![]() Procedure for manufacturing anatomical models and models obtained (Machine-translation by Google Tra
专利摘要:
Procedure for manufacturing anatomical models and models obtained comprising: - obtaining information through diagnostic imaging. - obtaining a computerized three-dimensional model of the anatomical structure. - and manufacture the following stages: - design of the mold (1) negative. - 3d printing of the mold (1) negative. - 3d printing of rigid parts (2) of internal elements that have been foreseen. - placing said pieces in the mold (1). - the mold (1) is closed and sealed. - soft material (3) is injected into the mold (1). - it is demold. The anatomical model (4) is a liver with hepato-biliary vasculature and tumors of rigid pieces (2) and hepatic parenchyma, of soft material (3), or is a mammary gland with a tumor and muscle tissue of rigid pieces (2), breast tissue of soft material (3) and outer lining (5) as skin. (Machine-translation by Google Translate, not legally binding) 公开号:ES2615034A1 申请号:ES201500800 申请日:2015-11-05 公开日:2017-06-05 发明作者:Dario GARCÍA CALDERÓN 申请人:Dario GARCÍA CALDERÓN; IPC主号:
专利说明:
MANUFACTURING PROCEDURE OF ANATOMIC MODELS AND MODELS OBTAINED OBJECT OF THE INVENTION The invention, as expressed in the statement of the present specification, refers to a method of manufacturing anatomical models and the models obtained, providing features, which will be described in detail below, which represent a novelty in the current state of the technique within its field of application. More particularly, the object of the invention focuses on a method of manufacturing anatomical models of human organs, or parts thereof, in particular soft organs, such as liver or breast models, which are useful in teaching and different disciplines of the medical sector, such as the planning and simulation of surgeries, incorporating notable innovations and advantages over current manufacturing procedures. A second aspect of the invention being the anatomical models obtained from said manufacturing process. FIELD OF APPLICATION OF THE INVENTION The field of application of the present invention is part of the medical sector, focusing particularly on the field of industry dedicated to the manufacture of anatomical models for teaching or other disciplines of the medical sector, such as planning and simulation of surgeries BACKGROUND OF THE INVENTION As is known, anatomical models are physical representations of different structures of the human body such as organs or limbs. They have application, among other fields, in teaching where they serve as an aid for the three-dimensional structural and functional understanding of the structures of the human body, and planning and / or simulation of surgical procedures that allow the surgeon to be trained in the procedure solving problems inherent to it. In the state of the art, it is known to manufacture standard anatomical models, that is, models that in no case correspond to a specific patient and which are manufactured by using molds. In document ES2523419A 1 a method of manufacturing specific anatomical models for each patient is described by means of a first stage, not considered inventive activity, which consists in the generation of a three-dimensional model of the structure from which the anatomical model is to be obtained. from a diagnosis by image of the patient and a second stage where the three-dimensional model is printed directly with a 3D printer. However, the direct printing of the piece limits the obtaining of soft organ models, since the available non-rigid 3D printing materials have hardness limitations and are expensive. In this way anatomical models of soft organs, such as liver or breast would not be possible with the real consistency of the organ, being only feasible to obtain them hard without the possibility of emulating surgical procedures of cut and suture, or with minimum levels of hardness of "shore A27 "which is not enough to emulate consistency and deformation of these organs. The scientific publication Zein, N. N. et al. Three-dimensional print of a liver for preoperative planning in living donorlivertransplantation. Uver Transpl. 19, 1304-1310 (2013) 3D print a liver using this procedure. Other scientific publications such as Valverde, 1. et al. 3D printed cardiovascular models for surgical planning in complex congenital heart diseases. Journal of Cardiovascular Magnetic Resonance 17, P196 (2015); Tam, M. D. B. S., Laycock, S. D., Brown, J. R. 1. & Jakeways, M. 3D printing of an aortic aneurysm to easily decision making and device selection for endovascular aneurysm repair in complex neck anatomy. J. Endovasc. Ther. 20, 863-867 (2013); Wang, J.-O. et al. Printed Threedimensional Anatomic Templates for Virtual Preoperative Planning Before Reconstruction of Old Pelvic Injuries: Initial Results. Chinese Medical Jouma / 128, 477 (2015) deal with 3D printing of different anatomical models. The objective of the present invention is, therefore, to develop an improved method of manufacturing anatomical molds to solve the previously described drawbacks, it should be noted that, the applicant is not aware of the existence of any other similar application method or invention that presents characteristics similar to those specifically presented here, as claimed. EXPLANATION OF THE INVENTION Thus, the method of manufacturing anatomical models that the invention proposes is configured as a remarkable novelty within its field of application, since, according to its implementation, the aforementioned objectives are satisfactorily achieved, the details characterizing it being conveniently set forth in the final claims that accompany the present description. In particular, what the invention advocates, as noted above, is a method of manufacturing anatomical models of soft organs, or parts thereof, in particular models of organs such as liver or breast, and, preferably , of specific patients, comprising the following essential stages: - Exploration using diagnostic imaging techniques, such as CT (Computed Axial Tomography) with or without vascular reconstruction, NMR (Nuclear Magnetic Resonance), Ultrasound, or similar technique of the anatomical structure from which the anatomical model is to be manufactured. - Use of specific medical image processing software that allows selecting (segmenting) the different elements of the anatomical structure of interest from the images obtained in the above-mentioned techniques and subsequently obtaining the three-dimensional computerized model of the anatomical structure, which is imported a. Stereolithography (.sU) or similar format, valid for 3D printing. - Manufacturing of the anatomical model set through 3D printing, contemplating: - First, the manufacture of the negative mold of the anatomical structure of interest, which is designed with a computer-aided design program (CAD). - Next, the manufacturing by 3D printing of pieces of rigid or semi-rigid material that constitute certain internal elements of the anatomical structure, according to the pre-established need in each case that it is necessary or not that they can be crossed with medical instruments, which They are placed inside the mold. - Subsequently, soft materials, such as silicones or silicone gels, are injected into the negative mold with the hard elements, after studying the consistency of the organ, to obtain one or more pieces of said soft material that conform to the external part of the anatomical model. - Finally, it is molded, obtaining the anatomical model of interest in which two types of elements are clearly distinguished, the internal elements made of rigid or semi-rigid pieces, preferably of opaque materials and differentiating colors, and external elements made of soft, preferably transparent, materials. allowing through them the vision of the internal elements and access to them with medical instruments. It is important to note that the process of the invention is particularly related to the manufacture of non-prosthetic parts, and in no case with those that are manufactured with biological material, since the purpose of the model obtained is not intended to be inserted inside the body, since its application, as noted above, is in teaching and different disciplines of testing or study of the medical sector. Thanks to these characteristics, health and teaching professionals are provided with personalized anatomical models to each patient economically and with more functionalities than current anatomical models, since they allow emulating surgical procedures. Other features and advantages of the manufacturing method object of the present invention will be apparent from the description of a preferred but not exclusive embodiment, which is illustrated by way of non-limiting example in the accompanying drawings. In any case, it is found that the described procedure represents an innovation of unknown characteristics until now for the purpose it is intended, reasons that together with its practical utility, provide it with sufficient grounds to obtain the privilege of exclusivity that is requested. DESCRIPTION OF THE DRAWINGS To complement the description that is being made and in order to help a better understanding of the characteristics of the invention, this descriptive report is attached, as an integral part thereof, of a set of drawings, in which for illustrative purposes and not limiting the following has been represented: Figure number 1. - It shows a schematic representation of the image of the three-dimensional reconstruction of the liver of a patient, obtained by means of specific software from diagnostic images, where the different parts of the organ are appreciated, and that constitutes one of the initial phases of the process object of the invention, in an example thereof for obtaining a liver model. Figure number 2. - It shows a schematic perspective view of the negative mold of the liver anatomical model shown in the preceding figure, including several of the internal elements thereof constructed with rigid material, said mold being represented only partially and openly, for show these elements in their pre-injection phase of the soft material. Figure number 3. - It shows a view similar to the previous one, also showing the open mold, in this case already with the soft material applied and dried, in the mold phase of the final piece. Figure number 4.- Shows a schematic representation of the anatomical model obtained as the final result of the procedure object of the invention, its configuration and the parts and elements it comprises being appreciated. Figure 5 shows a view of the representation of the three-dimensional reconstruction of the breast of a patient, and that constitutes one of the initial phases of the procedure object of the invention, in a new example thereof for obtaining a model anatomical breast. Figure number 6. - It shows another phase of the procedure where the negative mold is placed between supports and an internal element, in this case a tumor, is held by rods for the insertion of the soft material. and figure number 7.- Shows a perspective representation of the anatomical breast model piece obtained with the method of the invention. PREFERRED EMBODIMENT OF THE INVENTION In view of the aforementioned figures, and according to the numbering adopted, it can be seen in them two non-limiting examples of the manufacturing process of anatomical models of liver (A) and breast (8), which includes next: Example (A) for anatomical models of the Liver The method of manufacturing anatomical models of the liver includes, in the first stage, obtaining information about the patient's liver by means of an imaging diagnosis such as a CT (Computed Axial Tomography) with or without vascular reconstruction, NMR (Nuclear Magnetic Resonance ), Ultrasound, Cholangiography or similar technique. Then, in a second stage, for which specialized software has been developed that automatically selects (segments) different elements of the organ; specifically the following elements in the images obtained: hepatic parenchyma, hepato-biliary vasculature differentiating each of the elements and tumor (if any). It will be evident that other programs known to those skilled in the art, such as 3D-Doctor or 3D Slicer software, can also be used. Using these programs a three-dimensional computerized model of the entire organ is obtained, in this case the liver (a), as seen in Figure 1. Subsequently, in a third stage it is designed, with a computer-aided design program (CAD) such as FreeCAD or Blender, a negative mold (1) of the liver, that is, of the organ as a whole, including the hepato-biliary vasculature and tumors, using tools available in these programs. Preferably, the mold (1) is designed in several sections (1 a), as shown in Figure 2, to later facilitate its demolding. These sections (1a) have studs (1c) and complementary holes (1d) for mutual coupling. In addition, the mold shape design (1) with external recesses (1b) optimizes the amount of material used. A 3D printer, such as the Prusa i3, is then used to print the designed negative mold (1). The material used for printing can be any polymeric material commonly used for the manufacture of prototypes obtained from three-dimensional printing machines. In this embodiment, the material used is, for example, PLA (polylactic acid). Rigid parts (2) of the internal elements of the planned model are then printed in 3D, in the case of the liver, hepato-biliary vasculature and tumors. The material used can be any rigid material such as the previously used PLA or softer materials that have up to shore 27A as TANGO. The printer used for this purpose is a function of the material used. Then said rigid pieces (2) are placed the hepato-biliary vasculature and tumor in the negative mold (1), designed for such purpose as shown in Figure 2. Intrahepatic tumors, that is, those internal elements that are immersed in the organ, in this case the liver parenchyma and cannot be stuck in the mold (1), are placed in position by using rods (not shown) or by 3D printing of filaments in the hepatobiliary vasculature that connect with the tumor. And, before the insertion of the soft material (3) injected at a later stage, these supports or filaments are removed, leaving the tumors embedded in the soft material. Subsequently, a treatment of mold facilitator material such as petroleum jelly is applied to the internal surfaces of the mold and adhesives on the exposed surfaces of the rigid pieces, in this case of the hepato-biliary vasculature and tumors, to enhance the adhesion of these elements to the gel injected below. Subsequently, the negative mold (1) is closed and sealed with insulating material. It is then injected into the mold (1) with a soft material (3), preferably transparent, such as a silicone or silicone gel to create the external element of the organ, in this case the hepatic parenchyma. The injection volume is a function of the parenchyma volume of the three-dimensional computer model. Finally it is demoulded, being formed the anatomical piece or model (4) as shown in figure 3. Optionally, if the release is not viable due to the morphology of the liver or of the organ in question, the negative mold (1) is printed on soluble material such as ABS (acrylonitrile butadiene styrene). In this case, instead of unmolding, the mold (1) is immersed in the solvent of the material used, the piece being formed. In any case, the anatomical model (4) obtained is an organ, specifically a liver, which comprises internal elements, constituents of the hepato-biliary vasculature and tumors, consisting of rigid pieces (2) of PLA, and external elements, specifically the hepatic parenchyma, of soft (3) transparent material, of silicone gel or silicone. Example (B) for anatomical breast models. The method of manufacturing the anatomical models of mammary organs according to the invention comprises, in the first stage, obtaining information about the patient's breast by means of diagnostic imaging techniques such as a CT (Computed Axial Tomography), Mammography, NMR (Nuclear Magnetic Resonance), Ultrasound or similar technique. Then, in a second stage, through specialized software developed for this purpose, which automatically selects (segments) the different mammary elements of the image obtained: skin, breast fat tissue, breast fibroglandular tissue, muscle tissue, tumor (if any) ), vasculature and breast innervation. Segmented elements are a function of the diagnostic imaging technique used. It will be evident that other programs known to those skilled in the art, such as 3D-Doctor or 3D Slicer software, can also be used. In this way, a three-dimensional computerized model of the entire breast region is obtained. Figure number 5 shows a schematic representation of different views of the images of said three-dimensional models of the breast (b) that are obtained. Subsequently, in a third stage it is designed, with a computer-aided design program (CAD) such as FreeCAD or Blender, a negative mold (1) of the organ, in this case of the breast, using tools available in these programs. A 3D printer, such as Prusa i3, is then used to print the designed negative mold (1). The material used for printing can be any polymeric material commonly used for the manufacture of prototypes obtained from three-dimensional printing machines. In this embodiment, the material used is, for example, PLA (polylactic acid). A coating material (5), such as latex, is then applied on the surface of the mold to create the skin on the mold (1) as shown in Figure 6. The volume of material used is a function of the skin thickness in the three-dimensional model. In addition, prior to the application of said coating (5), several layers of rear mold release facilitating material such as petroleum jelly are applied to the surface of the mold (1). Then, if the presence of the fibroglandular tissue, vasculture and innervation in the final anatomical model is not necessary, the internal element is printed in 3D, in this case the tumor as a rigid piece (2) of the model to be made, and placed spatially inside the mold (1) by means of the use of rods (6) that will be removed before the cross-linking of the soft material (3) injected at a later stage. The printing material used can be any rigid material such as the previously used PLA or softer materials that have up to shore 27 A like those similar to the TANGO family rubber. The printer used for this purpose is a function of the material used. Subsequently, supports (7) are placed on the outside of the mold (1), as shown in Figure 6, so that, after the subsequent injection of soft material (3) that emulates the adipose tissue, it can be retained above the mold emulating the lower breast adipose tissue. The supports (7) can also be printed with the negative mold of the breast. Soft material (3) is then injected through the open part of the mold as silicone gels or silicones. The injection volume is a function of the volume of adipose tissue and muscle tissue of the three-dimensional computer model. Subsequently, the muscle tissue is printed in 3D, also as an internal element of the model, made with rigid pieces (2), and placed spatially on the soft material (3) not yet crosslinked. The printing material used can be any rigid material such as the previously used PLA or softer materials that have up to shore 27A as TANGO. The printer used for this purpose is a function of the material used. Finally, it is molded, forming an anatomical piece or model (4). As in the previous example, optionally, if the mold is not viable given the morphology of the breast, the mold (1) is printed on soluble material such as ABS (acrylonitrile butadiene styrene), in which case, instead of unmolding, immerse the mold in the solvent of the material used, forming the piece. If the presence of additional internal elements (8) is necessary in the final anatomical model, for example of the fibroglandular tissue, vasculature and innervation, these elements are printed in 3D with soluble material such as ABS that is water soluble and placed in the mold using adhesives for such purpose. Subsequently, the manufacturing process is continued by injecting the soft material (3) such as silicone gel or silicone. Once the soft material has been crosslinked, the solvent of the soluble material is injected with a fine needle in the areas where these elements are found, the material dissolving and leaving the corresponding holes that are filled with silicones or silicone gels of different colors. E These elements can also be printed on any rigid material such as the previously used PLA or softer materials that have up to shore 27 A as TANGO. They are subsequently placed in the mold and the manufacturing process continues with 3D printing of the tumor. Thus, in this example, the anatomical model (4) obtained from an organ is a mammary gland comprising internal elements consisting of a tumor and muscle tissue consisting of one or more rigid pieces (2) of PLA, additional internal elements (8) colored silicone representing fibroglandular tissue, vasculature and innervation, soft tissue breast tissue (3) made of transparent silicone or silicone gel and an outer coating (5) of latex, silicones or polyurethanes that represents the skin. Describes sufficiently the nature of the present invention, as well as the manner of 5 to put it into practice, it is not considered necessary to extend its explanation so that any expert in the field understands its scope and the advantages that derive from it, stating that, within its essentiality, it can be implemented in others embodiments that differ in detail from those indicated by way of example, and which will also achieve the protection that is sought as long as it is not altered, change 10 the fundamental.
权利要求:
Claims (18) [1] 1.-PROCEDURE OF MANUFACTURE OF ANATOMICAL MODELS of organs orparts thereof of a given patient, such as liver or breast,applicable for use in teaching and medical disciplines, such as planning andsurgery simulation, which includes:-Getting information of the anatomical structure of the organ, using techniques ofdiagnostic imaging, such as CT (Computed Axial Tomography) with or withoutvascular reconstruction, NMR (Nuclear Magnetic Resonance), Ultrasound.-Using medical image processing software to select(segment) the different elements of the anatomical structure of interest from theImages obtained and obtaining a three-dimensional computerized model of the structureanatomical, which is imported into a valid format for 3D printing.-And manufacture of the anatomical model through 3D printingis characterized in that said manufacturing by 3D printing comprises thefollowing stages:-Design, with a computer-aided design program (CAD), of a negative mold (1)of the whole organ.-Printing, with 3D printer, of the negative mold (1) designed.-Printing, with 3D printer of rigid parts (2) corresponding to internal elementsof the planned model.-Placement of said rigid pieces (2) in the negative mold (1).-Application of a treatment of release facilitator material such as petroleum jelly onthe internal surfaces of the mold (1) and glues on the exposed surfaces of therigid pieces (2).-The negative mold (1) is closed and sealed with insulating material.-It is injected into the mold (1) soft material (3).-It is demoulded, being formed the anatomical piece or model (4). [2] 2.-MANUFACTURING PROCEDURE OF ANATOMICAL MODELS, according to theclaim 1, characterized in that the soft material (3) that is injected is gelsilicone or silicone [3] 3.-MANUFACTURING PROCEDURE OF ANATOMICAL MODELS, according to the claim 1 or 2, characterized in that the mold (1) is designed in several sections (1 a). [4] 4.-MANUFACTURING PROCEDURE OF ANATOMICAL MODELS, according to any of claims 1 to 3, characterized in that the shape of the mold (1) has external holes (1b). [5] 5.-MANUFACTURING PROCEDURE OF ANATOMIC MODELS, according to any of claims 1 to 4, characterized in that the material used for printing the mold (1) is PLA (polylactic acid). [6] 6.-MANUFACTURING PROCEDURE OF ANATOMIC MODELS, according to claims 1 or 2, characterized in that the material in which the negative mold is printed (1) is soluble and, to demold, the mold (1) is immersed in the solvent of the used material. [7] 7.-ANATOMIC MODEL MANUFACTURING PROCEDURE, according to claim 6, characterized in that the material in which the negative mold is printed (1) is ABS (acrylonitrile butadiene styrene). [8] 8.-MANUFACTURING PROCEDURE OF ANATOMIC MODELS, according to any of claims 1 to 7, characterized in that the material used for 3D printing of the rigid parts (2) of the internal elements of the model is PLA. [9] 9.-MANUFACTURING PROCEDURE OF ANATOMICAL MODELS, according to any of claims 1 to 8, characterized in that the soft material (3) is transparent. [10] 10.-MANUFACTURING PROCEDURE OF ANATOMIC MODELS, according to any of claims 1 to 9, characterized in that those internal elements formed by rigid pieces (2) that are immersed in the organ and cannot be glued in the mold (1), they are placed in their position by means of the use of rods, and, before the insertion of the soft material (3) injected at a later stage, they are eliminated, being embedded in the soft material. [11] 11.-MANUFACTURING PROCEDURE OF ANATOMICAL MODELS, according to any of claims 1 to 9, characterized in that those internal elements formed by rigid pieces (2) that are immersed in the organ and cannot be glued in the mold (1), they are placed in their position by means of 3D filament printing and, before the insertion of the soft material (3) injected at a later stage, they are eliminated being embedded in the soft material. [12] 12.-MANUFACTURING PROCEDURE OF ANATOMIC MODELS, according to any of claims 1 to 11, characterized in that, when the organ has skin, such as a mammary gland, before placing the rigid pieces (2), it is applied on the surface of the mold (1) a coating material (5) and prior to the application of said coating (5) several layers of material facilitating the subsequent mold, such as petroleum jelly, are applied to the surface of the mold (1). [13] 13.-MANUFACTURING PROCEDURE OF ANATOMICAL MODELS, according to claim 12, characterized in that the coating material (5) is latex, silicones or polyurethanes. [14] 14.-MANUFACTURING PROCEDURE OF ANATOMIC MODELS, according to any of claims 1 to 13, characterized in that, when the organ is a mammary gland, supports (7) are placed on the outside of the mold (1), prior to the injection of the soft material (3), with the purpose that, after the subsequent injection of soft material (3) that emulates the adipose tissue. [15] 15.-MANUFACTURING PROCEDURE OF ANATOMICAL MODELS, according to claim 14, characterized in that the supports (7) are printed with the negative mold (1) of the breast. [16] 16.-MANUFACTURING PROCEDURE OF ANATOMICAL MODELS, according to any of claims 1 to 15, characterized in that when the presence of additional internal elements (8) in the final anatomical model is necessary, these elements are printed in 3D with water soluble material and they are placed in the mold (1) using adhesives. Subsequently, the manufacturing process is continued by injecting the soft material (3) and, once crosslinked, the solvent of the soluble material is injected with a fine needle in the areas where these elements are located leaving the corresponding holes which are filled with silicones or silicone gels of different colors. [17] 17. ANATOMIC MODEL, obtained by a procedure as described in any of claims 1 to 11, characterized in that it is a liver that 5 comprises internal elements, constituents of the hepato-biliary vasculature and tumors, consisting of rigid pieces (2), and external elements, specifically the hepatic parenchyma, of soft material (3). [18] 18.-ANATOMIC MODEL, obtained by a procedure like the one described in Any one of claims 1 to 16, characterized in that it is a mammary gland comprising internal elements consisting of a tumor and muscle tissue, consisting of one or more rigid pieces (2), soft tissue breast tissue (3) and an external lining (5) that represents the skin. 19. ANATOMIC MODEL, according to claim 18, characterized in that it comprises additional internal elements (8) representing fibroglandular tissue, vasculature and innervation. FIG. one FIG. 2 FIG. 3 FIG. 4 b b I - ~ L L --1L ~ I .. n t \ 1: " L , i ~ r \ r I 7 ~ I, J, - ' ~ = d . I " I -1" ./" ./" ~ f: b ~ t '--- . FIG. 5 76 FIG. 7 FIG. 6
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同族专利:
公开号 | 公开日 WO2017077146A1|2017-05-11| ES2615034B1|2018-08-16| US20180350266A1|2018-12-06| MX2018005740A|2018-11-12|
引用文献:
公开号 | 申请日 | 公开日 | 申请人 | 专利标题 EP3675083A1|2018-12-31|2020-07-01|Cella Medical Solutions, S.L.|Process for manufacturing anatomical models|JP5236103B1|2012-07-13|2013-07-17|株式会社ジェイ・エム・シー|Organ model manufacturing method, organ model manufacturing mold, and organ model| US20150250934A1|2014-03-07|2015-09-10|James K. Min|Subject-Specific Artificial Organs and Methods for Making the Same| JP6591997B2|2014-03-13|2019-10-16|アプライド メディカル リソーシーズ コーポレイション|A new first entry model for surgical imitation|US11234893B2|2019-02-27|2022-02-01|Steven A. Shubin, Sr.|Method and system of creating a replica of an anatomical structure| KR102260277B1|2019-10-08|2021-06-03|재단법인 아산사회복지재단|Phantom manufacturing method for airway intubation|
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申请号 | 申请日 | 专利标题 ES201500800A|ES2615034B1|2015-11-05|2015-11-05|Manufacturing procedure of anatomical models and models obtained|ES201500800A| ES2615034B1|2015-11-05|2015-11-05|Manufacturing procedure of anatomical models and models obtained| US15/774,179| US20180350266A1|2015-11-05|2016-11-04|Method for producing anatomical models and models obtained| PCT/ES2016/000123| WO2017077146A1|2015-11-05|2016-11-04|Method for producing anatomical models and models obtained| MX2018005740A| MX2018005740A|2015-11-05|2016-11-04|Method for producing anatomical models and models obtained.| 相关专利
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