System for vascular-surgery simulation

Abstract

The present invention patent refers to a system for vascular-surgery simulation that corresponds to an equipment and system designed to produce, by means of 3D printing using a 3D printer, real images of the aorta of the patients obtained by imagined examinations such as computed tomography and/or nuclear magnetic resonance in order to enable doctors to acquire complex skills and/or to refine their operating techniques, training in a controlled environment and with suitable guidance, without putting the patient at risk, being characterized in that it comprises connectors (2) made of silicone, pulsating flow pump (3), negatoscope (4), black box (5), camera (not shown) and monitor (6) such as to reproduce, in silicone or translucent resin, the aortic arch, thoracic aorta, abdominal aorta and the iliac arteries.

Claims

1. A system for vascular-surgery simulation comprising: a computer to receive data obtained from real imaging examinations of patients' aortas, processing data to create a three-dimensional model of the patient's aorta and convert data in a suitable format for printing by a 3D printer; a 3D printer that receives data in a suitable format and prints a printed model of the patient's aorta, and the model is printed in translucent and flexible material; a pulsed flow pump (3) connected to the printed model by means of connectors (2), a negatoscope (4) which provides a light source to be positioned under the printed model during the simulation; a black box (5) which is positioned on the printed model during the simulation, the black box being configured to hold a camera and configured to allow the simulation to be done under indirect vision; and a monitor (6) that is connected to the camera and configured to display the images of the model captured by the camera.

2. The system of claim 1, wherein the translucent and flexible material is selected from translucent silicone and translucent resin.

3. The system of claim 1, wherein the 3D printer prints the model by means of successive material layers.

4. The system of claim 1, wherein the computer receives data from imaging examinations of patient's real aortas in DICOM format, reconstructs the patient's aorta in 3D model, removes underlying tissues of the 3D model, converts the DICOM data into files in STL format, makes corrections in the template prepared for 3D printing, and sends data to the 3D printer.

5. The system of claim 1, further comprising processing the printed model to remove material with a water jet.

6. The system of claim 5, further comprising repairing ruptures that occurred during removal of the material with a water jet and exposing the printed models to ultraviolet (UV) light to improve transparency.

7. The system of claim 5, further comprising polishing the model surface to extract residues from the carrier material and exposing the printed model to UV light for 24 hours.

8. The system of claim 4, further comprising applying silicone to the printed model and curing the silicone.

Description

DESCRIPTION OF DRAWINGS

(1) For a complete view of how the Patient-Specific Simulator of the Aorta and Reproduction System are made up, find below the accompanying illustrative drawings, to which reference is made as follows:

(2) FIG. 1: FIG. 1: Represents perspective view of the Patient-Specific Simulator of the Aorta arranged or positioned on a table bench.

(3) FIG. 1/A: corresponds to the perspective view of the negatoscope.

(4) FIG. 1/B: illustrates the perspective view of the black box.

(5) FIG. 1/C: illustrates the schematic view of the Pulsed Flow Pump.

(6) FIG. 2: corresponds to the schematic superior view of an Abdominal Aorta and Iliacs printed in 3D, aorta and thoracic aorta made of silicone connected to pulsed flow pump.

(7) FIG. 2/A: represents complementary schematic superior view of the Abdominal Aorta and iliacs printed in 3D, Aorta and Thoracic Aorta made of silicone and connected to pulsed flow pump.

(8) FIG. 3: Top view of the five models of aneurysms.

(9) FIG. 4: shows constitution flowchart of the Patient-Specific Simulator of the Aorta and Reproduction System.

DESCRIPTION OF THE MODEL

(10) As can be seen from the accompanying drawings which complete an integral part of this specification, the Patient-Specific Simulator of the Aorta and Reproduction System (1) corresponds to an equipment and system intended to produce through 3D printing, using the 3D printer, of the real images of the aorta of patients obtained in examinations such as computed tomography and/or nuclear magnetic resonance in order to allow physicians to acquire complex skills and/or to refine their operative techniques, training in a controlled environment, under appropriate guidance, without exposing the patient at risk, characterized by the fact of comprising connectors (2) made of silicone; pulsed flow pump (3); negatoscope (4); black box (5); camera (not shown) and monitor (6), developed to reproduce, in silicone and/or translucent resin, the Crossa of the Aorta, the Thoracic Aorta, Abdominal Aorta and the Iliac Arteries.

(11) It should be noted that the Crossa of the Aorta is reproduced in silicone, the Thoracic Aorta, the Abdominal Aorta and the Iliac Arteries can be reproduced in silicone and/or in translucent resin.

(12) Equipment

(13) Simulator (1) was made of transparent and flexible material in order to allow visualization of the surgical material without the necessity of using radiation.

(14) The light source positioned under the model corresponds to the negatoscope (4) that has the function of helping the visualization of the surgical material during its navigation inside the model. The negatoscope (4) corresponds to a receptacle provided with a top surface in milky white translucent acrylic, illumination by means of lamps driven by electronic ballasts with independent lighting for each body through a switch and 110 or 220 V power supply. These types of models are routinely used in medical offices for X-ray film viewing.

(15) The Black Box (5) serves to comprise the camera (not shown) and connected it to the monitor (6), which is positioned on the model, allowing the training to be done under indirect vision, such as during surgery.

(16) In order to achieve the intended purposes, it is constituted by a trapezoidal-shaped passenger compartment and provided with side walls (12) with lower support brackets, bottom wall (13) and head (14), it being emphasized that the front face is open but provided with a retractable curtain (15), preferably in black color, for closure when it is in operation.

(17) The pulsed flow pump (3) has the purpose of reproducing the heart beats, it consists of electric motor (7), regulator (not shown) and water reservoir (8), as well as their electrical and hydraulic connections. It is connected to the printed aneurysm via connectors (2) and/or hoses, in such a way that the assembly formed by camera (not shown), monitor (6), computer (not shown) and 3D printer (not shown), in the physical form, are part of the Simulator Device (1) and in its operational form, of the technology involved in the System.

(18) The camera (not shown) corresponds to a camera of any brand and model on the market, and the same characteristics occur in relation to the monitor (6).

(19) System

(20) The Reproduction System of an aneurysm (A) by means of three-dimensional printing consists of four steps: image acquisition, image post-processing, three-dimensional printing and post-processing of the printed object.

(21) Image Acquisition

(22) Patients are submitted to an aorta angiotomography with incisions thickness of 1 mm in a 64-channel multislice tomograph. The data obtained are stored in DICOM (Digital Imaging and Communications in Medicine) format and available on CD or from the PACS (Pictures Archiving and Communication System) platform available on Hospitals computers.

(23) Image Post-Processing

(24) Data in DICOM is processed on dedicated workstations. Three-dimensional reconstructions are obtained from tools provided by TeraRecon iNtuition Unlimited software (Aquarius, TeraRecon, San Matteo, Calif., USA). The aorta is then isolated from other adjacent structures (organs, muscles, veins, etc.) and the DICOM file is converted to the STL (Surface Tesselation Language) format. The STL file is processed through the Mesh Mixer program (Mesh Mixer 2.8, Autodesk, Inc.) in order to make corrections to the mesh, soften the surface of the aorta and digitally create the desired thickness of the aortic wall (1.5 or 2 mm were the thicknesses used).

(25) Three-Dimensional Printing/Rapid Prototyping

(26) The 3D printer uses images from the STL files to reconstruct three-dimensional physical models by adding material layers. Several available technologies for this three-dimensional prototyping, as well as diverse materials like polymers or plastic films are used for the final printing of the physical model that is aimed.

(27) It was used the following printers: Connex 350 of Stratasys, Form 1+ of Formlabs and Sinterstation HiQ of 3D Systems.

(28) With these printers, 25 aneurysms were reproduced in 5 different models, as detailed in the table.

(29) Models 1 to 4 were printed directly as hollow models, made of translucent resins.

(30) Model 5 was produced through the silicon reproduction of a massive model printed in 3D. The silicone was cured on the printed object under rotation and heat, and then removed.

(31) Models 1, 3, 4 and 5 are flexible. Model 2 was made of rigid resin.

(32) TABLE-US-00002 TABLE 1 Produced Models from 3D printers Material Properties/Shore hardness/Ultimate Model Printer Material elongation/Tensile Force Model 1 Stratasys TangoPlus.sup.a 26-68 Connex 350 70-220%  .8-1.5 MPa Model 2 Stratasys Vero Clear.sup.b 83-86 Connex 350 0-25%  0-65 MPa Model 3 Stratasys TangoPlus and 57-63 Connex 350 Vero Clear.sup.c 5-85% .5-4.0 MPa Model 4 Formlabs Flexible Resin.sup.d 80-90 Form 1+  .sup.  0% 95-6.5 MPa   Model 5 3D System Duraform PA.sup.e 30 Sinterstation (Posterior .sup. 70% HQ Silicone.sup.f MPa reproduction) .sup.aPolyjet Material Rubber FLX930 .sup.bPolyjet material Standard Plastic RGD810 .sup.cPolyjet Digital Material Tanglo Plus + Vero-Clear Shore 60 .sup.dFormlabs Flexible Photopolymer Resin for Form 1+ .sup.ePowder thermoplastic material Duraform Poliamida for the SLS System .sup.fDow Corning Silastic MDX 4-4210
Post-Processing of the Printed Object

(33) Each technology demanded a different processing of the printed object,

(34) Model 1:

(35) Removal of support material (SUP705 non-toxic photopolymer support from Stratasys Ltd.) using water jet, repair of ruptures that occurred during removal of the support, exposure of the models to ultraviolet (UV) light to improve transparency. The iliac arteries were silicone reinforced.

(36) Model 2:

(37) Removal of the support material (SUP705 non-toxic photopolymer support from Stratasys Ltd.) using water jet, polishing the surface of the object to extract residues from the carrier material, exposure to UV light for 24 hours.

(38) Model 3:

(39) Removal of support material (SUP705 non-toxic gel-like photopolymer supported from Stratasys Ltd.) using water jet, and exposure to UV light for 24 hours.

(40) Model 4:

(41) During printing, the printer produces resin pillars to hold the object. These pillars were removed from the model. The FormH-print tray is small, so the models were printed in 2 or 3 parts, which were glued at the end by using flexible resin and UV light. The model was exposed to UV light for 48 hours to consolidate the curing of the material.

(42) Model 5:

(43) Silicone (Dow Corning Silastic MDX 4-4210 Biomedical Grade Elastomer) was applied to the surface of the solid aneurysm printed in 3D. It remained under rotation and heat for 24 hours to cure the material. At the end, the silicone was cut, removed from the massive model and restored.

CONCLUSIONS

(44) It is verified by everything that has been described and illustrated that it is a Patient-Specific Simulator of the Aorta and Reproduction System, which allows to improve the operative technique, to know the material and to anticipate possible difficulties of a surgery, reason why, it fits perfectly within the norms that govern the Patent of Invention, having to fill an important gap in the market, functioning perfectly well in subjective and objective analysis, well provides a platform for adjuvant training, deserving for what was exposed and as a consequence, the requested privilege.