Digital Healthcare – Stephen C. Roy, John D. Hodgeman, Merative Us LP, STRYKER IMAGING Corp, Stryker Corp
Abstract for “Systems and Methods for Enhancing the Viewing of Medical Images”
“The invention is a system and method for improving the delivery and display medical images over a network. By accessing a secure server, authorized users can view and access images. They can then select images to be viewed. You can modify various aspects of the image or images that you are viewing. A goniometer or other measuring device may be used to measure distances and angles. One or more templates, such as medical devices, can be placed on an image to be manipulated in one embodiment. Another embodiment allows two or more people to view the same image simultaneously while simultaneously viewing a template, measuring tool, image manipulations, and the like. Another embodiment allows two or more users to discuss one or more images through a discussion board.
Background for “Systems and Methods for Enhancing the Viewing of Medical Images”
“Medical images such as radiographs (X-rays)? ), computedtomography (?CT?) Magnetic resonance images (?MRIs), scans and magnetic resonance images Scans, magnetic resonance images (?MRIs), and sonograms are vital tools in diagnosing, planning, and other aspects of healthcare delivery. The ability to digitize or acquire digital images from images that were originally taken on radiographic film or other non-digital films is one of the most recent developments in medical imaging. A further advance allowed doctors and other healthcare workers the ability to share those digital images via a network. DICOM (Digital Imaging and Communications in Medicine) is a technology that has made it easier to transfer radiologic images and medical information between computers. This is the industry standard for the transfer of such images and information. Digitization allows radiologists, other doctors and healthcare workers to view and manipulate images more efficiently. Healthcare workers can view images remotely from a network, including another hospital or office.
U.S. Application Ser. 62 is a system and method to upload medical images to a server, secure server, or for distribution over a network. No. No. 09/219,956, filed Dec. 23, 1997, which is herein incorporated by reference. Remote Image? is a system that allows hospitals, urgent care facilities, and other healthcare providers to upload images to secure servers. Images can then be distributed over a network. Remote Image? While Remote Image?
“For example, surgeons and doctors in many specialties often insert devices into patients to treat trauma, disease, or deterioration. Because each patient is unique, manufacturers of surgical devices offer a variety of styles, shapes, and sizes to suit any procedure. Manufacturers have increased the number and variety of devices they offer as technology advances. Hospitals and other surgical facilities have had to stock large inventories to ensure they have the right device for every patient. Device manufacturers and surgeons began to use pre-operative planning. This allows them to provide templates. All available devices. In one embodiment, templates are images of devices that can be placed on top of patient images (such X-rays), in order to determine the type, size, and location of a device before surgery. A template is a plan of a device printed on clear film.
Magnification is an issue to be aware of when you use such templates. Magnification can often magnify an X-ray of a bone because of the distance between it and the Xray cassette (which holds film). Depending on the technique used and the anatomy, this magnification can be between 5% to 25%. To compensate for the Xray magnification, many template manufacturers offer multiple magnifications.
For proper pre-operative planning, the surgeon usually takes multiple images of the affected area (e.g. a broken bone) from different views. A surgeon can then use multiple templates to compare, placing them in sequence over images of the fractured bone. Before operating, surgeons can determine the best type, size, and location of a device. This reduces the amount of devices that hospitals and other surgical facilities often have on hand. A surgical facility may acquire templates with multiple magnifications depending on the size and type of each device. While it is easier to manage and store a large number of templates than an inventory, managing and maintaining an inventory can be difficult. For example, the orthopedic device industry includes many different manufacturers and thousands of device systems. These orthopedic device systems contain many parts. These parts include hip joints and knee joints, shoulder joint, ankle and elbow joints as well as finger and toe joints.
“There is a need for systems and methods that enable surgeons and other healthcare professionals to view and evaluate images more efficiently to perform pre-operative plans. There are also systems and methods that enable healthcare providers from remote locations to complete pre-operative planning. Systems and methods are needed to reduce the number of medical devices and templates that hospitals keep on hand for pre-operative planning and operative procedures.
The present invention provides systems, methods and devices for improving the viewing of medical pictures accessible via secure servers and networks. One embodiment of the method involves digitizing and acquiring medical images, sending them to an uploader device and transmitting them to a secure server over a network. The web page is then assembled by an authorized user and displayed on the page with a template. This template includes an image that the authorized user can place one or more medical images.
Other embodiments of this invention may include similar features, but they may allow an authorized user to view and manipulate medical images in other beneficial ways. One embodiment may provide a goniometer function that allows the user to measure angles on a medical picture. Two authorized users can view the same image at once and send and receive messages. Another embodiment allows authorized users to access a database, including general and patient information, while simultaneously viewing a medical image.
“BRIEF DESCRIPTION EXEMPLARY EDRAWINGS”
“Additional features of the invention will be evident after reviewing the non-limiting embodiments discussed in the specification and claims in conjunction with the accompanying Figures, wherein like numerals designate similar elements:
“FIG. “FIG.
“FIG. “FIG.
“FIG. “FIG.
“FIG. “FIG. 3. Image manipulations have been performed on the chosen template.
“FIG. “FIG.
The following description is only for illustrative purposes and does not limit the scope, applicability, or configuration of the invention. The following description is not intended to limit the scope, applicability or configuration of the invention. It is merely a useful illustration that can be used to implement exemplary embodiments. You can make modifications to the arrangement and design of elements in the preferred embodiments, but they do not have to be outside the scope of the invention.
“The present invention can be described in terms of functional blocks components and processing steps. These functional blocks can be implemented by any number hardware components that are capable of performing the required functions. The present invention can be implemented using various integrated circuit components such as memory elements, logic elements and look-up tables. These components may then be used to perform a variety functions under the control one or more microprocessors, or other control devices. The present invention can also be implemented in software or computer programs in any of a variety of computer systems environments. The present invention does not limit itself to the described process flows. Any process flow or arrangement of process steps that captures the characteristics of the invention is included in the scope of the invention. The present invention can employ any number conventional methods for processing steps, such as binary searches and the like. These general techniques, which are well-known to those skilled in art, are not discussed in detail in this invention.
“It is important to note that the specific implementations and processes described herein are intended to illustrate the invention and its best mode. They are not meant limit the scope or otherwise limit the invention’s scope. For the sake of simplicity, it may not be possible to describe in detail conventional object-oriented programming or other software programming techniques.
“Although some exemplary embodiments have been described below in terms of systems, methods and images for providing and displaying images in medical settings, it is important to understand that systems and methods of this invention can be used to enhance viewing of other images via a network or not. The present invention can be used to enhance the viewing, manipulation, and discussion of images by graphic artists, businesses, and others. The systems and methods of this invention can be used for many purposes, including images or medical use.
“The present invention is based on one exemplary embodiment and relates to systems, methods, and devices that facilitate viewing images distributed over a network. The U.S. Patent Application Ser. No. 09/219,956 (?the ‘956 application?) Filled Dec. 23, 1998 and is herein incorporated by reference in full. The systems and methods described by the ‘956 patent application include a secure network website, which is typically a secure web site for storing images, and other data, that has been uploaded by one of several medical service providers such as hospitals, urgent care facilities or radiological facilities. A user is sometimes referred to as a “medical professional” when accessing a secure website. A unique identifier may be required for each user that has been registered with the system. Once a user’s identification has been verified, they can view images in the system.
“According to one aspect of the invention, images can be transferred between multiple uploading websites, multiple secure sites, and/or multiple users using any suitable compression format and transfer protocol. DICOM 3.0 (Digital Imaging and Communications in Medicine), is an example embodiment of the invention. DICOM 3.0, the industry standard for transmitting radiologic images and medical information between computers, is an example of this. DICOM 3.0 is a digital communication protocol that allows for the exchange of diagnostic and therapeutic equipment as well as systems from different manufacturers. It was developed following the Open System Interconnection standard by the International Standards Organization. DICOM 3.0 allows communication between multiple vendors’ mainframes and workstations. Demonstration software for DICOM 3.0 is in the public domain and is available from the Mallinkrodt Institute of Radiology ftp server at ftp://ftp.ert.wustl.edu/pub/dicom, the entire contents of which is hereby incorporated by reference.”
“In one embodiment, the present invention provides systems and methods that allow for better viewing remote medical images. Referring to FIG. 1. One embodiment of the invention displays medical images on a viewing panel 100. One embodiment of the viewing screen 100 includes a module window 200 and a management console 101. Management console 102 can be used as a control panel. It allows the user to view images, read information about them, and control one or more of the aspects they are viewing. The module window 202 can be used to allow a user to view images, view and enter text and/or make modifications, measurements, additions, or other changes to images. Below are detailed descriptions of various embodiments of module window 202 and management console 102. Viewing screen 100 could include additional elements such as multiple management consoles, multiple module windows, or any other elements that enhance the accessing, viewing, viewing, and/or altering of medical images.
Management console 102, an exemplary embodiment, may contain one or more menus (104 or 106), one, or more buttons (114 or 116, 128, 118, 120), one, or more information windows (108, 110), and an image selection window (112. One embodiment of the invention includes an image menu 106 and an upload site menu. This may allow a user select specific aspects of images to be viewed. FIG. Image menu 106 and upload site menu104 can be accessed via drop-down menus. Upload site menu 104 allows a user to choose an upload site (e.g. a specific hospital, clinic, or the like) from a drop-down listing of multiple upload websites. The user can then view one or more images. Image menu 106 allows a user to choose one or more images from the selected upload site and display them on viewing screen 100. Image menu 106 can be used to display a list of patients. A user can view a set associated with a patient by selecting it from image menu 106.
According to one aspect, users may need to enter unique identifiers such as passwords to gain access screen 100. To determine whether a particular user has access to screen 100, identifiers can be used. Another aspect of the invention states that identifiers can be used to identify a list or images of upload sites. One physician might be allowed to view images uploaded to hospital A, but another physician may have access to images uploaded to hospitals A and B. Another physician might be authorized to view images from hospitals A or B but not to view images of patients in orthopedics at those hospitals. Users who are able to view screen 100 may have a limited number of upload sites (from upload site menu 104) and/or their options for patients or images (from image menu 106).
One exemplary system for providing and showing medical images can include a unique identifier and processor module to achieve the authentication function. These aspects of a system to display and provide medical images over a network will be covered in detail in the ‘956 patent, which is incorporated herein.
According to another aspect, management console 102 could include one or more information Windows, each of which can provide information to a User. Management console 102 could include an image description window 110 and a date window. Date window 108 can provide information such as the date and/or the time that a particular image was taken and the current date and/or the time that a patient was admitted to hospital. Image description window 110 can provide a description for a specific image or group of images. FIG. FIG. The image description window can also contain patient information such as the date of admission, the diagnosis, medication, treatment plan, and expected discharge date. The image description window 110 can also include non-patient information, or any other information that is relevant to the image, set, or like.
According to another aspect of the invention management console 102 could also include an image selection window 112. The image selection window 112 can display one or more smaller images that may be selected to be viewed in a larger format. Image selection window 112 might display, for example, a specific number of images taken by a patient that were selected from image menu 106. FIG. FIG. 1 shows four images of a patient displayed in the image selection window 112. Image selection window 112 can include a scrollbar 124, or another device that allows you to move through the images. A user may be able to choose one of the displayed images to view in a larger format in module windows 202. One embodiment allows the user to select an image by simply dragging an icon onto it and then selecting it with a mouse or a computer. Another embodiment of image selection window 112 can be set up as a touch sensitive screen so that users can select an image by touching it on the screen. Image selection window 112 can be configured with any combination of images, and may also include any method for selecting one of the images that is currently known or could be discovered in the future.
According to another aspect, management console 102 can further include one or several module selection buttons (114-116, 118 or 120), which allow the user to select one or more modules that will be displayed in module window.202. Management console 102, for example, may have an image module selector 114, documentation module selector 116, and a templating/debate module selector 118. A user can view several modules in module window 202 by clicking on one of these selector buttons or selecting another. Below are detailed descriptions of different modules and their aspects. One aspect of the invention states that management console 102, as well as various modules, can be provided by Java applets.
“According to another aspect of this invention, as illustrated in FIG. 1. Management console 102 may be viewed simultaneously with module window 202 on the viewing screen 100. Management console 102 can also be closed by clicking on the management console button 130. FIGS. FIGS.
“In one embodiment, module window 200 may display one or several modules. FIGS. FIG. 1?4 shows that module window 202 contains an image module 240 as well as a templating program 250. FIG. FIG. 1 shows how a user can select one or several modules to display on a module window. This is done by clicking on one of the module selection buttons 114-116, 118, 118, or 120 on management console.102. Image module 240 can be selected using image module selection button 112, and an image 200 can be chosen to view within image module 244. You can do this by selecting image 200 in the image selection window 112
Image module 240, in one embodiment of the invention, may display selected images and allow a user to modify certain features. Image module 240 may contain one or more buttons that allow manipulation of image 200, and/or other features of image module 244. This is described below. Image module 240 buttons may include, but not be limited to, a brightness 210, darkness 212, contrast button 214 and counterclockwise rotation buttons 220. A size magnification button 226, a size reduction button 228 are some examples. Another button that can be used to reset image 200’s characteristics to the original state before any manipulation by a user is 230. Another aspect of the invention may also include a rotation button (208), which allows a user rotate image 200 around a user-definable axis, and a gamma adjustment button (216), which allows a user adjust the gamma for image 200.
“In viewing and analysing radiographs (X-rays),? MRI scans, CT scans, MRI scanners and other similar devices, a doctor or another user may measure one or more angles between bones, bone parts, or other anatomical, or device features. A goniometer, which is a device that measures solid angles, can be used by a medical professional to measure angles on film. The disadvantages of this traditional method for measuring angles are described in the Background section. Films can magnify or distort normal anatomy. Also, it is awkward to hold a goniometer up to a screen.
“In one embodiment, the present invention provides a system and method that enable a medical professional to make more precise angular measurements on films. These measurements can be taken on image module 240 by pressing the goniometer button 222. One embodiment allows the user to select goniometer button 223. This can be done by clicking on that button 222. To draw (or place?) the goniometer button 222, click on image 200. The user may then click on two locations within image 200 to draw (or?place?) a second line 236, or vector, of the angle to measure. The second location defines the vertex 238. Clicking on a third location will allow the user to place a second vector 242 or line of the angle. The second line runs from the vertex 238, the angle, to the third clicked location. Image module 240 measures and displays 244 angles created between lines 236 & 242 by the user. It also updates the angle if there are any changes in the locations of lines 236 & 242. A user could place the third location on image 200, then move it around until they feel the line is the most accurate. One aspect of the invention states that display 244 may be updated continuously as the position of lines 236 or 242 changes. One embodiment of the invention allows users to see the bit size of an image by clicking on the button 224. Display 244 will show the bit size rather than the measured angle.
“In one embodiment, as shown in FIGS. 1?4, module windows 202 can contain both an image module 240 and a templating Module 250. FIG. 2. The templating module 250 includes two drop-down menus, 232 and 234, which are displayed in image module 240. FIG. FIG. 3. This screen shows an example of templating module 250. A user can select from the drop-down menus 234, 232, and 234. The image module 240 enhancement is achieved by templating module 250. It allows a user to view image 200 and select template characteristics and device templates to place the templates on image 200. Template selection menu 232 may be included in templating module 250. A template color selection menu 234. The template selection menu 232 could contain a drop-down menu of templates that a user can choose from to view a particular template. FIG. FIG. 3. A user has chosen?ForeSight Nail System 5 mm & 4 mm? You can view the device template. From the template color selection menu 234, the user also selected white as the template’s color. The template 306 is an overlay, similar to a transparency that might be placed over a traditional film. It includes two white-line images superimposed on the original image 200.
Image 200 shows an X-ray showing a fractured ulna bone. It is one of the bones in the forearm. A type of bone pin is the device that was chosen by the user for template 306 Template 306 displays two sizes of the specific brand and model of bone pin selected, with diameters of 5 mm and 4 mm respectively. A single template can be used to display multiple sizes of a device. This allows the user to compare the fit of these different sizes onto the patient. One embodiment allows users to choose different colors from the template color selection menu 234, which can be used for different sizes of devices. This makes it easier to differentiate between and compare different sizes.
“According to another aspect of the invention, image module 244 and templating program 250 may contain an image adjustment button 200 and a template adjustment buttons 206. To make changes or manipulations on image 200, a user can select the image adjustment button (204), or select the template adjustment button (206). If one of the adjustment buttons 204 or 206 is chosen, that feature can be adjusted while the other feature will remain fixed.
“As shown at FIG. Template 306 can be rotated relative to image 200 and vice versa. Click on the rotation button 208 to select an axis and click on the desired point on image 200. This will become the axis. You can then choose, or “grab” the template. Template 306 may then be selected or?grabbed? using an icon controlled with a mouse. Template 306 can also be rotated around the axis chosen by the user. One embodiment allows the user to adjust template 306’s characteristics by selecting template adjustment button 206 or gamma correction buttons 216. In the same manner as goniometer buttons 222, goniometer buttons 222 can be used to measure angles between template 306 or image 200.
According to another aspect, template 306 can be easily modified to reflect any image magnification desired, and not just the standard 5% to 10%, 15% to 20% magnifications that are available with conventional templates. A healthcare professional can place a radiopaque probe near the patient to determine the magnification. The gauge can then be viewed on the image by a user who is viewing it. Based on the magnification measurement, Template 306 may be selected.
“FIG. “FIG. Module window 202 may display discussion module 504 together with image module 244, template module 250, and/or other modules. One embodiment of discussion module 504 contains a message window 502 as well as a user list view 506. Message window 502 displays messages that have been entered by users viewing images in image module 244. The user list window 506 shows the names, passwords and other identifying information of all users who have accessed or viewed images in image module 244.
“Discussion module 504 can be accessed by authorized users, such as medical professionals, device makers, and/or other authorized users. It may improve diagnosis, pre-operative planning and post-operative review, and other aspects related to healthcare services, research, and the like. One embodiment of the invention allows two or more people to simultaneously view and access the same image, or set of images in image module 244. Using discussion module 504 they can also input and exchange messages. Another aspect of the invention states that users can view and discuss images simultaneously while manipulating an image or a template. After a discussion via discussion module 504. is over, the discussion can be saved along with the image/set of images being discussed. All such discussions can be archived for future review. Another aspect of the invention is that discussion module 504 can also allow for the sharing of real-time audio between multiple users.
“According yet another aspect, the invention may provide systems and methods that allow a user to email an image link, an actual image, or any other information to another user. Images may not be sent to more than one person authorized to view them. A second alternate embodiment supports voice recognition and/or text to speech capabilities.
“A documentation module is another aspect of the invention according one embodiment. One or more users may select documentation module button (116) to choose the module. The user can select documentation module from one or more drop down menus. This allows them to view the documentation associated with a specific patient, image, or set of images from management console 102. Documentation may include information such as patient medical records, insurance information or information from one or more radiologists. In accordance with another aspect, documentation can be stored in either image format or text format.
“In accordance to yet another aspect, the invention may provide a database of information. This information could include messages between users, recorded from discussion module 504, information about radiological conditions and medical conditions, and patient histories. One or more manufacturers of orthopedic devices may provide a database that includes data about the indications for using a particular device as well as instructions for its use. You may also have access to more general medical information. This may be displayed using images from the image module. This information can be accessed via a button located on screen 100.
A computerized database may contain information stored by a doctor, hospital, or medical device company. Any type of database can be used, including relational, hierarchical and object-oriented. Common database products that can be used to create a database are DB2 from IBM (White Plains), N.Y.), any database product available from Oracle Corporation Redwood Shores (Calif.), Microsoft Access (Redmond), Wash.) and any other database product. Any database can be organized in any way, including data tables and lookup tables. Any data association technique that is known and well-practiced in the art can be used to associate certain data. The association can be done manually or automatically, for example. For example, automatic association techniques could include a database search or database merge. A database merge function may be used to complete the association, such as using a key field. In each of the retailer and manufacturer data tables. A key field? The key field partitions the database according the high-level object class defined by the key. One example is that a class can be identified as a key field in the first and second data tables. The class data in this key field may then be used to merge the data tables. The data that corresponds to the key field of each of the merged tables should be identical in this embodiment. By using AGREP, data tables with similar data, but not identical, may be merged.
The system of the present invention can include a host computer or other computing systems, including a processor to process digital data, a memory to store digital data, and an input digitizer to the processor to input digital data. An application program is stored in said memory, and directed by the processor to direct processing of said digital data. A display is coupled to the processor and memory to display information derived from said digital data. This includes patient data, radiological data, and medical device data. A computer that is used by a doctor to access this system can include an operating system, such as Windows 95/97/98/2000 or Linux, Solaris, Solaris, and the like. It may also include various support software and drivers that are commonly associated with computers. You can have access to the internet from your home or office. In an exemplary embodiment, access is through the Internet through a commercially-available web-browser software package.”
“A user’s computer might provide a suitable website or another Internet-based user interface that is accessible to users. One embodiment uses the Microsoft Transaction Server and Microsoft Internet Information Server in conjunction with Microsoft NT web server software and a Microsoft SQL database system. Access Sequel Server and Oracle components may also be used to create an ADO-compliant database management software. The term “web page” is used herein. The term “web page” as used herein does not limit the types of applications and documents that can be used to interact directly with users. A typical website might contain, among other HTML documents, Java applets and Javascript, common gateway interface scripts(CGI), extensible Markup Language (XML), dynamic HTML (CGI), extensible Markup Language (XML), cascading Style Sheets (CSS), helper apps, plug-ins and the like.
“The present invention can be described in terms of functional blocks components, screen shots and optional selections, as well as various processing steps. These functional blocks can be implemented by any combination of hardware and/or computer components that are capable of performing the required functions. The present invention can employ various integrated circuit elements, such as memory elements, processing components, logic elements and look-up tables. These components may perform a variety functions under the control one or more microprocessors, or other control devices. The software elements of this invention can be implemented using any programming or scripting languages such as C++, Java COBOL, COBOL and assembler. Additionally, the algorithms can be implemented with any combination data structures, objects or routines. The present invention can use any combination of data structures, objects, routines, processes, or other programming elements to transmit data, signal, process data, control network traffic, and the like. The invention can also be used to detect and prevent security problems using client-side scripting languages such as JavaScript, VBScript, or the like. Bruce Schneider wrote a text entitled “Applied Cryptography: Protocols and Algorithms in C” that provides a basic introduction to cryptography. Published by John Wiley & Sons, second edition, 1996. This text is hereby incorporated into reference.
“Any computing unit that is used in the system according one embodiment of the invention can be connected to each other through a data communication network. The network could be a public network that is assumed to be unsecure and vulnerable to eavesdroppers. The network could be represented as the Internet in the illustration. The computers can or might not be connected to Internet at all times in this example. A computer used by a doctor may use a modem to connect occasionally to the Internet. However, a hospital’s computer system could have a permanent connection to it. This article may not contain specific information about the protocols, standards and software used in connection to the Internet. Further information about such details can be found in DILIP NAIK (1998), INTENET STANDARDS and PROTOCOLS (1998), JAVA 2 COMPLETE (Sybex 1999), DEBORAH RAY and ERIC RAY (1997). TCP/IP CLEARLY EXPLAINED (1997). These texts are all hereby included by reference.
“The systems could be connected to a network via data links. Data links can be made using a variety of communications protocols and media, including a connection to an Internet Service Provider, (ISP), over the local loop. This is commonly used in connection with standard modem communications, cable modems, Dish networks or ISDN. The computer system of a healthcare provider might also be located within a local network (LAN), which interfaces with the network via a lease line (T1, T3, etc.). These communication methods are well-known in the art and are covered in many standard texts. See, e.g. GILBERT HELD UNDERSTANDING DATA COMMUNICATIONS (1996). This reference is hereby incorporated.
The present invention can be described as a method, data processing system, device for data processing and/or computer program product. The present invention can be embodied in an entirely software embodiment, an entirely physical embodiment, or a combination of both. The present invention can also be a computer program product stored on a computer-readable medium with computer-readable code means. You can use any suitable computer-readable storage medium, such as hard drives, CD-ROMs, optical storage devices and magnetic storage devices.
“Communication between one user and the system according the invention can be achieved through any suitable communication medium, such as a telephone network or Intranet, Internet, point-of-interaction device (point to sale device, personal digital assistant), kiosk, etc. Online communications, offline communications and wireless communications are all possible. A skilled person in the art will also recognize that the databases, systems or components of this invention can be composed of any combination of databases and components at any single location or at multiple locations. Each database or system may include any number of security features such as firewalls or access codes, encryption or de-encryption, compression or decompression, and/or other suitable security features.
“The invention has been described in the above specification with specific embodiments. It will be apparent that modifications and other changes are possible without departing from this invention’s scope as described in the claims. All modifications to the specification and figures should be considered illustrative rather than restrictive. The appended claims and legal equivalents should determine the scope of the invention, not the examples. The steps in any method or process claim may be performed in any order, and not just in the order described in the claims.
Specific embodiments have been described in detail. The benefits, advantages, solutions, and any element that could cause any benefit, advantage or solution to occur, or become more prominent, are not to be considered essential, required, or necessary features or elements of any or all claims. The terms ‘comprises’,?comprising, and any variation thereof are used herein to mean a non-exclusive addition. This means that a process or method, article or apparatus that contains a list elements may not only include those elements, but also include elements that are not explicitly listed or inherent in such process, method or article. If an element is not specifically described as essential, it is not required to practice the invention. If a particular element is not described as?essential? or?critical?, it cannot be used in the practice of the invention.
Summary for “Systems and Methods for Enhancing the Viewing of Medical Images”
“Medical images such as radiographs (X-rays)? ), computedtomography (?CT?) Magnetic resonance images (?MRIs), scans and magnetic resonance images Scans, magnetic resonance images (?MRIs), and sonograms are vital tools in diagnosing, planning, and other aspects of healthcare delivery. The ability to digitize or acquire digital images from images that were originally taken on radiographic film or other non-digital films is one of the most recent developments in medical imaging. A further advance allowed doctors and other healthcare workers the ability to share those digital images via a network. DICOM (Digital Imaging and Communications in Medicine) is a technology that has made it easier to transfer radiologic images and medical information between computers. This is the industry standard for the transfer of such images and information. Digitization allows radiologists, other doctors and healthcare workers to view and manipulate images more efficiently. Healthcare workers can view images remotely from a network, including another hospital or office.
U.S. Application Ser. 62 is a system and method to upload medical images to a server, secure server, or for distribution over a network. No. No. 09/219,956, filed Dec. 23, 1997, which is herein incorporated by reference. Remote Image? is a system that allows hospitals, urgent care facilities, and other healthcare providers to upload images to secure servers. Images can then be distributed over a network. Remote Image? While Remote Image?
“For example, surgeons and doctors in many specialties often insert devices into patients to treat trauma, disease, or deterioration. Because each patient is unique, manufacturers of surgical devices offer a variety of styles, shapes, and sizes to suit any procedure. Manufacturers have increased the number and variety of devices they offer as technology advances. Hospitals and other surgical facilities have had to stock large inventories to ensure they have the right device for every patient. Device manufacturers and surgeons began to use pre-operative planning. This allows them to provide templates. All available devices. In one embodiment, templates are images of devices that can be placed on top of patient images (such X-rays), in order to determine the type, size, and location of a device before surgery. A template is a plan of a device printed on clear film.
Magnification is an issue to be aware of when you use such templates. Magnification can often magnify an X-ray of a bone because of the distance between it and the Xray cassette (which holds film). Depending on the technique used and the anatomy, this magnification can be between 5% to 25%. To compensate for the Xray magnification, many template manufacturers offer multiple magnifications.
For proper pre-operative planning, the surgeon usually takes multiple images of the affected area (e.g. a broken bone) from different views. A surgeon can then use multiple templates to compare, placing them in sequence over images of the fractured bone. Before operating, surgeons can determine the best type, size, and location of a device. This reduces the amount of devices that hospitals and other surgical facilities often have on hand. A surgical facility may acquire templates with multiple magnifications depending on the size and type of each device. While it is easier to manage and store a large number of templates than an inventory, managing and maintaining an inventory can be difficult. For example, the orthopedic device industry includes many different manufacturers and thousands of device systems. These orthopedic device systems contain many parts. These parts include hip joints and knee joints, shoulder joint, ankle and elbow joints as well as finger and toe joints.
“There is a need for systems and methods that enable surgeons and other healthcare professionals to view and evaluate images more efficiently to perform pre-operative plans. There are also systems and methods that enable healthcare providers from remote locations to complete pre-operative planning. Systems and methods are needed to reduce the number of medical devices and templates that hospitals keep on hand for pre-operative planning and operative procedures.
The present invention provides systems, methods and devices for improving the viewing of medical pictures accessible via secure servers and networks. One embodiment of the method involves digitizing and acquiring medical images, sending them to an uploader device and transmitting them to a secure server over a network. The web page is then assembled by an authorized user and displayed on the page with a template. This template includes an image that the authorized user can place one or more medical images.
Other embodiments of this invention may include similar features, but they may allow an authorized user to view and manipulate medical images in other beneficial ways. One embodiment may provide a goniometer function that allows the user to measure angles on a medical picture. Two authorized users can view the same image at once and send and receive messages. Another embodiment allows authorized users to access a database, including general and patient information, while simultaneously viewing a medical image.
“BRIEF DESCRIPTION EXEMPLARY EDRAWINGS”
“Additional features of the invention will be evident after reviewing the non-limiting embodiments discussed in the specification and claims in conjunction with the accompanying Figures, wherein like numerals designate similar elements:
“FIG. “FIG.
“FIG. “FIG.
“FIG. “FIG.
“FIG. “FIG. 3. Image manipulations have been performed on the chosen template.
“FIG. “FIG.
The following description is only for illustrative purposes and does not limit the scope, applicability, or configuration of the invention. The following description is not intended to limit the scope, applicability or configuration of the invention. It is merely a useful illustration that can be used to implement exemplary embodiments. You can make modifications to the arrangement and design of elements in the preferred embodiments, but they do not have to be outside the scope of the invention.
“The present invention can be described in terms of functional blocks components and processing steps. These functional blocks can be implemented by any number hardware components that are capable of performing the required functions. The present invention can be implemented using various integrated circuit components such as memory elements, logic elements and look-up tables. These components may then be used to perform a variety functions under the control one or more microprocessors, or other control devices. The present invention can also be implemented in software or computer programs in any of a variety of computer systems environments. The present invention does not limit itself to the described process flows. Any process flow or arrangement of process steps that captures the characteristics of the invention is included in the scope of the invention. The present invention can employ any number conventional methods for processing steps, such as binary searches and the like. These general techniques, which are well-known to those skilled in art, are not discussed in detail in this invention.
“It is important to note that the specific implementations and processes described herein are intended to illustrate the invention and its best mode. They are not meant limit the scope or otherwise limit the invention’s scope. For the sake of simplicity, it may not be possible to describe in detail conventional object-oriented programming or other software programming techniques.
“Although some exemplary embodiments have been described below in terms of systems, methods and images for providing and displaying images in medical settings, it is important to understand that systems and methods of this invention can be used to enhance viewing of other images via a network or not. The present invention can be used to enhance the viewing, manipulation, and discussion of images by graphic artists, businesses, and others. The systems and methods of this invention can be used for many purposes, including images or medical use.
“The present invention is based on one exemplary embodiment and relates to systems, methods, and devices that facilitate viewing images distributed over a network. The U.S. Patent Application Ser. No. 09/219,956 (?the ‘956 application?) Filled Dec. 23, 1998 and is herein incorporated by reference in full. The systems and methods described by the ‘956 patent application include a secure network website, which is typically a secure web site for storing images, and other data, that has been uploaded by one of several medical service providers such as hospitals, urgent care facilities or radiological facilities. A user is sometimes referred to as a “medical professional” when accessing a secure website. A unique identifier may be required for each user that has been registered with the system. Once a user’s identification has been verified, they can view images in the system.
“According to one aspect of the invention, images can be transferred between multiple uploading websites, multiple secure sites, and/or multiple users using any suitable compression format and transfer protocol. DICOM 3.0 (Digital Imaging and Communications in Medicine), is an example embodiment of the invention. DICOM 3.0, the industry standard for transmitting radiologic images and medical information between computers, is an example of this. DICOM 3.0 is a digital communication protocol that allows for the exchange of diagnostic and therapeutic equipment as well as systems from different manufacturers. It was developed following the Open System Interconnection standard by the International Standards Organization. DICOM 3.0 allows communication between multiple vendors’ mainframes and workstations. Demonstration software for DICOM 3.0 is in the public domain and is available from the Mallinkrodt Institute of Radiology ftp server at ftp://ftp.ert.wustl.edu/pub/dicom, the entire contents of which is hereby incorporated by reference.”
“In one embodiment, the present invention provides systems and methods that allow for better viewing remote medical images. Referring to FIG. 1. One embodiment of the invention displays medical images on a viewing panel 100. One embodiment of the viewing screen 100 includes a module window 200 and a management console 101. Management console 102 can be used as a control panel. It allows the user to view images, read information about them, and control one or more of the aspects they are viewing. The module window 202 can be used to allow a user to view images, view and enter text and/or make modifications, measurements, additions, or other changes to images. Below are detailed descriptions of various embodiments of module window 202 and management console 102. Viewing screen 100 could include additional elements such as multiple management consoles, multiple module windows, or any other elements that enhance the accessing, viewing, viewing, and/or altering of medical images.
Management console 102, an exemplary embodiment, may contain one or more menus (104 or 106), one, or more buttons (114 or 116, 128, 118, 120), one, or more information windows (108, 110), and an image selection window (112. One embodiment of the invention includes an image menu 106 and an upload site menu. This may allow a user select specific aspects of images to be viewed. FIG. Image menu 106 and upload site menu104 can be accessed via drop-down menus. Upload site menu 104 allows a user to choose an upload site (e.g. a specific hospital, clinic, or the like) from a drop-down listing of multiple upload websites. The user can then view one or more images. Image menu 106 allows a user to choose one or more images from the selected upload site and display them on viewing screen 100. Image menu 106 can be used to display a list of patients. A user can view a set associated with a patient by selecting it from image menu 106.
According to one aspect, users may need to enter unique identifiers such as passwords to gain access screen 100. To determine whether a particular user has access to screen 100, identifiers can be used. Another aspect of the invention states that identifiers can be used to identify a list or images of upload sites. One physician might be allowed to view images uploaded to hospital A, but another physician may have access to images uploaded to hospitals A and B. Another physician might be authorized to view images from hospitals A or B but not to view images of patients in orthopedics at those hospitals. Users who are able to view screen 100 may have a limited number of upload sites (from upload site menu 104) and/or their options for patients or images (from image menu 106).
One exemplary system for providing and showing medical images can include a unique identifier and processor module to achieve the authentication function. These aspects of a system to display and provide medical images over a network will be covered in detail in the ‘956 patent, which is incorporated herein.
According to another aspect, management console 102 could include one or more information Windows, each of which can provide information to a User. Management console 102 could include an image description window 110 and a date window. Date window 108 can provide information such as the date and/or the time that a particular image was taken and the current date and/or the time that a patient was admitted to hospital. Image description window 110 can provide a description for a specific image or group of images. FIG. FIG. The image description window can also contain patient information such as the date of admission, the diagnosis, medication, treatment plan, and expected discharge date. The image description window 110 can also include non-patient information, or any other information that is relevant to the image, set, or like.
According to another aspect of the invention management console 102 could also include an image selection window 112. The image selection window 112 can display one or more smaller images that may be selected to be viewed in a larger format. Image selection window 112 might display, for example, a specific number of images taken by a patient that were selected from image menu 106. FIG. FIG. 1 shows four images of a patient displayed in the image selection window 112. Image selection window 112 can include a scrollbar 124, or another device that allows you to move through the images. A user may be able to choose one of the displayed images to view in a larger format in module windows 202. One embodiment allows the user to select an image by simply dragging an icon onto it and then selecting it with a mouse or a computer. Another embodiment of image selection window 112 can be set up as a touch sensitive screen so that users can select an image by touching it on the screen. Image selection window 112 can be configured with any combination of images, and may also include any method for selecting one of the images that is currently known or could be discovered in the future.
According to another aspect, management console 102 can further include one or several module selection buttons (114-116, 118 or 120), which allow the user to select one or more modules that will be displayed in module window.202. Management console 102, for example, may have an image module selector 114, documentation module selector 116, and a templating/debate module selector 118. A user can view several modules in module window 202 by clicking on one of these selector buttons or selecting another. Below are detailed descriptions of different modules and their aspects. One aspect of the invention states that management console 102, as well as various modules, can be provided by Java applets.
“According to another aspect of this invention, as illustrated in FIG. 1. Management console 102 may be viewed simultaneously with module window 202 on the viewing screen 100. Management console 102 can also be closed by clicking on the management console button 130. FIGS. FIGS.
“In one embodiment, module window 200 may display one or several modules. FIGS. FIG. 1?4 shows that module window 202 contains an image module 240 as well as a templating program 250. FIG. FIG. 1 shows how a user can select one or several modules to display on a module window. This is done by clicking on one of the module selection buttons 114-116, 118, 118, or 120 on management console.102. Image module 240 can be selected using image module selection button 112, and an image 200 can be chosen to view within image module 244. You can do this by selecting image 200 in the image selection window 112
Image module 240, in one embodiment of the invention, may display selected images and allow a user to modify certain features. Image module 240 may contain one or more buttons that allow manipulation of image 200, and/or other features of image module 244. This is described below. Image module 240 buttons may include, but not be limited to, a brightness 210, darkness 212, contrast button 214 and counterclockwise rotation buttons 220. A size magnification button 226, a size reduction button 228 are some examples. Another button that can be used to reset image 200’s characteristics to the original state before any manipulation by a user is 230. Another aspect of the invention may also include a rotation button (208), which allows a user rotate image 200 around a user-definable axis, and a gamma adjustment button (216), which allows a user adjust the gamma for image 200.
“In viewing and analysing radiographs (X-rays),? MRI scans, CT scans, MRI scanners and other similar devices, a doctor or another user may measure one or more angles between bones, bone parts, or other anatomical, or device features. A goniometer, which is a device that measures solid angles, can be used by a medical professional to measure angles on film. The disadvantages of this traditional method for measuring angles are described in the Background section. Films can magnify or distort normal anatomy. Also, it is awkward to hold a goniometer up to a screen.
“In one embodiment, the present invention provides a system and method that enable a medical professional to make more precise angular measurements on films. These measurements can be taken on image module 240 by pressing the goniometer button 222. One embodiment allows the user to select goniometer button 223. This can be done by clicking on that button 222. To draw (or place?) the goniometer button 222, click on image 200. The user may then click on two locations within image 200 to draw (or?place?) a second line 236, or vector, of the angle to measure. The second location defines the vertex 238. Clicking on a third location will allow the user to place a second vector 242 or line of the angle. The second line runs from the vertex 238, the angle, to the third clicked location. Image module 240 measures and displays 244 angles created between lines 236 & 242 by the user. It also updates the angle if there are any changes in the locations of lines 236 & 242. A user could place the third location on image 200, then move it around until they feel the line is the most accurate. One aspect of the invention states that display 244 may be updated continuously as the position of lines 236 or 242 changes. One embodiment of the invention allows users to see the bit size of an image by clicking on the button 224. Display 244 will show the bit size rather than the measured angle.
“In one embodiment, as shown in FIGS. 1?4, module windows 202 can contain both an image module 240 and a templating Module 250. FIG. 2. The templating module 250 includes two drop-down menus, 232 and 234, which are displayed in image module 240. FIG. FIG. 3. This screen shows an example of templating module 250. A user can select from the drop-down menus 234, 232, and 234. The image module 240 enhancement is achieved by templating module 250. It allows a user to view image 200 and select template characteristics and device templates to place the templates on image 200. Template selection menu 232 may be included in templating module 250. A template color selection menu 234. The template selection menu 232 could contain a drop-down menu of templates that a user can choose from to view a particular template. FIG. FIG. 3. A user has chosen?ForeSight Nail System 5 mm & 4 mm? You can view the device template. From the template color selection menu 234, the user also selected white as the template’s color. The template 306 is an overlay, similar to a transparency that might be placed over a traditional film. It includes two white-line images superimposed on the original image 200.
Image 200 shows an X-ray showing a fractured ulna bone. It is one of the bones in the forearm. A type of bone pin is the device that was chosen by the user for template 306 Template 306 displays two sizes of the specific brand and model of bone pin selected, with diameters of 5 mm and 4 mm respectively. A single template can be used to display multiple sizes of a device. This allows the user to compare the fit of these different sizes onto the patient. One embodiment allows users to choose different colors from the template color selection menu 234, which can be used for different sizes of devices. This makes it easier to differentiate between and compare different sizes.
“According to another aspect of the invention, image module 244 and templating program 250 may contain an image adjustment button 200 and a template adjustment buttons 206. To make changes or manipulations on image 200, a user can select the image adjustment button (204), or select the template adjustment button (206). If one of the adjustment buttons 204 or 206 is chosen, that feature can be adjusted while the other feature will remain fixed.
“As shown at FIG. Template 306 can be rotated relative to image 200 and vice versa. Click on the rotation button 208 to select an axis and click on the desired point on image 200. This will become the axis. You can then choose, or “grab” the template. Template 306 may then be selected or?grabbed? using an icon controlled with a mouse. Template 306 can also be rotated around the axis chosen by the user. One embodiment allows the user to adjust template 306’s characteristics by selecting template adjustment button 206 or gamma correction buttons 216. In the same manner as goniometer buttons 222, goniometer buttons 222 can be used to measure angles between template 306 or image 200.
According to another aspect, template 306 can be easily modified to reflect any image magnification desired, and not just the standard 5% to 10%, 15% to 20% magnifications that are available with conventional templates. A healthcare professional can place a radiopaque probe near the patient to determine the magnification. The gauge can then be viewed on the image by a user who is viewing it. Based on the magnification measurement, Template 306 may be selected.
“FIG. “FIG. Module window 202 may display discussion module 504 together with image module 244, template module 250, and/or other modules. One embodiment of discussion module 504 contains a message window 502 as well as a user list view 506. Message window 502 displays messages that have been entered by users viewing images in image module 244. The user list window 506 shows the names, passwords and other identifying information of all users who have accessed or viewed images in image module 244.
“Discussion module 504 can be accessed by authorized users, such as medical professionals, device makers, and/or other authorized users. It may improve diagnosis, pre-operative planning and post-operative review, and other aspects related to healthcare services, research, and the like. One embodiment of the invention allows two or more people to simultaneously view and access the same image, or set of images in image module 244. Using discussion module 504 they can also input and exchange messages. Another aspect of the invention states that users can view and discuss images simultaneously while manipulating an image or a template. After a discussion via discussion module 504. is over, the discussion can be saved along with the image/set of images being discussed. All such discussions can be archived for future review. Another aspect of the invention is that discussion module 504 can also allow for the sharing of real-time audio between multiple users.
“According yet another aspect, the invention may provide systems and methods that allow a user to email an image link, an actual image, or any other information to another user. Images may not be sent to more than one person authorized to view them. A second alternate embodiment supports voice recognition and/or text to speech capabilities.
“A documentation module is another aspect of the invention according one embodiment. One or more users may select documentation module button (116) to choose the module. The user can select documentation module from one or more drop down menus. This allows them to view the documentation associated with a specific patient, image, or set of images from management console 102. Documentation may include information such as patient medical records, insurance information or information from one or more radiologists. In accordance with another aspect, documentation can be stored in either image format or text format.
“In accordance to yet another aspect, the invention may provide a database of information. This information could include messages between users, recorded from discussion module 504, information about radiological conditions and medical conditions, and patient histories. One or more manufacturers of orthopedic devices may provide a database that includes data about the indications for using a particular device as well as instructions for its use. You may also have access to more general medical information. This may be displayed using images from the image module. This information can be accessed via a button located on screen 100.
A computerized database may contain information stored by a doctor, hospital, or medical device company. Any type of database can be used, including relational, hierarchical and object-oriented. Common database products that can be used to create a database are DB2 from IBM (White Plains), N.Y.), any database product available from Oracle Corporation Redwood Shores (Calif.), Microsoft Access (Redmond), Wash.) and any other database product. Any database can be organized in any way, including data tables and lookup tables. Any data association technique that is known and well-practiced in the art can be used to associate certain data. The association can be done manually or automatically, for example. For example, automatic association techniques could include a database search or database merge. A database merge function may be used to complete the association, such as using a key field. In each of the retailer and manufacturer data tables. A key field? The key field partitions the database according the high-level object class defined by the key. One example is that a class can be identified as a key field in the first and second data tables. The class data in this key field may then be used to merge the data tables. The data that corresponds to the key field of each of the merged tables should be identical in this embodiment. By using AGREP, data tables with similar data, but not identical, may be merged.
The system of the present invention can include a host computer or other computing systems, including a processor to process digital data, a memory to store digital data, and an input digitizer to the processor to input digital data. An application program is stored in said memory, and directed by the processor to direct processing of said digital data. A display is coupled to the processor and memory to display information derived from said digital data. This includes patient data, radiological data, and medical device data. A computer that is used by a doctor to access this system can include an operating system, such as Windows 95/97/98/2000 or Linux, Solaris, Solaris, and the like. It may also include various support software and drivers that are commonly associated with computers. You can have access to the internet from your home or office. In an exemplary embodiment, access is through the Internet through a commercially-available web-browser software package.”
“A user’s computer might provide a suitable website or another Internet-based user interface that is accessible to users. One embodiment uses the Microsoft Transaction Server and Microsoft Internet Information Server in conjunction with Microsoft NT web server software and a Microsoft SQL database system. Access Sequel Server and Oracle components may also be used to create an ADO-compliant database management software. The term “web page” is used herein. The term “web page” as used herein does not limit the types of applications and documents that can be used to interact directly with users. A typical website might contain, among other HTML documents, Java applets and Javascript, common gateway interface scripts(CGI), extensible Markup Language (XML), dynamic HTML (CGI), extensible Markup Language (XML), cascading Style Sheets (CSS), helper apps, plug-ins and the like.
“The present invention can be described in terms of functional blocks components, screen shots and optional selections, as well as various processing steps. These functional blocks can be implemented by any combination of hardware and/or computer components that are capable of performing the required functions. The present invention can employ various integrated circuit elements, such as memory elements, processing components, logic elements and look-up tables. These components may perform a variety functions under the control one or more microprocessors, or other control devices. The software elements of this invention can be implemented using any programming or scripting languages such as C++, Java COBOL, COBOL and assembler. Additionally, the algorithms can be implemented with any combination data structures, objects or routines. The present invention can use any combination of data structures, objects, routines, processes, or other programming elements to transmit data, signal, process data, control network traffic, and the like. The invention can also be used to detect and prevent security problems using client-side scripting languages such as JavaScript, VBScript, or the like. Bruce Schneider wrote a text entitled “Applied Cryptography: Protocols and Algorithms in C” that provides a basic introduction to cryptography. Published by John Wiley & Sons, second edition, 1996. This text is hereby incorporated into reference.
“Any computing unit that is used in the system according one embodiment of the invention can be connected to each other through a data communication network. The network could be a public network that is assumed to be unsecure and vulnerable to eavesdroppers. The network could be represented as the Internet in the illustration. The computers can or might not be connected to Internet at all times in this example. A computer used by a doctor may use a modem to connect occasionally to the Internet. However, a hospital’s computer system could have a permanent connection to it. This article may not contain specific information about the protocols, standards and software used in connection to the Internet. Further information about such details can be found in DILIP NAIK (1998), INTENET STANDARDS and PROTOCOLS (1998), JAVA 2 COMPLETE (Sybex 1999), DEBORAH RAY and ERIC RAY (1997). TCP/IP CLEARLY EXPLAINED (1997). These texts are all hereby included by reference.
“The systems could be connected to a network via data links. Data links can be made using a variety of communications protocols and media, including a connection to an Internet Service Provider, (ISP), over the local loop. This is commonly used in connection with standard modem communications, cable modems, Dish networks or ISDN. The computer system of a healthcare provider might also be located within a local network (LAN), which interfaces with the network via a lease line (T1, T3, etc.). These communication methods are well-known in the art and are covered in many standard texts. See, e.g. GILBERT HELD UNDERSTANDING DATA COMMUNICATIONS (1996). This reference is hereby incorporated.
The present invention can be described as a method, data processing system, device for data processing and/or computer program product. The present invention can be embodied in an entirely software embodiment, an entirely physical embodiment, or a combination of both. The present invention can also be a computer program product stored on a computer-readable medium with computer-readable code means. You can use any suitable computer-readable storage medium, such as hard drives, CD-ROMs, optical storage devices and magnetic storage devices.
“Communication between one user and the system according the invention can be achieved through any suitable communication medium, such as a telephone network or Intranet, Internet, point-of-interaction device (point to sale device, personal digital assistant), kiosk, etc. Online communications, offline communications and wireless communications are all possible. A skilled person in the art will also recognize that the databases, systems or components of this invention can be composed of any combination of databases and components at any single location or at multiple locations. Each database or system may include any number of security features such as firewalls or access codes, encryption or de-encryption, compression or decompression, and/or other suitable security features.
“The invention has been described in the above specification with specific embodiments. It will be apparent that modifications and other changes are possible without departing from this invention’s scope as described in the claims. All modifications to the specification and figures should be considered illustrative rather than restrictive. The appended claims and legal equivalents should determine the scope of the invention, not the examples. The steps in any method or process claim may be performed in any order, and not just in the order described in the claims.
Specific embodiments have been described in detail. The benefits, advantages, solutions, and any element that could cause any benefit, advantage or solution to occur, or become more prominent, are not to be considered essential, required, or necessary features or elements of any or all claims. The terms ‘comprises’,?comprising, and any variation thereof are used herein to mean a non-exclusive addition. This means that a process or method, article or apparatus that contains a list elements may not only include those elements, but also include elements that are not explicitly listed or inherent in such process, method or article. If an element is not specifically described as essential, it is not required to practice the invention. If a particular element is not described as?essential? or?critical?, it cannot be used in the practice of the invention.
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