Medical systems and related methods

Abstract

To provide a system for identifying a material to be removed from a patient.SOLUTION: A system of the present invention includes: an imaging device configured so as to acquire image data; a display configured so as to display an image; an insertion device having a delivery shaft including a lumen; and a control unit. The control unit receives a first image data set from the imaging device, analyzes the first image data set on the basis of at least one of a darkness degree, contrast, and a saturation degree, generates a first coded image for identifying a material to be removed from a patient, and displays the first coded image on the display. The first coded image gives an instruction on whether or not the material to be removed from the patient can be removed from the patient using a recovery device extending so as to penetrate the lumen of the delivery shaft of the insertion device.SELECTED DRAWING: Figure 4A

Description

[Technical field]

[0001] Various aspects of the present disclosure relate generally to systems and methods useful for planning and / or performing medical procedures. [Background technology]

[0002] Substantial advances have been made to increase the effectiveness of medical procedures while reducing trauma and risk to patients. Many procedures that previously required open surgery are now performed with less invasive techniques, thus providing patients with less recovery time and risk of infection. Certain procedures requiring biopsy, electrical stimulation, tissue ablation, or removal of native or foreign objects are performed with minimally invasive surgery.

[0003] For example, in the field of urology, renal or kidney stones can accumulate in the urinary tract and become lodged in the kidney. Kidney stones are deposits of material from the urine, typically minerals and acid salts. Smaller stones may pass naturally from the body, but larger stones may require a surgical procedure for removal. While open surgery was once the standard procedure for stone removal, other minimally invasive techniques, such as ureteroscopy and percutaneous nephrolithotomy / nephrolithotomy (PCNL), have emerged as safer and more effective alternatives. Additionally, advances in imaging technology have improved the ability of medical professionals to identify and determine the location of stones before and during the procedure. Nevertheless, medical professionals must analyze the images to determine the location of the stone and whether any stones are present. Additionally, often the images are grayscale, blurry, and otherwise difficult to evaluate, thereby complicating the medical professional's task of determining the presence of any stones. Summary of the Invention [Problem to be solved by the invention]

[0004] The systems, devices, and methods of the present disclosure remedy some of the deficiencies discussed above and / or address other aspects of the prior art. [Means for solving the problem]

[0005] Examples of the present disclosure relate, inter alia, to medical systems and methods. Each of the examples disclosed herein may include one or more of the features described in connection with any of the other examples of the present disclosure.

[0006] One example of the present disclosure is a system for identifying a material to be removed from a patient, the system including an imaging device configured to obtain image data, a display configured to display the image, an insertion device, and a control unit configured to receive a first image data set from the imaging device, analyze the first image data set based on at least one of darkness, contrast, or saturation, generate a coded image identifying the material to be removed from the patient, and display the coded image on the display.

[0007] The system may further include one or more of the following features: The insertion device includes a deflectable delivery shaft having at least one lumen extending therethrough and including at least a camera and a light source positioned at a distal end of the delivery shaft. The display includes at least two screens, a first screen displaying the coded image and a second screen displaying the image from the camera. The system further includes at least one of a retrieval device or a laser source. The control unit is further configured to control the imaging device or the display. The control unit includes a processing unit and a memory unit. The control unit is configured to send a signal to the imaging device to obtain a second image data set and is further configured to compare the second image data set with the coded image generated based on the first image data set. The control unit is further configured to direct a progress during the material removal procedure based on comparing the second image data set with the coded image generated based on the first image data set. The control unit is further configured to indicate whether the material removal procedure is completed based on comparing the second image data set to the coded image generated based on the first image data set.

[0008] The image data obtained is grayscale or monotone, and the coded image identifies material to be removed from the patient with a different color, pattern, or shape relative to areas without material to be removed. The identifying of material to be removed from the patient in the coded image is further based on at least one of size, density, and location. The coded image indicates the location of the material to be removed from the patient relative to the patient's organs. The coded image indicates the size of the material and indicates whether the material is to be removed from the patient using a retrieval device. The imaging device is an x-ray machine with a rotatable C-arm, the x-ray machine including an x-ray tube and an x-ray detector configured to be positioned on either side of the patient. The control unit is integrally incorporated within a handle of the insertion device.

[0009] Another example is a method of identifying material to be removed from a patient using an imaging device, a display, a control unit, and an insertion device, the method including obtaining a first image data set from the imaging device, transmitting the first image data set from the imaging device to the control unit, analyzing the first image data set based on one of darkness, contrast, or saturation, generating a coded image identifying the material to be removed from the patient and 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.

[0010] The method may further include one or more of the following features: The method further includes removing at least a portion of the material from the patient with an insertion device, the removing at least a portion of the material from the patient includes displacing a delivery shaft of the insertion device, viewing an organ in the patient's body with at least a camera and a light positioned at a distal end of the delivery shaft, and displaying an image obtained from the camera on a second screen of the display. The method further includes obtaining a second image data set from the imaging device and comparing the second image data set with a coded image generated based on the first image data set. The method includes indicating a progress of the material removal procedure based on comparing the second image data set with the generated coded image and the first image data set. The obtained image data is grayscale or monotone, and the method further includes identifying material to be removed from the patient with a different color, pattern, or shape relative to areas without material to be removed.

[0011] The method further includes indicating a location of the material relative to an organ of the patient, identifying the material to be removed from the patient based on density, indicating a size of the material and indicating whether to remove the material from the patient using a retrieval device. Obtaining the first image data set from the imaging device includes using an X-ray machine with a rotatable C-arm, the X-ray machine including an X-ray tube and an X-ray detector configured to be positioned on either side of the patient, and a control unit integrally incorporated within a handle of the insertion device.

[0012] Another example is a system for identifying a material to be removed from a patient, the system including an imaging device configured to obtain image data, a display configured to display the image, an insertion device, and a control unit configured to receive a first image data set from the imaging device, analyze the first image data set based on at least one of intensity, contrast, or saturation, generate a coded image identifying the material to be removed from the patient, and display the coded image on the display.

[0013] The system may further include one or more of the following features: The insertion device includes a deflectable delivery shaft having at least one lumen extending therethrough. The delivery shaft includes at least a camera and a light source positioned at a distal end thereof. The display includes at least two screens, a first screen displaying the coded image and a second screen displaying the image from the camera. The control unit includes a processing unit and a memory unit. The control unit is configured to send a signal to the imaging device to obtain a second image data set and is further configured to compare the second image data set with the coded image generated based on the first image data set. The control unit is further configured to direct a progress during the material removal procedure based on comparing the second image data set with the coded image generated based on the first image data set.

[0014] The resulting image data is grayscale or monotone, and the coded image identifies material to be removed from the patient with a different color, pattern, or shape versus areas where there is no material to be removed. The coded image indicates the location of the material relative to the patient's organs, identifies the material to be removed from the patient based on density, indicates the size of the material, and indicates whether or not to remove the material from the patient using a retrieval device. The imaging device is an x-ray machine with a rotatable C-arm, the x-ray machine including an x-ray tube and an x-ray detector configured to be positioned on either side of the patient, and a control unit is integrally incorporated within a handle of the insertion device.

[0015] Another example is a non-transitory computer readable medium for identifying a substance to be removed from a patient, the non-transitory computer readable medium including instructions stored thereon that, when executed on a processor, perform the following: receive a first image data set; analyze the first image data set based on one of darkness, contrast, or saturation; generate a coded image that identifies the substance to be removed from the patient and that is displayable on a display; and transmit the coded image to the display.

[0016] The non-transitory computer readable medium may further include one or more of the following features: The non-transitory computer readable medium includes further instructions which, when executed on the processor, further perform the following: display an image obtained from the camera on a second display. The non-transitory computer readable medium includes further instructions which, when executed on the processor, further perform the following: compare the second image data set with a coded image generated based on the first image data set. The non-transitory computer readable medium includes further instructions which, when executed on the processor, further perform the following: indicate a progress of a material removal procedure based on comparing the second image data set with the coded image generated and the first image data set. Generating a coded image identifying the material to be removed from the patient includes indicating the location of the material relative to the patient's organs, identifying the material to be removed from the patient with a different color, pattern, or shape relative to areas without material to be removed, and identifying a size and / or density of the material and indicating whether the material is to be removed from the patient with a retrieval device. Receiving the first image data set includes receiving image data from an X-ray machine with a rotatable C-arm including an X-ray tube and an X-ray detector configured to be positioned on either side of the patient, and analyzing the first image data set is performed by a processing unit integrally incorporated into a handle of the insertion device.

[0017] Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not intended to limit the claimed features. The terms "comprise", "comprising", and the like, as used herein, are intended to cover an open-ended inclusion, and a process, method, article, or apparatus that includes a list of components may include not only those components, but other components not expressly included in the list or inherent to such process, method, article, or apparatus. Additionally, the term "exemplary" is used herein in the sense of "example" and not in the sense of "ideal". As used herein, the terms "about", "substantially", and "approximately" indicate a range of values ​​within ±5% of the stated value.

[0018] The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the present disclosure. [Brief description of the drawings]

[0019] [Figure 1] FIG. 1 illustrates a medical system according to an aspect of the present disclosure. [Diagram 2] 1 is a flow diagram of an exemplary method for imaging and removing material from an organ of a patient according to an aspect of the present disclosure. [Diagram 3] 1 is a flow diagram of an exemplary method for receiving, processing, and displaying images of a patient's organs and organ contents according to an aspect of the present disclosure. [Figure 4A] 1A-1D show images of a patient's kidneys at different stages of kidney stone removal according to an aspect of the present disclosure. [Figure 4B] 1A-1D show images of a patient's kidneys at different stages of kidney stone removal according to an aspect of the present disclosure. [Figure 4C] 1A-1D show images of a patient's kidneys at different stages of kidney stone removal according to an aspect of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] Examples of the present disclosure include systems and methods for facilitating and improving the effectiveness and safety of minimally invasive surgery. For example, aspects of the present disclosure provide a user (e.g., a physician, medical technician, or other healthcare provider) with the ability to more easily identify and remove kidney stones or other material from a patient's kidney or other organ. For example, in some embodiments, the present disclosure is used to plan and / or perform flexible ureteroscopic procedures, with or without laser lithotripsy.

[0021] Reference will now be made in detail to the examples of the present disclosure described above and illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

[0022] The terms "proximal" and "distal" are used herein to refer to the relative positions of components of an exemplary medical device or insertion device. As used herein, "proximal" refers to a position that is relatively closer to the exterior of the body or to an operator using the medical device or insertion device. In contrast, "distal" refers to a position that is relatively farther from an operator using the medical device or insertion device or to a position that is relatively closer to the interior of the body.

[0023] 1 illustrates a medical system 10 including a medical device 12, an imaging device 14, a display 16, and a patient support 18 for a patient 20. The medical device 14 may be wired (as shown), wirelessly, or otherwise coupled to a control unit 22. The imaging device 14 and / or the display 16 may also be wired, wirelessly, or otherwise coupled to the control unit 22. Images and other patient information may be displayed on the display 16 and / or on a monitor 24 coupled to the control unit 22.

[0024] As shown in FIG. 1, the medical device 12 may be an insertion device, such as a ureteroscope (e.g., Boston Scientific Corporation's Lithovue® Single Use Digital Flexible Ureteroscope). The medical device 12 includes a handle 26 having at least one port 28 and a deflection lever 30. The port 28 may be threaded and may include a T-connector, a Y-connector, or another suitable connector as shown in FIG. 1. The medical device 12 also includes a delivery shaft 32, the distal side of which terminates in a distal opening 34. The delivery shaft 32 may include multiple lumens, and the at least one port 28 may be connected to a proximal end of the delivery shaft 32 via a lumen (not shown) in the handle 26.

[0025] Various instruments or devices may be inserted through the port 28 and delivered to and / or out of the distal opening 34 of the delivery shaft 32, such as an energy device, such as a laser device for nephrolithotomy, and / or a retrieval basket. The distal end of the delivery shaft 32 may be operated by action on a biasing lever 30. The handle 26 may also be connected to the display 16 and / or control unit 22 via a communication and / or power conduit 36. For example, although not shown, the medical device 12 includes an integrated camera and / or light at the distal end of the delivery shaft 32, connected to the display 16 and / or monitor 24 of the control unit 22 through the communication and power conduit 36. The user positions the medical device 12 within the patient 20, for example, through the patient's urethra to the patient's kidney, inserts a retrieval device (not shown) through the port 28 and into the delivery shaft 32, and then uses the built-in camera and / or light and bias lever 30 to manipulate the distal end of the delivery shaft 32 to extend the retrieval device to retrieve and remove material, such as a kidney stone, with or without laser nephrolithotripsy.

[0026] The imaging device 14 is any medical imaging device used to collect patient data. For example, the imaging device 14 includes an x-ray, magnetic resonance imaging, computed tomography scan, rotational angiography, ultrasound, or another suitable internal body imaging device. For some imaging procedures, a contrast agent is used to help identify anatomical features in the image. For example, to aid in visualization of the kidneys and urinary system, a contrast agent is introduced into the patient prior to imaging (e.g., iodine, barium, or another suitable contrast agent is introduced through the patient's urinary tract through the ureters).

[0027] In one example, the imaging device 14 is a device with a movable C-arm that is useful for collecting X-ray images of the patient 20 in preparation for and / or during a ureteroscopic procedure in accordance with some aspects of the present disclosure. As shown, the C-arm 38 of the imaging device 14 includes an X-ray tube 40 and a detector 42 aligned therewith and positioned on the opposite side of the patient 20. The C-arm 38 is rotatable relative to the patient 20 (e.g., about an axis parallel to the patient 20 and / or about an axis perpendicular to the patient 20) in one or more planes without moving the patient 20 to allow collection of images in different orientations. Images are displayed and analyzed in real time on a monitor or display, e.g., the monitor 24 and / or the display 16. Images are also stored locally or remotely for later viewing and analysis. For example, as described in more detail below, the C-arm device 38 is used to collect patient images prior to a ureteroscopic procedure to locate and identify any stones or material to be removed. A user consults the images for guidance in the proper insertion and positioning of the ureteroscope and other instruments during the procedure. The C-arm device 38 is used during a ureteroscopic procedure to collect images of stones or material within, for example, the patient's kidney relative to the inserted ureteroscope. Similarly, the C-arm device 38 is used after a ureteroscopic procedure to determine whether all stones or material have been removed.

[0028] The movable C-arm device 38 may include a light source to identify a particular target or area on the patient, such as an intended incision or insertion site. For example, the C-arm 38 may include a light source coupled to or integrated with an X-ray tube 40, which is used to direct light to a predetermined imaging location. FIG. 1 shows light 44 focused on the central portion of the patient 20 in the form of an "X" or crosshairs indicating the intended imaging location. The direction, orientation, intensity, and / or shape of the light generated by the light source may be controlled at the control unit 22 via user input and / or by commands received via a wireless connection from any suitable user interface device.

[0029] The display 16 may be at least a two-screen display. In one example, one of the screens may display one or more images currently or previously acquired by the imaging device 14. The other screen may display an image or video acquired by a camera at the distal end of the delivery shaft 32. Alternatively, one screen of the display 16 may display an image previously acquired from the imaging device 14, and the other screen of the display 16 may display an image more recently acquired from the imaging device 14. Additionally, one screen of the display 16 may display one or more images acquired by an additional imaging device or may display other electronic medical record information, and the other screen of the display 16 may display one or more images acquired by the imaging device 14 and / or one or more images acquired by the camera at the distal end of the delivery shaft 32.

[0030] The patient support 18 may be a surgical stretcher, a hospital bed, or a surgical table. The patient support 18 may be a urological surgical table. The patient support 18 allows the imaging device 14 to take internal images of the patient 20 and does not interfere with the ability of the imaging device 14 to take images. The patient support 18 may also be adjustable and movable to better position the patient 20 while obtaining images and / or performing a procedure.

[0031] The control unit 22 may be wired or wirelessly connected to the medical device 12, the imaging device 14, and / or the display 16. A user uses the control unit 22 and the monitor 24 to initiate imaging and / or analysis and to otherwise control the imaging device 14 and the display 16. The control unit 22 includes one or more memory and / or processing units. The memory and / or processing units include installed software or applications that may be pre-programmed or downloaded for storage in the control unit 22 and / or the medical device 12. Additionally or alternatively, the medical device 12 includes a memory and / or processing unit, and the medical device 12 and the control unit 22 may communicate wired or wirelessly with respect to storing, processing patient data, and the resulting image data. As will be described in more detail below, the software or applications may manipulate, process, and interpret images received from the imaging device 14 to identify the presence, location, and characteristics of kidney stones or other substances. Additionally, the control unit 22 or medical device 12 may compare the received images with previously received and analyzed images. For example, a user may employ the control unit 22 or medical device 12 to process images from the imaging device 14 to identify the presence of a stone and determine the size, density, composition, location, orientation, and / or position of the stone relative to the kidney and surrounding anatomical structures.

[0032] 2 illustrates an exemplary method 200 for imaging and removing material from a patient's kidney in accordance with an aspect of the present disclosure. In particular, the method 200 illustrated in FIG. 2 can assist a user in ensuring that all kidney stones or other material is removed from the patient 20.

[0033] As shown, in step 202, the user first takes an image or scan of the patient's organ, such as a kidney, using the imaging device 14 to determine the size, location, and / or burden of the stone or material to be removed. Step 202 may include introducing a contrast agent into the patient to improve and / or enhance the clarity of the image or scan. In step 204, based on the image or scan, the user uses the control unit 22, monitor 24, and display 16 to determine the size, location, and / or burden of the stone or material to be removed. For example, the control unit 22 combines the sizes of multiple stones or materials to determine the area or volume of the stone or material occupying space in the patient's kidney. Then, in step 206, the user performs the material removal procedure. As described above, step 206 includes inserting the medical device 12 into the kidney in the patient 20, for example through the patient's urethra, and using an energy source and / or a retrieval device to break up and / or remove the kidney stone or other material.

[0034] Step 208 then includes taking another image or scan of the patient's organ. Based on such another image or scan, in step 210, the user again uses the control unit 22, monitor 24, and display 16 to determine whether any kidney stones or other material remain to be removed. If kidney stones or other material remain in the patient's organ to be removed, in step 212, the user again performs the material removal procedure. The user then repeats steps 208 and 210 as many times as necessary to take images or scans of the organ and determine whether material has been removed. However, if no kidney stones or other material remain in the patient's organ to be removed, in step 214, the user terminates the material removal procedure. Terminating the material removal procedure may include removing the medical device 12 from the patient 20.

[0035] 3 illustrates an exemplary method 300 for receiving, processing, and displaying images of a patient's organs and their contents, such as kidneys and kidney stones, in accordance with aspects of the present disclosure. In particular, the method 300 illustrated in FIG. 3 helps a user ensure that all of the stone burden or other material is properly identified and removed.

[0036] In step 302, a processing unit, for example a processing unit in the control unit 22, receives image or scan data of the patient's organ obtained by the imaging device 14. Then, in step 304, the processing unit analyzes the image or scan data based on the darkness, contrast, and / or saturation of the image or scan. The processing unit analyzes each pixel of the received image or scan data and compares each pixel to a scale (e.g., gray scale). A portion of the values ​​on the scale correspond to stone intensity, tissue intensity, and / or other known intensities, and shifts or modifies the scale depending on whether a contrast agent was used in step 202 described above. The processing unit may also incorporate the intensity of the energy from the imaging device 14 when the pixel matches a particular scale. Then, the processing unit determines the density, and therefore the size, location, and / or load, of the various detected elements based on the brightness of the pixel and the match of the pixel to the particular scale. If the processing unit or memory unit contains any previously acquired or stored image data or scan data of the patient's organ or a similar and / or ideal organ, then in step 306 the processing unit compares the acquired image data or scan data with the previously acquired or stored image data or scan data, which may have previously been analyzed by the processing unit as described above.

[0037] Based on the above analysis, in step 308, the processing unit generates or generates a heat map and / or coded image of the organ that is displayed on the display 16. The heat map and / or coded image may be color coded, for example, indicating material to be removed in red and areas without material in green. In addition, the heat map and / or coded image may include outlined regions that contain material to be removed, which may also be color coded. For example, the outlined regions are based on changes in pixel lightness or darkness and / or on changes in determined density or tissue composition. In one aspect, once the patient's kidneys have been scanned and analyzed, any stone burden is indicated in red and areas without stones are indicated in green. Alternatively, the coded image may include other colors, different patterns, or indicia to indicate material to be removed, such as circles, squares, triangles, or other shapes. In one aspect, for example, materials having different sizes and / or densities may be indicated with different colors, patterns, or may be surrounded by different shapes. For example, the coded image may indicate whether a particular retrieval device should be used to remove the stone, or whether the stone is too large and requires nephrolithotomy. Similarly, the coded image may indicate areas that are very likely to contain stones, such as the renal calyx, areas that are somewhat likely to contain stones, areas that may be free of stones, and areas that are definitely free of stones. The generated coded image may include a key (color tone or legend) to identify various details and / or a scale (gradations) to provide size and distance information to the user.

[0038] As a result, the user can see a 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 can relatively easily determine the size, density, shape, and location of the kidney stone. The user then plans which calyx or calyxes to access with the delivery shaft 32 of the medical device 12 to most effectively and efficiently remove the kidney stone. The user may also determine whether energy must be applied to break up large kidney stones, for example, whether laser nephrolithotripsy should be applied, in order to remove the kidney stone with the retrieval device. In addition, the user may determine the parameters of the energy to be applied.

[0039] Additionally, the method 300 of analyzing an image or scan described above may be repeated during a medical procedure, as shown in Figure 2. In particular, the method 300 of analysis shown in Figure 3 may be performed (as many times as necessary) at steps 204, 210 of Figure 2 to identify any material to be removed and to ensure that the material to be removed has been completely removed.

[0040] 4A-4C show exemplary images or scans displayed to a user via the display 16 at different stages of a material removal procedure to indicate the user's progress in removing material. FIG. 4A shows a user commencing a material removal procedure, e.g., ureteroscopic kidney stone removal from a patient's kidney 50. A first screen 52 of the display 16 may display a coded image generated by a processing unit from images or scans obtained from the imaging device 14, the coded image showing stone burden 54 in one pattern and stone-free areas 56 in another pattern. It should be noted that the stone burden 54 is shown in color, e.g., red as described above, and the stone-free areas 56 are shown in green. The stone burden 54, or portions thereof, may be shown in different colors and / or patterns to indicate different densities, sizes, materials, etc. The second screen 58 of the display 16 may display an image received by a camera disposed at the distal end of the delivery shaft 32 of the medical device 12, thereby allowing a user to view the interior of the kidney 50, including individual kidney stones 60. As described above, the user may refer to the image displayed on the first screen 52 to position the distal end of the delivery shaft 32 within the kidney 50 before and during the procedure. The user may apply energy to the kidney stone or stones via one of the lumens of the delivery shaft 32 and may capture and / or remove the kidney stones using a retrieval device.

[0041] FIG. 4B shows an intermediate stage of the material removal procedure. For example, the user has just removed some kidney stones from the kidney 50. However, at this point, the user is uncertain as to whether all of the kidney stone burden 54 has been removed. Thus, the user may perform steps 208 and 210 of FIG. 2, and the processing unit performs the method 300 of FIG. 3 again to generate a new coded image from the images or scans obtained from the imaging device 14. It should be noted that during the imaging step, the medical device 12 is positioned within the patient 20. During the method 300, the processing unit compares the obtained data with the data obtained before the procedure began, and in particular compares the previously determined location, size, and density of the stone burden 54 with the potential stone burden in the new image or scan. The new coded image is then displayed on the first screen 52. As shown, in this example, there are two areas in the kidney 50 where stone burden 54 remains, and the stone-free area 56 is larger than in FIG. 4A. In this case, the user then continues the stone removal procedure with the new coded image, as well as an image of the stone 60 from the camera at the distal end of the delivery shaft 32 displayed on the second screen 58.

[0042] 4C shows the final stage of the stone removal procedure, with the patient's kidney 50 free of stone burden 54. Again, the user may think that all stone burden 54 has been removed from the kidney 50. The user may then perform steps 208 and 210 of FIG. 2, and the processing unit may again perform the method 300 of FIG. 3 to generate a new coded image from the images or scans obtained from the imaging device 14. In this case, if the user has indeed removed all stone burden 54, the new coded image displayed on the first screen 52 will indicate the entire kidney 50 as a stone-free area 56. Additionally, as shown on the second screen 58, the image obtained from the camera at the distal end of the delivery shaft 32 also does not contain any stones 60.

[0043] It should be noted that the elements and functions of the control unit 22 may be incorporated within the medical device 12. The medical device 12 may be coupled to the imaging device 14 and the display 16. The medical device 12 may include a memory and a processing unit for performing the functions associated with the control unit 22, for example, within the handle 26 of the medical device 12. Thus, the medical device 12 may include a controller that interconnects with and controls the imaging device 14 and the display 16. Additionally, the medical device 12 may include software or applications that analyze the acquired images or scans and generate a coded image that identifies the material to be removed. The medical device 12 may be connected to an electronic medical record database to view and / or add to the patient's medical history.

[0044] The disclosed medical system 10 and method 200, 300 assist in enabling efficient and effective procedures to destroy and / or remove material from the patient's organs. In particular, the user can easily view the generated heat map and / or coded image, which identifies and provides the user with details of the material to be removed, e.g., a kidney stone in the patient's kidney. Thus, in the kidney stone example, the user can relatively efficiently remove the kidney stone 60 from a specific location in the patient's kidney 50 without wasting time examining the kidney 50 with the distal end of the delivery shaft 32. Similarly, during the procedure, the user does not need to guess or perform further examinations to determine whether the patient's kidney is stone-free. Instead, the user can obtain another heat map or coded image, which identifies any kidney stones 60 that the user still needs to remove. Additionally, both before and during the procedure, the user does not have to struggle to guess or interpret poor resolution images, often grayscale or monotone images, of the patient's organ that can result in overlooking kidney stones. Instead, the systems and methods of the present disclosure help to eliminate uncertainty and subjectivity, while still providing the user with high quality images that clearly identify the material to be removed from the patient's organ.

[0045] Moreover, while most of the disclosure of the present invention is directed to ureteroscopic kidney stone removal with or without nephrolithotomy, it is further believed that the systems and procedures described herein are applicable to other material removal procedures as well. For example, the systems and methods described above can be used to plan procedures during percutaneous nephrolithotomy / nephrolithotomy (PCNL) and to determine the location of any missed kidney stones during the procedure. The systems and methods described above may be used to plan or perform procedures for removing ureteral stones, gallstones, bile duct stones, etc. The methods and systems described above may also be used to plan and / or perform any procedures that rely on monotone imaging.

[0046] Although the principles of the present disclosure have been described herein with reference to embodiments for particular applications, it should be understood that the present disclosure is not limited to these examples. Those skilled in the art having access to the teachings provided herein will recognize additional modifications, applications, embodiments, and equivalent substitutions that are within the scope of the features described herein. Accordingly, the claimed features are not considered to be limited by the foregoing description.

Claims

1. 1. A system for identifying a substance to be removed from a patient, comprising: an imaging device configured to obtain image data; a display configured to display an image; an insertion device having a delivery shaft including an internal lumen; a control unit; the control unit is configured to receive a first image data set from the imaging device, analyze the first image data set based on at least one of intensity, contrast, or saturation to generate a first coded image identifying material to be removed from the patient, and display the first coded image on the display; the first coded image generated by the control unit indicates whether (1) the material to be removed from the patient can be removed from the patient using a retrieval device extending through a lumen of a delivery shaft of the insertion device, or (2) the material cannot be removed from the patient using a retrieval device extending through a lumen of a delivery shaft of the insertion device without reducing a size of the material.

2. The system of claim 1 , further comprising a retrieval device configured to be delivered through the lumen of the delivery shaft to remove at least a portion of the material to be removed from the patient.

3. The system of claim 1 or 2, wherein the delivery shaft of the insertion device is deflectable and a distal end of the delivery shaft includes a light source.

4. the insertion device includes at least one camera positioned at a distal end of the delivery shaft; the display includes a first screen and a second screen; 4. The system of claim 3, wherein the at least one camera is connected to the display to display an image from the camera on a second screen of the display, the second screen being adjacent to the first screen.

5. the control unit is configured to receive a second image data set from the imaging device, analyze the second image data set based on at least one of intensity, contrast, or saturation to generate a second coded image identifying material to be removed from the patient, and display the second coded image on the display; 5. The system of claim 1, wherein the second coded image indicates whether the material to be removed from the patient can be removed from the patient using a retrieval device extending through a lumen of a delivery shaft of the insertion device.

6. the imaging device is an X-ray machine with a rotatable C-arm, the X-ray machine including an X-ray tube and an X-ray detector configured to be positioned on either side of a patient; The system of any one of claims 1 to 5, wherein the control unit is integrally integrated into a handle of the insertion device.

7. the display includes at least two screens; 5. The system of claim 4, wherein a first screen displays a first coded image and a second screen displays an image from the camera.

8. the image data obtained is grayscale or monotone; The system of any one of claims 1 to 7, wherein the first coded image identifies material to be removed from the patient with a different color, pattern, or shape relative to areas that do not have the material to be removed.

9. The system of claim 8 , wherein identifying material to be removed from the patient in the first coded image is further based on at least one of size, density, and location.

10. 10. The system of claim 9, wherein the first coded image indicates a location of the material to be removed from the patient relative to an organ of the patient.

Images