# Patent

## Title
Surgical method and workflow

## Abstract

A surgical method and workflow to improve the efficiency of a surgical procedure by intraoperatively acquiring a digital radiographic image, processing the digital radiographic image, and using information based on the radiographic image to make adjustments during the surgical procedure. A checklist of parameters may be displayed so that the surgeon can confirm all considerations have been made for the surgical procedure.

## Background
TECHNICAL FIELD
This invention relates to a surgical method and a workflow or protocol to make a surgical procedure more efficient using digital radiographic imaging.
BACKGROUND
In conducting certain surgical procedures, such as total hip arthroplasty (“THA”), the surgeon relies on radiographic images to help guide the proper placement of the prosthesis. Unfortunately, even with current technology, any surgeon is likely to admit that a quality intraoperative X-ray cannot be achieved. Trying to get a quality X-ray of a patient can be time consuming and exposes the patient to more radiation than desirable. The surgeon has to wait as the film is taken to another location for processing and brought back for review. If there are any problems with the film, the X-ray must be taken again. As such, there is no convenient intraoperative technique available for achieving perfect prosthesis placement every time.
For the foregoing reasons there is a need for a system that allows the surgeon to acquire a high-quality radiographic image that can be processed in the operating room so as to minimize the overall surgical procedure time and potential excess radiation exposure.
SUMMARY
The present invention is directed to a method and system that improves the efficiency and effectiveness of a surgical procedure, such as total hip arthroplasty. The method comprises acquiring a digital radiographic image of a patient, processing the radiographic image through a checklist, and making necessary adjustments to the patient or prosthetic based on processed information with minimal interruption in the surgical procedure.
The surgeon can walk through a workflow of choice to guide him through each step of the surgical procedure selected. The workflow can guide the surgeon through estimated component placement and a checklist of items to consider during the surgery. For example, in estimating component placement, the system can identify standard bone preparation tools, approximate broach size and judge anteversion for the femur, determine standard acetabular placement with screw and trial liner, determine limb length and offset estimates, determine a trial range of motion, and obtain anteroposterior and posteroanterior radiographic images. In working through the checklist, the surgeon can reconcile right/left and contrasts, reconcile pelvic rotation using trans-ischial line and mid-sacral line, reconcile tilt, read all parameters, make adjustments as indicated, and repeat any films necessary.



BRIEF DESCRIPTION OF DRAWINGS
FIG. 1 shows an embodiment of the computer architecture of the present invention.
FIG. 2 shows an embodiment of an image frame.
FIG. 3 shows an embodiment of a patient information window.
FIG. 4 shows an embodiment of a scanning window.
FIG. 5 shows an embodiment of a digital radiographic image being acquired.
FIG. 6 shows an embodiment of an image quality check window.
FIG. 7 shows an embodiment of an image displayed on a touchscreen for processing.
FIG. 8 shows another embodiment of an image frame of a series of a study.
FIG. 9 shows an embodiment of a computer architecture embodying the present invention.



DETAILED DESCRIPTION OF THE INVENTION
The detailed description set forth below in connection with the appended drawings is intended as a description of presently-preferred embodiments of the invention and is not intended to represent the only forms in which the present invention may be constructed or utilized. The description sets forth the functions and the sequence of steps for constructing and operating the invention in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and sequences may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention.
The present invention is a system and method for a surgical workflow. It allows radiographic images, such as X-ray images, to be acquired and displayed in digital form on a host computer for immediate review. Quality intraoperative X-ray images cannot be achieved with current technology. With the present system, however, high-quality digital radiographic images can be acquired quickly. The digital images can also be archived or forwarded to other medical personnel for further evaluation as required. With immediate acquisition of a high quality radiographic image, the surgeon is able to make the necessary adjustment on the patient or a prosthetic to perform the surgery in a more efficient manner.
Image Acquisition
Digital radiographic images can be acquired via digital radiography or computed radiography. For example, as shown in FIG. 1, in computed radiography, a radiological device 100 scans erasable phosphor plates exposed to X-rays and transmits the images to an imaging onboard computer 110 (either through a wired or wireless connection) for review, archiving, or forwarding to other facilities 102a, 102b through a local area network 104 and/or through the Internet 106 for further evaluation and/or archiving 108. In some embodiments, a scanner 120 may scan existing X-ray files 122 and convert them to digital radiographic images. Acquired images can be saved in a variety of formats, such as tiff, jpeg, png, bmp, dicom, and raw formatted images for both reading and writing.
Digital radiography offers numerous advantages over traditional X-ray methods. For example, digital radiography generates low radiation levels, specifically, below levels required by traditional X-ray machines to capture a detailed image on radiographic film 122. In addition, a radiographic image 500 can be viewed much quicker than with traditional X-ray film due to the reduced image acquisition time. Therefore, overall exposure to radiation is reduced due to the lower levels and shorter exposure times.
As shown in FIGS. 2-8, once a digital radiographic image 500 has been acquired, the radiographic image 500 can be processed and optimized by a computer 110, or any other computing device, such as a tablet, a smart phone, and the like. The computer 110 will display on a display device 112 (such as a monitor, television, screen, tablet, etc.) a main screen or main window 200 providing workflow action buttons 202, an image frame 204 to display the radiographic image 500, an information frame 206 displaying the information associated with the radiographic image displayed, and typical menu items 208.
The workflow 202 steps may comprise creating a study, creating a series, scanning an image, performing quality control on the image, changing information, completing the study, and clearing the study. Creating a study begins with entering information related to the patient, the patient's medical condition, a recommended medical procedure, and any other information relevant to the patient and the condition being treated or diagnosed. As shown in FIG. 3, a create study button 300 can be provided to begin this process. A patient information window 302 may be provided with various fillable fields to input the relevant information. Once a study is created, an acquired radiographic image 500 can be uploaded and saved to that study.
Scanning an image allows the user to acquire a radiographic image of a particular body part for processing. As shown in FIG. 4, a scan image button 400 may be provided, actuation of which opens a scanning window 402 that allows the user to select such configurations as a particular body part or region 404 to be scanned, the view of the scan 406, the patient's size 408, the particular technique used 410, the grid type 412, the offset 414, and the like. Selecting a body part may involve selecting the corresponding body part of an image displayed on the image frame, or selecting the body part from a list of body parts. Once the scan is initiated, the images may be displayed line by line in the image frame 204 as it is being scanned as shown in FIG. 5. In some embodiments, a grid 502 may be provided. Using the grid 502, the image orientation can be verified and adjusted. For example, the image 500 can be rotated by any degree, then flipped, inverted, or otherwise adjusted, and processed further as discussed below.
Once the image 500 has been acquired, the user can perform a quality control (QC) check on the image. As shown in FIG. 6, a layout template or a QC image button 600 may be provided, actuation of which opens an image QC window 602 providing a number of features to improve the quality and layout of the radiographic image 500 acquired. For example, the image QC window 602 may provide features to orient the image 604, add markers 606 to the image, annotate the image, change the image dimensions and take measurements or sizing on the image 608, change the appearance of the image 610, and the like.
Therefore, using the image QC window 602, the user can process, modify, and interact with the image 500, such as rotating to the left, rotating to the right, flipping horizontally, flipping vertically, cropping, zooming, magnifying, moving or panning the image, changing the window width, inverting the image to a negative image, adjusting the level (brightness and contrast) of the image, adding or creating markers to indicate various information about the image, adding measuring lines to determine lengths, distances, angles, and the like. Additional features can be added, and any feature can be removed and added back again so as to configure the layout template according to the user's needs.
In some embodiments, processing, modifying, and interacting with the image 500 can be done on the image frame 204 instead of with the image QC window 602. For example, the display device 110 showing the radiographic image 500 may be a touchscreen device 700 as shown in FIG. 7. The user may use his fingers or a pointing device or any tool 702 to make gestures on a touchscreen 700 to effectuate the desired feature and view parameters that would assist the surgeon during the surgical procedure. For example, if a scanned image 500 is not properly aligned in the image frame 204, the user may tap or double tap the touchscreen 700 on the scanned image 500 and cause it to automatically rotate into the proper orientation. Gridlines 502 may be displayed on the image frame 204 as a guide for proper alignment. Alternatively, the user can place one or more fingers on the image frame 204 and make a rotating gesture to cause image 500 to rotate in the direction of the gesture. In some embodiments, the user may input specific values as the precise measurement for modification. For example, the user may indicate that the radiographic image 500 is to be rotated by a specified angle of rotation.
Taking measurements can be done in a similar fashion. Actuation of any of the features in the image QC window 602 may open a tools window 704 containing a checklist with electronic tools that are specific for the feature actuated. For example, if a measurement button is actuated, a tools window 704 may be displayed with a set of electronic tools that can be actuated to take measurements on the radiographic image. Actuating a length tool may allow the user to draw lines 706 on the radiographic image 500 which represents a length on the image 500. Actuating an angle tool allows the user to draw angles 708 and adjust the angle 708 drawn so that the user can measure the angle between structures shown on the radiographic image 500. Using the touchscreen 700, the user is able to move the lines 706 or angles 708 to various positions on the radiographic image 500 to take the measurement of various structures on the radiographic image. Lines 706 and angles 708 already drawn can be modified to change the length and/or angles. New lines and angles can also be created to measure multiple structures.
Based on measurements determined on the radiographic image 500, the surgeon or other medical personnel can make adjustments during the surgical procedure, such as adjusting the position of the patient, the patient's body part, a prosthetic, a surgical tool, and the like to achieve a desired position, thereby eliminating any delay and interruption during the surgical procedure.
By way of example only, as shown in FIG. 7, a radiographic image of the hip area is displayed on a touchscreen 706 along with the surgeon's checklist 704 to allow the surgeon to check desired parameters to assure the surgical procedure will be performed efficiently and accurately. Based on the acquired image, the surgeon can make sure the left and right sides of the image are properly displayed and the contrast adjusted. The surgeon may touch a point on the mid sacrum. This displays a vertical line 706 which can be used to determine the presence of pelvic tilt. Significant tilt or rotation of the pelvis would render subsequent measurements inaccurate. If this line 706, starting at mid sacrum passes to one side of the symphysis pubis by more than, for example, a centimeter, then the patient's position should be adjusted so that the line 706 is as close to mid symphysis as possible to reconcile pelvic tilt.
Next, the surgeon may actuate a horizontal line tool to draw either a transischial or trans-ischial tuberosity line 707 to reconcile pelvic rotation. This identifies a horizontal axis orientation in relation to the pelvis. This line 707 creates, for example, a reference for subsequent angular and linear limb length and offset measurements.
The surgeon may then actuate an angle tool from the checklist 704 to display an acetabular abduction angle 708, for example, at 45 degrees. This 45 degree angle is referenced to the previously drawn horizontal (teardrop or trans-ischial) line 707 representing the transverse pelvic axis.
The surgeon may actuate a measure offset tool from the checklist 704 to display a measuring line 709. In this example, the measuring line 709 is displayed as a line parallel to horizontal 707. The measuring line 709 can be set to start at any predetermined length, for example, the measured amount on the pre-op X-ray. This is, generally speaking, the amount of late realization of the femur in relation to the pelvis, which is as important as limb length in THA.
With the measuring line 709, major and minor diameters of acetabular component can be determined. These numbers feed into a calculation of “acetabular anteversion,” another important parameter in THA.
Actuation of an annotation tool permits annotation of accuracy of femoral component sizing. All annotations can be saved as part of the patient's medical record. Once the combination of these steps are complete, the surgeon is in a much better position to accurately place the acetabular component and assure that the location of the screws is acceptable. By performing this combination of steps from the checklist and getting immediate results during the actual surgical procedure, the surgeon is able to perform the surgery more accurately and quicker than without the checklist. Other parameters to be checked may be determined by the surgeon as needed.
Specific regions of interest can also be isolated and that region of interest modified in the ways described above. For example, the user can click on the image 500 and create a box 612 around the region of interest to display a blow-up of the region of interest.
Multiple images may be acquired and saved as a series of a study. Selected images can be displayed together or individually in the image frame 204. All images in the series may be provided as thumbnail images 800 adjacent to the image frame 204 to show all images related to the image 500 displayed in the image frame 204 as shown in FIG. 8.
Once the image 500 has been acquired, before, during, or after any processing, the system can provide a checklist of parameters for the user to review and indicate whether the necessary steps have been performed. The checklist can include, but is not limited to, the following items or parameters: orientation of the radiographic image, component orientation, cup apposition (in-growth), cup anteversion angle, cup abduction angle, screw positions, femoral sizing, femoral component alignment, limb length, and offset between the first edge of a bone and a second edge of the bone.
Additional buttons may be provided to delete the image, save the image, clear the image, undo an action, redo an action, and the like. Each of these steps can be done during the operation without the surgeon having to leave his patient.
Saved files can be opened in the typical manner from a database or directory 802. The system may display a worklist window for the user to view and select study from a worklist. The worklist may be organized by a specific filter, such as name, date, medical condition, and the like. Selection of a specific filter displays all studies categorized under that filter. Each study may have additional information associated with it. The list of studies may be sortable based on any of the additional information. Selection of a study displays an image window that allows the surgeon to review acquired digital radiographic images.
Any created study can be transmitted to another computer 102a, 102b via a local area network 104 and/or the Internet 106, saved to a hard drive or saved to any other type of non-transitory computer readable medium, such as a CD, DVD, USB drive, and the like.
Additional workflow states include the state of arrival of a study, a verification state to indicate that a study is complete and accurate, a dictated state to indicate a report for a study has been dictated, a transcribed state to indicate that a report has been transcribed, and a finalized state to indicate that a report has been approved and finalized.
This system allows the user to take an X-ray before and during the middle of an operation and make the necessary adjustments immediately upon acquiring the results to greatly improve the accuracy of the surgical procedure. In addition, the accuracy resulting from each step synergistically improves the accuracy of any subsequent step and, therefore, significantly improves the outcome of the total surgical procedure in a way that cannot be achieved by improving the accuracy of any one step alone.
FIG. 9 depicts exemplary hardware for a surgical method and workflow system for providing efficient acquisition and processing of radiographic images for surgery. The system may be in the form of a computer 900 that includes a processing unit 904, a system memory 904, and a system bus 920 that operatively couples various system components, including the system memory 906 to the processing unit 904. There may be only one or there may be more than one processing unit 904, such that the processor of computer 900 comprises a single central processing unit (CPU), or a plurality of processing units, commonly referred to as a parallel processing environment. The computer 900 may be a conventional computer, a distributed computer, a web server, a file server, a tablet or iPad, a smart phone, or any other type of computing device.
The system bus 920 may be any of several types of bus structures including a memory bus or memory controller, a peripheral bus, a switched fabric, point-to-point connections, and a local bus using any of a variety of bus architectures. The system memory 906 may also be referred to as simply the memory, and includes read only memory (ROM) 908 and random access memory (RAM) 907. A basic input/output system (BIOS) 910, containing the basic routines that help to transfer information between elements within the computer 900, such as during start-up, is stored in ROM 908. The computer 900 may further include a hard disk drive 932 for reading from and writing to a hard disk, not shown, a magnetic disk drive 934 for reading from or writing to a removable magnetic disk 938, and/or an optical disk drive 936 for reading from or writing to a removable optical disk 940 such as a CD-ROM or other optical media.
The hard disk drive 932, magnetic disk drive 934, and optical disk drive 936 may be connected to the system bus 920 by a hard disk drive interface 922, a magnetic disk drive interface 924, and an optical disk drive interface 926, respectively. The drives and their associated computer-readable media provide nonvolatile storage of computer-readable instructions; data structures, e.g., a catalog and a context-based index; program modules, e.g., a web service and an indexing robot; and other data for the computer 900. It should be appreciated by those skilled in the art that any type of computer-readable media that can store data that is accessible by a computer, for example, magnetic cassettes, flash memory cards, USB drives, digital video disks, RAM, and ROM, may be used in the exemplary operating environment.
A number of program modules may be stored on the hard disk 932, magnetic disk 934, optical disk 936, ROM 908, or RAM 907, including an operating system 912, browser 914, stand alone program 916, etc. A user may enter commands and information into the personal computer 900 through input devices such as a keyboard 942 and a pointing device 944, for example, a mouse. Other input devices (not shown) may include, for example, a microphone, a joystick, a game pad, a tablet, a touch screen device, a satellite dish, a scanner, a facsimile machine, and a video camera. These and other input devices are often connected to the processing unit 904 through a serial port interface 928 that is coupled to the system bus 920, but may be connected by other interfaces, such as a parallel port, game port or a universal serial bus (USB).
A monitor 946 or other type of display device is also connected to the system bus 920 via an interface, such as a video adapter 948. In addition to the monitor 946, computers typically include other peripheral output devices, such as speakers 960 connected to the system bus 920 via an audio adapter 962, and printers. These and other output devices are often connected to the processing unit 904 through the serial port interface 928 that is coupled to the system bus 920, but may be connected by other interfaces, such as a parallel port, game port, or a universal serial bus (USB).
The computer 900 may operate in a networked environment using logical connections to one or more remote computers. These logical connections may be achieved by a communication device coupled to or integral with the computer 900; the application is not limited to a particular type of communications device. The remote computer may be another computer, a server, a router, a network personal computer, a client, a peer device, or other common network node, and typically includes many or all of the elements described above relative to the computer 900, although only a memory storage device has been illustrated in FIG. 9. The computer 900 can be logically connected to the Internet 972. The logical connection can include a local area network (LAN), wide area network (WAN), personal area network (PAN), campus area network (CAN), metropolitan area network (MAN), or global area network (GAN). Such networking environments are commonplace in office networks, enterprise-wide computer networks, intranets and the Internet, which are all types of networks.
When used in a LAN environment, the computer 900 may be connected to the local network through a network interface or adapter 930, which is one type of communications device. When used in a WAN environment, the computer 900 typically includes a modem 950, a network adapter 952, or any other type of communications device for establishing communications over the wide area network. The modem 950, which may be internal or external, is connected to the system bus 920 via the serial port interface 928. In a networked environment, program modules depicted relative to the personal computer 900, or portions thereof, may be stored in a remote memory storage device. It is appreciated that the network connections shown are exemplary and other means of, and communications devices for, establishing a communications link between the computers may be used.
The system can take the form of a computer program product 916 accessible from a computer-usable or computer-readable medium providing program code for use by or in connection with a computer or any instruction execution system. For the purposes of this description, a computer-usable or computer readable medium can be any apparatus that can contain, store, communicate, propagate, or transport the program for use by or in connection with the instruction execution system, apparatus, or device.
The medium can be an apparatus or device that utilizes or implements electronic, magnetic, optical, electromagnetic, infrared signal or other propagation medium, or semiconductor system. Examples of a computer-readable medium comprise a semiconductor or solid-state memory, magnetic tape, a removable computer diskette, a random access memory, a read-only memory, a rigid magnetic disk and an optical disk. Current examples of optical disks comprise compact disk-read only memory (CD-ROM), compact disk-read/write (CD-R/W) and DVD formats.
A data processing system suitable for storing and/or executing program code comprises at least one processor coupled directly or indirectly to memory elements through a system bus. The memory elements can include local memory employed during actual execution of the program code, bulk storage, and cache memory that provide temporary storage of at least some program code in order to reduce the number of times code is retrieved from bulk storage during execution.
Input/output or I/O devices (including, but not limited to, keyboards, displays, pointing devices, etc.) can be coupled to the system either directly or through intervening I/O controllers.
Network adapters may also be coupled to the system to enable the data processing system to become coupled to other data processing systems or remote printers or storage devices through intervening private or public networks. Modems, cable modems and Ethernet cards are just a few of the currently available types of network adapters.
Furthermore, computers and other related electronic devices can be remotely connected to either the LANs or the WAN via a digital communications device, modem and temporary telephone, or a wireless link. It will be appreciated that the Internet comprises a vast number of such interconnected networks, computers, and routers.
The foregoing description of the preferred embodiment of the invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of the above teaching. It is intended that the scope of the invention not be limited by this detailed description, but by the claims and the equivalents to the claims appended hereto.

## Claims

1. A method of intraoperative imaging, comprising:
a. capturing a radiographic image using low radiation levels;
b. verifying an orientation of the radiographic image;
c. adding markers and annotations based on measurements taken from the radiographic image in real time;
d. collecting information taken from the radiographic image and transmitting the information to a surgeon while the surgeon is conducting an operation; and
e. presenting to the surgeon while the surgeon is conducting an operation a checklist of a plurality of parameters associated with the measurements taken from the radiographic image on a display device.

2. The method of claim 1, wherein the plurality of parameters comprises any combination of parameters selected from the group consisting of:
a. orientation of the radiographic image,
b. cup apposition (in-growth),
c. cup anteversion angle,
d. cup abduction angle,
e. screw positions,
f. sizing, and
offset between the first edge of a bone and a second edge of the bone.

3. The method of claim 1, wherein the information is selected from the group consisting of disease, measurements, limb length, and deformities.

4. The method of claim 1, further comprising taking a measurement of a structure depicted in the radiographic image.

5. The method of claim 4, further comprising making an adjustment to a surgical procedure based on the measurement.

6. The method of claim 1, wherein a reading of at least one of the parameters is displayed on the display device as a check for a desired reading.

7. A computer system comprising at least one processor; a database for storing information; and a memory operatively coupled to the processor, the memory storing program instructions that, when executed by the processor, causes the processor to:
a. capture a radiographic image using low radiation levels;
b. verify an orientation of the radiographic image;
c. adding markers and annotations based on measurements taken from the radiographic image in real time;
d. collect information taken from the radiographic image and transmitting the information to a surgeon while the surgeon is conducting an operation; and
e. present to the surgeon while the surgeon is conducting an operation a checklist of a plurality of parameters associated with the measurements taken from the radiographic image on a display device.

8. The method of claim 7, wherein the plurality of parameters comprises any combination of parameters selected from the group consisting of:
a. orientation of the radiographic image,
b. cup apposition (in-growth),
c. cup anteversion angle,
d. cup abduction angle,
e. screw positions,
f. sizing, and
g. offset between the first edge of a bone and a second edge of the bone.

9. The method of claim 7, wherein the information is selected from the group consisting of disease, measurements, limb length, and deformities.

10. The method of claim 7, further comprising taking a measurement of a structure depicted in the radiographic image.

11. The method of claim 10, further comprising making an adjustment to a surgical procedure based on the measurement.

12. The method of claim 7, wherein a reading of at least one of the parameters is displayed on the display device as a check for a desired reading.

13. A non-transitory computer readable medium storing instructions for causing at least one processor to perform a method that allows a user to acquire and process a radiographic image for surgery, the method comprising:
a. capturing a radiographic image using low radiation levels;
b. verifying an orientation of the radiographic image;
c. adding markers and annotations based on measurements taken from the radiographic image in real time;
d. collecting information taken from the radiographic image and transmitting the information to a surgeon while the surgeon is conducting an operation; and
e. presenting to the surgeon while the surgeon is conducting an operation a checklist of a plurality of parameters associated with the measurements taken from the radiographic image on a display device.

14. The method of claim 13, wherein the plurality of parameters comprises any combination of parameters selected from the group consisting of:
a. orientation of the radiographic image,
b. cup apposition (in-growth),
c. cup anteversion angle,
d. cup abduction angle,
e. screw positions,
f. sizing, and
g. offset between the first edge of a bone and a second edge of the bone.

15. The method of claim 13, further comprising taking a measurement of a structure depicted in the radiographic image.

16. The method of claim 15, further comprising making an adjustment to a surgical procedure based on the measurement.

17. The method of claim 13, wherein a reading of at least one of the parameters is displayed on the display device as a check for a desired reading.