Measurement markings within the imaging field of the distal tip

Abstract

A method and device are provided for determining anatomical distance and / or position measurements during an endoscopic procedure. The markings are physically placed or superimposed on the distal end of the elongated tool such that the markings are visible within the imaging field of the endoscope. Anatomical distances may be determined by measurements performed with the tool. Sizes and / or locations of anatomical structures or unknown objects may also be determined using the marked tool.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 155,939, filed Mar. 3, 2021, the disclosure of which is incorporated herein by reference.

[0002] The disclosure of the present invention relates to medical devices, and more particularly, to measurement devices for endoscopic procedures and methods of using such medical devices.

Background Art

[0003] Benign prostatic hyperplasia (BPH) is a common disorder in middle - aged and older men with an enlarged prostate that causes stenosis of the prostatic urethra and resistance to urine flow. Treatment may include injection of steam into the prostate. An exemplary procedure is the Rezum® steam procedure, in which sterile steam is injected into the enlarged portion of the prostate. The steam kills the prostate cells that are the cause of the enlargement, thereby causing the prostate to shrink, and thereby resulting in a more open urinary tract. This procedure may involve devices as described in U.S. Patent Nos. 8,273,079, 10,194,970, and 10,342,593, the entire disclosures of which are incorporated herein by reference.

[0004] In the Rezum® procedure, the physician moves the device distally to find the bladder neck opening and then proximally to find the seminal colliculus. The prostate tissue is treated between these two landmarks. In the current Rezum® system, one visual frame is approximately 5 mm, and thus the physician can estimate the length of the prostate by counting the number of frames. Additionally, a similar estimate is made to determine the height of the prostate. This gives a rough estimate of how many injection points are needed and what type of injection point pattern (such as a straight line, double line, or zigzag pattern) is needed. The current recommendation is to have injection points every 1 cm. It is speculated that if the treatment points are too close together, it creates a risk of unnecessary tissue inflammation, or if the treatment points are too far apart, it creates a risk of ineffective treatment. The visual measurement methods used today are very susceptible to the effects of this variation. There remains a continuing need to provide clear measurement marking devices and methods.

[0005] Regardless of the imaging system used, the user must know the actual physical size of the object being viewed in order to accurately interpret the image. In an optical imaging system that images a 2D scene at a fixed point in space, generally this physical size is obtained by calibrating the optical parameters of the system, such as the focal length and distortion, and using information (often presented using a scale bar) to calculate the pixel size. In a single-lens optical imaging system that images a 3D scene with significant depth, this acquisition is not possible. In these systems, the pixel size of the image sensor is fixed, but the physical size of the object being viewed depends on the distance of that object from the light-gathering optics. Two objects of equal size may appear different in the image, with the object farther from the optics appearing smaller.

[0006] This is a problem common to all endoscopic systems. In ureteroscopy procedures, it is particularly important to solve this problem. Knowing the physical size of kidney stones (and / or remaining stone fragments) can directly affect the decision-making of the procedure and the overall procedure efficiency. Optical calibration between anatomical features alone is insufficient for ureteroscopy applications, and / or the stone fragments will have a significant distance range from the main objective lens.

Prior Art Documents

Patent Documents

[0007]

Patent Document 1

Patent Document 2

Patent Document 3

Summary of the Invention

Problems to be Solved by the Invention

[0008] In today's practice, the size of the field of view is estimated using an intuitive comparison with an object of a known diameter (e.g., comparing the size of a stone via with an adjacent laser fiber). Generally, this intuition is built through repeated sizing errors during the procedure, which is an inherently imperfect approach. This also requires the surgeon to spend a significant amount of time developing this intuition. Providing guidance during this critical sizing stage will increase procedure effectiveness, facilitate standardization of care, and improve patient safety.

Means for Solving the Problems

[0009] The disclosure of the present invention provides alternatives for the design, materials, manufacturing methods, and use of medical devices. An exemplary system for providing anatomical distance measurements during an endoscopic procedure includes an elongate tool having a first marking on a distal end of the elongate tool, the first marking being configured to extend longitudinally along the tool and be visible within an imaging field of view of the endoscope, and a video processor configured to display the first marking extending longitudinally along the tool including a reference line spaced equidistantly apart, preferably 1 mm apart, as a virtual marking in a field of view image.

[0010] As an alternative to or in addition to the above-described embodiments, the video processor is further configured to display a second virtual marking representing an anatomical structure visible within the field of view.

[0011] As an alternative to or in addition to any of the above-described embodiments, the video processor is further configured to overlay the virtual marking on the distal end of the tool and maintain the virtual marking in a fixed position relative to the tool as the tool is rotated and axially moved.

[0012] As an alternative to or in addition to any of the above-described embodiments, the system further includes an inclination and / or rotation sensor configured to sense the inclination and / or rotation of the tool such that the virtual marking remains in a fixed position relative to the tool.

[0013] As an alternative to or in addition to any of the above-described embodiments, the virtual marking is sized to scale to depict depth.

[0014] As an alternative to or in addition to any of the above-described embodiments, a portion of the marking is a physical marking on the tool, and a portion of the marking is virtual and visible within the field of view.

[0015] An exemplary device for providing an anatomical distance measurement during an endoscopic procedure comprises an elongate tool having a first marking at a distal end on the elongate tool, the first marking being configured to extend longitudinally along the elongate tool and to be visible within an imaging field of view of the endoscope.

[0016] As an alternative to or in addition to the above-described embodiment, the first marking is a physical line on the tool that is transverse to the longitudinal axis of the tool, the line being placed longitudinally 1 mm apart along both sides of the tool.

[0017] As an alternative to or in addition to any of the above-described embodiments, the device further includes a second physical marking including lines that are longitudinally 5 mm apart along at least one side of the tool.

[0018] As an alternative to or in addition to any of the above-described embodiments, the tool has a width, the second physical marking extends across the width in 1 mm increments, and the first and second physical markings are visually different.

[0019] As an alternative to or in addition to any of the above-described embodiments, the first marking includes a geometric pattern applied on the tool, the area of the geometric pattern having a known dimension.

[0020] As an alternative to or in addition to any of the above-described embodiments, the first marking is a groove in the tool or a raised marking on the tool.

[0021] An exemplary method for providing an anatomical distance measurement during an endoscopic procedure includes placing a first marking on a distal end of an elongate tool, the placing step being configured such that the first marking extends longitudinally along the elongate tool and is visible within an imaging field of view of the endoscope, extending the elongate tool through the endoscope until the first marking is visible within the imaging field of view, and measuring an anatomical distance based on the first marking.

[0022] As an alternative to or in addition to the above-described embodiments, the first marking is a physical line on the tool that is transverse to the longitudinal axis of the tool, and the lines are placed longitudinally 1 mm apart along both sides of the tool.

[0023] As an alternative to or in addition to any of the above-described embodiments, the method further includes a second physical marking that includes lines longitudinally spaced 5 mm apart along at least one side of the tool.

[0024] As an alternative to or in addition to any of the above-described embodiments, the tool has a width, the second physical marking extends across the width in 1 mm increments, and the first and second physical markings are visually different.

[0025] As an alternative to or in addition to any of the above-described embodiments, the first marking includes a geometric pattern applied on the tool, the area of the geometric pattern has known dimensions, and the method further includes determining the size and / or position of an unknown object within the field of view by comparing the observed dimensions of the unknown object to the known dimensions of the geometric pattern on the tool.

[0026] As an alternative to or in addition to any of the above-described embodiments, the first marking is a groove within the tool or a raised marking on the tool.

[0027] As an alternative to or in addition to any of the above-described embodiments, the first marking is a virtual marking displayed in the field of view image by a processor, and the first marking includes a reference line extending longitudinally along the tool 1 mm apart.

[0028] As an alternative to or in addition to any of the above-described embodiments, the method further includes a second virtual marking representing an anatomical structure visible within the field of view.

[0029] As an alternative to or in addition to any of the above embodiments, the virtual marking is superimposed on the distal end of the tool and remains in a fixed position relative to the tool as the tool is rotated and axially moved.

[0030] As an alternative to or in addition to any of the above embodiments, the method further comprises an inclination and / or rotation sensor configured to sense the inclination and / or rotation of the tool such that the virtual marking remains in a fixed position relative to the tool.

[0031] As an alternative to or in addition to any of the above embodiments, the virtual marking is sized to scale to draw depth.

[0032] As an alternative to or in addition to any of the above embodiments, a portion of the marking is a physical marking on the tool, a portion of the marking is virtual, and is visible within the field of view.

[0033] An exemplary method of identifying a tool within an endoscopic field of view comprises adding different geometric patterns on portions of each of a plurality of tools, inserting at least one of the plurality of tools through an endoscope, and identifying when one of the plurality of tools enters the field of view based on the geometric pattern seen within the field of view.

[0034] As an alternative to or in addition to the above embodiments, the method further includes determining the rotational position and axial position of the tool based on the geometric pattern.

[0035] As an alternative to or in addition to any of the above embodiments, the geometric pattern is applied on the tool using at least two high-contrast colors.

[0036] As an alternative to or in addition to any of the above embodiments, the geometric pattern includes alternating black and white regions.

[0037] As an alternative to or in addition to any of the above embodiments, the geometric pattern includes lines of varying thickness positioned at progressive intervals.

[0038] As an alternative to or in addition to any of the above embodiments, each tool has a distal tip and a shaft, the distal tip having a first pattern and the shaft having a second pattern different from the first pattern.

[0039] As an alternative to or in addition to any of the above embodiments, the method further comprises determining the size and / or position of an anatomical structure or unknown object visible within the field of view by placing a tool adjacent to the structure or object and comparing the outline of the structure or object to a geometric pattern on the tool.

[0040] An exemplary method for determining position information and / or size information regarding an unknown object or anatomical structure within a patient's body comprises inserting an endoscope having a camera and a light source into the patient's body, transmitting an image of the unknown object or anatomical structure using the endoscope, displaying the transmitted image, inserting through the endoscope a tool having a geometric pattern of known dimensions, positioning the tool adjacent to the unknown object or anatomical structure, and determining the position information and / or size information regarding the unknown object or anatomical structure by comparing the unknown object or anatomical structure to the geometric pattern.

[0041] The above summary of some embodiments, aspects, and / or examples is not intended to describe each embodiment or every implementation of the present disclosure. The following drawings and detailed description illustrate these embodiments more specifically.

[0042] The disclosure of the present invention can be more fully understood by considering the following detailed description of various embodiments in connection with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0043]

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Figures 8A - 8B

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Figure 15B

[0044] Aspects of the disclosure of the present invention have room for various modifications and alternative forms. Some of the details are illustratively shown in the drawings and will be described in detail below. However, it must be understood that the intention is not to limit the aspects of the disclosure of the present invention to the specific embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of the disclosure of the present invention.

Modes for Carrying Out the Invention

[0045] Regarding the terms defined below, the following definitions shall apply unless different definitions are presented in the claims or elsewhere in this specification.

[0046] In this specification, all numerical values are assumed to be modified by the term "about," whether explicitly indicated or not. The term "about" in the context of numerical values generally means a range of numbers that would commonly be considered the same (e.g., having the same function or result) by those skilled in the art. In many instances, the term "about" can include numbers rounded to the nearest significant digit. Other uses of the term "about" (e.g., in situations other than numerical values) can be assumed to have the normal and customary definition of this term as understood from the context of this specification and not in conflict therewith, unless otherwise specified.

[0047] The enumeration of a numerical range by endpoints includes all the numbers within that range including the endpoints (e.g., from 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some appropriate dimensions, ranges, and / or values regarding various components, features, and / or specifications are disclosed, those skilled in the art, upon being evoked by the disclosure of the present invention, will understand that the desired dimensions, ranges, and / or values may deviate from those explicitly disclosed.

[0048] As used in this specification and the claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the claims, the term "or" is generally used in the sense that includes "and / or" unless the context clearly dictates otherwise. It should be noted that, for ease of understanding, even if certain features of the disclosure of the present invention are plural or repeated within an embodiment of the disclosure of the present invention, these features can be described in the singular. Each instance of these features can include and / or be encompassed by the singular disclosure unless the contrary is explicitly stated. For purposes of simplification and clarity, not all elements of the disclosure of the present invention are necessarily shown in each figure and discussed in detail below. However, it will be understood that, for cases where there are more than one component, the following discussion may equally apply to any and / or all of these components unless the contrary is explicitly stated. In addition, for purposes of clarity, all instances of some elements or features may not be shown in each figure.

[0049] Relative terms such as "proximal", "distal", "advancing", "retracting", and variations thereof can generally be determined with respect to the positioning, orientation, and / or actuation of various elements relative to the user / operator / operator of the device. "Proximal" and "withdrawal" indicate or mean close to or towards the user, and "distal" and "advancing" indicate or mean away from or away from the user. In some cases, the terms "proximal" and "distal" may be arbitrarily assigned in an attempt to facilitate understanding of the disclosure of the present invention, but such cases will be readily apparent to those skilled in the art. Other relative terms such as "upstream", "downstream", "inflow", and "outflow" mean the direction of fluid flow within a body lumen, such as a blood vessel, or within a device.

[0050] The term "extent" can be understood to mean the maximum measured value of the dimension being described or identified, unless the term "minimum" is prefixed to such an extent or dimension and these extents or dimensions are identified as "minimum". For example, "outer extent" can be understood to mean the maximum outer dimension, "radial extent" can be understood to mean the maximum radial dimension, "longitudinal extent" can be understood to mean the longitudinal dimension, and so on. Each example of "extent" may vary (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and will be apparent to those skilled in the art from the individual usage context. Generally, "extent" can be considered the largest possible dimension measured according to the intended use, while "minimum extent" can be considered the smallest possible dimension measured according to the intended use. In some cases, "extent" can generally be measured in orthogonal directions within a plane and / or cross-section, but as will be apparent from the particular situation, for example, angular, radial, circumferential (e.g., along an arc), etc., but not limited thereto and can be measured otherwise.

[0051] The terms "monolithic" and "unitary" shall generally mean one or more elements manufactured or composed from a single structure or base unit / element. Monolithic elements and / or unitary elements shall exclude structures and / or features manufactured by assembling or otherwise joining a plurality of individual elements to each other.

[0052] Note that references in this specification to "embodiments", "some embodiments", "other embodiments", etc., indicate that the embodiments being described may include certain features, structures, or characteristics, but not all embodiments necessarily include these specific features, structures, or characteristics. Further, such phrases do not necessarily refer to the same embodiment. Moreover, when a particular feature, structure, or characteristic is described with respect to an embodiment, whether explicitly described or not, it is considered within the knowledge of those skilled in the art to achieve these particular features, structures, or characteristics with respect to other embodiments, unless the contrary is explicitly stated. That is, as will be understood by those skilled in the art, the various individual elements described below are still considered combinable or arrangeable with each other to form other additional embodiments or to complement and / or extend the described embodiments, even if not specified in a particular combination.

[0053] For purposes of clarity, a certain identification number nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout this specification and / or the claims to name and / or distinguish between various features being described and / or claimed. It is understood that this number nomenclature is not intended to be limiting, but is merely illustrative. In some embodiments, there may be changes and departures from the previously used number nomenclature for purposes of brevity and clarity. That is, a feature identified as a "first" element may later be referred to as a "second" element, a "third" element, etc., or may be completely excluded, and / or a different feature may be referred to as the "first" element. The meaning and / or indication in each case will be apparent to those skilled in the art.

[0054] The following description must be read with reference to drawings which are not necessarily to scale and in which like elements in the various drawings are numbered the same. The detailed description and the drawings illustrate the disclosure of the invention and are not intended to be limiting. One of ordinary skill in the art will recognize that the various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of the disclosure of the invention. The detailed description and the drawings illustrate exemplary embodiments of the disclosure of the invention. However, for purposes of clarity and ease of understanding, not all features and / or elements may be shown in each drawing, but nevertheless, unless otherwise specified, it can be understood that features and / or elements are present.

[0055] Many endoscopic medical procedures benefit from measurement markings that appear within the field of view of an imaging catheter and enable a physician to more reliably estimate physical dimensions when diagnosing a disease or delivering a treatment. By utilizing the field of view of an imager system, the distal portion of the device can be marked to provide reference measurements in both the axial and perpendicular directions. Additionally, markings can be used to determine the size and orientation of the channels of the device. For example, the depth of focus or depth of field of an exemplary imager system can be from about 5 mm to about 50 mm. The overall length of the distal tip of a treatment device can be about 15 mm long and about 5 mm high. The entire distal tip may be visible by the imager lens. FIG. 1 illustrates the distal tip of a BPH treatment device 10 extending into the imaging field of view 5. The treatment device 10 can be an elongate tool. The treatment may involve the step of injecting vapor into various locations within the prostate.

[0056] In some examples, a physician may wish to measure approximately 1 cm from the bladder opening to a first needle injection site. FIG. 2 illustrates black marking lines 12 drawn 1 mm apart on the distal tip surface of the treatment device 10 of FIG. 1. In combination with common anatomical features visible within the prostate, the markings 12 can enable a physician to more accurately place the injection site when moving the device 10 downward from the bladder into the prostate. The lines or markings 12 can be drawn on the surface of the device 10 as shown in FIG. 2. In other examples, the markings can be molded, etched, or cut into the surface of the device. The measurement unit, e.g., "mm" to indicate millimeters, can be placed adjacent to the markings or on another region of the tip. Any color of marking that depends on the color of the device and the surrounding tissue being treated can be used for the markings drawn on the distal tip of the device. In some examples, black markings can be used. In other examples, light-colored or fluorescent markings such as yellow, orange, or green can be used.

[0057] FIG. 3 illustrates a physician's view from a 30° cystoscope with a needle 30 deployed that provides a perspective view of the device 10. The marking lines 12 indicate millimeter intervals and also provide an indication of depth by appearing closer together in the lower portion of the field of view. In other examples, the markings can be in the form of grooves 14 cut into the surface of the distal region of the tool. FIG. 4 illustrates the distal end of the device 10 with a series of grooves 14 cut into the struts 16. The grooves 14 can be in millimeter increments. The grooves 14 can be cut into one or both of the struts 16. In additional examples, the markings can be raised markings that extend above the surface of the tool. FIG. 5 illustrates a top view of the device 10 with a series of markings 12 extending transversely with respect to the longitudinal axis x-x. In some examples, the markings 12 can extend across the struts 16 and across the interior 15 of the device. The circle 18 serves as a reference point for the needle injection site or as a "zero marking" at the start of the millimeter increments of the markings.

[0058] In another example, the entire length and width of the distal tip of device 10 may be for marking. In the example shown in FIG. 6, the tip of device 10 is approximately 15 mm long and approximately 5 mm wide. The longitudinally extending markings 12 can be provided in a different manner than the width markings 13. In some examples, the longitudinal markings 12 can be a different color than the width markings 13. In other examples, one set of markings 12, 13 can be applied on the surface of device 10, and the other set can be grooves cut into this surface. The different sets of markings 12, 13 can provide orientation as well as sizing criteria. The markings 12, 13 can include sub - markings such as every 1 mm or every half - mm, and main markings such as every 5 mm or every 10 mm. In some examples, the longitudinal markings 12 can terminate at a zero marking 18, excluding the four marks 11 shown distal to the zero marking 18.

[0059] Exemplary treatment can include: (1) the step where the physician locates the distal bladder neck opening; (2) at this viewpoint, the step where the physician can view the landmarks on the anatomical wall as well as the markings on the distal tip of the device; (3) the step where the physician mentally notes where the desired length is; and (4) the step where the physician returns the device to such a desired anatomical position. The same process can be followed when the physician is looking at the upper and lower portions of the prostate to measure the height of the anatomical structure. By using the marker 12, the total length and total height of the prostate can be measured, thereby providing an optimal injection pattern and injection points.

[0060] In another example, additional digital or computer marking schemes can be provided to assist the measurement function for machine learning. By knowing the distance based on body tissue within the field of view using the region of interest detected within the field of view (e.g., a dark tissue section or blood vessel within an anatomical structure), accurate measurement values can be displayed to the physician along with the reference marker scheme. As shown in FIG. 7, the processor can provide a circular marking 211 that can serve as a basis for sizing and depth recognition for machine learning / artificial intelligence (AI) operation, and an orientation marking 215 at a known focal distance within the distal tip. These markings can be selected by an algorithm based on the intensity gradient pattern. For example, surface blood vessel features can be selected. In other examples, these markings can refer to polyps or cancerous tissue.

[0061] FIGS. 8A and 8B show a system with a video processor that uses an imager-based visualization system to overlay a virtual measurement marker 312 on the tip of the tool 310 by software. In this embodiment, since the tip feature is fixed relative to the camera, software can be easily used to add detailed markings 312 and strings such as "1 mm, 2 mm" to the geometry of the tip to assist navigation. When used in combination with an inclination / rotation sensor within the device, these markings can also be reoriented along with the tip when the software is used to properly orient the image. FIG. 8A shows the tip positioned vertically, and FIG. 8B depicts how the image might appear when the user rotates the device 90 degrees.

[0062] The tip markings 312 shown are merely examples, and it is also conceivable that these lines can extend across the screen. Further, the software will likely give the user the option to turn off these markings or dial-adjust the brightness and contrast of the markings, depending on preferences. The marking lines 312 can be scaled as shown in FIGS. 8A and 8B to depict depth. Finally, it is conceivable that a color can be selected to optimize visibility against anatomical features or to satisfy other customer requirements. This software embodiment eliminates the costs and constraints associated with physical markings. In other examples, the virtual markings shown in FIGS. 8A and 8B can be used in combination with physical markings on the device as shown in FIGS. 2-6.

[0063] The dimensions described in connection with the above figures are merely illustrative, and it will be understood that other dimensions are possible. The markings described can be added to other medical devices having visible portions within the field of view of the camera image, in addition to Rezum® for treating BPH. The markings can enable the physician to place the injection or other treatment sites more accurately and consistently, thereby reducing pain and discomfort after the procedure. These markers can reduce errors in treatment and further reduce the need for repetition of the procedure. For example, in the Rezum® procedure, if the initial injection sites are too close or too far from each other, the medical risk increases due to the need for additional future treatment.

[0064] In addition to the above-described sectional markings disposed or projected on the treatment device, the contrast geometry pattern on the tool itself can provide additional information indicating (1) when a new tool enters the field of view, (2) what type of tool it is, and (3) the position of the tool relative to the camera. Any video processor or processing system suitable for ureteroscopes and general endoscopes will benefit from this type of tool identification system. Currently, all artificial intelligence (AI) / machine learning (ML) algorithms infer information from the field of view that appears from the imager (e.g., digital chip).

[0065] The contrast geometry pattern on the tool itself can provide all three of the above types of information, and with careful design, the detectability, manufacturability, and signal-to-noise ratio of the geometric and tool identification information can be maximally enhanced. In addition to this, some geometric designs enable calibration during the execution of single-use devices (SUDs) that may have variations in optical geometry. The tool can be any entity within the field of view (FOV), such as a guidewire, laser fiber, basket, etc.

[0066] Assuming that a given tool has, near its tip, a region of circular cross-section suitable for marking by a surface treatment that affects, for example, reflectivity, a design composed of alternating sectors and having two or more bands offset from each other can be used to generate a pattern such as a moiré pattern. An even number of sectors sized such that at least two dark-to-bright transitions are visible from any rotation requires a total number of sectors such as six, eight, ten having sizes such as 60°, 45°, 36°. A total number of eight or more enables three transitions to be visible in each band, which is thought to enable additional data channels to be added by varying the dark / bright area ratio within the limited range near the average described above. While the total number of sectors itself is thought to provide data points, manufacturability and imaging constraints will limit the maximum number. Adjacent bands are thought to be similarly configured such that most of the dark sectors within one band are above the bright sectors within the adjacent band, although a deviation from a perfectly aligned moiré pattern is thought to provide additional data values.

[0067] Patterns 300, 301 shown in FIGS. 9A and 9B provide linear and arcuate multi-pixel high-contrast boundaries around the tool along its circumference, respectively, which will assist in more accurate inference of the tool geometry regardless of orientation within the FOV. The dimensions of the individual blocks or colors are known and provide additional measurement criteria for determining the size of unknown objects within the field of view as discussed above. The method can be made less resource intensive in an embedded environment where real-time decision-making is essential.

[0068] FIG. 10 shows an exemplary pattern 303 viewable from a ureteroscope fluoroscopy image of tool 310 adjacent to kidney stone 305 within the working channel. The known measurements of pattern 303 can be used to determine the physical size and / or position of stone 305, thereby assisting in determining the progress of treatment and removal of stone 305.

[0069] The alternating pattern embodiment provides on the tool, e.g., on the tool shaft, a simple progressive scale that provides both depth scale and linear scale by providing a detailed line or lines of varying thickness and / or known varying intervals. In another embodiment, the length of the ureter can be measured using progressive markings on a guide wire for stent sizing. This direct visualization can enable a more accurate measurement of the required stent. In an additional embodiment, the white balance of the camera system can be evaluated and adjusted based on white markings. Alternatively, to evaluate the color fidelity of objects and structures within the field of view, a step of changing the color markings to simple red, green, blue (RGB) or cyan, magenta, yellow, and black (CMYK) etc. can be used while maintaining high contrast unchanged on the geometric pattern. By counting the number of sectors of a detected known pattern, detection of turbidity comprising blood and / or other particles within the scene can be caused. Turbidity and particles may obscure some of the pattern sectors and thus a display of turbidity can be given by counting the visible sectors. In yet another embodiment, a simple pattern of intersection lines in the shape of an "L", "T", or + etc. can be used as a measurement criterion especially when the lengths of these lines are equal.

[0070] Using image analysis algorithms and geometric patterns, the type of tool present within the field of view can be detected, and using known tool dimensions, the reference physical size can be detected. Each type of tool can be uniquely colored and shaped. FIGS. 11-14 illustrate various retrieval devices that can be used to retrieve kidney stones. FIG. 11 shows a Dakota® Nitinol stone retrieval device, FIG. 12 shows an Escape® Nitinol stone retrieval basket, FIG. 13 shows a LithoCatch® fixation device, and FIG. 14 shows a Tricep® grasping forceps, all of which are by Boston Scientific. In addition to the retrieval tools, the fiber optic used in the procedure can be used as a size reference. FIG. 15A shows an AccuMax® holmium laser fiber with a flat end, and FIG. 15B shows a Flexiva® TracTip® laser fiber with a spherical end, both of which are by Boston Scientific. Since the diameter and end shape are known and have standard measurements, the laser fiber can be used to determine the size of a stone or other anatomical structure within the field of view. The various shapes and sizes of the tools can provide property information that can be detected using image processing algorithms. The above can be suitable for both conventional image processing algorithms or more advanced AI / ML algorithms.

[0071] In addition to using the known dimensions of various tools to measure an object seen within the field of view of an imaging device, the type of tool can be detected and used to deductively correlate it with reference information regarding the physical size of the tool features. For common areas, such as laser fibers having similar color schemes but different sizes, user input may be required to identify the tool. The detection of the tool can be performed using conventional image processing techniques and machine vision techniques. Alternatively, the detection of the tool can be performed using an AI approach in which a pre-trained network is provided to determine what types and sizes of tools are present within the field of view. In another example, the difference between the measured size of the shaft of the detected tool and the measured size of the tip can be used to estimate the change in the optical geometry across the scene and infer the physical pixel size.

[0072] It must be understood that the disclosure of the present invention is merely exemplary in many respects. Changes can be made without exceeding the scope of the disclosure of the present invention, particularly with regard to details, especially the shape, size, and arrangement of steps. This may include the use of any of the features of one exemplary embodiment used in other embodiments to the extent that it is appropriate. Of course, the scope of the disclosure of the present invention is defined by the language in which the appended claims are expressed.

Explanation of Signs

[0073] 10 BPH treatment device 12 Marking line

Claims

1. A system for providing an anatomical distance measurement value during an endoscopic procedure, The elongated tool having a first marking on a distal end of the elongated tool, the first marking being configured to extend longitudinally along the tool and be visible within an imaging field of view of an endoscope; A video processor configured to display the first marking as a virtual marking in the imaging field of view, the video processor including a reference line that extends longitudinally along the tool and is preferably spaced 1 mm apart at equal distances; comprising The video processor is further configured to superimpose the virtual marking over the distal end of the tool and maintain the virtual marking in a fixed position relative to the tool when the tool is rotated and axially moved.

2. The system according to claim 1, wherein the video processor is further configured to display a second virtual marking representing an anatomical structure visible within the imaging field of view.

3. The system according to claim 1 or 2, further comprising an inclination and / or rotation sensor configured to sense an inclination and / or rotation of the tool such that the virtual marking remains in a fixed position relative to the tool.

4. The system according to claim 1 or 2, wherein the virtual marking is sized and scaled to depict depth.

5. A device for providing an anatomical distance measurement value during an endoscopic procedure, The elongated tool having a first marking on a distal end of the elongated tool, the first marking being configured to extend longitudinally along the tool and be visible within an imaging field of view of an endoscope; A video processor configured to display the first marking in the imaging field of view as a virtual marking, the first marking including a reference line that extends longitudinally along the tool at equidistant intervals, preferably 1 mm apart, and the video processor. The video processor is further configured to superimpose the virtual marking on the distal end of the tool and to keep the virtual marking in a fixed position relative to the tool when the tool is rotated and moved axially. **Claim 6** The first marking includes a physical line on the tool that is transverse to the longitudinal axis of the tool, the line being placed 1 mm apart longitudinally along both sides of the tool. The device according to claim 5. **Claim 7** The device according to claim 6, further comprising a second physical marking including lines that are 5 mm apart longitudinally along at least one side of the tool. **Claim 8** The tool has a width, and the second physical marking extends across the width in 1 mm increments. The device according to claim 6, wherein the first marking and the second physical marking are visually different. **Claim 9** The first marking includes a geometric pattern applied on the tool. The device according to claim 5, wherein the area of the geometric pattern has known dimensions. **Claim 10** The device according to claim 5, wherein the first marking is a groove in the tool or a raised marking on the tool.

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