Device for simulating endoscopic ultrasound techniques

Abstract

The present invention relates to a system for simulating endoscopic ultrasound techniques, comprising an upper element (2) adapted to simulate a stomach wall and comprising a base (20), a first opening (21 ) for inserting an echoendoscope and a second opening (20') arranged on said base (20), a lower element (3) adapted to contain at least one element simulating a target intra-abdominal organ, said lower element (3) comprising a covering (30) and a third opening (30') arranged on said covering (30), said third opening (30') being connected to said second opening (20'), said upper element (2) and said lower element (3) being coupled to each other to form a simulating device (1 ).

Description

[0001] DEVICE FOR SIMULATING ENDOSCOPIC ULTRASOUND TECHNIQUES

[0002] The present invention relates to a device for simulating endoscopic ultrasound techniques.

[0003] In particular, the object of the present invention is a device for simulating echoendoscopic techniques using ultrasound.

[0004] As is well known, endoscopic ultrasound is a complex, innovative method which is continuously evolving compared to traditional endoscopy.

[0005] In particular, an echoendoscope is made up of a normal endoscope, for example like the ones used for ©esophagogastroduodenoscopy, to which an ultrasound component is added. An echoendoscope enables superior diagnostic functions compared to surface ultrasound due to the absence of air or other interposed structures.

[0006] Furthermore, by means of an echoendoscope it is possible to perform a Doppler test, a contrast-enhanced analysis, and above all it is possible to introduce, through the working channel, diagnostic and therapeutic devices which are directed through the wall of the intestine (oesophagus, stomach or duodenum), directly onto the surrounding organs (for example mediastinum, pancreas, liver and biliary tract, lymph nodes), guided by ultrasound images. The size and operation of an echoendoscope are similar to those of a common gastroscope.

[0007] However, the availability of such endoscopic ultrasound techniques is limited by the need to teach healthcare personnel and / or realistically demonstrate the various techniques that are developed.

[0008] This problem is even more evident in the field of paediatrics. Despite the preference for less invasive procedures, paediatricians have less opportunity to practice such procedures, because there are smaller volumes of activity than in centres for adults. Furthermore, the indications for endoscopic ultrasound in children often regard non-cancer conditions. Consequently, paediatricians have to go to specialised centres to learn the necessary techniques, applying them on a pathology that is often remote from what will then be their actual field of application on children.

[0009] Moreover, teaching through simulation has always been an essential step in training for the “in vivo” application of the most complex endoscopy methods. In the past, use was made of actual organs removed from specially housed and euthanised pigs, whose anatomical preparations were specifically set up for the technique it was desired to teach and sent, frozen, in order to be used at certain dedicated teaching centres, with all the evident ethical, logistical and economic limitations deriving from this.

[0010] In recent years, use has preferably been made of artisan-made synthetic anatomical preparations that ensure an equal level of realism and teaching efficacy, but only partly overcome the limitations of “ex vivo” simulators.

[0011] In fact, synthetic preparations generally allow the teaching of only one method and just a few repetitions of the procedure to be learned before the components used in the learning process need to be replaced. In addition, synthetic preparations are limited by the impossibility of using the normal electrical currents that are employed during clinical activity by means of electromedical generators on vital tissues. Furthermore, the structures to be replaced are generally not easily extractable. Finally, artisanal devices are not completely inspectable, and this conditions the student’s ability to rapidly understand the operation and spatial arrangement of the devices and of the echoendoscope.

[0012] Thus, in the specific sector there exists a need for a device for simulating endoscopic ultrasound techniques.

[0013] This need is satisfied by the device according to the present invention, which offers, moreover, further advantages that will become clear hereinafter.

[0014] The solution according to the present invention fits into this context; it is intended to simulate diagnostic and therapeutic endoscopic ultrasound procedures in the gastroenterological field with the aim of training doctors and nurses and realistically demonstrating the operation of echoendoscopes and of the devices most commonly used in various contexts.

[0015] These and other results are obtained according to the present invention by proposing a multimodal, modular, inspectable, electrifiable and extractable device.

[0016] The aim of the present invention is thus to provide a device that makes it possible to overcome the limits of the devices according to the prior art and to obtain the previously described technical results.

[0017] A further aim of the invention is that said device can be produced with substantially low costs, both as regards the production costs and as far as the operating costs are concerned.

[0018] Yet another aim of the invention is to propose a device that is simple, safe and reliable. Therefore, a specific object of the present invention is a system for simulating endoscopic ultrasound techniques comprising an upper element adapted to simulate a stomach wall and comprising a base, a first opening for inserting an echoendoscope and a second opening arranged on said base, a lower element adapted to contain at least one element simulating a target intra-abdominal organ, said lower element comprising a covering and a third opening arranged on said covering, said third opening being connected to said second opening, said upper element and said lower element being coupled to each other to form a simulating device.

[0019] Preferably, according to the present invention, said upper element and / or said lower element can comprise at least one perforation.

[0020] Furthermore, according to the present invention, said system can comprise means for fixing a membrane arranged at said second opening and at said third opening.

[0021] In particular, according to the present invention, said system can comprise an electroconductive membrane positioned at said second opening and at said third opening.

[0022] Moreover, according to the present invention, said system can comprise means for electrifying said element simulating a target intra-abdominal organ and / or said membrane.

[0023] Preferably, according to the present invention, said fixing means and / or said electrifying means can comprise two plates.

[0024] In particular, according to the present invention, said fixing means can comprise a first plurality of pins arranged on said covering, each pin being adapted to be coupled to a respective seat arranged on said base of said upper element.

[0025] In addition, according to the present invention, said upper element can comprise a fourth opening and a second plurality of pins adapted to enable a coupling of a membrane to said device.

[0026] Moreover, according to the present invention, said electroconductive membrane can have a thickness of 0.5 mm.

[0027] Preferably, according to the present invention, said upper element, said lower element and / or said plates can be produced by means of 3D printing techniques, preferably by printing with polylactic acid (PLA) filaments.

[0028] Furthermore, according to the present invention, said system can comprise a transparent container filled with water and adapted to contain said simulating device.

[0029] Finally, said system can comprise locking means adapted to fix said simulating device to said container.

[0030] The efficacy of the device of the present invention is evident, as the device makes it possible to simulate and demonstrate most of the presently known interventional abdominal endoscopic ultrasound procedures by setting up specific simulation environments that do not result in damage to the device itself and enable an adequate realism without the need for any animal involvement.

[0031] The present invention will now be described, by way of non-limiting illustration, according to a preferred embodiment thereof, with particular reference to the figures of the appended drawings, in which:

[0032] - figure 1 shows a side view of a first embodiment of the device according to the present invention,

[0033] - figures 2a-2b respectively show an exploded perspective view and an exploded side view of the device in figure 1 ,

[0034] - figure 3 shows a perspective view of an upper element of the device in figure 1 ,

[0035] - figure 4 shows a side view of an upper element of the device in figure 1 ,

[0036] - figure 5 shows a side view of an upper element of a second embodiment of the present invention,

[0037] - figure 6 shows a sectional view of a lower element of a second embodiment of the present invention,

[0038] - figure 7 shows a top view of the lower element in figure 6, and

[0039] - figures 8a and 8b respectively show a side perspective view and a front perspective view of a second embodiment of the present invention.

[0040] Making reference to figures 1 , 2a-2b, 8a and 8b, a device for simulating endoscopic ultrasound techniques is indicated by the reference number 1 .

[0041] Said device 1 comprises an upper element 2 adapted to simulate the wall of a distended stomach. Preferably, said upper element 2 has a bean shape to simulate the shape of a stomach in cross section. In particular, said upper element 2 comprises a first opening 21 , preferably circular, which simulates the oesophagogastric junction of a patient. More particularly, said opening 21 allows the insertion of a common echoendoscope, which will have to be stabilised by an operator in the same position as used in clinical practice. Furthermore, said device 1 comprises a lower element 3 adapted to enable the housing of an element simulating the target intra-abdominal organs, the set-up of which can be modified according to the method it is intended to simulate. Said simulating element can comprise synthetic preparations configured to simulate the features of the target organs. In particular, said synthetic preparations can be connected to a neutral electrode of an electromedical generator. By way of example, in order to simulate a pancreatic pseudocyst susceptible of transgastric endoscopic ultrasound-guided drainage, synthetic anatomical preparations coupled to the lower element 3 can be used. Moreover, said device 1 is adapted to comprise a perforable electrifiable membrane (not shown). Said membrane is adapted to simulate the portion of the gastric wall that is actually passed through by the various endoscopic ultrasound-guided devices commonly used in clinical practice and whose coupling is designed so as to allow its electrification and easy replacement in case of wear. Preferably, said membrane has a thickness of about 0.5 mm. More preferably, said membrane is an electroconductive membrane.

[0042] Said upper element 2 and said lower element 3 comprise a respective opening 20’, 30’. In particular, said upper element 2 comprises a second opening 20’ arranged on a base 20 of said upper element 2 and said lower element 3 comprises a third opening 30’ arranged on a covering 30 of said lower element 3. In particular, said third opening 30’ is arranged at said second opening 20’ so that when said upper element 2 is coupled to said lower element 3, said second opening 20’ is connected to said third opening 30’, thus defining a passage from said upper element 2 to said lower element 3, in particular for the passage of an endoscope.

[0043] In order to position the membrane correctly inside said passage, making reference to the embodiment shown in figures 2a and 2b, said device comprises a first plate 5 and a second plate 6 positioned between said upper element 2 and said lower element 3. In said embodiment, each of said plates 5, 6 has a rectangular shape and comprises an opening 51 , 61 adapted to be covered by a membrane with a defined tension.

[0044] Making reference to the embodiment shown in figures 5-8b, the same reference numbers indicate the same or corresponding parts, elements or components already illustrated in figures 1 -4. Furthermore, in the embodiment shown in figures 5-8b, said lower element 3 comprises a first plurality of pins 34 adapted to enable the coupling of the membrane covering said third opening 30’ to said device. In particular, said first plurality of pins 34 is arranged on said covering 30 of said lower element 3.

[0045] Furthermore, again making reference to the embodiment shown in figures 5- 8b, each pin of said first plurality of pins 34 of said lower element 3 is adapted to be coupled with a respective seat 25 arranged on said base 20 of said upper element 2 so as to enable a coupling between said upper element 2 and said lower element 3.

[0046] Furthermore, making reference to the embodiment shown in figures 5-8b, said upper element 2 further comprises a fourth opening 40’ (not shown) and a second plurality of pins 24 adapted to enable the coupling of a second membrane to said device. In particular, said second plurality of pins 24 is arranged on an inner surface of said upper element 2.

[0047] In addition, said device 1 comprises electrification means for electrifying said element simulating a target intra-abdominal organ and said membrane. In the embodiment shown in figures 1 -4, said electrification means are said plates 5,6. In the embodiment shown in figures 5-7, said electrification means are said base 20 of said upper element 2 and said covering 30 of said lower element 3.

[0048] Making reference to figure 5, said upper element 2 comprises two channels 26 adapted to allow the passage of electrical cables connected at one end respectively to said second opening 20’ and said fourth opening 40’ of said upper element 2 and at the opposite end to a neutral electrode. Preferably, said electrical cables are reversibly connected to said second opening 20’ and said fourth opening 40’, for example by means of screws, thus allowing their replacement or removal in case of need.

[0049] Furthermore, making reference to figures 2a, 2b and 5, the upper element 2 has a side perforation 23 which enables direct inspection during the performance of the simulated task and the housing of target structures inside said device.

[0050] In addition, making reference to figures 2a, 2b and 6, said lower element 3 comprises a perforation 31.

[0051] Furthermore, making reference to figures 2a, 3 and 7, said upper element 2, said lower element 3 and / or said plates 5, 6 comprise at least one respective hole 7, adapted to collaborate with fixing means, for example bolts produced by 3D printing, adapted to be inserted into said at least one hole 7 to lock together said upper element 2, said lower element 3 and / or said plates 5, 6. In addition, said upper element 2, said lower element 3 and / or said plates 5, 6 can be produced by means of 3D printing techniques. In particular, for the printing of said elements it is preferable to use light pink polylactic acid (PLA), with a smooth, opaque finish so as to obtain a sufficiently realistic gastric wall, which does not damage the echoendoscope during the simulation and does not generate annoying reflections in the endoscopic image or ultrasound artifacts at the time of immersion.

[0052] Preferably, said upper element, said lower element and / or said fixing plates can be produced with conductive copper filaments connected with a neutral electrode of an electromedical generator, so as to ensure the closing of the electric circuit and the application of a cutting or coagulation current on the artificial target organs of the simulation.

[0053] In one embodiment, not shown, said device is immersed in a container filled with water to facilitate ultrasound propagation. In particular, said container is transparent in order to allow a direct view of the target structure, thus overcoming the need for a video camera or X-ray image and further simplifying the logistics of use and the understanding of the simulation. Should this need be present for assessment and scientific purposes (for example to standardise the learning assessment), use thereof is not precluded. Preferably, said container is a transparent plexiglass aquarium, i.e. a parallelepiped without the top side, with dimensions of 23 cm x 23 cm x 18 cm, which allows the simulating device to be immersed in water so as to enable a realistic propagation of ultrasound waves.

[0054] In addition, according to the present invention, said system can provide for a structure in cross section directly inspectable through the container in which it is inserted, so as to facilitate the understanding of the method being simulated.

[0055] Making reference to the embodiment shown in figures 2a, 8a and 8b, said upper element 2 comprises a handle 22 to enable the transport and placement of the simulating device 1 and, in particular, the housing and removal of the simulating device 1 assembled inside the container. In one embodiment, not shown, said handle 22 can comprise a neutral electrode connected to said plates 5,6 and / or to said second opening 20’ and / or said fourth opening 40’ by means of electrical cables.

[0056] Moreover, said device 1 can comprise locking means adapted to anchor said device to said container, so as to prevent movements of the device in the container. Preferably, said locking means comprise a plexiglass anti-float block, i.e. a 1 cm x 5 cm x 20 cm rectangle with two slots of 2 cm each and holes where two bolts are inserted to enable anchorage onto the container so as to prevent the movements of the device once immersed in the container. Said container can comprise two felt pads to allow the fixing bolts of the anti-float block to be screwed in without damaging the container itself.

[0057] When not in use, the simulating device can be easily stored together with the container in a rigid universal case having dimensions of 50 cm x 20 cm x 40cm, with a modular cubic foam housing so as to avoid damage to the device and container during transport. Given its ease of transport and use, the device may be used for teaching and demonstration purposes in any environment, since it only requires an electrical power supply for the endoscopic ultrasound tower and the possibility of filling the container with running water.

[0058] Said simulating device can be used for the purpose of training or re-training healthcare personnel involved in more complex endoscopic ultrasound procedures, as well as for commercial demonstration purposes on the part of manufacturers of echoendoscopes or endoscopic ultrasound devices. Another interesting field of application is that of involving and educating the patient or caregiver.

[0059] Given the availability of 3D printing design, the current expenses are rather modest, as they are represented by printing material, the container and the anti-float block. The printing times may change depending on the printer. For example, with fused deposition 3D printing, the printing times can range from two to eight hours for a complete simulating device.

[0060] By way of example, using the simulating device according to the present invention the following techniques can be performed:

[0061] - basic principles of positioning and using an echoendoscope;

[0062] - needle biopsy of solid lesions;

[0063] - drainage of fluid collections with a “double pigtail” plastic stent;

[0064] - drainage of pseudocysts by means of a lumen apposing metal stent;

[0065] - endoscopic ultrasound-guided marsupialisation of intestinal cysts;

[0066] - radiofrequency ablation of solid pancreatic lesions;

[0067] - placement of fiducial markers for radiotherapy; and

[0068] - gastrojejunal anastomosis by means of a lumen apposing metal stent;

[0069] - cholecystogastrostomy for inoperable acute cholecystitis.

[0070] The present invention has been described by way of non-limiting illustration according to preferred embodiments thereof, but it is understood that variations and / or modifications may be introduced by the person skilled in the art without going outside the relevant scope of protection, as defined by the appended claims.

Claims

CLAIMS1 ) A system for simulating endoscopic ultrasound techniques, comprising an upper element (2) adapted to simulate a stomach wall and comprising a base (20), a first opening (21 ) for inserting an echoendoscope and a second opening (20’) arranged on said base (20), a lower element (3) adapted to contain at least one element simulating a target intra-abdominal organ, said lower element (3) comprising a covering (30) and a third opening (30’) arranged on said covering (30), said third opening (30’) being connected to said second opening (20’), said upper element (2) and said lower element (3) being coupled to each other to form a simulating device (1 ).2) The system according to the preceding claim, characterised in that said upper element (2) and / or said lower element (3) comprise at least one perforation (23, 31 ).3) The system according to any one of the preceding claims, characterised in that it comprises fixing means (5,6, 24, 34) for a membrane arranged at said second opening (20’) and said third opening (30’).4) The system according to any one of the preceding claims, characterised in that it comprises an electroconductive membrane positioned at said second opening (20’) and said third opening (30’).5) The system according to any one of the preceding claims, characterised in that it comprises electrification means for electrifying said element simulating a target intra-abdominal organ and / or said membrane.6) The system according to any one of claims 3-5, characterised in that said fixing means (5,6) and / or said electrification means comprise two plates (5,6).7) The system according to any one of claims 3-6, characterised in that said fixing means (34) comprise a first plurality of pins (34) arranged on said covering (30), each pin (34) being adapted to be coupled to a respective seat (25) arranged on said base (20) of said upper element (2).8) The system according to any one of claims 3-7, characterised in that said upper element (2) comprises a fourth opening (40’) and a second plurality of pins (24) adapted to enable the coupling of a membrane to said device.9) The system according to any one of claims 4-8, characterised in that said electroconductive membrane has a thickness of 0.5 mm.10) The system according to any one of the preceding claims, characterised in that said upper element (2), said lower element (3) and / or said plates (5, 6) are produced by means of 3D printing techniques, preferably by printing with polylactic acid (PLA) filaments.11 ) The system according to any one of the preceding claims, characterised in that it comprises a transparent container filled with water and adapted to contain said simulating device (1 ).12) The system according to the preceding claim, characterised in that it comprises locking means adapted to fix said simulating device (1 ) to said container.

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