The present invention relates to an apparatus, system and method for teaching and training students in medical procedures, and more particular but not exclusively to a system for training students in the procedures of angioplasty.
Angioplasty is a common name for a minimally invasive, catheter-based, endovascular procedure that is used for reopening of narrow blood vessels, blood flow restoration and other surgical and diagnostic procedures in the vasculature. Essentially, Angioplasty is performed by inserting a catheter, which is a hollow flexible tube, into a blood vessel, usually through the skin of the groin or arm of the subject, typically with the assistance of a guidewire. The catheter, guidewire or any other interventional instrument (hereinafter: “interventional instrument”) is manipulated by a trained physician through specialized controls. The end of the interventional instrument which is inserted into the subject can contain various surgical tools, such as a deflated balloon or a stent. The physician must maneuver the interventional instrument carefully within the blood vessel without damaging its walls. Such procedures are typically carried out in a CathLab using fluoroscopy that yields current images of a changing situation. The images guide the physician. Interventional fluoroscopy is a specialty in which the physician utilizes fluoroscopic images to perform the aforementioned therapeutic procedure. Physicians currently rely on real-time fluoroscopic 2D images, available as analog video or digital information viewed on video monitors.
However, the lack of direct view of the treated vascular tract is one factor which renders angioplasty a complex and difficult procedure to master. Such lack of feedback and lack of depth perception also increase the difficulty of hand-eye coordination and correct manipulation of the angioplasty device. Thus, angioplasty is a complicated procedure that requires a high level of skill to perform and it may be hard to learn to control the tools through the indirect point of view of the real-time fluoroscopic 2D images.
Because a mistake in such a complicated setting can be dangerous a high level of dexterity is required from the specialized physicians. Thus, comprehensive training in performing such a procedure is an obligatory phase for these trainees.
In the traditional model for medical education students observe and assist more experienced physicians. However, such observation alone cannot provide the necessary training for such complicated medical procedures. In addition, the performance of such procedures on substitutes such as animals and human cadavers, does not bestow the trainee with the same visual and tactile sensations of a live human patient. Thus, traditional medical training is not adequate for complex medical procedures.
In order to provide more realistic training and to reduce healthcare costs, surgical simulators that have been developed in an attempt to replicate the tactile sensations and the visual feedback for these procedures, in order to provide improved medical training without endangering human patients.
There are a few known simulation devices developed for this purpose. An example of such a simulation device is disclosed in U.S. Pat. No. 5,403,191 in which the disclosed device is a box containing simulated human organs. Various surgical laparoscopic procedures can be performed on the simulated organs. Visual feedback is provided by a system of mirrors. However, the system of both visual and tactile feedback is primitive in this device, and does not provide a true representation of the visual and tactile sensations which would accompany such surgical procedures in a human patient.
Attempts to provide a more realistic and accurate experience from medical simulation devices are disclosed in U.S. Pat. No. 6,538,634, issued on Mar. 25, 2003, in which the disclosed apparatus that simulates image guided angioplasty surgery with a box containing a simulated organ. This application discloses comprises a rolling ball or two roller and encoder assemblies as motion detectors, clamping means and a processor. The mechanical detectors are responsive to movement of the practice intervention instrument. Movement information is entered into the apparatus and the instrument can be manipulated by the operator. The motion detectors produce signals representative of displacement and rotation of the interventional instrument movement. The processor receives these displacement and rotation signals, and is programmed to plot the path of the interventional instrument as it is manipulated by the user. Additionally, the processor produces the controlling signal to the clamping means in response to the instantaneous position along the path. The processor may be coupled to a display device for displaying an image of the instantaneous position of the interventional instrument movement therealong, or other information. Another attempt to provide a realistic surgical simulation for a similar procedure is described in U.S. Pat. No. 6,926,531, issued on Aug. 9, 2005 of an apparatus for use in a simulated intervention device for an endoscopy system. This apparatus's motion device comprises a rotational disc on which a plurality of rollers is mounted to surround the axis of rotation of the disc to provide linear and rotary sensing of the position of the probed interventional instrument.
However, the mechanical motion detectors as described in U.S. Pat. No. 6,926,531 and in U.S. Pat. No. 6,538,634 are subjected to a number of shortcomings. The main shortcoming is the accuracy of the mechanical motion detectors. Such a transducer does not reflect the exact movement of the instrument movement and does not aptly reflect minor alterations in the interventional instrument position. In addition, the precision of those transducers is affected by the level of cleanliness of the interventional instrument movement or the motion detectors, resulting in a reduction in the accuracy of the outputs when the equipment is dirty. Another shortcoming is deterioration of the mechanic parts or damage to its surface, and degradation of the ease of rotation for the contact rollers owing to the accumulation of dirt or of lint or because of wear or both. This concern requires constant maintenance of the motion detectors and the interventional instrument as a whole to ensure accurate measurement of catheter motion.
Thus, there is a widely recognized need, not satisfied by the prior art, for an accurate motion detectors for measuring the small changes in the position of the navigating device within such simulated intervention devices apparatus, and it would be highly advantageous to have, surgical simulator for angioplasty procedures devoid of the above mentioned limitations.
The present invention includes a method and a system to simulate the minimally invasive medical angioplasty procedures. Such a system is designed to simulate the actual medical procedure of angioplasty as closely as possible by providing both a simulated medical instrument, tactile feedback and visual feedback as the simulated procedure is performed by a trainee on the simulated patient. In particular, the present invention enables an accurate simulation of the insertion and maneuvering of a catheter, guidewire or other navigation devices, within a simulated vascular tract or system which is being examined through the performance of the minimally invasive medical procedure.
According to the present invention, there is provided an apparatus and a system for performing a simulated medical procedure, comprising: (a) a simulated interventional instrument for performing the simulated medical angioplasty procedure; (b) a motion detector circuit to provide navigation signals representative of the movement of the interventional instrument, the motion detector comprising a laser radiation detector, used for determining the location of the interventional instrument in a predetermined area at proximity of the detector and a laser radiation emitter used for emitting laser beam toward the predetermined area; (c) a movement calculation unit receiving the navigation signals from the motion detector circuit, programmed to calculate changes in position of the interventional instrument as it is maneuvered by the system operator. Preferably, the apparatus and system further comprising a tactile feedback mechanism for providing simulated tactile feedback according to the position of the interventional instrument.
According to one preferred embodiments of the present invention, the laser radiation detector is a complimentary metal-oxide semiconductor (CMOS) sensor, the laser emitter is used for illumination the interventional instrument in the area and the movement calculation unit calculates the interventional instrument precise location, speed and direction based upon changes in patterns over a sequence of consecutive photos.
According to other preferred embodiments of the present invention, the laser radiation detector produces output signal representing distance according to the distance between said radiation detector and said interventional instrument, wherein said laser radiation emitter is configured to emit a laser beam, said radiation detector is configured to detect light from said laser beam that as it reflected from said interventional instrument. More preferably, the movement calculation unit is configured to determine the position of the interventional instrument relatively to predetermined position, based upon the distance sensor signal and predetermined datum.
According to another embodiment of the present invention, there is provided a method for performing a simulated angioplasty procedure comprising the steps of: (a) providing a system for performing the simulated angioplasty procedure by applying motion to an interventional instrument and using a laser beam to measure movement of said instrument; applying said measured movement as an input to a software simulation of a vascular tract; (b) inserting the simulated interventional instrument into the simulated vascular tract; (c) receiving visual feedback according to the displayed image according to the interventional instrument as it is maneuvered by the system operator; (d) receiving tactile feedback according to the location of the interventional instrument within the vascular tract as it is maneuvered by the system operator.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The materials, methods, and examples provided herein are illustrative only and not intended to be limiting.
Implementation of the method and system of the present invention involves performing or completing certain selected tasks or steps manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of preferred embodiments of the method and system of the present invention, several selected steps could be implemented by hardware or by software on any operating system of any firmware or a combination thereof. For example, as hardware, selected steps of the invention could be implemented as a chip or a circuit. As software, selected steps of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In any case, selected steps of the method and system of the invention could be described as being performed by a data processor, such as a computing platform for executing a plurality of instructions.
The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in order to provide what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.
In the drawings:
The present embodiments comprise an apparatus, system and a method for training students in the procedures of angioplasty.
The principles and operation of an apparatus, system and a method according to the present invention may be better understood with reference to the drawings and accompanying description.
Before explaining at least one embodiment of the invention 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 the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.
The apparatus and system as in the embodiment of the present invention discloses a unique technique for realistic visualization of the human anatomy and interventional instrument such as catheter or a guidewire thereof behavior under live fluoroscopy. The apparatus and system are enhanced with sensitive laser based motion detectors that provide navigation signals representative to the manipulations of the simulated interventional instrument. The laser based motion detectors generate signals that may be used to create a continuous flow of simulated images that is provided through a video monitor, which displays realistic images, according to the instantaneous manipulations of the simulated interventional instrument. Additionally, the apparatus and system are equipped with a force feedback mechanism, providing realistic tactile feedback that mimics the look and feel of an actual CathLab vasculature procedure, or angiography suite, preferably in such a manner that the tactile and visual feedback are linked as they would be in a human patient. The system is designed to enhance skills required across the range of invasive percutaneous cardio/endovascular procedures, including diagnostic angiography, angioplasty intervention, administering thrombolytic agents, and capabilities for recognition and management of developing complications. Thus, the apparatus, system and method of the present invention provide a realistic simulation of the medical procedure of angioplasty for training and testing students.
In particular, the present embodiments enable the trainee to perform a simulation of a diagnostic angiogram by inserting a catheter into an artery under fluoroscopic guidance, with subsequent injection of contrast material and imaging of the entire vascular system.
The trainee can assess the significance of vascular occlusive diseases as well as the outcome of an interventional procedure, by monitoring intra-arterial pressure gradients. Additionally, the trainee can perform full Angioplasty balloon dilation procedures, or similar procedures using a stent or other interventional devices, in various appropriate sites. Moreover, according to a preferred embodiment of the invention, the simulation device enables the user to practice monitoring patient's vital signs, performing full neurological examination, and administering drugs accordingly, all in a controlled and safe environment. Thus, preferably the trainee is exposed to a wide variety of situations and taught how to recognize and handle different medical situations in a plurality of formats.
In addition, the present embodiments are designed to improve technical and operational skills of the trainee while using X-rays and other CathLab equipment, by simulation and a display device that displays sequence of consecutive photos of fluoroscopic images and C-arm operation, providing images of still frames and structured graphical representation of various vascular tracts, cineangiographic and digital subtraction angiography and image archive management—an image reviewing facility that allows reviewing all archived images.
The principles and operation of a apparatus, system and method according to the present invention for medical simulation, and in particular for the simulation of the medical procedure of angioplasty, may be better understood with reference to the drawings and the accompanying description, it being understood that these drawings are given for illustrative purposes only and are not meant to be limiting.
Additional objects, advantages, and novel features of the present invention will become apparent to one ordinarily skilled in the art upon examination of the following examples, which are not intended to be limiting. Additionally, each of the various embodiments and aspects of the present invention as delineated hereinabove and as claimed in the claims section below finds experimental support in the following examples.
Referring now to the drawings,
Referring now to
Referring once again to
At the same time, the imaging module receives navigation signals from the motion detectors 41, 42, 43 which are located along the enclosure cavity. The imaging module uses the processor to calculate the catheter position within the enclosure cavity according to the navigation signals and updates the visual image of the vascular tract, as described above, with the instantaneous respective position of the interventional instrument 38. Moreover, if the trainee maneuvers the catheter 38A, the guidewire 38B and the deflated balloon 38C, in a manner that if performed on a real patient would harm or effect the patient vascular tract, the imaging module simulates a negative reaction of the vascular tract to the interventional instrument maneuvers.
In addition, and in correspondence with the visual information, the imaging module also operates the resisting force generators 45 in a manner that simulates the instantaneous tactile feedback of the procedure. Such visual images and tactile feedback simulate the actual feedback as received during an actual medical procedure as performed on an actual subject and therefore reflect to the trainee the current location and bending of the interventional instrument along the simulate vascular tract.
Clearly, the system is not bound to the simulation of a particular vascular tract, but can reflect a visual display of various vasculature elements relative to the instantaneous position of the interventional instrument.
Since surgical simulators that simulate image guided angioplasty surgery are already disclosed and comprehensibly described in the incorporated patents, this description is focused on the mechanism for detecting the motions of the dummy interventional instrument relative to the predetermined sites within the enclosure.
Reference is now made to
Another preferred embodiment of the present invention motion detector 23 is shown in
In addition, since the laser diode itself is current-modulated and its beam undergoes modulation, the movement direction of the dummy catheter can be detected using an Interference and Doppler Effect calculation. Thus, the movement direction of the dummy catheter on a certain axis can be transferred to the processor.
In this preferred embodiment, the laser-emitting and detecting units emitting top are positioned orthogonally with respect to one another 37 in a manner that the movement direction of the dummy catheter in two perpendicularly axis are measured and used for calculating up-down movements and left-right movements of the dummy catheter.
As shown, in step 46, the image of a vascular tract is displayed to the operator on the display screen/monitor 46. The image is preferably constructed as previously described with regard to
In step 47, the operator performs angioplasty procedure by inserting a catheter instrument into the simulated vascular tract 47; and in step 48, the “reaction” of the surrounding tissue to the procedure, as well as the image of the catheter itself, is preferably simulated as part of the image being displayed on the display screen/monitor at step 49 the operator will receiving tactile feedback according to the positioning and maneuvering of the catheter within the simulated vascular tract 49.
It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.
Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents, and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.
This Application claims the benefit of U.S. Provisional Patent Application No. 60/748,220 filed on Dec. 8, 2005, the contents of which are hereby incorporated by reference.
Number | Date | Country | |
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60748220 | Dec 2005 | US |