Vacuum sealing 3D printer

Abstract

A vacuum-sealed 3D printer comprising: at least one vacuum chamber defining at least one operating area, the at least one vacuum chamber being dimensioned and shaped sealingly to enclose: at least one build plate movable along at least one axis; and at least one printhead movable along at least one axis, comprising at least one printing nozzle for depositing at least one curable polymer on the at least one build plate to form at least one 3D object; and at least one vacuum pump in fluid-tight communication with the at least one vacuum chamber such that when the vacuum pump is activated, a vacuum is applied within the vacuum chamber to remove bubbles generated during deposition of the at least one curable polymer. When the at least one vacuum pump does not work, no vacuum is applied in the at least one vacuum chamber; and preventing the at least one curable polymer from being extruded from the at least one printing nozzle to form the at least one 3D object.

Description

Technical Field

[0001] The utility model relates to a method for manufacturing a heat-curable polymer object such as an implant. Background Art

[0002] Medical implants that are customized to specific patients and address clinical needs have become a reality in recent years, and customized implants are an excellent clinical solution for many patients.

[0003] Silicone is well suited for use in medical implants due to its lack of reactivity with the human body and the fact that it can be easily molded into any desired shape and retains its shape for a long time.

[0004] Silicone implants are made of medical grade silicone (FDA / CE approved, e.g. NUSIL) with different properties (e.g., Shore hardness levels) and are typically manufactured using large-scale methods such as injection molding, compression molding, or rotational molding. These methods require the design and manufacture of dedicated molds for each product and certification of the molding process. This is a lengthy and expensive process, and therefore, it is not suitable for customized implants.

[0005] Custom silicone implants are typically manufactured by manually carving a block of silicone; the manufacturing is usually performed by the surgeon using a knife. This method is relatively inexpensive but highly inaccurate and surgery-specific, and therefore the surgical results of surgeries utilizing carved block implants vary in quality.

[0006] It would therefore be desirable and highly advantageous to have an inexpensive and relatively rapid method for manufacturing highly precise and personalized silicone implants. Utility Model Content

[0007] The purpose of the utility model is to provide a vacuum sealed 3D printer, the vacuum sealed 3D printer comprising:

[0008] at least one vacuum chamber defining at least one operating area, the at least one vacuum chamber being sized and shaped to sealingly enclose:

[0009] (i) at least one build plate, the at least one build plate being movable along at least one axis; and

[0010] (ii) at least one print head, the at least one print head being movable along at least one axis, the at least one print head comprising at least one print nozzle for depositing at least one curable polymer on the at least one build plate to form at least one 3D object;

[0011] At least one vacuum pump is fluidically connected to the at least one vacuum chamber so that when the vacuum pump is activated, vacuum is applied in the vacuum chamber to remove bubbles generated during the deposition of the at least one curable polymer, characterized in that when the at least one vacuum pump is inoperative, no vacuum is applied in the at least one vacuum chamber; and the at least one curable polymer is prevented from being squeezed out of the at least one printing nozzle to form the at least one 3D object.

[0012] Another object of the present invention is to provide a vacuum 3D printer as defined above, wherein the at least one vacuum chamber comprises at least one door, the at least one door being hingedly connected to the at least one vacuum chamber.

[0013] Another object of the present invention is to provide a vacuum 3D printer as defined above, comprising at least one sealing member, the at least one sealing member being disposed along the periphery of the at least one vacuum chamber.

[0014] Another object of the present invention is to provide a vacuum 3D printer as defined above, wherein when the at least one door is closed, the at least one vacuum chamber is fluid-tightly sealed.

[0015] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein said at least one curable polymer is extruded from said at least one printing nozzle.

[0016] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein the at least two curable polymers are extruded from the at least one printing nozzle.

[0017] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein the at least two curable polymers are extruded in a substantially constant quantitative ratio relative to each other or in a variable quantitative ratio relative to each other.

[0018] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein, when the at least one vacuum pump is activated, a vacuum is applied within the at least one vacuum chamber; and the at least one curable polymer is extruded from the at least one printing nozzle.

[0019] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein the at least one curable polymer is contained in at least one container.

[0020] Another object of the present invention is to provide a vacuum-sealed 3D printer as defined above, wherein the at least one container comprises at least one valve, the at least one valve being adapted to facilitate extraction of the curable polymer from the at least one container when opened; and the at least one valve being adapted to prevent extraction of the curable polymer from the at least one container when closed.

[0021] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein when the at least one vacuum pump is activated, a vacuum is applied within the at least one vacuum chamber, the valve opens to facilitate the entry of air into the at least one container and facilitates the extraction of the curable polymer from the at least one container.

[0022] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein when the at least one vacuum pump is inoperative, the valve is closed to prevent air from entering the at least one container and to prevent the curable polymer from being extracted from the at least one container.

[0023] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein the applied vacuum facilitates the removal of any trapped air bubbles in the extruded curable polymer.

[0024] Another object of the present invention is to provide a vacuum-sealed 3D printer as defined above, further comprising at least one vibration actuator, the at least one vibration actuator being arranged to provide vibration motion to the at least one building plate, the at least one print head and / or the at least one printing nozzle.

[0025] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein the vibration actuator is an ultrasonic transducer or any motorized device capable of applying vibration.

[0026] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein said vibration facilitates the removal of any trapped air bubbles in the extruded curable polymer.

[0027] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, further comprising at least one vibration actuator, wherein the at least one vibration actuator is arranged to provide a vibration movement to the at least one print head and / or the at least one print nozzle in a direction selected from x, y, z and any combination thereof.

[0028] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein the vibration actuator is an ultrasonic transducer or any motorized device capable of applying vibration.

[0029] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein said vibration facilitates the removal of any trapped air bubbles in the extruded curable polymer.

[0030] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein the at least one print head and the at least one building plate are arranged to translate relative to each other.

[0031] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein the at least one curable polymer is provided in a form selected from the group consisting of powder, liquid, gel and any combination thereof.

[0032] Another object of the present invention is to provide a vacuum-sealed 3D printer as defined above, wherein each printing nozzle is in communication with at least one feed line.

[0033] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein each printing nozzle is in communication with a plurality of feed lines.

[0034] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein each feed line is adapted to provide a different type of curable polymer to the printing nozzle.

[0035] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein each printing nozzle additionally comprises at least one mixer adapted to mix different types of curable polymers prior to extrusion from said printing nozzle.

[0036] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein the at least one print head is formed as a swivel plate.

[0037] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein the print head comprises at least one opening, so that once the at least one printing nozzle is aligned with the at least one opening, only the at least one curable polymer is extruded from the at least one printing nozzle.

[0038] Another object of the present invention is to provide a vacuum-sealed 3D printer as defined above, wherein the at least one print head is electrically connected to at least one stepper motor or servo motor, and the at least one stepper motor or the servo motor is suitable for rotating the at least one print head so that at each movement, one of the at least one print nozzles is aligned with the opening to facilitate extrusion of the at least one curable polymer.

[0039] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, further comprising a processor, which controls the position of the at least one print head and the at least one print nozzle on the operating area during the formation of the 3D object.

[0040] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein the processor is adapted to control at least one of the printing nozzles and the flow rate of the at least one curable polymer flowing therethrough.

[0041] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein at least one selected from the group consisting of the at least one print head and the at least one print nozzle is single use.

[0042] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein the at least one print head comprises at least one cleaning element, the at least one cleaning element being suitable for wiping and cleaning the at least one print nozzle.

[0043] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein said at least one curable polymer is silicon.

[0044] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein the at least one curable polymer is characterized by a viscosity lower than 10,000 cPs, a curing time longer than 20 minutes, and any combination thereof.

[0045] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein at least one of the at least one printing nozzles is suitable for at least one additive manufacturing of an extrusion mold; and further wherein the mold is a support structure for the 3D object.

[0046] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, further comprising at least one heating element for heating the polymer in the mold.

[0047] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, further comprising a first reservoir for storing a soluble material for additive manufacturing of the mold.

[0048] Another object of the present invention is to provide a vacuum-sealed 3D printer as defined above, further comprising at least one additional reservoir for storing a liquid component of the heat-curable polymer.

[0049] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein the at least one curable polymer is a polymer selected from the group consisting of medical grade silicone, any long-term implant and any combination thereof.

[0050] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein the heating element is positioned close to or in contact with at least one of the at least one printing nozzle.

[0051] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein the print head comprises at least one tray, and the at least one tray is placed under the at least one printing nozzle; wherein at least one of the following is true: (a) the at least one tray is tilted to facilitate the collection of any unprinted curable polymer; (b) the at least one tray is suitable for preventing any unwanted deposition of the at least one curable polymer on the at least one building plate; and any combination thereof.

[0052] Another object of the present invention is to provide a vacuum sealed 3D printer as defined above, wherein the at least one tray comprises at least one opening, so that when the at least one printing nozzle is aligned with the at least one opening, the deposition of the at least one curable polymer on the at least one building plate is promoted.

[0053] Another object of the utility model is to provide a vacuum sealed 3D printing method, comprising the following steps:

[0054] (a) providing at least one vacuum chamber defining at least one operating area, the at least one vacuum chamber being sized and shaped to sealingly enclose:

[0055] (i) at least one building plate

[0056] (ii) at least one print head, the at least one print head comprising at least one print nozzle, the at least one print nozzle for depositing at least one curable polymer on the at least one build plate to form at least one 3D object;

[0057] (b) placing at least one vacuum pump in fluid-tight communication with the at least one vacuum chamber;

[0058] (c) activating the vacuum pump to apply a vacuum within the vacuum chamber.

[0059] It is another object of the present invention to provide the method as defined above, wherein the at least one vacuum chamber comprises at least one door, the at least one door being hingedly connected to the at least one vacuum chamber.

[0060] Another object of the present invention is to provide a method as defined above, comprising at least one sealing member disposed along a periphery of said at least one vacuum chamber.

[0061] It is another object of the present invention to provide a method as defined above, wherein said at least one vacuum chamber is fluid-tightly sealed when said at least one door is closed.

[0062] It is another object of the present invention to provide a method as defined above, wherein said at least one curable polymer is extruded from said at least one printing nozzle.

[0063] Another object of the present invention is to provide a method as defined above, wherein said at least two curable polymers are extruded from said at least one printing nozzle.

[0064] Another object of the present invention is to provide a method as defined above, wherein said at least two curable polymers are extruded in a substantially constant quantitative ratio relative to each other or in a varying quantitative ratio relative to each other.

[0065] Another object of the present invention is to provide a method as defined above, wherein, when the at least one vacuum pump is inoperative, no vacuum is applied in the at least one vacuum chamber; and, the at least one curable polymer is prevented from being extruded from the at least one printing nozzle to form the at least one 3D object.

[0066] Another object of the present invention is to provide a method as defined above, wherein, when said at least one vacuum pump is activated, a vacuum is applied within said at least one vacuum chamber; and said at least one curable polymer is extruded from said at least one printing nozzle.

[0067] It is another object of the present invention to provide a method as defined above, wherein the at least one curable polymer is contained in at least one container.

[0068] Another object of the present invention is to provide a method as defined above, wherein said at least one container comprises at least one valve adapted to facilitate extraction of said curable polymer therefrom when opened; and to prevent extraction of said curable polymer therefrom when closed.

[0069] Another object of the present invention is to provide a method as defined above, wherein when said at least one vacuum pump is activated, a vacuum is applied within said at least one vacuum chamber, said valve opens to facilitate entry of air into said at least one container and extraction of said curable polymer therefrom.

[0070] Another object of the present invention is to provide a method as defined above, wherein when said at least one vacuum pump is inoperative, said valve is closed to prevent air from entering said at least one container and extracting said curable polymer therefrom.

[0071] It is another object of the present invention to provide a method as defined above, wherein said applied vacuum facilitates the removal of any trapped air bubbles in the extruded curable polymer.

[0072] Another object of the present invention is to provide a method as defined above, further comprising at least one vibration actuator arranged to provide a vibration motion to the at least one building plate in a direction selected from x, y, z and any combination thereof.

[0073] Another object of the present invention is to provide a method as defined above, wherein said vibration actuator is an ultrasonic transducer or any motorized device capable of imparting vibrations.

[0074] It is another object of the present invention to provide a method as defined above, wherein said vibration facilitates the removal of any trapped air bubbles in the extruded curable polymer.

[0075] Another object of the present invention is to provide a method as defined above, further comprising at least one vibration actuator, wherein the at least one vibration actuator is arranged to provide vibration movement to the at least one print head and / or the at least one print nozzle in a direction selected from x, y, z and any combination thereof.

[0076] Another object of the present invention is to provide a method as defined above, wherein said vibration actuator is an ultrasonic transducer or any motorized device capable of imparting vibrations.

[0077] It is another object of the present invention to provide a method as defined above, wherein said vibration facilitates the removal of any trapped air bubbles in the extruded curable polymer.

[0078] It is another object of the present invention to provide the method as defined above, wherein said at least one print head and said at least one building plate are arranged to translate relative to each other.

[0079] Another object of the present invention is to provide a method as defined above, wherein the at least one curable polymer is provided in a form selected from the group consisting of powder, liquid, gel and any combination thereof.

[0080] It is another object of the present invention to provide a method as defined above, wherein each printing nozzle is in communication with at least one feed line.

[0081] It is another object of the present invention to provide a method as defined above, wherein each print nozzle is in communication with a plurality of feed lines.

[0082] It is another object of the present invention to provide a method as defined above, wherein each feed line is adapted to provide a different type of curable polymer to said printing nozzle.

[0083] It is another object of the present invention to provide a method as defined above, wherein each printing nozzle additionally comprises at least one mixer adapted to mix different types of curable polymers prior to extrusion from said printing nozzle.

[0084] Another object of the present invention is to provide a method as defined above, wherein the at least one print head is in the shape of a swivel plate.

[0085] Another object of the present invention is to provide a method as defined above, wherein the print head comprises at least one opening, such that once the at least one printing nozzle is aligned with the at least one opening, only the at least one curable polymer is extruded from the at least one printing nozzle.

[0086] Another object of the present invention is to provide a method as defined above, wherein the at least one print head is electrically connected to at least one stepper motor or servo motor, and the at least one stepper motor or the servo motor is suitable for rotating the at least one print head so that at each movement, one of the at least one print nozzles is aligned with the opening to facilitate extrusion of the at least one curable polymer.

[0087] Another object of the present invention is to provide a method as defined above, further comprising a processor for controlling the position of said at least one print head and said at least one print nozzle on said operating area during forming of said 3D object.

[0088] Another object of the present invention is to provide a method as defined above, wherein said processor is adapted to control at least one of said printing nozzles and a flow rate of said at least one curable polymer flowing therethrough.

[0089] It is another object of the present invention to provide a method as defined above, wherein at least one selected from the group consisting of: said at least one print head, said at least one print nozzle is single use.

[0090] Another object of the present invention is to provide a method as defined above, wherein the at least one print head comprises at least one cleaning element, the at least one cleaning element being adapted to wipe clean the at least one print nozzle.

[0091] It is another object of the present invention to provide a method as defined above, wherein said at least one curable polymer is silicon.

[0092] It is another object of the present invention to provide a method as defined above, wherein the at least one curable polymer is characterized by a viscosity lower than 10,000 cPs, a curing time longer than 20 minutes, and any combination thereof.

[0093] Another object of the present invention is to provide a method as defined above, wherein at least one of the at least one printing nozzles is suitable for at least one additive manufacturing of an extrusion die; further wherein the die is a support structure for the 3D object.

[0094] Another object of the present invention is to provide a method as defined above, further comprising at least one heating element for heating said polymer in said mould.

[0095] Another object of the present invention is to provide a method as defined above, further comprising a first reservoir for storing a dissolvable material for additive manufacturing of the mold or skeleton support structure.

[0096] Another object of the present invention is to provide a method as defined above, further comprising at least one additional reservoir for storing a liquid component of the heat-curable polymer.

[0097] It is another object of the present invention to provide a method as defined above, wherein said heat curable polymer is selected from the group consisting of medical grade silicone, any long-term implant and any combination thereof.

[0098] It is another object of the present invention to provide a method as defined above, wherein said heating element is positioned close to or in contact with at least one of said at least one printing nozzle.

[0099] Another object of the present invention is to provide a method as defined above, wherein the print head comprises at least one tray, and the at least one tray is placed under the at least one printing nozzle; wherein at least one of the following is true: (a) the at least one tray is tilted to facilitate the collection of any unprinted curable polymer; (b) the at least one tray is suitable for preventing any unwanted deposition of the at least one curable polymer on the at least one building plate; and any combination thereof.

[0100] Another object of the present invention is to provide a method as defined above, wherein the at least one tray comprises at least one opening, such that when the at least one printing nozzle is aligned with the at least one opening, deposition of the at least one curable polymer on the at least one building plate is facilitated.

[0101] It is another object of the present invention to provide a method as defined above, additionally comprising the step of manufacturing a portion of the mould using additive manufacturing.

[0102] Another object of the present invention is to provide a method as defined above, additionally comprising the step of filling said portion of said mould with a heat curable polymer.

[0103] Another object of the present invention is to provide a method as defined above, additionally comprising the step of heating at least a portion of said curable polymer.

[0104] It is another object of the present invention to provide a method as defined above, wherein said heating is performed at preselected locations to provide mechanical support to said at least one 3D object without the need for printing dissolved support additives.

[0105] It is another object of the present invention to provide a method as defined above, wherein repeating said steps (a)-(c) results in manufacturing said at least one 3D object.

[0106] Another object of the present invention is to provide a method as defined above, wherein said steps are performed simultaneously.

[0107] It is another object of the present invention to provide the method as defined above, wherein the at least one 3D object is a medical implant.

[0108] It is another object of the present invention to provide a method as defined above, wherein the mold is made of a dissolvable material.

[0109] Finally, the present invention provides a method as defined above, wherein said dissolvable material is selected from the group consisting of high impact polystyrene (HIPS) or polyvinyl alcohol (PVA) or any other dissolvable element.

[0110] According to one aspect of the present invention, a method for manufacturing an object from a heat-curable polymer is provided, comprising: (a) using additive manufacturing to manufacture a portion of a mold; (b) filling a portion of the mold with a heat-curable polymer; (c) heating the polymer; and repeating steps (a)-(c) to manufacture the object.

[0111] According to an embodiment of the present invention, the heating is performed at preselected locations to provide mechanical support to the at least one 3D object without the need for printing dissolved support additives.

[0112] According to an embodiment of the present invention, steps (a) and (b) are performed simultaneously.

[0113] According to an embodiment of the present invention, the heat curable polymer is selected from the group consisting of medical grade silicone, any long-term implant, and any combination thereof.

[0114] According to an embodiment of the present invention, the object is a medical implant.

[0115] According to an embodiment of the present invention, steps (b) and (c) are performed simultaneously.

[0116] According to an embodiment of the present invention, step (c) is performed using a heated polymer delivery nozzle.

[0117] According to an embodiment of the present invention, step (a) is performed using 3D printing.

[0118] According to an embodiment of the present invention, the mold is made of a dissolvable material.

[0119] According to an embodiment of the present invention, the dissolvable material may be high impact polystyrene (HIPS) or polyvinyl alcohol (PVA) or any other dissolvable element.

[0120] According to an embodiment of the present invention, (a) and (b) are performed using side-by-side printing nozzles.

[0121] According to another aspect of the present invention, a system for manufacturing an object from a heat-curable polymer is provided, the system comprising: (a) a first nozzle, the first nozzle being configured for additive manufacturing of a mold (the mold may be, for example, a support structure for a printed 3D object); (b) a second nozzle, the second nozzle being used to fill the mold with a heat-curable polymer; and (c) a heating element, the heating element being used to heat the polymer in the mold.

[0122] According to an embodiment of the present invention, the heating is performed at preselected locations to provide mechanical support to the at least one 3D object without the need for printing dissolved support additives.

[0123] According to an embodiment of the present invention, the first nozzle and the second nozzle are side-by-side printing nozzles.

[0124] According to an embodiment of the present invention, the system further comprises a first reservoir, wherein the first reservoir is used to store a soluble material for additive manufacturing of the mold.

[0125] According to an embodiment of the present invention, the system further comprises at least one additional reservoir, wherein the at least one additional reservoir is used to store a liquid component of the heat-curable polymer.

[0126] According to an embodiment of the present invention, the heat-curable polymer is selected from the group consisting of medical grade silicone, any long-term implant and any combination thereof.

[0127] According to an embodiment of the present invention, the heating element is positioned close to or in contact with the second nozzle.

[0128] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those of ordinary skill in the art to which the utility model belongs. Although methods and materials similar or equivalent to the methods and materials described herein can be used in the practice or testing of the utility model, suitable methods and materials are described below. In the event of a conflict, the patent specification (including definitions) shall prevail. In addition, materials, methods and examples are illustrative only and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0129] The present invention is described herein by way of example only with reference to the accompanying drawings:

[0130] Figure 1 is a flow chart outlining a manufacturing process according to one embodiment of the present invention.

[0131] FIG. 2A to FIG. 2B Schematically shows a dual nozzle print head ( Figure 2A ) and two independent print heads ( Figure 2B ) of the system configuration.

[0132] Figure 3 A silicone implant fabricated in a perishable mold is shown.

[0133] Figure 4 Another embodiment of the present invention is shown, in which a vibration plate is used.

[0134] Figure 5 Figures 8 to 8 show another embodiment of the present invention, in which a unique print head / nozzle is used.

[0135] Figure 9a to Figure 9bAnother embodiment of the present invention is shown, in which a vacuum chamber is utilized. DETAILED DESCRIPTION

[0136] The utility model provides a method for manufacturing a customized implant from a medical-grade heat-curable polymer. Specifically, the utility model can be used to manufacture a customized implant from implantable (and certified) medical-grade silicone.

[0137] The principles and operations of the present invention may be better understood with reference to the drawings and accompanying descriptions.

[0138] Before explaining at least one embodiment of the utility model in detail, it should be understood that the application of the utility model is not limited to the details of the construction and arrangement of the components set forth in the following description or shown in the accompanying drawings. The utility model can have other embodiments or be practiced or executed in various ways. Moreover, it should be understood that the words and terms used herein are for descriptive purposes and should not be considered as limiting.

[0139] Silicone elastomers are formed by crosslinking silicone polymer chains via an addition reaction between the vinyl functional groups of the vinyl silicone polymer and the silicon hydride of a crosslinking agent containing SiH functional groups. This reaction requires the presence of a catalyst, typically an organometallic complex of platinum. Medical grade silicone implants are manufactured from certified silicone components (raw materials) and a certified manufacturing process by heat curing the mixed components under the manufacturer's specified temperature and curing time parameters.

[0140] To meet FDA / CE regulations, implant materials must fully pass inspection and validation tests, including biocompatibility testing and clinical testing as defined by the regulatory agencies (FDA / CE).

[0141] Raw silicone cannot be easily used in additive manufacturing methods because the relatively long curing time makes it unsuitable for rapid manufacturing.

[0142] Additive manufacturing of silicone components utilizes chemically modified silicones to achieve rapid polymerization suitable for 3D printing.

[0143] Any modification of the original silicone renders the product manufactured therefrom unsuitable for use as an implant, since the addition of components to the raw material redefines the silicone product as a new material that must be recertified by regulatory agencies (including certification of a specific manufacturing process).

[0144] Therefore, while the modified silicone can be 3D printed, the resulting product does not meet regulatory guidelines and therefore cannot be used to manufacture medical implants.

[0145] While reducing the present invention to practice, the inventors have devised a method of making an implant from a medically approved heat curable polymer for implant devices, such as silicone.

[0146] Therefore, according to one aspect of the present invention, there is provided a method of manufacturing an object from a heat curable polymer.

[0147] The heat curable polymer may be any single or multi-component polymer and is preferably approved for medical use or for use in the food and health industry. Examples of such polymers include silicone (NUSIL 48XX), polychloroprene (CR) / chloroprene rubber, ethylene propylene diene monomer (EPDM), fluoroelastomer (FKM) / Viton, and acrylic rubber (ACM).

[0148] The object may be a medical implant used, for example, in plastic surgery or reconstructive / aesthetic / corrective surgery. Such implants may be, for example, breast implants, sternal implants, facial and ear reconstruction implants, stents, indwelling catheters, etc.

[0149] The method of the utility model is performed by using additive manufacturing to make a part of the mold and filling the part with a heat-curable polymer. The polymer is then heated to a solid or semi-solid state, and the steps of mold making and polymer filling and curing are repeated one or more times until the object is completely manufactured. The object can then be released from the mold by, for example, dissolving the mold material.

[0150] This method, referred to herein as "on-the-fly" molding, enables:

[0151] (i) Rapidly and accurately manufacture a wide variety of customized medical implants;

[0152] (ii) Use of medical grade heat-curable polymers such as silicone;

[0153] (iii) producing structures with thin elements and textures; and

[0154] (iv) Create complex designs with almost fully enclosed cavities.

[0155] Now referring to the accompanying drawings, Figure 1 is a flow chart outlining the steps of making a medical implant via the present method.

[0156] In order to manufacture a customized implant, the desired shape of the implant is first determined and modeled. For example, in the case where an implant enhances or replaces an existing anatomical structure, the anatomical structure is first scanned using an imaging modality (e.g., X-ray, MRI) and a 3D model is generated using well-known methods.

[0157] This model can then be used to generate a model of the structure and the required molds using a CAD / CAM program and / or specially designed and customized software for creating print files directly from the picture or any other scanning technology.

[0158] Custom software calculates and sets all required printing parameters, such as print increments, sequence, and mold design.

[0159] The mold parameters are then fed to a dual / two nozzle system that is able to 3D print the mold and inject the heat curable polymer (silicone) into the mold. FIG. 2A to FIG. 2B Such a system is further described.

[0160] The system prints the mold and fills the mold in a stepwise or continuous manner. The resolution of each step of the printing process can be determined by the structure of the printed part and the accuracy required for that product. For simple objects with larger volumes (e.g., simple aesthetic implants), this process can be performed simultaneously with filling the mold with silicone at the time of manufacturing. For objects with more complex shapes, a stepwise mold building and filling process can be used. The mold can be manufactured with channels that facilitate filling the mold with polymer.

[0161] As mentioned above, the polymers used in the present invention are heat curable. Curing can be performed during mold filling and / or after mold filling. In any case, a heated nozzle or heated environment can be used to achieve curing. Curing can be partial during manufacturing and completed in an oven after the object is completed. Curing is performed using the heat and time recommended for the polymer.

[0162] Once the implant is fully fabricated and cured, it can be extracted from the mold (e.g., pulled) or the mold can be dissolved (in the case of HIPS or PVA mold materials). The final implant can then be trimmed to remove residual polymer elements or defects resulting from the mold structure, cleaned, sonicated (in detergent), and sterilized (gamma irradiation or autoclave) and packaged for use.

[0163] Since the method enables rapid and accurate manufacture of medical implants, it can be used in a hospital setting to manufacture implants before or during surgery.An additional advantage of the method is that several variations of the implant can be produced and the fit of each variation can be tested within the time frame of surgery.

[0164] FIG. 2A to FIG. 2B Two configurations of system 10 are shown that may be used to perform the manufacturing process of the present invention.

[0165] The system 10 may include a 3D printer with a 3D (X, Y, Z) platform, with two print heads each equipped with a nozzle. The print head and nozzle for printing the mold may be a standard 3D print head. The print head and nozzle for dispensing the polymer may be configured to mix the two components of the polymer (in the correct mixing ratio) and dispense the mixed material through the print nozzle. The device may have a specially designed heating system including a heat exhaust nozzle that can cure the printed polymer. The system 10 may include an enclosure for creating an air-free atmosphere in close proximity to the manufactured object to prevent unwanted air cavities (bubbles) within the printed mold or injected object.

[0166] The system 10 is configured for additive manufacturing using a first nozzle 12 and for injecting a heat-curable polymer using a nozzle 14 and a heating element 16 .

[0167] Figure 2A The system 10 includes a single movable head on which nozzles 12 and 14 are mounted. Figure 2B The system 10 comprises two heads, each equipped with a nozzle. Figure 2A In the configuration, nozzles 12 and 14 move together along the X-axis (arrow), while Figure 2B In the configuration, nozzles 12 and 14 are independently movable (along the X-axis, arrow).

[0168] Nozzle 12 is used to print soluble mold materials using FDM (fused deposition modeling) technology, including a delivery and placement material system that pushes the wire material through the nozzle. Nozzle 14 is used to print polymer materials. It consists of a nozzle, a delivery and placement system that extrude the mixed polymer material through a specially designed nozzle and sets the correct volume for the object being manufactured. It also includes an automatic mixing system for mixing the two components of the polymer.

[0169] The system 10 also includes a reservoir 18 or material wire box for feeding the mold material nozzle 12 and reservoirs 20 and 22 for feeding liquid components of the heat-curable polymer to the nozzle 14. In the case of silicone, the components are fed independently from the reservoirs 20 and 22 and mixed (e.g., using a mixer) before being pushed into the nozzle 14. Once injected into the mold 24, the heating element 16 is used to fully or partially cure the heat-curable polymer 26.

[0170] It should be understood that a single reservoir can also be used for heat-curable polymers. Such a reservoir can be filled with a premixed liquid. The heating element 16 can be integrated into the nozzle 14 or positioned adjacent to (e.g., 1-10 mm) the nozzle 14 or positioned away from the mold 24. As described above, the polymer 26 is injected into the mold 24 during mold production (step by step or simultaneously). To achieve this function, the system 10 is programmed to first print the mold from a soluble material using the nozzle 12. Once the first volume layer of the mold is manufactured, the polymer is printed / filled into the layer. These steps are repeated for each layer. Software-controlled manufacturing can automatically set the appropriate manufacturing sequence and can determine the printing increment based on the final product specifications or the accuracy and speed specified by the user.

[0171] Figure 3 The mold 24 and the manufactured implant 26 are shown prior to extraction of the implant.

[0172] According to another embodiment of the invention, the device is suitable for removing bubbles and defects caused during the printing process (in each layer being printed).

[0173] According to this embodiment, the 3D printer includes a build / print plate on which the resulting 3D print is printed. The print plate is coupled at at least one location to an ultrasonic / RF transducer adapted to vibrate the build / print plate up to 50 microns. The vibration frequency is typically greater than or equal to 5 Hz (and up to 300 Hz). This movement will facilitate the removal of any trapped bubbles (bubbles trapped in the printed model) from each layer of printed polymer (e.g., silicone) during the printing process.

[0174] Reference now Figure 4 , shows a build / print plate 1 placed on a substrate 3 and capable of moving in the Z direction. The build / print plate 1 has at least one ultrasonic transducer 2 at one edge thereof, and the at least one ultrasonic transducer 2 is suitable for vibrating the build / print plate 1 along the X, Y, Z axes and any combination thereof.

[0175] like Figure 5 As shown in FIG. 6 , the print head can be moved along the X and Y directions (or any combination thereof).

[0176] According to another embodiment of the present invention, the nozzle from which the polymer (e.g., silicon) is extruded is coupled to at least one ultrasonic transducer adapted to directly vibrate the printed polymer as it is printed (it should be emphasized that any motorized device capable of applying vibration is also within the scope of the present invention). In such an embodiment, the vibration of the ultrasonic transducer can "utilize" the liquid medium polymer (when a liquid phase polymer is used, such as silicon) to convert the vibration to ultimately eliminate any unwanted bubbles.

[0177] Reference now Figure 5 6 shows another embodiment of the present invention. According to this embodiment, a unique printing nozzle 10 and a printing head 100 are provided.

[0178] According to this embodiment, printing of various types of materials (eg, powders, liquids, gels, and any combination thereof) is provided.

[0179] According to one embodiment, at least two feed lines (each feeding a different type of material) are provided to the nozzle head. When the two lines meet, a mixer is provided to mix the materials, and only thereafter the nozzle prints the mixture.

[0180] Reference now Figure 5 , which shows this unique nozzle 10. As described above, the two feed lines 1, 2 mix at the Y intersection and the mixture flows (or is pushed) within the tube 5 towards the print nozzle end 6.

[0181] According to one embodiment, the two printing materials chemically react and harden when mixed.

[0182] According to another embodiment, a motorized mixer (eg, a piercer) is provided to mix the materials.

[0183] According to one embodiment, the user can select the amount of material to be printed and the mixing ratio of the materials in the nozzle 10 (e.g., in the feed lines 1, 2). Such extrusion can be provided by, for example, an extruder, a piston disposed in a feed line, and any other means known in the art.

[0184] According to one embodiment, the amount of material to be printed and the mixing ratio of said materials in the nozzle 10 (eg in the feed lines 1 , 2 ) are automatically selected based on the desired 3D object to be printed.

[0185] According to another embodiment, a print head comprising several such unique nozzles is provided.

[0186] Reference now Figure 6a , which shows such a print head. In the figure, the print head 100 includes 5 print nozzles 10, each of which includes 2 feed lines. A total of 10 types of printed materials are achieved by using this print head.

[0187] As mentioned above, the printhead will have multiple nozzles and mixers to enable printing of multiple materials.

[0188] According to one embodiment, the head may be a swivel head. According to this embodiment, a dedicated tray is provided for closing the print nozzles and preventing dripping between layers.

[0189] According to one embodiment, the print head is a single-use print head and is replaced after each printing (both the mixer and the nozzles are replaced).

[0190] Return to reference Figure 6a , a rotating wheel 2 (placed on a dedicated track 1 ) is provided, on which at least one printing nozzle 10 is arranged. The rotating wheel 2 communicates with at least one stepper motor or servo motor 4 .

[0191] As shown, two feed lines are provided to each print nozzle.

[0192] Also shown is a tray 8. As mentioned above, the tray is adapted to prevent any leakage of printing material from inadvertently spilling from the print head onto the build plate.

[0193] According to one embodiment, at least one opening 9 is provided in the tray to enable printing from at least one print nozzle aligned adjacent to the at least one opening 9 .

[0194] According to another embodiment of the present invention, any excess material from the print nozzles assembled on the tray 8 will be collected for reuse or disposal. According to one embodiment, the tray includes a slope to facilitate the collection of any excess curable polymer (e.g., silicon) leaving at least one print nozzle.

[0195] According to another embodiment of the present invention, the tray 8 is used to prevent any printing of the curable polymer when printing of the curable polymer is not required.

[0196] Reference now Figure 6b , which shows such an inclined tray 8. As shown, the tray 8 has a slope that facilitates the collection of any overflowing polymer (i.e. silicon) from the printing nozzle 10. According to one embodiment, the tray may include at least one tube 8a into which all collected curable polymer flows.

[0197] According to another embodiment of the utility model, at least one of the printing nozzles is connected to the rotating wheel 2 by a flexible arm (e.g., a spring) so that when the nozzle is needed to print, the nozzle is located above the opening 9 and moves to the building / printing plate for printing. Figure 7 , shows such an embodiment. When the print nozzle 10a is needed for printing, the nozzle is positioned near the opening 9 and slightly below the tray 8 to facilitate printing (extruding the curable polymer therefrom). It is worth noting that the remaining print nozzles 10 are above the tray 8, thus preventing printing from the remaining print nozzles 10.

[0198] Reference now Figure 8a to Figure 8b, shows another embodiment of the present invention, according to which the distal end of the printing nozzle 10 comprises an elastic / flexible tube 83 from which the curable polymer exits.

[0199] As shown, two stops are provided: a fixed stop 81 and a movable stop 82. The movable stop 82 can move laterally relative to the fixed stop 81.

[0200] Therefore, when printing of curable polymer is required, the movable stopper 82 moves away from the fixed stopper 81; and when printing of curable polymer is required to be prevented, the movable stopper 82 moves into contact with the fixed stopper 81 so that the elastic / flexible tube 83 is squeezed therebetween.

[0201] This design is very advantageous because, unlike the tray 8 being positioned below the distal tip of the print nozzle 10 (and therefore interfering with printing), the stops 81, 82 are positioned at the same level as the distal-most tip of the print nozzle 10 and therefore do not interfere with printing.

[0202] Reference now Figure 9a to Figure 9b , which shows another embodiment of the utility model, according to which the entire printing is provided in a vacuum chamber. This vacuum will (similar to the vibration disclosed above) promote the removal of unwanted bubbles generated during printing.

[0203] According to one embodiment, the vacuum is activated always during printing or only during certain time intervals.

[0204] According to another embodiment, vacuum provides extrusion of printing material as redundancy. Unlike standard force application that extrudes (ie, pushes) printing material into and within the printing nozzle, application and removal of vacuum will provide the same result.

[0205] Reference again Figure 9a to Figure 9b As shown, a polymer (ie, silicone) print nozzle 1 and an additional print nozzle 2 and a print / build plate 11 are placed within a vacuum chamber 3 .

[0206] The polymer (ie silicon) is supplied from a container 4 to the nozzle printing nozzle 1 via a feed tube 6 .

[0207] According to this embodiment, the air valve 5 is arranged to enable (when the air valve 5 is open) air to enter the container, and (when the air valve 5 is closed) prevent air from entering the container 4. As described below, when the at least one vacuum pump is activated, a vacuum is applied within the at least one vacuum chamber 3, and the valve 5 is opened (and therefore, air enters the container 4); thus, the curable polymer can be extracted therefrom (the air entering the container pushes the curable polymer out, and the vacuum pulls it to be extruded through the nozzle).

[0208] Conversely, when the at least one vacuum pump is inactive and the valve 5 is closed, the curable polymer is prevented from being extracted therefrom (air is prevented from entering the container 4).

[0209] Thus, when vacuum is continuously applied, valve 5 enables extrusion of polymer (when valve 5 is open) and valve 5 prevents extrusion of polymer (when valve 5 is closed).

[0210] Note that the vacuum is provided in the vacuum chamber 3 by at least one vacuum pump 7. At least one door 8 and a seal (preferably a rubber seal) 9 are provided to ensure that the vacuum is provided.

[0211] According to another embodiment of the utility model, the printing process is modified. When it is necessary to print a liquid medium (e.g., silicon), harden a layer, or provide support to enable printing of a complex 3D model, a 3D printing method is disclosed within the scope of the utility model, wherein after printing a liquid medium layer, specific locations on the layer are hardened (using, for example, a heating element; hot air or IR heating) to provide support for the next required liquid medium layer. This step can be repeated as many times as needed.

[0212] According to another embodiment, the printing of a complex 3D model is provided by hardening the entire last layer of the print. Thus, between the layers, at least one hardened layer is provided.

[0213] According to another embodiment, ensuring that the desired mold is completely filled, additional polymer (eg, silicone) in the last layer is used to fill in any areas that may be missing or to compensate for material shrinkage.

[0214] According to another embodiment, dedicated management software will be provided. Such management software will provide indication of any need for support within the 3D structure / between different silicone types / layers.

[0215] Within the scope of the present invention, the management software will also control at least one of the following:

[0216] 1) The order in which silicone and support / additive materials are printed;

[0217] 2) Manage different types of support materials, soluble additives, and silicone-cured supports;

[0218] 3) Manage the filling of the mold in different pre-specified printing steps;

[0219] 4) automatically determining the positioning of a printing component and the positioning of a print head relative to the printing component;

[0220] 5) Automatic setting of the required support (amount of soluble additive or solidifying polymer) and combining it with the filling step of the resulting mold.

[0221] It is expected that during the life of this patent, many related heat-curable medical grade polymers will be developed, and the scope of the term heat-curable polymer is intended a priori to include all such new technologies.

[0222] As used herein, the term "about" refers to ± 10%.

[0223] It should be understood that, for the sake of clarity, certain features of the present disclosure described in the context of separate embodiments may also be provided in combination in a single embodiment. Conversely, for the sake of brevity, various features of the present disclosure described in the context of a single embodiment may also be provided separately or in any suitable sub-combination or in any other described embodiment of the present disclosure as appropriate. Unless explicitly specified, features described in the context of an embodiment are not considered essential features of that embodiment.

[0224] Although the steps of the method according to some embodiments can be described in a specific order, the method of the present disclosure may include some or all of the described steps performed in a different order. The method of the present disclosure may include several steps described or all steps described. Unless explicitly stated, specific steps in the disclosed method are not considered to be essential steps of the method.

Claims

1. A vacuum sealed 3D printer, the vacuum sealed 3D printer comprising: at least one vacuum chamber defining at least one operating area, the at least one vacuum chamber being sized and shaped to sealingly enclose: at least one build plate, the at least one build plate being movable along at least one axis; as well as at least one print head, the at least one print head being movable along at least one axis, the at least one print head comprising at least one print nozzle for depositing at least one curable polymer on the at least one build plate to form at least one 3D object; at least one vacuum pump in fluid tight communication with the at least one vacuum chamber such that when the vacuum pump is activated, a vacuum is applied within the vacuum chamber to remove air bubbles generated during deposition of the at least one curable polymer; and It is characterized in that when the at least one vacuum pump does not work, no vacuum is applied in the at least one vacuum chamber; and the at least one curable polymer is prevented from being squeezed out of the at least one printing nozzle to form the at least one 3D object.

2. The vacuum sealed 3D printer according to claim 1, characterized in that: The at least two curable polymers are extruded from the at least one printing nozzle.

3. The vacuum sealed 3D printer according to claim 2, characterized in that: The at least two curable polymers are extruded in a constant quantitative ratio relative to each other or in a varying quantitative ratio relative to each other.

4. The vacuum sealed 3D printer according to claim 1, characterized in that: When the at least one vacuum pump is activated, a vacuum is applied within the at least one vacuum chamber; and the at least one curable polymer is extruded from the at least one printing nozzle.

5. The vacuum sealed 3D printer according to claim 1, characterized in that: The at least one curable polymer is contained within at least one container.

6. The vacuum sealed 3D printer according to claim 5, characterized in that: The at least one container comprises at least one valve adapted to facilitate extraction of the curable polymer from the at least one container when open; and adapted to prevent extraction of the curable polymer from the at least one container when closed.

7. The vacuum sealed 3D printer according to claim 5, characterized in that: When the at least one vacuum pump is activated, a vacuum is applied within the at least one vacuum chamber and the valve opens to facilitate entry of air into the at least one container and facilitate extraction of the curable polymer from the at least one container.

8. The vacuum sealed 3D printer according to claim 5, characterized in that: When the at least one vacuum pump is inactive, the valve is closed to prevent air from entering the at least one container and to prevent extraction of the curable polymer from the at least one container.

9. The vacuum sealed 3D printer according to claim 1, characterized in that: The vacuum sealed 3D printer further comprises at least one vibration actuator arranged for providing a vibrational motion to the at least one building plate, the at least one print head and / or the at least one printing nozzle.

10. The vacuum sealed 3D printer according to claim 9, characterized in that: The vibration results in the removal of any trapped air bubbles in the extruded curable polymer.

11. The vacuum sealed 3D printer according to claim 1, characterized in that: The at least one print head is formed as a swivel plate.

12. The vacuum sealed 3D printer according to any one of claims 1 to 11, characterized in that: The print head comprises at least one opening such that once the at least one printing nozzle is aligned with the at least one opening, only the at least one curable polymer is extruded from the at least one printing nozzle.

13. The vacuum sealed 3D printer according to claim 12, characterized in that: The at least one print head is electrically connected to at least one stepper motor or servo motor, and the at least one stepper motor or servo motor is suitable for rotating the at least one print head so that during each movement, one of the at least one print nozzles is aligned with the opening to facilitate extrusion of the at least one curable polymer.

14. The vacuum sealed 3D printer according to claim 1, characterized in that: The at least one print head comprises at least one cleaning element adapted to wipe clean the at least one print nozzle.

15. The vacuum sealed 3D printer according to claim 1, characterized in that: The at least one curable polymer is a polymer selected from the group consisting of medical grade silicone, any long-term implant, and any combination thereof.

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