WO2015053737A1 - Ballon de repérage - Google Patents

Ballon de repérage Download PDF

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Publication number
WO2015053737A1
WO2015053737A1 PCT/US2013/063642 US2013063642W WO2015053737A1 WO 2015053737 A1 WO2015053737 A1 WO 2015053737A1 US 2013063642 W US2013063642 W US 2013063642W WO 2015053737 A1 WO2015053737 A1 WO 2015053737A1
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WO
WIPO (PCT)
Prior art keywords
balloon
ultrasound
location
marker
monitored
Prior art date
Application number
PCT/US2013/063642
Other languages
English (en)
Inventor
George Charles PEPPOU
Original Assignee
Empire Technology Development Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Empire Technology Development Llc filed Critical Empire Technology Development Llc
Priority to PCT/US2013/063642 priority Critical patent/WO2015053737A1/fr
Publication of WO2015053737A1 publication Critical patent/WO2015053737A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/52—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/5215—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data
    • A61B8/5223—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data for extracting a diagnostic or physiological parameter from medical diagnostic data
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/12—Devices for detecting or locating foreign bodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/44—Constructional features of apparatus for radiation diagnosis
    • A61B6/4417—Constructional features of apparatus for radiation diagnosis related to combined acquisition of different diagnostic modalities
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/0841—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4416—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to combined acquisition of different diagnostic modalities, e.g. combination of ultrasound and X-ray acquisitions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • A61L29/085—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/18—Materials at least partially X-ray or laser opaque
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/30—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indices; for individual health risk assessment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3925—Markers, e.g. radio-opaque or breast lesions markers ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3995—Multi-modality markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1079—Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1048—Monitoring, verifying, controlling systems and methods
    • A61N5/1049—Monitoring, verifying, controlling systems and methods for verifying the position of the patient with respect to the radiation beam
    • A61N2005/1058—Monitoring, verifying, controlling systems and methods for verifying the position of the patient with respect to the radiation beam using ultrasound imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N2005/1092—Details
    • A61N2005/1094—Shielding, protecting against radiation

Definitions

  • Embodiments generally relate to the field of ultrasound imaging.
  • Ultrasound techniques can be used for obtaining images in a variety of technologies.
  • ultrasound provides a powerful imaging modality and can be used in medical procedures to image various internal organs and structures.
  • an ultrasound balloon is provided.
  • the ultrasound balloon includes an inflatable balloon configured to be deformable when inflated.
  • the ultrasound balloon includes an echogenic marker and a radiopaque marker. The echogenic marker is distinguishable from the radiopaque marker.
  • a kit for imaging includes an ultrasound balloon configured to be inflatable and deformable when inflated.
  • the kit also includes an echogenic marker, and a radiopaque marker. The echogenic marker is distinguishable from the radiopaque marker.
  • a method for locating a structure to be monitored within a body of a subject includes providing an ultrasound balloon, wherein the ultrasound balloon comprises an area of deformation and wherein the area of deformation is due to a structure to be monitored within the body of a subject.
  • the method includes measuring a first distance from a first point on the ultrasound balloon to a known feature of the subject using radiographic imagery.
  • the method also includes measuring a second distance from the first point on the ultrasound balloon to the area of deformation using ultrasound.
  • the method also includes combining the first distance and the second distance to determine a location of the structure to be monitored.
  • a method for determining a location of a structure to be monitored within a subject includes determining a first location of an ultrasound balloon within a body of a subject. The method also includes determining a second location on the ultrasound balloon that is in contact with a structure to be monitored. The method also includes combining the first location of the ultrasound balloon with the second location on the ultrasound balloon to determine a location of the structure to be monitored in within the subject.
  • FIG. 1 is a drawing depicting some embodiments of an ultrasound balloon.
  • FIGS. 2A-2C are drawings depicting some embodiments of radiopaque markers pattern on an ultrasound balloon.
  • FIG. 3 is a flow chart depicting some embodiments of a method of location a structure to be monitored within a subject.
  • FIG. 4 is a flow chart depicting some embodiments of a method of location a structure to be monitored within a subject.
  • FIG. 5 is a flow chart depicting some embodiments of a method of determining a location of an ultrasound balloon.
  • FIG. 6 is a flow chart depicting some embodiments of a method of locating a structure to be monitored relative to an ultrasound balloon.
  • FIG. 7 is a drawing depicting some embodiments of a computing system
  • devices including an ultrasound balloon
  • methods for locating a structure to be monitored such as a target organ
  • the method involves determining two separate distances (one from a reference point to an edge on the balloon and the other from the edge of the balloon to a point of deformation on the balloon) and combining them to obtain a more accurate location of an object of interest within a subject, relative to the reference point.
  • an ultrasound balloon that includes both an echogenic marker that can be visualized using ultrasound imaging and a radiopaque marker than can be visualized using radiographic imaging (such as a CT scanner or other x-ray scanner).
  • the two markers are adequately distinguishable from one another to allow the echogenic marker to be visualized by ultrasound imaging and the radiopaque maker to be visualized by radiographic imaging.
  • the first distance can be the "balloon distance" itself, which is the distance from the edge of the balloon to a landmark structure in the body (such as a particular bone). This distance can be determined via radiographic imaging of the radiographic marker.
  • the second distance can be the "deformation distance,” which is the distance of the structure to be monitored to the edge of the balloon. This distance can be determined via an ultrasound of the echogenic marker on the balloon. The distances from both markers are then combined to determine a relatively specific location of the structure to be monitored in relation to the known structure.
  • FIG. 1 is a drawing depicting some embodiments of an ultrasound balloon 100 having two markers. While any ultrasound balloon can be employed, the ultrasound balloon should be deformable when inflated. The deformability of the balloon allows for the localization of the structure to be monitored 160, upon the surface of the balloon 100, via a deformation in the balloon 100.
  • the balloon 100 includes a radiopaque marker 110 and an echogenic marker 120. When the balloon is positioned against a structure to be monitored 160 in a body of a subject, the radiopaque marker 110 can be used to measure a balloon distance 130, which is a first distance between the balloon 100 and a known structure 140 in the body.
  • the echogenic marker 120 can be used to measure a deformation distance 150, which is a second distance between the balloon and the structure to be monitored 160. Combining these two distances allows for one to determine a more specific distance and/or location of the structure to be monitored 160 from the known structure 140 in the subject's body, than would otherwise be possible.
  • the ultrasound transducer 10 can be positioned elsewhere, as long as the positioning allows for the deformation distance 150 to be determined via the ultrasound.
  • the ultrasound transducer 10 can be positioned such that the balloon 100 is between the ultrasound transducer 10 and the structure to be monitored 160.
  • the ultrasound transducer 10 is placed as close to the balloon as possible, without touching the balloon 100 itself. The ultrasound transducer can be positioned such that the deformation distance 150 is maximized to thereby find the most accurate deformation distance 150.
  • a radiation system 20 can be used in conjunction with the radiopaque marker 110 on the balloon 100. While depicted separately from the rest of the arrangement, the entire system, including the subject, can be located within the radiation system 20.
  • the radiation system 20 can be a CT scanner.
  • the radiation system can be any x-ray and/or radiation system that allows one to determine the position of the known structure 140, relative to the radiopaque marker 110 on the balloon 100, that is, the balloon distance 130.
  • the radiation system can be positioned such that the balloon distance 130 is maximized to thereby find the most accurate balloon distance 130.
  • the radiation system 20 can include two or more parts, a radiation source and a radiation detector.
  • the source and the detector can be positioned on opposite sides of the balloon 100 and/or known structure 140.
  • a first part of the radiation system 20 (for example the radiation source) can be positioned in the plane of the page and above the line designating balloon distance 130, while a second part of the radiation system 20 (for example, the radiation detector) can be positioned within the plane of the page but below the line designating balloon distance 130.
  • any radiation source and/or radiation detector can be used as the radiation system 20, as long as the resulting system is adequate to detect the radiopaque maker 110 on the balloon so as to determine the balloon distance 130.
  • a variety of radiopaque markers and echogenic markers can be employed on the balloon.
  • markers on and/or within the balloon can be employed as well.
  • the markers used and their distributions should permit the determination of the balloon distance 130 and the deformation distance 150, and these distances should also be known relative to one another.
  • balloon distance 130 and deformation distance 150 can be known relative to each other, and they both have a common end point (the edge of the balloon).
  • any pair of markers can be used, as long as the data regarding the two distances can be distinguished adequately. In some embodiments, any two distinguishable markers can be employed.
  • the balloon can be made of any material as long as it be adequately deformable when at least partially inflated and placed adjacent to the structure to be monitored 160. While the degree of deformation preferred can vary, in some embodiments, it is sufficient when a peak of a deformation is observable in the ultrasound.
  • a surface of the balloon includes a co-polymer of polylactide acid and epsilon caprolactone.
  • a surface of the balloon includes a polymer, such as PLGA, PLA-PEG, polycaprolactone and/or polydioxane and/or additional options and equivalents.
  • the preparations may include additional plasticisers to achieve necessary physical properties.
  • the balloon can also include other biocompatible and/or absorbable materials.
  • the balloon itself can be relatively transparent to ultrasound (echo transparent) and/or radiation (radiolucent), in comparison to the markers themselves.
  • the balloon is made of and/or filled with one or both of the markers, and thus, the balloon itself need not be transparent.
  • the balloon can be structured so that it is readily deformed.
  • the balloon is only partially filled to allow deformation around surrounding structures.
  • the balloon can be filled sufficiently so that any pattern of any of the markers takes on a desired and/or predetermined configuration.
  • the balloon is at least adequately inflated such that an edge of the balloon (such as the edge where balloon distance 130 and deformation distance 150 meet in FIG.
  • the radiopaque marker 110 can include at least one of a radiopaque dye, a metallic marker, a barium molecule, an iodine molecule, a gold particle, or a titanium particle.
  • the radiopaque dye or metallic marker can be incorporated into the balloon 100 itself (for example, the shell of the balloon and/or inside the balloon).
  • the echogenic marker and radiopaque markers are sufficiently distinguishable from one another so as to allow the two distances (balloon distance 130 and deformation distance 150) to be determined without the markers excessively interfering with one another. In some embodiments, this can be achieved by selecting the two markers such that they do not excessively interfere with one another when the other mode of detection is employed. For example, an echogenic marker can be selected so that it is less detectable via the radiation system than the previously selected radiopaque dye. Similarly, a radiopaque dye can be selected such that it is less detectable via an ultrasound, than the selected echogenic marker. In some embodiments, the echogenic marker is relatively radiolucent compared to the radiopaque marker.
  • the radiopaque marker is relatively echotransparent compared to the echogenic marker. In some embodiments, this can be achieved via the type of material selected and/or the amount of the material employed. In some embodiments, the two markers are distinguishable based upon a known pattern for each marker on the balloon. Thus, for example, the radiopaque marker can be in a specific first pattern on a surface of the balloon, while the echogenic markers are in a specific (and different) second pattern on the surface of the balloon. Alternatively, one marker can be used to inflate the balloon, while the other can be used on a surface of the balloon itself. In some embodiments, the balloon material itself can be relatively echotransparent. In some embodiments, the balloon material itself can allow for the transmission of x-rays (for example, it can be radiolucent). In such embodiments, the pattern provided by the marker will provide a higher contrast when on such transparent material.
  • the radiopaque marker can have a particular configuration or pattern on the balloon.
  • the radiopaque marker 110 may be configured as a pattern arranged on the surface of the balloon.
  • FIGs. 2A-2C are drawings depicting embodiments of radiopaque markers on the balloon.
  • FIG. 2A depicts embodiments of two different perspectives (top down and a side perspective) of a radiopaque marker 210 configured as a grid pattern on a surface 220 of the balloon.
  • FIG. 2B depicts embodiments of two different perspectives (top down and a side perspective) of a radiopaque marker 230 configured as a target pattern on a surface 240 of the balloon.
  • the echogenic marker can have a particular configuration or pattern on the balloon.
  • one or more of the markers can have a particular pattern on the balloon.
  • the pattern is a desired or predetermined pattern, such as in FIGs. 2A-2C.
  • the pattern can be random, but can be subsequently identified. As long as one of the patterns is identifiable, the pattern can be employed for various methods provided herein. In some embodiments, no specific pattern need be present.
  • a pattern or other defining characteristic on the balloon can also allow one to define the distances differently, if desired. For example, rather than having to measure a distance from an outer edge of the balloon and having balloon distance 130 and deformation distance 150 meet there, one can instead move the meeting point of balloon distance 130 and deformation distance 150 elsewhere on the balloon, to any pattern or part of the pattern.
  • the center of the cross formed by the radiopaque marker 210 in FIG. 2A can be the point at which balloon distance 130 and deformation distance 150 are measured.
  • the pattern can allow one to measure the balloon distance 130 and deformation distance 150 in a manner in which the distances do not need to connect to one another directly, but can be indirectly associated with one another.
  • the inner most ring can be used for measurement of deformation distance 150, the outer most ring for balloon distancel30, and then a known distance between the inner most ring and outer most ring added to the two distances, to obtain the full distance between the structure to be monitored 160 and the known structure 140.
  • the pattern on the balloon can give an orientation of the balloon. This orientation can be used to determine additional information regarding the positioning of the structure to be monitored 160 and the balloon 100 relative to the object. For example, if deformation distance 150 and optional first leg distance 155 are determined (and the second leg distance 157 is known from, for example, the pattern on the balloon), then the pattern can also be employed to determine the angle 156 of the line for the deformation distance 150.
  • the first leg distance 155 can also be useful in that it gives a distance of the structure to be monitored 160 from the second leg 156 of the triangle having deformation distance 150 as the hypotenuse.
  • deformation distance 150 can be obtained by solving the Pythagorean theorem using first leg distance 155 and second leg distance 157.
  • balloon distance 130 is the parameter being applied in the various methods.
  • the system can operate without the need for imaging aspects apart from radiographic imaging.
  • a minimal distance 151 between the known structure 140 and the structure to be monitored 160 can be determined if desired (rather than relying simply on the sum of the balloon distance 130 and the deformation distance 150). For example, once deformation distance
  • angle 156 can be determined, which when subtracted from 180 degrees can provide the inner angle of the noted triangle, and the length of the minimal distance
  • the quantity of radiopaque markers can vary depending on the configuration (for example, pattern) selected. Furthermore the amount can be selected so that the balloon can be left in the subject. For example, if the radiopaque marker is included in the balloon material, the marker dye will be released into the body at the rate the balloon material is absorbed. This release can prevent a single high dosage from being received by the patient, instead releasing a gradual dosage over a period of time. Thus, one can also select the amount of marker so that the subject does not receive too much of the marker once the balloon has been reabsorbed. [0029] While any of a variety of echogenic markers can be employed, the particular options of echogenic markers can depend upon the particular application of the device.
  • the echogenic marker 120 includes at least one of a microbubble, an albumin, a polyethylene glycol, a lipid-galactose, a polymer including regular acoustic irregularities, a glass microsphere, or a magnetic contrast agent.
  • the microbubbles are gas filled particles that can be between about 0.1 and 100 microns in size, for example about 2 to 8 microns size.
  • the echogenic marker 120 can be integrated into a surface of the balloon 100.
  • the balloon 100 is at least partially filled with a fluid including the echogenic marker 120.
  • the balloon 100 can include the echogenic marker as a coating on a surface of the balloon 100.
  • the balloon 100 can include a coating on a surface of the balloon 100, and the coating can include microbubbles in a sufficient amount to serve as an echogenic marker.
  • the coating can be made of any suitable material, and can include, for example, at least one of an albumin, a polyethylene glycol, or a lipid-galactose.
  • the microbubble can be coated and directly integrated into the material of the balloon 100.
  • the microbubble can be attached using an adhesive.
  • the balloon 100 can be filled with fluid that includes the microbubble.
  • microbubbles can provide an additional dynamic aspect to the process. While the patient is in the supine position, the microbubbles can localize to the side of the balloon in contact with the organ, further allowing a greater degree of localization of the object to be monitored.
  • the coating can be applied only to the side of the balloon 100 nearest the structure of interest. This selective application can enhance the echogenicity of that side of the balloon.
  • the ultrasound can be performed when the microbubbles are in their desired location, and then the subject can be repositioned so that the bubbles are relocated, allowing less interference between the microbubbles and the radiopaque marker.
  • the first and the second measurements are taken at the same or overlapping points in time.
  • the balloon 100 includes a magnetic contrast agent.
  • the magnetic contrast agent can allow the detection of the balloon 100 under magnetic resonance imaging (MRI). This can allow the balloon 100 to be detected without using radiographic imaging.
  • the balloon and/or method can involve magnetic contrast agents (and MRI) with echogenic markers (and ultrasound).
  • a kit for imaging can include an ultrasound balloon, the ultrasound balloon can be configured to be inflatable and deformable when inflated.
  • the kit can also include an echogenic marker, and a radiopaque marker.
  • FIG. 3 depicts some embodiments of a method 300 for locating a structure to be monitored within a body of a subject.
  • the method 300 includes providing an ultrasound balloon. Once inflated and in position, the ultrasound balloon will include an area of deformation (because it is physically abutting the structure to be monitored), at block 310.
  • the method 300 also includes measuring a first distance (the balloon distance) from a first point on the ultrasound balloon to a known feature of the subject using radiographic imagery at block 320.
  • the method includes measuring a second distance (the deformation distance) from the first point on the ultrasound balloon to the area of deformation using ultrasound.
  • the method includes combining the first distance (the balloon distance) and the second distance (the deformation distance) to determine a location of the structure to be monitored at block 340. Measuring the balloon distance and the deformation distance can be performed after the balloon is inserted and adequately inflated in the subject.
  • Measuring the second distance can include performing at least one of a transperitoneal ultrasound or a transrectal ultrasound.
  • the method 300 can include placing the ultrasound balloon into the subject proximally to the structure to be monitored.
  • the manner of insertion of the balloon into the subject can depend upon the organ to be monitored.
  • the balloon is inserted into the subject transrectally.
  • the balloon can be inserted in a specific orientation, which is maintained via the direction of insertion into the subject and/or by rolling the balloon into a tube form for insertion.
  • the balloon can be inflated via a catheter.
  • the uninflated balloon is placed proximally to the structure to be monitored 160.
  • the method can further include expanding the ultrasound balloon to a point that an area of deformation in the ultrasound balloon is provided due to the abutment of the structure to be monitored against the balloon, as shown in FIG. 1.
  • Expanding the ultrasound balloon can include filling the ultrasound balloon with at least one of an echogenic marker and/or a radiopaque marker.
  • the balloon can be inflated with saline.
  • the ultrasound balloon includes at least one of an echogenic marker or a radiopaque marker.
  • the radiopaque marker can be arranged in a predetermined pattern on a surface of the ultrasound balloon.
  • the device and/or method allows for real-time or near real-time location data for the object to be monitored.
  • the balloon can be removed after the process.
  • the balloon is an absorbable balloon and can be left in the subject.
  • FIG. 4 depicts some embodiments of a method for locating a structure to be monitored within a body of a subject.
  • the method 400 includes, at block 410, determining a first location of an ultrasound balloon within a body of a subject.
  • the method 400 includes determining a second location on the ultrasound balloon that is in contact with a structure to be monitored.
  • the method 400 includes combining the first location of the ultrasound balloon with the second location on the ultrasound balloon to determine a location of the structure to be monitored in within the subject.
  • Determining the first location of the ultrasound balloon can include radiographic detection of the first location.
  • at least two radiographic images are used (for example an X/Y plane and an Y/Z plane).
  • Portal imaging for example, electronic portal imaging
  • Conventional radiotherapy conducted prior to the radiotherapy can also be included as part of the process.
  • the radiographic data can be used to determine a location of the balloon relative to a nearby landmark structures.
  • FIG. 5 depicts embodiments of a method for determining the first location of the ultrasound balloon.
  • the method 500 includes obtaining an image of the balloon in a first plane (for example, X/Y plane) at block 510 and obtaining an image of the balloon in a second plane (for example, Y/X plane) at block 520.
  • the method 500 includes inputting the images.
  • the method 500 includes detecting edges of the balloon from both images at block 540.
  • the method 500 includes performing radiopaque pattern recognition.
  • the method 500 includes determining a boundary of the balloon at block 560.
  • the method 500 includes measuring the distance from the boundary to a known structure (for example, a landmark) of the patient.
  • Determining the second location on the ultrasound balloon can include detecting a contour of the balloon along at least a portion of a surface of the balloon in contact with the structure.
  • a 4D ultrasound device and/or method can be employed to provide contour detection.
  • the relative location of the structure to be monitored can be determined by the surface deformation of the balloon where the structure contacts the balloon.
  • the contour can be measured in any number of ways, for example, by at least one of ultrasound, radiography, or magnetic resonance imaging.
  • FIG. 6 depicts some embodiments of a method 600 of determining the second location on the ultrasound balloon.
  • the method 600 includes obtaining ultrasound input from an ultrasound transducer at block 610.
  • the method includes detecting a boundary of the balloon at block 620.
  • the method includes detecting a contour of the balloon.
  • the method 600 includes detecting a peak in the ultrasound input at block 640.
  • the method includes measuring a height of the peak.
  • the method 600 includes determining a location of a peak maximum at block 660.
  • the method 600 includes measuring a distance from a center of the peak maximum to the boundary of the balloon. This can then be combined with the data in FIG. 5, by any of the methods outlined in FIGs. 3 or 4 to determine the final distance of the object of interest from the known structure.
  • a 4-dimensional ultrasound can be used to determine the second location in real-time.
  • 4-dimensional ultrasound can offer high spatial resolution and real time data acquisition to provide real-time tracking.
  • the mode of ultrasound can be selected based on characteristics of the patient. For example, for some patients transperitoneal ultrasound may be suitable, while for obese patients, transrectal ultrasound may be used.
  • the method 400 further includes positioning the ultrasound balloon adjacent to the prostate of a patient. In other embodiments, the method 400 includes positioning the ultrasound in other locations of the body. In some embodiments, the method and/or devices provided herein can be employed in any situation where there is a rigid structure (such as a bone that can serve as the known structure) adjacent to a flexible structure (structure to be monitored 160). [0044] The methods and devices described herein can be used to image treatment areas during radiotherapy, for example radiotherapy of the prostate. The imaging devices and methods described herein can provide improved accuracy due to tracking of the organ to be treated. In some embodiments, the ultrasound balloon disclosed herein also allows minimally invasive placement. Placement of the balloon can be transrectally.
  • the proper placement can be achieved by inserting the balloon in a rolled configuration and unrolling it in place.
  • the orientation of the balloon can be examined by checking for the pattern (such as in FIG. 2B) of one of the markers on the balloon.
  • the balloon can be of any desired size, for example, it can be between about 5 and 30 mm in diameter, including about 10 to 20 mm in diameter.
  • the balloon can be large enough to contain about 50 to 300 mL of liquid when inflated (to the point where deformation is still adequate). In some embodiments, the balloon can contain a volume of about 100 mL.
  • the ultrasound balloon can provide some spacing effect and shielding during radiotherapy, protecting other nearby organs, for example the rectum in the case of prostate radiotherapy.
  • the ultrasound balloon can provide a low cost solution to the problem of accurate imaging during radiotherapy.
  • the ultrasound balloon can remain in place following completion of a radiotherapy course.
  • the ultrasound balloon and methods of use described herein can also be compatible with immobilizing devices (for example, the balloon can be an endorectal balloon).
  • a computer-readable media including program instructions for determining a location of a structure to be monitored within a subject is provided.
  • any of the operations, processes, etc. described herein can be implemented as computer-readable instructions stored on a computer-readable medium
  • the computer-readable instructions can be executed by a processor of a mobile unit, a network element, and/or any other computing device.
  • the user may opt for a mainly hardware and/or firmware vehicle; if flexibility is paramount, the user may opt for a mainly software implementation; or, yet again alternatively, the user may opt for some combination of hardware, software, and/or firmware.
  • a signal bearing medium examples include, but are not limited to, the following: a recordable type medium such as a floppy disk, a hard disk drive, a CD, a DVD, a digital tape, a computer memory, etc.; and a transmission type medium such as a digital and/or an analog communication medium (for example, a fiber optic cable, a waveguide, a wired communications link, a wireless communication link, etc.).
  • a typical data processing system generally includes one or more of a system unit housing, a video display device, a memory such as volatile and non-volatile memory, processors such as microprocessors and digital signal processors, computational entities such as operating systems, drivers, graphical user interfaces, and applications programs, one or more interaction devices, such as a touch pad or screen, and/or control systems including feedback loops and control motors (for example, feedback for sensing position and/or velocity; control motors for moving and/or adjusting components and/or quantities).
  • a typical data processing system may be implemented utilizing any suitable commercially available components, such as those typically found in data computing/communication and/or network computing/communication systems.
  • any two components so associated can also be viewed as being “operably connected”, or “operably coupled”, to each other to achieve the desired functionality, and any two components capable of being so associated can also be viewed as being “operably couplable”, to each other to achieve the desired functionality.
  • operably couplable include but are not limited to physically mateable and/or physically interacting components and/or wirelessly interactable and/or wirelessly interacting components and/or logically interacting and/or logically interactable components.
  • FIG. 7 is a block diagram illustrating an example computing device 700 that is arranged for determining location aspects of an ultrasound balloon in accordance with the present disclosure.
  • computing device 700 typically includes one or more processors 704 and a system memory 706.
  • a memory bus 708 may be used for communicating between processor 704 and system memory 706.
  • processor 704 may be of any type including but not limited to a microprocessor ( ⁇ ), a microcontroller ( ⁇ ), a digital signal processor (DSP), or any combination thereof.
  • Processor 704 may include one more levels of caching, such as a level one cache 710 and a level two cache 712, a processor core 714, and registers 716.
  • An example processor core 714 may include an arithmetic logic unit (ALU), a floating point unit (FPU), a digital signal processing core (DSP Core), or any combination thereof.
  • An example memory controller 718 may also be used with processor 704, or in some implementations memory controller 718 may be an internal part of processor 704.
  • system memory 706 may be of any type including but not limited to volatile memory (such as RAM), non-volatile memory (such as ROM, flash memory, etc.) or any combination thereof.
  • System memory 706 may include an operating system 720, one or more applications 722, and program data 724.
  • Application 722 may include a distance calculating method and/or algorithm 726 that is arranged to perform the functions as described herein including those described with respect to process 300 of FIG. 3, process 400 of FIG. 4, process 500 of FIG. 5 and process 600 of FIG. 6.
  • Program data 724 may include a) data regarding a location of an ultrasound balloon within a subject and a location on the ultrasound balloon that is in contact with a structure to be monitored, b) data regarding a first distance and a second distance, c) image data in X/Y and Y/Z planes, and/or d) ultrasound data sufficient for boundary detection, contour detection, peak detection, peak height measurement, and/or distance from center of maximum peak to balloon boundary that may be useful for the distance calculating method and/or algorithm 726 as is described herein.
  • application 722 may be arranged to operate with program data 724 on operating system 720 such that implementations of robust distance calculation may be provided as described herein. This described basic configuration 702 is illustrated in FIG. 7 by those components within the inner dashed line.
  • Computing device 700 may have additional features or functionality, and additional interfaces to facilitate communications between basic configuration 702 and any required devices and interfaces.
  • a bus/interface controller 730 may be used to facilitate communications between basic configuration 702 and one or more data storage devices 732 via a storage interface bus 734.
  • Data storage devices 732 may be removable storage devices 736, non-removable storage devices 738, or a combination thereof. Examples of removable storage and non-removable storage devices include magnetic disk devices such as flexible disk drives and hard-disk drives (HDD), optical disk drives such as compact disk (CD) drives or digital versatile disk (DVD) drives, solid state drives (SSD), and tape drives to name a few.
  • Example computer storage media may include volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information, such as computer readable instructions, data structures, program modules, or other data.
  • System memory 706, removable storage devices 736 and nonremovable storage devices 738 are examples of computer storage media.
  • Computer storage media includes, but is not limited to, RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital versatile disks (DVD) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which may be used to store the desired information and which may be accessed by computing device 700. Any such computer storage media may be part of computing device 700.
  • Computing device 700 may also include an interface bus 740 for facilitating communication from various interface devices (for example, output devices 742, peripheral interfaces 744, and communication devices 746) to basic configuration 702 via bus/interface controller 730.
  • Example output devices 742 include a graphics processing unit 748 and an audio processing unit 750, which may be configured to communicate to various external devices such as a display or speakers via one or more A/V ports 752.
  • Example peripheral interfaces 744 include a serial interface controller 754 or a parallel interface controller 756, which may be configured to communicate with external devices such as input devices (for example, keyboard, mouse, pen, voice input device, touch input device, etc.) or other peripheral devices (for example, printer, scanner, etc.) via one or more I/O ports 758.
  • An example communication device 746 includes a network controller 760, which may be arranged to facilitate communications with one or more other computing devices 762 over a network communication link via one or more communication ports 764.
  • the network communication link may be one example of a communication media.
  • Communication media may typically be embodied by computer readable instructions, data structures, program modules, or other data in a modulated data signal, such as a carrier wave or other transport mechanism, and may include any information delivery media.
  • a "modulated data signal" may be a signal that has one or more of its characteristics set or changed in such a manner as to encode information in the signal.
  • communication media may include wired media such as a wired network or direct-wired connection, and wireless media such as acoustic, radio frequency (RF), microwave, infrared (IR) and other wireless media.
  • RF radio frequency
  • IR infrared
  • the term computer readable media as used herein may include both storage media and communication media.
  • Computing device 700 may be implemented as a portion of a small- form factor portable (or mobile) electronic device such as a cell phone, a personal data assistant (PDA), a personal media player device, a wireless web-watch device, a personal headset device, an application specific device, or a hybrid device that include any of the above functions.
  • a small- form factor portable (or mobile) electronic device such as a cell phone, a personal data assistant (PDA), a personal media player device, a wireless web-watch device, a personal headset device, an application specific device, or a hybrid device that include any of the above functions.
  • PDA personal data assistant
  • Computing device 700 may also be implemented as a personal computer including both laptop computer and non-laptop computer configurations.
  • the present example outlines an embodiment of a method of imaging a prostate using an ultrasound balloon.
  • the ultrasound balloon includes a metallic marker arranged as a grid pattern on the surface of the ultrasound balloon.
  • the ultrasound balloon also includes a microbubble coating.
  • the ultrasound balloon is placed into the body of a subject, proximally to the prostate.
  • the ultrasound balloon is expanded so that the prostate is deforming a portion of the balloon.
  • Radiographic imaging is used to determine a location of the edge of the balloon relative to a bony structure of the patient.
  • 4-D ultrasound imaging using a transrectal transducer, is used to determine a contour of the balloon that is in contact with the prostate, and thereby determine a location of the prostate on the balloon, and the relative distance of the location of the prostate to the same point on the edge of the balloon.
  • the location of the ultrasound balloon and the distance between the location of the prostate to the same point on the edge of the balloon are combined to determine the location of the prostate, relative to the bony structure of the patient.
  • the ultrasound balloon is placed into the body of a subject, proximally to the prostate.
  • the patient is kept in the supine position.
  • the ultrasound balloon is expanded with a solution containing microbubbles in a sufficient quantity to serve as an echogenic marker, and barium, in an amount sufficient to serve as a radiopaque marker.
  • the balloon is expanded until relatively rigid, but still flexible enough so that the prostate deforms a portion of the balloon.
  • Radiographic imaging is used to determine the distance between the edge of the balloon to a bony structure of the patient.
  • Ultrasound imaging, using a transrectal transducer is used to determine the contour of the balloon that is in contact with the prostate.
  • the distance between a peak of the contour in the balloon (that is due to the presence of the prostate) and the same point on the edge of the balloon is then determined.
  • the distance of the ultrasound balloon from the boney structure and the distance between the peak to the same point on the edge of the balloon are combined to determine the distance of the prostate from the bony structure of the patient.
  • At least one of A, B, and C, etc. is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (for example, " a system having at least one of A, B, and C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.).
  • a range may include each individual member.
  • a group having 1-3 cells may refer to groups having 1 , 2, or 3 cells.
  • a group having 1 -5 cells may refer to groups having 1, 2, 3, 4, or 5 cells, and so forth.
  • Embodiments of the present disclosure may not to be limited in terms of the particular embodiments described in this application, which are intended as illustrations of various aspects. Many modifications and variations can be made without departing from its spirit and scope, as will be apparent to those skilled in the art. Functionally equivalent methods and apparatuses within the scope of the disclosure, in addition to those enumerated herein, will be apparent to those skilled in the art from the foregoing descriptions. Such modifications and variations are intended to fall within the scope of the appended claims. The present disclosure is to be limited only by the terms of the appended claims, along with the full scope of equivalents to which such claims are entitled.

Abstract

L'invention concerne des compositions et des procédés pour déterminer une localisation d'une structure à surveiller à l'intérieur d'un corps. La composition comprend un ballon gonflable conçu pour être déformable lorsqu'il est gonflé et comprend un marqueur radio-opaque et un marqueur échogène. Lors de l'utilisation, le marqueur échogène peut être distingué du marqueur radio-opaque. Le marqueur radio-opaque est utilisé pour déterminer une localisation absolue du ballon dans le corps, par exemple en relation avec une structure repère (telle qu'un os). Le marqueur échogène est utilisé pour déterminer la localisation de la structure à surveiller par rapport au bord du ballon. Les deux localisations ou distances sont combinées pour déterminer la localisation de la structure à surveiller par rapport à la structure repère.
PCT/US2013/063642 2013-10-07 2013-10-07 Ballon de repérage WO2015053737A1 (fr)

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