Abstract:
A method and system for enhanced ophthalmic surgery training by using simulation techniques. Each type of ophthalmic surgery, such as retinal or cataract surgery, is broken down into a sequence of surgical tasks, and each task is programmed into the system. A user practices each task via a simulator on a virtual human subject until a pre-determined level of skill is acquired for the task. The present invention objectively and effectively assesses a user&#39;s skill and expertise level in performing ophthalmic surgery via gated performance testing, thereby ensuring that the user has a pre-determined skill and expertise level, and eliminating undue risk to patients.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 60/778,378, entitled “TASK ASSESSMENT-BASED SKILLS COMPETENCY SYSTEMS (TASC),” filed Mar. 3, 2006, the entirety of which is incorporated by reference herein. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates to a method and system for using simulation techniques in surgery training. In particular, the present invention provides a method and system for ophthalmic surgery training using simulation via task breakdown and analysis and score-dependent gated-progression to higher-level task training. 
         [0004]    2. Description of the Related Art 
         [0005]    There are known in the art methods for providing ophthalmic surgery training. These known methods include observation by ophthalmic surgery trainees of experienced ophthalmic surgeons performing surgery. Eventually, after a period of observation, each trainee begins to perform ophthalmic surgery. Because the training is based primarily on observation, however, the trainees&#39; practical experience is little or non-existent. Any practical experience a trainee may have would be gained by practicing ophthalmic surgery on animals, or other subjects that are not anatomically similar to humans, or on cadavers. 
         [0006]    These known methods for ophthalmic surgery training are deficient in that it is not possible for trainees to break down each type of ophthalmic surgery (e.g., cataract and retinal surgery) into a sequence of separate tasks or steps, and to practice performing each task or step until they are ready to begin practicing the next surgical task or step in the sequence. Furthermore, the known methods suffer from the disadvantage of not being able to effectively assess or evaluate a trainee&#39;s skill and expertise level in performing any type of ophthalmic surgery prior to the trainee actually practicing the surgery on a living human patient. In addition, the known methods have the disadvantage of placing patients undue risk, if a trainee has not reached an acceptable level of skill prior to performing the surgery. 
         [0007]    There is a need in the art, therefore, for methods and systems for ophthalmic surgery training by simulating the practice of ophthalmic surgery on a human patient. There is a further need in the art for methods and systems that provide enhanced ophthalmic surgery training by breaking down each type of surgery into a sequence of separate tasks or steps, and practicing each task until a pre-determined level of skill is acquired, prior to practicing the next step in the sequence. Furthermore, there is a need in the art for methods and systems for ophthalmic surgery training that have the capacity to objectively and effectively assess a trainee&#39;s skill and expertise level in performing the surgery in a low-risk environment, i.e., prior to the trainee actually practicing the surgery on a human patient, thus avoiding placing patients in situations of undue risk. 
       SUMMARY OF THE INVENTION 
       [0008]    The present invention solves the above identified needs, as well as others, by providing a method and system for ophthalmic surgery training by using simulation techniques. One embodiment of the present invention provides a method and system for enhanced ophthalmic surgery training by breaking down each type of surgery into a sequence of separate tasks or steps, and practicing each task via a simulator on a virtual human subject until a pre-determined level of skill is acquired, prior to practicing the next step in the sequence. In one embodiment, the method and system for ophthalmic surgery training of the present invention has the capacity to objectively and effectively assess a trainee&#39;s skill and expertise level in performing ophthalmic surgery via a simulator, prior to the trainee actually practicing the surgery on a human patient. 
         [0009]    It will be readily recognized by those of ordinary skill in the art that, although the embodiments of the present invention described herein refer specifically to ophthalmic surgery, the method and system of the present invention is applicable to any type of surgery, and specifically to any surgery the performance of which may be broken down into a series of discrete tasks. 
         [0010]    Additional advantages and novel features of the invention will be set forth in part in the description that follows, and in part will become more apparent to those skilled in the art upon examination of the following or upon learning by practice of the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]    The foregoing and other objects, features, and advantages of the invention will become more readily apparent upon reference to the following detailed description of presently preferred embodiments, when taken in conjunction with the accompanying drawings in which: 
           [0012]      FIG. 1  illustrates a flow diagram of the method of the present invention, in accordance with one embodiment; 
           [0013]      FIG. 2  illustrates an example task breakdown of a surgical procedure, in accordance with one embodiment of the present invention; 
           [0014]      FIG. 3  illustrates an example of gated performance testing used in conjunction with an embodiment of the present invention; 
           [0015]      FIG. 4  illustrates exemplary system features for use in accordance with an embodiment of the present invention; and 
           [0016]      FIG. 5  illustrates exemplary system components for use with embodiments of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0017]    In one embodiment of the present invention, as shown in  FIG. 1 , a method  100  is provided for enhanced ophthalmic surgery training by simulating the practice of ophthalmic surgery on a human subject. At step  110 , each surgical procedure is broken down into a series of discrete tasks to be performed as part of the procedure. The information associated with each discrete task may include: the goal of each task; the risks associated with each task; the instruments necessary to perform each task; and the task&#39;s place as part of the sequence. 
         [0018]    At step  120 , individual and/or collective task scenarios may be developed. The scenarios may include, for example, any scenario ranging from a single task to be performed by a single individual, to difficult and critical scenarios, to abnormal scenarios and scenarios involving severe complications, which may require team participation (e.g., one or more surgeons, circulation nurse(s) and/or anesthesiologist(s)). Each of these scenarios, when programmed and executed on a programmable simulator, may be performed repetitively by a user until a pre-determined level of repetitions and/or a pre-determined skill/experience level has been achieved. In accordance with one embodiment, task simulation is performed at step  130 , individual scenario simulation is performed at step  140 , and collective scenario simulation is performed at step  150 . In one embodiment, collective scenario simulation is used to optimize and enhance surgical team performance. 
         [0019]    Upon completion of each simulation step  130 ,  140  and/or  150 , the received user input is assessed and scored at step  160 . The scoring may be performed, for example, in accordance with agreed upon performance standards established by a panel of expert surgeons, or other objective criteria. In one embodiment, the score may reflect the extent to which the goal of each simulated task has been accomplished, or may be a combination score evaluating multiple factors, such as the user&#39;s efficiency, dexterity, decision-making and risk-avoidance capabilities, complication management, and protocol optimization. If a user&#39;s performance score is not acceptable, simulation steps  130 ,  140  and/or  150  are repeated until a desired performance score is achieved. 
         [0020]    Referring now to  FIG. 2 , therein shown is a task breakdown of a surgical procedure, in accordance with one embodiment of the present invention. As an example, the specific surgical procedure discussed is an Epi-Retinal Membrane Peel (also referred to herein as a “Peel ERM”), which may be divided into discrete performance steps, such as steps  210  to be performed by surgeon  215 , as shown in  FIG. 2 . In one embodiment, the discrete performance steps  210  may include: inserting a pick; orienting the pick; memorizing the position of an Epi-Retinal Membrane (ERM); advancing the pick to the ERM surface; creating a small tear in the ERM; elevating the ERM with the pick; withdrawing the pick; inserting forceps; orienting the forceps; engaging the ERM with the forceps; peeling the ERM circumferentially; inspecting the retina; identifying residual peel with arcades; identifying iatrogenic tears; and withdrawing the forceps. 
         [0021]    In accordance with one embodiment, one or more of steps  210  may be performed in an instructor-led environment  220 , may be interactive  225 , performed via simulation  230 , or in an operating room environment  235 . Each of the steps  210  may be pre-assigned a degree of difficulty  240 , importance  245  and/or frequency  250 . Each user&#39;s training or skill level may be assessed  255  based on the difficulty  240 , importance  245 , and/or frequency  250  factors. In addition, in one embodiment, a variety of resources  260  may be used, such as instruction texts, photographs, diagrams, simulation videos, and actual videos. 
         [0022]    Another example of an ophthalmic surgery procedure that may be performed using the method and system of the present invention is Capsulorhexis, more commonly known as cataract surgery. In one embodiment, this surgery may be divided into discrete performance steps as follows: (1) inserting a viscoelastic canula through the paracentesis incision into the anterior chamber of the eye; (2) injecting viscoelastic fluid to fill the anterior chamber; (3) removing the viscoelastic canula from the eye when viscoelastic fluid begins to egress from the incision, indicating that the anterior chamber is full; (4) inserting a cystotome through the tunnel incision oriented horizontally; (5) orienting the cystotome vertically upon entry of the anterior chamber, with the tip pointing toward the anterior lens capsule; (6) piercing the center of the lens capsule using the cystotome; (7) continuing the incision by directing the cystotome laterally 2-3 mm (depending on whether the capsulorhexis will proceed clockwise or counterclockwise); (8) completing the incision by directing it 1 mm toward the surgeon to create a triangular flap in the lens capsule; (9) inserting a capsulorhexis forceps through the tunnel incision oriented horizontally; (10) orienting the capsulorhexis vertically upon entry into the anterior chamber; (11) clasping the anterior capsular flap with the capsulorhexis at its edge; (12) directing the capsulorhexis in a circumlinear fashion staying within the plane of the anterior lens capsule; (13) while the flap proceeds circumlinearly, increasing the distance from the edge of the tear to the forceps; (14) releasing and regrasping the flap with the capsulorhexis forceps closer to the edge of the tear to maintain better control over its direction, keeping in mind that the ideal diameter of the capsulorhexis is 5-6 mm; (15) completing the capsulorhexis when the capsulorhexis tear converges at its starting point; (16) orienting the capsulorhexis forceps horizontally; and (17) removing the capsulorhexis forceps from the eye through the tunnel incision. 
         [0023]    An alternative procedure, also divided into discrete steps, may be performed if the flap goes out to the periphery. The discrete steps in this case include the following: (1) releasing the flap from the capsulorhexis forceps; (2) orienting the capsulorhexis forceps horizontally; (3) removing the capsulorhexis forceps from the eye through the tunnel incision; (4) observing the anterior chamber and determining whether its depth is adequately; (5) if too much viscoelastic has egressed during the procedure, inserting the viscoelastic canula into the anterior chamber; (6) injecting additional viscoelastic fluid into the chamber to deepen it; and (7) removing the viscoelastic canula from the eye. 
         [0024]    At least two options are available to complete the capsulorhexis procedure when the flap goes out to the periphery. Option I (redirecting the tear) may be divided into the following discrete steps: (1) inserting a capsulorhexis forceps through the tunnel incision oriented horizontally; (2) orienting the forceps vertically upon entry into the anterior chamber; (3) regrasping the tear close to its edge by pulling towards the center of the pupil, thereby returning the direction of the tear to its intended course; (4) releasing and regrasping the flap with the capsulorhexis forceps closer to the edge of the tear to maintain better control over its direction, keeping in mind that the ideal diameter of the capsulorhexis is 5-6 mm; (5) completing the capsulorhexis when the capsulorhexis tear converges at its starting point; (6) orienting the capsulorhexis forceps horizontally; and (7) removing the capsulorhexis forceps from the eye through the tunnel incision. 
         [0025]    Option II for completing the capsulorhexis procedure when the flap goes out to the periphery (starting a new flap from an opposite direction) may be divided into the following discrete steps: (1) inserting the cystotome through the tunnel incision oriented horizontally; (2) orienting the cystotome vertically once the anterior chamber is entered; (3) approaching the beginning of the flap with the cystotome; (4) making an incision in the anterior lens capsule and directing it 1 mm away from the surgeon to create a new flap; (5) orienting the cystotome horizontally; (6) removing the cystotome from the eye through the tunnel incision; (7) inserting a capsulorhexis forceps through the tunnel incision oriented horizontally; (8) orienting the forceps vertically once the anterior chamber is entered; (9) grasping the new flap with the capsulorhexis forceps; (10) directing the capsulorhexis circumlinearly in the opposite direction staying within the plane of the anterior lens capsule; (11) while the flap proceeds circumlinearly, increasing the distance from the edge of the tear to the forceps; (12) releasing and regrasping the flap with the capsulorhexis forceps closer to the edge of the tear to maintain better control over its direction, keeping in mind that the ideal diameter of the capsulorhexis is 5-6 mm; (13) completing the capsulorhexis when the capsulorhexis tear converges at its starting point; (14) orienting the capsulorhexis forceps horizontally; and (15) removing the capsulorhexis forceps from the eye through the tunnel incision. 
         [0026]    Referring now to  FIG. 3 , therein shown is an example of gated performance testing in accordance with an embodiment of the present invention.  FIG. 3  shows three performance gates (also interchangeably referred to herein as “post-test levels”): Beginner  310 ; Intermediate  320 ; and Advanced  330 . The user may have, for example, a pre-test level  305 . Remediation (or multiple repetition of simulation task performance)  340  may be necessary for some users to reach the Advanced gate  330  (the third post-test level of guaranteed performance). It will be readily apparent to those of ordinary skill in the art that the present invention may be used with any other system of gated performance testing and/or testing levels. 
         [0027]    It will be appreciated that the present invention may be implemented in an Internet environment, on a stand-alone computer, in an interactive television environment, or in any other environment that supports storage and display of data.  FIG. 4  presents an exemplary system diagram  400  of various hardware components and other features in accordance with an embodiment of the present invention. As shown in  FIG. 4 , in an embodiment of the present invention, some data for use in the system is, for example, input by a customer (also referred to interchangeably herein as a “user”) via terminals  442 ,  466 , such as personal computers (PC), minicomputers, mainframe computers, microcomputers, telephonic devices, or wireless devices, such as hand-held wireless devices, each coupled to one or more simulators  474 ,  476 , and a server  443 , such as a PC, minicomputer, mainframe computer, microcomputer, or other device having a processor and a repository for data and/or connection to a processor and/or repository for data, via, for example, a network  444 , such as the Internet or an intranet, and couplings  445 ,  446 ,  464 . The couplings  445 ,  446 ,  464  include, for example, wired, wireless, or fiberoptic links. In another embodiment, the method and system of the present invention operate in a stand-alone environment, such as on a single terminal. 
         [0028]    In operation, in an embodiment of the present invention, via the network  444 , surgical procedure data, task data, individual and collective scenario data, performance standards, and/or other information is communicated with and stored on the server  443  (e.g., electronically). 
         [0029]    In one embodiment of the present invention, simulator  474  comprises a platform  470  with a simulated human head  472  (e.g., made out of plastic or other malleable material) with a simulated human eye, which has multiple openings corresponding to various incisions via which the eye may be surgically accessed. Further, simulator  474  comprises one or more Light-Emitting Diode (LED) computer screens, which may act as a microscope  468  for the user to look through and to view the simulated virtual reality human eye, which is anatomically similar to an actual human eye. In addition, simulator  474  may have a variety of simulated instruments, such as probe  478 . Probe  478  may have a sensor at one end, which, upon entry into the eye via the incisions, is recognized by the system as a specific pre-programmed surgical instrument (i.e., a pick, forceps and a light pipe, among others). Thus, when the specific instrument is recognized by the system, a user looking through microscope  468  will see the virtual reality instrument as recognized by the computer. Thus the user may perform a simulated virtual reality surgery, such as retinal, cataract, or other. 
         [0030]    The present invention may be implemented using hardware, software or a combination thereof and may be implemented in one or more computer systems or other processing systems. In one embodiment, the invention is directed toward one or more computer systems capable of carrying out the functionality described herein. An example of such a computer system  500  is shown in  FIG. 5 . 
         [0031]    Computer system  500  includes one or more processors, such as processor  504 . The processor  504  is connected to a communication infrastructure  506  (e.g., a communications bus, cross-over bar, or network). Various software embodiments are described in terms of this exemplary computer system. After reading this description, it will become apparent to a person skilled in the relevant art(s) how to implement the invention using other computer systems and/or architectures. 
         [0032]    Computer system  500  can include a display interface  502  that forwards graphics, text, and other data from the communication infrastructure  506  (or from a frame buffer not shown) for display on the display unit  530 . Computer system  500  also includes a main memory  508 , preferably random access memory (RAM), and may also include a secondary memory  510 . The secondary memory  510  may include, for example, a hard disk drive  512  and/or a removable storage drive  514 , representing a floppy disk drive, a magnetic tape drive, an optical disk drive, etc. The removable storage drive  514  reads from and/or writes to a removable storage unit  518  in a well-known manner. Removable storage unit  518 , represents a floppy disk, magnetic tape, optical disk, etc., which is read by and written to removable storage drive  514 . As will be appreciated, the removable storage unit  518  includes a computer usable storage medium having stored therein computer software and/or data. 
         [0033]    In alternative embodiments, secondary memory  510  may include other similar devices for allowing computer programs or other instructions to be loaded into computer system  500 . Such devices may include, for example, a removable storage unit  522  and an interface  520 . Examples of such may include a program cartridge and cartridge interface (such as that found in video game devices), a removable memory chip (such as an erasable programmable read only memory (EPROM), or programmable read only memory (PROM)) and associated socket, and other removable storage units  522  and interfaces  520 , which allow software and data to be transferred from the removable storage unit  522  to computer system  500 . 
         [0034]    Computer system  500  may also include a communications interface  524 . Communications interface  524  allows software and data to be transferred between computer system  500  and external devices. Examples of communications interface  524  may include a modem, a network interface (such as an Ethernet card), a communications port, a Personal Computer Memory Card International Association (PCMCIA) slot and card, etc. Software and data transferred via communications interface  524  are in the form of signals  528 , which may be electronic, electromagnetic, optical or other signals capable of being received by communications interface  524 . These signals  528  are provided to communications interface  524  via a communications path (e.g., channel)  526 . This path  526  carries signals  528  and may be implemented using wire or cable, fiber optics, a telephone line, a cellular link, a radio frequency (RF) link and/or other communications channels. In this document, the terms “computer program medium” and “computer usable medium” are used to refer generally to media such as a removable storage drive  514 , a hard disk installed in hard disk drive  512 , and signals  528 . These computer program products provide software to the computer system  500 . The invention is directed to such computer program products. 
         [0035]    Computer programs (also referred to as computer control logic) are stored in main memory  508  and/or secondary memory  510 . Computer programs may also be received via communications interface  524 . Such computer programs, when executed, enable the computer system  500  to perform the features of the present invention, as discussed herein. In particular, the computer programs, when executed, enable the processor  504  to perform the features of the present invention. Accordingly, such computer programs represent controllers of the computer system  500 . 
         [0036]    In one embodiment where the invention is implemented using software, the software may be stored in a computer program product and loaded into computer system  500  using removable storage drive  514 , hard drive  512 , or communications interface  524 . The control logic (software), when executed by the processor  504 , causes the processor  504  to perform the functions of the invention as described herein. In another embodiment, the invention is implemented primarily in hardware using, for example, hardware components, such as application specific integrated circuits (ASICs). Implementation of the hardware state machine so as to perform the functions described herein will be apparent to persons skilled in the relevant art(s). 
         [0037]    In yet another embodiment, the invention is implemented using a combination of both hardware and software. 
         [0038]    While the invention has been described in detail in particular embodiments using specific examples, it would be appreciated by those skilled in the art that various modifications of those details could be developed in light of the overall teaching of the disclosure. For example, while the invention has been described in terms of a method and system for tracking and compensation of distributors of medical test products, the invention is equally applicable to distributors, including retailers and wholesalers, of other products and services. The particular embodiments disclosed herein are intended to be illustrative only and not limiting to the scope of the invention.