JP2008522661A - System and method for determining the mass of an organ wall with three-dimensional ultrasound - Google Patents

Abstract

An ultrasound system and method for measuring the weight and mass of an organ wall. If the organ is a bladder, bladder weight (UEBW) is determined using 3D ultrasound imaging acquired using a handheld transceiver or an instrument controlled ultrasound transceiver. In order to allow calculation of urine volume and bladder surface area, the lower urinary tract region of the bladder is outlined in this 3D data set. To allow calculation of bladder wall thickness (BWT), the outer wall of the outside of the bladder is outlined. UEBW is calculated as the product of bladder surface area, bladder wall thickness, and bladder wall specific gravity.
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Description

This application claims priority to US Provisional Patent Application Serial No. 60 / 633,485, filed December 6, 2004.

  This application is a continuation-in-part of US patent application Ser. No. 11 / 213,284 filed Aug. 26, 2005 and claims priority.

  This application claims priority of US Provisional Patent Application Serial No. 60 / 566,127, filed April 30, 2004, and priority of US Patent Application Serial No. 11 / 119,355, filed April 29, 2005. This is a continuation-in-part application. This application further claims US Patent Application Serial No. 10 / 443,126, filed May 20, 2003, which is a continuation-in-part of US Patent Application Serial No. 10/701, filed November 5, 2003. , 955 claiming priority and is a continuation-in-part application.

  This application claims priority from US Provisional Patent Application Serial No. 60 / 545,576 filed February 17, 2004 and US Provisional Patent Application Serial No. 60 / 566,818 filed April 30, 2004, 2005. This is a continuation-in-part application claiming the priority of US patent application serial number 11 / 061,867 filed on February 17th.

  This application is also a continuation-in-part of US patent application serial number 10 / 704,966 filed on November 10, 2004 and claims priority.

  This application is a continuation-in-part of US patent application serial number 10 / 607,919 filed June 27, 2005 and claims priority.

  This application claims priority to US Provisional Patent Application Serial No. 60 / 423,881 filed November 5, 2002 and US Provisional Patent Application Serial Number 60 / 400,624 filed August 2, 2002, 2003. This is a continuation-in-part of PCT application serial number PCT / US03 / 24368 filed on August 1, and claims priority.

This application is also a continuation-in-part of PCT application serial number PCT / US03 / 14785 filed May 9, 2003, which is a continuation application of US patent application serial number 10 / 165,556 filed June 7, 2002. Claim its priority.
This application is also a continuation-in-part of US patent application serial number 10 / 888,735 filed July 9, 2004 and claims priority.

  This application further claims priority of US Provisional Patent Application Serial No. 60 / 423,881 filed November 5, 2002 and US Provisional Application Serial No. 60 / 400,624 filed August 2, 2002. US patent filed July 31, 2003 claiming priority of US patent application serial number 10 / 443,126 filed on May 20, and US provisional patent application serial number 60 / 423,881 filed November 5, 2002 This is a continuation-in-part of application serial number 10 / 633,186 and claims its priority. This application further claims priority to US Provisional Patent Application Serial No. 60 / 470,525 filed May 12, 2003 and US Patent Application Serial No. 10 / 165,556 filed June 7, 2002. All of the above applications are incorporated herein by reference as if fully set forth herein.

TECHNICAL FIELD OF THE INVENTION The present invention relates generally to ultrasound-based diagnostic systems and procedures.

Background of the Invention Benign prostatic hypertrophy (BPH) and other disorders can cause dynamic bladder outlet obstruction (BOO). A marker for predicting BOO measures the weight of the bladder wall. By using ultrasound to probe, ultrasound estimated bladder wall weight (UEBW) can be obtained in a non-invasive manner. Existing methods for obtaining UEBW assume that the bladder is spherical and the thickness of the bladder wall is relatively constant in the bladder from almost empty to almost full. Furthermore, existing two-dimensional methods are carefully performed manually using the leading edge from the leading edge of the opposite wall of the bladder for a series of two-dimensional images, with analysis errors. (Hiroaki Miyashita, Somon Kojima, Tsuneharu Miki, “Ultrasonic measurement of bladder weight as a possible predictor of acute urinary retention in men with lower urinary tract symptoms suggestive of benign prostate hyperplasia” Ultrasonic measurement of bladder weight as a possible predictor of acute urinary retention in men) ”, Ultrasound in Medicine and Biology 2002, 28, 8, 985-990, K. Aerke, K. Hofner, B. Weeze , V. Granweld, U. Jonas, “Increase in detrusor wall thickness indicates bladder outlet obstruction in men”, World J. of Urology, 2002, No. Volume 19, Issue 443-452, L. Müller, T. Bergstrom, M. Helstrom, E. Svenson, B. Jacobson, “Standardized u ltrasound method for assessing detrusor muscle thickness in children ”, J. Urol., 200, 164: 134-138, Yoshio Naya, Somon Kojima, Book Joji Hisashi, Atsushi Ochiai, Osamu Ukimura, Satoshi Watanabe “Intraobserver and interobserver variance in the measurement of ultrasound-estimated bladder weight” Ultrasound in Med. & Biol, 1999, Vol. 24, No. 5, pp. 771-773).

  To avoid the error from the fixed bladder hypothesis and the error generated by the manual image processing method of the resulting 2D ultrasound image, the bladder wall by accurately measuring the bladder wall volume It is necessary to accurately and non-invasively measure the weight.

SUMMARY OF THE INVENTION A method and system for obtaining ultrasound estimated organ wall mass or weight from 3D ultrasound echo information is disclosed.

  Embodiments of the present invention will be described in detail with reference to the following drawings.

Detailed Description of Preferred Embodiments A method and system for obtaining ultrasound-estimated mass and / or weight of a wall of an organ, such as a bladder, using 3D ultrasound echo information is described. Ultrasound information based on three dimensions (3D) can be used to properly align an organ or other region of interest (ROI) to the inside of the organ wall as part of the process of measuring the weight or mass of the organ wall. Generated from a microprocessor-based system using an ultrasonic transceiver that uses an algorithm to delineate the boundaries of the (submucosal) and outer (subserosa) walls. If the organ is a bladder, the bladder wall algorithm works without making a geometric assumption of the bladder, so the shape, area, and thickness between the submucosa and subserosa of the bladder wall are more accurately determined As a result, the bladder wall volume can be determined more accurately. Knowing the exact bladder volume allows a more accurate determination of bladder wall weight or mass as the product of bladder wall volume and bladder wall density or specific gravity.

  Embodiments are for automated and convenient procedures for obtaining estimated bladder weight (UEBW) and / or bladder wall mass based on analysis of 3D images and analysis of 1D and 2D information comprising 3D images Including systems and methods. In one particular embodiment, the subject or patient is scanned using an ultrasound transceiver. An ultrasound transceiver similar to the BladeScan (R) BVM6500, sold by Diagnostic Ultrasound, Inc., Redmond, Washington, provides an ultrasound image in the form of a three-dimensional scanning cone. The 3D scanning cone provides an image of the ROI probed with ultrasound in the form of a rotating array of 2D scanning planes, referred to as one or more images of V-mode®. The plurality of V-mode images may also include a V-shaped array and a translation array.

  After scanning, the transceiver displays the amount of urine stored in the bladder with the aiming information for the transceiver so that the probe can be correctly positioned relative to the bladder. With aiming information, the user can repeat the scan as needed to center the image and / or obtain a complete image of the bladder.

Once the scan is complete, the three-dimensional data can be securely transmitted to a server computer on a remote computer connected to a network such as the Internet. Alternatively, a local computer network or an independent stand-alone personal computer may be used. In any case, the image processing algorithm on the computer analyzes the 2D portion of the 3D image or the pixels in the voxels of the 3D image. The image processing algorithm then defines which pixels or voxels occupy or constitute the inner or outer wall layer. Then, the wall area of the inner layer and the outer layer and the thickness between them are determined. The weight of the organ wall or bladder wall is determined as the product of the wall layer area, the thickness between the wall layers, and the wall density.
The image processing algorithm outlines the outer and inner walls of the anterior portion of the bladder wall within the bladder region and uses, for example, a modification of the Marching Cubes algorithm used from the VTK library maintained by Kitware (Clifton Park, NY, USA) Then, the actual surface area S of the bladder wall is determined. The above algorithm is incorporated herein by reference. The bladder wall thickness t is then calculated as the distance between the outer and inner surfaces of the bladder wall. Finally, as shown in equation E1, the weight of the bladder is estimated as the product of the surface area, the thickness, and the specific gravity ρ of the bladder muscle.

  One advantage of embodiments of the present invention is that it generates a more accurate and more consistent estimate of UEBW. Reasons for higher accuracy and consistency include:

  1. Instead of 2D data, 3D data is used to calculate surface area and thickness. In another embodiment, the outer wall of the outside of the bladder is outlined so that the bladder wall thickness (BWT) can be calculated.

  2. Instead of using a surface area based on a spherical model, use the measured surface area.

  3. Automatic and consistent measurement of bladder wall thickness.

  Additional benefits provided by embodiments include non-invasiveness and ease of use since UEBW is measured over a range of bladder volumes and does not require insertion of a catheter into the patient to fill to a constant volume.

  1A-D are a partial schematic and partial isometric view of a transceiver, an array of scan cones of a scan plane, and the scan plane of that array.

  FIG. 1A shows a transceiver 10A having an ultrasound transducer housing 18 and a transceiver dome 20 that emits ultrasound energy to explore a patient or subject. Information from the ultrasonic echo returned from the ultrasonic wave to be searched is displayed on the display 14. The information may be alphanumeric, images, depicting the location of the target organ or ROI.

  FIG. 1B is a graphical representation of a plurality of scan planes 42 containing the ultrasound to be probed. The plurality of scan planes 42 define the scan cone 40 in a three-dimensional (3D) array format having a substantially conical shape that projects outwardly from the dome 20 of the transceiver 10A.

The plurality of scan planes 42 are oriented about the axis 11 extending through the transceiver 10A. One or more, or alternatively, each of the scan planes 42 is positioned about the axis 11 and may be positioned at a predetermined position angle θ. The scanning plane 42 is spaced from each other at angles θ ₁ and θ ₂ , and the value of the angle may be variable. That is, the angles θ ₁ and θ ₂ to θ _n are drawn approximately equal, but angles of different values may be used. Other scan cone configurations are possible. For example, a V-shaped scan cone or other similar shape may be generated by the transceiver 10A.

  FIG. 1C is a graphical representation of the scan plane 42. The scan plane 42 includes peripheral scan lines 44 and 46 and an internal scan line 48 having a length r that extends between the scan lines 44 and 46 in a direction outward from the transceiver 10A. Therefore, the selection points along the peripheral scanning lines 44 and 46 and the internal scanning line 48 can be defined with reference to the distance r and the angle coordinate values φ and θ. The length r preferably extends from approximately 18 centimeters to 20 centimeters (cm), although other lengths are possible. Some embodiments include approximately 77 scan lines 48 extending outward from the dome 20, although any number of scan lines may be used.

  FIG. 1D is a graphical representation of a plurality of scan lines 48 emanating from an ultrasound transceiver that forms a single scan plane 42 that extends through a cross section of a portion of an organ within the body. Scanning surface 42 has a fan-shaped, semi-circular dome-shaped cutout 41 bounded by peripheral scanning lines 44 and 46. The number and position of the internal scan lines radiating from the transceiver 10A within a given scan plane 42 is around the axis 11 with different position coordinates as necessary to fully image the structure or image within the scan plane 42. It may be distributed. As shown, four portions of the off-center region of interest (ROI) are shown as irregular regions 49 of the internal organ. The three parts can be fully projected in the scan plane 42, one being cut by the peripheral scan line 44.

As previously mentioned, the angular movement of the transducer may be performed mechanically and / or generated electronically or otherwise. In either case, the number of lines 48 and the length of the lines are variable so that the tilt angle φ (FIG. 1C) scans an arc of about 120 degrees in total with an angle between about −60 degrees and +60 degrees. Also good. In one certain embodiment, transceiver 10A is configured to generate approximately 77 scan lines between first limited scan line 44 and second limited scan line 46. In certain other embodiments, each of the scan lines has a length of approximately 18 centimeters (cm) to 20 centimeters (cm). The angular distance (FIG. 1B) between adjacent scan lines 48 may be uniform or non-uniform. For example, and in certain other embodiments, the angular distances θ ₁ and θ ₂ to θ _n (shown in FIG. 1B) may be about 1.5 degrees. In another embodiment, the angular distances θ _1, θ _2, θ _n are 1.5 degrees between the first scan line and the second scan line, and the second scan line and the third scan line Adjacent, with a distance of 6.8 degrees between them, a distance of 15.5 degrees between the third and fourth scan lines, and a distance of 7.2 degrees between the fourth and fifth scan lines The angle to be performed may be continuous in an order including angles of 1.5 degrees, 6.8 degrees, 15.5 degrees, 7.2 degrees, and the like. The angular distance between adjacent scanning lines may be a combination of uniform and non-uniform angular intervals. For example, the series of angles are 1.5 degrees, 1.5 degrees, 1.5 degrees, 7.2 degrees, 14 degrees The order may include .3 degrees, 20.2 degrees, 8.0 degrees, 8.0 degrees, 8.0 degrees, 4.3 degrees, 7.8 degrees, and the like.

  FIG. 2 shows an array 30 of scan cones composed of a partial schematic and partial isometric side view of transceiver 10B and scan lines distributed in 3D. Each of the scan lines has a length r that projects outward from the transceiver 10B. As shown in the figure, the transceiver 10B radiates scanning lines dispersed in 3D, which are one-dimensional ultrasonic A-lines, into the scanning cone 30. As an aggregate, the A lines distributed in 3D define the cone shape of the scanning cone 30. The ultrasonic scanning cone 30 extends outward from the dome 20 of the transceiver 10B and is concentrated around the axis 11 (FIG. 1B). The scan lines distributed in 3D of the scan cone 30 include a plurality of internal scan lines and peripheral scan lines distributed within a volume defined by the circumference of the scan cone 30. Accordingly, the peripheral scan lines 31A-31F define the outer surface of the scan cone 30, and the internal scan lines 34A-34C are each distributed between the peripheral scan lines 31A-31F. The scanning line 34B is generally collinear with the axis 11, and the scanning cone 30 is generally concentrically concentrating on the axis 11.

The positions of the internal scan line and the peripheral scan line can be further defined by an angular interval between the internal scan line and the peripheral scan line from the center scan line 34B. The angular interval between the scanning line 34B and the peripheral scanning line or the internal scanning line is indicated by an angle Φ, and the angular interval between the internal scanning line or the peripheral scanning line is indicated by an angle θ. The angles Φ ₁ , Φ ₂ , and Φ ₃ define angular intervals from the scanning line 34B to the scanning lines 34A, 34C, and 31D, respectively. Similarly, the angles Φ ₁ , Φ ₂ , and Φ ₃ define angular intervals between the scan lines 31B and 31C, 31C and 34A, and 31D and 31E, respectively.

  Still referring to FIG. 2, the plurality of peripheral scanning lines 31 </ b> A-E and the plurality of internal scanning lines 34 </ b> A-D are three-dimensionally dispersed A lines (scanning lines) and are confined in the scanning plane. Instead, the scanning may be performed along the circumference of the scanning cone 30 instead through the internal region. Thus, an arbitrary point in the scanning cone 30 can be identified by coordinates r, Φ, θ (generally different values). The number and position of the internal scan lines 34A-D radiating from the transceiver 10B can be adjusted so that the scan cones at such different position coordinates as necessary to fully image the structure or image within the region of interest (ROI) of the patient. 30 may be distributed. The angular movement of the ultrasonic transducer in the transceiver 10B may be mechanically and / or electronically generated. In any case, the number of lines and the length of the lines so that the angle Φ is scanned at an angle of approximately −60 degrees between the scanning lines 34B and 31A and at an angle of +60 degrees between the scanning lines 34B and 31B. May be equal or different. Accordingly, the angle Φ can include a total arc of approximately 120 degrees. In one embodiment, the transceiver 10B is configured to generate a plurality of 3D distributed scan lines within a scan cone 30 having a length r of approximately 18 centimeters (cm) to 20 centimeters (cm).

  FIG. 3 shows a transceiver 10A (FIG. 1) removably placed in a communication cradle 50A operable to communicate with data uploaded wirelessly to a computer or other microprocessor device (not shown). The data is securely uploaded to a computer or via a computer to a server where it is processed by a bladder weight estimation algorithm described in more detail below. The transceiver 10B may be similarly accommodated in the cradle 50A. In this wireless embodiment, cradle 50A has circuitry that receives the information content of scan cone 40 or scan cone 30 and converts it to a radio signal 50A-2.

  FIG. 4 shows a transceiver 10A removably placed in a communication cradle 50B where data is uploaded to a computer or other microprocessor device (not shown) via electrical connection 50B-2. The data is securely uploaded to a computer or via a computer to a server and processed by a bladder weight estimation algorithm. The transceiver 10B may similarly be removably placed in the cradle 50B. In the present embodiment, the cradle 50B has a circuit that receives the information content of the scanning cone 40 or the scanning cone 30 and converts it into a non-wireless signal. The non-wireless signal is an electrical signal, an optical signal, or a sound-based signal. It is transmitted to the conduit 50B-2 that can transmit. Certain electrical embodiments of conduit 50B-2 may include a universal serial bus (USB) for signal communication with a microprocessor-based device.

  FIG. 5 shows an image showing the abdomen of patient 68 being scanned with transceiver 10C and wireless to a personal computer while initially aiming at the umbilicus 68 and the left region of interest (ROI) of umbilical line 68C. Indicates the data uploaded in. FIG. 5 is an image showing a patient 68 being scanned with the bladder wall mass system 60A during the initial aiming phase using a transceiver 10C capable of generating wireless signals. The transceiver 10C has a circuit that converts the information content of the scan cone 40 or the scan cone 30 into a radio signal 25C-1, which is visible light, invisible light (such as infrared), or sound-based signal. It may be in the form of As shown, the data is uploaded to the personal computer 52 wirelessly while initially aiming the organ or ROI. In certain embodiments of transceiver 10C, a focused 3.7 MHz single element transducer is used and mechanically steered to obtain a 120 degree scan cone. On the display screen 54 connected to the computer 52, the scanning cone image 40A displays a diagram in which the organ 56A is cut off from the center.

  The scanning protocol for obtaining the UEBW begins with the transceiver 10C being positioned approximately 1 inch above the pubic joint with the scanning head slightly toward the tailbone. Three-dimensional ultrasound data is collected by pressing the scanning button of the scanner. When the scanning is completed, the aiming information is displayed as an arrow on the display 14 of the device 10C. A flashing arrow tells the user to scan the device again in the direction of the arrow. The scan is repeated until the device displays solid arrows or no longer displays arrows. The display 16 on the device can further display the calculated bladder volume. The aforementioned aiming process is described more fully in McMolow et al., US Pat. No. 6,884,217, which is hereby incorporated by reference as if fully set forth herein. The bladder volume required to measure UEBW is between 200 and 400 ml. If the bladder volume reading is less than 200 ml, the patient can be given a volume of fluid and wait a short while before scanning. When the scan is complete and the patient has a bladder volume between 200 and 400 ml, the device can be placed in a communication cradle connected to a personal computer. Other methods and systems described in US Pat. Nos. 4,926,871, 5,235,985, 6,569,097, 6,110,111, 6,676,605 are now fully described. Incorporated herein by reference as if made.

  Details of the protocol described above, and continuing reference to FIG. 5, system 60A further includes a personal computing device 52 configured to wirelessly exchange information with transceiver 10C. However, if transceiver 10C is used, other means of information exchange may be used. In operation, the transceiver 10C is placed against the side of the patient's 68 abdominal region. For example, when obtaining a cross-abdominal image of a female patient's uterine organ, the transceiver 10B is placed off-center from the center line 68C of the patient 68. The transceiver 10B may contact the patient 68 through a pad 67 containing an acoustic coupling gel, which pad is placed substantially to the left of the patient 68 at the umbilicus 68A and centerline 68C. Alternatively, the acoustic coupling gel may be applied to the patient 68 skin. Pad 67 advantageously reduces ultrasonic attenuation between patient 68 and transceiver 10B by maximizing acoustic conduction from transceiver 10B to patient 68. As shown in FIGS. 6 and 7 below, the ultrasound imaging system 60B includes a transceiver 10D that communicates with a computer 52 in a wired manner. In this wired embodiment, the transceiver 10D has circuitry that receives and converts the information content of the scan cone 40 or scan cone 30 into a non-wireless signal that is a conduit between the transceiver 10D and the computer 52. And the wireless signal may include an electrical signal, an optical signal, or a sound-based signal.

  The wireless signal 25C-1 includes echo information that is transmitted to the image processing algorithm of the personal computer device 52 and processed. Scan cone 40 (FIG. 1B) displays internal organs as a partial image 56A on computer display. Due to the positioning of transceiver 10B, image 56A is significantly cut and off-center compared to the central portion of scan cone 40A.

  As shown in FIG. 5, the image acquired across the abdomen at the stage of aiming the image is initially acquired. During initial aiming, the first freehand position may represent a substantially off-center organ or ROI 56A. The transceiver 10C is operated in a two-dimensional continuous acquisition mode. In the two-dimensional continuous mode, data is acquired continuously and presented as a scan plane image as shown and described above. The data acquired in this way is displayed on a display device such as the display 24 connected to the transceiver 10B while the operator physically translates the transceiver 10C from end to end of the patient's abdomen. Can do. When it is desirable to acquire data, the operator can depress the trigger 14 of the transceiver 10C to acquire the data and obtain a real-time image presented to the operator on the transceiver display 14. If the initial position of the transceiver is significantly off-center, as in the first freehand position, only a portion of the organ or ROI 56A will be visible on the scan plane 40A.

  FIG. 6 shows the ROI data properly targeted at the abdomen near the midline 68C under the umbilicus 68A being scanned with the transceiver 10C and wirelessly uploaded to a personal computer. It is an image. Here, the data being scanned wirelessly to the patient and personal computer 52 being scanned by the transceiver 10C occurs when the ROI 56B is properly aimed. The isometric view shows the ultrasound imaging system 60A applied to the patient's central abdominal site. The transceiver 10C may translate or move to a second freehand position below the navel 68A on the center line 68C of the patient 68. A radio signal 25C-2 having information from the transceiver 10C is transmitted to the personal computer device 52. An inertial reference device located within the transceiver 10C senses changes in the position of the transceiver 10C relative to the reference coordinate system. Information from the inertial reference device, described in more detail below, allows for the acquisition of an up-to-date, real-time scan cone image so that a scan cone 40B with a complete image of organ 56B can be acquired. Other embodiments are also within the scope of the present invention. For example, transceiver 10C may also be used in system 60A, as shown in FIG. The transceiver 10A and support cradle 50A shown in FIG. 3 and the transceiver 10A and support cradle 50B of FIG. 4 may also be used as shown in FIGS. 7 and 8 below, respectively. Further, the transceiver 10A or 10B may include an inertial reference device to determine the position coordinates of the transceiver 10A or 10B relative to the patient 68. The inertial reference device may use the accelerometer 22 to measure the position coordinate and the component of translation of the gyroscope 23 to determine the rotational component of the position coordinate.

  FIG. 7 is a schematic and partial isometric view of an ultrasound system 100 connected to a network in communication with the ultrasound imaging systems 60A-D. The system 100 includes one or more personal computer devices 52 coupled to a server 56 by a communication system 55. Device 52 is then coupled to one or more ultrasound transceivers of systems 60A-60D, for example. Server 56 may be practicable to provide additional processing of ultrasound information, or other server (eg, in FIG. 7) with transceiver 10A or 10B having an inertial reference system with a snap in the collar. (Not shown) and further connected to the device. The inertial reference device may use at least one accelerometer 22 to determine a translation component of position coordinates and at least one gyroscope 23 to determine a rotation component of position coordinates.

  The computer array 114 may include other computers similar to the computer 52 of the systems 60A-D. The system 110 may also communicate with a transceiver 10A or 10B having inertial reference capability as described above.

FIG. 9A is a B-mode or two-dimensional cross-sectional bladder using one of the transceivers 10A-B of FIGS. 1A and 2 respectively at a pulse frequency of 3.7 MHz from the imaging system 60A-D. It is an ultrasound image. FIG. 9A is an ultrasound image of a transverse section of the bladder lumen 150 imaged as a dark, slightly circular or pumpkin-shaped region within the scan plane 142. The bladder lumen 150 is projected as a dark region in the central region of the scanning plane 142 because the nature of the fluid cavity or empty cavity inside the bladder lumen is low echo. Tissue barriers, such as more solids, are reflective of the incident or exploring ultrasonic energy and reflect the incident exploring ultrasonic wave back. The ultrasonic wave reflected by the barrier is projected as a light-colored area by the scanning cone 142. An echoic barrier delineating the proximal bladder around the domed cutout 41 of the transducer is projected as a submucosal layer 146 and a subserosa layer 148 in the anterior region of the bladder wall.
FIG. 9B is a close-up of the image of FIG. 9A showing the anterior wall of the bladder. The zoomed image is generated from a series of log-compressed A-mode lines that closely mirror the structure of the cross-section of the anterior wall of the bladder 150. The relatively low brightness area 147 is projected between the lighter submucosa 146 and the lower serosal layer 146,148. The detrusor muscle of the bladder wall occupies a region 147 with less light color. Although not as bright as layers 146 and 148, detrusor region 147 is brighter than bladder lumen 150.

  FIG. 9C is an A-mode line log-compressed of one scan line similar to scan line 48 through the bladder, illustrating relative echogenicity as a function of scan line position or depth through the bladder. To do. The submucosa, subserosa, and detrusor of the wall are imaged with this particular set of data in zoomed B and A modes. The two layers of the bladder wall are most clearly projected when the ultrasound beam is normally incident on the bladder wall. As the angle of incidence of the ultrasound deviates from normal, the two layers begin to appear as one and may not be reliably detected. In many data sets, the above two layers of the bladder wall are clearly projected at normal incidence, while in some cases, tissue surrounding the bladder (such as the peritoneum) hits the bladder wall and joins with the subserosa layer. Several specimens of images with the peritoneum combined with the subserosa layer are shown in FIG. 9C.

  As shown in FIG. 9C, a significantly higher resolution histogram is obtained when the ROI is probed with incident ultrasound that is substantially perpendicular to the organ or ROI. Here, the cross sections of the structures of FIGS. 9A and 9B are seen with sufficient detail to distinguish each other. A one-dimensional histogram plot of ultrasound echo intensity along the A-line scan line, similar to scan line 49, scan line 31A-F in FIG. 1D, or scan line 34A-C in FIG. Plotted against depth. Subserosa 148 is shown with a slightly stronger echo intensity than the more distal submucosa 146. Serosa lower layer 148 is approximately 3 cm from scan head dome 20, and serosa lower layer is approximately 3.5 cm from dome 20. The bladder lumen 150 is shown at a posterior depth of close to 9.5 cm across the anterior serosa sublayer 146. Compared to the darker bladder lumen 150, a relatively lighter detrusor region 147 is shown sandwiched between the lighter submucosa and subserosa sublayers 146 and 148.

  FIG. 10 shows an algorithm 170 for calculating the UEBW from the ultrasonic data of V-mode. The algorithm allows the calculation of UEBW from the V-mode ultrasound data. Block 178 of algorithm 178 outlines the bladder region. This outlined bladder region is then used to calculate the bladder surface area as indicated by block 186. Using the outlined bladder region and the input V-mode data obtained at block 172, the anterior wall of the bladder is determined. This anterior wall delineation is used to calculate the bladder wall thickness. Finally, as shown in block 198, the surface area and thickness measurements are combined to calculate UEBW. Although the algorithm 170 is used to measure the weight and / or mass of the bladder wall, the algorithm 170 can also be a bladder such as a uterus, heart, kidney, or cancerous tumor and / or non-cancerous origin. May be used for other regions of interest. Non-cancerous tumors include parasitic infections with pouch-like growth.

  FIG. 11 is an extension of the sub-algorithm 172 of FIG. At block 172-2, the ultrasound probe is placed on the abdomen to ultrasonically scan at least a portion of the bladder. The echo returned from the bladder is received by the transceiver 10A or 10B. Next, at process block 172-6, a signal is generated in proportion to the intensity of the ultrasound echo that is returned. The signal is processed into an ultrasound image by an image processing algorithm that can be executed by a microprocessor on the computer 52, local server 56, or other server and computer accessible by the Internet 114, described below. In either case, the bladder image is displayed on the computer display 54 so as to be visible to the user. Next, diamond decision block 172-8 submits a query, "Is the bladder well-aimed?" A fully aiming indexing method is described more fully in McMolow et al., US Pat. No. 6,884,217, which is hereby incorporated by reference as if fully set forth herein. If the answer is “no”, sub-algorithm 172 returns to block 172-2 and proceeds to diamond decision block 172-8. If the answer is “yes”, then sub-algorithm 172 ends and exits to subsequent sub-algorithms 178 and 182.

  FIG. 12A is an extension of the sub-algorithm 178 of FIG. The sub-algorithm 178 begins by entering a diamond decision block 178-4 to answer the query "Is the urine volume between 200ml and 400ml?" Expressed as the mathematical term "200 <urine volume <400ml". . If the answer is yes, then the data is processed at block 178-8 to delineate the bladder. If the answer is no, then at block 178-6, the bladder is allowed to accumulate until the urine is in the 200 and 400 ml range. After the urine volume is in the range of 200 ml and 400 ml, the position of the anterior submucosal wall and the anterior subserosa wall is determined at block 178-12. Sub-algorithm 178 then exits to process block 186 or 192.

  FIG. 12B is an extension of another embodiment of the sub-algorithm 178 of FIG. Although accuracy may not be optimal compared to a bladder with between 200 and 400 ml of urine, UBEW may be determined in volumes of less than 200 ml or more than 400 ml. If 200-400 ml cannot be stored in the bladder, then process block 172 may proceed directly to process block 178-8, where the acquired data is processed to delineate the bladder. Next, at process block 178-12, the location of the submucosa and subserosa front wall is determined. From here, the method continues to process blocks 186 and 192.

  FIG. 13 is an extension of sub-algorithm 178-8 that processes the data to delineate the bladder of FIGS. 12A and 12B. Sub-algorithm 178-8 consists of eight processes or decision routines, and after sub-algorithm 172 ends, begins with a first process block 178-8A called to search the original wall. Following block 178-8A searching for the original wall is block 178-8B called searching for the center of gravity. Next, block 178-8C is the initial wall fixation. After fixing the original wall, decision block 178-8D asks for the query “Is it non-bladder?”. If the answer is “yes”, ie if the organ is non-bladder, the next process is block 178-8E which clears the wall. Next, the volume is displayed at block 178-8H and process 178-8 continues to sub-process 178-8J. Returning to diamond decision block 178-8D, if the organ is not a non-bladder, ie "no", then another decision 178-8F submits a query "is volume less than 40 ml?". If the answer to diamond decision block 178-8F is "no", then the volume is indicated at terminal 178-8H and algorithm 178-8 proceeds to sub-algorithm 178-8J. If the decision to the diamond decision block 178-8F is “yes” to the “volume is less than 40 ml” query, another decision is to ask the diamond 178-8G with the query “bladder region?”. Submitted. If the answer is “no”, then sub-algorithm 178-8 proceeds to clear the walls of block 178-8E and from there to terminal block 178-8H where the volume is displayed. If the diamond decision block 178-8G answers “yes” to the query “Is it a bladder region?” Then the volume is displayed at terminal 178-8H, and the process 178-8 uses algorithm 180 and Continue to 186. In sub-algorithm 178-8, the interlayer lines are superimposed on the B-mode scan plane image, for example, to approximate the initial position of the wall of the organ of the uterus or bladder. This initial interlaminar line is further used as a seed point or initial reference point as a basis for adjusting the index of the inner and outer wall layers of the organ wall. The algorithm also determines if the detected area of the scan plane is a bladder or uterus. This occurs particularly when the gender button (not shown) of the transceiver 10A (FIG. 1A) indicates that the scan is for a woman. If the area is found to be indeed the uterus, it is cleared and a zero volume is displayed. If the volume is very small in a non-uterine region such as the bladder, then it is related to the magnitude of the signal characteristics within that region to ensure that the detected region is the bladder and not another tissue Verification is performed. If the region is indeed a bladder region, that region is calculated and displayed in the output.

  FIG. 14 is an extension of sub-algorithm 178-8A that searches the original wall of FIG. The sub-algorithm 178-8A is composed of 11 process loops, judgments, and terminals. Sub-algorithm 178-8A begins at process 180A2, where a local average is calculated for 15 to 16 samples, which acts as a low pass filter (LPF) to reduce signal noise. Other embodiments can calculate an average from 15 or fewer and 16 or more samples. Next is block 180A4 where the gradient is calculated using a central difference formulation taken from more than seven sets of samples. The process of block 180A4 then proceeds to loop start 180A6. At block 180A6, each specimen is considered in the detection area. Then, in the diamond decision block 180A8, a query is performed "Is the slope minimal?" If the answer is “no”, then a diamond decision block 180A18 executes another query, “Are you searching for the maximum BW and slope?”. Here, BW indicates the rear wall. If the answer to the query in block 180A18 is "no", the loop end proceeds to block 180A30. Then, from the loop end of 180A30, a terminator is reached at block 180A40 which ends the initial wall search. Returning to diamond decision block 180A8, if the answer to the query “Is the slope minimal?” Is “yes”, another query is submitted to diamond decision block 180A10. The query of 180A10 is “is the candidate FW / BW the best?”, Where FW indicates the front wall and BW indicates the rear wall. If the answer to the query in block 180A10 is "no", process 180A62 is used where the front wall is saved and another back wall is searched. If the answer to the 180A10 query is “yes”, the process is to save the candidate to be made at block 180A14. The process is then resumed by returning to loop beginning 180A6. Returning to diamond decision block 180A10, if the answer to the query "Candidate FW / BW is best?" Is "yes", the process proceeds to block 180A12 where the candidate is a back / front wall pair. Assigned as. Thereafter, from block 180A12, the algorithm 186A returns to the loop start 180A6, and then the process ends at the end of each sample at the loop end 180A30 and then proceeds to the subalgorithm terminal 180A40 which ends the search for the original wall. Proceed to -8B. Sub-algorithm 178-8 attempts to find the best set of front and back walls for points that plot the inner and outer wall layers. The best set of front and back walls for each scan line is the largest difference between the back and front wall gradients, often referred to as tissue delta, and between the front and back wall pairs. Is defined as the set of front and back walls with the smallest pixel value.

  FIG. 15 is an extension of the sub-algorithm 178-8C that fixes the original wall of FIG. Sub-algorithm 178-8C is composed of several diamond-shaped decision blocks and a loop process. The scan plane that is processed first is the scan plane that is closest to the original wall center aid, and then the scan plane base that is processed by moving the remaining scan planes in either direction of the original scan plane, Sub-algorithm 178-8C operates on the scan plane. Sub-algorithm 178-8C begins with block 180C2, which is called to start the initial wall anchoring. The first process is block 180C4 where the centerline is modified as necessary. The center line is defined as the line on the scan plane where the gradient difference between the front and back walls is the largest. The correction of the front and rear wall positions at any line is done in a step like matched filtering, where the optimal position within the search range is the point just outside the bladder and the point just inside the bladder. The difference between is defined as the largest. Of course, although the bladder is used here as an example of certain embodiments, this applies to any organ other than the bladder. Then, at block 180C6, the average of the front and rear walls is calculated for the five centerlines. If the basic intensity of the pixel is calculated and the calculated intensity is less than expected from the noise at that depth, then the line is cleared and the algorithm determines in diamond decision block 180C8 that "BW level is noise. Proceed to the next plane, as shown in the query of “is it smaller?”. Here, BW refers to the posterior wall (or posterior wall) of the bladder. If the answer to this query is “yes” at block 180C10, the wall data is cleared but activated to proceed to the end of the initial wall fixing of the terminator 180C50. Returning to diamond decision block 180C8, if the answer to the query "Is BW level less than noise?" Is "no", sub-algorithm 180C is the process of block 180C12 described as fixing three centerlines. Proceed to From here to the end of sub-algorithm 180C, the goal is to first modify the line to the left of the center line, called the left half plane (LHP), until either end of the bladder or the end of the ultrasound cone is found. When the algorithm corrects the LHP, it proceeds to correct the line to the right of the center line called the right half plane. Since the same steps are used for all lines, process blocks 180C16-180C42 are used both for LHP and once for the right half, regardless of whether the line position is on the left side of the center or the right side of the center. The “line index” of process 180C14 indicates the identifier of the current line processed. The line index is set to be 2 indices less than the center line to start the LHP process. The loop procedure started at block 180C16 continues to loop as long as the line index is a valid index (ie, corresponding to a scan line). Sub-loop 180C18 is started with the aim of adjusting the initial wall position, sub-process 180C20 to the correct position if correction is required. This loop, which ends at process 180C24, completes two runs. The first run uses subprocess 180C20 to modify the anterior bladder wall on the current line, and the second run modifies the posterior wall of the bladder, but the order of which wall is modified first can be reversed. . Once the current line wall position has been modified, sub-algorithm 180C proceeds to sub-process 180C28 of "Verify Wall Stretch". This sub-process ensures that the length of the scan line that intersects the bladder in the current line is not significantly extended compared to the corrected previous line. In a preferred embodiment, the length of the scan line intersecting the bladder is constrained to be less than 1.125 times longer than in the previous line. If a loop closed by subprocesses 180C16 and 180C42 is running on LHP, the previous line is one index larger than the current line index. Otherwise, the previous line index is one index smaller than the current index. After sub-process 180C28 is completed, sub-process 180C30 of “Verify Wall Consistency” partially overlaps the part of the scan line before the current scan line that intersects the bladder. Confirm that there is. After sub-process 180C30 is completed, decision 180C32 executes a query “LHP is working?” (Ie, a loop closed at terminals 180C16 and 180C42 is being executed on the center left line). If the answer to the query is yes, then subprocess 180C34 “Decrease Line Index” reduces the line index by one index. The decision 180C36 executes a query “Is the line index invalid?”. The loop closed at terminals 180C16 and 180C42 is executed on the next current scan line. If the line index decrement corresponds to an invalid value, the end of the LHP has been reached. Sub-process 180C38 is called to reset the line index to the first line to the right of the unadjusted center. The loop closed at terminals 180C16 and 180C42 is then executed on the right half plane (RHP). Returning to decision 180C32, if the answer to the query is “No”, sub-process 180C40, “Increment line index” increases the line index by one index. Loop terminal 180C42 returns the loop to 180C16 while the line index matches the actual scan line. As soon as the above conditions are not met, the loop terminal advances sub-algorithm 178-8C to terminal 180C50 “end initial wall fixing” and proceeds to sub-algorithm 178-8D.

  FIG. 16 is an extension of the surface area sub-algorithm 186 of FIG. Once the bladder outline is delineated with sub-algorithm 178, the process continues to block 186-2 where the 2D scan plane is a 3D scan cone such as scan cone 40 of FIG. 1B or scan cone 30 of FIG. Assembled in the lower layer. When the 3D scan cone is configured with a scan plane that is substantially similar to scan plane 42 with scan lines 48 confined within a constant scan plane 42, the 3D arrangement is a rotational arrangement, a V-shaped arrangement, a translational arrangement. Scan planes assembled into an array may be included. Alternatively, the 3D scan cone in the form of the scan cone 30 of FIG. 2 is made of an arbitrarily distributed assembly of 3D distributed scan lines that are not confined within a fixed scan plane. Next, at process block 186-6, the serosa sublayer is divided into triangular assemblies. The subserosa surface area is then calculated using marching cubes or other suitable algorithm at process block 186-10. Knowing the surface area allows the organ or bladder mass to be calculated taking into account the thickness determination and organ wall density as described below.

  FIG. 17 is an extension of the sub-algorithm 186 for calculating the surface area of FIG. Once the bladder outline is delineated by sub-algorithm 178 and the position of subserosal layer 148 is approximated, process 186 begins at block 186-12 where the 2D scan plane is a 3D scan cone similar to scan cone 40 or scan cone 30. And assembled into a submucosal layer within a 3D distributed scan line that is not confined within a scan plane. Next, at process block 186-16, the submucosa is divided into triangular assemblies. The submucosal surface area is then calculated using marching cubes or other suitable algorithm at process block 186-20. Knowing the surface area allows the organ or bladder mass to be calculated taking into account the thickness determination and organ wall density as described below.

  FIG. 18 is an extension of the sub-algorithm 186-10 of FIG. The algorithm 186-10 begins by creating a triangular mesh of voxel or pixel body elements defined as isosurfaces of the subserosal layer 148 or provisional working representation at block 186-10A. Next, at block 186-10C, the isosurface layer is defined as a plurality of voxel cubes having eight pixel vertices. Next, at block 186-10E, for the purpose of further dividing or classifying the voxels as an isosurface of the serosa sublayer 148 or as a part of the temporary work display, the value of the pixel vertex is set to the selected threshold value. Compared to the brightness value of the voxel or pixel. The way of dividing voxels is described in block 186-10G. A voxel is defined as a component or non-component of the isosurface of the serosa sublayer 148. A voxel component is defined as a component if it has a light intensity greater than a threshold, and a non-component if the voxel has a light intensity below a threshold. After the voxels are further divided and classified at block 186-10J, vertex index values are defined and normal values are assembled into voxels. Next, at block 186-10M, the voxels that are components of the isosurface are calculated and summed to obtain the cumulative surface area of the serosa sublayer 148. The algorithm then continues to sub-algorithm 198.

  FIG. 19 is an extension of the sub-algorithm 186-20 of FIG. The algorithm 186-20 begins by creating a triangular mesh of voxel or pixel body elements defined as isosurfaces of the subserosal 148 or provisional working representation at block 186-20A. Next, at block 186-20C, the isosurface layer is defined as a plurality of voxel cubes having eight pixel vertices. Next, at block 186-20E, for the purpose of further dividing or classifying the voxels as an isosurface of the serosal sublayer 148 or as part of a provisional work display, the value of the pixel vertex is set to the selected threshold voxel or It is compared with the luminance value of the pixel. The way of dividing the voxels is described in blocks 186-20G. A voxel is defined as a component or non-component of the isosurface of the serosa sublayer 148. A voxel component is defined as a component if it has a light intensity greater than a threshold, and a non-component if the voxel has a light intensity below a threshold. After the voxels are further divided and classified at block 186-20J, vertex index values are defined and normal values are assembled into voxels. Next, at block 186-20M, the voxels that are components of the isosurface are calculated and summed to obtain the cumulative surface area of the serosa sublayer 148. The algorithm then continues to sub-algorithm 198.

  FIG. 20 is an extension of the sub-algorithm 192 for calculating the thickness of FIG. When the inner (submucosal) and outer (subserosa) layers of the anterior bladder muscle are outlined, the thickness calculation requires the determination of the distance between the two surfaces. From block 180, the process 192 begins at block 192-2, where the pixel with the largest echo signal is identified to obtain the inner and outer wall layer trajectories. Next, at block 192-6, the organ wall thickness is calculated as the difference between the pixel location of the inner wall layer trajectory and the outer wall layer trajectory. The average distance between the inner wall trajectory and the outer wall trajectory is determined for all scan lines approximately perpendicular to the bladder surface. The distance is reported as an output and is also used to calculate bladder weight. The bladder wall drawn on the output image shows this average thickness plotted along the two leading edges of the bladder muscle. From here the process algorithm 192 goes to algorithm 198.

  FIG. 21 shows a sample depicting the outline of the bladder at the scan planes 242-2, 4 and 6, respectively. Here, the periphery of the bladder lumens 250-2, 4, 6 is outlined by the submucosa 246-2, 4, 6 using the sub-algorithm 180A for searching the original wall described above. This outline is used to outline the hypoechoic bladder lumens 250-2, 4, 6 to approximate the general location of the submucosa 246-2, 4, 6 and to estimate urine volume. Provide the basis. Assess whether the bladder contains between 200 and 400 ml so that more accurate positioning of the submucosa and subserosa can be determined by sub-algorithms 178-12, 186, 186-10, 182-20 Therefore, urine volume is estimated. A brighter area is projected toward the dome-shaped cutout 41 in front of the submucosa 246-2, 4 and 6. The area behind the submucosa 246-2, 4, 6 is brighter than the bladder lumens 250-2, 4, 6 because the posterior tissue is the essence of stronger echo intensity.

  Once the bladder wall or subserosa inner surface is outlined on a set of data surfaces, a computer graphics algorithm known as the Marching Cube's algorithm, or other suitable algorithm, to calculate the 3D surface area of the bladder May be used. The Marching Cubes algorithm creates a three-dimensional surface consisting of triangles that are rendered by a computer graphics engine such as the VTK library from Kitware, Inc., Clinton Park, USA. The luminance values of the pixels at the vertices of the triangle determine whether a certain pixel constitutes a certain wall layer component. For example, a pixel value below a selected threshold is defined as a pixel location that is not a component of the surface layer pixel, and a pixel value above the threshold is defined as a component of the surface layer. When a surface consisting of triangles becomes available, the calculation of the surface area of that 3D surface is obtained by summing the areas of all triangles that make up the 3D surface.

  Using the outlined bladder surface as a starting point, the anterior wall of the bladder muscle is then determined to allow for thickness calculations. The following model is used to search the bladder wall. When the ultrasound beam is perpendicularly incident on the surface of the bladder, the bladder wall appears as two bright areas representing the submucosal plus mucosal layer and the subserosal layer separated by a dark area representing the detrusor, as shown in FIG. 9C. It is. Thus, the angle of incidence of the scan line on the surface of the bladder is first determined, and then for every scan line approximately perpendicular to the surface of the bladder, two bright peaks just in front of the bladder lumen are present. Automatically found and labeled as the inner and outer walls of the bladder muscle.

  FIG. 22 is a first set of standard magnified sagittal cross-sectional images projected by the ultrasonic transceiver 10A-B. FIG. 22 shows specimens that outline the bladder wall in front of the bladder adjacent to the bladder lumens 250-10, 12, 14 of the bladder at the scan planes 242-10, 12, 14 respectively. The three images in the upper half of the panel show a complete image in almost standard display. The lower three images are enlarged or zoomed images of square insertions highlighted with solid lines. The bladder wall submucosa 246-10, 12, 14 and the subserosa sublayer 248-10, 12, 14 are drawn with dashed lines superimposed on the enlarged image. When the inner (submucosa) and outer (subserosa) layers of the anterior bladder muscle are outlined, the thickness calculation involves determining the distance between the two surfaces. The average distance between the inner and outer walls is measured on all scan lines approximately perpendicular to the bladder surface, and this distance is reported as an output and is also used to calculate the weight of the bladder. The bladder wall drawn on the output image shows this average thickness plotted along the two leading edges of the bladder muscle. If the tissue around the bladder binds to the bladder's lower serosa, the ultrasound reflection from the tissue around the bladder combines with the reflection from the lower serosa, resulting in a less well defined peak representing the lower serosa. Wall thickness is overestimated.

  FIG. 23 is a second set of standard enlarged sagittal images projected by the ultrasound transceiver 10A-B, with the bladder lumens 250-16 of the bladder at the scan planes 242-16, 18, 20 respectively. , 18 and 2 show specimens delineating the bladder wall in front of the bladder. The three images in the upper half of the panel show a complete image in almost standard display. The lower three images are images in which the insertion of a square highlighted with a solid line is enlarged. The bladder wall submucosa 246-16, 18, 20 and the serosa sublayer 248-16, 18, 20 are drawn with dashed lines superimposed on the magnified image, which represents the determined thickness of the bladder wall. The positioning of the overlapping thickness lines and the separation between them are automatically determined. A sagittal cross-sectional image is displayed so that the peritoneum and the lower serosa layer of the bladder wall are automatically distinguished. Bladder wall delineation can result in overestimation of thickness when tissue surrounding the bladder, such as the peritoneum, joins with the serosal sublayer of the bladder wall.

Once the bladder wall thickness t and surface area S are available, the UEBW is simply calculated by equation E1.

  The specific gravity ρ, used in the calculation of UEBW, is 0.957 as measured by Kojima et al.

  FIG. 24 is a schematic diagram of the elements of the four sections of the surface. Certain embodiments for processing surface compartment elements may be performed by different surface processing algorithms. For example, the B-spline interpolation algorithm described in US Pat. No. 6,676,605 is incorporated herein by reference or used from a VTK library maintained by Kitware (Clinton Park, NY). The application of the marching cubes algorithm is also incorporated herein by reference. As depicted in FIG. 24 in three dimensions, by way of example, it can be seen that five scan planes 320-328 are transmitted across the subserosa wall position 332 substantially longitudinally relative to a three-axis graph grid 340. . The five scan planes include a first scan plane 320, a second scan plane 322, a third scan plane 324, a fourth scan plane 326, and a fifth scan plane 328. The scan plane is represented by the subscripted variable j in the above formula. Substantially perpendicular to the five longitudinal scanning planes are five latitude integrated lines 360-368, a first integrated line 360, a second integrated line 362, a third integrated line 364, a fourth integrated line 366, a fifth Number integrated line 368. The integrated line is represented by the subscripted variable i in the above formula.

The function of the four compartments on the surface is highlighted in FIG. 24 as the subserosa wall location 372. The aforementioned subscripts i and j correspond to the indices of the latitude and longitude lines on the bladder surface. For the purpose of explanation here, it is noted that i corresponds to a longitude line and j corresponds to a latitude line, but the meanings of i and j are interchangeable with the same mathematical result. Using the scan plane and integration line definitions defined in FIG. 20, the functions of the four sections of the surface start in the upper left and rotate clockwise, s ₃₂₂ , ₃₆₂ , s ₃₂₄ , ₃₆₂ , s ₃₂₄ , ₃₆₄ , s ₃₂₂ , ₃₆₄ .

The surface compartment is defined as a function of the compartment coordinates, s _{i, j} (u, v). The partition coordinates u and v are 0 ≦ u, v <1, 0 represents the start coordinate of latitude or longitude (position of i and j), and 1 is the next coordinate of latitude or longitude (position of i + 1 and j + 1) ). The surface function is Cartesian coordinates s _{i, j} (u, v) = x _{i, j} (u, v) i + y _{i, j} (u, v) j + z _{i, j} (u, v) k Where i, j, and k are unit vectors in the x-, y-, and z- directions, respectively. The definition of the surface section function shown in Equation 1 above in vector form describes k and is a unit vector in the x-, y-, and z- directions, respectively, as shown in the following equation. The definition of the surface compartment function in the form of a vector is shown in equation E2.

Now that the definition of the surface compartment function is complete, focus on the surface area calculation shown in the fifth block 206-10 of FIG. As shown in equation E3, the surface areas S, A (S) can be defined as the integral of the area elements on the surface S.

Since S consists of a function of multiple surface compartments, the calculation of the area of the surface S can be approximated as the sum of the area of the function of the individual surface compartments, as shown in equation E4.

As shown in equation E5, the area of the surface section is the integral of the area elements on the surface section.

  FIG. 25 is a schematic illustration of three scan lines passing through the location of the subserosa wall and the submucosa wall of the organ, here representing the bladder. Three scan lines 362, 364, 366 pass through the bladder. The dashed portion represents the portion of the scan line that passes through the bladder muscle wall at the anterior or anterior wall location 370A and the posterior or posterior wall location 370B. It can be seen that the first scan line 362, the second scan line 364, and the third scan line 366 are transmitted through the sub-serosa front wall position 372A and the submucosal front wall position 374A. Similarly, the first scan line 362, the second scan line 364, and the third scan line 366 are transmitted across the internal region 375 of the bladder through the submucosal posterior wall position 374B and the subserosa posterior wall position 372B. I can see it. The subserosa front and rear positions 372A, 372B occupy the outer periphery of the bladder wall, and the submucosal front and rear positions 374A, 374B occupy the inner periphery of the bladder wall. Bladder wall thickness value 376 may be calculated for each scan line 362 between subserosa wall location 372A and submucosal wall location 374A, or between subserosa wall location 372B and submucosal wall location 374B. With each difference along -366. These maximum, minimum and average thickness values are used for bladder wall mass calculation and data history tracking. In selected embodiments, since the bladder is assumed to have an equal wall thickness, the average wall thickness value is derived from the scan data and used to determine the bladder lumen volume 375. Three scanning lines separated by 7.5 degrees from each other are shown on one surface, but the number of scanning lines on the surface and the angle at which each scanning line is separated within the surface can be changed.

  When the bladder wall thickness and inner and outer surface areas are measured, the volume of the internal region of the organ, such as the intravesical 375, is the submucosal anterior wall along each scan line that penetrates the bladder lumen 375. And the respective difference between the rear wall positions 374A and 374B. The difference between the submucosal anterior and posterior wall locations 374A and 374B defines the distance within the submucosa. The internal volume of the bladder lumen 375 is then calculated as a function of the submucosal distance of the scan line passing through and the area of the subserosa boundary or the inner periphery of the bladder. The volume of the bladder lumen 375 is assumed to be the surface area multiplied by a function of the submucosal distance, which further assumes that the subserosa wall boundary is even at all points around the inner circumference of the bladder. It is based on something. In the illustrated embodiment, this volume calculation corresponds to the eighth block 206-20 of FIG.

  A method for obtaining wall thickness data, mass data, and bladder lumen 375 volume via downloaded digital signals is set up by a microprocessor system for remote operation via an internet web-based system. Can do. An Internet web-based system "System For Remote Evaluation Of Ultrasound Information Obtained By A Program Application-Specific Data Collection Device" is US Pat. No. 6,569. , 097 (Gerald McMorrow et al.) And incorporated herein by reference. The Internet web-based system has a number of programs that collect, analyze, and store organ thickness and organ mass index. Alternative embodiments thus provide the ability to measure the rate at which an organ grows over time, enable disease tracking, disease progression, and provide useful instructions to the patient.

  Figures 26-28 show tabulated graphs of UEBW measurements from 17 healthy male subjects between the ages of 24 and 55. Each subject was scanned during 2 or 3 visits within a week. A certified sonographer scanned each subject with three different BVM6500 devices. The sonographer further scanned the subject with a freehand translatable ultrasound transceiver using a 10-5 Mhz linear array probe. Bladder wall thickness was manually measured from the leading edge of the subserosa sublayer to the leading edge of the submucosa plus mucosal layer on the horizontal and sagittal images with a freehand, translating ultrasound probe. The subject then urinated into the urine flow meter to measure the total amount of urination. Finally, residual volume after urination (PVR) was measured using the same three BVM6500 devices. All scans that were outside the specified volume range of 200 ml to 400 ml were excluded from the analysis. In addition, all scans that did not produce a well-centered or well-targeted image based on the aiming arrow information were also excluded from the analysis. Visual examination also confirmed all cases where the peritoneum was associated with the subserosal layer of the bladder.

  FIG. 26 shows the measured value of UEBW of a group of 17 subjects. Certain embodiments measured the average UEBW of healthy male subjects, resulting in 46 g with a standard deviation of 8.5 g in a total of 103 tests with various subjects. FIG. 7 shows actual UEBW measurements for different subjects. The UEBW was found to be fairly consistent across a single subject between different instruments with different volumes between 200 ml and 400 ml. The average coefficient of variation (standard deviation divided by the average value) of the measured values for UEBW was 8%, between 2% and 19% for different subjects. When calculating UEBW by multiplying the thickness measured by a sonographer using a freehand, translating ultrasound instrument by the surface area measured by certain embodiments of the UEBW device, an average coefficient of variation of 11% And shows that the manual thickness measurement is somewhat less consistent.

  FIG. 27 shows the measured values of UEBW of the subject group after excluding the case where the peritoneum was combined with the lower serosa layer of the bladder wall. For 17 subjects, 11 cases were visually excluded where the peritoneum was associated with the subserosa. For this 11, the average coefficient of variation of the measured value of UEBW dropped to 6% at a minimum of 2% and at a maximum of 9%. A plot of the remaining 92 UEBW measurements for 17 subjects is also shown in FIG.

  FIG. 28 shows the bladder surface area calculated by certain method embodiments plotted against bladder volume. The bladder surface area was calculated by the method of certain embodiments and plotted against the bladder volume. The gray line in the figure indicates the surface area of the bladder when the bladder is assumed to have a spherical structure. The bladder surface area calculated by certain embodiments of the method is on average about 18% higher than the surface area calculated under the spherical assumption (p-value <0.001, maximum at 3% minimum) 67%), as expected, indicates that the surface of the bladder cannot be sufficiently estimated by the spherical shape.

  The volume of the bladder before urination as measured by certain embodiments of the device was compared to the sum of the urine volume measured with a urine flow meter and the residual volume after urination. An average difference of -4.6% (95% confidence interval (CI), -2.7% to -6.4%) was found by volume measurement, which was -17 ml (95% CI, -11 to -23) It corresponds to the difference.

  Certain embodiments provide an automatic and convenient way to estimate UEBW. The results show that UEBW can be measured consistently and accurately using 3D V-mode ultrasound. Accuracy and reproducibility are improved when the 3D ultrasound scan is centered and the bladder volume is between 200 ml and 400 ml. Aiming information and bladder volume measurements are immediately provided to the user for optimal scanning.

  Several researchers have previously proposed measuring UEBW, but their methods have some limitations, and certain embodiments overcome that limitation. The accuracy of existing methods for estimating bladder weight is limited due to the assumption that the bladder shape is spherical. Certain embodiments provide results indicating that the bladder shape is significantly non-spherical. Furthermore, since the thickness is manually measured in the existing method, the measurement of the bladder wall is subject to large fluctuations within and between the measurers. In addition, both the need to fill the patient's bladder to a known fixed volume using a catheter and the need for expensive high-resolution B-mode ultrasound equipment and the availability of an ultrasound technician Such measurements are difficult in daily practice. Certain embodiments are non-invasive, accurate, reliable and easy to use.

  The UEBW average coefficient of variation (CV) of 8%, found using certain embodiments of the method, resulted from a combination of several causes of variability and requires further study. Errors in surface area and thickness measurements are two of the possible sources of variability. Differences between the three devices used are also a source of possible variability. Yet another source of variability is due to diurnal changes in actual bladder weight. As yet another source of variability, the bladder weight itself as measured by certain embodiments of the method may not be constant in all bladder volumes.

  Certain embodiments have a normal subject average UEBW measurement that is slightly higher than the 35 gram average reported by Kojima et al. This difference may be explained by the assumption of a sphere-shaped bladder forced by islets. The actual bladder shape is significantly different from the spherical shape, and using actual surface area results in a UEBW measurement that is at least 18% higher. A second reason for the difference between the Kojima et al. UEBW measurement and certain embodiments may be the thickness measurement method. Certain embodiments measure wall thickness by measuring the distance between peaks projected in the submucosa plus mucosal layer and the subserosa layer. However, Kojima et al. Measure bladder wall thickness via the distance from the leading edge to the leading edge. The distance from the leading edge to the leading edge makes some difference in the weight of the bladder.

  Certain embodiments provide an automatic, easy to use, and consistent method of estimating UEBW as a diagnostic marker for bladder outlet obstruction problems. Ultrasound estimated bladder weight (UEBW) has the potential to be an important indicator for diagnosing bladder outlet obstruction (BOO). Various embodiments have established an approach to measure UEBW accurately, consistently, easily and non-invasively using 3D ultrasound imaging. A three-dimensional (3D) image of the bladder is acquired using a handheld ultrasound device. To allow calculation of bladder volume and bladder surface area, the lower urinary tract region of the bladder is outlined in this 3D data set. To allow calculation of bladder wall thickness (BWT), the outer wall of the outside of the bladder is outlined. UEBW is measured as the product of bladder surface area and the specific gravity of BWT and bladder muscle. UEBW was measured on 17 different healthy subjects, and each subject was imaged several times with different bladder volumes to assess the consistency of UEBW measurements. Our approach measured that the average UEBW of healthy subjects was 46 g (σ = 8.5 g). The UEBW was found to be fairly consistent with an average coefficient of variation of 8% across different bladder volumes between 200 ml and 400 ml in a single subject. The inventor's surface area measurements show that the bladder shape is significantly non-spherical.

  While certain embodiments have been shown and described, numerous changes can be made without departing from the spirit and scope of the invention. For example, certain embodiments are not limited to rotating array scan planes, and may include scan planes configured with V-shaped arrays and translation arrays. Accordingly, the scope of the invention is not limited to the disclosure of the preferred embodiment. Rather, the invention should be determined entirely by reference to the following claims.

It is a transceiver. It is a scanning cone composed of a rotating array of scanning planes. 2 is a partial schematic diagram of a scan plane of an array. FIG. 3 is a partial isometric view. FIG. 5 is a partial schematic and partial isometric side view of a transceiver and a scan cone array composed of 3D distributed scan lines. The ultrasonic transceiver contained in the communication cradle and the data being uploaded wirelessly are shown. Figure 2 shows an ultrasonic transceiver housed in a communication cradle where data is uploaded via an electrical connection. FIG. 5 is an image showing data being wirelessly uploaded to a personal computer during initial setting of a patient's abdomen being scanned with a transceiver and a region of interest (ROI). FIG. 6 is an image showing a patient being scanned with a transceiver and data of an appropriately aimed abdominal ROI being wirelessly uploaded to a personal computer. FIG. 2 is a schematic and partial isometric view of a networked ultrasound system 100 in communication with ultrasound imaging systems 60A-D. 2 is a schematic and partial isometric view of an internet-connected ultrasound system 110 that communicates with ultrasound imaging systems 60A-D. FIG. FIG. 5 is a B-mode ultrasound image of a cross-section of the bladder from an imaging system 60A-D using any of the transceivers 10A-C with a 3.7 MHz pulse frequency. FIG. 9B is a close-up view of the image of FIG. 9A showing the anterior wall of the bladder. A scan line log-compressed single scan line similar to scan line 48 through the bladder, illustrating relative echogenicity as a function of scan line position or depth through the bladder. It is an algorithm which calculates UEBW from the ultrasonic data of V-mode. This is an extension of the sub-algorithm 172 of FIG. This is an extension of the sub-algorithm 178 of FIG. FIG. 11 is an extension of another embodiment of the sub-algorithm 178 of FIG. 12 is an extension of sub-algorithm 178-8 that processes data to delineate the bladder of FIGS. 12A and 12B. This is an extension of the sub-algorithm 178-8A for searching the original wall in FIG. It is an extension of the sub-algorithm 178-8C that fixes the original wall of FIG. FIG. 11 is an extension of the surface area sub-algorithm 186 of FIG. FIG. 11 is an extension of sub-algorithm 186 for calculating the surface area of FIG. FIG. 17 is an extension of the sub-algorithm 186-10 of FIG. FIG. 20 is an extension of the sub-algorithm 186-20 of FIG. This is an extension of the sub-algorithm 192 for calculating the thickness of FIG. A set of three specimens that outline the bladder lumen. FIG. 2 is a first set of standard and enlarged sagittal cross-sectional images projected by an ultrasonic transceiver 10A-B. It is a 2nd set of the standard and enlarged sagittal cross-sectional images projected by the ultrasonic transceiver 10A-B. Fig. 4 is a schematic illustration of four compartment elements on the surface. Figure 2 is a schematic illustration of three scan lines passing through the location of the subserosa and submucosa walls of an organ. The measured value of UEBW of a certain subject group is shown. The measured value of UEBW of the subject group after excluding the case where the peritoneum combined with the lower serosa of the bladder wall is shown. FIG. 5 shows the bladder surface area calculated for a particular method embodiment plotted against bladder volume.

Claims (20)

A method for determining the mass of an organ wall,
Positioning the exterior of the transceiver to the patient so that at least a portion of the organ wall can be imaged by the ultrasound transceiver;
Transmitting radio frequency ultrasonic pulses and receiving reverberant pulses corresponding to the transmitted pulses reverberated from the eternal and internal surface portions of the organ wall;
Calculating at least one portion of the surface area of the exterior and interior surfaces of the organ wall, the thickness between the surfaces, and the mass between the surfaces.   The method of claim 1, wherein the organ wall calculation is outlined in a 3D depiction.   The method of claim 2, wherein the surface area calculation is determined by a marching cubes algorithm applied to the 3D depiction.   4. The method of claim 3, wherein determining the 3D representation includes an array of 2D scan planes and an array of scan lines distributed in 3D.   The method of claim 1, wherein locating the transceiver generates an ultrasonic pulse echo substantially perpendicular to the organ wall.   6. The method of claim 5, wherein the organ wall is a bladder wall.   The method of claim 6, wherein the bladder contains between approximately 200 ml and 400 ml of fluid.   8. The method of claim 7, wherein the weight of the bladder wall is calculated as a product of the surface area of the inner wall, the thickness of the wall, and the density of the wall.   The method of claim 7, wherein the weight of the bladder wall is calculated as a product of the surface area of the outer wall, the thickness of the wall, and the density of the wall. A system for determining the mass of an organ wall,
The transceiver is placed outside the patient so that at least a portion of the organ wall can be imaged by an ultrasound transceiver, receiving radio frequency ultrasound pulses from the transceiver and receiving ultrasound echoes returned from the organ wall. The transceiver to collect; and
A system comprising a microprocessor in communication with the transceiver capable of executing a program to process information from the echo to determine an organ surface area and organ mass.   The system of claim 10, wherein the organ wall is outlined in a 3D depiction.   11. The system of claim 10, wherein the surface area is determined by a marching cubes algorithm applied to the 3D depiction.   The system of claim 10, wherein the 3D representation includes an array of 2D scan planes and an array of scan lines distributed in 3D.   The system of claim 10, wherein the ultrasound echo is substantially perpendicular to the wall of the organ.   11. The system of claim 10, wherein the organ wall is a bladder wall.   The system of claim 15, wherein the bladder contains a volume of fluid between approximately 200 ml and approximately 400 ml.   11. The system of claim 10, wherein the organ surface layer includes an inner area, and the weight of the bladder wall is a product of the inner area, wall thickness, and wall density.   The system of claim 10, wherein the organ surface layer includes an outer area, and the weight of the bladder wall is a product of the outer area, wall thickness, and wall density.   The system of claim 10, wherein the transceiver further includes an inertial reference device to determine a position coordinate of the transceiver relative to the patient.   The system of claim 19, wherein the inertial reference device includes at least one accelerometer and at least one gyroscope.

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