A system and a method for simulating a manual interventional operation by a user in a medical procedure
Abstract
The present invention deals with a method of simulating an interventional operation on a human or animal body, said method comprising the steps of modelling an internal system such as the cardiovascular system of said body with a mesh geometry, and simulating blood pressure, an/or collision with heart attacks and/or expansion produced during the cure of stenosis characterized in that spasms are simulated and it further comprises the step of modelling the contrast fluid diffusion in relation with the veins elasticity, and the possible presence of stenosis.

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11 claims: 7 independent, 4 dependent
- 1A method of simulating an interventional operation on a human or animal body, said method comprising the steps of :- modelling an internal system such as the cardiovascular system of said body with a mesh geometry, - and simulating blood pressure, an/or collision with heart attacks and/or expansion produced during the cure of stenosis characterized in that spasms are simulated and it further comprises the step of modelling the contrast fluid diffusion in relation with the veins elasticity, and the possible presence of stenosis.
- 3The method according to any of claims 1 and 2, wherein it gives at each moment the value of contrast fluid density in each position of the vascular net, and allows its visualization in the fluoroscopic image, graphing the different colour of blood vessel's surface, thereby authorising to regulate the flow rate and the duration of fluid injection as the amount of injected contrast fluid model is captured and memorised.
- 5The method according to any of precedent claims 5, for computing thickness of the simulated part of the human body, wherein the polygonal object is rendered to off-screen render targets using some measure of depth interpolated across the polygons, and that the thickness is computed at each rendered pixel.
- 7The method according to any of the preceding claims 1 to 6, wherein the mesh deformation is based on the pressure exercised from the balloon while at the same time the balloon must continue to expand based on the supplied pressure, and wherein the balloon's visualization is obtained by interpolation of a curve.
- 8The method according to any of the preceding claims 1 to 7, wherein it further comprises the step of simulating a stent by simulating a metallic mesh, every node of the metallic mesh being a particle with own physical properties connected to the other nodes according to an established design, the behaviour of every node being assimilated to a sphere's behaviour and wherein, when a self-expandable stent is deployed, the spheres that represent the nodes of the mesh are released assuming a speed that depends on their own physical properties and therefore the expansion of the simulated stent according to the invention follows physics of the expansion of a metallic mesh.
- 10The method according to the preceding claim 9, wherein systems spring-damper are applied to the bodies in every joint so that for every joint it is possible to define dumping and stiffness.
- 11The method according to any of the preceding claims 1 to 10, wherein the waveforms of the curbs are generated from a model that modify them in real time depending on the characteristics of the simulated patient's and depending on the user's actions during the procedure, wherein the ECG curves algorithm connects the animation of the heart, the curve of the pump cardiac pressure, pertaining to the physical model of the liquid of contrast, and the model of visualization, the curves being also able to represent the spasm's effects, particular cardiac situations, tachycardia and lowering of the pressure.
Independent claims7
313 paragraphs, as filed
0001The present invention is related to a system and a method for simulating a manual interventional operation by a user in a medical procedure.
0002It is more particularly, but not exclusively related to endoscopic procedures such as bronchoscopy, laryngoscopy, gastroscopy, colonoscopy, arthoroscopy, laparoscopy or ureteroscopy.
0003In the field of medical procedure simulation there exists a need for improved devices and methods which will authorize better realistical portray of an actual surgical procedure.
0004This is due to the fact that performance of endoscopic procedure requires skill to avoid complications that may cause important injury to a patient.
0005In case of angioplasty-balloon procedure for instance, the surgeon should direct a guide wire, a catheter and a sheath through arteries to a blockage point and inflate a balloon to withdraw the blockage.
0006This has to be done while avoiding numerous complications, such as hurting an artery and creating hemoragy.
0007Therefore these practionners imperatively need to develop expertise in order to ensure successful operations.
0008Training on live patients is efficient but need a skilled physician to supervise and avoid serious injuries to the patient.
0009It also needs the use of hospital facilities and equipment, and of course live patients to allow sufficient experience to perform these types of procedure.
0010That is why simulation has occurred in this field with expertise originally coming from simulating procedures used in other fields such as aeronautics or vehicle driving.
0011The prior art which has attempted to overcome the above described disadvantages of live patients to train physicians is basically disclosing (see for instance <patcit id="pcit0001" dnum="US4907973A"><text>US 4,907,973</text></patcit>) expert simulator system for modeling realistic internal environment having a mock tool such as an endoscope inserted and manipulated within a model. The model has a mock bodily region to be monitored and a plurality of sensors to detect the position of the tool (an endoscope) within the body.
0012A computer is used for representing the views observed from the measured endoscope position during a real operation.
0013Such systems present disadvantages.
0014The use of physical models restricts training to particular bodily regions, obliges simplification as a model cannot contain the same complex anatomy than a real body, and also is not providing feedback on the applied force.
0015In order to be more realistic it has then been developed (see for instance <patcit id="pcit0002" dnum="US5821920A"><text>US 5,821,920</text></patcit>) a medical procedure simulation system that utilizes virtual reality technology. Such system includes a display device and programmable tactile/force reflecting mechanisms that provide force feedback to generate the feeling of medical instrument and the interaction of the instruments with a simulated anatomy.
0016But such systems of the prior art are also suffering of some disadvantages concerning both the way the feedback is provided to the physician coming from the difficulty of grasping correctly elongated object such as an endoscope, thereby degrading the accuracy of object motion measurements, and the difficulty of realistically simulating such instrument during a medical procedure with all the different positions and orientations which can be provided in real life, as well as with several instruments provided simultaneously.
0017Accordingly, it is an object of the present invention to allow enhanced training of medical procedure to surgeons by providing better accuracy on the feedback forces together with more realistic simulation of a plurality of situations involving a plurality of tools.
0018It is therefore a main object of the present invention to provide improved system and method for simulating a manual interventional operation by a user which are better than those presently known for fulfilling the requirements of practice, particularly in that they provide a better grasp of the tools and make it possible to simulate real operations more accurately than in the past.
0019Another object of the present invention is related to the particular efficiency of new algorithms which are implemented for obtaining such realistic results. To this end, the present invention provides a system for simulating a manual interventional operation by a user on a simulated body with at least two real instruments, wherein said device comprises a longitudinal track, a plurality of moveable carriages along said track, each carriage having clamping means for securing one of said real instruments to said corresponding carriage, means for rotating and moving longitudinally said real instrument, visuals means, processing means for simulating a medical procedure and providing visual elements on said visual means and feed back means for receiving and transmitting to the user hand a feed back force from said real instrument with respect to simulation characteristic, characterised in that it comprises means for recognizing a real instrument to be fit within said clamping means, said clamping means comprising first electro-magnetic means with an hollow part for receiving the real instrument to be secured therein, second electro-magnetic means with a protruding part for pressing at least a part of said real instrument within said hollow part while said electromagnetic means are actuated and electric means for supplying or not electric current to the first and second magnetic means to be actuated accordingly, whereby said real instrument can be secured within said clamping means to be moved longitudinally and rotated by the user.
0020Advantageously the first electro-magnetic means comprise a generally cylindrical block having a broader center part for receiving a solenoid and a longitudinal hollow channel for receiving said real instrument.
0021In an other advantageous embodiment the second electro-magnetic means comprise a block having a central protruding part, said block being provided with a central spine arranged to cooperate with the instrument when inserted in the longitudinal hollow.
0022Also advantageously the generally cylindrical block comprises three parts connected together, i.e. a first part which is cylindrical and comprises a funnel or conical hollow element that authorises insertion of the guide of the tool by progressive guiding into an axial cylindrical channel provided inside said part in the prolongation of such conical entry, a parallelepipedic second part or central part integrally connected to the first part, forming said broader center part, made of magnetic material and arranged to cooperate with the second element, said central part including a central and axial prolongation of channel, which is half cylindrical on its inferior part and opened on its superior part such as the part presents a plane interconnecting superior surface with second element, on which is affixed the negative or positive pole of the electromagnet clamping means, and a third part, with a central channel in the prolongation of channels, symmetrical to first part with regard to the center part.
0023The bloc having a central protruding part comprises a parallelepipedic element on which is affixed the positive or negative pole of the electromagnet clamping means.
0024Advantageously the system further comprises two ball bearings, into which are inserted the elements for rotation around a central axis.
0025The invention also provides a method of simulating an interventional operation on a human or animal body, said method comprising the steps of modelling the internal system such as the cardiovascular system of said body with a mesh geometry, while in the embodiment of the present invention particularly described here, using accurate clamping means as above described and/or simulating blood pressure, and/or collision with heart attacks and/or expansion produced during the cure of stenosis.
0026In advantageous embodiments, recourse is further had to one and/or other of the following arrangements: <ul id="ul0001" list-style="dash" compact="compact"><li>the spasms are simulated;</li><li>it further comprises the step of modelling the contrast fluid diffusion in relation with the veins elasticity, and the possible presence of stenosis.</li></ul>
0027The invention will be better understood from reading the following description of particular embodiment, given by way of non limitating example.
0028The description refers to the accompanying drawings, in which : <ul id="ul0002" list-style="none" compact="compact"><li>Figure 1 is a simplified diagram providing a perspective of an overview of a system according to an embodiment of the invention.</li><li>Figure 2 is a lateral cross sectional view in perspective of the movement guide of the embodiment of figure 1.</li><li>Figures 3A to 3E are views which show the female part of the clamping means according to the embodiment of the invention more particularly described therein.</li><li>Figure 4A to 4E are views of the male part of the clamping means of figure 3.</li><li>Figure 5 shows a cross-cut of the ballbearings used with the clamping means of figures 3 and 4.</li><li>Figure 6 is a flow chart of a program (haptic software) used with the system and process of the invention.</li><li>Figure 7 is a temperature diagram showing the appropriate thermal expansion of an example of structural material on which a gage is to be used for measuring feedback strains.</li><li>Figure 8 shows an example of the simulation of the contrast liquid transport inside a simplified model of the vascular tree.</li><li>Figure 9 shows an organigram allowing double feedback.</li><li>Figure 10 is an organigram showing the steps to follow in order to simulate the contrast fluid in relation with the veins elasticity.</li></ul>
0029Figure 1 shows a system 1 for simulating a manual interventional operation by a user 2 on a simulated body which could be materialized by a manikin (not represented), with three real instruments 3, 4, 5 such as for instance a guide wire, a catheter and a sheath, comprising a device 6 having a protecting casing 7, a longitudinal track 8, three movable identical carriages 9, 10, 11 along said track, each arranged for securing a corresponding instrument.
0030Each carriage is respectively connected to an interface box 12 connected to a computer 13 having a processing unit 14, storing memories 15 and a set of two visual screens 16.
0031Figure 2 shows more precisely in cross section and perspective the device 6 comprising the three carriages 9, 10, 11 having the same functionalities and which are similar or identical in the present embodiment.
0032Each carriage comprises detecting means 17, for instance optical captors, for recognizing the presence of real instrument 3, 4, 5 to be fitted in, such as an endoscope, a catheter, etc.
0033It also comprises feedback means 18, known per se, for receiving and transmitting to the user hands 19 (see figure 1) a feedback force from said real instrument with respect to the movement of the hand and of the simulation procedure stored in the memories 15 of the computer. Such feed back means are formed, for example is the following manner.
0034First, it is observed that the locking system is situated on a feedback control system member, held on by two metal leaves allowing feedback working in pulling and pushing.
0035Finding the relation between the user's force applied on the locked tool and feedback control system member response is the problem to be solved.
0036Here, the feedback control system member response depends on the leaves' deformation, caused by the force applied on the locked tool. The deformation of the leaves has to determine a feedback control system member response so that the users feel a real tactile-feedback.
0037The amount of leaves' deformation is proportional to the force applied by the user and has to be detected to be used in determining the feedback-response.
0038It was therefore applied, on one of the leaves, a gage to detect the amount of deformation, by measuring the change of its resistance. From the tests made on the managing tool dedicated elements (tool wagon), the range of the force applied on the locked tool was about ±3 Newton and provided an electronic signal which is amplified.
0039The amplified signal is then sent to the electronic case that facilitates or contrasts the managing tool dedicated elements (tool wagon) movement, using a motor.
0040The output voltage change is at least 10 mV with a voltage supply of ±2.5 V to be processed by the instrumentation amplifier.
0041The leaves' thickness is chosen considering an excursion of the feedback control system member of maximum ±0.3 mm and considering a minimum leaves' thickness that couldn't permanently be deformed by the applied force.
0042The measurement tests have been implemented using a strain indicator and recorder and a 3D control system: <ul id="ul0003" list-style="dash" compact="compact"><li>First test session : Extensometer mounted on harmonic steel leaf, thickness 0.3 mm and the other leaf with same thickness (Fig. J-4).</li><li>Second test session : Extensometer mounted on harmonic steel leaf, thickness 0.2 mm and the other leaf with same thickness (Fig. J-5) .</li><li>Third test session : The 0.4 and 0.5 mm leaves are too much rigid.</li></ul>
0043Finally it appears that using as support the 0,3mm leaf, the system can be prevented from abrupt movements so that the feedback control system member does not go in collision with the mechanics fixed (cones of entrance and exit cones).
0044For the conversion factor µε/ε -> mV/V, a 350 Ω full-bridge extensometer has been selected.
0045The core of the feedback control system is a deformation transducer that measures the deformation of an extensometer known per se for instance a transducer manufactured by the firm VISHAY or equivalent sited on one of the metal leaves changing output voltage. It was considered an open-faced constantan foil gages with a thin, laminated, polyimide-film backing. This gage is recommended for use in precision transducers and characterized by low and repeatable creep performance.
0046Also recommended for stress analysis applications employing large gage patterns, where the especially flat matrix eases gage installation.
0047The extensometer used is a compact full-bridge pattern for use on small, double-bending beams, axial grid centerline spacing 0.250 in (6.35 mm), resistance in Ω is 350±0.2% and gage self-temperature compensation, the approximate thermal expansion coefficient in ppm/<sup>o</sup>F of the structural material on which the gage is to be used, follow the characteristics shown on figure 7, where K-Allay (curb 65), A-Allay (curb 66) and D-Allay (curb 67) evaluate according to said curbs, with absciss in 0 and Thermal output in ue along the Y axis.
0048It is observed therefore that deformation is proportional to the force impressed to the locked tool.
0049Transducer's output voltage being used to control motors that, according to the impressed force, help the independent dedicated system's movement.
0050An example of tables which could be used with the invention is provided hereafter. <tables id="tabl0001" num="0001"><table frame="all"><title><b>Table 1</b></title><tgroup cols="3"><colspec colnum="1" colname="col1" colwidth="19mm" /><colspec colnum="2" colname="col2" colwidth="26mm" /><colspec colnum="3" colname="col3" colwidth="26mm" /><thead><row><entry align="center" valign="top">Force (N)</entry><entry align="center" valign="top">T<sub>+</sub> (µε/ε)</entry><entry align="center" valign="top">T<sub>-</sub> (µε/ε)</entry></row></thead><tbody><row><entry align="center">3</entry><entry align="center">1095(0,20mm)</entry><entry align="center">1080(0,18mm)</entry></row><row><entry align="center">2,5</entry><entry align="center">920</entry><entry align="center">890</entry></row><row><entry align="center">2,0</entry><entry align="center">730</entry><entry align="center">670</entry></row><row><entry align="center">1,5</entry><entry align="center">530</entry><entry align="center">530</entry></row><row><entry align="center">1,0</entry><entry align="center">385</entry><entry align="center">345</entry></row><row><entry align="center">0,5</entry><entry align="center">185</entry><entry align="center">180</entry></row></tbody></tgroup></table></tables><tables id="tabl0002" num="0002"><table frame="all"><title><b>Table 2</b></title><tgroup cols="3"><colspec colnum="1" colname="col1" colwidth="19mm" /><colspec colnum="2" colname="col2" colwidth="24mm" /><colspec colnum="3" colname="col3" colwidth="26mm" /><thead><row><entry align="center" valign="top">Force (N)</entry><entry align="center" valign="top">T<sub>+</sub> (µε/ε)</entry><entry align="center" valign="top">T<sub>-</sub> (µε/ε)</entry></row></thead><tbody><row><entry align="center">3</entry><entry align="center">2340(0,6mm)</entry><entry align="center">2290(0,57mm)</entry></row><row><entry align="center">2,5</entry><entry align="center">2120</entry><entry align="center">1900</entry></row><row><entry align="center">2,0</entry><entry align="center">1660</entry><entry align="center">1530</entry></row><row><entry align="center">1,5</entry><entry align="center">1250</entry><entry align="center">1200</entry></row><row><entry align="center">1,0</entry><entry align="center">860</entry><entry align="center">830</entry></row><row><entry align="center">0,5</entry><entry align="center">460</entry><entry align="center">450</entry></row></tbody></tgroup></table></tables>
0051The feedback of the device is for example obtained through an electronic card with two custom programmed pic of the series 16f876.
0052Here three control signals have been withdrawn from the electronic board : direction control, PWMout, motor enable. The signals are sent to the 16f876 pic and managed by a feedback software of the type as follows (in picbasis).
0053The software loaded on the 16f876 pic waits for the activation data of the feedback status sent by the PC. In these data there is the value of the gain constant of the derivative integrative proportional system that the feedback implements. When the data string is sent, a local retro-action starts. The local retro-action takes the digital value of the extensimeter - opportunely converted by the analogical digital converter of the pic 16f876 - as reference signal,. The relation implemented in the algorithm that manages the retroaction is: <maths id="math0001" num=""><math display="block"><mi mathvariant="normal">x</mi><mo mathvariant="normal">=</mo><mfenced separators=""><mi mathvariant="normal">a</mi><mo mathvariant="normal">-</mo><mi mathvariant="normal">b</mi></mfenced><mo mathvariant="normal">*</mo><mi mathvariant="normal">c</mi></math><img file="EP1903537A2_D0001.tif" /></maths> with : <ul id="ul0004" list-style="none" compact="compact"><li>a : initial value of the strain gage;</li><li>b : it is the current value of the strain gage;</li><li>c : the value of the gain constant;</li><li>x : pic output (pin C1) that it is a PWM value that interacts on the motor's drivers to send command to the motor.</li></ul>
Attached A
0054<pre listing-type="program-listing"> Include "modedefs.bas" DEFINE OSC 20 DEFINE HSER_CLROERR 1 ' SR reset of the USART DEFINE HSER_RCSTA 90h DEFINE HSER_TXSTA 24h DEFINE HSER_SPBRG 0Ah 'sampling time DEFINE ADC_SAMPLEUS 50 DEFINE ADC_BITS 8 DEFINE ADC_CLOCK 3 'output port settino of the PWM signal portc.2 DEFINE CCP1_REG PORTC B0 var byte INSTAT var byte Num var byte Konst var byte ValueFeed var word ADCONO = 00000001 ADCON1 = 00001110 TRISA = 255 TRISB=%11000000 START: PORTB.2 = 0 'DIRECTION CONTROL PORTC.2=0 'PWM OUT PORTB.4 = 0 'ENABLE MOTOR PORTB.5 = 1 'LED MONITOR 'POTRTB.0 E PORTB.1 DIP SWITCH SETTAGGIO IF (PortB.0=0 AND PortB.1=0) THEN Num=1 ELSE IF (PortB.0=1 AND PortB.1=0) THEN Num=4 ELSE Num=9 ENDIF ENDIF PAUSE 4000 ADCIN O,INSTAT PORTB.5 = 0' END INIZIALIZZATION B0=170 WAIT: HSERIN [B0] 'HEX AA IF (B0 = 170) THEN HSERIN [B0] IF (B0 = Num) THEN GOTO Verifica ELSE GOTO PWMREG ENDIF ELSE GOTO WAIT ENDIF Verify: HSERIN [B0] IF (B0 = 39) THEN' Hex 27 HSERIN [Konst] PORTB.5 = 1 PORTB.4 = 1 GOTO PWMREG ELSE IF(BO = 23) THEN 'Hex 17 Konst = 0 PORTB.4 = 0 PORTB.5 = 0 ENDIF GOTO WAIT ENDIF PWMREG: ADCIN 0,B0 ValueFeed = (Konst * (ABS(B0 - INSTAT)))/16 IF (B0 > INSTAT )THEN PORTB.2 = 1 'inverse ELSE PORTB.2 = 0 ENDIF IF(ValueFeed<255) THEN HPWM 1,ValueFeed.BYTEO,15000 else HPWM 1,255,15000 ENDIF GOTO WAIT END</pre>
0055The device 1 (see figure 2) further comprises motors 20, 20', 20" and transmission belts 21, 21', 21" for having the carriages moving on track 8, an entry 22 for introducing the elongated instruments in the device, and interconnecting elements 23, 23', 23" , for instance in the form of telescopic pipes 24, 24', 24", for interconnecting the carriages and letting the elongated instruments go through freely.
0056As shown on figure 1 each carriage is connected to the interface box 12.
0057According to the embodiment of the invention more particularly described here, each carriages further comprises clamping means 25 which shall now be more precisely described in reference to figures 3 and 4.
0058Clamping means 25 provide a locking and rotating system which does not use motors.
0059Opening and closing the clamp happen through electromagnets that are activated when the tool or elongated instrument is recognized by the detecting means 17.
0060The clamping means comprise two elements 26 (see figures 3A-3E) and 27 (see figures 4A-4D) (i.e. first electromagnetic means 26 and second electromagnetic means 27).
0061Elements 26 is shown on figures 3A-3E. More precisely figure 3A is a top view, figure 3B a side view, figure 3C a front view and figure 3D a bottom view of element 26. Figure 3E is a cross section according to III<sub>E</sub>-III<sub>E</sub> of figure 3B.
0062In view of the figures, it appears that element 26 comprises three parts integrally connected together 28, 29, 30. A first part 28 which is cylindrical and comprises a funnel or conical hollow entry 31 that authorises a perfect insertion of the guide of the tool (not represented) by progressive guiding into an axial cylindrical channel 32 provided inside said part in the prolongation of such conical entry.
0063The second part 29 or central part is integrally connected to the first part. It is parallelepipedic and arranged to cooperate with the second element 27.
0064Such part includes a central and axial prolongation 33 of channel 32, which is half cylindrical on its inferior part and opened on its superior part such as the part 29 presents a plane interconnecting superior surface 34 with second element 27.
0065Part 29 is made of magnetic material to form, when activated by adjacent wrapping coil 35 for instance fixed on a plastic U shape portion attached on the external inferior face of said part 29, (see figure 3C) the negative pole of the electromagnet clamping of the preferred embodiment of the invention described herewith.
0066The wrapping coils 35 are provided in a manner which will be described hereafter.
0067The superior face 34 has four cylindrical hollow cavities 37 disposed at each of the rectangle corners and containing heloïcodal springs 38.
0068Finally element 26 is terminated by the third and end part 30 also cylindrical, symmetric of first part 28 with regard to second part 29.
0069Figures 4A-4D show details on element 27. More particularly figure 4A is a top view, figure 4B a side view and figure 4C a front view of element 27.
0070Figure 4D shows a detail of figure 4C on the edge of the protruding part of element 27.
0071Referring to these figures, element 27 is formed of magnetic material such as ferromagnetic iron to constitute the positive pole of the electromagnet to be obtained.
0072More particularly element 27 is a parallelepipedic bloc of the same lateral and longitudinal dimensions or slightly smaller than second part 29 of element 26, so to slidably fit between lateral facing sides 39 respectively of parts 28 and 30.
0073It has a plane inferior face 40 arranged to cooperate with plane superior face 34 of element 26, and comprises four corresponding hollow cavities 41 identical to holes 37 for containing the other extremities of springs 38, such as, without any pressure between element 27 and part 29 the springs maintain at distance their respective superior and inferior surface.
0074Element 27 further comprises a protruding longitudinal arrest or shelf 42 arranged to penetrate and slidably match with half cylindrical channel prolongation 33. This arrest presents on its longitudinal periphery summit or edge 43, a concave cylindrical wall 44 (see figure 4D), to shapily cooperate with the elongated tool (not represented).
0075An adjacent coil 45, for instance fixed on a plastic U shape portion 46 attached on the external superior face of element 27, is provided.
0076When current comes inside coils 35 and 45 associated to the magnetic elements, the magnetic parts 29 and 27 are attracted and they concur to grip the tool between the cylindrical wall of channel 33 provided inside element 27 and concave wall 44 of shelf 42 of element 27.
0077Therefore the dimension of the diameter of channel 33 in the clamp system changes automatically, depending on the tool used with the clamp system.
0078Furthermore, the force, with which the clamp is created can vary and change as instructed by the computer, as it depends on the current supplied to the magnetic system which is easily regulated in a manner known per se.
0079When the two magnetic parts are attracted they become loyal to the inserted tool and all the system, the clamp system and the tool, can then rotate together.
0080In the embodiment of the invention more particularly described the coils are provided within a system which both allows magnetic activation while authorizing a perfect and smooth rotation of the whole system along the axis of the carriages.
0081For this purpose (see figure 5) two plastic cages 48 with two cylindrical walls 49, 50, in which balls 51 are inserted, are provided to form two ballbearings 52.
0082The clamp per se i.e. elements 26 and 27, heart of the locking system, is inserted within these two bearings as it will be further described here after.
0083On their part, coils are formed by solenoid with very thin windings of copper. The two elements are on their side realized in ultralight metallic material.
0084In the embodiment more particularly described here it is further emphasized that element 26 is a unique block, with shape substantially of a cylinder on its end parts (28 and 30), and in which the center zone 29 has increased dimensions for the connection with solenoid 35.
0085Elements 27 is on its part, traversed from its beginning to its end by channel 32-33, whose diameter depends on the maximum dimension of the tools that the clamp will have to block.
0086As already seen above a cone shape is provided at the entrance of element 26 in order to guide the inserted tool into the channel 32. In the center zone, channel 33 has then the same diameter than channel 32 when no activation of the clamp is performed.
0087The two cylindrical parts 28 and 30 (of enter and exit of the tool) are on their part, covered, on their internal surface, by an oxidating layer that isolates them electrically from the magnetic action coming from the solenoid.
0088At the exit 53 (see figure 3B) of the third part 30 of element 26, on the outside of the lateral external wall, there is a disc 54, interlocked and concentric to the cylinder, with a hole circular 55 sector. On the corresponding carriage on which the external wall of cage 48 is affixed, there is an optical encoder, arranged to recognize the spin of the hole circular sector 55 disc.
0089As indicated earlier, element 27 is also made by a unique block, with a parallelepipedic shape provided with a protruding longitudinal arrest 42 of the same length than the whole element 27 and with a smaller width than the diameter of the channel 32 of element 26. The depth and shape section of such arrest on their part, are designated according to the locking of the different kinds of tools.
0090The two cylindrical enter and exit parts 28 and 30 are inserted in the two ball bearings 52 and fixed in the internal walls 50 of the cages, so that the entire block of the clamp can rotate about the axis of the channel 32. In the two inner metal rings of the ball bearings there are two circular holes 53, one for each metal ring, in order to host an electrical contact.
0091The electrical contact created on the income wall is connected with the windings of the solenoid 35 interlocked to element 26, while the one on the exit wall with the windings of the solenoid 45 is interlocked to element 27.
0092The external metal rings of the bearings are fixed to the corresponding walls, and are electrically connected with the walls, and also with the inner metal rings, through the spheres of the bearing.
0093The cage is itself interlocked to the plain base (not represented) of the corresponding carriage which has the possibility to move along the axis of the channel 32 within the casing 7.
0094The way the clamping means and their installation is provided will now be further described.
0095Elements 26 and 27 are joined together through four springs, placed in the holes 37 and 41 of the central zone.
0096The arrest 42 of element 27 is inserted in the channel 32 of element 26, in order to guide the movement of element 27 in orthogonal direction to the axis of holes 37 and 41.
0097When an elongated tool is entering part of element 26, the cone 31 forces the tool to enter the channel 32.
0098In rest state, i.e. when the tool still has not been recognized from the Presence System, element 27 has a height, regarding to the plane of the channel, such to allow to have a continuation of the channel also in the center zone.
0099The tool therefore can continue in its way without obstacles, until catching up the escape cylinder of element 26 and passing through.
0100When the tool catches up the presence system, sited after the exit wall, the electromagnetic operation of the clamp is activated, as described hereafter.
0101The activation of the presence sensor makes the electronic circuit of solenoids' control transmit an electrical impulse, and then provides a current in the solenoids' windings.
0102In the windings of the solenoid 35 loyal with element 26, the current flows in clockwise director, while in the windings of the solenoid 45 interlocked to element 27, the current flows in counter-clockwise direction.
0103In this way two magnetic fields with opposite polarity are created, so that they are attracted: the intensity of the impulse is such as to exceed the elastic force of the four springs, and element 27, guided through the inside part of the channel, is pushed towards element 26.
0104Therefore the channel's diameter in the center zone is decreased, until touching and locking the inserted tool.
0105At this point the electrical impulse is interrupted, and a lower continuous current flow is generated with a value high enough to hold tight the two parts of the clamp. The friction between tool and the narrow channel is such to allow the user who has inserted the tool to move the tool itself in the requested ways, along the axis of the channel (longitudinal axis), with consequent cage's movement.
0106The movement of the cage is then captured from a sensor (not shown) (reluctance transducer), connected to a motor.
0107The variation of the sensor's output induces a spin in the axis of the motor, that enhances or impedes the movement of the global system (managing tool dedicated element), generating a tactile feedback sent to the customer.
0108In spin or rotation the spin impressed by the user is captured from an optical encoder (not shown), through the capture of the spin of disc 54, loyal to element 26, sited after the exit wall.
0109The encoder, activated from the tool presence sensor, captures the clamp's spin through the disc field's spin (via indicator 55), and transmits this value to the computer 13 (PC).
0110When the global system (managing tool dedicated element) catches up its zero (start) position, an electrical signal is sent to the solenoids' electronic control circuit. Therefore the current flow in the solenoids' windings is interrupted, thus eliminating the magnetic attraction force between element 26 and 27.
0111When the magnetic force disappears, the elastic force of the four springs 38 makes element 27 to go away from element 26, towards the rest situation, and makes the channel 33 in the center zone increase, eliminating contact and forces of friction with the tool. The user can then remove the tool easily.
0112With such a new and inventive locking system the dimensions and the weight are considerably reduced.
0113The single clamp has a total weight near 50 grams, and a maximum dimensions of the order of 40 millimeter in length and 20 of diameter.
0114This is of remarkable importance, because it allows to reduce the dimensions of the devices connected to the clamp, as they have to deal with a lighter and smaller locking system.
0115It allows to develop a device that can simulate more than three tools inserted at the same time, and consequently to simulate last generation interventional techniques, respecting the real man's dimensions.
0116Moreover this locking system or clamping means allows the insertion of guidewires with a dimension's range of the diameter bigger than with the previous locking systems, because the electrical impulse, setting in action the attraction magnetic field, makes the two elements of the clamp come close until touching the inserted probe: thus it is independent from its diameter.
0117With such advantages of precision and accuracy with the new clamping system, new results can be obtained in simulation which authorizes development on the method as follows.
0118It is hereafter described in reference to figure 6, the program of carts or carriers management (haptic programm).
0119This process is divided in two parts.
0120The first part, high-level software, is developed in visual C. It resides in the computer host and deals to transfer and to manage the data coming from the sensors toward the software of visualization.
0121The second part is a program developed with low-level languages, loaded in the microcontrollers present in the electronic cards sited next to the carts.
0122As it regards this low-level language, it is divided in two parts related to the nature of the sensors on the cart. The first section manages sensors that capture the presence of the catheter inside the clamp, the second section manages the strengths of retroaction that the motors have to apply on the cart when some strengths of movement are acting on the chart itself.
0123The sensors and the transducer on the cart are: <ul id="ul0005" list-style="bullet" compact="compact"><li>a couple electro-optics, that captures the presence of the catheter;</li><li>an electromagnetic transducer, that has the function to lock the catheter;</li><li>an optic encoder, that detects the rotation of the catheter;</li><li>an interrupter of end run;</li><li>a force transducer, that measures the longitudinal strengths that act on the cart;</li><li>the optic encoder, integral to the motor traction's rotor of the cart.</li></ul>
0124The algorithm of the first section follows the firmware structure and the planned chain of measure.
0125The cyclical footsteps of the program have the function of acquiring the output values of the sensors, of transferring these information to the haptic program, of receiving commands from the haptic program and to turn these commands into physical operations performed by the transducer.
0126More particularly, a detailed description of the algorithm of this section of the program is provided in reference to figure 6.
0127After the phase of variables' declaration and initialisation (60) an initialisation (61) of the interrupt vector providing that, when the instrument vector is activated, it allows the microcontroller to listen to demands and incomings haptic's program instruction, is performed then the program cyclically reads the electro-optic sensor, that has the function to detect the presence of the catheter. When the catheter's presence is detected, the program manages to close the electromagnetic clamps (step 62), sending the command of closing to a high tension driver. In the main cycle, the program reads constantly the value of the encoder, that monitors the rotation of the clamp around its own axis, and the electro-optic sensor, whose value is transformed by the analogical/digital converter of the microcontroller in a digital word : this digital word can be sent by request to the haptic program.
0128In other words, it is provided a main loop (63) to read the encoder value to control the clamper's angular position and to read the A/D converter value that transforms the electro-optic sensor's value in a logic word.
0129The program's request is made by sending to the microcontroller the pre-planned sequences of characters that the device is able to interpret. The program haptic, receiving an answer to the sent command, knows that the microcontroller has received correctly the command and that has performed it.
0130This part of the program is loaded in the microcontroller, that is a Microchip 16f876. If there is no interruption of the haptic program's data request or close of the clamps, then there is a routine analysis (step 64) of the haptic's program's commands and request and values of the sensors are sent on demand transforming the closure clamp command in electrical signal. The interrupt generally by tools insertion involves the routine too.
0131For launching the principal software executable file, in order to implement the process having the different features of the embodiment of the invention more particularly described here, a first java interface is loaded and allows to select the type of procedure and to choose one of the available cases.
0132In each case there is a description of the patient history.
0133Once the case has been selected the following applications are loaded: <ul id="ul0006" list-style="dash" compact="compact"><li>graphic motor that manages the fluoroscopy visualization</li><li>control of the electric connection and the state of the hardware: if the hardware is not correctly connected or all the electronic cards deticated to data signals transfer are not detected, some error messages are produced and the interface loading is interrupted</li><li>initialization of the apparatus: the carriages are moved to their zero initial position and a test on the opening and closing electromagnetic block system is performed</li><li>if the control of the electric connection and the state of the hardware have had positive result, the graphical user interface is loaded and it is possible to select the devices and to check the projections of the fluoroscope and the movement of the table of the patient,</li><li>generation of the ecg of the patient</li></ul>
0134The graphical user interface introduces on its part a list of the available devices classified by functionality and associated to a carriage. The selection of a device activates the sensors dedicated to this type of device recognition.
0135When the device introduced by the user reaches the detection system on the dedicated carriage, a signal is sent to the haptic interface that activates the locking system related to that carriage and have the device locked to the carriage.
0136The position of the device, and therefore of the carriage, is connected to the motor's encoder which provides a value used to manage the movement and the feedback of the carriages. Such value is brought to zero in the phase of the apparatus' initialization and is updated 20 Hz.
0137An active cart movement determines a variation of the corresponding encoder value. Such variation is detected by the haptic interface that update the positions of all the following carriages, not yet activated, maintaining the distance between them constant.
0138The values of the encoders are sent to the high-level software that manage the devices visualization.
0139The system is provided with additional peripheral: <ul id="ul0007" list-style="dash" compact="compact"><li>a syringe for the contrast liquid; the syringe is connected to a flow sensor that detects the quantity of air injected by the user transforming it into an electric signal that through the haptic interface is sent to the high-level software that elaborates it and visualizes the effects of it by the graphic motor</li><li>the indeflator; it is connected to a sensor that detects the pressure practiced by the user and turns this information into an electric signal that through the haptic interface is sent to the high-level software that elaborates it and visualizes the effects of it by the graphic motor</li><li>Pedals: the pressure of the first pedal sends an activation/deactivation signal of the fluoroscopy to the high-level software through haptic interface; the pressure of the second pedal sends through the haptic interface a signal that activates fluoroscopy image or movie capture in the high-level software.</li></ul>
0140Therefore the user is able to practice easily and with a great impression of reality an operation which is simulated in real time, with very efficient and accurate pedagogical results.
0141With a first embodiment of the method of the invention as it can be ameliorated due to the use of a quasi perfect clamping system, a mesh structure is used for modelling the body of a patient.
0142A mesh is a geometric structure of flat or curve surfaces composed of adjacent polygons.
0143Shape and dimension of the polygons are variable, therefore the mesh can easily represent both flat surfaces (a little number of big polygons) and curves surfaces (a big number of little polygons).
0144The geometric structure of the mesh is then introduced in the system of physical simulation and can simulates the entire human vascular system.
0145In fact, the geometric model of the surfaces can be widened with physical property such as the elasticity allowing to simulate the vascular system deformation due to blood pressure, collision with an operating device or expansion produced during the cure of the stenosis, which will authorize a much more realistic simulation.
0146More precisely an embodiment of the method of simulation used with the invention provides use of algorithms which authorizes correctly the tree-structure of the vascular system and/or the arterial and the venous one together with the mesh technic.
0147Differently from the prior-art which took advantage of pre-calculated stenosis' models, it doesn't exist pre-calculated lesions in the method of the invention which provide lesions belonging to the same one mesh of the constructed anatomies.
0148A more greater freedom in modeling stenosis assigning anatomical shapes and articulated physical property is then surprisingly obtained.
0149A possible algorithm for this mesh structure use in simulation is provided hereafter.
0150//* It is calculated the pressure that the device expresses on the tissue taking into account the inducible of the tissue and the characteristics of the stenosis (shape, extension, hardness). This value of pressure is used in order to modify the points of the mesh and in order to adapt the device to the shape of the vase in real time <pre listing-type="program-listing"> FOR (AllTrianglesOfVesselMesh) IF (Collide(Triangle, Balloon)) { //* The direction of the mesh expansion is estimated for every triangle Direction=CalculateDirection(Triangle) Triangle.x Triangle.x+Pressure*Direction.x Triangle.y = Triangle.y+Pressure*Direction.y Triangle.z = Triangle.z+Pressure*Direction.z</pre>
0151It is remarked that the flexibility of this kind of modelling system allows to perform different anatomical shapes according to what happens in nature.
0152For hemodinamists, interventional radiologists and cardiologists, it is a normal situation that blood vessels shapes change for different patients.
0153Therefore the possibility to create different anatomical shapes allows to be able to offer different simulation sessions that are didactically more effective.
0154It is then possible, with the present method, to study the deformability, resistance and physical behaviour of the organs and tissues, due to a more flexible basic anatomical reconstruction system, which allows to simulate more clinical cases and more different anatomical shapes.
0155With the mesh structure, complications can be better dealed with.
0156Furthermore, in real life spams and dissections can occur during a less-invasive hemodinamic intervention.
0157A spasm is a contraction of an artery with a consequent reduction of the blood flow, which can determine a cardiac frequency variation, high or low, and can change the ECG waveform display.
0158A total or partial occlusion of the artery with a device can determine a spasm.
0159In the simulator of one embodiment of the invention, it is possible to simulate a spasm which is obtained by changing the cardiac heartbeat animation frequency, the ECG waveform and the diffusion of the contrast liquid in the vessel.
0160Such spasm simulation involves for instance the use of an algorithm as follows : <pre listing-type="program-listing"> IF (Spasmo) { HeartAnimation(SpasmoHeartRate) ECGDiagram(SpasmoHeartRate) }</pre>
0161With the method of another embodiment of the invention as described here, it is taken care of the fact that the walls of the arteries are constituted from three overlapped layers of tissue.
0162In real practice, a bad manipulation during a procedure or a wrong choice of the tool could damage the vessel.
0163For example the tip of the device can tear one or all of the tissue's layer and pass through them instead of going through the vessel.
0164The doctor in this case finds a greater resistance to the advance of the device.
0165In the simulator of this embodiment of the invention the dissection is realized showing the device in its position coinciding with the wall of the vase and giving back a tactile feedback adapting continuously to the performing of the dissection.
0166It is here emphasized the progress it involves in comparison with the prior art and the importance of such possibilities in medical procedures.
0167Spasm is a suffering state of the patient and must immediately be identified by hemodinamist so that he can proceed to the opportune procedures.
0168Dissection is also a serious complication because of the risk to perfore the artery.
0169However if spasm and dissection happen during a less-invasive intervention, the procedure must be continued by the vascular surgeon.
0170In the simulator the spasm is reflected in altered cardiac heartbeat animation frequency, abnormal ECG waveform and less smooth dispersion of the contrast liquid in the vessel
0171An other point has been improved in the embodiment of the invention more particularly described therein. It is due to the fact that vascular system can be assimilated to an hydraulic net, which contains a fluid moved by a pump (the heart). A mathematical model of contrast fluid's diffusion has here been developed, allowing the fluid to be injected in whichever point of the net.
0172The model is arranged so that the course of the pressure caused by the hearth can be freely modelled, making possible and easy the simulation of different anatomies, pathological and physiological conditions.
0173The model considers the sections of all the veins interested by the blood stream, the veins' elasticity and the eventual presence of stenosis.
0174It gives at each moment the value of contrast fluid density in each position of the vascular net, and allows its visualization in the fluoroscopic image, graphing the different colour of blood vessel's surface.
0175It is therefore possible to regulate the flow rate and the duration of fluid injection as the model captures and memorises the amount of injected contrast fluid.
0176More precisely the physical model for the contrast liquid is a fluid-dynamics net model, that means that in every moment length and section of the net are known.
0177The simulation algorithm takes into account different parameters i.e. : heart rate, curve of pressure of the cardiac pump (the heart cycle can be appropriately modified), vessel's sections, connections between vessels, length of the vessels, presence of the stenosis and complications.
0178Contrast liquid density is calculated in real time along all the vascular system therefore automatically authorizing a time evolution of the contrast liquid simulation.
0179The contrast liquid visualization algorithm consists therefore in a perfect mapping in each fraction of the vessel which could be described as follows.
0180This algorithm is first based on a contrast fluid library which has the following functionality: <ul id="ul0008" list-style="bullet" compact="compact"><li>Management of the human vascular system, with a tree model structure, based on a monodimensional approximation of the vessels;</li><li>Simulation of the blood circulation approximated by an equivalent hydraulic-net model and a simplified mechanical model of the heart;</li><li>Simulation of the contrast agent's transport approximated by a transport model of a passive scalar inside the coronary net.</li></ul>
0181Furthermore, concerning the interface, the API is for instance and here designed to coronography applications and it is structured to allow the following operations: <ul id="ul0009" list-style="bullet" compact="compact"><li>Instance of a standard vascular tree dedicated to the systemic circulation, pulmonary and coronary. The vascular tree is simplified to allow the real time simulation;</li><li>Instance of right and left coronary tree is get with a descriptor of the tree structure and the length and radius of every branch. The library transform these information in the physical constants, required by the simulator, using parametrization available in literature;</li><li>Instance of a simplified cardiac model;</li><li>Assignment of stenosis' conditions on coronary vascular net specifying relative position, length and middle radius;</li><li>Assignment of default values for the control parameters of the cardiac rhythm;</li><li>Activation/ deactivation of the flow and transport simulator;</li><li>Injection of contrast liquid at the base of a tree coronary vascular net;</li><li>Reading the value of contrast liquid concentration in every point of the coronary vascular trees.</li></ul>
Description of the system's components.
0182The principal components of the simulator are the followings: <ul id="ul0010" list-style="bullet" compact="compact"><li>generator of input signals : in particular, a generator of blood pressure's signal, based on a parameterization of the cardiac behavior;</li><li>simulation of the hemodynamic flow : it deals with a mono-dimensional flow model with assembled parameters;</li><li>simulation of the flow of the liquid contrast.</li></ul>
Generator of input signals.
0183The input signal for the simulation of the hemodynamic's system is a pressure signal, that is obtained through parameterization of the cardiac behavior.
0184It is used a simple periodic generator of pressure, obtained through periodic interpolation of a pre-assigned pressure curve.
Simulation of the hemodynamic flow.
0185The hemodynamic flow inside the vascular system is calculated through a simple assembled parameters model, that considers the various branches of the blood vessels like electric nets, whose parameters depend on the geometric characteristics of the considered branches.
0186The components that are modelled inside the electric net, equivalent to the vascular system, are the followings: <ul id="ul0011" list-style="bullet" compact="compact"><li>the cardiac pump, modelled as an electric scheme, characterized by constant resistances, independent from the volume (except the Cavum Vein and the systemic arteries), from constant viscosity of the blood, and from elastic walls of the vessels</li><li>generic arterial vessel, modelled through a electric parameters-assembled RLC net.</li></ul>
0187The net parameters are calculated considering the vessel's length and the section, through the following formulas: <maths id="math0002" num=""><math display="block"><mi mathvariant="normal">R</mi><mo>=</mo><mfrac><mrow><mn>8</mn><mo></mo><mi mathvariant="normal">μl</mi></mrow><msup><mi>πr</mi><mn>4</mn></msup></mfrac><mo>;</mo><mspace width="3em" /><mi>L</mi><mo>=</mo><mfrac><mrow><mi mathvariant="italic">ρ</mi><mo></mo><mi mathvariant="normal">l</mi></mrow><msup><mi>πr</mi><mn>4</mn></msup></mfrac><mo>;</mo><mspace width="2em" /><mi>C</mi><mo>=</mo><mfrac><mrow><mn>2</mn><mo></mo><msup><mi mathvariant="italic">πr</mi><mn>3</mn></msup><mo></mo><mi mathvariant="normal">l</mi></mrow><mrow><mi mathvariant="italic">E</mi><mo></mo><mi mathvariant="normal">h</mi></mrow></mfrac><mo>;</mo></math><img file="EP1903537A2_D0002.tif" /></maths> where µ, ρ, E, h are, respectively, blood viscosity, blood density, the modulus of vessel elasticity and the thickness of the wall, that now is approximated with h = 0.16r. <ul id="ul0012" list-style="bullet" compact="compact"><li>arteries connector, equivalent to a short electric circuit, and used for modelling non binary trees of arteries.</li><li>stroke of terminal artery, equivalent to a RLC net with a load. The RLC parameters are obtained through the length and the radius of the artery as a generic branch of artery, while the load resistance is approximated with a piecewise constant function dependent from the section of the blood vessel.</li></ul>
Contrast liquid transport.
0188The contrast liquid is modelled as a passive scalar inside blood vessels and it is described as mean concentration in every vessel section. It is a function c(x,t) with x varying from 0 to 1, 0 is the value at the tube head. The evolution of the c is based on the following limited difference equation: <maths id="math0003" num=""><math display="block"><mi mathvariant="normal">c</mi><mo></mo><mfenced separators=""><mi mathvariant="normal">x</mi><mo mathvariant="normal">,</mo><mi mathvariant="normal">t</mi><mo mathvariant="normal">+</mo><mn mathvariant="normal">1</mn></mfenced><mo mathvariant="normal">=</mo><mi mathvariant="normal">c</mi><mfenced separators=""><mi mathvariant="normal">x</mi><mo></mo><mi mathvariant="normal">t</mi></mfenced><mo>-</mo><mfrac><mi mathvariant="normal">ΦΔt</mi><mi>aΔx</mi></mfrac><mo></mo><mfenced separators=""><mi mathvariant="normal">c</mi><mfenced separators=""><mi mathvariant="normal">x</mi><mo></mo><mi mathvariant="normal">t</mi></mfenced><mo mathvariant="normal">-</mo><mi mathvariant="normal">c</mi><mo></mo><mfenced separators=""><mi mathvariant="normal">x</mi><mo mathvariant="normal">-</mo><mi mathvariant="normal">Δx</mi><mo mathvariant="normal">,</mo><mi mathvariant="normal">t</mi></mfenced></mfenced><mo>+</mo><mfrac><mrow><mi mathvariant="italic">D</mi><mo></mo><mi>Δ</mi><mo></mo><mi>t</mi></mrow><mrow><mi>Δ</mi><mo></mo><mi>x</mi><mo></mo><mi>Δ</mi><mo></mo><mi>x</mi></mrow></mfrac><mo></mo><mfenced separators=""><mi mathvariant="normal">c</mi><mo></mo><mfenced separators=""><mi mathvariant="normal">x</mi><mo mathvariant="normal">+</mo><mi mathvariant="normal">Δx</mi><mo mathvariant="normal">,</mo><mi mathvariant="normal">t</mi></mfenced><mo>+</mo><mi mathvariant="normal">c</mi><mo></mo><mfenced separators=""><mi mathvariant="normal">x</mi><mo mathvariant="normal">-</mo><mi mathvariant="normal">Δx</mi><mo mathvariant="normal">,</mo><mi mathvariant="normal">t</mi></mfenced><mo mathvariant="normal">-</mo><mn mathvariant="normal">2</mn><mo></mo><mi mathvariant="normal">c</mi><mfenced separators=""><mi mathvariant="normal">x</mi><mo></mo><mi mathvariant="normal">t</mi></mfenced></mfenced></math><img file="EP1903537A2_D0003.tif" /></maths>
0189Φ,a,D are respectively the entering flow, normal section of the blood vessels and the diffusivity of the passive scalar.
0190The integral curve that solve the flow and transport equations is a 4th-order adaptive step Runge-Kutta. Figure 8 shows an example of the simulation of the contrast liquid transport inside several simplified model of the vascular tree 68-68'".
0191On the contrary (see here above) the mesh consists of triangles. Due to this specific aspect of the method as described and corresponding to an embodiment of the invention, the calculations are more express.
0192In other words, for every triangle pertaining to the anatomy mesh, it is pre-calculated the correspondence with the physical model that represents the course of the contrast liquid.
0193The visualization algorithm then interrogates the physical simulation algorithm of the fluid in order to obtain information concerning fluid density and the liquid percentage with which the triangles, that belong to the mapping of the net representing the fluid-dynamic system, must be coloured.
0194Here it should be noted that fluid contrast injection is indispensable to the hemodinamists in order to see in the fluoroscopic image the shape of organs crossed by the blood.
0195The possibility to verify the amount of contrast fluid injected allow the hemodinamist to trust he is practicing a real endovascular procedure.
0196This is because in a real procedure, the amount of contrast fluid used has to be reduced to minimum, in order to avoid damaging the patient.
0197One of the other advantage of this simulation is that it renders the simulation incredibly realistic because it considers the effective point of fluid injection without considering pre-calculated outlines, far from the really operating conditions, and because it considers the effective point of fluid injection and does not show a flat black patch that appears within a given outline
0198Furthermore the model takes into account the presence of blood in the vessels and the interactions between two fluids (blood and contrast liquid). For this purpose, the model of the blood pressure, as it flows through the vessels, takes into account: section, elasticity and presence of stenosis, while it captures and memorises the amount of contrast injected fluid.
0199In an other embodiment of the invention, it is furthermore implemented a fluoroscopy's algorithm, based on NVIDIA technology. This technology, generally used to compute special 3D real-time effects rendering for example industrial research and development as in car and vehicle production was not implemented in the present field for practical reason.
0200With the algorithm used in one embodiment of the present invention, which involves calculation of the thickness of one or more objects so the overlaps of the objects can be managed working to pixel levels (picture element), it has been possible to use this technology.
0201The structure of the algorithm allows to modify every object's pixels colour (more real- simulate x-ray crossing several layers having a better image definition).
0202All computations are managed from GPU Graphics Processor Unit so that CPU (Computer Processor Unit) is involved in the physical simulation obtaining a greater speed in the calculations.
0203With the invention it is therefore possible to upgrade permanently the result of simulator as it is open to new technologies such as the "floating point blending" which ultimately accelerates the speed of the algorithm due to a less computational complexity of the shaders.
0204The "floating point blending" develops the realism of the rendering increasing precision from 12-16 bit integer to 16-32 bit floating point.
0205Furthermore, and as indicated earlier, using NVIDIA technology, the real-time rendering can be offloaded from the CPU to high-performance Graphics Processing Units (GPUs).
0206This technology reduces programming complexity using a dedicated high-level language for graphics. This method for programming real-time pixel and vertex effects eliminates the need to write applications with extensive low-level assembly code. With built-in abstractions and optimizations, a new graphics programming language can increase the number of applications with cinematic-quality effects.
0207The Cg programming language used with the programming of the algorithm involved with the invention, provides ease and speed of programming of special effects and accelerates delivery of real-time cinematic-quality graphics experiences.
0208The visualization applications that take advantage of Cg shader technology get the most realistic visual effects. Cg runtime feature can benefit from the addition of a new GPU when it becomes available without recompiling or upgrading the software.
0209Furthermore Cg allows for a range of high-fidelity film effects to be efficiently merged into fluoroscopy application and executed in real time such as motion blur and other camera effects and accurate skin, muscles.
0210An example of implementing algorithm is provided thereafter.
0211It is here provided a shader realized with the CG that executes the removal of two buffer: FrontBuffer e BackBuffer. <pre listing-type="program-listing"> //*********************** //* INPUTS STRUCT * //*********************** struct Inputs { float2 Text : TEXCOORD0; }; //*********************** //* OUT STRUCT * //*********************** struct Outputs { float4 Color : COLOR0 }; //************************ //* FRAGMENTPROGRAM * //************************ Outputs main(Inputs IN, uniform float4 DecodeValues, uniform samplerRECT FrontBuffer, uniform samplerRECT BackBuffer) { Outputs OUT; float4 Texture,Texture2; Texture=texRECT(FrontBuffer,IN.Text); Texture2=texRECT(BackBuffer, IN.Text); Texture2 = Texture2-Texture; Texture2 = dot(Texture2,Decode Values); OUT.Color=1-Texture2; return OUT; }</pre>
0212Computerized visual effects involve the manipulation of display data.
0213Shaders--the programs and parameters necessary to implement an effect on a set of pixels or vertices-were traditionally written for a specific GPU. The Cg Language provides the constructs for creating platform-independent shaders.
0214The NVIDIA Cg Compiler works with a C-like language for programming shaders on GPUs. This high-level approach offers also several benefits when compared with assembly-level programming such as simplicity, flexibility, reusability, automatic optimisations and low-level access.
0215As a runtime compiler, UCA automatically takes advantage of the hardware that is available at the time the shader application is executed.
0216Application performance is also enhanced because the NVIDIA Cg Compiler includes optimizations for NVIDIA GPUs making it possible to get the best performance out of the hardware without every shader developer learning the intricacies of every platform.
0217Using specific profiles when writing shaders, developers can easily write for multiple targets. Less capable programmable GPUs can be addressed with separate programs that may not use the full extent of the language, just a subset of its flexibility.
0218Vertex and pixel shaders are used in multi-pass rendering to generate a measure of the object's thickness at each pixel. The thickness at each pixel is then used to produce the colors of the object on screen.
0219With the algorithms used with the invention, thickness information is computed each time from the appropriate point of view; and the result is a true volumetric rendering of ordinary polygon objects.
0220No preprocessing of object data is required, and the result is a volumetric technique suitable for interactive dynamic scenes.
0221An efficient method which is further described here after, is used to properly render any closed convex or concave mesh as a thick volume and to handle any intersection cases where opaque objects penetrate the volumes to overcome the effects of aliasing in the per-pixel thickness information.
0222This algorithm can be summarized as follows :
0223The procedure is divided in three parts: <ol id="ol0001" compact="compact" ol-style=""><li>a) Rasterization of the visible faces of all the present objects in the scene. After this operation in a FrontBuffer data structure that is used from the GPU are stored the sum of all visible faces depths from the actual point of view;</li><li>b) Rasterization of the invisible faces. After this operation in a FrontBuffer data structure that is used from the GPU are stored the sum of all invisible faces depths from the actual point of view;</li><li>c) Through an abstracting shader is done the difference FrontBuffer - BackBuffer pixel by pixel so that is possibile to obtain the information about the objects thickness. This information is use to set the pixel's color</li></ol>
0224It is suitable for volumes of single-scattering material. Material where light arriving at each pixel is the result of only one scattering interaction in the material, thus the total amount of light is a function only of thickness.
0225As the visible thickness increases, the number of scattering particles increases and so does the probability of scattering. Scattering may both add light and attenuate transmitted light.
0226The technique for rendering objects as thick volumes start from traditional 3D rendering.
0227It involves rendering to off-screen render-target textures, rendering depth information as RGBA colors, using vertex shaders and textures to encode information, and using alpha blending to add and subtract high-precision encoded depth information.
0228One advantage of this technique is that the rendering does not change in order to handle various intersection cases and camera positions.
0229No extra passes or knowledge about the objects or scene is required as long as the depth complexity of the volume objects remains below a certain adjustable limit.
0230The depth complexity limit depends on the precision of the thickness information and the number of bits of each color channel used to hold the thickness information. The trade-off between depth complexity and precision can be adjusted from frame to frame. A depth complexity of 16 or 32 volume object faces can be rendered with 15 or 12 bits of depth precision in a single pass.
0231On hardware that supports blending to floating point render targets, there is no limit to the depth complexity that can be handled.
0232More particularly, the algorithm for computing thickness considers that the polygonal object is rendered to off-screen render targets using some measure of depth interpolated across the polygons, and that the thickness is computed at each rendered pixel.
0233At any given pixel, the depths of all of an object's front faces at that pixel are summed as well as the depths of all back faces are summed, the thickness through the object being the back face sum minus the front face sum.
0234For a given pixel on screen, the thickness through the objects is the sum of the depths of all front faces at that pixel subtracted from the sum of the depths of all back faces at that pixel.
0235Depth is calculated at each vertex as part of the standard 3D view transform.
0236Programmable shaders and a few render-to-texture passes, which are known per se, are added to render ordinary polygon objects as thick volumes of light scattering material.
0237With this technology are obtained high precision values using 8-bit-per-component render targets, objects intersecting handling and occluding any volume object shape, and good eliminating aliasing artifacts.
0238The approach works for any viewpoint in the scene, and it is then easy to animate the volume geometry. The technique can be used on the large installed base of Direct3D8 ps.1.3 hardware.
0239Using thickness to determine the appearance of objects was not suggested nor taught and did offer exciting new possibilities for real-time interactive rendering. Intuitive controls and color ramps govern the appearance of the volume objects, though more sophisticated treatments of scattering could also be employed.
0240The fluoroscopy's algorithm being based on NVIDIA technology, there exists an algorithm centralized on the calculation of the thickness of one or more objects, so the overlaps of the objects can be managed working to pixel levels (picture element)
0241The structure of the algorithm allows to modify every object's pixels colour (more real- simulate x-ray crossing several layers having a better image definition).
0242A fluoroscopy's colouration algorithm to be used with the invention is for instance as follows : <pre listing-type="program-listing"> Outputs main(Inputs IN) { Outputs OUT; float4 Texture,Texture2; 01) Texture=tex2D(FrontBuffer,CurrentPosition); 02) Texture2=tex2D(BackBuffer,CurrentPosition); 03) Texture2 = Texture2-Texture; 04) Texture2 = dot(Texture2,DecodeValues); 05) OUT.Color=Texture2; return OUT; }</pre>
0243This algorithm decodes the buffers' values to obtain the fluoroscopy visualization.
0244Lines 01 and 02 reads the values stored in the buffers that contain the depth of each pixel of the previous calculated scene's objects.
0245In line 03 is calculated the thickness of every scene's pixel. The thickness has values comprised between 0 and 1. In the overlapping zone the thickness is near 1.
0246In line 04 the data are decoded : pixels are transformed into the float original format, drawn on the frame buffer and visualised.
0247The vascular system and its interaction with the introduced devices are physically simulated through shape, elasticity and resistance, as this model allows the physics modelling and the right interaction of each new device.
0248For example the EPD, a filter that is delivered in the arteries, against the flow of the blood, in order to stop and to collect fragments that were detached from the stenosis.
0249Another example is the stent of newest generation, with an "Y" shape, that is used in the case of Abdominal Aneurysm Aorta.
0250The prior-art algorithm allows the expansion of the balloon until it attains the walls of the vase, no ulterior expansion being possible. Such algorithm previewed for balloon an expansion with linear course regarding the pressure.
0251The algorithm according to the embodiment of the invention more particularly described here authorizes to go further, as it is among other more detailed and takes care of the complexity.
0252More particularly physical model with which the balloon is represented, consists of n elements independent in their expansion, i.e. provides series of spheres of specific diameters.
0253Every sphere's expansion is a linear function of the pressure to which it is expanded until the spheres are not in collision with the walls of the vase (mesh).
0254If there are collisions with the walls of the vase a model of resistance dedicated to the mesh that are interested in the interaction is then considered.
0255Here, every contact point on the mesh exercises force on the sphere that composes the balloon and every sphere pertaining to the balloon exercises its own force on the mesh.
0256Accordingly, the expansion is not linear, but is proportionally limited by the resistance exercised between the mesh and the contact points.
0257Every mesh's point can be regulated with its own rigidity (resistance) and such variable resistance of the points pertaining to the mesh allows a full control on the mesh.
0258As an example it is possible to create lesions with aspect and rigidity of various structure.
0259The mesh deformation is on its part based on the pressure exercised from the balloon and at the same time the balloon must continue to expand based on the supplied pressure.
0260Working on interaction's force between balloon and mesh we have to take into account the possible use of a balloon whose diameter to the nominal pressure may be bigger than the diameter of the vase in which it is inflated, the force with which the balloon interacts with the mesh grows and may break off the vase.
0261The balloon's visualization is obtained by interpolation of a curve called "spline" that gives good fluoroscopy results.
0262An example of the relevant model used for balloons operating in pseudo code is provided. <pre listing-type="program-listing"> FOR(i=1 TO NumBalloonSpheres) { //*Physics: The radius of the sphere depends on the pressure exercised between the mesh and the sphere itself. If the central spheres are in collision and the edge sphere are not in collision, the result will be a typical hourglass-shape PressureOfSphereBalloon=PressuireFunc(BalloonSpheres[i]) RadiusSphere=CalculateRadius(BalloonSpheres[i], PressureOfSphereBalloon) //*Dati per Rendering AllRadius[i]= PressureOfSphereBalloon AllCenter[i]= Center(BalloonSpheres[i]) } //*Rendering CalculateSpline(AllRadius[],AllCenter[]) DrawSpline()</pre>
0263The physical model of the stent consists of a metallic mesh. Every node of the metallic mesh is a particle with own physical properties connected to the other nodes according to an established design. The behaviour of every node can be assimilated to a sphere's behaviour.
0264The spheres that represent the stent are compliant with the associated balloon following its behaviour. If the balloon is expanded until the walls of the vase, then also the nodes that compose the mesh of the stent comply to the walls of the vase.
0265A self-expandable stent model is close to the standard stent one.
0266Every node of the metallic mesh is a particle with its own physical properties and it is connected to the other nodes depending on a pre-established design.
0267When a self-expandable stent is deployed, the spheres that represent the nodes of the mesh are released assuming a speed that depends on their own physical properties and therefore the expansion of the simulated stent according to the invention follows physics of the expansion of a metallic mesh.
0268The catheter is modelled with a sequence of cylinders interconnected with a two degrees of rotational freedom's joints.
0269When the cylinders clash with the walls of the mesh, they follow the physical laws with which they have been modelled.
0270Furthermore, systems spring-damper are applied to the bodies in every joint so that for every joint it is possible to define dumping and stiffness.
0271A torque is therefore provided for every direction of movement. The force that acts on every joint is a function of the torque force that is a function of the angle and the angular velocity.
0272The calculation of the elastic force function of the Keθ angle and the calculation of the viscous force based on the angular velocity Keθ are then applied as a torque to the joint in the normal direction to the angle so that it is possible to give physical properties and shape to guides.
0273In order to simulate the motion of the catheter in a viscous environment forces are applied, that are obtained through an algorithm that works on every single body of the multilink chains, to the catheter.
0274Such algorithm is as follows : <pre listing-type="program-listing"> FOR(i=1 TO NumBodies) { Vel=CalcVel(Body[i]) Force.x=Kdamp*Vel.x Force.y=Kdamp*Vel.y Force.z=Kdamp*Vel.z ApplyForce(Body[i], Force) }</pre>
0275Depending on the real time speed of the body's center of mass, it is calculated Kv and therefore the viscous force. The calculated viscous force is then applied to the body in normal direction to the center of mass.
0276The algorithm to model the guide wire is such to concur the local management of viscosity and elasticity. The tip of devices is therefore much more ameliorated.
0277All these new produced devices have specific ways of use and specific fields of application.
0278Therefore it is extremely important to have the possibility to follow a specific course of formation on specific device.
0279Interaction between vascular system and the introduced devices physically simulated through shape, elasticity and resistance, the improved interaction between device-anatomy (pressures on the walls of the arteries), device-device (perceive the resistance using two devices) and insertion of guidewire 0,035" before catheter are also better performed.
0280Smoother balloon dilatation and stent delivery (When a balloon is inflated it is possible to see it expanding little by little and when a stent is deployed it is possible to see its compliance with the vessel's wall) is obtained.
0281More and more small diameter devices (as new technology evolves), more realistic embolic protection devices, filterwire EZ, are possible to be implemented with such improvements due to a preferred embodiment of the invention.
0282Technology to realize new devices with their own characteristics and physical properties, such as Carotid Wallstent, NexStent, Picture, Interaction between two different tools is available with the new method of the invention.
0283In order to render the invention more understandable, concerning its result the following example in the real life can be provided. Here it exists many problems during the interaction between devices that are in an artery at the same time . For example, a balloon that slides along the guide who supports an EPD, cannot cross over a point, situated on the guide, because at the end of the guide a thickening is present.
0284The hemodinamist perceives this situation as an obviously resistance to the advance of the balloon.
0285In modelling device as in a preferred embodiment of the invention it has been introduced the possibility to add to the device's physical model the presence of such physical obstacles during the interaction.
0286An algorithm to implement this double feedback could be provided on figure 9.
0287A test 70 is provided to check if Pasiz Balloon >= Pasiz MarkerEpd. If yes (line 71) then the 2° Cart activated block is performed (72). If not (line 73) the 2° Cart Disable Block (73).
0288Therefore the haptic device gives back to the operator a realistic feedback of the interaction.
0289The customer perceives the same resistance that he would perceive if he really used two devices.
0290This effect is obtained varying in real time the advance resistance of the carriages.
0291The tactile feedback due to the interaction between two tools contributes to increase the realism of the simulation and to increase the didactic power of the simulator.
0292A simulator monitor visualizes therefore the characteristic curves of the patient's electrocardiogram.
0293The waveforms are generated from a model that modify them in real time depending on the characteristics of the simulated patient's and depending on the user's actions during the procedure.
0294The ECG curves algorithm connects the animation of the heart, the curve of the pump cardiac pressure, pertaining to the physical model of the liquid of contrast, and the model of visualization.
0295The visualization is in real time. The curves are able to represent also the spasm's effects, particular cardiac situations, tachycardia and lowering of the pressure.
0296Here, it shall be remarked that the ECG is fundamental during angioplasty or angiography procedures because it allows to constantly hold under control the patient's conditions and to correct or suspend the undertaken actions.
0297According to the algorithms used with the invention, the waveforms are generated from a model that modify them in real time depending on characteristics of the simulated patient during stenting and balloon operations user's actions during the procedure.
0298The simulation model of the heart and of the vascular system is responsible for performing the visible movement of the heart, performing the visualized waveforms, regulating the spread of the contrast liquid injected.
0299In the case of complication the simulation model of the heart and of the central vascular system communicates the change to the cardiac heartbeat animation and to the ECG, so that the variations are synchronized to advantages of the simulation's realism.
0300The simulation model of the heart and of the vascular system is responsible of performing the visible movement of the heart, performing the visualized waveforms, regulating the spread of the contrast liquid injected.
0301An example of the algorithm used accordingly is provided here after :
0302//* This pseudocode underline the dependency from the cardiac frequency of the heart animation and the visualization of the ECG <pre listing-type="program-listing"> HeartAnimation(NormalHeartRate) ECGDiagram(NormalHeartRate)</pre>
0303When a complication arrives, like a spasm, the simulation model of the heart and of the central vascular system communicates the change to the cardiac heartbeat animation and to the ECG, so that the variations are synchronized to advantage of the simulation's realism.
0304A surface model realized with mesh give a simple solution to the anatomies construction based on real patients.
0305Working on images obtained with various tomography diagnostic techniques it is possible to have the exact anatomical structure of the patient and to simulate the interventional procedure before that it really comes.
0306A possible algorithm for this centration operation is provided in reference to figure 10.
0307Tomography data 75 are provided to instruction concerning information extraction (lengths vessels, radius of vessels, morphology) (76) in order to obtain Mesh Construction 77 and Centerline Construction (78).
0308The different algorithms provided herewith, written in their corresponding languages, are given in a no limitative way and could be, of course, substituted by algorithms in other languages having the same functionalities.
10 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4 Sheet 5 Sheet 6 Sheet 7 Sheet 8 Sheet 9 Sheet 10
Every citation, both ways
| Document | Relation | Office | Cited during |
|---|---|---|---|
| CN112382176A | Cited by | China | Search report |
| US2004249617A1 | Cites | United States of America | Search report |
| US4907973A | Cites | United States of America | Applicant |
| US5800179A | Cites | United States of America | Search report |
| US6249287B1 | Cites | United States of America | Search report |
9 members in 3 offices
Priority claims3
| Document | Office | Kind | Date |
|---|---|---|---|
| 05291563 | European Patent Office (EPO) | A | |
| EP20050291563 | – | – | – |
| 05291563 | – | – | – |
Members9
| Document | Office | Kind | |
|---|---|---|---|
| EP1746558A2 | European Patent Office (EPO) | A2 | |
| WO2007009763A2 | World Intellectual Property Organization (WIPO) | A2 | |
| EP1746558A3 | European Patent Office (EPO) | A3 | |
| WO2007009763A3 | World Intellectual Property Organization (WIPO) | A3 | |
| EP1903537A2This record | European Patent Office (EPO) | A2 | |
| EP1903537A3 | European Patent Office (EPO) | A3 | |
| US2008286735A1 | United States of America | A1 | |
| US8485829B2 | United States of America | B2 | |
| EP1746558B1 | European Patent Office (EPO) | B1 |
22 legal events, as the office reported them to INPADOC
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Numbers
- Publication
- 1903537
- Publication, DOCDB
- 1903537
- Publication, EPODOC
- EP1903537
- Application
- 7022742
- Application, DOCDB
- 07022742
- Application, EPODOC
- EP20070022742
Titles3
- German
- System und Verfahren zur Simulation eines manuellen Eingriffs in ein medizinisches Verfahren durch einen Benutzer
- English
- A system and a method for simulating a manual interventional operation by a user in a medical procedure
- French
- Système et procédé de simulation d'une opération d'intervention manuelle par un utilisateur dans une procédure médicale
Classification
- CPC, 2
- G09B23/30
- G09B23/285
- IPC, 1
- G09B23 28
Designated states36
- Contracting states, 31
- Austria
- Belgium
- Bulgaria
- Switzerland
- Cyprus
- Czechia
- Germany
- Denmark
- Estonia
- Spain
- Finland
- France
- United Kingdom
- Greece
- Hungary
- Ireland
- Iceland
- Italy
- Liechtenstein
- Lithuania
- Luxembourg
- Latvia
- Monaco
- Netherlands (Kingdom of the)
and 7 moreShow fewer
- Poland
- Portugal
- Romania
- Sweden
- Slovenia
- Slovakia
- Türkiye
- Extension states, 5
- Albania
- Bosnia and Herzegovina
- Croatia
- North Macedonia
- Yugoslavia, later Serbia and Montenegro (until 2006)