System and method of manufacturing a medical implant

A system and method for forming a medical implant using a printing device. The printing device includes a print head having a heated nozzle, a heated build plate for receiving the printed material thereon, and a reflective plate having an active heater. A method for forming a medical device includes extruding a printing material by contiguous deposition to form a porous object having a lattice-like structure. The medical device, such as a spinal implant, may have interconnected pores and different regions, each having a different porosity for encouraging bone growth therein. The printed medical implant may be designed to be patient-specific, customized, and printed on-demand.

BACKGROUND

Embodiments of the invention relate to a method, system and printing device for printing a customized object, such as a medical implant. More specifically, embodiments of the invention relate to a method, system, and printing device for forming a surgical implant of a polymeric material.

2. Related Art

What is needed is a process for manufacturing a medical implant of a polymeric material that allows for customizing at least the size, shape, and porosity thereof.

The invention describes an improved method and system for manufacturing a surgical device, such as a spinal implant or other medical implant.

The invention describes a printing device for three-dimensional printing that can be programmed to create a custom medical device. The printing device is configured to allow the printing material to be a polymeric material, such as polyaryletherketone (PAEK), or more specifically polyether ether ketone (PEEK).

Prior printing devices were not capable of adequately maintaining the printing material at an optimized temperature during the entire printing process to ensure that each layer of the final printed device was integrally attached to each other layer.

In one embodiment, the final printed object may be a medical implant, such as a spinal implant. The spine consists of a column of twenty-four vertebrae that extend from the skull to the hips. Discs of soft tissue are disposed between adjacent vertebrae. In addition, the spine encloses and protects the spinal cord, defining a bony channel around the spinal cord, called the spinal canal. There is normally a space between the spinal cord and the borders of the spinal canal so that the spinal cord and the nerves associated therewith are not pinched.

Over time, the ligaments and bone that surround the spinal canal can thicken and harden, resulting in a narrowing of the spinal canal and compression of the spinal cord or nerve roots. This condition is called spinal stenosis, which results in pain and numbness in the back and legs, weakness and/or a loss of balance. These symptoms often increase after walking or standing for a period of time.

There are a number of non-surgical treatments for spinal stenosis. These include non-steroidal anti-inflammatory drugs to reduce the swelling and pain, and corticosteroid injections to reduce swelling and treat acute pain. While some patients may experience relief from symptoms of spinal stenosis with such treatments, many do not, and thus turn to surgical treatment. The most common surgical procedure for treating spinal stenosis is decompressive laminectomy, which involves removal of parts of the vertebrae. The goal of the procedure is to relieve pressure on the spinal cord and nerves by increasing the area of the spinal canal.

Interspinous process decompression (IPD) is a less invasive surgical procedure for treating spinal stenosis. With IPD surgery, there is no removal of bone or soft tissue. Instead, an implant or spacer device is positioned behind the spinal cord or nerves and between the interspinous processes that protrude from the vertebrae in the lower back.

Prior medical implants have limited porosity for encouraging bone growth. Known implants may have only surface porosity on an outer surface thereof or discrete openings in defined layers. The present invention provides an improvement over prior implant devices by creating an implant that is porous throughout the entire internal structure. The implant may have a lattice-type structure that allows for interconnected pores extending throughout the entire device. This will advantageously improve the integration of the implant into the body and encourage bone growth therein.

SUMMARY

Embodiments of the invention solve the above-mentioned problems by providing a system and method for printing a customized object, such as a surgical implant, using a printing device having multiple heated elements that are configured to maintain the printing material at a predetermined temperature during the entire printing process.

The construction of the implant according to an embodiment of the invention also allows for customizing the implant to have multiple different portions with different porosities.

A first embodiment of the invention is directed to a printing device for forming a surgical implant from a first material comprising: a housing forming an enclosed space; a print head comprising a heated nozzle for extruding the first material; a planar heated build plate having a top surface for receiving the first material thereon; a reflective plate comprising an active heating element. The reflective plate is located adjacent the heated nozzle and has a bottom surface configured to reflect heat towards the build plate. The reflective plate, the heated build plate, and the heated nozzle are all configured to maintain the first material at a predetermined temperature while forming the surgical implant.

Another embodiment of the invention is directed to a method for using a printing device to create a medical implant, the method comprising: providing a first material for printing the medical implant; providing a printing device; moving the print head and the reflective plate vertically in a Z-plane; and moving the build plate horizontally in a X-plane and in a Y-plane. The printing device comprises: a housing forming an enclosed space; a print head comprising a heated nozzle for extruding the first material; a planar heated build plate having a top surface for receiving the first material thereon; and a reflective plate comprising an active heating element. The reflective plate is located adjacent the heated nozzle and has a bottom surface configured to reflect heat towards the build plate. The reflective plate, the build plate, and the nozzle are all configured to maintain the first material at a predetermined temperature while forming the medical device.

Another embodiment of the invention is directed to a system for 3-D printing a medical device comprising: a printing material for forming the medical device; and a printing device. The printing device comprises: a housing forming an enclosed space; a print head comprising a heated nozzle for extruding the printing material; a planar heated build plate having a top surface for receiving the printing material thereon; a reflective plate comprising an active heating element. The reflective plate is located adjacent the heated nozzle and has a bottom surface configured to reflect heat towards the build plate. The reflective plate, the build plate, and the nozzle are all configured to maintain the printing material at a predetermined temperature while forming the medical device.

Yet other embodiments of the invention are directed to one or more non-transitory computer-readable media storing computer executable instructions, that, when executed by a processor, perform a method of three-dimensionally printing a medical implant, the method comprising: selecting a custom final shape of the implant based at least in part on an anatomy of a particular patient; selecting a first porosity for a first region and selecting a second porosity for a second region of the implant; providing a printing material to a nozzle of a printing device; heating the printing material to at least a glass transition temperature; and dispensing a plurality of layers of the printing material through the nozzle onto the build plate to form the implant.

Another embodiment of the invention is directed to a method for printing a medical implant comprising: providing a printing material and a printing device including a nozzle; selecting a final shape, size, and configuration of the implant; selecting a first porosity for a first region of the implant; selecting a second porosity for a second region of the implant; controlling a dispense rate of the printing material from the nozzle onto a build plate; monitoring a temperature of at least one portion of the printing device by at least one temperature sensor; and adjusting the temperature of at least one element of the printer device to maintain the implant at a predetermined temperature during the entire printing process.

Another embodiment of the invention is directed to a method for forming a porous surgical device by contiguous deposition comprising: providing a printing material; extruding the printing material through a nozzle head; moving the nozzle head vertically in a Z-plane; receiving the printing material on a top surface of a build plate; moving the build plate horizontally in a X-plane and in a Y-plane; and depositing a plurality of layers of the printing material on the build plate to form the surgical device. Depositing the plurality of layers of the printing material further comprises: a) depositing a first layer on the build plate; b) rotating the substantially contiguous pattern by about 36°; and c) depositing a second layer on top of the first layer; and repeating steps a, b, and c until a predetermined number of layers are formed.

A further embodiment of the invention is directed to a selectively porous customizable medical implant made by the process of fused filament fabrication (FFF) by a printer comprising: at least a first region having a first porosity; at least a second region having a second porosity, wherein the pores of the first region are larger than the pores of the second region. The first region may have a lattice structure with interconnected pores. The implant may be made of a polymer, such as polyether ether ketone (PEEK). The implant may further include a coating of hydroxyapatite that extends into the pores.

Another embodiment of the invention is directed to a spinal implant formed by a polymer monofilament printing process, comprising: a top surface, a bottom surface, a peripheral outer surface, and a central opening; and a porous section having a plurality of interconnected pores. The porous section has a first plurality of openings on the top surface and a second plurality of openings on the bottom surface. The implant shape and pore size is selectable for customizing the implant to a particular patient.

DETAILED DESCRIPTION

FIGS. 1A-1Billustrate one embodiment of printing device10. Printing device10may be a three-dimensional printer or an additive manufacturing printer, which is configured to form printed objects800from a printing material. In some embodiments, printing device10may be used to manufacture objects800using any known or yet to be discovered method of additive manufacturing, including but not limited to inkjet, material extrusion, light polymerized, powder bed, laminated, powder fed, or wire methods of additive manufacturing. In some embodiments, printing device10is a fused filament fabrication (FFF) printer. In some embodiments, printing device10is supplied with a printing material, such as PAEK, PEEK, polyetherketoneketone (PEKK), and/or other high-performance plastics, and combinations thereof. Additional printing materials include acrylonitrile butadiene styrene (ABS), polylactic acid (PLA), poly-ethylene terephthalate (PET), poly-ethylene trimethylene terephthalate (PETT), nylon filament, polyvinyl alcohol (PVA), sandstone filament, and combinations thereof. Printing material may be supplied to the printing device10in multiple forms. In one embodiment, printing material is supplied in a filament form.

FIG. 1Ashows the exterior of printing device10comprising a housing unit12. Housing unit12may comprise a frame14for supporting and enclosing the components of printing device10. In some embodiments, frame14may be generally be designed as a rectangular housing unit, however, it will be appreciated that frame14may be designed in any geometric shape or design, such as cylindrical or square. Furthermore, the dimensions of frame14may likewise vary depending on the embodiment, and for example, may be configured based on the dimensions of the final printed object. For example, in some embodiments, frame14may comprise the following dimensions: a length of about 25 inches to about 45 inches; a width of about 18 inches to 38 inches; and a height of about 33 inches to 53 inches. Frame14may be constructed from any suitable material, including but not limited to metallic alloys such as aluminum, magnesium, titanium, stainless steel, or other known structural frame materials.

In some embodiments, frame14may support at least one panel16thereon. In some embodiments, multiple panels16may be provided to form an enclosure for protecting printing object800. For example, panels16may form a cube-like enclosure, as seen inFIG. 5. Panels16may provide a partially or fully closed-frame design to aid in maintaining a desired temperature inside housing unit12. The partially or fully closed-frame design may also prevent a user from contacting the inside of the printing device10during operation.

Panels16may be constructed from any suitable material, including but not limited to metallic alloys, such as aluminum, magnesium, titanium, stainless steel, or other known materials. In some embodiments, panels16may be composed of at least one material having a thermally insulating property to aid in maintaining the desired temperature inside housing unit12during operation. In some embodiments, at least one interior surface of panel16may include a thermally insulating material18. In some embodiments, thermally insulating material18may be applied as a lining or additional layer, may be manufactured into panels16, or may be applied as a coating on a surface of panels16. In some embodiments, panels16may be manufactured from a material that has inherent thermally insulating properties or such material may be added during the manufacturing process.

In some embodiments, frame14may further comprise at least one means for accessing the interior of housing unit12, such as one or more doors20or a hatch. In some embodiments, doors20are configured with handles and rotate on hinges. In some embodiments, one or both doors20may further comprise a viewing portal22or window for observing the interior of housing unit12during operation of printing device10. Viewing portal22may be constructed from any suitable transparent or translucent material and, for example, may be laminated safety glass. In some embodiments, viewing portal22may be located on one of panels16supported on frame14. In some embodiments, there may be a plurality of viewing portals22located on door20, panels16, or any combination thereof. Printing device10may also have a safety shut-off switch24, which may be located on a front panel. Printing device10may also have a key lock26for locking the doors20while the printing device10is in operation. In some embodiments, the printing device10automatically locks the door20to prevent a user from opening the chamber during printing.

As further illustrated inFIG. 1A, printing device10may comprise a control system50, which is communicatively coupled to printing device10. Control system50may comprise a processor, which as described in greater detail herein, may be configured to receive custom design parameters from a user for controlling printing device10before and/or during operation. Control system50may further comprise a display52. Display52may provide an interface for inputting instructions, such as a touch-screen interface. Display52may also provide any information to a user about printing device10before, during, and after operation. For example, display may provide information that may be required for pre-operation, post-operation, diagnostic testing, and/or troubleshooting. An additional computer702may be connected to printing device10. Computer702may allow a user to input additional instructions and is configured to interact with control system50.

FIG. 1Billustrates a schematic view of the interior of housing unit12, illustrating additional components of printing device10. It is noted that panels16are not shown in this view in order to better see the other internal components. In some embodiments, printing device10may comprise a build plate100, a print head200, and a reflector unit300. As can be seen inFIG. 1B, frame14supports an upper assembly201and a lower assembly260. Lower assembly260includes a support structure262for receiving build plate100thereon. Upper assembly201includes a support structure278for receiving print head200and reflector unit300thereon. In some embodiments, build plate100may be positioned below print head200and reflector unit300. Build plate100is configured to receive the printed material400thereon to form the object800.

FIGS. 2A-2Billustrate an embodiment of build plate100.FIG. 2Aillustrates a perspective view of build plate100in an assembled state andFIG. 2Bis an exploded view. In one embodiment, build plate100may be designed in a generally rectangular shape and configuration. However, in other embodiments build plate100may be designed in any geometric shape and may be for example circular, triangular, rectangular, pentagonal, or any other polygonal geometric shape or design. Furthermore, it will be appreciated that the size and shape of build plate100may also vary depending on the embodiment and the desired use. However, build plate100may generally be designed such that it is larger than the desired dimensions of the object800to be printed. Thus, the entirety of the printed object800may be received within the interior perimeter of build plate100.

With reference toFIG. 2B, in some embodiments, build plate100may comprise a plurality of layers. In some embodiments, build plate100comprises a flat and planar design. In some embodiments each of the plurality of layers of build plate100may comprise a generally flat and planar shape and design. Alternatively, in some embodiments each of the plurality of layers may comprise other shapes and designs, and for example, may comprise curved, concave, or convex designs. In one embodiment, as seen inFIG. 2B, build plate100may comprise a bottom frame layer102, at least one insulating layer104, at least one heating layer106, at least one intermediate layer108, a top frame layer109and a top build layer110. It will be appreciated that in some embodiments, build plate100may comprise greater or fewer layers.

In one embodiment, bottom frame layer102may be constructed from aluminum. In alternative embodiments, bottom frame layer102may be constructed from other materials, such as stainless steel, titanium, or other suitable materials and combinations thereof. In some embodiments, upper surface of bottom frame layer102may comprise a recess112or formed indention, configured such that at least one other layer of build plate100may be placed on and rest in recess112. Bottom frame layer102may include one or more openings105for receiving fasteners therein for anchoring the layers of the build plate together. Specifically, the openings105may receive fasteners for connecting bottom frame layer102to corresponding openings113located on the underside of top frame layer109. Alternatively, bottom frame layer102and top frame layer109may be connected together by any known means, such as mechanical fasteners or adhesives. Bottom frame layer102may further include one or more openings103for receiving connectors130therein for connecting the build plate100to lower assembly260, as discussed further below.

In some embodiments, build plate100may comprise one or more insulating layers104. Insulating layer104can act as a heat break in build plate100, limiting, reducing, or eliminating the migration of heat generated by build plate100to undesirable locations. In one embodiment, build plate100includes insulating layer104positioned above and adjacent to bottom frame layer102. In one embodiment, insulating layer104may be planar and generally be configured in the same shape as recess112such that it is received entirely within recess112. In one embodiment, insulating layer104has a thickness of about 0.2 inches to about 0.3 inches. In some embodiments, insulating layer104may have a thickness in a range of from about 0.1 inch to about 0.75 inches. It will be appreciated that in some embodiments, insulating layer104can be constructed from a single material, alloy, or polymer. In alternative embodiments, insulating layer104can be constructed from a mixture of multiple materials, alloys, or polymers. Insulating layer104can be constructed from a variety of different materials, alloys, or polymers, each having different thermally insulating properties. For example, in one embodiment, insulating layer104can be at least partially constructed from mica. In one embodiment, insulating layer104can be at least partially constructed from ceramic. In one embodiment, insulating layer104can be at least partially constructed from PEEK, PAEK, or PEKK.

Alternatively, in some embodiments, insulating layer104can comprise a plurality of distinct units positioned in recess112in a spaced manner. The plurality of units may be designed as any geometric shape and may be for example, round, triangular, rectangular, pentagonal, or any other polygonal shape. In some embodiments, the plurality of units are round and circular in shape. The plurality of units may have any desired thickness, such as about 0.25 inch. Alternatively, in some embodiments the thickness of the plurality of units may be 0.1-0.75 inches thick. The number of units may vary, depending on the embodiment, and may consist of any number of desired units. In some embodiments, insulating layer104may comprise five thermally insulating units.

In some embodiments, build plate100may further comprise at least one heating layer106. In one embodiment, heating layer106may be positioned above and adjacent to insulating layer104and, in some embodiments, may rest against the top surface of insulating layer104. Heating layer106can comprise a selectively operable and/or programmable heating element114for generating heat and for maintaining a predetermined temperature of the top build layer110of build plate100during operation. In some embodiments, heating layer106can be a solid layer of material such as silicone, aluminum, titanium, platinum, or other metal alloys with conductive properties that is capable of generating heat. In some embodiments, heating layer106can be coupled to wiring, cables, coils, or other conductive circuitry116capable of transferring an electric current to the heating layer106. Conductive circuitry116can transfer electricity from an external source, such as a battery or standard electrical outlet, to heating layer106for generating heat. In some embodiments, heating element114and/or conductive circuitry116can be communicatively coupled to control system50. Control system50can be programmed and/or configured to receive instructions from a user to increase and/or decrease the heat generated by heating element114as desired during operation.

In some embodiments, build plate100may further comprise at least one intermediate layer108. In some embodiments, intermediate layer108can be positioned above and adjacent to heating layer106. In some embodiments, intermediate layer108can be placed above and rest on the top surface of heating layer106. Intermediate layer108can be designed in any geometric design or shape, such as circular, triangular, rectangular, pentagonal, or any other polygonal shape. In some embodiments, intermediate layer108may generally comprise the same shape as build plate100. The dimensions of intermediate layer108can further vary depending on the embodiment. In some embodiments, intermediate layer108will have dimensions such that it can be placed within recess112, along with insulating layer104and heating layer106.

In some embodiments, intermediate layer108can act as a diffuser, distributing the heat generated by heating layer106in a uniform and even manner. In some embodiments, intermediate layer108can aid in preventing, reducing, or eliminating any focused pockets of heat, or hot spots. Intermediate layer108acts to dissipate the hot spots across the entirety of its surface. The dissipation of hot spots can aid in forming a uniform distribution of heat, which creates a more optimum environment on top surface of build plate100for printing an object800. In one embodiment, intermediate layer108is constructed from stainless steel, however, it will be appreciated that intermediate layer108can be constructed from any suitable material having heat dissipation properties.

In some embodiments, build plate100may further comprise a top frame layer109. Top frame layer109is positioned directly above and adjacent to intermediate layer108. Top frame layer109may be constructed from aluminum, titanium, stainless steel, or any other suitable material, or combinations thereof. In some embodiments, top frame layer109cooperates with bottom frame layer102to enclose insulating layer104, heating layer106, and intermediate layer108therebetween. Top frame layer109and bottom frame layer102may have similar dimensions such that they fit together. Top frame layer109may further include one or more openings111, which may align with one or more openings103in bottom frame layer102for receiving connectors130therein. In some embodiments, openings111and openings103are located at the four corners of top frame layer109and bottom frame layer102, respectively. Connectors130may anchor the build plate100to the lower assembly260, as discussed further below. Alternatively or additionally, connectors130and openings111may further be used for fine bed leveling top build layer109.

In some embodiments, an upper surface of top frame layer109may comprise a recess122for receiving a top build layer110therein. Thus, top frame layer109may have a larger length and width than top build layer110. In some embodiments, top build layer110may have a thickness greater than the depth of recess122, such that an upper surface of top build layer110protrudes therefrom. In some embodiments, top build layer110and top frame layer109has upper surfaces that are flush with one another to form the upper surface of the build plate100. In some embodiments, recess122includes a plurality of holes119for receiving fasteners120therein.

In some embodiments, top build layer110provides a surface for receiving the printed material thereon to form printed object800. Top build layer110may be designed as any geometric shape or design, including but not limited to circular, triangular, rectangular, pentagonal, or any other polygonal shape. As shown inFIG. 2B, top build layer110may be substantially rectangular. For example, in some embodiments, top build layer110can comprise a length of about 1.5 inches to about 4.5 inches and further comprise a width of about 1.5 inches to about 4.5 inches. In some embodiments, top build layer110includes a plurality of holes118that cooperate with holes119in top frame layer109for receiving fasteners120therein. In one embodiment, fasteners120may be used to secure top build layer110to top frame layer109. Securing top build layer110to top frame layer109aids in preventing the top build layer110from warping or curving during use. Maintaining a planar structure of the top build layer110during operation ensures reliability in the printed object800having a flat base. In alternative embodiments, top build layer110may be secured to top frame layer109through any known fastening method, including but not limited to adhesives or other mechanical fasteners such as for example nails, bolts, or clamps.

In some embodiments, top build layer110can also act as a diffuser, distributing the heat generated by heating layer106in a uniform and even manner. In some embodiments, top build layer110can aid in preventing, reducing, or eliminating any focused pockets of heat, or hot spots. Top build layer110acts to dissipate the hot spots across the entirety of its surface. The dissipation of hot spots can aid in forming a uniform distribution of heat, which creates a more optimum environment on top surface of build plate100for printing an object800. In one embodiment, top build layer110is constructed from stainless steel, however, it will be appreciated that top build layer110can be constructed from any suitable material having heat dissipation properties.

In some embodiments, top build layer110may be constructed at least partially from polyetherimide (PEI), PEEK, PAEK, PEKK, UItem™, or other thermoplastic polymers or any combination thereof. In some embodiments, top build layer110may be partially or fully constructed of glass, aluminum, stainless steel, or other metallic alloys, or combinations thereof. In some embodiments, top build layer110may have a thickness of about 0.25 inches. In some embodiments, the thickness of top build layer110may be from about 0.1 inch to about 0.75 inch.

As discussed above, in some embodiments top build layer110may comprise a plurality of holes118or void spaces in the top surface thereof. The number and placement of holes118may vary, depending on the embodiment. In some embodiments, the number and placement of holes118may correspond to the number and placement of holes119in top frame layer109. Holes118may be machined or manufactured into top build layer110during construction, or alternatively, may be placed in top build layer110after construction. In some embodiments, holes118may be selectively positioned in rows and/or columns of a predetermined quantity. In some embodiments, holes118may be placed randomly, without a predetermined selection of placement. In some embodiments, holes118may be througholes extending completely through top build layer110, thereby creating continuous openings into top build layer110. Alternatively, in some embodiments one or more holes118may be defined partially into top build layer110and stop short of creating a continuous opening entirely through top build layer110. In some embodiments, top build layer110may comprise a combination of througholes118and partial holes118.

In some embodiments, as heat generated by heating layer106begins to move up in the z-plane of the build plate100and reaches top build layer110, holes118may aid in distributing the heat across the entire surface of top build layer110. In some embodiments, holes118may also aid in dissipating the heat as it reaches top build layer110. As described in greater detail below, printing device10may further comprise additional heat sources, and in some embodiments the additional heat sources may be located axially above top build layer. In addition to distributing and dissipating heat directed from the lower heating layer106, top build layer110may further distribute and dissipate heat from the above additional heat sources, in a similar manner. The distribution or dissipation of heat can help to prevent, reduce, or eliminate the build-up of hot spots or heat sinks on top build layer110. The reduction or elimination of hot spots and heat sinks can be beneficial during operation, as this may cause warping or distortion of the top build layer110and/or of the final printed object800. In some embodiments, top build layer110may be comprised of a thermal expansion material, that expands as the temperature within housing unit12increases. In such an embodiment, holes118can aid in providing spacing or clearance for the material to expand, thus preventing and/or reducing warping of top build layer110.

In some embodiments, at least some of the void spaces created by holes118may be filled with a compatible element. In some embodiments, one or more holes118may receive mechanical fasteners120such as screws, nails, glue or epoxy, or other suitable fasteners therein. In some embodiments, fasteners120may be constructed from aluminum, titanium, stainless steel, or other metallic alloys. In some embodiments, fasteners120may be constructed from a thermoplastic polymer. In some embodiments, fasteners120may be constructed from any known or yet to be discovered material that is capable of maintaining its form and shape up to the highest temperature range that printing device10is capable of achieving. Fasteners120may aid in increasing the heat distribution or dissipation properties of top build layer110. For example, fasteners120may aid in distributing or dissipating heat generated from heating layer106across the surface of top build layer110.

In some embodiments, fasteners120may be used to mechanically couple top build layer110to at least one of the plurality of layers of build plate100, such as top frame layer109. Alternatively, in some embodiments, each of the plurality of layers of build plate100may secured together through the use of mechanical fasteners, such as screws, bolts, or epoxy.

For example, as illustrated inFIG. 2B, in some embodiments bottom frame layer102may form the bottom of build plate100. Insulating layer104may be positioned within recess112. Heating layer106may then be placed within recess112adjacent to and on top of insulating layer104. Intermediate layer108may then be positioned within recess112adjacent to and on top of heating layer106. Top frame layer109may then be placed on top of bottom frame layer102, acting as an enclosure for insulating layer104, heating layer106, and intermediate layer108. Top frame layer109and bottom frame layer102can then be coupled or secured together using mechanical fasteners, adhesives, or other fastening methods. Top build layer110may be positioned within recess122of top frame layer109and anchored therein, as discussed above.

In some embodiments, build plate100may further include at least one optional or additional cooling device (not shown) to aid in regulating the temperature of build plate100. In some embodiments, a cooling device may be located internally within build plate100. In some embodiments, printing device10may include an additional cooling device located externally from build plate100. Cooling device may be configured as any known system or device for cooling hardware or parts and may be configured as a fan, a baffle, a water-cooling device, or any other known cooling devices or systems. In some embodiments, there may be a plurality of cooling devices for cooling heated build plate100.

In some embodiments, build plate100can be positioned below print head200in the z-plane and provide a printing surface for receiving printing material thereon. In some embodiments, printing material can be printed directly onto top build layer110. In some embodiments, heat generated by heating layer106can transfer up through build plate100and reach top build layer110, where the heat may then be distributed across the top surface of top build layer110. This distribution of heat can reduce, prevent, or eliminate the presence of heat sinks or hot spots, which can cause warping of printed objects800and/or top build layer110.

In some embodiments, a heated build plate100can aid in improving the quality of the printed object800. For many printing filaments and materials, there can be a tendency for the material to crystallize if it cools too quickly after being dispensed, Therefore, it is advantageous to maintain the temperature of the printing material while it is on the printing surface, such as top build layer110. In some embodiments, heat generated from heating layer106can transfer up through the z-plane until reaching top build layer110. Once reaching top build layer110, the heat can dissipate or otherwise be distributed throughout top build layer110. The heat generated from heating layer106and dissipated in top build layer110can create a heating effect to the printed object, thereby preventing or reducing crystallization of the printed object800.

In some embodiments, build plate100may be configured to operationally and selectively move in the z-plane. Lower assembly260includes a support structure262for receiving build plate100thereon. In some embodiments, build plate100may be secured to support structure262via connectors130, whereby connectors130anchor build plate100to support structure262. Alternatively or additionally, in some embodiments build plate100may be configured to move in the x-y plane. In some embodiments, as illustrated inFIG. 1B, build plate100may be attached via support structure262to a motorized lower drive train124or mechanized platform having a motor126, that can be selectively and controllably configured to move in the z-plane and/or the x-y plane. In some embodiments, motorized lower drive train124can comprise a first lower sub-assembly264and a second lower sub-assembly266. In some embodiments, first lower sub-assembly264can be configured to move build plate100in the x-plane. In some embodiments, second lower sub-assembly266can be configured to move build plate100in the y-plane. Alternatively, in some embodiments, first lower sub-assembly264can be configured to move build plate100in the y-plane. In some embodiments, second lower sub-assembly266can be configured to move build plate100in the x-plane. In some embodiments, lower drive train124can be communicatively coupled to control system50. Control system50can be programmed and/or configured to command lower drive train124to move up and/or down in the z-plane and/or to move laterally in the x-y plane. In some embodiments, control system50can respond to manual controls for moving build plate100. In some embodiments, control system50can be programmed with a machine learning algorithm and instructions to move build plate100in response to certain predetermined parameters such as, for example, temperature of the interior of housing unit12, temperature of the printed object800, and/or distance between build plate100and print head200. In alternative embodiments, lower drive train124may be manually operated by a non-motorized means. For example, lower drive train124could be manually operated by a mechanical lift. It will be appreciated that there are numerous methods and systems that could be implemented for moving build plate100in the z-plane and/or in the x-y plane, and any suitable method or system could be implemented in the present invention.

FIGS. 3A-3Billustrate an embodiment of a portion of upper assembly201.FIG. 3Aillustrates a perspective view of upper assembly201in an assembled state andFIG. 3Bshows an exploded view thereof.

In some embodiments, upper assembly201may be used for heating and dispensing a printing material, such as printing filament400. As can be seen inFIG. 1B, upper assembly201includes a support structure278for receiving print head200and reflector unit300thereon. Upper assembly201includes coupling plate272, bracket274, and vertical support270. Upper assembly201also includes a motor276operatively connected to an upper drive train280. In some embodiments, coupling plate272is anchored to support structure278and bracket274is anchored to coupling plate272. Bracket274receives vertical support270therein and is anchored thereto. In some embodiments, print head200and reflector unit300are secured to vertical support270.

In some embodiments, vertical support270may be coupled to an upper drive train280, for selectively moving vertical support270and the components secured to vertical support270. Upper drive train280may be configured to selectively move in the z-plane. In some embodiments, upper drive train280can be communicatively coupled to control system50. Control system50can be programmed and/or configured to command upper drive train280vertically in the z-plane. In some embodiments, upper drive train280may additionally or alternatively be configured to selectively move in the x-y plane. In some embodiments, control system50can respond to manual controls for moving print head200and reflector unit300. In some embodiments, control system50can be programmed with a machine learning algorithm and instructions to move print head200in response to certain predetermined parameters, such as for example the temperature of the interior of housing unit12, the temperature of the printed object800, or the distance between build plate100and print head200. In alternative embodiments, upper drive train280may be a manually operated by a non-motorized means. For example, upper drive train280could be manually operated by a mechanical lift. It will be appreciated that there are numerous methods and systems that could be implemented for moving print head200and reflector unit300in the z-plane and/or the x-y plane, and any suitable method or system could be implemented in the present invention.

FIG. 4illustrates a cross-sectional view of print head200. In some embodiments, print head200may consist of various components and parts for heating and dispensing printing material, such as printing filament400. In some embodiments, print head200may comprise a cooler204, a heater206, at least one bridge208, and a nozzle210. Print head200may further comprise a feed tube212for feeding printing material400into and through print head200prior to dispensing printing material400onto build plate100. Feed tube212may be constructed from a metal, such as aluminum, titanium, or any other suitable material. In some embodiments, feed tube212may extend generally axially. Feed tube212may comprise an inlet214for receiving a forwardly driven printing filament400of a solid disposition material. Feed tube212may further comprise an outlet216, positioned downstream from inlet214. An hollow internal passage218may connect inlet214to outlet216. Internal passage218may comprise an upstream portion220and a downstream portion222. In some embodiments, feed tube212may have an inner surface coated with an adhesion-reducing substance to prevent the printing material400from sticking thereto. For example, inner surface of feed tube212may be coated with electroless nickel, an electroless nickel-boron composite, tungsten disulfide, molybdenum disulfide, boron nitride, diamond-like carbon, or any other suitable material, or combinations thereof.

In some embodiments, heater206may be thermally coupled with downstream portion222. Heater206may be used for heating the printing filament400as the printing filament400passes through feed tube212and reaches downstream portion222. Heater206may comprise a heating element224, which can be selectively controlled to heat printing filament400. In some embodiments, heating element224may be a thermally conductive material comprising a heater, such as a glow wire or conductive circuitry. In some embodiments, heating element224may be any known electrical or chemical heating element. In some embodiments, heater206may be communicatively coupled to control system50, for selectively controlling the parameters of heater206. For example, control system50may control when heater206is activated, the duration of the activation, and/or the amount of generated heat such that printing material400may be maintained at the desired temperature. In some embodiments, heater206may be manually controlled and adjusted by inputs entered into control system50. In some embodiments, heater206may be automatically controlled based on predetermined parameters and adjusted by control system50for automatically regulating temperature of printing material400during operation.

In some embodiments, heater206may be heated to a temperature that is capable of melting printing filament400as printing material400is transported through downstream portion222. For example, in some embodiments printing material400may be a PEEK filament. Heater206may heat printing material400to at least 430° C. In some embodiments, heater206can be configured to heat printing material400from about 130° C. to about 500° C. Printing material400may be selected from any known material or filament for printing or additive manufacturing, and heater206can be configured to heat the printing material400to at least a melting temperature.

In some embodiments, cooler204may be thermally coupled with upstream portion220and can be used for regulating the temperature of printing filament400as it passes through feed tube212. In some embodiments, cooler204may be spaced generally axially upstream from heater206with a defined gap226or space separating cooler204from heater206. Gap226may be filled with at least one bridge208, providing a rigid mechanical connection between heater206and cooler204. In some embodiments, cooler204may comprise a thermoelectric cooler or a heat sink comprising heat-conductive material. In some embodiments, cooler204may comprise a strain-hardened stainless steel surgical tubing, which may have a thermal conductivity of less than about 15 W/mK, a tensile strength of greater than about 100 MPA, and a surface roughness of less than about 0.5 μm. In some embodiments, cooler204may comprise an internal heat transfer passage (not shown) configured to receive a cooling fluid. In some embodiments, a heat transfer passage may be configured to receive air for cooling. In some embodiments, upstream portion220may further be coupled with at least one secondary cooler228for directly cooling printing material400.

In some embodiments, print head200may be configured to comprise a hot zone240. Hot zone240may generally be a defined space, void, or heat break zone positioned approximately in the area between heater206and cooler204and secondary cooler228. In some embodiments, hot zone240can provide a clean line of separation, separating the heat generated from heater206from the cooler temperatures defined by the cooler204and secondary cooler228. For example, as printing material400passes through feed tube212, it is advantageous for the printing material400to remain in a solid state until reaching the break zone of hot zone240. As printing material400travels down through downstream portion222and reaches hot zone240, printing material400can begin to be heated by heater206. The heat generated by heater206begins to heat and melt printing material400only after printing material400passes through hot zone240, transitioning printing material400from a solid to a molten liquid state. In some embodiments, the heater206comprises a copper alloy, which may have a conductivity of greater than about 300 w/mK, and a tensile strength of greater than about 500 MPA, which is especially resistant to creep at high temperatures. The heat flows efficiently inward through the heater206to melt the filament quickly. Hot zone240maintains printing material400in a solid state until reaching downstream portion222surrounded by heater206. The clean line of separation defined by hot zone240further prevents heat creep in feed tube212. For example, in FFF printing systems, it is problematic to heat printing material400prior to dispensing. Heating printing material400prior to dispensing can cause the printing material to crystalize, which can lead to imperfections in the final printed object. In some embodiments, hot zone240can have a dimension of about 0.5 mm to about 1.5 mm, such that there is minimal space between the solid and the melted material.

Print head200may further comprise a nozzle210, which may be attached to heater206and coupled to outlet216of feed tube212. Nozzle210may be the lowest positioned part of print head200and may further be the final part that printing filament400passes through prior to dispensing. Nozzle210may be smooth bored or threaded, depending on the embodiment. In some embodiments, an inner surface of nozzle210may be coated with an adhesion-reducing material. In some embodiment, the adhesion-reducing material may be electroless nickel, an electroless nickel-boron composite, tungsten disulfide, molybdenum disulfide, boron nitride, diamond-like carbon, or any other suitable material, or combination thereof. The diameter of nozzle210may vary, depending on the embodiment, and may be designed to generally match of dimensions of printing material400. In some embodiments the diameter of nozzle210may be selected from a range of about 0.2 mm to about 0.5 mm. Furthermore, it will be appreciated that in some embodiments, nozzle210may be removable and replaceable. In some embodiments, a plurality of nozzles210each having a different diameter or size may be provided whereby a user may select a desired size. For example, in some embodiments printing material400may comprise a filament having a diameter of about 1.75 mm, which requires a nozzle210having a diameter of about 0.2 mm to about 0.5 mm. A nozzle210having a diameter of 3 mm can be selected from a plurality of nozzles210and attached to print head200for dispensing a particular printing material400.

In some embodiments, print head200may further comprise one or more sensors242for measuring the temperature of printing material400, feed tube212, heater206, cooler204, and/or any other portion of print head200. Sensors242may be located internally at various locations within print head200or alternatively, may be externally located. In some embodiments, sensors may be communicatively coupled to control system50and the measurement therefrom may be provided to display52.

In some embodiments, printing device10may comprise a reflector unit300that cooperates with print head200. In some embodiments, reflector unit300may be located adjacent to and/or partially surrounding print head200. In some embodiments, reflector unit300comprises a reflective plate302having a bottom surface314configured to reflect heat towards build plate100and/or the printed object800. In some embodiments, reflective plate302may be constructed from a material having heat reflecting properties. For example, reflective plate302may be constructed from stainless steel, aluminum, titanium, or other materials having heat reflecting properties. In some embodiments, reflective plate302is a thick film stainless steel plate.

Reflective plate302may generally comprise any geometric shape and depending on the embodiment may be circular, triangular, rectangular, pentagonal, or any other geometric shape. The dimensions of reflective plate302may further vary, depending on the embodiment. In some embodiments, reflective plate302may have a dimension that is larger than the dimensions of the object800being printed. In some embodiments, reflective plate302may have a maximum dimension such that when reflector unit300is moved in the x-y plane, reflective plate302will not come into contact with frame14, panels16, or thermally insulating material18.

For example, in some embodiments, printing device10may be used for printing three-dimensional objects800, such as medical implants. Such implants may have a dimension of about three inches in width and/or length. In some embodiments, reflective plate302may have a dimension that is at least larger than the dimension of the three-dimensionally printed object800. In some embodiments, reflective plate302may have a dimension of about 140 mm2. In some embodiments, reflective plate302may have larger or smaller dimensions, such as about 25 mm2to about 300 mm2.

In some embodiments, reflector unit300may be configured to be an active heater. In some embodiments, when in an off or non-energized state, reflector unit300may be configured to be a passive heat reflector. In some embodiments, bottom surface314of reflective plate302reflects heat, which may be generated by build plate100or other sources of heat, towards top build layer110and/or the printed object800during operation. In some embodiments, reflector unit300can reflect heat generated from heating layer106and thus heat the printed object800from multiple directions. For example, in some embodiments the printed object800can be heated from below by heating layer106and from above by reflector unit300. The reflection of heat by reflector unit300can aid in maintaining a desired temperature of the printed object800, preventing unwanted crystallization or warping. A controlled heat environment aids in forming a more uniform and structurally sound printed object800.

In some embodiments, reflector unit300may further comprise an active heater303configured to be selectively controlled. In some embodiments, active heater303may be configured to generate heat, which may be directed towards the top surface of build plate100and/or the printed object800. In some embodiments, active heater303may be positioned on top surface of reflective plate302. In some embodiments, active heater303can be constructed from a conductive material, such that when an electric current is applied thereto, the conductive material generates heat. In some embodiments, reflective plate302can comprise a plate of at least partially composed of a thermally insulating material, having an active heater303, such as a glow wire, conductive conduit, or other conductive material positioned on a top surface thereof. The active heater303may generate heat when an electric current is applied thereto. Active heater303can be coupled to an energy source, such as a battery or electrical outlet, for supplying an electrical current to active heater303. In some embodiments, an energy source may be incorporated into printing device10. In some embodiments, an energy source may be external to the printing device10.

In some embodiments, reflector unit300may further comprise a reflector housing306and an insulator304. In some embodiments, insulator304may be placed on a spacer, providing a gap between reflective plate302and insulator304. Reflective plate302and insulator304may be attached and secured within reflector housing306. In some embodiments, reflector housing306may be configured to have the same general shape and design as reflective plate302. In some embodiments, insulator304may be configured to have the same general shape and design as reflective plate302. In some embodiments, insulator304can have dimensions such that it may be placed and secured between reflector housing306and reflective plate302. Reflector housing306may include side walls316forming a recess318. Insulator304and reflective plate302may be received within recess318of reflector housing306, as seen inFIGS. 3A and 3B. In order to anchor the reflector unit300together, in some embodiments, plate302includes holes322, insulator304includes holes324, and reflector housing306includes holes326for receiving connectors therethrough.

In some embodiments, reflector unit300can be configured to at least partially surround print head200. As illustrated inFIGS. 3A and 3B, in one embodiment, a central opening308may be defined in reflective plate302, a central opening310may be defined in insulator304, and a central opening312may be defined in reflector housing306. Openings308,310, and312may be aligned such that they create one continuous opening when reflective plate302, insulator304, and reflector housing306are assembled. In some embodiments, openings308,310, and312may be configured to correspond to the shape of the distal end of print head200. In some embodiments, a distal portion of print head200may pass through openings308,310, and312such that reflector unit300at least partially surrounds print head200. As illustrated inFIG. 3A, in some embodiments, a distal end of print head200will extend out from reflector unit300. In some embodiments, a distal portion of print head200, which may include nozzle210, is positioned below reflector unit300.

In another embodiments, reflector unit300may be positioned adjacent to print head200and thus not require openings308,310, and312. In such an embodiment, print head200does not pass through reflector unit300. In some embodiments, there may be one or more reflector unit300and the reflector units300may be positioned adjacent to print head200. In some embodiments comprising a plurality of reflectors300, all reflector units300may not be active at the same time. Thus, each of the reflector units300can be independently controlled and independently operated. For example, in an embodiment comprising two reflector units300, active heater303of a first reflector unit300may be energized and generate heat in an active state, while a second reflector unit300may include active heater303that is off and in a passive state. In such an example, although only the first reflector unit300is actively generating heat, both reflector units300are passively reflecting heat towards build plate100.

In some embodiments, one or more active heaters303can be communicatively coupled to control system50for selectively controlling the parameters for active heater303. As described in greater detail below, control system50may monitor and regulate the temperature and state (on/off) of active heater303. For example, control system50may sense and monitor the temperature of printed object800and, depending on the sensed temperature, may energize or de-energize active heater303to control the heat directed towards printed object800. For example if the temperature of printed object800is above a predetermined threshold, control system may de-energize active heater303to reduce the heat directed towards printed object800. In some embodiments, control system50may be used to transmit manually inputted commands and may energize or de-energize active heater303in response to the manually inputted commands.

In some embodiments, reflector unit300may further comprise at least one cooling device or system (not shown) for cooling reflector unit300. In some embodiments, cooling device may be located within reflector housing306. In some embodiments, cooling device may be located externally on reflector housing306. Cooling device may be configured as any known cooling device or system, such as a fan or a liquid cooling system. In some embodiments, cooling device may be communicatively coupled to control system50. In some embodiments, control system50may automatically monitor and regulate cooling device. In some embodiments cooling device may be manually controlled by instructions and inputs entered into control system50.

FIG. 5is a perspective view of an embodiment of the interior of housing unit12. In some embodiments, printing device10may further comprise at least one additional heat source. In some embodiments, the additional heat source may comprise at least one infrared (IR) light500. It will be appreciated that IR light500could be replaced with any other known and suitable source for generating heat and is not intended to be a limiting feature. In some embodiments, IR light500may be positioned above build plate100and oriented to direct heat towards build plate100. In some embodiments, IR light500may be attached and/or connected to housing unit12. IR light500may be fastened to frame14or may be a stand-alone device located within interior of housing unit12. In some embodiments, IR lights500may be attached to upper assembly201such that IR lights500are configured to move together with print head200and reflector unit300. As can be seen inFIG. 5, one embodiment of printing device10comprises two opposing IR lights500. In some embodiments, printing device10may comprise any number of IR lights500. In some embodiments, IR light500may be communicatively coupled to control system50to selectively operate IR light500. For example, control system50may be manually controlled to transition each IR light500from an off state to an on state. Alternatively, in some embodiments IR light500may be automatically controlled by control system50such that it is programmed to turn on or off based on predetermined parameters to maintain an optimized temperature of printed object800on build plate100.

FIG. 6is a perspective view of a material housing402for printing material400that may be used with printing device10. Printing device10may be compatible with numerous printing materials including but not limited to high-performance polymers, such as PEEK, PAEK, PEKK, and/or combinations thereof. In some embodiments, printing material400may be in a filament form. Printing material400may comprise a range of diameters such as about 1 mm to about 5 mm in diameter.

In some embodiments, the printing material400may be implantable grade poly ether ketone rod stock, such as Vestakeep® i-Grade materials, Vestakeep® i4 R, or Vestakeep® i4 G resin. In some embodiments, the printing material400may be any medical grade FDA-approved material. In some embodiments, the printing material400may have a diameter of about 6-20 mm, about 25-60 mm or about 70-100 mm and a length of about 3000 mm, about 2000 mm, or about 1000 mm. In some embodiments, the printing material may be provided on a spool and have a length of about 60 mm or 160 mm and a diameter of about 1.75 mm. Printing material may be biocompatible, bistable, radiolucent, and sterilizable.

In some embodiments, printing material400may be housed in a material housing402, which may be in the form of a spool, cylinder, or other suitable enclosure for the printing material400. In one embodiment, material housing402can be a cylindrical housing unit comprising a filament spool404for rotatably receiving printing material400in a rotating manner. Spool has a central core410and side wall412for receiving the printing material400therebetween and a top cover414. In some embodiments, printing material400may be wound around the central core410in a concentric manner.

In one embodiment, material housing402may be coupled to housing unit12by being mounted on frame14. In one embodiment, material housing402may be coupled to one of the panels16. In some embodiments, material housing402may be externally located, such as for example on a surface near printing device10. In one embodiment, material housing402may be located on top of housing unit12, either internally or externally. In some embodiments, material housing402can protect printing material from damage and heat. In some embodiments, material housing402may also help control the input of printing material400and prevent printing material400from unrolling on its own.

A distal end of the filament of printing material400extends from the material housing402to be receiving into feed tube212of print head200. Printing material400can be conveyed to print head200by way of a transport device406. Transport device406can provide a mechanical means for unspooling or otherwise transferring printing material400from material housing402to feed tube212. In some embodiments, printing material400is conveyed to print head200via transport device406while printing material400is in a solid state. In some embodiments, transport device406may be configured as a mechanical extruder. Transport device406may have at least one operating state, for dispensing printing material400from material housing402to feed tube212. The rate at which printing material400may be dispensed may be selectively controlled by control system50. In some embodiments, printing material400may be dispensed at a rate of about 2 mm to about 20 mm per second. In some embodiments, printing material400may be dispensed at a faster or slower rate, which may vary during operation as desired. In some embodiments, transport device406may further be coupled to an extruder assembly408. In some embodiments, extruder assembly408may comprise a motor, planetary gear, and extruder to provide a forward drive element to transport device406for feeding printing material400from material housing402to feed tube212. Extruder assembly408can aid in ensuring that printing material400is fed to print head200in a consistent and reliable manner. Furthermore, extruder assembly408can aid in dispensing printing material400consistently and achieving a stable build during printing.

In some embodiments, printing device10may further include one or more temperature sensors for measuring the temperature within housing unit12at multiple locations. For example, sensor510may measure the temperature of build plate100, sensor244may measure the temperature of printing material400within print head200, sensor242may measure the temperature of nozzle210of print head200. Sensors may be located at a plurality of positions within the interior of housing unit12. In some embodiments, sensors may be located within build plate100, print head200, and/or reflector unit300. Alternatively, in some embodiments, sensors may be located externally on build plate100, print head200, and/or reflector unit300. In some embodiments, sensors may be used to measure the temperature of various elements in printing device10. For example, sensors may be used to measure the temperature of printing material400at various points in the process, such as prior to reaching print head200, at the print head200, while printing material400is being dispensed, and after printing material400is received on top build layer110. In some embodiments, sensors510,242,244may be thermistors or thermocouples. In some embodiments, sensors may be communicatively coupled to control system50. For example, sensors could be used to measure the temperature of the current layer being printed of printed object800during printing. The measured temperature may then be transmitted to control system50and may be shown on display52.

In some embodiments, printing device10may further comprise one or more cooling devices (not shown). In some embodiments, cooling devices may be one or more fans positioned within the interior of housing unit12. In some embodiments, fans may be directionally oriented such that airflow may be directed towards build plate100and the printed object800, thereby selectively cooling only build plate100and/or the printed object800. Alternatively, in some embodiments, fans may be directionally oriented and positioned to direct airflow throughout the interior of housing unit12, thereby providing ambient cooling of interior of housing unit12, rather than specific cooling of selected locations. In some embodiments, cooling devices may comprise tubing located within housing unit12for liquid cooling. In some embodiments, tubing may be positioned at various points within housing unit12, and may be used for cooling build plate100, print head200, reflector unit300, and/or for cooling the interior of housing unit12generally. Tubing may be configured to receive water, liquid nitrogen, ethylene glycol/water mixture, propylene glycol/water mixture, or any other liquids that may be used in liquid cooling systems. In some embodiments, cooling devices may be communicatively coupled to control system50. Control system50may be programmed to automatically control cooling devices and/or cooling devices may be manually controlled by instructions inputted into control system50.

FIG. 7illustrates an exemplary computer hardware system700, that may cooperate with printing device10and control system50. Computing device702can be a desktop computer, a laptop computer, a server computer, a mobile device such as a smartphone or tablet, or any other form factor of general- or special-purpose computing device. Depicted with computing device702are several components, for illustrative purposes. In some embodiments, certain components may be arranged differently or absent. Additional components may also be present. Included in computing device702is system bus704, whereby other components of computing device702can communicate with each other. In certain embodiments, there may be multiple busses or components may communicate with each other directly. Connected to system bus704is central processing unit (CPU)706. Also attached to system bus704are one or more random-access memory (RAM) modules708.

Also attached to system bus704is graphics card710. In some embodiments, graphics card710may not be a physically separate card, but rather may be integrated into the motherboard or the CPU706. In some embodiments, graphics card710has a separate graphics-processing unit (GPU)712, which can be used for graphics processing or for general purpose computing (GPGPU). Also on graphics card710is GPU memory714. Connected (directly or indirectly) to graphics card710is computer display716for user interaction. In some embodiments no display is present, while in others it is integrated into computing device702. Similarly, peripherals such as keyboard718and mouse720are connected to system bus704. Like computer display716, these peripherals may be integrated into computing device702or absent. Also connected to system bus704is local storage722, which may be any form of computer-readable media and may be internally installed in computing device702or externally and removably attached.

Finally, network interface card (NIC)724is also attached to system bus704and allows computing device702to communicate over a network such as network726. NIC724can be any form of network interface known in the art, such as Ethernet, ATM, fiber, Bluetooth, or Wi-Fi (i.e., the IEEE 802.11 family of standards). NIC724connects computing device702to local network726, which may also include one or more other computers, such as computer728, and network storage, such as data store730. Local network726is in turn connected to Internet732, which connects many networks such as local network726, remote network734or directly attached computers such as computer736. In some embodiments, computing device702can itself be directly connected to Internet732.

The computer program of embodiments of the invention comprises a plurality of code segments executable by a computing device for performing the steps of various methods of the invention. The steps of the method may be performed in the order discussed, or they may be performed in a different order, unless otherwise expressly stated. Furthermore, some steps may be performed concurrently as opposed to sequentially. Also, some steps may be optional. The computer program may also execute additional steps not described herein. The computer program, system, and method of embodiments of the invention may be implemented in hardware, software, firmware, or combinations thereof, which broadly comprises server devices, computing devices, and a communications network.

The computer program of embodiments of the invention may be responsive to user input. As defined herein user input may be received from a variety of computing devices including but not limited to the following: desktops, laptops, calculators, telephones, smartphones, smart watches, in-car computers, camera systems, or tablets. The computing devices may receive user input from a variety of sources including but not limited to the following: keyboards, keypads, mice, trackpads, trackballs, pen-input devices, printers, scanners, facsimile, touchscreens, network transmissions, verbal/vocal commands, gestures, button presses or the like.

The monitor, server devices, and computing devices702may include any device, component, or equipment with a processing element and associated memory elements. The processing element may implement operating systems, and may be capable of executing the computer program, which is also generally known as instructions, commands, software code, executables, applications (“apps”), and the like. The processing element may include processors, microprocessors, microcontrollers, field programmable gate arrays, and the like, or combinations thereof. The memory elements may be capable of storing or retaining the computer program and may also store data, typically binary data, including text, databases, graphics, audio, video, combinations thereof, and the like. The memory elements may also be known as a “computer-readable storage medium” and may include random access memory (RAM), read only memory (ROM), flash drive memory, floppy disks, hard disk drives, optical storage media such as compact discs (CDs or CDROMs), digital video disc (DVD), and the like, or combinations thereof. In addition to these memory elements, the server devices may further include file stores comprising a plurality of hard disk drives, network attached storage, or a separate storage network.

The computing devices may specifically include mobile communication devices (including wireless devices), workstations, desktop computers, laptop computers, palmtop computers, tablet computers, portable digital assistants (PDA), smartphones, and the like, or combinations thereof. Various embodiments of the computing device may also include voice communication devices, such as cell phones and/or smartphones. In preferred embodiments, the computing device will have an electronic display operable to display visual graphics, images, text, etc. In certain embodiments, the computer program facilitates interaction and communication through a graphical user interface (GUI) that is displayed via the electronic display. The GUI enables the user to interact with the electronic display by touching or pointing at display areas to provide information to the monitor.

The communications network may be wired or wireless and may include servers, routers, switches, wireless receivers and transmitters, and the like, as well as electrically conductive cables or optical cables. The communications network may also include local, metro, or wide area networks, as well as the Internet, or other cloud networks. Furthermore, the communications network may include cellular or mobile phone networks, as well as landline phone networks, public switched telephone networks, fiber optic networks, or the like.

The computer program may run on computing devices or, alternatively, may run on one or more server devices. In certain embodiments of the invention, the computer program may be embodied in a stand-alone computer program (i.e., an “app”) downloaded on a user's computing device or in a web-accessible program that is accessible by the user's computing device via the communications network. As used herein, the stand-alone computer program or web-accessible program provides users with access to an electronic resource from which the users can interact with various embodiments of the invention.

In some embodiments, prior to the printing process, the object data corresponding to an object800to be printed can be transmitted to control system50, which may cooperate with or include computing device702. In some embodiments, the object data may be transmitted to control system50in file formats such as .stl, obj. or .amf, or any other file format created by a computer-aided design (CAD) program or software. In some embodiments, the object data may include the geometry of the object800to be printed as well as additional information such as tolerances, expansions, strength properties, etc. Subsequently, the CAD data may be divided up into individual layers, such as by means of a slicer program or software. Accordingly, the slicer software may transform the 3D model of the CAD software into a readable format for control system50. In this regard, division into layers can take place both externally and in printing device10itself. In some embodiments, before the printing process, a shrinkage process of the printed object during cooling after a printing process may be calculated. The print routine of the individual layers can be translated into machine readable code and transmitted to control system50. In some embodiments, the software of control system50can be a web-based application. In some embodiments, the software of control system50can be a computer-based software program.

In some embodiments, the object data transmitted to printing device10may be a generic, or otherwise non-custom designs for objects800. Such designs may be useful for mass production products or when the printed object800will be repeatedly printed. In some embodiments, the object data may be for creating a specific, custom, or one-of-a-kind object, wherein the printed object800will be a uniquely designed.

For example, in some embodiments, printing device10may be used to print objects800such as medical devices or surgical implants, including spinal implants, maxillo-facial implants, ankle or foot wedges, or cranial plates. Implants that are designed to be patient-specific and are custom-made may have increased effectiveness. Such implants may be custom designed and configured to match the anatomy of a specific patient and may be configured to be printed on-site. Computer modeling may be used for obtaining three-dimensional images of the specific patient's anatomy through the use of MRI or CT scans, and designs, parameters, and other object data information may be constructed and designed using various CAD programs or software. Accordingly, in some embodiments, the object data may comprise unique and patient specific instructions for printing a patient-specific object800, such as a surgical implant.

FIG. 8Aillustrates an exemplary embodiment of a printed object800that may be printed using a FFF process with printing device10. Printed object800may comprise a medical implant802, a raft816, and a scaffolding818. Implant802may comprise a plurality of layers804, a first porous region806, a second porous region808having a lattice work structure810, and a void812. Raft816may be a printed structure, printed directly on top build layer110and which acts as a barrier between direct contact of medical implant802and top build layer110. Raft816may further reduce or limit the frequency of warping or crystallization of medical implant802. Raft816creates an interface between the implant and the top build layer110. Raft816is composed of the same material as the implant800. In some embodiments, raft816may be composed of about three printed layers on top of one another. The printing material in the raft816may be loosely spaced and is simply to provide structure to build the implant802upon.

As described in greater detail below, printed object800may further comprise a scaffolding818. In some embodiments, scaffolding818may be used to create a level build plane for medical implant802, such that when each layer of the plurality of layers804is printed, printing material400is dispensed on a generally horizontal and level plane. Scaffolding818may be broken away once the implant802is finished and ready for use. In some embodiments, the scaffolding818may be have a slanted top surface, such as when it is desired for the bottom surface of the implant802to be tapered. The top surface of the scaffolding818may be slanted at a particular angle, such as 7 degrees to about 45 degrees, however any angle may be used as desired. Thus, the orientation of the implant802may change based on the shape of the scaffolding818.

In some embodiments and as described in greater detail below, a test circle814may be printed prior to printing printed object800to ensure that printing material400is being dispensed at the correct consistency and flow rate. After receiving the object data of a printed object800, printing device10may begin the printing process. As stated above, printing device10may be used in a variety of additive manufacturing processes including without limitation FFF printing.

FIG. 9illustrates one embodiment of a method900of using printing device10to print printed object800. A first step in method900may comprise a power up902and review step. Power up902may comprise diagnostics of control system50and the user interface, web-based application, or program, ensuring that control system50is working properly. Power up902may further include a review of a network status of control system50, a review of lower drive train124and upper drive train280, and a review of an ambient temperature within housing unit12.

A second step of method900may further include a build prep904step. For example, during build prep904a cleaner may be used to clean top build layer110of build plate100in order to prepare the surface of top build layer110to receive printing material400. In some embodiments, the cleaner may be an acetone cleaner. Build prep904may further include wiping top build layer110with a lint-free cloth and isopropyl alcohol.

A third step of method900may include a nozzle prep906step. During nozzle prep906, print head200may be inspected and reviewed to ensure that it is prepared for printing. For example, during nozzle prep906feed tube212may be inspected for debris or other blockages, such as leftover printing filament400from a previous printing. For example, in an embodiment in which printing filament400is comprised as PEEK, print head200may be heated to about 350° C. to melt any leftover PEEK that may be blocking feed tube212. Print head200may further be cleaned with a cleaner, such as a cotton swab.

A fourth step of method900may include a filament prep908step. In some embodiments, printing material400may comprise a material that is either dangerous to touch with a bare hand or would otherwise lose effectiveness is touched by a bare hand. Therefore, it may be advantageous to load printing material400into material housing402using nitrile, or other sterile gloves. Printing filament400may then be partially unspooled, or otherwise fed into transport device406. In some embodiments, there may be printing material400that is at least partially exposed to air, or otherwise not contained within material housing402. The exposed printing material400may further be cleaned, wiped, or otherwise prepped with isopropyl alcohol or another cleaner, to aid in maintaining purity of printing material prior to printing. During filament prep908, printing material400may be cut to a predetermined length.

A fifth step of method900may include a build plate prep910step. In some embodiments, build plate100may be pre-heated to a predetermined temperature. In some embodiments, the predetermined temperature may be based on the specific composition of printing material. For example, in some embodiments, printing material400may comprise a PEEK filament, printed using a FFF method of additive manufacturing. In such an embodiment, build plate100can be preheated to about 145° C. Pre-heating build plate100to about 145° C. can help to prevent warpage of top build layer110and/or help prevent crystallization of printed object800during printing. Build plate100may alternatively be pre-heated to a range of temperatures, depending on the embodiment and the composition of printing material400. In some embodiments, build plate100may be preheated to a temperature of about 50° C. to about 350° C. It will be appreciated that depending on the embodiment, build plate100may be pre-heated to any temperature required for additive manufacturing. Build plate may be pre-heated using the heating layer106, the reflector unit300, and/or the IR lights500.

A sixth step of method900may include a heating print head912step. In some embodiments, print head200may be pre-heated to a temperature that is hot enough to melt printing material400, and transition printing filament400from a solid state to a liquid or molten state. For example, in some embodiments, printing material400may comprise a PEEK material and print head200may be pre-heated to about 450° C. to melt the PEEK for dispensing. In some embodiments, print head200may be heated to a temperature that transitions printing filament400from a solid state to a glossy state, whereby print head200can be heated to a temperature that is able to maintain printing material400at or near a glass transition state.

A seventh step of method900may include priming filament914. During priming filament914, a pre-determined amount of printing material400can be transported from material housing402to feed tube212and dispensed out from nozzle210onto top build layer110. In some embodiments, the predetermined amount of material400may be dispensed out into a test circle814, for example, or as a line or other shape. Test circle814may be used as a test to determine whether the flow and dispensing of printing material is at an acceptable level, ensuring that the flow of printing material400is even and at a desired dispensing speed.

An eighth step of method900may include an object print process916step. During object print process, lower drive train124, upper drive train280, build plate100, print head200, reflector unit300, IR lights500, sensors242,244,510, and any other component of printing device10that is communicatively coupled to control system50can be controlled by control system50. The temperature of print head200, the temperature of printing material400, the position of build plate100, and other pertinent parameters can be displayed on display52during object print process916. During object print process916, object data for a specific printed object800can be selected and uploaded or transmitted to control system50, whereby the design, parameters, and other information comprising the object data may be used for mapping or setting the printing pattern of printed object800. As discussed in greater detail below, in some embodiments G-code or software executed by control system50can break down a 3-D model of printed object800into slices or a plurality of layers, wherein a printing pattern can be implemented for each slice or layer.

During object print process916, printing material400may be continuously fed through feed tube212and continuously dispensed from nozzle210. The rate at which printing material400is fed through feed tube212and dispensed from nozzle210may be monitored and regulated by control system50. Accordingly, control system50may be used to increase or decrease the rate at with dispensing material400is fed through feed tube212. It will be appreciated that during object print process916, the rate at which printing material400is fed through feed tube212or dispensed from nozzle210may fluctuate. In some embodiments, as printing material400is fed through feed tube212and reaches heater206, printing material400may be heated and melted so that it can be dispensed out from nozzle210. After melting, printing material400can then be dispensed from nozzle210onto the pre-heated top build layer110.

In some embodiments, printing material400may be used to print a raft816on top build layer110, prior to printing implant802. Raft816may be printed on top build layer110and act as either a stabilizer, buffer layer, or protection layer providing a barrier between printed implant802and top build layer110, preventing direct contact between printed implant802and top build layer110. Accordingly, raft816may comprise a dimension that is larger than the dimensions of printed implant802, wherein raft816prevents any direct contact between printed implant802and top build layer110. Raft816may have a surface that is larger than the surface of printed object800, wherein printed implant802is printed entirely on the surface of raft816and does not come into contact with top build layer110. In some embodiments, raft816may comprise a generally elliptical shape. In some embodiments raft816may comprise any geometric shape, and for example, may be circular, triangular, rectangular, pentagonal, or any polygonal shape. In some embodiments, printed implant802may be printed directly on raft816rather than on top build layer110. In some embodiments, raft816may be removed from printed implant802after object print process916has been completed. For example, in some embodiments raft816may only be required only during object print process916.

In some embodiments, printing material400may be used to print scaffolding818, prior to printing implant802. Scaffolding818may be used to print a leveling plane or structure to aid in maintaining printed implant802at a level, or approximately horizontal build-plane. For example, in some embodiments printed implant802may be printed having a varying angle or approximation of the angle of each layer of the plurality of build layers. Accordingly, scaffolding818may be printed and comprise a plurality of layers comprising different levels or angles wherein implant802may be printed upon. The levels or angles of scaffolding818may be used to provide a structure or base level wherein each layer of implant802may be printed at an approximately horizontal plane. Scaffolding818may be particularly advantageous when implant802comprises a slanted or angled design, wherein each layer of implant802may be printed at approximately a horizontal level or plane. Scaffolding818may comprise a plurality of layers, depending on the embodiment, to provide a level build plane for implant802. The plurality of layers of scaffolding818may comprise varying heights or dimensions, depending on the dimensions and final height of implant802. The dimensions of scaffolding818may vary, and in some embodiments may have a dimension that is larger than the dimensions of implant802. Alternatively, in some embodiments the dimensions of scaffolding818may have be equal to the dimensions of implant802. Alternatively, in some embodiments the dimensions of scaffolding818may be smaller than the dimensions of implant802.

Thus, an exemplary object print process916may comprise printing raft816on top of the build plate100, printing a scaffolding818on top of the raft816, and printing the implant802on top of the scaffolding818. Furthermore, implant802may be printed in a plurality of layers, with each layer being completed before the next layer is begun. For example, in some embodiments a first printed layer may be printed in a pre-determined pattern, thickness, or other parameters. In some embodiments, a first layer of implant802may be printed in its entirety before moving up in the z-plane and printing of a second layer begins. In some embodiments, printing material400can be contiguously dispensed from nozzle210, wherein implant802comprises a near constant or contiguous composition, void of gaps, breaks, or spaces in the dispensed printing material. Alternatively, in some embodiments printing material400can be dispensed as droplets or in an otherwise non-contiguous flow from nozzle210.

In some embodiments, after a first layer has been completed, a second layer of implant802can begin to be printed. In some embodiments, build plate100may be moved down in the z-plane via lower drive train124, moving top build layer110and partially printed implant802further away from print head200. Accordingly, as implant802is moved away from print head200, printing material400can be dispensed on top of the printed first layer. In some embodiments build plate100may remain static and print head200may be moved directionally in the z-plane. For example, after dispensing a first layer of printed object800, upper drive train280can be used to directionally move print head200up in the z-plane, further away from build plate100. In some embodiments, either or both of build plate100and print head200may be directionally moved in the z-plane during printing.

An exemplary method for forming a porous surgical device by contiguous deposition may include providing a printing material400comprised of a filament material and forming a first layer of the surgical device by depositing the printing material400on a top surface of a build plate100. Forming the first layer may include the step of extruding the printing material through a nozzle210beginning at a first X-Y position relative to the top surface of the build plate, wherein the first layer is formed by depositing the printing material400in a substantially contiguous pattern to form at least a first region of the porous surgical device, wherein the first region has a first porosity. A further step comprises forming a second layer of the surgical device by moving the print head200in a Z-plane to a second Z-plane position and extruding the printing material400through the nozzle210beginning at a second X-Y position relative to the top surface of the build plate100, wherein the second X-Y position is a predetermined distance or angle from the first X-Y position. Additional layers may be formed by moving the nozzle head in the Z-plane relative to a prior Z-plane position, extruding the printing material400through the nozzle210beginning at an X-Y position relative to the surface of the build plate100, wherein the X-Y position for any one of the plurality of layers is a predetermined distance or angle from any prior X-Y position. Any one of the plurality of layers may have a region having a porosity that is smaller or larger than any prior-formed layer. Additionally, the porosity of each layer may vary within the layer itself.

In some embodiments, it may be advantageous or necessary to heat printed object800during object print process916. For example, in some embodiments printing material400may consist of a filament material, such as PEEK, PAEK, or PEKK for example. In some embodiments, printing material400may be prone to crystallization, warping, or other problematic instances caused by the temperature within housing unit12being too low or too high. Therefore, it can be advantageous to maintain a temperature range within housing unit12that will prevent or limit the frequency of printing material400crystalizing or warping. For example, prior to dispensing printing filament400, top build layer110may be preheated to about 140° C. to about 160° C., and the temperature may be maintained during the entirety of object print process916. Sensors510located internally within build plate100or sensors located externally to build plate100may measure the temperature of top build layer110, and control system50may actively monitor and regulate the temperature of top build layer110. The heat generated from build plate100and subsequent heating of top build layer110can provide heat to printed object800. The generated heat can aid in preventing crystallization or warping of printed object800during object print process.

In some embodiments, heat generated by reflector unit300can further aid in preventing crystallization or warping. During object print process916, sensors located within housing unit12can measure the temperature of printed object800, including the temperature of one or more layers of printed object800. It will be appreciated that in some embodiments, it may be advantageous to selectively heat printed object800rather than creating a static heating environment within housing unit12. For example, as each layer of printed object800is dispensed and formed, the temperature of each layer, or a plurality of layers, can be measured. The measured temperature can be transmitted to control system50, whereby control system50can instruct active heater303of reflector unit300to generate more or less heat to printed object800. In some embodiments, control system50can further instruct IR lights500to generate more or less heat to printed object800. In some embodiments, it may be advantageous to keep or maintain printed object800or its layers, near or at a glass transition state to prevent crystallization or warping and keep printed object800at a glossy state during object print process916. Therefore, control system50can continually monitor the temperature of printed object800or its layers and maintain the temperature by sending instructions to reflector unit300and/or IR lights500. In some embodiments, as printed object800is moved further away from reflector unit300and/or IR lights500may be energized at a higher level to increase the generated heat directed to printed object800. It will be further appreciated that in addition to, or alternatively as a sole means of temperature control, reflector unit300and bottom surface314may also reflect heat generated from heating layer106back towards printed object800. Accordingly, it will be appreciated that during object print process916printed object800may be heated from below by heating layer106of build plate100and/or from above by reflector unit300(either actively through active heater303or passively by reflective bottom surface314) and/or IR lights500.

In some embodiments, control system50can monitor the temperature of printed object800during object print process916, and through the heating elements within housing unit12, can maintain a pre-determined temperature of printed object800. For example, in some embodiments printing material400may comprise a PEEK filament. It may be determined that a printed object800made from PEEK filament is required to be maintained within a range of about 140° to about 160° C. during object print process916. Sensors within housing unit12may measure the temperature of printed object800and transmit that information to control system50, which can further send instructions to active heating elements (active heater303, heating layer106, IR lights500) within housing unit12to maintain the temperature of printed object800within the determined range. For example, as printed object800is moved further away from print head200as object print process916progresses, control system50may send instructions to active heater303to energize and direct more heat to printed object800.

In some embodiments, the thickness of the dispensed printing material400may be controlled by the rate at which printing material400is dispensed from print head200. For example, in some embodiments, the thickness of the dispensed printing material400can inversely corresponded to the flow rate at which printing material400is dispensed. Thus, the bead of printing material400dispensed at 10 mm per second will be thinner than a bead of printing material400dispensed at 8 mm per second. In some embodiments, the flow rate and dispensing speed of printing material400can be selectively controlled by control system50and in accordance with the object data.

In some embodiments, the thickness of the dispensed printing material400may be controlled by the rate at which build plate100is moved in the x-y plane. For example, in some embodiments, if the flow rate of printing material400is kept constant, the thickness of the dispensed printing material400can inversely correspond to the acceleration or deceleration of build plate100in the x-y plane. Thus, the bead of printing material400dispensed on build plate100moving at 12 mm per second will be thinner than a bead of printing material400dispensed on build plate100moving at 8 mm per second. In some embodiments, the acceleration or deceleration of build plate100in the x-y plane can be selectively controlled by control system50and in accordance with the object data.

In some embodiments, the flow rate of printing material400dispensed from print head200may be synchronized with the rate at which build plate100is moved in the x plane and/or y plane. For example, in some embodiments, printing material400may be dispensed at a constant rate to achieve a constant and uniform bead thickness and build plate100may be moved in the x-y plane at the same speed that printing material400is dispensed from print head200. For example, in some embodiments, if printing material400is dispensed at 10 mm per second, a consistent and uniform bead thickness can be achieved if build plate100is moved in the x-y plane at 10 mm per second. In some embodiments, there may be variance between the flow rate of printing material400dispensed from print head200and the speed that build plate100is moved in the x plane and/or the y plane. For example, in some embodiments the variance between the flow rate of the printing material400and the speed of build plate100may vary in increments of about 2 mm/second. For example, if printing material400is dispensed at a constant rate of 10 mm/second, to achieve a thicker bead size, build plate100may be moved at about 8 mm/second in the x-y plane. Conversely, if printing material400is dispensed at a constant rate of 10 mm/second, to achieve a thinner bead size, build plate100may be moved at about 12 mm/second in the x-y plane. Alternatively, the same effect may be achieved by moving build plate100at a constant speed in the x-y plane and varying the flow rate of printing material400.

It will be appreciated that the flow rate and dispensing speed of printing material400may fluctuate or vary during object print process916. For example, in some embodiments, printed object800may comprise layers or sections of varying thicknesses or sizes, requiring multiples sizes and thicknesses of dispensed printing material400. Accordingly, the flow rate and dispense rate of printing material400may be regulated so that printing material400is dispensed at the correct size and thickness at the correct position.

A ninth step of method900may comprise an end object print process918. For example, after the final layer of printed object800has been dispensed, printed object800may be removed from top build layer110. In some embodiments, after removing printed object800from top build layer110, raft816may be removed from printed implant802. In some embodiments, scaffolding818may also be removed from implant802. As described in greater detail herein, after removing scaffolding818and/or raft816, implant802may be cleaned or sterilized.

A tenth step of method900may comprise a power down and cooldown920step. During power down and cooldown920, heating element114, heater206, active heater303, IR lights500, and/or any other heated component of printing device10may be turned off and cooling may begin. The temperature of printing device10and the various heating elements may be monitored by sensors and control system50. In some embodiments power down and cooldown920may be expedited by one or more coolers, such as fans or liquid coolers.

An eleventh step of method900may comprise a filament store922step. Any excess printing material400may be removed from material housing402and stored in a storage unit (not shown). In some embodiments, printing material400may comprise a material that is either dangerous to touch with a bare hand or would otherwise lose effectiveness if touched by bare hands. Therefore, it may be advantageous to remove printing material400from material housing402using nitrile, or other sterile gloves. Printing material400may be stored in a dry storage unit to prevent moisture or other contamination, which may limit the effectiveness of printing material400for future uses.

A twelfth step of method900may comprise a shut down924step. During shut down924, control system50may be turned off or shut down. Printing device10may further be power downed or shut off. This may include unplugging printing device10from a power source or removing a battery or other energy source from printing device10.

With respect toFIGS. 8A-8E, in some embodiments, printing device10may be used to print or create printed objects800having one or more porous regions, each having a different porosity. For example,FIG. 8Aillustrates one embodiment of printed object800, where printed object800comprises a medical implant802. Implant802is composed of a plurality of layers804that create at least a first porous region806and a second porous region808. It will be appreciated that in alternate embodiments, medical implant802may comprise one, two, or more different porous regions. In some embodiments, medical implant802may be a patient-specific or custom-made implant, that is designed for a specific patient and modeled on that particular patient's anatomy using computer-aided design software. Alternatively, in some embodiments medical implant802may comprise a generic design that is not custom or patient-specific. While references herein refer to printed object800as a medical implant, it will be appreciated that printing device10is not intended to be limited to printing objects for use in the medical or surgical field. Accordingly, printing device10may be used to print or construct any type of object800that can be formed through additive manufacturing.

In some embodiments, medical implant802may comprise a plurality of layers804, wherein each layer within the plurality of layers804comprises both a first porous region806and a second porous region808. In some embodiments, medical implant802may be printed layer-by-layer, wherein the entirety of one layer is printed prior to starting printing of the next layer. This process can be repeated until each layer has been printed and medical implant802is completely formed.

In some embodiments, after the object data of medical implant802is uploaded to control system50, a three-dimensional model of medical implant802may be mapped by control system50, which may be programmed with a G-code or other software, and a printing pattern may be implemented. For example, in some embodiments the three-dimensional model of medical implant802may be broken down or paired down to a plurality of layers or slices, thereby transitioning the three-dimensional model into a two-dimensional representation of what the printing footprint will comprise. For example, a 3-D model of medical implant802, or any other object, may be uploaded to control system50. Starting from the top of the 3-D model, the G-code or software can begin breaking or pairing down the 3-D model into slices or layers. In some embodiments, the slices may be about 50 μm to about 250 μm in thickness, and may depend on the printing material used. The G-code or software can then map or design a printing pattern for depositing printing material400for ultimately forming medical implant802. In some embodiments, the G-code or software can further set or define the outer boundary or perimeter844. During printing, printing material400may be deposited in the pattern mapped out by the G-code or software. In some embodiments, the G-code or software can further map or design the location of first porous region806and/or second porous region808. In some embodiments, the printing pattern or porosity may be altered between each slice, providing for multiple printing patterns and porosities within the fully formed medical implant802.

FIG. 8Billustrates an exemplary embodiment of a first layer840of the plurality of layers804. As illustrated, in some embodiments, first layer840may be formed from printing material400that is dispensed in a wave, zigzag, serpentine, curved, or other pattern. In some embodiments, printing material400may be dispensed in a singular straight-line pattern.FIG. 8Billustrates an exemplary embodiment of first layer840wherein printing material is dispensed in a wave-like sinusoidal pattern842. As seen inFIG. 8B, in some embodiments, wave pattern842may be dispensed in a near contiguous or continuous manner. As such, printing material400may be dispensed from print head200at a substantially continuous or contiguous rate. For example, when printing material is dispensed400, it can be dispensed nearly continuously to avoid gaps, breaks, or an otherwise disruption of dispensing. Accordingly, wave pattern842can comprise a generally contiguous and solid bead of printing material400, absent any breaks or gaps. In some embodiments, printing material400can be dispensed beginning at a first x-y position, relative to top build layer110. Printing material400can be contiguously dispensed in wave pattern842and moved in the x-y plane until reaching a predetermined perimeter844defining the outer dimension of medical implant802. In some embodiments, upon reaching perimeter844, print head200can be moved in the x-y plane and continue depositing printing material in wave pattern842back in the direction towards the interior of medical implant802until reaching perimeter844again. In some embodiments, there may be a multiple gaps846or spaces between printing material400deposited in wave pattern842. For example, in some embodiments gaps846may be about 300 μm. In some embodiments, gaps846may be selected from a range of about 50 μm to about 500 μm. As further illustrated inFIG. 8B, printing material400may be contiguously deposited in wave pattern842, turning back to the interior each time perimeter844is reached until first layer840is completed. Upon completion of first layer840, depositing of second layer850may begin. In some embodiments, printing material400may be contiguously printed after each layer is completed, such that there is no gap or space of printing material between each layer, resulting in a contiguous or nearly contiguous medical implant802. For example, after completing first layer840, depositing of second layer850may begin without stopping the feed of printing material400through feed tube212from nozzle210.

FIG. 8Cillustrates second layer850deposited on top of first layer840, as illustrated inFIG. 8B. In some embodiments, the G-code or software programming can rotate the layout or orientation of wave pattern842. For example, in some embodiments, second layer850is deposited on top of first layer840in wave pattern842in the same design as present in first layer840. However, the pattern can be rotated at a predetermined angle or degree, whereby printing material400is not deposited in the exact same layout, and instead, there is a crisscrossing effect of printing material400between first layer840and second layer850. For example,FIG. 8Cillustrates an embodiment in which the printing pattern is rotated about 36° for printing second layer850after first layer840is completed. InFIG. 8C, wave pattern842in second layer850comprises the same design as wave pattern842of first layer840, but due to the pattern rotation, printing material400is deposited in a resultant crisscrossing manner.

In some embodiments, the process of rotating the print pattern after completion of a build layer of medical implant802can be repeated for all layers. In some embodiments, the pattern may be rotated a different amount at different layers. In some embodiments, the pattern may not be rotated for all layers, but rather may be rotated after a number of successive layers. The pattern may be rotated at any predetermined degree, such as within the range of about 1° to about 179°. In some embodiments, the pattern will be rotated at the chosen degree after completion of each layer that is printed. For example, in some embodiments after each layer is completed the pattern will rotate 36° degrees. Furthermore, while the pattern is rotated by control system50via the G-code or other software, neither print head200nor build plate100needs to be physically rotated. The pattern is rotated solely within the software programming, modifying the angle or direction with which the pattern is dispensed. While build plate100and print head200may be configured to be directionally movable, neither is required to be mechanically rotated during the printing process.

FIG. 8Dillustrates an exemplary embodiment of a medical implant1000, detailing a first porous region1002and a second porous region1006.FIG. 8Eillustrates a cross-section of medical implant1000. In some embodiments, medical implant1000may comprise at least a first porous region1002having a first porosity and a second porous region1006having a second porosity. In some embodiments, medical implant1000may comprise more or less than two porous regions and may comprise any number of porous regions having various porosity. In some embodiments, medical implant1000may comprise a plurality of layers1010. In some embodiments, medical implant1000may be printed layer-by-layer, wherein the entirety of one layer is printed prior to starting printing of the next layer. This process can be repeated until each layer has been printed and medical implant1000is completely formed. In some embodiments, each layer within the plurality of layers1010can comprise a first porous region1002and a second porous region1006.

As illustrated inFIGS. 8D-E, in some embodiments, first porous region1002may comprise a lattice framework or structure1004or otherwise comprise a general structure having defined openings, holes, or spacing throughout the entirety of first porous region1002. In some embodiments, the lattice framework1004comprising first porous region1002may comprise pores of about 300 mm to about 350 mm. In some embodiments, first porous region1002may comprise pores of about 50 mm to about 500 mm in size. In some embodiments, first porous region1002may comprise pores of varying and non-uniform sizes.

As further illustrated inFIGS. 8D-8E, in some embodiments second porous region1006may comprise a substantially solid structure1008, having minimal pores, openings, or gaps. Second porous region1006may be printed with the same printing material400as first porous region1002or may be printed using a different printing material. In some embodiments, second porous region1006may comprise a density having minimal or no pores, openings, or gaps. In some embodiments, second porous region1006may be formed or printed using an alternative or different pattern than first porous region1002. For example, in some embodiments second porous region1006may be printed using a solid bead of printing material laid in a seam-to-seam manner, resulting in a substantially or completely solid structure. In some embodiments, second porous region1006may act as a structural support, aiding in maintaining the structural stability of medical implant1000.

In some embodiments, the porosity of first porous region1002and second porous region1006can be predetermined and selectively positioned. For example, in some embodiments medical implant1000is a custom, surgical implant designed to be anatomically compatible with a specific patient. Accordingly, it may be advantageous to selectively position a first porous region1002in a certain design, shape, configuration, or location that will promote bone growth. Additionally, second porous region1006may also be selectively positioned, ensuring that it is positioned in a location and comprises a porosity that supports any load bearing on medical implant1000.

As described above, the thickness of the bead of dispensed printing material400can be dependent on the flow rate of printing material400from print head200. Generally, when printing material400is dispensed at a faster rate, the bead will be thinner in diameter than when printing material400is dispensed at a slower rate. Accordingly, in some embodiments the flow rate can be selectively programmed or controlled to correspond to the predetermined porosity of sections of object1000. For example, in some embodiments, the printed material400in first porous region1002may have a predetermined diameter of about 300 nm to about 350 nm. When dispensing material that will comprise first porous region1002, printing material400may be dispensed at a flow rate of about 10 mm/second. In some embodiments, the printed material400in second porous region1006may have a predetermined diameter of about 500 nm to about 700 nm. When dispensing material that will comprise second porous region1006, printing material may be dispensed at a flow rate of about 5 mm/second.

As further illustrated inFIG. 8E, in some embodiments, medical implant1000may further comprise at least one overlap area1012where first porous region1002and second porous region1006can interconnect. For example, during the printing process, when printing material400is dispensed to print first porous region1002, printing material400may intentionally extend beyond the boundary of first porous region1002into the boundary of second porous region1006. Accordingly, as each layer of medical implant1000is printed, overlap area1012can also comprise a plurality of interconnected layers, wherein first porous region1002and second porous region1006continuously interconnect. Overlap area1012and the interconnection of first porous region1002with second porous region1006may result in a more structurally stable medical implant1000. For example, after the printing process has been completed, and medical implant begins to harden, first porous region1002and second porous region1006can harden together in an interconnected manner, thereby strengthening the coupling between first porous region1002and second porous region1006.

Using the printing device10, a user can print an implant1000on-site for a patient. Additional embodiments of objects to be printed are described with respect toFIGS. 10, 11, 12 and 13A-E. Specifically, exemplary medical implants2000,3000,4000are described below.

FIG. 10shows an anterior cervical interbody cage2000that can be printed using the printing device10. A cervical interbody cage2000is designed to support cervical loads while maximizing the surface area between the implant and the vertebral bodies it is in contact with. Cervical interbody cage2000is configured to be placed between a first vertebral body and a second vertebral body in a spinal disc space in an anterior cervical interbody fusion (ACIF) procedure. Cervical interbody cage2000has a top surface2002, a bottom surface2004, an anterior side2008, a posterior side2006, and peripheral sides2007and2009. Cervical interbody cage2000may include a central opening2010that extends from the top surface2002to the bottom surface2004. In some embodiments, the central opening2010may be substantially rectangular, square, circular, oval, or any other desired shape. The central opening2010may be configured to receive bone graft material therein for stimulating bone growth in situ.

In some embodiments, the top surface2002may be slanted at an angle of about 0-30 degrees, angled from anterior side2008towards posterior side2006. In some embodiments, the bottom surface2004may be slanted at an angle of about 0-30 degrees, angled from anterior side2008towards posterior side2006. In some embodiments, cervical interbody cage2000has a width of about 12-20 mm and a length of about 11-15 mm, and a height of about 5-14 mm.

In some embodiments, the anterior side2008may include one or more peripheral openings2005therein for receiving a distal end of an instrument for implantation. In some embodiments, one or more peripheral openings2005may be internally threaded to cooperate with a distal end of an instrument. In some embodiments, one or more peripheral openings2005may be circular. In some embodiments, peripheral sides2007and/or2009may have openings (not shown) that act as graft windows. However, due to the porous structure of the cervical interbody cage2000, graft windows in the peripheral sides2007,2009may be unnecessary. In some embodiments, the peripheral openings, or any other openings, may be added after the cervical interbody cage2000is printed.

Cervical interbody cage2000may be designed to have a plurality of different porous regions. The porosity may be carefully balanced to provide for structural integrity while also providing for optimal bone fixation. For example, the top surface2002and the bottom surface2004may have the greatest porosity in the implant2000. In some embodiments, the top surface2002and the bottom surface2004may have pores of about 300-350 μm. A first region of porosity2012may extend down from the top surface2002about 1-1.5 mm into the implant2000. A second region of porosity2014may extend up from the bottom surface2004about 1-1.5 mm into the implant2000. It has been found that bony ingrowth may generally extend into an implant about 1-1.5 mm from the adjacent bone surface. A third region of porosity2016may extend into the center of the implant2000between the first region2012and the second region2014. In some embodiments, a fourth region of porosity2018may extend around a periphery of the implant, forming a less porous outer peripheral surface, as seen inFIG. 10. In some embodiments, the fourth region2018may have such a small porosity such that it appears solid or almost solid.

FIG. 11shows an exemplary lumbar spine cage3000that can be printed using the printing device10. A lumbar spinal cage3000is designed to support lumbar loads while maximizing the surface area between the implant and the vertebral bodies it is in contact with. Lumbar spinal cage3000is configured to be placed between a first vertebral body and a second vertebral body in a spinal disc space in a posterior lumbar interbody fusion (PLIF) procedure. In one embodiment, first vertebral body may be L4 and second vertebral body may be L5. In another embodiment, first vertebral body may be L5 and second vertebral body may be S1. In some embodiments, two lumbar spinal cages3000may be implanted in the same disc space.

Lumbar spinal cage3000has a top surface3002, a bottom surface3004, an anterior side3008, a posterior side3006, and peripheral sides3007and3009. Lumbar spinal cage3000may include a central opening3010that extends from the top surface3002to the bottom surface3004. In some embodiments, the central opening3010may be substantially rectangular, square, circular, oval, or any other desired shape. The central opening3010may be configured to receive bone graft material therein for stimulating bone growth in situ.

In some embodiments, lumbar spinal cage3000may be substantially rectangularly shaped. In some embodiments, anterior side3008and posterior side3006are shorter, and peripheral sides3007,3009are longer. In such embodiments, central opening3010may also be substantially rectangularly shaped. In some embodiments, top surface3002and/or bottom surface3004may be substantially planar. In some embodiments, top surface3002and/or bottom surface3004may be substantially convex such that the center has a slightly larger height for engaging the adjacent bones. In some embodiments, lumbar spinal cage3000has a width of about 8-12 mm and a length of about 20-40 mm, and a height of about 6-16 mm.

In some embodiments, anterior side3008may be shaped to have a substantially triangular-shaped bulleted tip. In some embodiments, the posterior side3006may include one or more peripheral openings3005therein for receiving a distal end of an instrument for implantation. In some embodiments, one or more peripheral openings3005may be internally threaded to cooperate with a distal end of an instrument. In some embodiments, one or more peripheral openings may be circular. In some embodiments, peripheral sides3007and/or3009may have openings (not shown) that act as graft windows. However, due to the porous structure of the lumbar spinal cage3000, graft windows in the peripheral sides3007,3009may be unnecessary. In some embodiments, the peripheral openings, or any other openings, may be added after the lumbar spinal cage3000is printed.

Lumbar spinal cage3000may be designed to have a plurality of different porous regions. The porosity may be carefully balanced to provide for structural integrity while also providing for optimal bone fixation. For example, the top surface3002and the bottom surface3004may have the greatest porosity in the implant3000. In some embodiments, the top surface3002and the bottom surface3004may have pores of about 100-500 μm. A first region of porosity3012may extend down from the top surface3002about 1-1.5 mm into the implant3000. A second region of porosity3014may extend up from the bottom surface3004about 1-1.5 mm into the implant3000. It has been found that bony ingrowth may generally extend into an implant about 1-1.5 mm from the adjacent bone surface. A third region of porosity3016may extend into the center of the implant3000between the first region3012and the second region3014. In some embodiments, a fourth region of porosity3018may extend around at least a portion of the periphery of the implant, forming a less porous outer peripheral surface. In some embodiments, the fourth region3018may have such a small porosity such that it appears solid or almost solid. In some embodiments, the fourth region is primarily on the anterior side3008and the posterior side3006, as seen inFIG. 11.

FIG. 12shows an exemplary lumbar spine cage4000that can be printed using the printing device10. A lumbar spinal cage4000is designed to support lumbar loads while maximizing the surface area between the implant and the vertebral bodies it is in contact with. Lumbar spinal cage4000is configured to be placed between a first vertebral body and a second vertebral body in a spinal disc space in a transforaminal lumbar interbody fusion (TLIF) procedure. In one embodiment, first vertebral body may be L4 and second vertebral body may be L5. In another embodiment, first vertebral body may be L5 and second vertebral body may be S1. In some embodiments, one lumbar spinal cage4000is implanted in the intervertebral space.

Lumbar spinal cage4000has a top surface4002, a bottom surface4004, an anterior side4008, a posterior side4006, and peripheral sides4007and4009. Lumbar spinal cage4000may include a central opening4010that extends from the top surface4002to the bottom surface4004. In some embodiments, the central opening4010may be substantially rectangular, square, circular, oval, or any other desired shape. The central opening4010may be configured to receive bone graft material therein for stimulating bone growth in situ.

In some embodiments, lumbar spinal cage4000may form a substantially curved rectangular shape. In some embodiments, anterior side4008and posterior side4006are shorter, and peripheral sides4007,4009are longer. In such embodiments, central opening4010may be substantially curved and substantially rectangularly shaped. In some embodiments, top surface4002and/or bottom surface4004may be substantially planar. In some embodiments, top surface4002and/or bottom surface4004may be substantially convex such that the center has a slightly larger height for engaging the adjacent bones. In some embodiments, lumbar spinal cage4000has a width of about 8-14 mm and a length of about 28-34 mm, and a height of about 6-16 mm.

In some embodiments, anterior side4008may be shaped to have a substantially triangular-shaped bulleted tip. In some embodiments, the posterior side4006may include one or more peripheral openings4005therein for receiving a distal end of an instrument for implantation. In some embodiments, one or more peripheral openings4005may be internally threaded to cooperate with a distal end of an instrument. In some embodiments, one or more peripheral openings may be circular. In some embodiments, peripheral sides4007and/or4009may have openings (not shown) that act as graft windows. However, due to the porous structure of the lumbar spinal cage3000, graft windows in the peripheral sides4007,4009may be unnecessary. In some embodiments, the peripheral openings, or any other openings, may be added after the lumbar spinal cage4000is printed.

Lumbar spinal cage4000may be designed to have a plurality of different porous regions. The porosity may be carefully balanced to provide for structural integrity while also providing for optimal bone fixation. For example, the top surface4002and the bottom surface4004may have the greatest porosity in the implant4000. In some embodiments, the top surface4002and the bottom surface4004may have pores of about 100-500 μm. A first region of porosity4012may extend down from the top surface4002about 1-1.5 mm into the implant3000. A second region of porosity4014may extend up from the bottom surface4004about 1-1.5 mm into the implant4000. It has been found that bony ingrowth may generally extend into an implant about 1-1.5 mm from the adjacent bone surface. A third region of porosity4016may extend into the center of the implant4000between the first region4012and the second region4014. In some embodiments, a fourth region of porosity4018may extend around at least a portion of the periphery of the implant, forming a less porous outer peripheral surface. In some embodiments, the fourth region4018may have such a small porosity such that it appears solid or almost solid. In some embodiments, the fourth region4018is primarily on the anterior side4008and the posterior side4006, as seen inFIG. 12.

In some embodiments, implants1000,2000,3000, or4000may include a coating on the outer surfaces thereof. In some embodiments, the coating may include a titanium plasma spray coating and/or a hydroxyapatite (HA) coating. In some embodiments, the coating may be a HAnanoSurface® coating, such as manufactured by Promimic. In some embodiments, the coating may be on the outer surfaces and/or may extend into the pores throughout the implant, such as when the implant1000,2000,3000, or4000is dipped into a solution for coating.

In some embodiments, the implants1000,2000,3000, or4000may include radiopaque markers to optimize visibility and placement. In some embodiments, the radiopaque markers may be tantalum.

In some embodiments, a portion of an implant may be printed on or attached to a secondary material for providing greater structural integrity. Secondary material may be a metal, such as stainless steel or titanium. In some embodiments, the secondary material may form a scaffold for receiving the printing material400thereon.

Further to the process as described above, in one embodiment, before printing, a polymeric filament400may be dried in a dehydrator overnight. Then the spool404having filament400thereon is inserted into a material housing402, and attached to the printing device10. The polymeric filament400is then fed into a transport device406, which may be a tube running from the housing402to the print head200. The nozzle210is heated to the desired melt temperature for the material400. In some embodiments, the desired melt temperature is about 420° C. to about 450° C. In order to purge the line, about 50 mm of material400may be extruded to provide a consistent flow. The build plate100is then heated to the desired temperature. In some embodiments, the build plate100temperature is about 140° C. to about 160° C. A program is then selected and the object800is printed, as described above. After the printing is completed, the raft816is removed from the build plate100. Then the implant802is removed from the raft816and the scaffolding818. A knife may be used to remove any excess material.

FIGS. 13A-Eshows additional exemplary embodiments of implants that may be printed. Implants may be printed for use in a patient, such as in the spine, an extremity, or the skull. Exemplary implants may be cranial plates, maxillo-facial implants, osteotomy wedges, spinal spacers or cages, or screws or fasteners.

In some embodiments, after printing an annealing process is then conducted. Annealing of the polymeric material is done to relieve the internal stresses introduced during fabrication. The polymeric material is heated to a temperature that is below the glass transition temperature such that the polymer chains are excited and realign. For example, the implant1000,2000,3000, or4000may be placed in the oven for about 6 hours. In some embodiments, the annealing process may ramp up for the first hour to a temperature of about 150° C., remain at this temperature for about 1 hour, ramp up to about 200° C. over about 30 minutes, remain at about 200° C. for about 1 hour, decrease to about 150° C. over about 30 minutes, remain at about 150° C. for about 30 minutes, and decrease to room temperature (about 20° C.). In some embodiments, the annealing process may be done at a higher temperature, such as about 300° C. when larger printed structures are involved.

In some embodiments, the implant1000,2000,3000, or4000is left in the oven overnight so that the implant1000,2000,3000, or4000has time to cool to room temperature before being removed. In some embodiments, about fifty implants1000,2000,3000, or4000can be placed in the oven at the same time.

The implant1000,2000,3000, or4000can then be cleaned. For example, the implant1000,2000,3000, or400may be placed in a heated ultrasonic cleaner with a cleaning solution for about 30 minutes. The implant1000,2000,3000, or4000may then be placed in an unheated ultrasonic cleaner with a solution of water and isopropyl alcohol.

After the annealing process, any post-machining is done on the implant1000,2000,3000, or4000. Post-machining may include, for example, adding holes or threading to the implant1000,2000,3000, or4000. The implant1000,2000,3000, or4000may then undergo a cleaning process where any external debris is removed.

The implant1000,2000,3000, or4000may be placed in a hyperclean environment for the application of a coating. The implant may be submerged in a hydroxyapatite (HA) solution so that all surfaces are coated with HA. In some embodiments, the coating may be as thin as a nanometer. Due to the fully porous structure of the implant1000,2000,3000, or4000, the HA coating may extend through the internal porous structure of the device. The use of a HA coating on the implant1000,2000,3000, or4000creates a hydrophilic surface and promotes faster osseointegration. The full porosity encourages new bone on-growth and in-growth of the implant leading to greater integration strength. The implant1000,2000,3000, or4000may be heated after coating/dipping to evaporate any excess coating material. The implant1000,2000,3000, or4000may then be placed in sterile packaging and undergo gamma radiation for sterilization.

Features described above as well as those claimed below may be combined in various ways without departing from the scope thereof. the following examples illustrate some possible, non-limiting combinations:

(A1) A printing device for forming a surgical implant from a first material comprising: a housing forming an enclosed space, a print head, a planar heated build plate having a top surface for receiving the first material thereon, and a reflective plate. The print head comprises a heated nozzle for extruding the first material. The reflective plate comprises an active heating element, said reflective plate is located adjacent to the heated nozzle and has a bottom surface configured to reflect heat towards the build plate. The reflective unit, the heated build plate, and the heated nozzle are all configured to maintain the first material at a predetermined temperature while forming the surgical implant.

(A2) For the printing device denoted as (A1), the heated build plate comprises: a top build layer comprising the top surface; a top frame layer beneath the top build layer; a heating layer comprising a resistant heater beneath the top frame layer; an insulating layer beneath the heating layer; and a bottom frame layer.

(A3) For the printing device denoted as (A2), further comprising an intermediate layer between the heating layer and the top frame layer, wherein the intermediate layer aids in heat dissipation.

(A5) For the printing device denoted as any of (A2) through (A4), wherein at least one of the top frame layer and the bottom frame layer comprises aluminum.

(A6) For the printing device denoted as any of (A3) through (A5), wherein the intermediate layer comprises stainless steel.

(A7) For the printing device denoted as any of (A2) through (A6), wherein the insulating layer comprises mica or ceramic.

(A8) For the printing device denoted as any of (A1) through (A7), further comprising at least one infrared heater within the enclosed space configured to direct heat to the surgical implant during printing.

(A9) For the printing device denoted as any of (A1) through (A8), comprising at least one temperature sensor.

(A10) For the printing device denoted as any of (A2) through (A9), further comprising a plurality of openings in the top build layer and the top frame layer, wherein the plurality of openings are configured to receive mechanical couplings therein and to aid in heat dissipation.

(A11) For the printing device denoted as any of (A1) through (A10), further comprising a control system including a processor, configured to receive custom design parameters for forming the surgical implant.

(A12) For the printing device denoted as (A11), the design parameters include size, shape, and porosity.

(A13) For the printing device denoted as any of (A1) through (A12), wherein the first material is a thermoplastic polymer and the predetermined temperature is near the glass transition temperature of the polymer.

(A14) For the printing device denoted as any of (A1) through (A13), wherein an inner surface of the housing comprises a thermally insulating material.

(B1) A system for 3-D printing a medical device comprising: a printing material for forming the medical device and a printing device. The printing device comprises a housing forming an enclosed space, a print head comprising a heated nozzle for extruding the printing material, a planar heated build plate having a top surface for receiving the print material thereon, and a reflective plate comprising an active heating element. The reflective plate is located adjacent to the heated nozzle and has a bottom surface configured to reflect heat towards the build plate. The reflective unit, the build plate, and the nozzle are all configured to maintain the printing material at a predetermined temperature while forming the medical device.

(B2) For the system denoted as (B1), the build plate comprises: a top build layer comprising the top surface; a top frame layer beneath the top build layer; a heating layer comprising a resistant heater beneath the top frame layer; an insulating layer beneath the heating layer; and a bottom frame layer.

(B3) For the system denoted as (B1), further comprising an intermediate layer between the heating layer and the top frame layer, wherein the intermediate layer aids in heat dissipation.

(B5) For the system denoted as any of (B2) through (B4), wherein at least one of the top frame layer and the bottom frame layer comprises aluminum.

(B6) For the system denoted as any of (B3) through (B5), wherein the intermediate layer comprises stainless steel.

(B7) For the system denoted as any of (B2) through (B6), wherein the insulating layer comprises mica or ceramic.

(B8) For the system denoted as any of (B1) through (B7), further comprising at least one infrared heater within the enclosed space configured to direct heat to the surgical implant during printing.

(B9) For the system denoted as any of (B1) through (B8), comprising at least one temperature sensor.

(B10) For the system denoted as any of (B2) through (B9), further comprising a plurality of openings in the top build layer and the top frame layer, wherein the plurality of openings are configured to receive mechanical couplings therein and to aid in heat dissipation.

(B11) For the system denoted as any of (B1) through (B10), further comprising a control system including a processor, configured to receive custom design parameters for forming the medical device.

(B12) For the system denoted as (B11), the design parameters include size, shape, and porosity.

(B13) For the system denoted as any of (B1) through (B12), wherein the printing material is a thermoplastic polymer and the predetermined temperature is near the glass transition temperature of the polymer.

(B14) For the system denoted as any of (B1) through (B13), wherein an inner surface of the housing comprises a thermally insulating material.

(C1) A method for using a printing device to create a medical implant, the method comprising: providing a first material for printing the medical implant; providing a printing device; moving the print head and reflective plate vertically in a Z-plane; and moving the build plate horizontally in a X-plane and in a Y-plane. The printing device comprises a housing forming an enclosed space; a print head comprising a heated nozzle for extruding the first material; a planar heated build plate having a top surface for receiving the first material thereon; and a reflective plate comprising an active heating element. The reflective plate is located adjacent to the heated nozzle and has a bottom surface configured to reflect heat towards the build plate. The reflective unit, the build plate, and the nozzle are all configured to maintain the first material at a predetermined temperature while forming the medical device.

(C2) For the method denoted as (C1), further comprising: providing heat to the build plate to maintain the first material at the predetermined temperature.

(C3) For the method denoted as (C1) or (C2), further comprising: activating the heater in the reflective plate to maintain the first material at the predetermined temperature.

(C4) For the method denoted as any of (C1) through (C3), the printing device further comprises at least one temperature sensor, and the method further comprising: sensing a temperature in at least one location within the housing unit to maintain the first material at the predetermined temperature.

(C5) For the method denoted as (C4), wherein the predetermined temperature is near the glass transition temperature of the first material.

(D1) A method for forming a porous surgical device by contiguous deposition comprising: providing a printing material; extruding the printing material through a nozzle head; moving the nozzle head vertically in a Z-plane; receiving the printing material on a top surface of a build plate; moving the build plate horizontally in a X-plane and in a Y-plane; and depositing a plurality of layers of the printing material on the build plate to form the surgical device. Depositing the plurality of layers comprises (a) depositing a first layer on the build plate; (b) rotating the substantially contiguous pattern by about 36°; and (c) depositing a second layer on top of the first layer; and repeating steps a, b, and c until a predetermined number of layers are formed.

(D2) For the method denoted as (D1) wherein the second layer extends beyond an outer perimeter of the first layer and the second layer.

(D3) For the method denoted as any of (D1) through (D2), further comprising: adjusting a speed at which the printing material is dispensed to control the porosity of the produced surgical device.

(D4) For the method denoted as any of (D1) through (D3), further comprising: heating the printing material at the nozzle to a predetermined temperature, wherein the predetermined temperature is near the glass transition temperature of the printing material.

(D5) For the method denoted as (D4), wherein the predetermined temperature of about 140° C. to about 160° C.

(D6) For the method denoted as any of (D1) through (D5), further comprising: maintaining the predetermined temperature of the printing material on the build plate during the entire process.

(D7) For the method denoted as any of (D1) through (D6), further comprising: customizing the size, shape, and porosity of the implant for a particular patient.

(D8) For the method denoted as any of (D1) through (D7), the printing material comprises polyether-ether-ketone (PEEK), polyaryletherketone (PAEK), polyetherketoneketone (PEKK), or other thermoplastic polymers.

(E1) A method for 3-D printing a medical implant comprising: providing a printing material and a printing device comprising a nozzle; selecting a final shape, size, and configuration of the printed implant; selecting a first porosity for a first region of the implant; selecting a second porosity for a second region of the implant; controlling a dispense rate of the printing material from the nozzle onto a build plate; monitoring a temperature of at least one portion of the printing device by at least one temperature sensor; and adjusting the temperature of at least one element of the printer device to maintain the implant at a predetermined temperature during the entire printing process.

(E2) The method denoted as (E1), further comprising: heating the build plate to maintain the implant at a predetermined temperature.

(E3) The method denoted as (E1) or (E2), wherein the first porosity forms a network of interconnected pores.

(E4) The method denoted as any of (E1) through (E3), wherein the second porosity forms a substantially solid region.

(E5) The method denoted as any of (E1) through (E4), wherein the printing material comprises polyether-ether-ketone (PEEK), polyaryletherketone (PAEK), polyetherketoneketone (PEKK), or other thermoplastic polymers.

(F1) A method for forming a porous surgical device by contiguous deposition comprising: forming a first layer of the surgical device by depositing the printing material on a top surface of a build plate; forming a second layer of the surgical device by depositing the printing material on top of the first layer; and forming the surgical device by continuing to form a plurality of layers relative to the first and second layers. The method may further include forming the first layer by extruding the printing material through the nozzle beginning at a first X-Y position relative to the top surface of the build plate and depositing the printing material in a substantially contiguous pattern to form at least a first region of the porous surgical device, wherein the first region has a first porosity. The method may further include forming the second layer by moving the nozzle in a Z-plane to a second Z-plane position; extruding the printing material through the nozzle beginning at a second X-Y position relative to the top surface of the build plate, wherein the second X-Y position is a predetermined distance or angle from the first X-Y position. The method may further include forming the surgical device by continuing to form a plurality of layers relative to the first and second layers by moving the nozzle in the X-plane relative to a prior Z-plane position, extruding the printing material through the nozzle beginning at an X-Y position relative to the top surface of the build plate, wherein the X-Y position for any one of the plurality of layers is a predetermined distance or angle from any prior X-Y position. Any one of the plurality of layers has a region having a second porosity that is different than a porosity of any prior-formed layer.

(F2) The method denoted as (E1), further comprising: heating the build plate to maintain the device at a predetermined temperature.

(F3) The method denoted as (F1) or (F2), wherein the first porosity forms a network of interconnected pores.

(F4) The method denoted as any of (F1) through (F3), wherein the second porosity forms a substantially solid region.

(F5) The method denoted as any of (F1) through (F4), wherein the printing material comprises polyether-ether-ketone (PEEK), polyaryletherketone (PAEK), polyetherketoneketone (PEKK), or other thermoplastic polymers.

(G1) One or more non-transitory computer-readable media storing computer executable instructions that, when executed by a processor, perform a method of three-dimensionally printing a medical implant, the method comprising: selecting a custom final shape of the implant based at least in part on an anatomy of a particular patient; selecting a first porosity for a first region and selecting a second porosity for a second region of the implant; providing a printing material to a nozzle of a printing device; heating the printing material to at least a melting temperature; and dispensing a plurality of layers of the printing material through the nozzle onto the build plate to form the implant.

(G2) For the media denoted as (G1), further comprising: controlling the nozzle to move vertically in the Z-plane.

(G3) For the media denoted as (G1) or (G2), further comprising: controlling the build plate to move horizontally in a X-plane and/or in a Y-plane.

(G4) For the media denoted as (G1) through (G3), further comprising: dispensing the printing material in a predetermined pattern and after each layer is completed, rotating the pattern by about 36° before printing a successive layer.

(G5) For the media denoted as (G1) through (G4), further comprising: controlling heating of the build plate to maintain the implant at a predetermined temperature during the entire process.

(G6) For the media denoted as (G1) through (G5), wherein the printing material comprises polyether-ether-ketone (PEEK), polyaryletherketone (PAEK), polyetherketoneketone (PEKK), or other thermoplastic polymers.

(G7) For the media denoted as (G1) through (G6), further comprising a memory for storing a library of printable designs for a plurality of different implants.

(H1) A selectively porous customizable medical implant made by the process of fused filament fabrication by a 3-D printer comprising: at least a first region having a first porosity and at least a second region having a second porosity, wherein the pores of the first region are larger than the pores of the second region.

(H2) For the implant as denoted by (H1), the first region has a lattice structure with interconnected pores.

(H3) For the implant as denoted by (H1) or (H2), the implant comprises polyether-ether-ketone (PEEK), polyaryletherketone (PAEK), polyetherketoneketone (PEKK), or other thermoplastic polymers.

(H4) For the implant as denoted by (H1) through (H3), further comprising a hydroxyapatite (HA) coating, wherein the coating extends through the pores.

(H5) For the implant as denoted by (H1) through (H4), the implant is configured to be used as a spinal implant, a cranial flap implant, a maxillofacial implant, or a foot or ankle wedge implant.

(H6) For the selectively porous customizable medical implant as denoted by (H1) through (H5), the pores of the first region have a pore size of about 300 μm.

(I1) A spinal implant formed by a polymer monofilament 3-D printing process, comprising: a top surface; a bottom surface; a peripheral outer surface; and a central opening; and a porous section having a plurality of interconnected pores. The porous section has a first plurality of openings on the top surface and a second plurality of openings on the bottom surface. The implant shape and pore size are selectable for customizing the implant to a particular patient.

(I2) For the spinal implant denoted as (I1), comprising a solid section on the outer peripheral surface.

(I3) For the spinal implant denoted as (I1) or (I2), the porous section comprises a first material, wherein the first material is polyetheretherketone (PEEK), polyaryletherketone (PAEK), polyetherketoneketone (PEKK), or another thermoplastic polymer.

(I4) For the spinal implant denoted as any of (I2) through (I3), the solid section comprises a second material, wherein the second material is titanium, stainless steel, or thermoplastic polymer.

(I5) For the spinal implant denoted as any of (I1) through (I4), the implant is formed by a contiguous deposition of a first material in a plurality of layers.

(I6) For the spinal implant denoted as any of (I1) through (I5), the porous section comprises pores having a size of about 300 μm.

(J1) A surgical implant formed by additive manufacturing comprising: a plurality of layers forming at least one region of interconnected pores, wherein the pores are configured to facilitate bone growth therein. The implant is customizable to the anatomy of a particular patient and is configured for use within the spine, an extremity, or the skull of a patient. The plurality of layers comprise a printing material deposited in a particular predetermined pattern to form the interconnected pores.

(J2) For the surgical implant denoted as (J1) the implant comprises polyetheretherketone (PEEK), polyaryletherketone (PAEK), polyetherketoneketone (PEKK), or another thermoplastic polymer.

(J3) For the surgical implant denoted as (J1) or (J2), comprising a hydroxyapatite (HA) coating extending into the pores.

(J4) For the surgical implant denoted as any of (J1) through (J3), comprising pores having a size of about 300 μm.