WO2016112224A1 - Additive manufacturing to produce an encapsulated sterile item - Google Patents

Abstract

Processes, additive manufacturing printers, and platform/packaging units that may be used to create a sterile item through and additive manufacturing process on a sterile surface of the platform/packaging unit within a sterile chamber within the additive manufacturing printer. The platform packaging unit subsequently encapsulates and seals the created sterile item within the platform/packaging unit so that the platform/packaging unit may be removed from the additive manufacturing printer into a non-sterile environment with the created sterile item remains sterile within the sealed platform/packaging unit. The created item may be a patient specific implant for use in a medical procedure. A sterile item may alternatively be created and immediately used without encapsulation.

Description

Additive Manufacturing to Produce an Encapsulated Sterile Item

[0001] This application claims benefit of and incorporates by reference co-pending United States Provisional Application Serial No. 62/101 ,354 filed January 08, 2015 with title System For Sterile Printing With An FFF 3D Printer.

BACKGROUND

[0002] Field of the Disclosure.

[0003] This disclosure relates generally to sterile printing of an item which is then enclosed so that the sterility of the item is maintained during transportation for subsequent use.

[0004] Vocabulary.

[0005] Encapsulate.

[0006] For purposes of this disclosure, to encapsulate the created item is to envelope the created item within a closed volume. The closed volume may be defined by a number of components but those components are sealed one to another in a manner sufficient to protect the sterility of the enclosed created item. The seal may be an air-tight seal but a lesser seal may be sufficient in some instances. The seal does not need to be able to withstand pressure differentials across the seal such as may be required for an item that need to withstand the pressure of immersion in a tank of water.

[0007] Or.

[0008] Unless explicit to the contrary, the word "or" should be interpreted as an inclusive or rather than an exclusive or. Thus, the default meaning of or should be the same as the more awkward and/or.

[0009] Patient.

[0010] The term patient should not be limited to humans. The patient may be an animal undergoing a procedure by a veterinarian. [0011] Translucent.

[0012] The term translucent as used in this application indicates that a substantial amount of UV light passes through the material. This is relevant for the process of using UV light for sterilization. If the material blocks all UV light or enough UV light to interfere with sterilization on a commercially feasible time scale, then the material is not translucent. One of skill in the art will recognize that a thin layer of a material may be translucent and a thick layer of the same material may be functionally opaque. Transparent is a particular subset of the super set of translucent. Frequently, the material substantially translucent to UV light will be substantially translucent to light in the visible frequency but that is not required. Note in order to avoid distractions that might impede the conveyance of information in this disclosure, many items that will be at least partially translucent to visible light will be shown in the figures as opaque. This precludes having a multiplicity of lines as lower edges of items and the various hidden lines of lower items are not all visible at once. [0013] The field of additive manufacturing has seen many advancements. An appropriate data file is used to create a three-dimensional object with precise dimensions. There are a number of additive manufacturing processes. One of the best known is 3D printing.

[0014] Additive manufacturing may be used in a variety of industries and disciplines. Additive manufacturing may be used within the medical arts including dentistry and veterinary medicine. An example of a use of additive manufacturing within the dentistry field may be found in United States Patent Application Publication No. US 2015/03511866 for Method of Establishing Drill Trajectory for Dental Implants. In the '866 application, a frame to fit over a portion of the patient's teeth and gum is produced through 3D printing. Likewise a cartridge is printed to fit within the frame as part of a system to ultimately guide a drill to place a bore in a suitable location for an implant to be inserted.

[0015] One 3D printer choice for making these components is a fused filament fabrication printer using polylactic acid (commonly known as PLA). FDA compliant PLA is used in many other medical applications and if left in the body will safely degrade over time to lactic acid. Being able to degrade into innocuous lactic acid, PLA is used as medical implants in the form of anchors, screws, plates, pins, rods, and as a mesh. Depending on the exact type used, PLA breaks down inside the body within a period ranging from six months to about two years. This gradual degradation is desirable for a support structure, because it gradually transfers the load to the bone structure of the body as that area heals. PLA is a common choice for medical implants as the strength characteristics of PLA implants are well documented.

[0016] The process of printing with extruded PLA is normally done at approximately 190 to 220 degrees Centigrade which is well above the 121 degrees Centigrade recommended for steam sterilization or even the 170 degrees Centigrade recommended for dry heat sterilization. Multiple studies demonstrate that the extruded material post heating is free of pathological contaminates. When clean catch samples are cultured no microorganisms are found in the sample.

[0017] Another well-known 3D printable material is Polyglycolic acid (PGA). PGA, like PLA has been demonstrated to be a safe biodegradable material for implants and suture materials.

[0018] Using the current methods contamination of the created item occurs during and after the printing process by exposure of the item to the environment during and after the printing process. The problem of contamination is further compounded by the fact that most common methods for sterilization are not suitable for PLA or PGA. Using methods such as steam sterilization would distort the printed object.

[0019] One common technique for sterilizing items in dentistry is a bath of Glutaraldehyde. Glutaraldehyde presents challenges for use with printed materials as Glutaraldehyde has a short useful life and is toxic. The cost, short shelf life, and difficulty in adhering to and documenting adherence to strict protocols make this option unattractive. Further, it would be undesirable to implant a created item that had Glutaraldehyde residue.

[0020] Gas sterilization such at EtO is a well-known process. Gas sterilization would not be a desirable choice as gas sterilization takes a long time, requires expensive equipment and uses materials that are toxic gases and thus are not great choices for use in dentist offices.

[0021] No matter what sort of cold sterilization process is used, the problem remains in maintaining sterility from the end of the sterilization procedure to the use with the patient. SUMMARY OF THE DISCLOSURE

[0022] This disclosure teaches the use of a sterile platform and packaging unit that can be used in a self-contained sterile environment that allows for fused filament fabrication ("FFF") or other additive manufacturing process to deposit a medical item that is customized to the patient.

[0023] The material used in fabrication of the item may be sterilized by the heating process of extruding the material. The platform and packaging unit is sterile and provides a medium for proper retention of the deposited material. Proper retention of the deposited material prevents failure of the print process from detachment of the created item from the substrate that receives the created item. The environment within the printer is a closed system that can be purified. After the item is created upon the sterile platform and packaging unit, the platform and packaging unit may be closed and sealed while within the sterile environment of the printer.

[0024] One set of teachings of the present disclosure may be summarized as a method for producing a sterile created item encapsulated to maintain sterility of the created item; the method comprising:

· preparing a chamber within an additive manufacturing device to become a sterile chamber with a sterile printing surface;

• creating a created item upon the sterile printing surface;

• encapsulating the created item while still on the sterile printing surface and within the sterile chamber;

· opening the chamber to a non-sterile environment; and

• removing the encapsulated created item from the chamber while retaining the sterility of the encapsulated created item.

[0025] One set of teachings of the present disclosure may be summarized as a platform/packing unit for encapsulating a sterile created item, the platform/packing unit comprising: • a sterile printing surface to receive a created item created by an additive manufacturing process, the sterile printing surface surrounded by a lower frame;

• the platform/packing unit adapted to close to put an upper portion in proximity with the lower frame while covering a top of the created item created upon the sterile printing surface; and

• the platform/packing unit adapted for sealing so that the created item created upon the sterile printing surface remains sterile after the platform/packing unit is removed from a sterile environment. [0026] One set of teachings of the present disclosure may be summarized as creation of an encapsulated item comprising:

• an item created through an additive manufacturing process that uses heat above 121 degrees Centigrade;

• the item created on a sterile printing surface;

· the item covered by a sterile face of an upper portion placed above the item created on the sterile printing surface; and

• an air tight seal created so that after creation of the air tight seal, non-sterile air cannot reach the item created on the sterile printing surface. [0027] One set of teachings of the present disclosure may be summarized as a printer adapted for use in an additive manufacturing process; the printer having:

• at least one print head on a print head assembly that is adapted for relative motion relative to an item created in additive manufacturing; and

• a tool that may be selectively and reversibly extended from the print head assembly for use in closing a platform/packing unit.

[0028] One set of teachings of the present disclosure may be summarized as a method for producing a created item for use in a medical procedure; the method comprising:

• preparing a chamber within an additive manufacturing device to become a sterile chamber with a sterile printing surface; • creating a sterile created item upon the sterile printing surface;

• opening the chamber to a non-sterile environment; and

• removing the created item from the chamber while retaining the created item remains sterile.

[0029] A great variety of printing/packaging units are disclosed including some with hinges between an upper portion (sometimes called an upper frame) and a lower portion. In some instances the upper portion (frame) uses a flexible material that may be stretched over the created item. In other instances the upper portion is created so that there is clearance between an inner face of the upper portion and the created item that is on the lower frame.

[0030] Not all printing/packaging units have hinged upper and lower portions. An upper portion not connected to a lower portion may be lifted and placed upon a lower portion (lower frame) without making contact with a created item on the lower portion.

[0031]

[0032] This summary is meant to provide an introduction to the concepts that are disclosed within the specification without being an exhaustive list of the many teachings and variations upon those teachings that are provided in the extended discussion within this disclosure. Thus, the contents of this summary should not be used to limit the scope of the claims that follow.

[0033] Inventive concepts are illustrated in a series of examples, some examples showing more than one inventive concept. Individual inventive concepts can be implemented without implementing all details provided in a particular example. It is not necessary to provide examples of every possible combination of the inventive concepts provide below as one of skill in the art will recognize that inventive concepts illustrated in various examples can be combined together in order to address a specific application.

[0034] Other systems, methods, features and advantages of the disclosed teachings will be immediately apparent or will become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be included within the scope of and be protected by the accompanying claims. BRIEF DESCRIPTION OF THE FIGURES

[0035] The disclosure can be better understood with reference to the following figures. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the disclosure. Moreover, in the figures, like reference numerals designate corresponding parts throughout the different views.

[0036] FIG. 1 is a perspective view of a 3D printer 100 that uses heated filament for an added manufacturing process.

[0037] FIG. 2 is a perspective bottom view, showing an outside surface of an opened sterile platform/packing unit 300.

[0038] FIG. 3 is a perspective bottom view showing an outside surface of the PPU 300 from FIG. 2.

[0039] FIG. 4 shows a PPU 300 after adhesion to the translucent printer bed 108.

[0040] FIG. 5 shows a printer 100 with the PPU 300 adhered to the translucent printer bed 108 before the printer door 104 is closed.

[0041] FIG. 6 shows an inner frame 336 that is removed to expose adhesive perimeter 338 to allow flexible layer 334 and upper frame 330 to encapsulate the created item 400 (not shown here) in a closed and sealed PPU 300. The adhesive in the adhesive perimeter is selected to be active within a range of ambient temperatures (room temperature plus some elevation from the activity within the printer chamber) expected within the printer 100.

[0042] FIG. 7 helps illustrate the process of using UV light to sterilize the interior of the printer 100.

[0043] FIG. 8 shows the print head 204 creating created item 400 on print surface 344 on the lower frame 340 adhered to the translucent printer bed 108 by adhesive layer 308.

[0044] FIG. 9 shows the horizontal projection 224 of the hook 220 has engaged an end of the upper frame 330 and is rotating the upper frame 330 around hinge 350 so that the flexible layer 334 may encapsulate created item 400 on printing surface 344 surrounded by lower frame 340.

[0045] FIG. 10 shows a created item 400 encapsulated in a sealed PPU 300. Note that the flexible layer 334 stretches to encapsulate the created item 400.

[0046] FIG. 11 illustrates the hook 220 in a retracted position. [0047] FIG. 12 illustrate that the hook 220 extended out of print head assembly 200.

[0048] FIG. 13 is a high-level flow chart of the process 1000 of producing a created item 400 encapsulated in a PPU 300 so that the created item 400 remains sterile till the PPU 300 is opened and the sterile created item 400 removed for use.

[0049] FIG. 14 shows an alternative PPU 1300 that has an upper frame 1330 that surrounds a sterilized flexible layer 1334 where the inner face of the sterilized flexible layer 1334 remains sterile as it is isolated from the outside world.

[0050] FIG. 15 is a top perspective view of a printer bed 604 which may be used within a printer 100.

[0051] FIG. 16 shows a top perspective view of a PPU holder 620.

[0052] FIG. 17 shows a top perspective view of a printer bed 604, PPU holder 620 and PPU 700.

[0053] FIG. 18 provides a bottom perspective view of printer bed 604 with PPU holder 620.

[0054] FIG. 19 shows a hook 240 which has a U-shape end engaging with handle 738.

[0055] FIG. 20 shows the PPU 700 after upper portion 730 has been rotated around hinge 750.

[0056] FIG. 21 shows PPU 800 which is in two distinct parts, a lower frame 340 surrounding a printing surface 344 and an upper portion 830 for placement over the lower frame 340 after printing the created item.

[0057] FIG. 22 is a top perspective view of a PPU holder 660.

[0058] FIG. 23 is a top perspective view of PPU holder 660 and before movement of the upper portion 830.

[0059] FIG. 24 is a top perspective view of PPU holder 660 after movement of the upper portion 830 over the lower frame.

DETAILED DESCRIPTION [0060] FIG. 1 is a perspective view of a 3D printer 100 that uses heated filament for an added manufacturing process. One possible filament is PLA. The printer door 104 is open exposing the translucent printer bed 108, lower UV light 124, upper UV light 128, and X-Y mechanism 150 for moving the print head assembly 200. There are advantages of sealing or partially sealing the X-Y mechanism 150 so that the outer surfaces of the sealed X-Y mechanism could be sealed within a need to sterilize the various moving parts within the X- Y mechanism 150. When the printer door 104 is closed on the printer 100, the contents of the printer 100 are isolated from the outside world.

[0061] One suitable material for the translucent printer bed 108 is glass. Other materials may be used providing that the material is sufficiently translucent to UV light to avoid significant slowdowns in the sterilizing process. The material would need to be non- porous for easy sterilization. The material would need to tolerate the heat associated with the intended sterilization and additive manufacturing processes. The material would need to be sufficiently durable that the material was not unduly prone to deep scratches or other marks from incidental contact and handling so as to avoid having surfaces that are difficult to sterilize. Substantially translucent polymers or ceramics are examples of potential acceptable materials.

[0062] FIG. 2 is a perspective bottom view, showing an outside surface of an opened sterile platform/packing unit 300 (hereinafter "PPU"). The PPU 300 has an upper frame 330 that surrounds a flexible layer 334. The lower frame 340 surrounds a printing surface 344 (not visible here). Visible in FIG. 2 is a covering layer 304 that covers an adhesive layer 308 (not visible here). One of skill in the art will recognize that the lower frame 340 may simply be a perimeter of the printing surface 344 that is reserved for interaction with the upper frame 330 and is otherwise indistinguishable from the printing surface 344.

[0063] FIG. 3 is a perspective bottom view showing an outside surface of the PPU 300 from FIG. 2. Visible in FIG. 3 is a covering layer 304 that covers an adhesive layer 308 which is used to firmly adhere the PPU 300 to the translucent printer bed 108 within the printer 100 so that the PPU 300 does not move during the additive manufacturing process so that the created item 400 is made in accordance with the digital file used by the printer 100. The covering layer 304 is shown partially peeled back to partially expose adhesive layer 308. [0064] FIG. 4 shows a PPU 300 after adhesion to the translucent printer bed 108. FIG. 4 is a perspective top view of the PPU 300 showing the upper frame 330, flexible layer 334, and lower frame 340 and printing surface 344 after PPU 300 is adhered to the translucent printer bed 108. Once the printer door 104 is closed, the sterilization process may be started.

[0065] FIG. 5 shows a printer 100 with the PPU 300 adhered to the translucent printer bed 108 before the printer door 104 is closed.

[0066] FIG. 6 shows the open PPU 300 with the lower frame 340 and printing surface 344 adhered to the translucent printer bed 108 via the adhesive layer 308. An inner frame 336 is removed to expose adhesive perimeter 338 to allow flexible layer 334 and upper frame 330 to encapsulate the created item 400 (not shown here) in a closed and sealed PPU 300. In one embodiment, the PPU 300 is placed within a specific portion of the printer 100. This may come from having a cavity in the upper surface of the translucent printer bed 108 that receives the PPU 300. Having a cavity in the translucent printer bed 108 will assist in the placement of the PPU 300 in a predictable and repeatable manner. This cavity may be sized to be approximately the size of the footprint of the open PPU 300 so that the PPU 300 is stabilized within the cavity and not prone to unplanned movement when contacted by the hook 220 discussed below. This cavity may be sized to be approximately the size of the footprint of the lower frame 340 of the PPU 300 so that the PPU 300 is stabilized within the cavity and not prone to unplanned movement when contacted by the hook 220 discussed below. The term cavity should be interpreted to include a volume defined by a frame that is above the baseline elevation of the translucent printer bed 108 so that the cavity is above the baseline elevation. The term cavity should be interpreted to include a recess that places the cavity below the baseline elevation of the translucent printer bed 108.

[0067] A facility that needed to print several different sizes of created item 400 (whether difference sizes of the same sort of item (adult size versus pediatric size) or different types of items) may have different sizes of PPU 300 adapted for each size item. The printer may have a set of interchangeable translucent printer beds 108 to accommodate different size PPU 300 footprints. Alternatively, a single translucent printer bed 108 sized for the largest contemplated PPU 300 may have translucent frames to downsize the cavity in the translucent printer bed for smaller PPU 300.

[0068] The placement of the PPU 300 within the translucent printer bed 108 may be done without the use of adhesive and rely solely on the cavity within the translucent printer bed 108 to maintain the position of the PPU 300.

[0069] The precise placement of the PPU 300 may be achieved by providing UV translucent markings on the translucent printer bed 108 to direct the placement of the PPU 300 so the PPU 300 is adhered to the translucent printer bed 108 in a predicted position so that further intervention from the user or use of machine vision is not required.

[0070] FIG. 7 helps illustrate the process of using UV light to sterilize the interior of the printer 100 and open PPU 300. UV light only sterilizes the surfaces that the UV light reaches. Thus, if an object is between the UV light and a surface to be sterilized, the shadow of the object may preclude sterilization of the entire surface. The design of the interior of the printer 100 should avoid having any location that is shielded from both the upper UV light 128 and the lower UV light 124. Should there be an area that is not adequately exposed to UV light, additional lights (perhaps on the back or side walls) may be added. Non-porous surfaces for both the interior of the printer 100 and the open PPU 300 are preferred as these surfaces are more easily sterilized by UV light.

[0071] UV light is a well-known and well-used tool in sterilizing items. The wavelength of UV radiation ranges from 328 nm to 210 nm (3280 A to 2100 A). The maximum bactericidal effect for UV light occurs at 240-280 nm. Mercury vapor lamps emit more than 90% of their radiation at 253.7 nm, which is near the maximum microbicidal activity. UV radiation has been employed in the disinfection of many different items including: drinking water, air, titanium implants, and contact lenses.

[0072] UV lights tend to operate in excess of a first level of intensity for a minimum number of operating hours. After that minimum number of operating hours, the UV intensity may diminish. A printer relying on a minimum intensity from the set of UV lights, may track the hours of use of the UV lights and disable the printer at the maximum number of UV use hours. After replacement of the UV lights the printer would be enabled for another period of hours of use. [0073] A different test for the UV light effectiveness is a periodic spore test. A test PPU with a set of encapsulated spores may be opened and subject to the UV sterilization cycle. The test PPU can then be sealed and sent to a lab for confirmation of effective sterilization.

[0074] Moving the upper UV light 128 and lower UV light 124 from end to end of the translucent printer bed 108 while emitting UV light is helpful but if done while the print head assembly 200 was stationary, there could be portions of the translucent printer bed 108 that are not exposed to UV light. Fortunately, the print head assembly 200 is moving after the printer door 104 is closed as the print head assembly 200 has a calibration procedure that calls for the print head assembly 200 to move to each of three calibration plates 170, 174, and 178 to ensure that the three calibration plates are at the proper height. In many printers, the translucent printer bed 108 moves relative to the print head assembly 200. The print head assembly 200 moves in the X and Y axes but not in the Z axis.

[0075] As the print head assembly 200 is moved from calibration plate to calibration plate, different portions of the X-Y mechanism 150 are exposed to the upper UV light 128 and lower UV light 124. This concept is illustrated by showing a pair of worm gears 154 and 158 which would rotate to move the print head assembly 200 or away from the printer door 104. As the worm gears rotate, different portions of the worm gears are exposed to UV light. Those of skill in the art will recognize that sterilization of the surfaces within the printer 100 will be a function of the intensity of the UV light and the duration of exposure. More intense UV light will allow shorter exposure times. The glass in the translucent printer bed 108 will not significantly attenuate the UV light.

[0076] Those of skill in the art will appreciate if the intensity/duration of UV exposure to the least exposed portions of the printer cavity is not sufficient for reliable sterilization that the print head assembly 200 may be moved after the calibration process for the exclusive purpose of providing exposure of surfaces to UV light for ample sterilization. The hook described below may be extended during the sterilization process to expose the hook to UV light.

[0077] The UV light could optionally be left on during the entire printing process to continue to sterilize. This might be useful against incidental inflows of ambient air. [0078] Those of skill in the art will appreciate that UV light while beneficial for its intended purpose of sterilizing a space, needs to be managed to avoid any unintended impacts on the users. The printer door 104 should be substantially opaque to the passage of UV light so that UV light does not exit the printer 100. An interlock that precludes the operation of the UV light unless the printer door 104 is locked is prudent.

[0079] After adequate sterilization of the entire interior of the printer, including the inside face of the printer door 104, the handled portions of the upper frame 330 and lower frame 340 of the PPU 300, and the X-Y mechanism 150 that moves the print head assembly 200, the process may move to the creation of the created item 400.

[0080] The print head assembly 200 may be used to print the created item 400 using conventional processes including fused filament fabrication using a medical grade PLA filament.

[0081] For a particular printer, the process may be to place the lower frame 340 on the door side of the printer, but the lower frame 340 could be placed towards the printer wall away from the door side of the printer, parallel to the printer door 104, or in some other alignment such as on one of the diagonals of the translucent printer bed 108. The placement would need to allocate room for the opening of the PPU 300 and work with the hook mechanism associated with the print head assembly 200.

[0082] FIG. 8 shows the print head 204 creating created item 400 on print surface 344 on the lower frame 340 adhered to the translucent printer bed 108 by adhesive layer 308. The print surface 344 may have a texture that is suitable for adhesion of the additive material. The desirable texture for use in receiving additive material varies from process to process. A balance may need to be struck between providing a texture that is the absolute best surface for receiving additive material and selection of a surface that is readily sterilized by UV light.

[0083] Also visible are hook 220 including horizontal projection 224. While the specific mechanisms for precise X-Y movement of the print head assembly 200 are beyond the focus of the present disclosure, representative components have been indicated as X-Y mechanism 150. As discussed below, the hook 220 can be substantially withdrawn into the print head assembly 200 so that the hook 220 does not strike the created item 400 during the creation process as the print head assembly 200 is moved. [0084] FIG. 9 shows the horizontal projection 224 of the hook 220 has engaged an end of the upper frame 330 and is rotating the upper frame 330 around hinge 350 so that the flexible layer 334 may encapsulate created item 400 on printing surface 344 surrounded by lower frame 340. After the upper frame 330 is in contact with the lower frame 340, the base of the hook 220 may be pressed over portions of the adhesive perimeter 338 to firmly seal the upper frame 330 to the lower frame 340.

[0085] For implementations using a receiver in the translucent printer bed 108 to receive the open PPU 300, the precise location of the upper frame 330 is known so the hook 220 may interact with the upper frame 330 as part of a process routine and not require a human to guide the hook based upon an image of the PPU 300.

[0086] FIG. 10 shows a created item 400 encapsulated in a sealed PPU 300. Note that the flexible layer 334 stretches to encapsulate the created item 400. While the precise shape of the created item 400 will vary from procedure to procedure, the general size of the item will stay within a range. Thus the printer 100, printing components for a dental procedure may make components within a certain size range that fit within a printing surface 344 with ample distance to the lower frame 340 so that the upper frame 330 and flexible layer 334 can encapsulate the created item 400. Lines 360 have been added to this drawing to show the three-dimensional stretch of flexible layer 334. These lines 360 would not necessarily appear in an actual PPU 300 that is encapsulating created item 400.

[0087] The flexible layer 334 does not have to start as a planar layer as shown in this disclosure. If the nature of the created item 400 is such that the created item has a significant Z component relative to the X and Y components such as a cube, then the flexible layer 334 could be created in a shape that would allow encapsulation of the created item without risk of puncture of the flexible layer through excessive stretching of a portion of the flexible layer. One of skill in the art will appreciate that an item with a significant Z component may need to be created in a printer 100 of adequate size to allow a PPU 300 with a printing surface 344 that is much bigger than the X-Y footprint of the created item 400 so that the flexible layer 334 is encapsulates the created item 400 without risk of rupture.

[0088] After the PPU 300 is sealed to complete the encapsulation of the created item 400, the printer door 104 may be opened and the PPU 300 removed. The exterior of the PPU 300 will no longer be sterile, but the interior of the PPU 300 and the created item 400 will remain sterile. Retrieval of a sterile item from packaging with a non-sterile exterior is a well-known process within the medical arts.

[0089] FIG. 11 and FIG. 12 illustrate that the hook 220 may be extended and retracted out of print head assembly 200. Hook 220 includes a rack 228 which may be used with a rack and pinion mechanism to extend and retract the hook 220. Many other mechanisms are known to those of skill in the art to extend and retract a rod with precision and there is no intention to limit the scope of this disclosure to the rack and pinion mechanism.

[0090] To ensure the sterility of the PPU 300 and created item 400, the hook 220 may be extended out of print head assembly 200 after the print head assembly has moved away from the open PPU 300 and the created item 400 (if the production of the created item 400 has begun). The newly extended hook 220 may be sterilized by the UV light before moving the extended hook 220 back over the PPU 300 and created item 400.

[0091] The hook 220 may be made of a material with high heat conductivity and heated to a temperature sufficient to establish or maintain the sterility of the hook 220 even when fully extended. Reliance on heating to sterilize the hook 220 or other tool that extends from the print head assembly 200 may be augmented by UV light sterilization or may be the sole form of sterilization used for an extended hook or other tool.

[0092] If the hook 220 is retracted and to be re-extended, then the process of working to sterilize the hook 220 would be repeated. The process includes extending the hook 220 in a portion of the printer 100 away from the PPU 300 and the created item 400, then sterilizing the newly extended hook 220 before moving it in proximity to the PPU 300 and created item 400.

[0093] A modified print head assembly 200 with drive mechanism for extending and retracting the hook 220 that remains sterile and thus does not pose risk of contaminating the retracted portion of the hook would not need to employ the routine set forth above.

[0094] Process.

[0095] FIG. 13 is a high-level flow chart of the process 1000 of producing a created item 400 encapsulated in a PPU 300 so that the created item 400 remains sterile till the PPU 300 is opened and the sterile created item 400 removed for use. The use may be a use in a medical procedure.

[0096] Step 1004— Open door to additive manufacturing device.

[0097] Step 1008— Affix the open PPU to the additive manufacturing device. This may be done via use of an adhesive layer as disclosed but it could be done using a range of mechanisms known to those of skill in the art including placing the PPU in a cavity in the additive manufacturing device, engaging a clamp in the additive manufacturing device, or some other mechanism.

[0098] Step 1012— Close door to additive manufacturing device.

[0099] Step 1016— Sterilize the interior chamber of the additive manufacturing device that contains the PPU. This may be done with the use of one or more ultraviolet lights.

There may be a bank of ultraviolet lights so that there is no need for ultraviolet lights to move within the interior chamber. The sterilization process may include movement of the components within the interior chamber that are used in the additive manufacturing process so that the various surfaces of these components are sterilized.

[00100] Step 1020— Create the created item through an additive manufacturing process that results in a sterilized item.

[00101] Step 1024— Encapsulate the created item within the PPU by placing a portion of the PPU above the created item and creating an air-tight seal so that the sterile created item remains sterile after removal from the sterile environment in the interior chamber of the additive manufacturing device.

[00102] Step 1028— Open the door of the additive manufacturing device and remove the sterile created item encapsulated in the PPU. [00103] Printer Bed with PPU Sizing Insert & Alternative PPU.

[00104] In order to illustrate that the teachings of the present disclosure extend beyond the disclosure set forth above, a second set of examples of various components are provided so that the broad scope of the teachings may be more readily recognized.

[00105] FIG. 15 is a top perspective view of a printer bed 604 which may be used within a printer 100 as set forth above. The printer bed 604 may be translucent to UV light so that a UV light positioned below the printer bed 604 may be used to sterilize items above the printer bed 604. The printer bed 604 has a recessed perimeter 608 surrounded by an outer frame 612 so that the a PPU holder 620 may be inserted into the printer bed 604 and held in place by the combination of the recessed perimeter 608 and outer frame 612.

[00106] FIG. 16 shows a top perspective view of a PPU holder 620. This PPU holder 620 has an outer perimeter 644 that fits on the recessed perimeter 608 and is bounded by the outer frame 612 of the printer bed 604. PPU holder 620 has a print surface area 624 bounded on three sides by a print surface edge 648 to receive and hold the lower frame of a PPU (discussed below).

[00107] The PPU holder 620 has an open area 628 bounded by sloped walls 632 which constrain the PPU lid discussed below. The PPU lid can extend beyond the lower face of the PPU holder 620 and the lower face of the printer bed 604 but would need to avoid contact with the moving lower UV light 124 during use of the lower UV light 124.

[00108] FIG. 17 shows a top perspective view of a printer bed 604, PPU holder 620 and PPU 700. PPU 700 may have a lower frame 340 and printing surface 344 as described in connection with PPU 300.

[00109] FIG. 17 has a rigid upper portion 730. The upper portion 730 may be connected to the lower frame 340 by a hinge 750. The upper portion 730 from this perspective is a concave three dimensional object extending downward from the surface of the PPU holder 620 into the open area 628 and bounded by sloped walls 632 of the PPU holder 620. The upper portion 730 in FIG. 17 could be described as a square pyramid truncated at a frustum. One of skill in the art will appreciate that the shape of the upper portion 730 could be a rectangular pyramid with a frustum, a cone with a frustum; or some other shape. While the square pyramidal shape that is truncated with a frustum is a right pyramid (with the apex over the center point), this is not required. One could imagine use of an upper portion 730 that is not symmetric if the PPU 700 was intended for use with a created item 400 that is much taller on one end than the other end.

[00110] As indicated in FIG. 17, the PPU 700 may have a handle 738 attached to the upper portion 730 that fits within the first handle gap 636 in the PPU holder 620. The non- sterile PPU 700 may be opened with the handle 738 in the first handle gap 636 before the printer door 104 is closed. [00111] PPU 700 may be held in place in PPU holder 620 by an interference fit. PPU 700 may be held in place in PPU holder 620 through use of an adhesive layer that is uncovered just before inserting the PPU 700 into PPU holder 620. Magnetic or mechanical holders may be used given the need to avoid UV shadows that would obstruct the sterilization process.

[00112] FIG. 18 provides a bottom perspective view of printer bed 604 with PPU holder 620 with the upper portion 730 protruding downward through the open area 628 of the PPU holder 620 bounded by walls 632. Visible are first handle gap 636 with a partial view of handle 738 and second handle gap 640.

[00113] FIG. 19 shows a hook 240 which has a U-shape end engaging with handle 738. The hook 240 may be reversibly extended from the print head assembly 200 as discussed above. The movement of the print head assembly 200 and perhaps partial retraction and extension of the hook 240 may be used to move the upper portion 730 via engagement of the handle 738. The upper portion 730 may be rotated around hinge 750 so that the handle 738 is placed in second handle gap 640 with to enclose whatever created item 400 (not shown here) was printed on printing surface 344.

[00114] FIG. 20 shows the PPU 700 after upper portion 730 has been rotated around hinge 750 so that upper flange 732 is placed over lower frame 340 (See FIG. 19). The enclosed volume between the upper surface of the upper portion 730 and the print surface 344 (See FIG. 19) is designed to provide ample room for the created item 400 of a prescribed height (not shown here).

[00115] The print head 204 may be pressed on the upper flange 732 to heat activate a bead of adhesive to bind the upper flange 732 to the lower frame 340. The bead of adhesive may be on the surface of the lower surface of the upper flange 732, the upper surface of the lower frame 340 or both. The bead of adhesive may be in a channel that is formed in the lower surface of the upper flange 732, in the upper surface of the lower frame 340, or both.

[00116] Retention of the PPU 700 in the PPU holder 620 may be achieved by a press fit of the lower frame 340 into the PPU holder 620. Additional retention of the PPU 700 may be achieved by use of an adhesive as disclosed in connection with other PPU examples. One or more mechanical clips could help stabilize the lower frame 340 within the PPU holder 620. [00117] Hinge-Free PPU.

[00118] While PPUs 300, 700, and 1300 discussed in this disclosure share a common feature of a hinge to facilitate closing the PPU after printing the created item 400 on a printing surface, a hinge is not required for a functional PPU. FIG. 21 shows PPU 800 which is in two distinct parts, a lower frame 340 surrounding a printing surface 344 and an upper portion 830 for placement over the lower frame 340 after printing the created item 400 (not shown here) on the printing surface 344. Note that the thinness of the walls of upper portion 830 is emphasized in these drawings by showing upper portion 830 as transparent.

[00119] The upper unit 830 has a flange 832 for placement over the lower frame 340. A handle 838 on the upper surface of the upper portion 830 may be engaged by an appropriate hook to move the upper unit in a predictable manner over the lower frame 340.

[00120] FIG. 22 is a top perspective view of a PPU holder 660. PPU holder 660 has a shallow upper portion cavity 664 of depth 668 and a lower frame cavity 674 of depth 678. The PPU holder 660 may work in conjunction with a cavity 110 the translucent printer bed 108. Having the PPU 660 fit within cavity 110 of the translucent printer bed 108 allows the use of a number of different sized hinge-free PPU units and different sized PPU holders and allows the holders to be swapped out quickly.

[00121] The PPU holder 660 may fit within a cavity in the printer bed 108 so that the PPU holder 660 is in a known position within the printer 100. Having the PPU holder in a known position in the printer 100 allows the printing surface 344 to be in a known position for receipt of the created item 400. Having the PPU holder in a known position in the printer 100 allows interaction between the horizontal portion of hook 250 (FIG. 23) and handle 838.

[00122] FIG. 23 is a top perspective view of PPU holder 660 with an upper portion 830 of the PPU 800 placed in the upper portion cavity 664 and a lower frame 340 placed in the lower frame cavity 674. The upper portion cavity 664 approximates the footprint of the upper portion 830 so that the location of the upper portion 830 is known when the position of the PPU holder 660 is known. The lower frame cavity 674 approximates the footprint of the lower frame 340 so that the position of the lower frame 340 is known when the position of the PPU holder 660 is known.

[00123] Note that the depth 678 of the lower frame cavity 674 exceeds the thickness 842 (FIG. 21) of the lower frame 340, there is a residual cavity 684 between the top face of the frame 340 and the horizontal face 688 of the PPU holder 660.

[00124] FIG. 23 shows hook 250 which has a horizontal component that substantially fills the volume under the handle 838. The hook 250 may be connected to the print head assembly 200 and sterilized as disclosed for the other hooks. Through movement of the print head assembly 200 and possible retraction and extension of the hook 250 the upper portion 830 may be lifted out of the upper portion cavity 664 and set down above the lower frame 340 with flange 832 within the residual cavity 684 as shown in FIG. 24. The movement of the hook 250 may be done automatically without human intervention as the precise location of all relevant components is predictable.

[00125] Flange 832 of the upper portion 830 may be adhered to the lower frame 340 as discussed in connection with PPU 700. The vertical distance between the inside of the upper portion 830 in the frustum with the handle 838 to the printing surface 344 is sized to allow ample room for the intended printed item 400 (not shown).

[00126] Printing Unit.

[00127] This disclosure has provided teachings that allow a created item 400 to be deposited on a printing surface 344 on one of several disclosed PPU items and then have a cover placed over the created item 400 before creating a seal to encapsulate the created item.

[00128] Portions of this disclosure may be used for a somewhat streamlined process wherein a printing unit (which may be very much like the previously discussed lower frame 340 with printing surface 344) may be placed within a cavity in the translucent printer bed 108 or in a cavity in a holder that fits within a cavity in the translucent printer bed. Either way the printing unit is constrained from horizontal movement and is in a position known to the printer 100. [00129] A sterilization process using at least an upper UV light 128 and possibly more than one UV light such as a lower UV light 124 can be cycled to sterilize surfaces and air within the printer 100 after the printer door 104 is closed.

[00130] A print head 204 from a print head assembly 200 may be used to print a created item 400 on the printing unit using a filament heated sufficiently so that the created item 400 is deemed sterile. After creating the created item 400, the printer door 104 may be opened and the created item 400 removed from the printer 100 through use of a sterile tool (not shown) or a user wearing one or more sterile gloves. This process may be appropriate when the created item 400 is to be used immediately and need not have the protective encapsulation of a completed PPU to preserve the sterility of the created item 400 for a non- immediate use.

[00131] Thus the present disclosure has taught the printing of a created unit 400 on two types of receivers: PPUs and printing units.

[00132] ALTERNATIVES and VARIATIONS .

[00133] Alternative Additive Manufacturing Processes.

[00134] While use of a fused filament 3D printer using PLA is discussed at length within this disclosure, the teachings for sterilizing of a chamber for use in additive manufacturing and the capture of a newly created object within a sterile container are applicable to 3D printers using other materials or more generally to other additive manufacturing processes.

[00135] Fans & Air Sterilization.

[00136] The printer 100 described above may be operated with a simply seal to limit movement of air into the printer 100 after the printer door 104 has been closed as the ongoing use of UV light would sterilize the contents of the small inflows of air. However, some designers may choose to have the printer cavity that is sterile under positive air pressure to resist inflows of non-sterile air. To maintain positive air pressure, sterilized air may need to be introduced to the printer cavity so that all flows of air are outflows from the cavity rather than inflows of air of questionable sterility. The sterile air could be compressed sterile air provided to the printer or air that is taken from the ambient environment and sterilized using UV light or other methods before introduction to the printer cavity to maintain positive air pressure.

[00137] Alternative Relative Motion.

[00138] This disclosure discussed the teachings in context with an additive manufacturing process that moved a printer bed in the Z direction relative to a print head assembly and move the print head assembly in the X and Y directions to allow for the deposition of material to create a 3D item. This is a common form of additive manufacturing device but other devices exist or are possible. Nothing in the present disclosure requires a Z-movable print bed or an X-Y movable print head.

[00139] The teachings of the present disclosure could be used with small print bed that moves in the X and Y directions within the printer. The print head may be adapted to move in the Z direction instead of the X and Y directions or the print head may be given many degrees of freedom to move in the X, Y, Z directions and perhaps rotate in various planes too.

[00140] There is no requirement that the instructions provided to the additive manufacturing device use Cartesian coordinates of X, Y, and Z. The data set for the created device could use cylindrical coordinates of height, radius and rotation angle. Spherical coordinates may be used. All that is required for use with the teachings of the present disclosure is that a 3D object may be printed on the printing surface of the PPU and then encapsulated so that the item remains sterile after the PPU is removed from the sterile confines of the additive manufacturing device.

[00141] Alternative Hooks.

[00142] One of skill in the art can appreciate that other hook configurations may be used. While the hook configuration discussed in this disclosure is desirable in that the hook may be used to pick up a portion of the PPU 300 and to apply pressure to a closed PPU 300, other hooks are possible. A hook for purposes of claims based upon this disclosure is any shape sufficient to achieve the process steps achieved through use of the hook and not limited to an L-shaped hook unless the claim specifies an L-shaped hook. One of skill in the art could use the teachings of the present disclosure to have a print head with two different tools that may be reversibly extended. One tool may be adapted for moving the upper frame 330. One tool may be adapted for sealing the closed PPU 300. Other combinations are possible. Two tools may be used for the same task. [00143] Alternative PPU.

[00144] While the PPU 300 disclosed above was not sterilized prior to placement in printer 100, an alternative shown in FIG. 14 is to have a PPU 1300 that has an upper frame 1330 that surrounds a sterilized flexible layer 1334 where the inner face of the sterilized flexible layer 1334 remains sterile as it is isolated from the outside world. The PPU 1300 has a lower frame 1340 with a sterile printing surface 1344. The PPU 1300 includes tabs 1320, 1324, and 1328 which are removed by the user just before adhering the PPU 1300 in the final placement of the PPU 1300 into a recess in the translucent printer bed 108 just before closing the printer door 104. After the printer chamber has been sterilized, the hook 220 may be used to open the PPU 1300 by rotating the upper frame 1330 relative to a hinge 1350.

[00145] The advantage of including tabs 1320, 1324, and 1328 is to provide a sturdy seal to protect the inner sterilized surfaces of the PPU 1300. With all three tabs in place, the seal holding the upper frame 1330 to the lower frame 1340 is solid. After the tabs 1320, 1324, and 1328 are removed, simple manipulations such as by hook 220 can open the PPU 1300 and reveal the inner surfaces.

[00146] There are other options for keeping sterile interior faces of a PPU closed while a PPU is handled in preparation for use in a printer. These options include various mechanical locks, magnetic clasps, suction, friction, a hook and loop type attachment (like the trademarked product known as Velcro).

[00147] PPU 1300 would preferably not have inner frame 336 covering adhesive perimeter 338 as removing the inner frame 336 with the hook 220 would add complexity to the process. A heat activated adhesive perimeter that did not require an inner frame could be used or another method to seal the PPU 1300 once it is closed over the created item 400. [00148] Grasp Targets on PPU.

[00149] One of skill in the art will appreciate that the PPU may be adapted to have features on the PPU that make the process of hook engagement more reliable. These features may include a towel rod type feature that extends laterally or vertically from a portion of the PPU. The features may include cavities along the perimeter of the PPU to allow engagement with the hook. Those of skill in the art will be able to devise a wide variety of hook and engagement features to facilitate engagement of the PPU by the hook.

[00150] Alternative to the Use of the Inner Frame.

[00151] While the teachings of the present disclosure call for sealing the PPU after the created item is captured within the PPU, this does not need to be accomplished through the removal of the inner frame 336 to expose adhesive perimeter 338. An alternative is to omit the inner frame 336 and use a heat activated adhesive for the adhesive perimeter 338. After the upper frame 330 had been rotated relative to hinge 350, the print heat which operates at approximately 190 to 220 degrees Centigrade when using PLA and at other elevated temperature ranges when using other filaments could be pressed against the upper frame 330 and moved slowly around upper frame 330 above the adhesive perimeter 338 sufficiently slowly to activate the adhesive perimeter 338 to seal the upper frame 330 to the lower frame 340.

[00152] A variation of this idea is to not use an adhesive perimeter 338 but to select materials for the inside face of the upper frame 330 and the inside face of the lower frame 340 that may be fused together when the hot print head 204 is pressed against the outer face of the upper frame 330.

[00153] A variation of this idea is to not use an adhesive perimeter 338 but use a layer of PLA on the inside face of one or both frame so that the proximity of the print head 204 to the PLA will cause the PLA to seal the PPU 300.

[00154] A variation of this idea is to not use an adhesive perimeter 338 but to use a lower frame 340 that extends on the three non-hinge sides of the PPU 300 beyond the upper frame 330 so that the print head 204 may apply a bead of PLA on the lower frame 340 surrounding the three non-hinge sides of the PPU 300 beyond the upper frame 330 to seal the PPU 300. [00155] As this disclosure includes a PPU 800 that does not have a hinge, the various alternative sealing methods referenced above may be extended to a PPU 800 where the upper portion is placed upon the lower portion and then sealed. When there is not a side already connected by a hinge that forms a seal, then all sides must be sealed. Likewise, if there is a hinge used to connect an upper portion and a lower portion but does so in a way that would not provide an adequate seal, then all sides would be sealed even the side with the hinge.

[00156] PPU Opening.

[00157] The PPU may be opened by the interaction of a hook associated with the print head assembly 200 as disclosed. An alternative is a PPU that is spring loaded so that pressing upon the upper frame 330 causes the upper frame 330 to move away from the lower frame 340 so that a hook 220 may easily engage the upper frame 330 to rotate the upper frame 330 relative to the hinge 350. The hook 220 may later be used to close the PPU 300.

[00158] Types of Created Items.

[00159] One example of an item that may be created, encapsulated in a sterile container, and then inserted into the body is a membrane used as cover over bone graft to expand a jawbone. The membrane is shaped to fit the specific shape for the expanded jawbone but keeps gum tissue from moving into the newly grafted bone. As the membrane is being inserted into tissue, it will be important to maintain the sterility of the membrane until it is placed within the patient's mouth. [00160] Alternative Methods of Sterilizing the Interior of the Printer.

[00161] While the disclosure discussed the use of ultraviolet light to sterilize the contents of the interior of the printer 100 before opening the PPU 300, other sterilization methods may be used that do not use ultra-violet lights including the use of gases or chemicals, including aerosols. [00162] Alternatives for Securing the PPU to the Printer Bed.

[00163] While use of adhesives or simply wedging the PPU 300 into a cavity of some sort in the translucent printer bed 108 are options for limiting movement of the open PPU 300 during the printing process, those of skill in the art will recognize that other options including mechanically securing the PPU 300 are possible. The mechanical securing mechanism would need to be designed with a plan for how this is sterilized. The mechanical securing mechanism may be UV translucent or may have one or more open positions for sterilization that allows the UV light to reach all surfaces.

[00164] Another alternative would be to use magnets in the PPU 300 to augment or replace the use of adhesives. A magnet on an outer surface of the PPU 300 would be subject to UV light and could be sterilized. A magnet embedded within the PPU 300 and covered with a non-porous surface would not need to be sterilized. A translucent magnet could be embedded within the translucent printer bed 108 and allow the passage of UV light. One suitable magnet would be an aerogel: a solid so porous that it is almost entirely air. Such a magnet would be made of small particles of silica in a rigid network. The aerogel could include a distribution of fine grains of a strongly magnetic mixture of neodymium, iron and boron, (Nd2Fel4B) blended with the reagents that make the silica particles. The resulting aerogel is substantially translucent.

[00165] Non-Medical Uses.

[00166] There are some non-medical procedures that may seek to have sterile items created for a specialized use and then packaged to maintain the sterile nature of the item after creation through an additive manufacturing process. Nothing in the present disclosure is intended to preclude appropriate claims from covering uses of the disclosed teachings outside of the medical field.

[00167] One of skill in the art will recognize that some of the alternative implementations set forth above are not universally mutually exclusive and that in some cases additional implementations can be created that employ aspects of two or more of the variations described above. Likewise, the present disclosure is not limited to the specific examples or particular embodiments provided to promote understanding of the various teachings of the present disclosure. Moreover, the scope of the claims which follow covers the range of variations, modifications, and substitutes for the components described herein as would be known to those of skill in the art.

[00168] The legal limitations of the scope of the claimed invention are set forth in the claims that follow and extend to cover their legal equivalents. Those unfamiliar with the legal tests for equivalency should consult a person registered to practice before the patent authority which granted this patent.

Claims

CLAIMS What is claimed is:

1. A method for producing a sterile created item encapsulated to maintain sterility of the created item; the method comprising:

preparing a chamber within an additive manufacturing device to become a sterile chamber with a sterile printing surface;

creating a created item upon the sterile printing surface;

encapsulating the created item while still on the sterile printing surface and within the sterile chamber;

opening the chamber to a non-sterile environment; and

removing the encapsulated created item from the chamber while retaining the sterility of the encapsulated created item.

2. The method of claim 1 wherein the chamber within the additive manufacturing device is made sterile through use of UV light.

3. The method of claim 1 wherein sterile air is provided to the chamber.

4. The method of claim 1 wherein the additive manufacturing device uses medical grade PLA to create the created item.

5. The method of claim 1 wherein the method includes using a component that is extended from a print head assembly to seal a sterile platform/packing unit that includes the sterile printing surface.

6. The method of claim 1 wherein the method includes using a component that is extended from a print head assembly to open and subsequently close and seal a sterile platform/packing unit that includes the sterile printing surface.

7. The method of claim 1 wherein the encapsulation of the created item includes removal of a covering for an adhesive that is operative at an ambient temperature within the chamber in the additive manufacturing device.

8. The method of claim 1 wherein the encapsulation of the created item includes use of heat from a print head assembly to activate a heat activated adhesive.

9. The method of claim 1 wherein the encapsulation of the created item includes fusing two portions of a sterile platform/packing unit including one portion that includes the sterile printing surface.

10. The method of claim 1 wherein encapsulation involves stretching a sterile flexible layer to cover the created item.

1 1. The method of claim 1 wherein encapsulation involves rotating an upper portion around a hinge and sealing a flange from the upper portion to a set of non-hinged portions of a lower frame.

12. The method of claim 1 wherein encapsulation involves moving an upper portion over the created item and lowering the upper portion to locate a flange from the upper portion on lower frame then sealing the flange from the upper portion to the lower frame.

13. A platform/packing unit for encapsulating a sterile created item, the

platform/packing unit comprising:

a sterile printing surface to receive a created item created by an additive manufacturing process, the sterile printing surface surrounded by a lower frame;

the platform/packing unit adapted to close to put an upper portion in proximity with the lower frame while covering a top of the created item created upon the sterile printing surface; and the platform/packing unit adapted for sealing so that the created item created upon the sterile printing surface remains sterile after the platform/packing unit is removed from a sterile environment.

14. The platform/packing unit of claim 13 wherein the lower frame connected to the upper portion by a hinge to facilitate the process to close the platform/packing unit to put the upper portion in proximity with the lower frame while allowing the upper portion to cover the top of the created item created upon the sterile printing surface.

15. The platform/packing unit of claim 14 wherein the upper portion comprises an upper frame and a flexible layer that may stretch to cover a created item.

16. The platform/packing unit of claim 14 wherein the upper portion is sized so that no contact occurs between the upper portion and a created item of a prescribed height when the upper portion is moved to cover a created item.

17. The platform/packing unit of claim 13 wherein the platform/packing unit is adapted to be opened to allow the additive manufacturing process to create a created item upon the sterile printing surface.

18. The platform/packing unit of claim 13 wherein sealing is accomplished by removing a covering over an adhesive and pressing the upper portion against the lower frame.

19. The platform/packing unit of claim 13 wherein sealing is accomplished by using a heated print head to press against the platform/packing unit to activate a heat activated adhesive.

20. The platform/packing unit of claim 13 wherein sealing is accomplished by using a heated print head to press against the platform/packing unit to fuse portions of the platform/packing unit.

21. The platform/packing unit of claim 13 wherein sealing is accomplished by using a heated print head at a temperature above 121 degrees Centigrade-to press against the platform/packing unit to activate a heat activated adhesive.

22. The platform/packing unit of claim 13 wherein the upper portion is not connected to the lower frame while the created item is being made by additive manufacturing and the upper portion has a handle which may be used by a tool to move the upper portion over the lower frame.

23. An encapsulated item comprising:

an item created through an additive manufacturing process that uses heat above 121 degrees Centigrade;

the item created on a sterile printing surface;

the item covered by a sterile face of an upper portion placed above the item created on the sterile printing surface; and

an air tight seal created so that after creation of the air tight seal, non-sterile air cannot reach the item created on the sterile printing surface.

24. The encapsulated item of claim 23 wherein the item is created from a PLA filament.

25. The encapsulated item of claim 23 wherein

the sterile printing surface is surrounded by a lower frame;

the upper portion is surrounded by an upper flange; and

the lower frame is separated from the upper portion by a hinge.

26. The encapsulation item of claim 23 wherein;

the sterile printing surface is surrounded by a lower frame; and

the sterile face of the upper portion is a flexible material that may stretch to fit over the item created on the sterile printing surface.

27. The encapsulation item of claim 23 wherein;

the sterile printing surface is surrounded by a lower frame; and

the upper portion is sized so that an inner surface of the upper portion does not make contact with the item when the inner surface is moved over the item.

28. The encapsulation item of claim 27 wherein:

an inner surface of the upper portion is moved over the item by rotating the upper portion relative to a hinge that connects the upper portion to the lower frame.

29. The encapsulation item of claim 27 wherein:

the inner surface of the upper portion is moved over the item by lifting the upper portion relative to the lower frame; and

then lowering an outer flange of the upper portion onto the lower frame.

30. The encapsulation item of claim 23 wherein the air tight seal is created though removal of a covering of an adhesive that operates at ambient temperature.

31. The encapsulation item of claim 23 wherein the air tight seal is created though heat activation of an adhesive that is not operative at ambient temperature unless heat activated.

32. The encapsulation item of claim 23 wherein the air tight seal is created through application of heat to fuse components.

33. A printer adapted for use in an additive manufacturing process; the printer having: at least one print head on a print head assembly that is adapted for relative motion relative to an item created in additive manufacturing; and

a tool that may be selectively and reversibly extended from the print head assembly for use in closing a platform/packing unit.

34. The printer of claim 33 wherein heat may be applied to the tool from the print head assembly to sterilize the tool.

35. The printer of claim 33 wherein the tool is hook.

36. The printer of claim 35 wherein the tool is an L-shaped hook.

37. The printer of claim 35 wherein the hook has a horizontal portion designed to fill a void defined by a handle used to lift and move an upper portion of a multi-piece printing/packing unit to cover a created item.

38. The printer of claim 33 wherein the tool may be selectively and reversibly extended through use of a rack and pinion.

39. The printer of claim 33 wherein the tool may be selectively and reversibly extended from the print head assembly for use in opening the platform/packing unit.

40. The printer of claim 39 wherein the tool that may be selectively and reversibly extended from the print head assembly for use in closing the platform/packing unit is a same tool that may be selectively and reversibly extended from the print head assembly for use in opening the platform/packing unit.

41. The printer of claim 33 wherein the printer includes a sterilization mechanism to sterilize a set of surfaces in a chamber within the printer including all exposed surfaces of an open platform/packing unit.

42. The printer of claim 41 wherein the sterilization mechanism uses UV light.

43. The printer of claim 33 wherein the printer has a printer bed that allows a UV light positioned below the printer bed to sterilize items above the printer bed.

44. The printer of claim 43 wherein at least a portion of the printer bed is made of glass.

45. The printer of claim 43 wherein the printer bed has a cavity in an upper surface of the printer bed that is sized to correspond with a footprint of an open platform/packing unit.

46. The printer of claim 43 wherein the printer bed has a cavity in an upper surface of the printer bed that is sized to correspond with a footprint of a lower frame of a

platform/packing unit.

47. A method for producing a created item for use in a medical procedure; the method comprising:

preparing a chamber within an additive manufacturing device to become a sterile chamber with a sterile printing surface;

creating a sterile created item upon the sterile printing surface;

opening the chamber to a non-sterile environment; and

removing the created item from the chamber while retaining the created item remains sterile.

48. The invention as described and illustrated in the specification and referenced figures.