Patent Application
20140370474
Endoscopy is a minimally invasive diagnostic medical procedure used to view interior parts of the body, such as the interior or exterior surfaces of organs, joints or cavities. A flexible endoscope is used to view interior parts of the body and has a moveable tip with an objective lens, a flexible shaft and a handle. Light is usually transferred from an external light source via glass fiber bundles to the moveable tip, where the light is emitted to illuminate the bodily features to be viewed. The illuminated bodily feature is projected by an objective lens onto a separate thin bundle of glass fibers, each fiber diameter typically ranging from 4 μm to 18 μm and the number of fibers from approximately 3,000 to over 20,000. This fiberoptic bundle optically transfers the image to the handle of the flexible endoscope where it is enlarged and made visible by an eyepiece lens. The fiberoptic bundles are extremely flexible, and an image can be transmitted even when tied in a knot.
The movable tip also includes an operating channel which allows the passage of additional instruments, such as forceps or snares, to be inserted into the endoscope handle and passed along the length of the endoscope shaft. The instrument emerges from the distal end of the endoscope into the field of view. An endoscopist can then use various endoscopic maneuvers to navigate the different instruments to achieve therapeutic and diagnostic results.
One example of an additional instrument which can be inserted through the operating channel of the flexible endoscope is a rat tooth forcep. Rat tooth forceps have interdigitating teeth and are typically used to hold skin or dense tissue without slipping or to retrieve stones, stents or other objects from inside body cavities. Another example of an additional instrument is a polypectomy snare which is typically used during colonoscopy procedures to remove polyps. The loop of the polypectomy snare is tightened and pulled away to grip the stalk of the polyp attached to the intestinal wall. An electric current is then passed through the snare loop to cut through the polyp, while simultaneously providing electrocautery.
Unfortunately, the skills used to perform these specific endoscopic maneuvers with different instruments takes years of practice. This is the case because typical methods for steering the endoscope tip are unusual. That is, the movable tip is controlled by pull wires attached at the moveable tip just beneath the outer protective shaft, and passing back through the length of the shaft to angling control knobs in the handle. One control knob, typically a larger control knob, moves the tip in an upward or downward direction, whereas a second control knob, typically a smaller knob, moves the tip from left to right. Simultaneously adjusting the control knobs and maneuvering the endoscope can be extremely challenging.
Currently there is no simple and affordable training device or simulator for developing the above skills and assessing endoscopic skills. Many of the current simulators use virtual environments where CT or MR images are processed by a computer to reconstruct a three-dimensional environment similar to that seen through an endoscope. Based on physical movement of an endoscope by the trainee, the computer program changes the view on the screen to simulate the endoscopic procedure. These systems have many shortcomings. They simulate entire procedures without the ability to identify a specific technical weakness or to focus on one aspect of a procedure with which a trainee may have difficulty. Additionally, these virtual training systems are typically rather expensive and most centers do not have the resources to purchase or maintain the systems. Thus, a trainee's initial clinical procedure is often the first time they will have handled an endoscope. Therefore, an affordable system is needed for the development of endoscopic skills and the objective assessment of basic technical competency.
The present invention relates to an affordable endoscopic training system for the development of endoscopic procedure skills and the assessment of technical competency of an endoscopist. It also allows for training, development, and evaluation of essential endoscopic part-tasks that are critical in the clinical performance of colonoscopy and upper endoscopy.
Some embodiments of the invention provide a system which includes a portable part-task enclosure with a plurality of walls defining an internal chamber. One of the walls includes an access port coupling the internal chamber to an external environment and the access port is configured to facilitate the passage of a flexible endoscope insertion member. The system further includes a plurality of objects disposed within the internal chamber. Each of the plurality of objects is configured for manipulation by a medical tool that extends through the flexible endoscope insertion member.
In another embodiment, the invention provides a method for the development of endoscopic procedure skills and the assessment of technical competency of an endoscopist. The method includes providing a portable part-task enclosure having a plurality of walls defining an internal chamber. The internal chamber has a plurality of objects disposed therein, and the portable part-task enclosure has an access port which couples the internal chamber to an external environment. The method also includes inserting a flexible endoscope insertion member through the access port and into the internal chamber and maneuvering the flexible endoscope insertion member within the internal chamber. The method further provides delivering a medical tool to the internal chamber via the flexible endoscope insertion member and manipulating one of the plurality of objects within the internal chamber using the medical tool.
In another embodiment, the invention provides an endoscopic training kit for development of endoscopic procedure skills and assessment of technical competency of an endoscopist. The endoscopic training kit includes a first portable part-task enclosure having a first plurality of walls that define a first internal chamber. At least one of the plurality of walls includes a first access port coupling the internal chamber to an external environment, and the first access port is configured to facilitate passage of a flexible endoscope insertion member. A plurality of objects are disposed within the first internal chamber. The plurality of objects are each configured for manipulation by a medical tool extending through the flexible endoscope insertion member. A second portable part-task enclosure has a second plurality of walls that define a second internal chamber. At least one of the second plurality of walls includes a second access port coupling the second internal chamber to the external environment. The second access port is configured to facilitate passage of the flexible endoscope insertion member. An object is disposed within the second internal chamber, and the object defines a passageway for maneuvering therethrough by the flexible endoscope insertion member.
These and other features, aspects, and advantages of the present invention will become better understood upon consideration of the following detailed description, drawings, and appended claims.
Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless specified or limited otherwise, the terms “mounted,” “connected,” “supported,” and “coupled” and variations thereof are used broadly and encompass both direct and indirect mountings, connections, supports, and couplings. Further, “connected” and “coupled” are not restricted to physical or mechanical connections or couplings.
The following discussion is presented to enable a person skilled in the art to make and use embodiments of the invention. Various modifications to the illustrated embodiments will be readily apparent to those skilled in the art, and the generic principles herein can be applied to other embodiments and applications without departing from embodiments of the invention. Thus, embodiments of the invention are not intended to be limited to embodiments shown, but are to be accorded the widest scope consistent with the principles and features disclosed herein. The following detailed description is to be read with reference to the figures, in which like elements in different figures have like reference numerals. The figures, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of embodiments of the invention. Skilled artisans will recognize the examples provided herein have many useful alternatives and fall within the scope of embodiments of the invention.
The present invention relates to multiple tasks, each of which focuses on specific endoscopic maneuvers. The tasks were developed based on important differences in technique and performance exhibited between expert and novice endoscopists. The present invention also relates to a tool to objectively assess and train basic endoscopic skills and technical competency that requires no computerized simulation. The training and assessment methods use all of the five embodiments described below and shown in the figures. However, it may be beneficial to only use one or a subset of the embodiments.
Different medical and surgical specialties (such as Gastroenterology, Urology, Otolaryngology, Gynecology, Cardiology, Vascular Surgery, and Interventional Radiology) use endoscopes of different size and functionality. Therefore, the dimensions of embodiments of the present invention and the associated tasks may be modified to accommodate use of various endoscopes.
Turning now to
The endoscopic training system 38 includes a portable part-task enclosure 40, made from a white Kydex material and having a plurality of walls 42. The walls 42 include a transparent cover disposed above a first internal chamber 46 and an opaque cover (omitted for illustrative purposes) disposed above a second internal chamber 44. The second internal chamber 44 can include a plurality of tubes 54 and a plurality of objects 58 hanging from support structures 56. The first internal chamber 46 can be connected to the second internal chamber 44 via a straight tube 53. The straight tube 53 is coupled to an open-topped straight channel or passage way 52 which is coupled to an open-topped elliptical shaped (as viewed from above) channel or passage way 50. Attached to one of the walls 42 is an access port 48 which couples the first internal chamber 46 to the external environment. The access port 48 can be configured to facilitate the passage of a flexible endoscope insertion member 16 through the elliptical shaped channel 50 and the straight channel 52.
Further, the straight channel 52 coupled to the elliptical shaped channel 50 of
Each of the plurality of tubes 54 of
Each of the plurality of objects 58 of
In order to develop and assess navigation and loop reduction endoscopic skills, an endoscopist performs the following tasks using the flexible endoscope system 10 and the training system 38. The endoscopist begins by maneuvering the flexible endoscope insertion member 16 through the access port 48, into the straight channel 52, and further into the elliptical shaped channel 50, to form a loop within the first internal chamber 46. To further advance the flexible endoscope insertion member 16 into the second internal chamber 44, the endoscopist eliminates the loop of the flexible endoscope insertion member 16 by pulling and/or twisting the control head 20 about the axis of the insertion member 16. Once the flexible endoscope insertion member 16 is unlooped by flipping the flexible endoscope insertion member 16 out of the open-top surface of the elliptical shaped channel 50, the endoscopist can navigate the flexible endoscope insertion member 16 and movable end 18, by manipulating the small and large control knobs 22, 24, through one of the plurality of tubes 54. The endoscopist also manipulates the rat tooth forcep 36 to grasp one of the plurality of objects 58 at the end of the path. The endoscopist then removes the object 58 by maneuvering the flexible endoscope insertion member 16 back through the tube 54, through the straight tube 53, and through the straight channel 52 to the external environment. The above task is repeated until all objects 58 are removed from the portable part-task enclosure 40.
The endoscopist is given a predetermined time period to complete the above tasks. The total number of objects 58 removed from their respective support structure 56 and moved to the external environment during the time period are counted and converted to a quantitative score. The quantitative score can increase if all of the plurality of objects 58 are removed from the portable part-task enclosure 40 prior to expiration of the predetermined time period. For instance, the predetermined time period could be 5 minutes, each object 58 removed successfully could be worth 20 points, and each second remaining prior to the expiration of 5 minutes after all of the plurality of objects 58 are removed could be worth 1 point.
Turning now to
The endoscopic training system 60 for developing and assessing an endoscopist's retroflexion skills includes a portable part-task enclosure 40 and a plurality of walls 42 defining an internal chamber 44. Walls 42 include an opaque cover 43 (omitted in
Further, the portable part-task enclosure 40 of
Each of the plurality of support structures 56, as seen in
Each of the plurality of objects 58 of
In order to develop and assess retroflexion skills, an endoscopist performs the following tasks using the flexible endoscope system 10 and the training system 60. During the task shown in
The endoscopist is given a predetermined time period to complete the above task. The total number of objects 58 transferred from the wall 42 containing the access port 48 to the opposing wall 42 are counted and converted to a quantitative score. The quantitative score can increase if all of the plurality of objects 58 is transferred from the wall 42 containing the access port 48 to the opposing wall 42 prior to expiration of the predetermined time period. If any of the plurality of objects 58 is dropped within the internal chamber 44, they can be ignored and retrieved if the time period has not expired before moving the other objects 58. For instance, the predetermined time period could be 5 minutes, each object 58 transferred successfully could be worth 10 points, and each second remaining prior to the expiration of 5 minutes after all of the plurality of objects 58 are transferred could be worth 1 point.
Turning now to
The endoscopic training system 62 for developing and assessing an endoscopist's torquing, precise targeting, and depth perception skills includes a portable part-task enclosure 40 and a plurality of walls 42 defining an internal chamber 44. Walls 42 include an opaque cover 43 (omitted in
Further, the portable part-task enclosure 40 of
The undulated floor 64 (that is, a floor having an array of side-by-side v-shaped surfaces as viewed from the side) shown in
The central post 66, seen in
Each of the plurality of objects 58, shown in
In order to develop and assess torquing, precise targeting, and depth perception skills, an endoscopist performs the following tasks using the flexible endoscope system 10 and the training system 62. During the task, best shown in
The endoscopist is given a predetermined time period to complete the above task. The total number of objects 58 transferred from the central post 66 to a support structure 56 and from a support structure 56 back to the central post 66 are counted and converted to quantitative score. The quantitative score can increase if all of the plurality of objects 58 are transferred from the central post 66 to the support structures 56 and back to the central post 66 prior to expiration of the predetermined time period. For instance, the predetermined time period could be 5 minutes, each object 58 transferred successfully could be worth 10 points, and each second remaining prior to the expiration of 5 minutes after all of the plurality of objects 58 are transferred back to the central post 66 could be worth 1 point.
Turning now to
The endoscopic training system 68 for developing and assessing an endoscopist's tip deflection skills includes a rectangular-shaped portable part-task enclosure 40 and a plurality of walls 42 defining an internal chamber 44. Walls 42 include an opaque cover 43 (omitted in
A side perspective view of the lock mechanism 76 can be seen in
Further, the portable part-task enclosure 40 of
The bin 70, seen in
Each of the plurality of objects 58, seen in
In order to develop and assess tip deflection skills, an endoscopist performs the following tasks using the flexible endoscope system 10 and the training system 68. Prior to the predetermined time period starting, each type of geometric shaped objects 58 are placed into their own compartment 72 of the bin 70, leaving one compartment 72 empty as seen in
The endoscopist is given a predetermined time period to complete the above task. The total number of objects 58 transferred from their initial compartment 72 to an empty compartment 72 are counted and converted to a quantitative score. The quantitative score can increase if all of the plurality of objects 58 are transferred from their initial compartment 72 to an empty compartment 72, in the manner described above, prior to expiration of the predetermined time period. For instance, the predetermined time period could be 5 minutes, each object 58 transferred successfully could be worth 10 points, and each second remaining prior to the expiration of 5 minutes after all of the plurality of objects 58 are transferred from their initial compartment 72 to an empty compartment 72 could be worth 1 point.
Turning now to
The endoscopic training system 80 for developing and assessing an endoscopist's polypectomy skills includes a rectangular shaped portable part-task enclosure 40 and a plurality of walls 42 defining a first internal chamber 46, and a second enclosure 100 disposed in the portable part-task enclosure 40. The walls 42 defining the second internal chamber 44 can include holes 82 through which indicators 84 extend into the second internal chamber 44, and each indicator 84 is coupled to a load sensor 86 (see
Further, the portable part-task enclosure 40 of
Each indicator 84 simulates a polyp and can be an LED light encased in a silicone shell that extends through one of the holes 82 on the plurality of walls 42 of the second enclosure 100. The LED indicators 84 can be shaped to simulate clinical polyps and also so the endoscopist is forced to snare the LED indicators 84 at the base with the polypectomy snare 34, rather than grabbing it elsewhere. The LED indicators 84 are dispersed throughout the plurality of walls 42 coupled to the holes 82 in a random fashion.
The controller 88 can be a microcontroller controlling the LED indicators 84 so that when snared by the polypectomy snare 34 with a predetermined amount of force sensed by the load sensor 86, the LED indicators 84 would flash, and after a certain about of time, the LED indicators 84 could stay illuminated. The dimensions, materials, and placement of the portable part-task enclosure 40, the second enclosure 100, the indicators 84, and the amount of time an LED indicator 84 flashes after being snared also advantageously provide an appropriate training/assessment score discrepancy between novice and experienced endoscopists as described below.
In order to develop and assess polypectomy skills, an endoscopist performs the following tasks using the flexible endoscope system 10 and the training system 80. Prior to the tasks, the controller 88 is reset so that all the LED indicators 84 are not illuminated. During the task, the endoscopist inserts the flexible endoscope insertion member 16 through the access port 48 and maneuvers the movable end 18 by controlling the small and large control knobs 22, 24 of the control head 20. The endoscopist uses a polypectomy snare 34 inserted through the medical tool channel 26 of the flexible endoscope insertion member 16 and moveable end 18 in order to capture an LED indicator 84 at the base. The endoscopist can snare the LED indicator 84 by opening the polypectomy snare 34 over the LED indicator 84, then closing the polypectomy snare 34 around the base to simulate resection. Once the LED indicator 84 is properly snared and a sufficient force is applied, it will flash and stay illuminated. The LED indicators 84 can be snared in any order, one at a time.
The endoscopist is given a predetermined time period to complete the above task. The total number of LED indicators 84 that are successfully snared or illuminated are counted and converted to a quantitative score. The quantitative score can increase if all of the LED indicators 84 are snared prior to expiration of the predetermined time period. For instance, the predetermined time period could be 5 minutes, each LED indicator 84 snared successfully could be worth 10 points, and each second remaining prior to the expiration of 5 minutes after all of the LED indicators 84 are snared could be worth 1 point.
Turning to
Other embodiments of the present invention could also include an endoscopic training system where the task includes dot connecting by coupling a pencil lead to the movable end 18 of the flexible endoscope insertion member 16. The endoscopist could be required to use the small or large control knobs 22, 24 to maneuver the movable end 18 of the flexible endoscope insertion member 16 in order to draw a continual line to connect dots of various configurations. Another version of this embodiment could include a touch screen with a stylus.
Another embodiment of the present invention could also include an endoscopic training system where the endoscopist is required to navigate the movable end 18 of the flexible endoscope insertion member 16 in three-dimensional space through a maze. This could be used to train endoscopists how to navigate by visualization. Other iterations could involve using the moveable end 18 of the flexible endoscope insertion member 16 to push a ball or object through the maze.
Yet another embodiment of the present invention could include an endoscopic training system where the endoscopist is required to navigate the movable end 18 of the flexible endoscope insertion member 16 through ring shaped objects 58 attached to different walls 42 that define an internal chamber 44. The endoscopist could also be required to collect the ring shaped objects 58 around the flexible endoscope insertion member 16.
Lastly, in another embodiment of the present invention could also include an endoscopic training system which includes cylinder shaped objects 58 that have a post sticking out from one end and a hole receptacle on the other end. The endoscopist could be required to retroflex the flexible endoscope insertion member 16 to grab each cylinder shaped object 58, rotate the flexible endoscope insertion member 16, and then stack each of the cylinder shaped objects 58 on one another.
It will be appreciated by those skilled in the art that while the invention has been described above in connection with particular embodiments and examples, the invention is not necessarily so limited, and that numerous other embodiments, examples, uses, modifications and departures from the embodiments, examples and uses are intended to be encompassed by the claims attached hereto. The entire disclosure of each patent and publication cited herein is incorporated by reference, as if each such patent or publication were individually incorporated by reference herein. Various features and advantages of the invention are set forth in the following claims.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/US2012/069763 | 12/14/2012 | WO | 00 | 6/10/2014 |
| Number | Date | Country | |
|---|---|---|---|
| 61570430 | Dec 2011 | US |
