Pause-print parts medical and dental parts library for robotic assembly

Abstract

A method of fabricating a dental or medical device, wherein the method comprises: (a) acquiring 3D digital image data of a body part of a patient; (b) creating a 3D digital model of a dental or medical device to be fabricated wherein the 3D digital model incorporates a model part selected from a digital library of virtual parts, each of the virtual parts corresponding to an associated physical part of a plurality of physical parts; (c) fabricating a first portion of the device from the 3D digital model using additive manufacturing or subtractive manufacturing; (d) selecting one physical part of the plurality of physical parts that corresponds to the model part; (e) inserting the one physical part into a location in the first portion of the device; and (f) fabricating a second portion of the device from the 3D digital model using additive manufacturing or subtractive manufacturing.

Description

Docket No.: 920171.00659-UMN 2024-331Pause-Print Parts Medical and Dental Parts Library for Robotic AssemblyCROSS-REFERENCES TO RELATED APPLICATIONS

[0001] This application is based on, claims benefit of, and claims priority to U.S. Application No. 63 / 682,872 filed on August 14, 2024, which is hereby incorporated by reference herein in its entirety for all purposes.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

[0002] Not Applicable.FIELD OF THE INVENTION

[0003] This invention introduces a simplified workflow that expedites the clinical and laboratory steps of a manufacturing process of a dental or medical device and ultimately renders a product that can be produced directly from 3D digital image data of a body part of a patient using additive manufacturing (e.g., three dimensional printing) or subtractive manufacturing (e.g., milling).BACKGROUND

[0004] Various dental or medical devices are known. For example, a denture is a prosthesis that replaces one or more natural teeth and supporting structures. It is supported by the teeth and / or the mucosa. It may be fixed or removable.

[0005] Historically, the prosthesis has been prototyped and manufactured in a long and drawn out process requiring many long dental appointments and a large number of steps where error can be introduced in the clinic or laboratory. Two of the large sources of error are using stone (plaster) models and the warping of acrylic during heat processing. Design-induced errors present themselves in abundance as the rudiments of traditional design become less and less familiar to the general dentist and technician. This is largely due to the fact that the basics of the prosthesis are complex and the hours and repetition required to master these concepts are not mastered in today’s dental education.

[0006] In addition to faulty design cues, many errors come from the traditional way denture production uses heat-activated polymethyl methacrylate denture-base resin pressed to stone. These stone models are duplicated several times throughout the course of the fabrication introducing error and discrepancy with each duplication. Thecrippling tendency of acrylic shrinkage and contraction during thermal polymerization and the error of expansion and contraction of stone amplified over several layers of duplication yields frustrating results. A step forward to replacing stone casts and pressed packed acrylics with digital design and 3D printing is long overdue.

[0007] In addition to detrimental effects of duplicating stone models and acrylic shrinkage, many tedious patient-dentist visits are inevitable to acquire physical records of oral anatomy to ensure proper fitting on the day of delivery. There are usually 3-5 appointments with the introduction of large error or failure at each. Each appointment also is separated by many calendar days if not weeks and along with time for shipping.

[0008] Various solutions to the foregoing problems associated with preparing a dental device, such as a denture, are disclosed in PCT Patent Application Publication Nos. WO 2021 / 262849 A2 and WO 2024 / 097183 A2. However, even further technological advances are desirable in methods for fabricating a dental or medical device.SUMMARY OF THE DISCLOSU E

[0009] The present disclosure meets the foregoing needs by providing a library of parts and a method to produce medical and dental devices using pause print technology to allow for robotic assembly of custom medical and dental devices. The present disclosure provides: (1 ) a general parts library of medical and dental parts designed to work with pause print technology wherein the library allows for later robotic assembly and easy CAD design, allowing for the automation of some CAD steps; (2) an apparatus that robotically assembles dental and medical devices during a print or a mill; and (3) a nesting software that allows for scaffolding or support of an object (not being actively printed or milled) that is to be inserted (robotically) during three-dimensional (3D) printing or milling. A method and library of the present disclosure allows for unsupervised manufacture and assembly of medical and dental devices.

[0010] In one aspect, the present disclosure provides a method of fabricating a dental or medical device. The method comprises: (a) acquiring 3D digital image data of a body part of a patient; (b) creating a 3D digital model of a dental or medical device to be fabricated wherein the 3D digital model incorporates a model part selected from adigital library of virtual parts, each of the virtual parts corresponding to an associated physical part of a plurality of physical parts; (c) fabricating a first portion of the dental or medical device from the 3D digital model using additive manufacturing or subtractive manufacturing; (d) selecting one physical part of the plurality of physical parts that corresponds to the model part; (e) inserting the one physical part into a location in the first portion of the dental or medical device; and (f) fabricating a second portion of the dental or medical device from the 3D digital model using additive manufacturing or subtractive manufacturing.

[0011] In one embodiment of the method, step (e) comprises inserting the one physical part into the location in the first portion of the dental or medical device such that the one physical part does not extend beyond a surface region of the first portion of the dental or medical device that surrounds the inserted one physical part. In one embodiment of the method, step (e) comprises inserting the one physical part into the location in the first portion of the dental or medical device using a robotic arm.

[0012] In one embodiment of the method, the dental or medical device comprises a surgical template, and the one physical part comprises a surgical guide sleeve. In one embodiment of the method, the surgical guide sleeve includes a sleeve body and a flange that extends outwardly from the sleeve body. In one embodiment of the method, the flange includes throughholes, and step (e) comprises inserting the one physical part into the location in the first portion of the dental or medical device such that projections in the first portion of the dental or medical device are received in the throughholes of the flange of the surgical guide sleeve.

[0013] In one embodiment of the method, the dental or medical device comprises a surgical template, and the one physical part comprises a surgical guide pin. In one embodiment of the method, the surgical guide pin includes a pin body and a flange that extends outwardly from the pin body. In one embodiment of the method, the flange includes throughholes, and step (e) comprises inserting the one physical part into the location in the first portion of the dental or medical device such that projections in the first portion of the dental or medical device are received in the throughholes of the flange of the surgical guide pin.

[0014] In one embodiment of the method, the dental or medical device is selected from the group consisting of locator dentures, hybrid dentures, and hybrid bridges, and the one physical part is selected from the group consisting of locator attachments, coping, and abutments. In one embodiment of the method, the locator attachment includes a locator attachment body and a flange that extends outwardly from the locator attachment body. In one embodiment of the method, the flange includes throughholes, and step (e) comprises inserting the one physical part into the location in the first portion of the dental or medical device such that projections in the first portion of the dental or medical device are received in the throughholes of the flange of the locator attachment. In one embodiment of the method, the locator attachment includes a tapered outer wall terminating in a lip. In one embodiment of the method, the locator attachment includes an outer wall having one or more ribs. In one embodiment of the method, step (e) comprises inserting the one physical part into the location in the first portion of the dental or medical device such that a projection in the first portion of the dental or medical device is received in a rib of the outer wall of the locator attachment.

[0015] In one embodiment of the method, the dental or medical device comprises a dental prosthesis, and the one physical part comprises an abutment. In one embodiment of the method, the abutment has a flange that extends outwardly from a body of the abutment. In one embodiment of the method, the abutment has a tapered outer wall. In one embodiment of the method, the abutment has an internally threaded hole.

[0016] In one embodiment of the method, the one physical part includes a part body and a flange that extends outwardly from the part body. In one embodiment of the method, the flange includes at least one outwardly extending tab. In one embodiment of the method, the flange includes at least one inwardly directed slot. In one embodiment of the method, the flange includes at least one outwardly extending rib. In one embodiment of the method, the flange includes at least one outwardly extending leg. In one embodiment of the method, the flange includes a perimeter having a circular, oval, or polygonal shape.

[0017] In one embodiment of the method, the dental or medical device comprises a prosthesis, and the one physical part comprises a magnetic material.

[0018] In one embodiment of the method, the one physical part includes a part body having an internally threaded hole.

[0019] In one embodiment of the method, the dental or medical device is selected from the group consisting of locator dentures, hybrid dentures, and hybrid bridges, and the one physical part comprises a lingual support structure.

[0020] In one embodiment of the method, the dental or medical device comprises a hybrid bridge, and the one physical part comprises a support structure including a locator section and one or more arms extending outward from the locator section.

[0021] In one embodiment of the method, the dental or medical device comprises a hybrid bridge, step (b) comprises creating a 3D digital model of a dental or medical device to be fabricated wherein the 3D digital model incorporates a plurality of model parts selected from the digital library of virtual parts, step (d) comprises selecting two or more of the physical parts from the plurality of physical parts, each of the two or more of the physical parts corresponding to one of the model parts, step (e) comprises inserting each of the selected two or more physical parts into a location in the first portion of the dental or medical device, and each physical part comprises a support structure including a locator section and one or more arms extending outward from the locator section.

[0022] In one embodiment of the method, the dental or medical device comprises a dental device, and the one physical part comprises a palatal mesh.

[0023] In one embodiment of the method, the dental or medical device comprises a palatal expander, and the one physical part comprises an expansion assembly.

[0024] In one embodiment of the method, the dental or medical device comprises a dental night guard, and the one physical part comprises a clasp.

[0025] In one embodiment of the method, the dental or medical device comprises an orthodontic retainer, and the one physical part comprises a clasp.

[0026] In one embodiment of the method, the dental or medical device comprises a dental device, and the one physical part comprises a clasp selected from the groupconsisting of ball clasps, C-clasps, wing clasps, l-bar clasps, Y-bar clasps, combination clasps, RPI clasps, RPA clasps, rest seats, orthodontic clasps, and Adams clasps. In one embodiment of the method, the clasp comprises a ball clasp or a C-clasp.

[0027] In one embodiment of the method, step (b) comprises creating a 3D digital model of a dental or medical device to be fabricated wherein the 3D digital model incorporates a plurality of model parts selected from the digital library of virtual parts, step (d) comprises selecting two or more of the physical parts from the plurality of physical parts, each of the two or more of the physical parts corresponding to one of the model parts, and step (e) comprises inserting each of the selected two or more physical parts into a location in the first portion of the dental or medical device.

[0028] In one embodiment of the method, step (c) comprises fabricating the first portion of the dental or medical device from the 3D digital model using additive manufacturing, and step (f) comprises fabricating the second portion of the dental or medical device from the 3D digital model using additive manufacturing.

[0029] In one embodiment of the method, step (c) comprises fabricating the first portion of the dental or medical device from the 3D digital model using 3D printing, and

[0030] step (f) comprises fabricating the second portion of the dental or medical device from the 3D digital model using 3D printing.

[0031] In one embodiment of the method, step (a) comprises acquiring 3D digital image data of a patient's mouth and dentition, and step (b) comprises creating a 3D digital model of a removable dental appliance to be fabricated.

[0032] In one embodiment of the method, the dental or medical device comprises a hearing aid, and the one physical part comprises at least one electronic component.

[0033] In one embodiment of the method, the dental or medical device comprises a facial prosthesis, and the one physical part comprises a support structure.

[0034] In one embodiment of the method, the dental or medical device comprises a limb prosthesis, and the one physical part comprises a support structure.

[0035] In one embodiment of the method, the dental or medical device comprises an implant, and the one physical part comprises a support structure.

[0036] In another aspect, the present disclosure provides an apparatus for fabricating a dental or medical device. The apparatus comprises: a three dimensional (3D) printing device; and a controller in electrical communication with the 3D printing device. The controller is configured to execute a program stored in the controller to: (i) receive a 3D digital model of the dental or medical device to be fabricated wherein the 3D digital model incorporates a model part selected from a digital library of virtual parts, each of the virtual parts corresponding to an associated physical part of a plurality of physical parts; (ii) send a first group of signals to the 3D printing device to fabricate a first portion of the dental or medical device from the 3D digital model; (iii) pause the printing device for a time period sufficient for insertion of one physical part of the plurality of physical parts into the first portion of the dental or medical device, the one physical part corresponding to the model part; and (iv) send a second group of signals to the 3D printing device to fabricate a second portion of the dental or medical device from the 3D digital model. This may repeat as needed until all the parts in the design have been inserted and the object is complete.

[0037] In one embodiment the apparatus further comprises a robotic arm positioned to insert the one physical part of the plurality of physical parts into the first portion of the dental or medical device. In one embodiment of the apparatus, the robotic arm inserts the one physical part of the plurality of physical parts into the first portion of the dental or medical device such that the one physical part does not extend beyond a surface region of the first portion of the dental or medical device that surrounds the inserted one physical part. In one embodiment of the apparatus, the robotic arm is located within a chamber of the apparatus.

[0038] In one embodiment of the apparatus, the one physical part includes a body and a first locating structure associated with the body, and the robotic arm inserts the one physical part of the plurality of physical parts into the first portion of the dental or medical device such that a second locating structure in the first portion of the dental or medical device matingly engages the first locating structure. In one embodiment of the apparatus, the first locating structure comprises a flange. In one embodiment of the apparatus, the flange includes throughholes, the second locating structure includesprojections in the first portion of the dental or medical device, and the robotic arm inserts the one physical part of the plurality of physical parts into the first portion of the dental or medical device such that the projections in the first portion of the dental or medical device are received in the throughholes of the flange. In one embodiment of the apparatus, the flange includes at least one outwardly extending tab. In one embodiment of the apparatus, the flange includes at least one inwardly directed slot. In one embodiment of the apparatus, the flange includes at least one outwardly extending rib. In one embodiment of the apparatus, the flange includes at least one outwardly extending leg. In one embodiment of the apparatus, the flange includes a perimeter having a circular, oval, or polygonal shape. In one embodiment of the apparatus, the first locating structure comprises a tapered outer wall of the body terminating in a lip. In one embodiment of the apparatus, the first locating structure comprises an outer wall of the body having one or more ribs.

[0039] In one embodiment of the apparatus, the 3D digital model is created from a scan taken with an intraoral scanner. In one embodiment of the apparatus, a dispenser positioned to dispense an adhesive material adjacent the inserted one physical part.

[0040] In one embodiment of the apparatus, the controller is configured to execute the program stored in the controller to pause the 3D printing device for a time period sufficient for insertion of two or more of the physical parts from the plurality of physical parts, each of the two or more of the physical parts corresponding to one of the model parts.

[0041] In one embodiment of the apparatus, the one physical part includes support scaffolding to maintain a predetermined orientation of the one physical part during fabricating the second portion of the dental or medical device from the 3D digital model.

[0042] In one embodiment of the apparatus, the controller is configured to execute the program stored in the controller to send a third group of signals to the 3D printing device to fabricate one or more of the physical parts of the plurality of physical parts. In one embodiment of the apparatus, at least one of the one or more of the physical parts includes support scaffolding to maintain a predetermined orientation of the one physicalpart during fabricating the second portion of the dental or medical device from the 3D digital model.

[0043] In yet another aspect, the present disclosure provides an apparatus for fabricating a dental or medical device. The apparatus comprising: a milling device; and a controller in electrical communication with the milling device. The controller is configured to execute a program stored in the controller to: (i) receive a 3D digital model of the dental or medical device to be fabricated wherein the 3D digital model incorporates a model part selected from a digital library of virtual parts, each of the virtual parts corresponding to an associated physical part of a plurality of physical parts; (ii) send a first group of signals to the milling device to fabricate a first portion of the dental or medical device from the 3D digital model; (iii) pause the milling device for a time period sufficient for insertion of one physical part of the plurality of physical parts into the first portion of the dental or medical device, the one physical part corresponding to the model part; and (iv) send a second group of signals to the milling device to fabricate a second portion of the dental or medical device from the 3D digital model. This may repeat as needed until all the parts in the design have been inserted and the object is complete.

[0044] In one embodiment the apparatus further comprises a robotic arm positioned to insert the one physical part of the plurality of physical parts into the first portion of the dental or medical device. In one embodiment of the apparatus, the robotic arm inserts the one physical part of the plurality of physical parts into the first portion of the dental or medical device such that the one physical part does not extend beyond a surface region of the first portion of the dental or medical device that surrounds the inserted one physical part. In one embodiment of the apparatus, the robotic arm is located within a chamber of the apparatus. In one embodiment of the apparatus, the one physical part includes a body and a first locating structure associated with the body, and the robotic arm inserts the one physical part of the plurality of physical parts into the first portion of the dental or medical device such that a second locating structure in the first portion of the dental or medical device matingly engages the first locating structure. In one embodiment of the apparatus, the first locating structure comprises a flange. In oneembodiment of the apparatus, the flange includes throughholes, the second locating structure includes projections in the first portion of the dental or medical device, and the robotic arm inserts the one physical part of the plurality of physical parts into the first portion of the dental or medical device such that the projections in the first portion of the dental or medical device are received in the throughholes of the flange. In one embodiment of the apparatus, the flange includes at least one outwardly extending tab. In one embodiment of the apparatus, the flange includes at least one inwardly directed slot. In one embodiment of the apparatus, the flange includes at least one outwardly extending rib. In one embodiment of the apparatus, the flange includes at least one outwardly extending leg. In one embodiment of the apparatus, the flange includes a perimeter having a circular, oval, or polygonal shape. In one embodiment of the apparatus, the first locating structure comprises a tapered outer wall of the body terminating in a lip. In one embodiment of the apparatus, the first locating structure comprises an outer wall of the body having one or more ribs.

[0045] In one embodiment of the apparatus, the 3D digital model is created from a scan taken with an intraoral scanner.

[0046] In one embodiment the apparatus further comprises a dispenser positioned to dispense an adhesive material adjacent the inserted one physical part.

[0047] In one embodiment of the apparatus, the controller is configured to execute the program stored in the controller to pause the milling device for a time period sufficient for insertion of two or more of the physical parts from the plurality of physical parts, each of the two or more of the physical parts corresponding to one of the model parts.

[0048] In one embodiment of the apparatus, the one physical part includes support scaffolding to maintain a predetermined orientation of the one physical part during fabricating the second portion of the dental or medical device from the 3D digital model.

[0049] In one embodiment of the apparatus, the controller is configured to execute the program stored in the controller to send a third group of signals to the milling device to fabricate one or more of the physical parts of the plurality of physical parts.

[0050] In one embodiment of the apparatus, at least one of the one or more of the physical parts includes support scaffolding to maintain a predetermined orientation of the one physical part during fabricating the second portion of the dental or medical device from the 3D digital model.

[0051] It is an advantage of the present disclosure to provide an apparatus used to robotically assemble medical or dental prosthetic devices using a mix of stock, custom, 3D printed, milled, and / or library components.

[0052] It is another advantage of the present disclosure to provide a 3D printer, mill, or other device with a robotic arm used to assemble parts for medical or dental devices (in the work chamber).

[0053] It is yet another advantage of the present disclosure to provide a 3D printer or mill that uses robotic assembly to insert parts during a pause or “pause print”.

[0054] It is still another advantage of the present disclosure to provide a 3D printing or milling software “nesting” method that accounts for and produces supports for parts not actively being printed and produces scaffolding for the parts to be inserted (e.g., robotically).

[0055] It is yet another advantage of the present disclosure to provide a library of medical or dental parts designed to remain below the “horizon layer” of a 3D print for a dental or medical device with the intention of continuing the print and not obstructing further operation of the machine (not obstructing further printing by blocking the print head or the build platform).

[0056] The foregoing and other aspects and advantages of the invention will appear from the following description. In the description, reference is made to the accompanying drawings which form a part hereof, and in which there is shown by way of illustration example embodiments of the invention. Such embodiments do not necessarily represent the full scope of the invention, however, and reference is made therefore to the claims, drawings, and description herein for interpreting the scope of the invention.BRIEF DESCRIPTION OF DRAWINGS

[0057] Figure 1 is a flowchart showing a process of the present disclosure for fabricating a dental or medical device.

[0058] Figure 2 is a perspective view of a surgical device that can be fabricated using a method according to the present disclosure.

[0059] Figure 2A is a side view of the surgical guide sleeve of the surgical device of Figure 2.

[0060] Figure 2B is a top view of the surgical guide sleeve of the surgical device of Figure 2.

[0061] Figure 3 is a side view of a surgical guide pin suitable for use in the surgical device of Figure 2.

[0062] Figure 3A is a side view of another surgical guide pin suitable for use in the surgical device of Figure 2.

[0063] Figure 4 is a perspective view of a locator denture that can be fabricated using a method according to the present disclosure.

[0064] Figure 4A is a side view of a locator attachment suitable for use in the locator denture of Figure 4.

[0065] Figure 4B is a top view of another locator attachment suitable for use in the locator denture of Figure 4.

[0066] Figure 4C is a side view of another locator attachment suitable for use in the locator denture of Figure 4.

[0067] Figure 4D is a side view of the locator attachment of Figure 4C.

[0068] Figure 4E is a side view of another locator attachment suitable for use in the locator denture of Figure 4.

[0069] Figure 4F is a side view of the locator attachment of Figure 4E.

[0070] Figure 5A is a side view of a base for an abutment suitable for use in a hybrid bridge, hybrid denture, crown, bridge, or other prosthetic.

[0071] Figure 5B is a bottom view of the base of Figure 5A.

[0072] Figure 6A is a side view of another base for an abutment suitable for use in a hybrid bridge, hybrid denture, crown, bridge, or other prosthetic.

[0073] Figure 6B is a bottom view of the base of Figure 6A.

[0074] Figure 7A is a side view of a magnetic part suitable for use in a hybrid bridge, hybrid denture, crown, bridge, other prosthetic or medical device.

[0075] Figure 7B is a side view of another magnetic part suitable for use in a hybrid bridge, hybrid denture, crown, bridge, other prosthetic or medical device.

[0076] Figure 8A is a perspective view of a part suitable for use in a hybrid bridge, hybrid denture, crown, bridge, other prosthetic or medical device.

[0077] Figure 8B is a perspective view of another part suitable for use in a hybrid bridge, hybrid denture, crown, bridge, other prosthetic or medical device.

[0078] Figure 8C is a perspective view of the part of Figure 8B with a bolt attached.

[0079] Figure 9A is a top view of a flange of a part suitable for use in a method according to the present disclosure.

[0080] Figure 9B is a top view of another flange suitable for use in a method according to the present disclosure.

[0081] Figure 9C is a top view of another flange suitable for use in a method according to the present disclosure.

[0082] Figure 9D is a top view of another flange suitable for use in a method according to the present disclosure.

[0083] Figure 9E is a top view of another flange suitable for use in a method according to the present disclosure.

[0084] Figure 10A shows top views of lingual bars suitable for use in a method according to the present disclosure.

[0085] Figure 10B shows side views of lingual bars suitable for use in a method according to the present disclosure.

[0086] Figure 11 shows top views of palatal meshes suitable for use in a method according to the present disclosure.

[0087] Figure 12 is a perspective view of a palatal expander that can be fabricated using a method according to the present disclosure.

[0088] Figure 13 is a perspective view of a dental night guard that can be fabricated using a method according to the present disclosure.

[0089] Figure 14 is a perspective view of an orthodontic retainer that can be fabricated using a method according to the present disclosure.

[0090] Figure 15 is a side view of a hybrid bridge that can be fabricated using a method according to the present disclosure.

[0091] Figure 15A is a side view of a support structure suitable for use in a method according to the present disclosure for fabricating a hybrid bridge.

[0092] Figure 15B is a side view of another support structure suitable for use in a method according to the present disclosure for fabricating a hybrid bridge.

[0093] Figure 15C is a side view of another support structure suitable for use in a method according to the present disclosure for fabricating a hybrid bridge.

[0094] Figure 15D is a side view of another support structure suitable for use in a method according to the present disclosure for fabricating a hybrid bridge.

[0095] Figure 16A is a top view of two components of another support structure suitable for use in a method according to the present disclosure for fabricating a hybrid bridge.

[0096] Figure 16B is side view of the components of Figure 16A.

[0097] Figure 16C is a top view of four components of another support structure suitable for use in a method according to the present disclosure for fabricating a hybrid bridge.

[0098] Figure 17 is a perspective view of a metal frame suitable for use in a method according to the present disclosure.

[0099] Like reference numerals will be used to refer to like parts from Figure to Figure in the following description of the drawings.

[0100] The invention will be better understood, and features, aspects, and advantages other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such detailed description makes reference to the drawings.DETAILED DESCRIPTION

[0101] Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

[0102] Figure 1 is a flowchart showing a non-limiting example method of the present disclosure for fabricating a dental or medical device. The method 110 for fabricating a dental or medical device includes in step 112, acquiring 3D digital image data of a body part of a patient. In one example embodiment, a scan is taken with an intraoral scanner which can be a 3D measurement system that is able to capture information on the shape and size of dental arches and to reproduce 3D models of the teeth and soft tissues of the oral cavity, thus allowing complete digitalization of the mouth anatomy. In step 114, a 3D digital model of a dental or medical device to be fabricated is created wherein the 3D digital model incorporates a model part selected from a digital library of virtual parts, each of the virtual parts corresponding to an associated physical part of a plurality of physical parts. In step 116, a first portion of the dental or medical device is fabricated from the 3D digital model using additive manufacturing or subtractive manufacturing. In step 118, one physical part of the plurality of physical parts is selected that corresponds to the model part. In step 122, the one physical part is inserted into a location in the first portion of the dental or medical device. In step 124, a second portion of the dental or medical device is fabricated from the 3D digital model using additive manufacturing or subtractive manufacturing.

[0103] In step 122, the one physical part can be inserted into the location in the first portion of the dental or medical device such that the one physical part does not extend beyond a surface region of the first portion of the dental or medical device thatsurrounds the inserted one physical part. In step 122, the one physical part can be inserted into the location in the first portion of the dental or medical device using a robotic arm.

[0104] In one embodiment, in step 114, a 3D digital model of a dental or medical device to be fabricated can be created wherein the 3D digital model incorporates a plurality of model parts selected from the digital library of virtual parts, and in step 118, two or more of the physical parts can be selected from the plurality of physical parts, each of the two or more of the physical parts corresponding to one of the model parts, and in step 122, each of the selected two or more physical parts can be inserted into a location in the first portion of the dental or medical device. Thus, the number of physical part(s) is not limited in the present invention.

[0105] In step 116, the first portion of the dental or medical device can be fabricated from the 3D digital model using additive manufacturing, and step 124 can comprise fabricating the second portion of the dental or medical device from the 3D digital model using additive manufacturing. In one embodiment, the additive manufacturing can be 3D printing.

[0106] In one embodiment, step 112 can comprise acquiring 3D digital image data of a patient's mouth and dentition, and step 114 can comprise creating a 3D digital model of a dental device to be fabricated.

[0107] Turning now to Figures 2, 2A, and 2B, there is shown a surgical device 200 that can be fabricated using a method 110 according to the present disclosure. A surgical guide sleeve 210 can be used during a stop-print in 3D printing. The surgical guide sleeve 210 can be inserted during a 3D print and covered in place when the print resumes, using especially multi-jet or poly-jet printing, and potentially with 3MF files. A flange is covered during 3D print with the flange including holes that “snap in” to already printed relational topography (e.g., projections) in the first printed portion of the dental or medical device meant to ensure precise location, timing and direction, and that aid in retention when printing resumes and covers the flange. In one embodiment, the surgical device 200 includes a surgical template 205 dimensioned to conform to 3D digital image data of a patient's dentition, and a surgical guide sleeve 210 for guiding adental instrument such as a drill used to create a location for a dental implant. The surgical guide sleeve 210 includes a sleeve body 212 having an inner diameter 218, an outer diameter 214, and a flange 216 that extends outwardly from the sleeve body 212. The flange 216 includes throughholes 219, and in the method of Figure 1 , step 122 comprises inserting the surgical guide sleeve 210 into the location in the first portion of the surgical template 205 being fabricated such that projections in the first portion of the surgical template 205 are received in the throughholes 219 of the flange 216 of the surgical guide sleeve 210. The surgical guide sleeve 210 may comprise a polymeric material, such as PEEK / acetal / nylon, or a metallic material.

[0108] Referring now to Figure 3, there is shown a surgical guide pin 300 suitable for use in the surgical device 200 of Figure 2. The surgical guide pin 300 can be used during a stop-print in 3D printing. The surgical guide pin 300 can be inserted during a 3D print and covered in place when the print resumes, using especially multi-jet or polyjet printing, and potentially with 3MF files. A flange is covered during 3D print with the flange having holes that “snap in” to already printed relational topography (e.g., projections) meant to ensure precise location, timing and direction, and that aid in retention when printing resumes and covers the flange. The surgical guide pin 300 includes a tubular body 302 having a flange 304 that extends outwardly from the body 302. The flange 304 includes throughholes, and in the method of Figure 1 , step 122 comprises inserting the surgical guide pin 300 into the location in the first portion of the surgical device 200 being fabricated such that projections in the first portion of the surgical device 200 are received in the throughholes of the flange 304 of the surgical guide pin 300. The body 302 of the surgical guide pin 300 defines a hole 306 for receiving a pin. The surgical guide pin 300 may comprise a polymeric material, such as PEEK / acetal I nylon I polyurethane I polymer, or a metallic material.

[0109] Referring now to Figure 3A, there is shown another surgical guide pin 350 suitable for use in the surgical device 200 of Figure 2. The surgical guide pin 350 can be used during a stop-print in 3D printing. The surgical guide pin 350 can be inserted during a 3D print and covered in place when the print resumes, using especially multi-jet or poly-jet printing, and potentially with 3MF files. A flange is covered during 3D printwith the flange having holes that “snap in” to already printed relational topography (e.g., projections) meant to ensure precise location, timing and direction, and that aid in retention when printing resumes and covers the flange. The surgical guide pin 350 includes a square or rectangular body 352 to lay flush with the horizon layer (i.e. , a surface region of the first portion of the dental or medical device that surrounds the inserted physical part). The body 352 has a flange 354 that extends outwardly from the body 352. The square or rectangular body 352 has a hole for receiving a pin 357. The flange 354 includes throughholes 358, and in the method of Figure 1 , step 122 comprises inserting the surgical guide pin 350 into the location in the first portion of the surgical device 200 being fabricated such that projections in the first portion of the surgical device 200 are received in the throughholes 358 of the flange 354 of the surgical guide pin 350. The body 352 of the surgical guide pin 350 defines a hole 356 for receiving a pin. The surgical guide pin 300 may comprise a polymeric material, such as PEEK / acetal I nylon / polyurethane / polymer, or a metallic material. A square or rectangular “tube” allows the guide pin "tubes" (bodies) to be laid horizontal with the horizon layer in the most beneficial way possible.

[0110] Turning now to Figures 4 to 4F, there is shown a locator denture 400 that can be fabricated using a method 110 according to the present disclosure. The locator denture 400 can include any of the embodiments of locator housings, inserts, or attachments 410, 420, 430, 440 that engage a dental implant when the locator denture is positioned in a patient’s mouth.

[0111] In Figure 4A, locator attachment 410 includes a tapered wall 412 to be set during stopped print and printed over the lip 414 without a metal housing. The purpose being to eliminate the need for a metal housing by directly placing the library locator part or directly printing it in PEEK / acetal / nylon / polyurethane or other polymer. The locator attachment 410 may comprise a polymeric material, such as PEEK I acetal I nylon / polyurethane.

[0112] In Figure 4B, locator housing attachment 420 includes a uniform ribbed design to be snapped in the first portion of the locator denture 400 being fabricated with or without cement or resin. The outer surface 422 of the locator attachment 420includes ribs 424. The locator housing attachment 420 may comprise a polymeric material, such as PEEK / acetal / nylon / polyurethane, or metallic material.

[0113] In Figures 4C and 4D, in one embodiment, locator housing or part attachment 430 includes a single rib 434 to snap in the first portion of the locator denture 400 being fabricated, an internally threaded or ribbed inside diameter 438 for engaging a locator part, and an outwardly extending flange 436 with throughholes 439 to prevent rotation and provide timing, retention, and direction. In the method of Figure 1 , step 122 comprises inserting the locator attachment 430 into the location in the first portion of the locator denture 400 being fabricated such that projections in the first portion of the locator denture 400 are received in the throughholes 439 of the flange 436 of the locator attachment 430. The locator attachment 430 may comprise a polymeric material, such as PEEK I acetal I nylon / polyurethane, or metallic material.

[0114] In Figures 4E and 4F, locator housing attachment 440 includes multiple ribs 444 for metal or cement, an internally threaded or ribbed inside diameter 448 for engaging a fastener or locator part, and a flange 446 with throughholes 449 to prevent rotation and provide timing, retention, and direction. In the method of Figure 1 , step 122 comprises inserting the locator housing attachment 440 into the location in the first portion of the locator denture 400 being fabricated such that projections in the first portion of the locator denture 400 are received in the throughholes 449 of the flange 446 of the locator denture 400. The locator attachment 440 may comprise a polymeric material, such as PEEK / acetal / nylon / polyurethane, or a metallic material.

[0115] In step 114 of Figure 1 , the digital library of virtual parts, each of which corresponds to an associated physical part of a plurality of physical parts, can be an implant multi-unit titanium coping / base library for multi-jet printing. Referring now to Figures 5A and 5B, there is shown a coping / base 500 of a Ti-base / coping / cylinder suitable for use in the locator denture 400, such as shown in Figure 4, or a hybrid bridge 1500, such as shown in Figure 15. In one embodiment, the base 500 can be an implant titanium coping / base for a multi-unit abutment. The coping / base 500 includes a body 511 having a flange 506 that extends outwardly from the body 511 . The flange 506 has throughholes 519 to prevent rotation and provide timing, retention, and direction whenthe coping / base is inserted the first portion of the dental device being fabricated. The body 511 has a tapered outer surface 512, and the body 511 has an internally threaded screw hole 517 for engaging a fastener (e.g., a screw). In the method of Figure 1 , step 122 comprises inserting the coping / base 500 into the location in the first portion of the locator denture or hybrid bridge being fabricated such that projections in the first portion of the locator denture or hybrid bridge are received in the throughholes 549 of the flange 546 of coping / base 500. The coping / base 500 may comprise a metallic material, such as titanium, or some polymer.

[0116] In step 114 of Figure 1 , the digital library of virtual parts, each of which corresponds to an associated physical part of a plurality of physical parts, can be a titanium implant abutment base for bone level or implant level or platform level (timed connection or non-engaging). The titanium implant abutment base is meant to be inserted during a manufacturing process (3D printing or milling) by stopping the printing or milling process (3D, multi-jet, multi-material processes). Turning now to Figures 6A and 6B, there is shown an implant abutment base 600 for an abutment suitable for use in the locator denture 400, such as shown in Figure 4, or a hybrid bridge 1500, such as shown in Figure 15 or single unit restoration (not shown). The implant abutment base 600 can be used for bone level or implant level or platform level (timed connection or non-engaging). The implant abutment base 600 is meant to be inserted during a manufacturing process (3D printing or milling) by stopping the printing or milling process (3D, multi-jet, multi-material processes). The implant abutment base 600, which is suitable for a restoration or crown or other prosthesis, includes a body having a flange 606 that extends outwardly from the body. The flange 606 has throughholes 619 to prevent rotation and provide timing, retention, and direction. The throughholes 619, or slots or other unique feature, allow for precise or “timed” insertion and in direction. The flange 606 is to be printed over after stopped printing or manufacturing. The implant abutment base 600 engages an implant interface 620. In the method of Figure 1 , step 122 comprises inserting the implant abutment base 600 into the location in the first portion of the locator denture or hybrid bridge or crown being fabricated such that projections in the first portion of the locator denture or hybrid bridge (or crown) arereceived in the throughholes 619 of the flange 606 of base 600. The implant abutment base 600 may comprise a metallic material, such as titanium or polymer.

[0117] Referring now to Figure 7A, there is shown a magnetic part 710 suitable for use in the locator denture of Figure 4, a denture, or other prosthetic. The magnetic part 710 includes a magnetic body 722 body having a flange 716 that extends outwardly from the body 722. The flange 716 has throughholes 719 to prevent rotation and provide timing, retention, and direction. The flange 716 is to be printed over after stopped printing or manufacturing. In the method of Figure 1 , step 122 comprises inserting the magnetic part 710 into the location in the first portion of the locator denture, hybrid bridge, denture, or other prosthetic (facial, digit, or limb prosthetic) being fabricated such that projections in the first portion of the locator denture, hybrid bridge, denture, or other prosthetic (facial, digit, or limb prosthetic) are received in the throughholes 719 of the flange 716 of magnetic part 710. In one embodiment, the magnetic part 710 has a polygonal perimeter.

[0118] Turning now to Figure 7B, there is shown another magnetic part 750 suitable for use in the locator denture of Figure 4, a denture, or other prosthetic (facial, digit, or limb prosthetic). The magnetic part 750 includes a magnetic body 762 body having a flange 756 that extends outwardly from the body 762. The flange 756 has throughholes 759 to prevent rotation and provide timing, retention, and direction. The flange 756 is to be printed over after stopped printing or manufacturing. In the method of Figure 1 , step 122 comprises inserting the magnetic part 750 into the location in the first portion of the locator denture or hybrid bridge, denture, or other prosthetic (facial, digit, or limb prosthetic) being fabricated such that projections in the first portion of the locator denture or hybrid bridge, denture, or other prosthetic (facial, digit, or limb prosthetic) are received in the throughholes 759 of the flange 756 of magnetic part 750. In one embodiment, the magnetic part 750 has a circular perimeter.

[0119] Referring now to Figure 8A, there is shown a part 810 suitable for use in the locator denture of Figure 4, a denture, or other prosthetic (facial, digit, or limb prosthetic). The outer surface of the part 810 includes ribs 814, and an internally threaded inside diameter 817 for engaging a fastener, such as a screw. In the methodof Figure 1 , step 122 comprises inserting the part 810 into the location in the first portion of the locator denture, denture, or other prosthetic (facial, digit, or limb prosthetic) being fabricated.

[0120] Turning now to Figures 8B and 8C, there is shown another part 850 suitable for use in the locator denture of Figure 4, a denture, or other prosthetic (facial, digit, or limb prosthetic). The part 850 include a ribs 854, an internally threaded inside diameter 857 for engaging a fastener, and a body 851 with an outwardly extending flange 856 with throughholes 859 to prevent rotation and provide timing, retention, and direction. In the method of Figure 1 , step 122 comprises inserting the part 850 into the location in the first portion of the locator denture 400, denture, or other prosthetic (facial, digit, or limb prosthetic) being fabricated such that projections in the first portion of the locator denture 400 are received in the throughholes 859 of the flange 856 of the part 850. In Figure 8C, there is shown a bolt 862 attached to the part 850.

[0121] Referring now to Figure 9A, there is shown one embodiment of a flange 916 of a part suitable for use in a method according to the present disclosure. The flange 916 includes tabs 915, in any amount, arrangement, or form.

[0122] Turning now to Figure 9B, there is shown another embodiment of a flange 926 of a part suitable for use in a method according to the present disclosure. The flange 926 includes slots 925 in any amount, arrangement, or form.

[0123] Referring now to Figure 9C, there is shown another embodiment of a flange 936 of a part suitable for use in a method according to the present disclosure. The flange 936 includes ribs 935 in any amount, arrangement, or form.

[0124] Turning now to Figure 9D, there is shown another embodiment of a flange 946 of a part suitable for use in a method according to the present disclosure. The flange 946 includes legs 945, T-sleeves, or squaring of the flange 946.

[0125] Referring now to Figure 9E, there is shown another embodiment of a flange 956 of a part suitable for use in a method according to the present disclosure. The flange 956 includes a hexagonal perimeter 955. However, other polygonal shapes (e.g., octagon), or flattening of the sides of the flange 956 to correspond with timing,direction, or orientation of the implant or implant surgical part (sleeve, pin, etc.) are possible.

[0126] In step 114 of Figure 1 , the digital library of virtual parts, each of which corresponds to an associated physical part of a plurality of physical parts, can be a lingual bar library comprising a library of bars in various sizes to provide strength across the arch for a denture, a partial denture, or an implant dental appliance (hybrids). The lingual bar can be inserted during a stop-print 3D print, multi-jet print, or other 3D print, and can be applicable for medicine or dentistry. The lingual bar may have hooks or slots as stored in a library for relation, speed, direction (timing) of implant components, and may have another library stored for retention or placement. The lingual bar component is designed to aid in proper placement in the first portion of the dental device being fabricated. Turning now to Figure 10A, there is shown lingual bars 1010, 1020, 1030, 1040 suitable for use as a part in a denture 1000 that can be fabricated using a method according to the present disclosure. In the method of Figure 1 , step 122 comprises inserting any of the lingual bars 1010, 1020, 1030, 1040 into the location in the first portion of the denture being fabricated. The lingual bars 1010, 1020, 1030, 1040 can be smooth or perforated. As shown in Figure 10B, in one embodiment, the lingual bar 1010 has slots and holes 1015; in another embodiment, the lingual bar 1020 has uniform holes 1025; in another embodiment, the lingual bar 1030 has stamped shaped texturing 1035 rather than holes; and in another embodiment, the lingual bar 1040 has stamped shaped texturing 1055.

[0127] Referring now to Figure 11 , there is shown an orthodontic retainer 1100 having ball clasps 1137. Each ball clasp 1137 is attached at its tail component to a palatal portion 1120 . The orthodontic retainer 1100 has a labial wire 1132 which is attached at both ends to the palatal portion 1120 of the orthodontic retainer 1100. The labial wire 1132 will generally be attached to the palatal portion 1120 in a manner which retains the teeth 11 12 of a patient between the labial wire 1132 and the front edge 1122 of the palatal portion 1120. The labial wire 1132 also includes at least one arch wire 1134 for gripping by the patient. The orthodontic retainer 1100 has an embedded palatal mesh 1150. In the method of Figure 1 , step 122 comprises inserting the palatalmesh 1150 into the location in the first portion of the orthodontic retainer 1100 being fabricated. As shown in Figure 11 , the palatal mesh 1150 has holes 1159; another smaller example palatal mesh 1160 has holes 1169; another smaller example palatal mesh 1170 has holes 1179; another example palatal mesh 1180 has holes 1184; another smaller example palatal mesh 1185 has holes 1189; and another smaller example palatal mesh 1190 has holes 1199.

[0128] Turning now to Figure 12, there is shown a palatal expander 1200 that can be fabricated using a method according to the present disclosure. A pause print library of palatal expanders is provided where the expanders remain below the “horizon layer” (i.e., a surface region of the first portion of the dental or medical device that surrounds the inserted physical part) and do not obstruct operation of the print head. It is also beneficial to have nesting software print scaffolding to support the expander part that will be inserted. In one embodiment, the palatal expander 1200 includes an expansion screw device 1210 and tooth-engaging portions 1202 and 1204 at opposite ends of the expansion screw device 1210. The expansion screw device 1210 includes a main body 1212, a first extension in the form of a pair of metal wires 1214, 1219 and a second extension in the form of a pair of metal wires 1216, 1218. In the method of Figure 1 , step 116 comprises fabricating a first portion of the tooth-engaging portion 1202 from the 3D digital model, step 122 comprises inserting the metal wires 1216, 1218 into the tooth-engaging portion 1202, and step 124 comprises fabricating a second portion of the tooth-engaging portion 1202 from the 3D digital model. In the method of Figure 1 , step 116 comprises fabricating a first portion of the tooth-engaging portion 1204 from the 3D digital model, step 122 comprises inserting the metal wires 1214, 1219 into the tooth-engaging portion 1204, and step 124 comprises fabricating a second portion of the tooth-engaging portion 1204 from the 3D digital model.

[0129] A library of ball clasps with specific ends (flat with the “horizon”) may be used to create night guards (occlusal guards) during a pause print. To complete this, it may be beneficial to print the night guards with the occlusal fitting surface facing down towards the build platform. Referring now to Figure 13, there is shown a dental night guard 1300 that can be fabricated using a method according to the present disclosure.The dental night guard 1300 includes a guard section 1305 dimensioned to conform to 3D digital image data of a patient's dentition, and a ball clasp 1309. In the method of Figure 1 , step 122 comprises inserting the ball clasp 1309 into the location in the first portion of the guard section 1305 being fabricated. The guard section 1305 may comprise a polymeric material, such as PEEK / acetal / nylon.

[0130] A clasp pause print library lends itself to pause print in a dental or medical device, such as in dental night guard 1300 or a denture. The clasp retention tails create a void in the plastic pink denture base or tooth. The print is paused at the top of this void and the clasp is inserted. The print can continue. Some of the clasps have an arm part external to the denture being printed. That external arm is lower than the “horizon layer” and does not interfere with the continuation of the print (in some cases, the part may be nested / printed upside down to allow for this). The external arm of the clasp can include support scaffolding to be printed to maintain the correct orientation of the clasp while the print continues and finishes.

[0131] Figure 14 is a perspective view of an orthodontic retainer 1410 that can be fabricated using a method according to the present disclosure. The orthodontic retainer 1410 has ball clasps 1437. Each ball clasp 1437 is attached at its tail component 1441 to a palatal portion 1420 having a rear edge 1424 and extend forwardly between teeth 1412 such as cuspids. A first ball clasp 1437 will generally extend along a first side of a tooth 1412 such as a cuspid and a second ball clasp 1437 will generally extend along a second side of the tooth 1412 for ensuring proper retention and alignment. The orthodontic retainer 1410 has a labial wire 1432 which is attached at both ends to the palatal portion 1420 of the orthodontic retainer 1410. The labial wire 1432 will generally be attached to the palatal portion 1420 in a manner which retains the teeth 1412 of a patient between the labial wire 1432 and the front edge 1422 of the palatal portion 1420. The labial wire 1432 also includes at least one arch wire 1434 for gripping by the patient. In the method of Figure 1 , step 122 comprises inserting the ball clasps 1437 into locations in the first portion of the orthodontic retainer 1410 being fabricated. Thus, the wires and clasps for a Hawley retainer may also be designed to work with pause print. This may require the ends to be embedded to be flat and level with the "horizonlayer" of the pause print. To function, it may be beneficial to have the retainer printed with the tissue side facing downward.

[0132] In step 114 of Figure 1 , the digital library of virtual parts, each of which corresponds to an associated physical part of a plurality of physical parts, can be a printed bridge support bar library for poly-jet / multi-jet printing or any stop print or interrupted print. The bridge support bar library can be a pre-made library of different shapes, sizes, and configurations of metal (or other material) supports intended to strengthen crowns and bridges that are 3D printed. This library is designed to be used in an interrupted or halted 3D print. The part is inserted when the print is stopped and then the print is resumed encapsulating or embedding the library part in the print. No cement or luting is required. Turning to Figure 15, there is shown a hybrid bridge 1500 that can be fabricated using a method according to the present disclosure. The hybrid bridge 1500 includes a prosthesis 1505, a pair of abutments / copings / cylinders 1506, 1507, and a support structure 1510. In Figure 15A, in one embodiment, the support structure 1510 includes a main section 1512 and a pair of arms 1513, 1514 extending outwardly from opposite ends of the main section 1512. In the method of Figure 1 , step 122 comprises inserting support structure 1510 into the location in the first portion of the hybrid bridge being fabricated.

[0133] In Figure 15B, there is shown another embodiment in which the support structure 1520 includes a shorter main section 1522 and a pair of arms 1523, 1524 extending outwardly from opposite ends of the main section 1522. In Figure 15C, there is shown another embodiment in which the support structure 1530 includes a shorter main section 1532 and a pair of arms 1533, 1534 extending outwardly from opposite ends of the main section 1532. In Figure 15D, there is shown another embodiment in which the support structure 1540 includes a shorter main section 1542 and a pair of arms 1543, 1544 extending outwardly from opposite ends of the main section 1542.

[0134] In Figures 16A and 16B, there is shown another embodiment of a support structure 1550 for a hybrid bridge I locator denture. Each support structure 1550 includes a tubular coping / cylinder section 1552 and an arm 1554 extending outward from the locator section 1552. In the method of Figure 1 , step 122 comprises insertinga pair of support structures 1550 into the location in the first portion of the hybrid bridge being fabricated. The pair of support structures 1550 can be arranged in the location in the first portion of the hybrid bridge being fabricated with the arms 1554 being adjacent as shown in Figures 16A and 16B. This creates spaced apart coping / cylinder sections 1552 in the hybrid bridge / locator denture after the second portion of the hybrid bridge / locator denture is fabricated in step 124 of Figure 1 . The coping / cylinder sections 1552 can engage an abutment or an implant.

[0135] In Figure 16C, there is shown another embodiment of a support structure 1560 for a hybrid bridge / locator denture. Each support structure 1560 includes a tubular coping / cylinder section 1562 and arms 1564, 1565 extending outward from the coping / cylinder section 1562. In the method of Figure 1 , step 122 comprises inserting a pair of support structures 1550 and a pair of support structures 1560 into the location in the first portion of the hybrid bridge / locator denture being fabricated. The pair of support structures 1550 and the pair of support structures 1560 can be arranged in the location in the first portion of the hybrid bridge / locator denture being fabricated with the arms 1554, 1564 and the arms 1564, 1565 being adjacent as shown in Figure 16C. This creates spaced apart coping / cylinder sections 1552, 1562 in the hybrid bridge / locator denture after the second portion of the hybrid bridge / locator denture is fabricated in step 124 of Figure 1 . The coping / cylinder sections 1552, 1562 can engage an abutment or an implant.

[0136] Pause Print Custom Flat Horizon Frame for Partial Framework, Hybrid Framework, or Prosthetic Assembly: To use a pause print for dental or medical assembly of a prosthetic, we refer to the model-less, “flat frame” partial denture assembly disclosed in PCT Patent Application Publication No. WO 2024 / 097183 A2. The idea in the present disclosure is that the entire frame must be designed to intentionally remain below the “horizon line” of the pause print void (i.e., a surface region of the first portion of the dental or medical device that surrounds the inserted physical part). This requires both design changes to traditional designs, software changes, nesting software additions, and CAM software additions.

[0137] This of course causes problems for the rest seats and rest seat / clasp assemblies. It is common for rest seats and guide planes with clasps to sit on a plane above the mesh of the frame. The solution is to treat these as two separate custom parts intended to be inserted on multiple different planes. Achieving this may require a combination of custom-made parts and stock library parts. Referring to Figure 17, scaffolding 1710 is printed to support all the frame parts 1700 even though they do not include the parts being printed. The horizon plane 1730 of pause print is chosen such that the metal frame 1700 fits below the 3D printing heads to avoid contacting the heads.

[0138] Nesting Support for Metal Parts to be Inserted: It may be necessary to print supports during the print for future parts to be inserted during the print. If a library part has components that are external to the part being printed, support scaffolding may be required to support it and ensure its correct orientation while the print is resumed and completed. This requires the nesting software to account for scaffolding to support this part either in the CAD, CAM, or nesting software.

[0139] Robotic Assembly: Library parts allow for rapid manufacturing. Robotic assembly inside the printing or milling chamber allows for the least amount of operator involvement and the highest volume output. The library parts are designed to be easily returned by robotic arm. The parts may be accessible from the printing or milling chamber and inserted during multiple pause prints at the correct layer. This allows for unattended operation. Furthermore, oversize parts may be milled or machined in the chamber to ensure precision after placement.

[0140] Horizon Layer: Pause print parts are designed to be inserted manually or robotically during a polyjet print, 3D print, or milling operation to expedite and scale production. To be inserted during a print, the part must be designed to be embedded below the surface of the last (or highest) print later in a void. The part may achieve this by including a flange for embedment and orientation. This last or highest layer in a void might be called the horizon layer. The part may be inserted with a resin to be cured and secure the part. The resin must be leveled exactly so the print can continue correctly and accurately. Multiple horizon layers (pauses / stops) maybe required in one print tosuccessfully create a prosthetic design. As the number of horizon layers (pauses / stops) increases in a design, CAM, or nesting, the need for unsupervised printing increases. This is the main reason robotic assembly is required.

[0141] Other non-limiting additional use cases for the assembly methods of the present invention include robotic assembly of other medical device-related items (e.g., custom hearing aids, other implanted parts, prosthetics, etc.). For example, the method of the invention is useful for creating custom hearing aids. A printed silicone custom fit earpiece can be printed using a horizon layer as detailed above. Premade electronics and wire can be placed robotically and then printed over. The methods of the invention can be expanded for other implanted parts and facial and limb prosthetics with a support structure as well. All of these items can be assembled robotically using the concept of a "horizon layer" and 3D printing as in the present disclosure.

[0142] The present invention also provides an apparatus for fabricating a dental or medical device. The apparatus comprises: a three dimensional (3D) printing device; and a controller in electrical communication with the 3D printing device, the controller being configured to execute a program stored in the controller to: (i) receive a 3D digital model of the dental or medical device to be fabricated wherein the 3D digital model incorporates a model part selected from a digital library of virtual parts, each of the virtual parts corresponding to an associated physical part of a plurality of physical parts; (ii) send a first group of signals to the 3D printing device to fabricate a first portion of the dental or medical device from the 3D digital model; (iii) pause the printing device for a time period sufficient for insertion of one physical part of the plurality of physical parts into the first portion of the dental or medical device, the one physical part corresponding to the model part; and (iv) send a second group of signals to the 3D printing device to fabricate a second portion of the dental or medical device from the 3D digital model. The controller may include a microprocessor under the control of a software program stored in the controller memory.

[0143] The present invention also provides an apparatus for fabricating a dental or medical device. The apparatus comprising: a milling device; and a controller in electrical communication with the milling device, the controller being configured toexecute a program stored in the controller to: (i) receive a 3D digital model of the dental or medical device to be fabricated wherein the 3D digital model incorporates a model part selected from a digital library of virtual parts, each of the virtual parts corresponding to an associated physical part of a plurality of physical parts; (ii) send a first group of signals to the milling device to fabricate a first portion of the dental or medical device from the 3D digital model; (iii) pause the milling device for a time period sufficient for insertion of one physical part of the plurality of physical parts into the first portion of the dental or medical device, the one physical part corresponding to the model part; and (iv) send a second group of signals to the milling device to fabricate a second portion of the dental or medical device from the 3D digital model. The controller may include a microprocessor under the control of a software program stored in the controller memory.

[0144] In the method and apparatus of the present invention, the resulting dental or medical device meets all the criteria for the ideal digital prosthetic. It can be made from a patient scan (e.g., an intraoral scan) alone. It can be made in a small number of appointments. It requires no shipping by the dental or medical practitioner at all. It can be 3D printed (e.g., by fused deposition modeling, stereolithography, or selective laser sintering) or milled. It can be made from several materials. It can include a rigid or flexible major connector from the same design. As a dental device, it requires no stone model for assembly. Most importantly, the new design results in the most marketable dental or medical device that can be priced to match current models for the dental or medical practitioner.

[0145] In light of the principles and example embodiments described and illustrated herein, it will be recognized that the example embodiments can be modified in arrangement and detail without departing from such principles. Also, the foregoing discussion has focused on particular embodiments, but other configurations are also contemplated. In particular, even though expressions such as "in one embodiment", "in another embodiment," or the like are used herein, these phrases are meant to generally reference embodiment possibilities, and are not intended to limit the invention to particular embodiment configurations. As used herein, these terms may reference the same or different embodiments that are combinable into other embodiments. As a rule,any embodiment referenced herein is freely combinable with any one or more of the other embodiments referenced herein, and any number of features of different embodiments are combinable with one another, unless indicated otherwise.

[0146] Although the invention has been described in considerable detail with reference to certain embodiments, one skilled in the art will appreciate that the present invention can be practiced by other than the described embodiments, which have been presented for purposes of illustration and not of limitation. Therefore, the scope of the appended claims should not be limited to the description of the embodiments contained herein.

Claims

CLAIMSWhat is claimed is:1 . A method of fabricating a dental or medical device, the method comprising:(a) acquiring 3D digital image data of a body part of a patient;(b) creating a 3D digital model of a dental or medical device to be fabricated wherein the 3D digital model incorporates a model part selected from a digital library of virtual parts, each of the virtual parts corresponding to an associated physical part of a plurality of physical parts;(c) fabricating a first portion of the dental or medical device from the 3D digital model using additive manufacturing or subtractive manufacturing;(d) selecting one physical part of the plurality of physical parts that corresponds to the model part;(e) inserting the one physical part into a location in the first portion of the dental or medical device; and(f) fabricating a second portion of the dental or medical device from the 3D digital model using additive manufacturing or subtractive manufacturing.

2. The method of claim 1 wherein: step (e) comprises inserting the one physical part into the location in the first portion of the dental or medical device such that the one physical part does not extend beyond a surface region of the first portion of the dental or medical device that surrounds the inserted one physical part.

3. The method of claim 1 wherein: step (e) comprises inserting the one physical part into the location in the first portion of the dental or medical device using a robotic arm.

4. The method of claim 1 wherein: the dental or medical device comprises a surgical template, and the one physical part comprises a surgical guide sleeve.

5. The method of claim 4 wherein: the surgical guide sleeve includes a sleeve body and a flange that extends outwardly from the sleeve body.

6. The method of claim 5 wherein: the flange includes throughholes, and step (e) comprises inserting the one physical part into the location in the first portion of the dental or medical device such that projections in the first portion of the dental or medical device are received in the throughholes of the flange of the surgical guide sleeve.

7. The method of claim 1 wherein: the dental or medical device comprises a surgical template, and the one physical part comprises a surgical guide pin.

8. The method of claim 7 wherein: the surgical guide pin includes a pin body and a flange that extends outwardly from the pin body.

9. The method of claim 8 wherein: the flange includes throughholes, and step (e) comprises inserting the one physical part into the location in the first portion of the dental or medical device such that projections in the first portion of the dental or medical device are received in the throughholes of the flange of the surgical guide pin.

10. The method of claim 1 wherein: the dental or medical device is selected from the group consisting of locator dentures, hybrid dentures, and hybrid bridges, and the one physical part is selected from the group consisting of locator attachments, coping, and abutments.11 . The method of claim 10 wherein: the locator attachment includes a locator attachment body and a flange that extends outwardly from the locator attachment body.

12. The method of claim 11 wherein: the flange includes throughholes, and step (e) comprises inserting the one physical part into the location in the first portion of the dental or medical device such that projections in the first portion of the dental or medical device are received in the throughholes of the flange of the locator attachment.

13. The method of claim 10 wherein: the locator attachment includes a tapered outer wall terminating in a lip.

14. The method of claim 10 wherein: the locator attachment includes an outer wall having one or more ribs.

15. The method of claim 14 wherein: step (e) comprises inserting the one physical part into the location in the first portion of the dental or medical device such that a projection in the first portion of the dental or medical device is received in a rib of the outer wall of the locator attachment.

16. The method of claim 1 wherein: the dental or medical device comprises a dental prosthesis, and the one physical part comprises an abutment.

17. The method of claim 16 wherein: the abutment has a flange that extends outwardly from a body of the abutment.

18. The method of claim 17 wherein: the abutment has a tapered outer wall.

19. The method of claim 18 wherein: the abutment has an internally threaded hole.

20. The method of claim 1 wherein: the one physical part includes a part body and a flange that extends outwardly from the part body.21 . The method of claim 20 wherein: the flange includes at least one outwardly extending tab.

22. The method of claim 20 wherein: the flange includes at least one inwardly directed slot.

23. The method of claim 20 wherein: the flange includes at least one outwardly extending rib.

24. The method of claim 20 wherein: the flange includes at least one outwardly extending leg.

25. The method of claim 20 wherein: the flange includes a perimeter having a circular, oval, or polygonal shape.

26. The method of claim 1 wherein: the dental or medical device comprises a prosthesis, and the one physical part comprises a magnetic material.

27. The method of claim 1 wherein: the one physical part includes a part body having an internally threaded hole.

28. The method of claim 1 wherein: the dental or medical device is selected from the group consisting of locator dentures, hybrid dentures, and hybrid bridges, and the one physical part comprises a lingual support structure.

29. The method of claim 1 wherein: the dental or medical device comprises a hybrid bridge, and the one physical part comprises a support structure including a locator section and one or more arms extending outward from the locator section.

30. The method of claim 1 wherein: the dental or medical device comprises a hybrid bridge, step (b) comprises creating a 3D digital model of a dental or medical device to be fabricated wherein the 3D digital model incorporates a plurality of model parts selected from the digital library of virtual parts, step (d) comprises selecting two or more of the physical parts from the plurality of physical parts, each of the two or more of the physical parts corresponding to one of the model parts, step (e) comprises inserting each of the selected two or more physical parts into a location in the first portion of the dental or medical device, and each physical part comprises a support structure including a locator section and one or more arms extending outward from the locator section.31 . The method of claim 1 wherein: the dental or medical device comprises a dental device, and the one physical part comprises a palatal mesh.

32. The method of claim 1 wherein: the dental or medical device comprises a palatal expander, and the one physical part comprises an expansion assembly.

33. The method of claim 1 wherein: the dental or medical device comprises a dental night guard, and the one physical part comprises a clasp.

34. The method of claim 1 wherein: the dental or medical device comprises an orthodontic retainer, and the one physical part comprises a clasp.

35. The method of claim 1 wherein: the dental or medical device comprises a dental device, and the one physical part comprises a clasp selected from the group consisting of ball clasps, C-clasps, wing clasps, l-bar clasps, Y-bar clasps, combination clasps, RPI clasps, RPA clasps, rest seats, orthodontic clasps, and Adams clasps.

36. The method of claim 35 wherein: the clasp comprises a ball clasp or a C-clasp.

37. The method of claim 1 wherein: step (b) comprises creating a 3D digital model of a dental or medical device to be fabricated wherein the 3D digital model incorporates a plurality of model parts selected from the digital library of virtual parts, step (d) comprises selecting two or more of the physical parts from the plurality of physical parts, each of the two or more of the physical parts corresponding to one of the model parts, and step (e) comprises inserting each of the selected two or more physical parts into a location in the first portion of the dental or medical device.

38. The method of claim 1 wherein: step (c) comprises fabricating the first portion of the dental or medical device from the 3D digital model using additive manufacturing, and step (f) comprises fabricating the second portion of the dental or medical device from the 3D digital model using additive manufacturing.

39. The method of claim 1 wherein: step (c) comprises fabricating the first portion of the dental or medical device from the 3D digital model using 3D printing, and step (f) comprises fabricating the second portion of the dental or medical device from the 3D digital model using 3D printing.

40. The method of claim 1 wherein: step (a) comprises acquiring 3D digital image data of a patient's mouth and dentition, and step (b) comprises creating a 3D digital model of a removable dental appliance to be fabricated.41 . The method of claim 1 wherein: the dental or medical device comprises a hearing aid, and the one physical part comprises at least one electronic component.

42. The method of claim 1 wherein: the dental or medical device comprises a facial prosthesis, and the one physical part comprises a support structure.

43. The method of claim 1 wherein: the dental or medical device comprises a limb prosthesis, and the one physical part comprises a support structure.

44. The method of claim 1 wherein: the dental or medical device comprises an implant, and the one physical part comprises a support structure.

45. An apparatus for fabricating a dental or medical device, the apparatus comprising: a 3D printing device; and a controller in electrical communication with the 3D printing device, the controller being configured to execute a program stored in the controller to:(i) receive a 3D digital model of the dental or medical device to be fabricated wherein the 3D digital model incorporates a model part selected from a digital library of virtual parts, each of the virtual parts corresponding to an associated physical part of a plurality of physical parts;(ii) send a first group of signals to the 3D printing device to fabricate a first portion of the dental or medical device from the 3D digital model;(iii) pause the printing device for a time period sufficient for insertion of one physical part of the plurality of physical parts into the first portion of the dental or medical device, the one physical part corresponding to the model part; and(iv) send a second group of signals to the 3D printing device to fabricate a second portion of the dental or medical device from the 3D digital model.

46. An apparatus for fabricating a dental or medical device, the apparatus comprising: a milling device; and a controller in electrical communication with the milling device, the controller being configured to execute a program stored in the controller to:(i) receive a 3D digital model of the dental or medical device to be fabricated wherein the 3D digital model incorporates a model part selected from a digital library of virtual parts, each of the virtual parts corresponding to an associated physical part of a plurality of physical parts;(ii) send a first group of signals to the milling device to fabricate a first portion of the dental or medical device from the 3D digital model;(iii) pause the milling device for a time period sufficient for insertion of one physical part of the plurality of physical parts into the first portion of the dental or medical device, the one physical part corresponding to the model part; and(iv) send a second group of signals to the milling device to fabricate a second portion of the dental or medical device from the 3D digital model.

47. The apparatus of claim 45 or claim 46 further comprising: a robotic arm positioned to insert the one physical part of the plurality of physical parts into the first portion of the dental or medical device.

48. The apparatus of claim 47 wherein the robotic arm inserts the one physical part of the plurality of physical parts into the first portion of the dental or medical device such that the one physical part does not extend beyond a surface region of the first portion of the dental or medical device that surrounds the inserted one physical part.

49. The apparatus of claim 47 wherein: the robotic arm is located within a chamber of the apparatus.

50. The apparatus of claim 47 wherein: the one physical part includes a body and a first locating structure associated with the body, and the robotic arm inserts the one physical part of the plurality of physical parts into the first portion of the dental or medical device such that a second locating structure in the first portion of the dental or medical device matingly engages the first locating structure.51 . The apparatus of claim 50 wherein: the first locating structure comprises a flange.

52. The apparatus of claim 51 wherein: the flange includes throughholes, the second locating structure includes projections in the first portion of the dental or medical device, and the robotic arm inserts the one physical part of the plurality of physical parts into the first portion of the dental or medical device such that the projections in the first portion of the dental or medical device are received in the throughholes of the flange.

53. The apparatus of claim 51 wherein: the flange includes at least one outwardly extending tab.

54. The apparatus of claim 51 wherein: the flange includes at least one inwardly directed slot.

55. The apparatus of claim 51 wherein: the flange includes at least one outwardly extending rib.

56. The apparatus of claim 51 wherein: the flange includes at least one outwardly extending leg.

57. The apparatus of claim 51 wherein: the flange includes a perimeter having a circular, oval, or polygonal shape.

58. The apparatus of claim 50 wherein: the first locating structure comprises a tapered outer wall of the body terminating in a lip.

59. The apparatus of claim 50 wherein: the first locating structure comprises an outer wall of the body having one or more ribs.

60. The apparatus of claim 45 or claim 46 wherein: the 3D digital model is created from a scan taken with an intraoral scanner.61 . The apparatus of claim 45 or claim 46 further comprising: a dispenser positioned to dispense an adhesive material adjacent the inserted one physical part.

62. The apparatus of claim 45 wherein the controller is configured to execute the program stored in the controller to pause the 3D printing device for a time period sufficient for insertion of two or more of the physical parts from the plurality of physical parts, each of the two or more of the physical parts corresponding to one of the model parts.

63. The apparatus of claim 46 wherein the controller is configured to execute the program stored in the controller to pause the milling device for a time period sufficient for insertion of two or more of the physical parts from the plurality of physical parts, each of the two or more of the physical parts corresponding to one of the model parts.

64. The apparatus of claim 45 or claim 46 wherein: the one physical part includes support scaffolding to maintain a predetermined orientation of the one physical part during fabricating the second portion of the dental or medical device from the 3D digital model.

65. The apparatus of claim 45 wherein the controller is configured to execute the program stored in the controller to send a third group of signals to the 3D printing device to fabricate one or more of the physical parts of the plurality of physical parts.

66. The apparatus of claim 65 wherein at least one of the one or more of the physical parts includes support scaffolding to maintain a predetermined orientation of the one physical part during fabricating the second portion of the dental or medical device from the 3D digital model.

67. The apparatus of claim 46 wherein the controller is configured to execute the program stored in the controller to send a third group of signals to the milling device to fabricate one or more of the physical parts of the plurality of physical parts.

68. The apparatus of claim 67 wherein at least one of the one or more of the physical parts includes support scaffolding to maintain a predetermined orientation of the one physical part during fabricating the second portion of the dental or medical device from the 3D digital model.

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