Haptic Palpation for the Femoral Pulse in Virtual Interventional Radiology T.Coles1,2, N.W.John2, D.A.Gould3 ,D.G.Caldwell1, 1 Institute of Italian Technology, 2Bangor University, 3Royal Liverpool University Hospital [email protected] Abstract Interventional Radiology is a rapidly expanding speciality using minimally invasive techniques to treat a multitude of clinical problems. Current work in progress aims to create an affordable virtual training tool to reduce training times and patient risk during a trainee practitioners learning cycle. The procedure of arterial catheterisation has been broken down into a number of subtasks, one of which requires an operator to locate the femoral artery pulse by palpation. This is performed in preparation for a needle insertion to allow the entry of a guide wire and catheter into the patient. This paper presents the current state of research into a unique solution for affordable haptic simulation of pulse palpation in a virtual environment. 1. Introduction Modern methods of training a medical procedure are little changed since the earliest beginnings of medicine: the “apprenticeship” model uses the principle of “see one, do one, teach one”, where a trainee observes a procedure, practices it under supervision and, when proficient, becomes a mentor him/herself. Interventional Radiology (IR), as with most other specialisations utilises this approach. The IR procedure uses minimally invasive techniques to perform tasks such as unblocking or blocking vessels, biopsies, draining abscesses and, infusing drugs to specific sites in the vascular system. The procedure starts with the Seldinger technique [1], the first and most essential step in performing an endovascular procedure. In this procedure a needle is inserted into an artery or vein guided commonly by palpating for a pulse. Through this entry point a guidewire is then navigated along the vessel. The practitioner uses x-ray guidance to see the position of objects within the patient. The wire acts as a guide for a catheter which is fed over the wire so that fluoroscopic dye can be injected for guidance purposes; a catheter sheath also may act as a channel to insert tools such as balloons and stents or, fluids to a specific location. Palpation for a pulse and instrument guidance is highly tactile as the visual feedback is reduced. Whilst guiding a wire it is essential to respond to the force feedback felt at the finger tips as the visual feedback is limited. The number of straightforward invasive diagnostic procedures, which are the main source of IR training opportunities, have greatly reduced as non-invasive imaging methods have improved. At the same time, cost minimisation is high on hospital agendas, yet training under the apprenticeship model is expensive as it increases procedure duration [2]. This is due to the increased time an expert practitioner must dedicate to simple cases when training. This increased time applies to all staff involved, as well as the patient. In addition, work time directives in the US and EU are reducing trainee practitioners’ hours of work, further limiting the available training time. A further significant disadvantage to the apprenticeship model is that learning, in part, involves the experience of errors, albeit under the guidance of an expert mentor. Yet performing an operation incorrectly through inexperience can lead to patient discomfort and complications. The latter can prolong a patient’s hospital stay or, in the worst case scenario, can cause permanent damage or death. It is not acceptable to make mistakes on patients when alternatives are available. There are many ways of simulating medical procedures for training purposes. Traditionally, students train using anesthetised animals or cadavers, or by practicing on mannequins or fellow students. However, the deformations that occur in an animal’s or cadaver’s tissues vary from those of living humans due to varying anatomy or absence of blood pressure. Not only are cadavers expensive, but procedures can only be performed once and a mistake can render the body useless to re-demonstrate a procedure. This type of simulation also raises ethical issues. Sophisticated mannequins are also becoming increasingly common to simulate a patient e.g. [3], though they are limited in their replication of physiology, and have at best a limited range of anatomical variability. One alternative that is making an impact on the medical community is computer simulation [4-6], which can train practitioners by critically analysing skills and providing feedback on the performed procedure. This feedback can then be used to refine the required skills until the operator reaches an agreed level of proficiency before commencing training with patients. Simulations can also provide the user with an opportunity to virtually practice difficult cases, or those in which patient anatomy is unconventional before performing the procedure in a patient. Such ‘mission rehearsals’ can highlight operational and equipment difficulties that would otherwise be overlooked until they are encountered during the real procedure. Simulation involving the manipulation of living human structure can require a much greater complexity than that already achieved in simulations for aviation or military applications. Aviation and military simulation follows a known set of rules. A medical simulation on the other hand would ideally simulate the mechanical properties of organs which are still little known. Further to the obvious computational difficulty, procedural variety between practitioners causes a problem. The simulation should accommodate all correct and incorrect approaches to performing a procedure. Despite these complexities, both computational and mechanical approximations can be made that provide sufficient visual and haptic fidelity to effectively simulate real world situations. Palpation is a very common medical examination that relies on haptic response which has been little researched for simulation [7-8]. The clinician presses lightly on the surface of the patient’s body to feel the organs or tissues underneath. Palpation is used in the IR procedure to guide a needle into an artery in the initial phase of the Seldinger Technique. One available entry site for the procedure is the femoral artery. Although commercial endovascular simulations such as [9] exist they include neither the palpation nor needle insertion procedure. Including the palpation stage within a virtual training simulation for IR would give the simulation an essential component of validity, allowing the trainee to practice palpating a pulse in a variety of patients, and to use this to guide a virtual arterial puncture procedure. Depending on a patient’s body habitus, which is in turn related to their quantity of muscle and fat, the displacement of tissues necessary to feel a patient’s pulse varies. The strength of the pulse also varies due to tissue thickness, as well as a range of pathologies that might be present. These varying conditions must also be taken into consideration and simulated in the virtual environment. This paper outlines research into the affordable simulation of palpating for a pulse in the femoral artery. The developed software and hardware solutions are explained and reviewed in the following chapters. 2. Pulse Palpation From firsthand experience, observation in theatre and video documentation, the task of palpation for the femoral artery specifically during an IR procedure has been analysed. In addition, research into the exact forces applied during palpation is being performed. Figure.1: Palpation for a pulse during needle insertion In combination with visual feedback, the haptic component of the simulation (the feeling of the pulse) has been investigated using both force and tactile feedback. 2.1. Virtual Environment The goal of this simulation is to create a realistic, high fidelity visual model that also provides a realistic touch sensation. The simulation hardware and software is made up of the following components: • A flat screen LCD monitor mounted horizontally such that the user looks down into the monitor to give an impression of seeing the patient lying below. It was initially, but incorrectly, thought that a time sequenced stereo image could be projected in this manner, but the refresh rate of the LCD display proved to be too low to permit this approach [10]. The visual display is now being replaced with a Zalman ZM-M220W [11], an LCD display capable of projecting a stereo image using linear polarisation. • • • A haptic device is placed below the monitor and a hand avatar is displayed in a position that matches the users hand on the haptic device to help the user visualise the situation [12]. An anatomical model of a virtual patient has been created by segmenting the visible human dataset using ITKSnap [13]. A three dimensional mesh of a segment of the skin’s surface (seen in figure. 3) is used in the visualisation. Future developments will implement the underlying structures, using soft tissue modelling techniques, allowing an accurate model of the deformation. The simulation has been developed using Chai3D 1.51 [14] for force feedback support, and proprietary algorithms for tactile response. Pressure (a) Approximation of pulse pressure waveform. (b) Simulated square waveform. Time (c) Simulated Triangular waveform (around 1400 euro). The relatively new Falcon haptic device has undercut this with an extremely low price (200 euro in the EU), offering some interesting options particularly for teaching and training. As standard, the Omni uses a pen like end effector and the Falcon a ball shaped end effector. The Omni offers six DOF positional / orientation sensing and three DOF force feedback. The Falcon offers a more limited three DOF of force feedback and positional sensing. Nonetheless, after preliminary studies, the lower cost, limited DOF Falcon device proved to be better suited to this application due to the nature of a palpation. During an IR palpation the patient lies flat on their back upon the radiological table and the practitioner is tasked with locating the position of the femoral artery. The approximate location of the femoral artery on a patient’s right leg is indicated by the dark strip in Figure 3. The pulse is palpated by the practitioner, usually using 2-3 fingers (subject to practitioner preference). An example of this can be seen in Figure 1. The Omni’s armature based mechanics did not offer such an intuitive palpatable platform in comparison to the Falcon device. Figure.2: Pressure variations of a pulse and simulated pulse profiles. 2.2. Force feedback Hardware solutions for force feedback are readily available and many medical simulators use an off-theshelf haptic device – such as the PHANToM range from SensAble Technologies (Woburn, USA), with some using a purpose built haptic device – such as the Laparoscopic Impulse Engine from Immersion Medical (Gaithersburg, USA). Ideally the haptic device will provide a full six degrees of freedom (DOF) feedback, with an active force response to both position and orientation. However, devices with 6 DOF are expensive and most off-the-shelf haptics devices only provide 3 DOF force feedback to the stylus position, through which a force is applied to a user. Commercially available haptic devices are usually preferred over a custom build as they tend to be lower cost, stemming from higher production numbers. Further simulation development time can be reduced as such devices are pre-tested and API’s have been pre developed. The two devices considered in this project are SensAble’s PHANToM Omni [15] and, Novint’s Falcon [16]. Both are at the low cost end of the market with the Omni having achieved comparatively wide spread acceptance as “the” low cost haptic device Figure.3: Location of the femoral available in palpation. Removing the Falcon’s ball shaped end effector uncovers a vertical triangular plane. The device has been modified such that this vertical plane is now horizontal to the table top on which the device stands. To do this, the device (Figure.4(a)) has been rotated through 90 degrees and the commercial end effector replaced with a thin flat end effector (Figure.4(b)). This more closely mimics the orientation of the patient’s skin in the area to be palpated. The end effector has been fitted with two finger loops (Figure.4(c)) which ensure the users fingertips are always close to the end effector, making both the positioning of the hand avatar correct, and allowing the user to lift the end effector easily. This allows the user to navigate in the three dimensional simulation environment. Upon the end effector, in the position of the three palpating finger tips, three tactile devices are mounted (Figure.4(d)). These can be used to further simulate the pulsing effect and are described in section 2.3. The Falcon is used to convey force feedback when the model is palpated. A small amount of friction is applied in addition to the skins reactive force feedback when the skins surface is palpated to increase fidelity. When the area of the model corresponding to the site of the femoral artery is palpated, the haptic device conveys an additional force response. The force profile of each pulse wave is triangular such as the wave in figure 2(c). This profile is used as an approximation of a human pulse. Although the double peak (figure 2(a)) of a real pulse is ignored, it is a barely detectable feature in the femoral pulse of patients undergoing the IR procedure. The triangular force profile produces a sinusoidal motion of the end effector, due to device inertia, combined with the inertia of the user’s fingers. This inertia creates a slow in and out motion characteristic of a bouncing ball and, of the pressure/force profile of a pulse. Although the double peak of a real pulse could be simulated it didn’t seem necessary in the initial stages to do this due to the compelling feeling of a single peaked pulse. square pulse (figure 2(b)) producing a compelling pulse feeling. Presently a triangular wave profile (figure 2(c), the same as used in the force feedback simulation) seems to give the highest fidelity response. A more sinusoidal shaped wave profile can be used with the pin array device as the device’s power and displacement makes the pulsing detectable. 2.3.1. Piezoelectric Pads Piezoelectric material expands and contracts when a voltage is applied. This expansion and contraction can be controlled by varying the applied voltage. When incorporated into a fingerpad assembly the voltage changes create displacement of the piezoelectric material. This can create a pulsing effect that when pinched between thumb and forefinger creates a distinct feeling closely resembling that of a pulse. When driven at low frequencies (1Hz -3Hz) [17, 18] not typically used in applications of piezoelectric material, these sensations can be quite compelling. The pads are thin (<1mm) and have been mounted onto the custom modified end effector plane attached to the Falcon force feedback device (figure 5). A latex glove with the pads inserted at the fingertips has also been tested. The pads are driven by an integrated circuit board consisting of a microcontroller and OLED graphics display made by Luminary Micro (Austin, USA), and signal amplification circuitry. The pulse length and pause time can be manipulated to simulate zero to 300 pulses per minute. A major advantage of using piezoelectric pads is their extremely low cost. Figure.4: Modified falcon force feedback device. 2.3. Tactile devices To further increase the perception of pulse discovery when the correct location of the pulse is palpated, the use of tactile devices has been investigated. Three devices; piezoelectric pads, micro speakers, and a pin array have been used, each with their distinct advantages and disadvantages. In each case, a waveform is generated to represent a pulse. A variety of waveforms have been tested with the piezoelectric and speaker devices. A sinusoidal pulse profile was found to be tactically undetectable, with a Figure.5: Piezoelectric pads mounded onto customised Falcon end effector. Hand superimposed. 2.3.2. Micro Speakers Micro speakers have also been tested as potential pulse generation modules. These speakers are driven by small electromagnetic coils and can be activated using similar circuitry to that for the piezoelectric pads. The devices can be used in the same way to produce a displacement and simulate a pulsing sensation. The speakers produce a larger displacement than the piezoelectric pads, but produce a small reactive force which can be easily counteracted when applying a downward force through the device. To effectively feel a pulsing sensation, an alternative device arrangement to that of the piezoelectric pads has been sought. Figure.6: Micro speaker tactile device. Figure 6 shows the current implementation where the membrane of the speaker is strapped to the user’s finger. The mass of the speaker system is forced to move as the speaker is driven. The inertia involved in the movement produces a response at the finger tip which has been likened to a pulse. The fingertip device weighs approximately 7.5 grams and the base of the speaker has a diameter of 19mm. Incorporating force feedback is harder than with the piezoelectric pads as they can not be mounted directly onto a force feedback surface due to the low force produced by the electromagnetic coil. Alternative mounting techniques are being explored. 3. Evaluation Initial qualitative tests of the simulations have been carried out with a number of medically inexperienced subjects and an experienced interventional radiologist. Current verbal evaluations of the visual and force feedback components found that the pulse was relatively easy to find even after a short explanation of the position of the femoral artery. The users commented that the skin did not deform and that the 3D visualisation was of low quality. However, the simulation is to include a deformable mesh in future models and a higher quality 3D model is to be used. A low quality model was used in the initial stages as the development system has been a standard desktop computer for proof of concept. The simulation will be optimised for a more powerful graphics orientated machine. This feedback is promising especially as further relatively simple developments have still to be carried out. More structured and quantifiable evaluations of the simulations are to follow as development progresses. A table of the advantages and disadvantages of each tactile technology considered is given below in table 1. Table 1. Comparison of Tactile Technologies Technology Piezoelectric Pads Micro Speakers Pin Array 2.3.3 Pin Array A pin array device developed by Salford University [19] and further commercialised by Aesthesis [20] calling it Aphee-4x, demonstrates an alternative promising concept. The device has 16 individual remotely actuated pins in a 4 by 4 configuration. The array is small enough to be clipped onto the tip of a user’s finger. The actuators are housed in a wireless unit, which drives the pins using cables. Each pin can exert a force up to 1.3N and has a maximum displacement of 2mm. The actuators can be used to precisely manipulate the displacement of the pins at a high frequency and as such arbitrary pulse formations can be felt. An expert interventional radiologist’s reaction to this device was very positive but due to its high cost, a proposal to reduce the number of pins to a single large pin per fingertip is being considered. Advantages • Extremely low cost • Thin • Medium force • Large displacement • Low cost • High force • Large displacement Disadvantages • Small displacement • Limited life • Limited force • High Cost Currently a triangular pulse profile appears to produce the best perceptual waveform when using piezoelectric pads and micro speakers. As the pressure profile of a pulse is a complex waveform (resembling that of figure 2(a)), an investigation into the forces felt during palpation for a pulse is being undertaken. From this information, the waveform generated by the tactile and force feedback devices will be modified in the hope to further increase the realism of the tactile response. 4. Conclusion Simulating medical procedures at sufficient fidelity is inherently difficult. This is due to computation and hardware difficulties and also due to the aforementioned procedural variety between practitioners. This difficulty, coupled with the requirement for simulators to be available at an affordable cost further increases the difficulty of producing an effective simulator. Although cost is high on the list of requirements, this does not mean that money need not be spent in development, and that a more expensive solution should not be provided if its fidelity is much higher. Simulation development should first look to achieve fidelity, correct content and face validity. Meeting low cost requirements can be sought from the initial high quality target model produced. During the visual and force feedback simulations, experiments showed that although it was possible to see a user was palpating in the vicinity of the pulse, it was impossible to know if the user was feeling the pulse or not, or to evaluate the force they applied to palpate for the pulse. To combat this, it is proposed that a separate visual interface for the trainer is provided which will summarise the forces felt during the palpation process. This can be used to guide the user to feel the correct response, using the ideal force. The virtual nature of the simulation theoretically allows the simulation to be applied for various palpation procedures. However, task analysis must be performed to check the task similarity to the analysed IR palpation procedure. The similarity of the IR palpation to other procedures is currently unknown. Future work will be carried out in the development of the palpation simulation using both force and tactile feedback. The tactile devices currently showing most promise at this time are the piezoelectric pads and the proposed single pin modification to the pin array device. Measurements to record the exact forces involved during palpation and throughout the interventional procedure are being conducted and from these measurements, the accuracy of the simulation can be improved. This in turn increases the simulation’s validity. Development of the palpation simulation is not tied to any one device, either force feedback or tactile, so that new approaches can be easily implemented. Further professional validation of the approaches will be sought but preliminary testing has shown promise that a realistic palpation can be developed. 5. References [1] S.I. Seldinger, “Catheter replacement of the needle in percutaneous arteriography; a new technique”. Acta radiologica 39 (5) , 1953 pp 368–376 [2] D.A. Gould, “Interventional Radiology Simulation: Prepare for a Virtual Revolution in Training” Journal of Vascular Interventional Radiology, Vol. 18 Iss. 4, 2007, pp 483 - 490. [3] Y. 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