other instruments during the procedure. The C-arm device <NUM> may also be used during a ureteroscopic procedure to collect images of the stones or material relative to an inserted ureteroscope within, for example, a patient's kidney. The C-arm device <NUM> may also be used after a ureteroscopic procedure to determine whether all of the stones or material have been removed.

The mobile C-arm device <NUM> may include a light source to identify a specific target or region of a patient, such as an intended incision or insertion site. For example, the C-arm <NUM> may include a light source coupled to or incorporated into the X-ray tube <NUM>, wherein the light source may be used to direct light on a pre-determined imaging location. <FIG> illustrates light <NUM> focused on the midsection of the patient <NUM> in the form of an "X" or crosshairs to indicate the intended imaging location. The direction, orientation, intensity, and/or shape of the light generated by the light source may be controlled via user input at the control unit <NUM> and/or by instructions received over a wireless connection from any appropriate user interface device.

Display <NUM> is at least a dual screen display. One of the screens displays an image or images currently or previously obtained by imaging device <NUM>. The other screen displays an image or video obtained by the camera at the distal end of delivery shaft <NUM>. Alternatively, as an illustrative example, one screen of display <NUM> may display a previously obtained image from imaging device <NUM>, and the other screen of display <NUM> may display a more recently obtained image from imaging device <NUM>. Furthermore, one screen of display <NUM> may display an image or images obtained by an additional imaging device, or display other electronic medical record information, and another screen of display <NUM> may display an image or images obtained by imaging device <NUM> and/or an image or video obtained by the camera at the distal end of delivery shaft <NUM>.

Patient support <NUM> may be a surgical stretcher, gurney, hospital bed, or surgical bed. Patient support <NUM> may be an urological surgical bed. Patient support <NUM> allows the imaging device <NUM> to capture internal images of the patient <NUM>, and does not interfere with the ability of imaging device <NUM> to capture the images. Patient support <NUM> may also be adjustable and movable in order to better position the patient <NUM> while obtaining imaging and/or while performing the procedure.

Control unit <NUM> may be wired or wirelessly connected to medical device <NUM>, imaging device <NUM>, and/or display <NUM>. A user may use control unit <NUM> and monitor <NUM> to initiate imaging and/or analysis and to otherwise control imaging device <NUM> and display <NUM>. Control unit <NUM> includes one or more memory and processing units. The memory and/or processing units may include installed software or applications that may be preprogrammed or downloaded to be stored within the control unit <NUM> and/or the medical device <NUM>. Additionally or alternatively, medical device <NUM> may include memory and/or processing units, and medical device <NUM> and control unit <NUM> may communicate, wired or wirelessly, with respect to memory and processing of patient data and obtained image data. As will be discussed in more detail below, the software or applications may manipulate, process, and interpret received images from imaging device <NUM> to identify the presence, location, and characteristics of a kidney stone or other material. Moreover, control unit <NUM> or medical device <NUM> may compare received images to previously received and analyzed images. For example, the user may employ control unit <NUM> or medical device <NUM> to process images from imaging device <NUM> to identify the presence of a stone and to determine the dimensions, density, composition, location, orientation, and/or position of the stone(s) relative to the kidney and the surrounding anatomy.

<FIG> illustrates an exemplary non-claimed method <NUM> for imaging and removing material from a patient's kidney, according to aspects of the present disclosure. In particular, the method <NUM> shown in <FIG> may help to ensure that a user removes the entirety of the kidney stones or other material from the patient <NUM>.

As shown, in step <NUM>, a user may first take an image or scan, using imaging device <NUM>, of a patient's organ, such as, for example, kidney, and determine the size, location, and/or burden of the stone or material to be removed. Step <NUM> may include introducing a contrast agent in the patient in order to improve and/or enhance the clarity of the image or scan. Based on the image or scan, in step <NUM>, the user, with the aid of the control unit <NUM>, monitor <NUM>, and display <NUM>, may determine the size, location, and/or burden of the stone or material to be removed. For example, control unit <NUM> may combine the sizes of multiple stones or materials and determine an area or volume of stone or material occupying space in the patient's kidney. Then, in step <NUM>, the user may perform the material removal procedure. As discussed above, step <NUM> may include inserting medical device <NUM> into patient <NUM>, for example, through the patient's urethra into the kidney, and using an energy source and/or a retrieval device to break up and/or remove the kidney stones or other material.

Step <NUM> then includes taking another image or scan of the patient's organ. Based on this image or scan, in step <NUM>, the user, again using the control unit <NUM>, monitor <NUM>, and display <NUM>, may determine whether there is any remaining kidney stone or other material to be removed. If there is a kidney stone or other material to be removed remaining in the patient's organ, in step <NUM>, the user may again perform the material removal procedure. The user may then repeat steps <NUM> and <NUM> as many times as necessary to take an image or scan of the organ and determine whether the material has been removed. If, however, there is not a kidney stone or other material to be removed remaining in the patient's organ, then the user may end the procedure in step <NUM>. Ending the procedure may include removing the medical device <NUM> from the patient <NUM>.

<FIG> illustrates an exemplary non-claimed method <NUM> for receiving, processing, and displaying images of a patient's organ and its contents, for example, a kidney and kidney stones, according to aspects of the present disclosure. In particular, the method <NUM> shown in <FIG> may help to ensure that a user properly identifies and then removes the entirety of the stone burden or other material.

In step <NUM>, a processing unit, such as, for example, the processing unit within control unit <NUM> may receive image or scan data of the patient's organ obtained by imaging device <NUM>. Then, in step <NUM>, the processing unit may analyze the image or scan data based on the image or scan darkness, contrast, and/or saturation. The processing unit may analyze each pixel of the received image or scan data and compare each pixel to a scale, such as, for example, a grayscale. A portion of the values on the scale may correspond to a stone intensity, tissue intensity, bone intensity, and/or other known intensities, and the scale may be shifted or modified depending on whether a contrasting agent is used in step <NUM> above. The processing unit may also factor the intensity of the energy from imaging device <NUM> in the correspondence of the pixels to the particular scale. Based on the intensity of the pixels and their correspondence to the scale, the processing unit then determines the density, and thus the size, location, and/or burden, of the various detected elements. If the processing unit or memory unit contains any previously obtained or stored image or scan data of the patient's organ or a similar and/or ideal organ, the processing unit may compare the obtained image or scan data to the previously obtained or stored image or scan data in step <NUM>, which may have been analyzed previously by the processing unit as discussed above.

Based on the aforementioned analysis, in step <NUM> the processing unit may produce or generate a heat map and/or coded image of the organ, which may be displayed on display <NUM>. The heat map and/or coded image may be color coded, for example indicating material to be removed in red and areas free of material in green. Additionally, the heat map and/or coded image may include an outlined area that includes material to be removed, and the outlined area may also be color coded. For example, the outlined area may be based on a change in intensity or darkness of the pixels and/or a change in the determined density or tissue composition. In one aspect, if a patient's kidney is being scanned and analyzed, any stone burden may be indicated in red, and stone-free areas may be indicated in green. Alternatively, the coded image may include other colors, differing patterns, or indicia, such as, for example, circles, squares, triangles, or other shapes, to indicate material to be removed. In one aspect, materials having different sizes and/or densities may be indicated with different colors, patterns, surrounded by different shapes, etc. For instance, the coded image may indicate whether a stone may be removed with a particular retrieval device, or whether the stone is too large and requires lithotripsy. Similarly, the coded image may indicate an area, such as, for example, a kidney calyx, that is very likely to contain a stone, an area that is somewhat likely to contain a stone, an area that is likely free of stones, and an area that is definitely free of stones. The generated coded image may include a key to identify the various details and/or a scale to provide size and distance information to a user.

As a result, the user is able to refer to the heat map or coded image that identifies the material to be removed from the patient's organ. For example, if the organ is the patient's kidney, the user may be able to more easily determine the size, density, shape, and location of the kidney stones. The user may then plan which calyx or calyxes he or she should access with the delivery shaft <NUM> of medical device <NUM> to most effectively and efficiently remove the kidney stones. The user may also determine whether energy must be applied, for example, laser lithotripsy, to break up large kidney stones in order to be removed with a retrieval device. Additionally, the user may determine the parameters of the energy to apply.

Moreover, as shown in <FIG>, the aforementioned image or scan analysis method <NUM> may be repeated during a medical procedure. In particular, the analysis method <NUM> shown in <FIG> may occur in steps <NUM> and <NUM> (as many times as necessary) of <FIG> in order to identify any material to be removed, as well as to ensure that the material to be removed has been fully removed.

<FIG> illustrate exemplary images or scans that may be displayed to a user via display <NUM> at different stages of a material removal procedure to indicate a user's progress in material removal. <FIG> shows a user beginning a material removal procedure, such as, for example, ureteroscopic kidney stone removal from a patient's kidney <NUM>. A first screen <NUM> of display <NUM> may display the coded image generated by the processing unit from images or scans obtained from imaging device <NUM>, with the stone burden <NUM> shown in one pattern, and a stone-free area <NUM> shown in another pattern. It is noted that the stone burden <NUM> may also be shown in a color, such as, for example, red as discussed above, and the stone-free area <NUM> may be shown in green. The stone burden <NUM> or portions thereof may also be shown in different colors and/or patterns to indicate differing densities, sizes, materials, etc. A second screen <NUM> of display <NUM> may display images received by the camera located at the distal end of the delivery shaft <NUM> of medical device <NUM>, which may allow the user to view the interior of kidney <NUM>, including individual kidney stones <NUM>. As discussed, the user may refer to the image displayed on screen <NUM> before and during the procedure to position the distal end of the delivery shaft <NUM> within the kidney <NUM>. The user may apply energy to one or more kidney stones through one of the lumens within the delivery shaft <NUM>, or may use a retrieval device to capture and/or remove the kidney stones.

<FIG> illustrates an intermediate stage of a material removal procedure. For example, the user may have removed several kidney stones from the kidney <NUM>. However, the user may then be unsure whether the entirety of the kidney stone burden <NUM> has been removed. Therefore, the user may perform steps <NUM> and <NUM> of <FIG>, and the processing unit may again perform method <NUM> of <FIG> to generate a new coded image from images or scans obtained from imaging device <NUM>. It is noted that the medical device <NUM> may be positioned within the patient <NUM> during the imaging steps. During the performance of method <NUM>, the processing unit may compare the obtained data to the data obtained before the procedure began, in particular, comparing the location, size, and density of the previously determined stone burden <NUM> to the potential stone burden in the new image or scan. Then, the new coded image may be displayed on the first screen <NUM>. As shown, in this example, there are two areas within the kidney <NUM> where the stone burden <NUM> remains, with a larger stone-free area <NUM> than in <FIG>. As such, the user may then use the new coded image, as well as images of stone <NUM> from the camera at the distal end of the delivery shaft <NUM> on second screen <NUM>, to continue the stone removal procedure.

<FIG> illustrates a final stage of a stone removal procedure where the patient's kidney <NUM> is free of stone burden <NUM>. Again, the user may believe that he or she has removed all of the stone burden <NUM> from kidney <NUM>. The user may perform steps <NUM> and <NUM> of <FIG>, and the processing unit may again perform method <NUM> of <FIG> to generate a new coded image from images or scans obtained from imaging device <NUM>. Then, if the user has indeed removed all of the stone burden <NUM>, the new coded image displayed on first screen <NUM> will indicate the entirety of kidney <NUM> as a stone-free area <NUM>. Additionally, as shown on second screen <NUM>, the images obtained from the camera at the distal end of delivery shaft <NUM> would also be free of any stones <NUM>.

It is noted that the elements and functions of control unit <NUM> may be incorporated into the medical device <NUM>. Medical device <NUM> may be coupled to imaging device <NUM> and to the display <NUM>. Medical device <NUM> may also include the discussed memory and processing units that perform the functions associated with the control unit <NUM>, for example, in the handle <NUM> of medical device <NUM>. Therefore, the medical device <NUM> may also include controls in order to interface with and control the imaging device <NUM> and display <NUM>. Additionally, the medical device <NUM> may include the software or applications to analyze the obtained images or scans and produce the coded images identifying the material to be removed. Medical device <NUM> may be connected to an electronic medical record database to view and/or add to the patient's medical history.

The disclosed medical systems <NUM> and methods <NUM> and <NUM> may help enable efficient and effective procedures to breakup and/or remove material from a patient's organ. In particular, the user may easily view the generated heat map and/or coded image, with the heat map and/or coded image identifying and providing details to the user about the material to be removed, for instance, kidney stones within the patient's kidney. Therefore, in the kidney stone example, the user may more efficiently remove the kidney stones <NUM> from specific locations within the patient's kidney <NUM> without wasting time exploring the kidney <NUM> with the distal end of the delivery shaft <NUM>. Similarly, during the procedure, the user need not guess or conduct further exploration to determine whether the patient's kidney is free of stones. Instead, the user may obtain another heat map or coded image, which identifies the kidney stones <NUM>, if any, that the user still must remove. Additionally, both before and during the procedure, the user need not guess or struggle to read poor resolution, often grayscale or monochrome, images of the patient's organ, which may lead to the user missing a kidney stone. Instead, the disclosed systems and methods help remove the uncertainty and subjectivity, while also providing enhanced images to the user that clearly identify material to be removed from a patient's organ.

Moreover, while much of this disclosure is directed to ureteroscopic kidney stone removal, with or without lithotripsy, it is further contemplated that the systems and procedures discussed herein may be equally applicable to other material removal procedures. For example, the systems and methods discussed above may be used during a percutaneous nephrolithotomy/nephrolithotripsy (PCNL) to plan for a procedure and mid-procedure to locate any missed kidney stones. The systems and methods discussed above may also be used to plan for or conduct procedures to remove ureteral stones, gallstones, bile duct stones, etc. The methods and systems discussed above may further be used to plan for and/or conduct any procedure that relies upon monochrome imaging.

Claim 1:
A system (<NUM>) for identifying material to be removed from a patient comprising:
an imaging device (<NUM>) configured to obtain image data;
a display (<NUM>) configured to display images;
an insertion device; and
a control unit (<NUM>),
wherein the control unit (<NUM>) is configured to receive a first set of image data from the imaging device (<NUM>), analyze the first set of image data based on at least one of a darkness, a contrast, or a saturation, and generate a coded image identifying the material to be removed from the patient to be displayed on the display (<NUM>),
wherein the insertion device includes a deflectable delivery shaft (<NUM>) having at least one lumen extending through the delivery shaft (<NUM>), and wherein the delivery shaft (<NUM>) includes at least a camera and a light source positioned at a distal end of the delivery shaft (<NUM>), wherein the display (<NUM>) includes at least two screens,
wherein a first screen (<NUM>) displays the coded image and a second screen (<NUM>) displays images from the camera, and
wherein the control unit (<NUM>) includes a processing unit and a memory unit, wherein the control unit (<NUM>) is configured to signal the imaging device (<NUM>) to obtain a second set of image data, and wherein the control unit (<NUM>) is further configured to compare the second set of image data with the coded image generated based on the first set of image data.