Modeling devices used for guided bone regeneration and guided tissue regeneration

Abstract

The present disclosure describes the manufacture of a device configured to guide bone and tissue regeneration for a bone defect. The method can include receiving a three-dimensional digital model or scan depicting an anatomical feature to be repaired, generating a simulated membrane using the three-dimensional model, the simulated membrane configured to cover the anatomical feature to be repaired, generating a digital two-dimensional flattened version of the simulated membrane, and generating code or instructions configured to cause a three-dimensional printer or milling device to manufacture a trimming guide, the trimming guide including an opening corresponding to the flattened version of the simulated membrane and further including a cutout configured to hold a pre-fabricated membrane. The trimming guide can operate as a guide for marking or cutting the pre-fabricated membrane through the opening while the pre-fabricated membrane is held in the cutout.

Description

Technical Field

[0001] The present disclosure relates to the manufacture, customization, and use of devices configured to induce bone and tissue regeneration for bone defects.

[0002] [Priority] This application claims the benefit and priority of U.S. Patent Application No. 17 / 026,151, filed Sep. 18, 2020, and U.S. Provisional Patent Application No. 62 / 902,898, filed Sep. 19, 2019, the entire contents of which are hereby incorporated by reference herein in their entirety as if fully set forth below for all applicable purposes.

Background Art

[0003] It is widely known that the occurrence of tooth loss in the human dentition, which can result from dental disease, aging, genetic predisposition, accidents, etc., is the cause of many functional and aesthetic problems. For example, when chewing is insufficient, it affects the entire digestive system, and insufficient chewing can cause gastrointestinal dysfunction and complaints. Also, from an aesthetic point of view, proper dental care is of considerable importance.

[0004] Previously, missing teeth were replaced with partial dentures or permanently attached dental bridges, which were partially supported by the remaining natural teeth. However, bridges are a multi-piece, inflexible system, and their shape and color are not always as desired, and their participation in the chewing process is also often incomplete. Modern tooth replacement involves extracting damaged or unwanted teeth and implanting titanium implants supported by the patient's own natural bone. In cases where there is insufficient bone to support the implant, bone may be reconstructed with autologous bone grafting. This costly procedure requires hospitalization and also carries a risk of complications. There are also other options for bone reconstruction, such as guided tissue regeneration (GTR) and guided bone regeneration (GBR). Both of these techniques involve regenerating bone defects that affect natural teeth with a barrier membrane. GTR means the regeneration of bone and the attachment organs (ligaments, cementum) of natural teeth, and GBR involves implanting a membrane at the location where bone formation is intended. In either technique, bone and / or bone replacement materials are typically used under the membrane.

[0005] There is a continuing need for improved materials and techniques for use in GTR and GBR procedures. SUMMARY OF THE INVENTION

[0006] Certain aspects of the present disclosure relate to the manufacture of a membrane configured to induce the regeneration of bone and tissue for bone defects. The membrane can include a reinforced polytetrafluoroethylene (PTFE) mesh. The PTFE mesh may be referred to herein as the membrane. The membrane can include a first layer, a second layer, one or more perforations, a reinforcing binder, and / or other components. The first layer of the membrane can be configured to contact bone. This is not intended to be limiting. Depending on the situation, the user can contact the first layer of the membrane with soft tissue and / or other non-bone tissue. The second layer can be configured to substantially prevent fibrous connective tissue from growing into the bone defect. The reinforcing binder can be disposed over the bone defect and configured to bond to the surrounding bone. The reinforcing binder can include a plurality of elongated members extending from the junction. Certain aspects of the present disclosure relate to a membrane manufactured using modeling and / or simulation tools to design, configure, print, and / or cut the membrane and / or the materials used to make the membrane.

[0007] In one aspect of the present disclosure, a method of manufacturing a device configured to induce the regeneration of bone and tissue includes receiving a three-dimensional model representing an anatomical feature to be repaired, generating a simulated membrane using the three-dimensional model, the simulated membrane being configured to cover the anatomical feature to be repaired, manufacturing the device to match the physical structure of the simulated membrane, and making one or more holes in the device for use in fixing the device to bone adjacent to the anatomical feature to be repaired. In one example, manufacturing the device includes cutting a pre-manufactured membrane according to a template corresponding to the simulated membrane. In one example, manufacturing the device includes printing at least one layer of material using template information obtained from the simulated membrane and joining at least one layer of material to one or more other layers of material to obtain the device.

[0008] In one aspect of the present disclosure, a device configured for the repair of a bone defect includes a first layer configured to contact bone, the first layer including expanded polytetrafluoroethylene (ePTFE), and a second layer including high-density cell-occluding polytetrafluoroethylene (PTFE) configured to substantially prevent fibrous connective tissue from growing into the bone defect, and one or more holes formed in the device and configured to receive a fastener for securing the device to bone adjacent to an anatomical feature to be repaired. The device may be manufactured using template information generated from a three-dimensional model representing the anatomical feature to be repaired. In some examples, the device may be manufactured by cutting a pre-manufactured membrane according to the template information. In some examples, the device is manufactured from one or more layers of a material printed using the template information, and the one or more layers of the material are joined to obtain the device.

[0009] These and other objects, features, and characteristics of the systems and / or methods disclosed herein, as well as the operation methods and functions of the related elements of the structure, and the combinations of parts and the economies of manufacture, will become more apparent by considering the following description and the appended claims in reference to the accompanying drawings, which form a part of this specification. Like reference numerals refer to corresponding parts in the various drawings. However, it should be clearly understood that the drawings are for illustrative and explanatory purposes only and are not intended to define the limits of the present invention. As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

Brief Description of the Drawings

[0010]

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BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The detailed description set forth below in connection with the appended drawings is intended to describe various configurations and is not intended to represent the only configurations in which the concepts described herein may be implemented. The detailed description includes specific details for providing a thorough understanding of the various concepts. It will be apparent to those skilled in the art, however, that the concepts may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form in order not to obscure such concepts.

[0012] FIG. 1 shows a sequence 100 related to the treatment of a discontinuity defect 110 of a bone 108 using a device 116 that includes or can function as a membrane. The device may also be referred to as a membrane. In one example, sequence 100 may be related to a procedure to modify or repair an initial state 102 to obtain a desired result 106 by inducing, assisting, and / or enhancing bone regeneration 118 in the region of discontinuity defect 110. Bone regeneration 118 may be facilitated using a device 116 provided in accordance with certain aspects of the present disclosure. In some embodiments, device 116 may be perforated to promote ossification. In some embodiments, the device can include a PTFE mesh.

[0013] Device 116 can have multiple layers, including a first layer that faces the discontinuity defect 110 and is fixed to a second outward-facing layer. The first layer and / or the second layer can include perforations 18, and a reinforcing binder 114 is attached to device 116 to provide mechanical strength and / or to enable the device to be fixed to the region of bone 108 surrounding the discontinuity defect 110. During the bone regeneration stage 104, device 116 is positioned across, over, and / or around the location of the discontinuity defect 110 and can be fixedly positioned at the location of the discontinuity defect 110 by screws, staples, pins, and / or other fasteners.

[0014] Device 116 can be configured to induce bone and tissue regeneration for various types of bone defects. Device 116 is suitable for guided bone regeneration (GBR), guided tissue regeneration (GTR) and / or other therapies. Device 116 can form a barrier device used to induce bone and tissue regeneration for dental and / or other purposes. Device 116 can be used in oral surgery, maxillofacial surgery, craniofacial surgery to treat periodontal disease, for dental implants, to treat alveolar bone defects, and / or for other applications. Device 116 can be configured to maintain a space for bone regeneration, prevent connective tissue fibers from growing into bone tissue, fix bone, eliminate stimuli that may interfere with bone formation, and / or for other purposes. Device 116 may be a barrier device applicable in alveolar ridge augmentation and / or to other defects sized to be covered by Device 116. Device 116 can promote reduction and / or removal of damage and / or promote a more efficient bone and tissue regeneration process compared to conventionally known techniques. Device 116 can include perforations 18 disposed at various distances from each other throughout Device 116.

[0015] The perforations 112 of Device 116 can be provided so that the barrier membrane does not form a continuous surface at the desired bone and tissue regeneration locations. For example, if Device 116 includes perforations larger than the pore size of the surface of Device 116, a discontinuous surface can be presented. Device 116 can induce a beneficial effect on bone regeneration when a discontinuous surface is presented, especially in combination with the use of various biological growth factors. Perforated membranes have been shown to promote bone regeneration more than non-perforated membranes. The perforated design disclosed herein facilitates handling, fixation and / or shaping of Device 116 during application because a surgeon can more easily visualize pilot holes specially made for the purpose of fixing membrane fixation screws, pins or staples.

[0016] A device 116 that includes a perforated membrane or operates as a perforated membrane can facilitate the exchange between a patient's periosteum and growth factors used in GBR. The growth factors can include RhPDGF (platelet-derived growth factor), RhBMP (bone morphogenetic protein), and / or other growth factors. Also, the perforations 112 can facilitate the exchange between the periosteum and undifferentiated stem cells, particularly in the presence of mimicked growth factors. Applying a non-perforated collagen (for example) membrane may reduce the regenerative ability of PDGF. When a surgeon (and / or other user) utilizes autogenous bone that has been fragmented for bone generation, thereby requiring the application of a membrane, the "permeability" of the perforated membrane can enable the development of the connection with the periosteum using the PDGF technique.

[0017] Similarly, the device 116 can be used with RhBMP. By using the device 116 with RhBMP, a surgeon (and / or other user) can avoid using, for example, titanium net / mesh (used for its permeability to non-perforated membranes). Titanium net / mesh can cause complications because it is sharp and difficult to handle. Such complications can include, for example, damaging the patient's gingiva or difficult removal (taking up to 30 minutes). In contrast, the device 116 can be removed within a few minutes, reducing the duration of the surgery and the likelihood of complications.

[0018] Continuing the comparison with the above non-limiting examples of titanium net / mesh, the present invention differs from titanium mesh in several respects. These include mechanical compliance, placement, removal, customization and / or other differences. (1) Mechanical compliance: Perforated PTFE is more flexible compared to titanium mesh, and thus has improved compliance with soft tissue. Mechanical compliance is important because a biomaterial with high compatibility with soft tissue significantly reduces the risk of soft tissue detachment (opening) and / or complications of wound healing. (2) Placement: Due to its flexibility and softness, device 116 is easier to adapt, place and / or fix compared to titanium mesh. (3) Removal: Regenerated bone tends to grow through and / or on the struts of titanium mesh, as a result of which removal is extremely difficult. When removing titanium mesh, it may damage immature regenerated bone, resulting in a smaller amount of regenerated tissue than desired. In contrast, due to the flexibility of device 116, removal is much easier and it can actually be stretched, thus reducing the risk of damaging newly formed bone tissue when the device is removed. (4) Customization: With regard to the method, in "custom fit" applications, the present invention is much easier to trim and cut, and / or the surgeon can easily make holes directly during surgery with a simple hand punch, making it possible to create a truly custom surgical device for individual defects. The surgeon can accurately place the holes in the desired positions and can make more or fewer holes depending on the clinical application. For example, if membrane exposure is desired, it is advantageous to leave the exposed portion non-porous and create perforations in the area where exchange between the periosteum and the graft bed is desired. This operation would be extremely difficult with a titanium sheet.

[0019] Figure 2 shows a device 200 adapted or manufactured in accordance with certain aspects disclosed herein. In some embodiments, the device 200 can include a first layer 212, a second layer 214, one or more perforations 204, 206, 208, a reinforcing binder 210, and / or other components. In some embodiments, the first layer 212 is free of perforations and consists of a thin layer of lightweight polymer mesh, collagen, or expanded PTFE. Some of the perforations 206 are completed through only a single layer of the device 200, and the layer of lightweight polymer mesh, collagen, or expanded PTFE may be (for example) bonded to a single layer. In some examples, the device 200 may include or incorporate a titanium framework between the layers 212, 214. In the illustrated example, the device 200 includes a reinforcing binder 210.

[0020] In the illustrated example, the device 200 is generally rectangular in shape and can have a length 216 and a width 218. In one example, the length 216 may be less than about 50 mm. The length 216 may be from about 30 mm to about 50 mm. The length 216 may be about 40 mm. In some embodiments, the width 218 may be less than about 40 mm. The width 218 may be from about 20 mm to about 40 mm. The width 218 may be about 30 mm. In some embodiments, the device 200 can have a thickness 220 of from about 0.125 mm to about 0.25 mm. The generally rectangular shape and approximate dimensions of the device 200 shown in FIG. 2 are not intended to be limiting. The device 200 can take on any shape and have any dimensions that enable it to function as described in this disclosure.

[0021] In some embodiments, device 200 can be formed from collagen, PTFE and / or other materials, and / or combinations of materials. In some embodiments, device 200 may be formed from one or more of expanded PTFE, un-sintered PTFE, high density PTFE and / or other materials. In some embodiments, one or more layers 212, 214 of device 200 may be formed from un-sintered substantially non-expanded PTFE. The term sintering is a term well known in the art and is used herein in accordance with that understanding. The term un-sintered is used herein to describe a PTFE polymer that has not been subjected to a sintering process. Un-sintered PTFE may not be substantially expanded and typically does not include a substantially defined inter-node distance and can significantly reduce its porosity compared to expanded PTFE. The limited porosity of un-sintered substantially non-expanded PTFE can significantly reduce tissue adhesion to and / or tissue migration into un-expanded PTFE. However, the limited porosity can allow the passage of ions and other small molecules necessary for cell nourishment and waste transport. In some embodiments, the density of one or more layers 212, 214 of device 200 may be from about 1.2 gm / cc to about 2.3 gm / cc. In some embodiments, the density of one or more layers 212, 214 of device 200 may be from about 1.45 gm / cc to about 1.55 gm / cc.

[0022] Referring also to FIG. 1, the first layer 212 can be configured to contact the bone 108 (this is not intended to be limiting. In some situations, the user can contact the first layer of the device 200 with soft tissue and / or other non-bony tissue. For example, a surgeon can choose to place an expanded PTFE layer or a high-density PTFE layer towards the bone or soft tissue). The first layer 212 can have a surface 202 that includes pores or perforations 112 configured to promote the ingrowth of bone regenerative cells into the first layer 212. The second layer 214 can be fixedly coupled to the first layer 212 and / or can be coupled to the first layer 212 in some other way. The second layer 214 can be configured to substantially prevent fibrous connective tissue from growing into the bone defect. The second layer 214 can include a dense structure that prevents ingrowth of tissue. The second layer 214 can be, for example, relatively denser than the first layer 212. The first layer 212 and the second layer 214 can be separate layers of the device 200 (as described above), and / or the first layer 212 and the second layer 214 can be two faces on opposite sides of the device 200 (e.g., opposite sides of a single layer).

[0023] Pores in the materials used to construct the first layer 212 and / or the second layer 214 can be formed during the manufacture of the materials. The pores can be formed by the presence of an expanding gas during manufacture, deformation of the material, and other causes. For example, the pores can be formed as voids in the materials forming the layers 212, 214 of the device 200. The pores may occur during manufacture when a gas in the material expands to form bubbles. In one example, the pores may be formed in expanded polytetrafluoroethylene (ePTFE), and the pores may range in size from 30 microns to 500 microns. The process employed in the manufacture of the ePTFE material can be adapted to cause the formation of pores of a desired size and distribution over at least a portion of the ePTFE material. The pores in the ePTFE material can be configured to promote the ingrowth of bone-regenerating cells into the first layer. The other layer can include a high-density cell-occluding PTFE configured to substantially prevent the growth of fibrous connective tissue into the bone defect. In some embodiments, the cell-occluding PTFE has a high-density structure. The cell-occluding PTFE may be fixedly bonded to the ePTFE layer.

[0024] Figure 3 is an assembly diagram showing certain aspects of the manufacture and / or construction of a device 300 provided in accordance with an aspect disclosed herein. The illustrated device 300 has a reinforcing binder 302 provided between two layers 304, 306. As a non-limiting example, the first layer 304 can be composed of, or can include, ePTFE. The second layer 306 can be composed of, or can include, unsintered high-density PTFE (d-PTFE). In one example, the d-PTFE has a density of from about 1.2 gm / cc to about 2.3 gm / cc. In some embodiments, the density of the d-PTFE can range from about 1.45 gm / cc to about 1.55 gm / cc. The d-PTFE material can be an unsintered and non-stretched material having a nominal pore channel size of less than about 5 micrometers. In some embodiments, the unsintered, non-stretched d-PTFE can have a nominal pore channel size of less than about 2 micrometers. In some embodiments, the unsintered, non-stretched d-PTFE can have a nominal pore channel size of less than about 0.5 micrometers. In some embodiments, the unsintered, non-stretched d-PTFE can have a nominal pore channel size of less than about 0.2 micrometers. This small pore channel size enables the composite multilayer material employing d-PTFE to exhibit excellent functional properties and clinically to reduce host reaction (inflammation), soft tissue ingrowth, and resulting adhesions. (These pore channel sizes can be smaller than the pore sizes of the first layer 304 made of ePTFE that promotes bone ingrowth within.)

[0025] The reinforcing binder 302 can include a plurality of elongated members 308a-308e. In the illustrated example, the primary elongated member is coupled to a pair of elongated members 308b, 308c extending from the first joint 310 and a pair of elongated members 308d, 308e extending from the second joint 312. In some embodiments, the reinforcing binder 302 can be formed from titanium, stainless steel, platinum, ceramic, composite materials, carbon fiber materials, customized micro and / or nano-material-based materials, coated (e.g., coated with a non-toxic coating) materials, and / or other materials. The reinforcing binder 302 can be bent, and can include the elongated members 308a-308e such that the reinforcing binder 302 is shaped into a desired shape (e.g., during manufacture), and / or the user can bend, deform, and / or reform the reinforcing binder 302 to obtain the desired shape prior to placement around the bone defect so that the shaped form is maintained during placement. For example, one or more portions and / or all of the reinforcing binder 302 can be bent, twisted, and / or stretched as needed to obtain the desired shape. In some embodiments, the reinforcing binder 302 can be malleable and / or flexible because it is relatively thin. For example, a thin piece of titanium can be easily bent by the user.

[0026] The reinforcing binder 302 can be placed over a bone cavity such as, for example, an alveolar cavity. One or more of the elongated members 308a-308e can have at least one pre-drilled hole 314 formed therein. The pre-drilled hole 314 can be adapted to receive and / or position a fastener such as a surgical pin or screw at the bone defect site. In the illustrated example, two elongated members 308d, 308e are provided in a Y-shaped configuration, and both of those elongated members 308d, 308e have a pre-drilled hole 314 for receiving a fastener. The fastener can be a surgical screw configured to attach the corresponding elongated members 308d, 308e to a region of bone (typically at a surgical site including the buccal side of the jaw or the upper alveolar arch, for example, in the repair of an alveolar defect and / or a craniofacial defect).

[0027] The two layers 304, 306 can be coupled to the reinforcing binder 302 by fixing, attaching, and / or joining the layers and the reinforcing binder 302 together in any suitable manner, including the use of an adhesive layer to adhere and / or bond the two layers 304, 306 and the reinforcing binder 302. The two layers 304, 306 can partially cover the reinforcing binder 302. The two layers 304, 306 can substantially enclose the reinforcing binder 302.

[0028] The dimensions of the reinforcement binder 302 can be selected based on the application (e.g., based on the bone defect to be treated). Similarly, the physical and mechanical properties of the reinforcement binder 302 can be selected according to the application. In this specification, titanium is used as a main example. Surgical-grade titanium can be used to provide malleability, strength, and low weight. It should be understood that titanium has strength and weight properties that provide advantages in many applications, along with the biologically inert nature of the metal. In some applications, it is contemplated that other dimensions, dimensional ratios, and / or materials may be indicated for use. For example, the repair of pelvic and / or hip bone material may require the use of steel and / or other materials.

[0029] The structural configuration of the reinforcement binder 302 can be selected, for example, to facilitate the reconstructive repair of bone defects of various sizes, the repair of associated soft tissue, and / or placement and / or use in orthopedic surgery. The structural configuration of the reinforcement binder 302 can be selected to provide one or more appendages and / or elongated members suitable for placement around bone and / or surrounding tissue. The overall shape of the reinforcement binder 302 can be selected to achieve the desired strength, load distribution, membrane support, fastener placement, comfort, ease of insertion and / or removal, and / or to achieve other effects.

[0030] A texture pattern can be formed in one or more of layers 304 and 306. The texture pattern can include a plurality of depressions formed in layers 304 and 306. The depressions can have any shape that enables the film to function as described herein. In some embodiments, the depressions are hexagonal in shape, although other shapes are contemplated and within the scope of the present disclosure. The depressions can have a depth that is shallower than the thickness of the layers 304 and 306 in which they are formed. In some embodiments, the depressions can have a depth of, for example, up to about 0.15 mm and a width of up to about 0.5 mm. The dimensions of the depressions can be determined based on the intended use of the film and / or other factors. The distribution of the depressions can be substantially uniform across layers 304 and 306, can vary systematically across layers 304 and 306, can be randomly distributed across layers 304 and 306, and / or can have other distributions. For example, up to about 150 depressions per square centimeter can be provided on one of layers 304 and 306. As another example, up to about 250 depressions per square centimeter can be provided on one of layers 304 and 306.

[0031] The texture pattern can be produced by embossing a sheet having indentations after forming a thin sheet of PTFE. The PTFE resin can be mixed with a lubricant (e.g., mineral spirits) to form a paste. This paste can be calendered between rollers to form a thin flat sheet with a desired thickness (e.g., in the range of about 0.125 mm to about 0.25 mm). The calendering can be performed to thin the sheet and impart substantially uniform strength to the sheet in all directions. The lubricant can be removed by drying the sheet at a temperature slightly higher than the boiling point of the mineral spirits lubricant and well below the sintering temperature of PTFE. After the sheet is dried, the sheet can be embossed to form indentations on one of its surfaces. In some embodiments, the embossing step can be performed by placing a sheet of a patterned polymer mesh on top of the PTFE sheet. The patterned polymer mesh can be harder than the PTFE material and can have a higher compressive strength.

[0032] Figure 4 shows the use of device 300 in a bone defect. The first side cross-sectional view 400 relates to the maxilla of an adult after tooth extraction and shows the alveolar bone 402. The soft tissue gum 406 covers the bone 402. The alveolus 404 provides an example of a bone defect. Normal healing of the defect can include the migration of cells such as fibroblasts and gingival epithelial cells. As the cells proliferate into the defect (here, the alveolus 404), they can inhibit the regeneration of bone cells, and as a result, bone mass can be lost overall. In the case of tooth extraction, when bone mass is lost, the contour of the alveolar ridge can be lost.

[0033] The second side sectional view 410 shows the alveolus 404 filled with bone 408 and covered by the device 300. The alveolus 404 can be filled with, for example, autologous grafts, allogeneic grafts and / or particulate particles of bioabsorbable hydroxyapatite as bone precursors, and / or other materials. Other materials and / or articles, such as endosseous dental implants, can also be placed within the alveolus 404. The filled alveolus 404 can be covered by the device 300. In one example, after placing the device 300 over the alveolus 404 and the bone 402, the device 300 can be fixed in place via fasteners (not shown). The gingival flap 406 can be sutured over the device 300. The device 300 can hold hydroxyapatite particles and / or other materials in place within the alveolus 404 during healing and can prevent the movement of cells and / or connective tissue into the alveolus 404. Connective tissue (e.g., gingival tissue 406) can form a weak adhesion with the textured surface of the device 300 without growing through the device 300. This adhesion is weak enough to allow the device 300 to be removed after healing without significant trauma, but can be strong enough to prevent dislodgment.

[0034] Certain aspects of the present disclosure relate to the design, configuration, and manufacture of devices or membranes for use in guided bone regeneration and guided tissue regeneration. In some examples, the device or membrane includes a reinforced perforated PTFE mesh. Visualization or modeling systems can be used in the preparation of surgical procedures related to guided bone regeneration and guided tissue regeneration therapies. Imaging techniques can generate high-resolution three-dimensional (3D) renderings of physical structures and locations that can be subjects, targets, or candidates for guided bone regeneration and guided tissue regeneration therapies. For example, cone beam computed tomography (CBCT) can generate a series of high-resolution images for diagnostic purposes and / or for preparation in dental implant procedures, orthopedic procedures, and other medical and dental fields. In one example, a CBCT scanner can generate hundreds of images captured from various viewpoints around a location or feature of interest. The 3D image can be created by analyzing, combining, and / or correlating information obtained from the images generated by the CBCT scanner. The 3D image can be used to generate a model of the feature or location of interest. In one example, the model can combine the image and dimensional information.

[0035] The models generated by the 3D modeling system can be used in a simulation system. A particular 3D modeling system can be configured to use the models for one or more functions including simulation, animation, editing, rendering, and other functions. The models can be generated by any suitable commercial, proprietary, or public domain 3D modeling system known in the art. The 3D modeling system can be used to generate a model of a location in the preparation of surgical procedures related to guided bone regeneration and guided tissue regeneration therapies. FIG. 5 is a two-dimensional view of a 3D model 500 of an adult maxilla including a defect 502 treated using guided bone regeneration and guided tissue regeneration. The illustrated 3D model 500 is modified to simulate the effect of adding a filling material 504 to effect repair of the defect 502. The simulated filling material 504 can reproduce the properties and attributes of, for example, particulate grains of allografts, xenografts, and / or bioabsorbable hydroxyapatite. The simulation represented by the 3D model 500 can be used to calculate the volume and shape of the filling material to be applied to repair the defect 502.

[0036] Certain aspects of the present disclosure relate to systems, devices, and methods that can select, configure, and / or modify a membrane or components of a membrane used to facilitate and assist in guided bone regeneration and guided tissue regeneration. FIG. 6 is a two-dimensional view of a 3D model 600 used to plan and / or prepare materials for a surgical procedure related to guided bone regeneration and guided tissue regeneration therapies. This 3D model 600 relates to an adult maxilla and is modified to simulate the effect of adding a filling material to achieve repair of a defect 602. Further, the 3D model 600 is modified to arrange a simulated membrane 604 over the filling material in a manner that allows the simulated membrane 604 to be secured at an identifiable location on the maxilla.

[0037] The size, position, orientation, and shape of the simulated membrane 604 can be optimized based on the structure of the maxilla, the nature and location of the defect, the type and volume of the filling material, and other characteristics, including the mechanical characteristics of the completed device or component represented by the simulated membrane 604. The size, position, orientation, and shape of the simulated membrane 604 can be calculated using a curve fitting algorithm, including, for example, a smoothing and / or interpolation algorithm. In some cases, the characteristics of the simulated membrane 604 can be used to adjust or optimize the structure, shape, and / or volume of the filling material used. The simulated membrane 604 can be configured to meet the design goals of the maximum stress in the material of the simulated membrane 604 and the maximum and / or minimum pressures applied to the filling material.

[0038] Other aspects of the simulated membrane 604 can be customized for the procedure being performed. In one example, the surface of the simulated membrane 604 can be embossed with a pattern selected based on the type, size, and composition of the filling material. The pattern can be selected based on the area of the surface being embossed, the contact area between the simulated membrane 604 and the filling material and / or bone or tissue, and other aspects of the procedure being performed. In some embodiments, the pattern can be selected based on the physical structure and / or chemical composition of the simulated membrane 604. In another example, the location of holes for receiving fasteners, such as surgical pins or screws, at the bone defect site can be calculated for drilling holes in the reinforcement binder.

[0039] In some embodiments, the design of the simulated membrane 604, including the reinforcement binder, can be represented by one or more templates. The templates can be represented by information exchanged between different functional elements of a manufacturing system, including a visualizer, a modeler, a 3D printer, a cutting device, a drilling device, a joining / welding device, and other devices. In some examples, the template information can be used to create a physical template.

[0040] The template or template information can be used to customize a pre-manufactured device to conform to the shape of the simulated film 604. The template can include a drilling template that defines the positions of holes in the simulated film 604 and / or the reinforcing binder. The modeling system can be configured to generate a 3D model of the simulated film 604 and generate a template from a flattened version of the simulated film 604. The modeling system can identify a pre-manufactured film and / or a commercially available film that can be modified to match the simulated film 604. The template can be used to cut the device to size and / or drill holes in the device and / or the reinforcing binder. The pre-manufactured film and / or the commercially available film may be selected from a catalog or other list of available films based on the compatibility, structure, mechanical strength, shape, and position information generated by the modeling system.

[0041] In some embodiments, the design of the simulated film 604 including the reinforcing binder can be represented by code used to control a manufacturing machine that can manufacture a device that matches the simulated film 604. In one example, the code can be used to control a 3D printer that can print one or more layers of the finished device. In another example, the code can be used to control a cutting device that can modify the shape of a pre-manufactured film and / or a commercially available film. In another example, the code can be used to control a cutting device that can cut a binder material to form a reinforcing binder designed for the simulated film 604. In some cases, a laser or water jet cutter can be used. In another example, the code can be used to control a drilling device that can drill holes in the device to match defined holes in the simulated film 604 or the reinforcing binder.

[0042] Figure 7 shows an example of a material 700 that can be used to create a device corresponding to the simulated membrane 604 shown in FIG. 6. The two-dimensional template 702 can be generated from a 3D rendering of the simulated membrane 604. In some cases, the modeling system can identify a pre-fabricated membrane 706 that is cut to fit the shape of the simulated membrane 604, and / or a reinforcing binder 704 that is used to secure or strengthen the finished device. The template 702 can be used as an outline to customize the shape of the finished device.

[0043] Figure 8 shows a first example of a partially completed membrane 800 that conforms to the design of the simulated membrane 604. The first layer 804 is cut using the template 802, and the reinforcing binder 808 is drilled and positioned on the surface of the first layer 804. The reinforcing binder 808 can be drilled according to a drilling template or program defined for the simulated membrane 604. One or more holes 810 can be provided in the reinforcing binder 808. In some embodiments, the holes 810 may serve to supplement existing holes. In the illustrated example, the template 802 is used to mark and / or guide the cutting of the second layer 806.

[0044] FIG. 9 shows an example of a trimming guide 910 generated in accordance with an aspect disclosed herein. The upper surface 900 and the lower surface 920 of the trimming guide 910 are shown. The trimming guide 910 can be created using a 3D model of a site that is the subject or target of a surgical procedure related to guided bone regeneration and guided tissue regeneration therapy. The trimming guide 910 can be generated to conform to a simulated membrane designed by a 3D model of the surgical site or a simulated membrane developed from a 3D model of the surgical site, and / or a simulated membrane designed by a simulation of a surgical procedure based on a 3D model of the surgical site or a simulated membrane developed during such simulation. In one example, the trimming guide 910 may be 3D printed from a sterilizable acrylic resin or other suitable material. In other examples, the trimming guide 910 may be manufactured using a numerical control device that cuts, routes, or removes a suitable block or sheet of material to form the trimming guide 910. In some cases, a laser cutter or a water jet cutter can be used.

[0045] The modeling system can be configured to generate a 3D model of the simulated membrane 604. The 3D model can be further used in the simulation of a surgical procedure. In some cases, the simulated membrane 604 can be further developed or modified during the surgical procedure. The trimming guide 910 can be generated, modified, or developed from a flattened version of the simulated membrane 604. The modeling system can analyze the 3D model or simulation of the membrane and flatten the 3D simulated or modeled membrane to generate a two-dimensional (2D) rendering of the simulated or modeled membrane. In some embodiments, the 2D rendering of the simulated membrane 604 can be printed for use as a cutting template or trimming guide 910. A membrane that is cut or trimmed to match the 2D depiction of the simulated membrane 910 can assume the shape of the 3D simulated or modeled membrane when placed at the site of the surgical subject. In one example, the site of the surgical subject is on the patient's jaw, and a membrane that is cut to match the 2D rendering of the simulated membrane 910 curves over the jaw and can substantially acquire the shape of the 3D simulated or modeled membrane.

[0046] In one aspect, the modeling system can be configured to select a stock membrane that provides an optimal fit or best match to a flattened version of the simulated membrane 604. The stock membrane may be an off-the-shelf membrane that is not trimmed, commercially produced, or commercially available. The stock membrane can be selected from a catalog or list of off-the-shelf membranes based on the size, shape, and / or orientation information provided by the 3D modeling system. The 3D modeling system can generate information including code and dimensional information that characterizes the size and shape of the 2D drawing of the simulated membrane 604 generated from the 3D model of the surgical site. This information can be used to create a 3D printed trimming guide 910 that includes an opening 902 on one surface that matches the size and shape of the 2D drawing of the simulated membrane 604. The 3D modeling system can identify a commercially available off-the-shelf membrane of a suitable or optimal size that can be trimmed to fit the size and shape of the 2D depiction of the simulated membrane 604. In some embodiments, the 3D modeling system can be configured to have a list of specifications of commercially available off-the-shelf membranes and can select one or more candidates that function as the base or starting membrane to be cut or trimmed using the trimming guide 910. In some embodiments, the 3D modeling system may generate information to be used by other devices to select a commercially available off-the-shelf membrane of an appropriate or optimal size and / or to print the trimming guide 910.

[0047] In the illustrated example, the upper surface 900 of the trimming guide 910 can include a cutout portion 906 configured to receive and hold a selected commercially manufactured off-the-shelf film. The trimming guide 910 can include an opening 902 in the bottom surface 920 of the trimming guide 910, and this opening 902 is adapted to the shape and size of the 2D drawing of the simulated film 604. The practitioner or technician can place an example of a commercially available off-the-shelf film in the cutout portion 906. The practitioner or technician can cut, trim, or mark a commercially available off-the-shelf film through the opening 902 in the bottom surface 920 of the trimming guide 910, thereby enabling accurate shaping of the film. In some cases, the off-the-shelf film can be cut or trimmed while being held in place by the trimming guide 910. In some cases, the off-the-shelf film can be held in place by the trimming guide 910 while being marked using a surgical marker or scalpel, and can be removed from the trimming guide 910 for final trimming.

[0048] The use of 3D modeling as disclosed herein can generate a properly trimmed film that fits a digitally created model obtained, for example, from a cone beam scan. The resulting trimmed film is expected to fit the surgical site such that the surgeon does not need to further trim the film freehand in the operating room. In the prior art, it relies on trial-and-error film shaping, where the surgeon trims a little of the off-the-shelf film, tries it on the spot, trims it further, tries it on the spot, and such trial-and-error continues until it fits.

[0049] FIG. 10 shows an overlay 1000 of a shape 1004 corresponding to a 2D rendering of a simulated membrane 604 on a prefabricated membrane 1002. In one example, the overlay 1000 can show the placement of the opening 902 in the trimming guide 910 shown in FIG. 9. In another example, the shape 1004 can show an area of the surface of the prefabricated membrane 1002 created by marking the prefabricated membrane while the prefabricated membrane 1002 is held in the trimming guide 910. 3D modeling operated in accordance with the present disclosure can identify the prefabricated membrane 1002 and define the shape, size, and orientation of the shape 1004 within the trimming guide 910.

[0050] In some examples, the surgeon can choose to print the shape 1004 on paper or other material that can be used as a template for selecting a membrane or portion of a membrane that can correspond to the size, shape, and possibly orientation of the simulated membrane 604. For example, the surgeon can select the optimal one of the pre-trimmed membranes identified in a catalog that has the desired shape.

[0051] FIG. 11 shows a second example of a partially completed membrane 1100 that conforms to the design of the simulated membrane 604. The first layer 804 is joined to a reinforcing binder 808. The second layer 1102 is cut and can be joined or attached to the first layer 804.

[0052] FIG. 12 is a flowchart 1200 showing a first example of a method for manufacturing a device used in a procedure for repairing a bone defect by bone regeneration and tissue regeneration. In some embodiments, the device can include layers formed from collagen, polytetrafluoroethylene, and / or other materials. The operations of the method shown below are for illustrative purposes. In some embodiments, the method can be achieved using one or more additional operations not described and / or without using one or more of the operations considered. Further, the order of the operations of the method shown in FIG. 12 and described herein is not intended to be limiting.

[0053] In block 1202, a three-dimensional model showing the anatomical features to be repaired can be received by the manufacturing system. The three-dimensional model may be generated using a measurement system, a scanning system, an imaging system, and / or a processing system. In block 1204, the manufacturing system or another device generates a simulated membrane using the three-dimensional model. The simulated membrane can be configured to cover the simulation or model of the anatomical features to be repaired. In block 1206, the manufacturing system can manufacture or customize the device to match the physical structure of the simulated membrane. In block 1208, the manufacturing system can generate a drilling template for making one or more holes in the device, which is used to fix the device to the bone adjacent to the anatomical features to be repaired. In some examples, the manufacturing system can use the drilling template to make holes.

[0054] In one example, the manufacturing system can manufacture the device by manufacturing a template corresponding to the simulated membrane and cutting a pre-manufactured membrane according to the template to obtain the device. In another example, the manufacturing system can use template information obtained from the simulated membrane to print at least one layer of material and manufacture the device by joining at least one layer of material to one or more other layers of material to obtain the device. The manufacturing system can optionally include a 3D printer that receives instructions, data, or code describing or representing the simulated membrane and prints a physical membrane corresponding to the simulated membrane.

[0055] In one example, a manufacturing system can generate a digital or digitized two-dimensional flattened version of a simulated membrane, generate a trimming guide that includes an opening corresponding to the flattened version of the simulated membrane, and use the trimming guide to trim a pre-manufactured membrane. The trimming guide can be manufactured using a 3D printer or a milling machine. The manufacturing system can select a pre-manufactured membrane from a catalog of membranes based on its suitability to the size and shape of the flattened version of the simulated membrane, provide a cutout in the trimming guide, and configure it to mark or cut the pre-manufactured membrane through the opening while the pre-manufactured membrane is held in the cutout. The cutout can be configured to hold the pre-manufactured membrane. After trimming the pre-manufactured membrane, it can be applied to an anatomical feature to be repaired. The pre-manufactured membrane assumes a three-dimensional shape corresponding to the shape of the simulated membrane when applied to the anatomical feature to be repaired.

[0056] In some embodiments, a manufacturing system can produce a device or a component of a device that includes a first layer configured to contact bone and including ePTFE, and a second layer including high-density cell-occlusive PTFE configured to substantially prevent fibrous connective tissue from growing into a bone defect. The device can include at least one layer having collagen, a bioabsorbable polymer, animal tissue, or human tissue.

[0057] In one example, a device has a size, density, or spacing defined by a simulated membrane and calculated by a modeling system based on one or more properties of the materials included in the completed device, the thickness of the completed device, or the size of the completed device.

[0058] In certain embodiments, the reinforcement binder is configured to attach the device to bone adjacent to the anatomical feature to be repaired. The reinforcement binder can include a plurality of elongated members extending from the junction, including a first elongated member having a free end extending away from the junction. The reinforcement binder can include a hole formed in the first elongated member, the hole being configured to receive a fastener that holds the device in a fixed position in the bone defect through a first layer of the device and a second layer of the device. The fastener can include a pin, a staple, a suture, or a screw. The reinforcement binder can be disposed between a first layer of the device and a second layer of the device. The reinforcement binder can be composed of titanium. One or more holes of the device can be drilled using a drilling template generated using a three-dimensional model.

[0059] In some embodiments, a membrane can be manufactured by generating a template corresponding to a simulation and cutting a pre-manufactured membrane according to the template to obtain the membrane. Manufacturing the membrane can include printing one or more layers of material using information obtained from the simulation and joining one or more layers of material to obtain the membrane.

[0060] A device manufactured according to certain aspects of the present disclosure and configured for repairing a bone defect includes a first layer configured to contact bone, the first layer including ePTFE, and a second layer including high-density cell-occlusive PTFE configured to substantially prevent fibrous connective tissue from growing into the bone defect, and one or more holes formed in the device, the one or more holes being configured to receive a fastener for fixing the device to bone adjacent to the anatomical feature to be repaired. The device can be manufactured using template information generated from a three-dimensional model representing the anatomical feature to be repaired.

[0061] In one embodiment, the device is manufactured by cutting a pre-manufactured film according to template information. In certain embodiments, the device is manufactured using one or more layers of material printed using template information. The layers can be printed using a 3D printer. The device can be obtained by joining the layers of material including the printed layers.

[0062] In some examples, the device includes at least one layer having collagen, a bioabsorbable polymer, animal tissue, or human tissue. The device can include a combination of materials configured to have a size, density, or spacing defined by the template information, where the template information can be based on one or more properties of the materials included in the completed device, the thickness or size of the completed device.

[0063] In some examples, the device can include a reinforcement binder configured to couple the device to bone adjacent to the anatomical feature to be repaired. The reinforcement binder includes a plurality of elongated members extending from a junction, the plurality of elongated members including a first elongated member having a free end extending away from the junction, and a hole formed in the first elongated member, the hole being configured to receive a fastener that holds the device in place at the bone defect through a first layer of the device and a second layer of the device. In various examples, the fastener includes a pin, a staple, a suture, or a screw. In some embodiments, the reinforcement binder is disposed between a first layer of the device and a second layer of the device.

[0064] Figure 13 is a flowchart 1300 showing a second example of a method for manufacturing a device used in a procedure for repairing bone defects by bone regeneration and tissue regeneration. In this example, a trimming guide is printed and used to cut or trim a pre-manufactured membrane. The pre-manufactured membrane may be commercially available or selected from a catalog or other list. In some embodiments, the device can include layers formed from collagen, polytetrafluoroethylene, and / or other materials. The operations of the method shown below are for illustrative purposes. In some embodiments, the method may be achieved using one or more additional operations not described and / or without using one or more of the operations considered. Further, the order of the operations of the method shown in FIG. 13 and described herein is not intended to be limiting.

[0065] In block 1302, a 3D digital model or scan is received, and the 3D digital model or scan particularly shows the anatomical features to be repaired. In block 1304, a simulated membrane can be generated using the three-dimensional model, and the simulated membrane is configured to cover the anatomical features to be repaired. In block 1306, a digital two-dimensional flattened version of the simulated membrane can be generated. In block 1308, code or instructions can be generated to cause a 3D printer or milling device to generate a trimming guide that includes an opening corresponding to the flattened version of the simulated membrane and further includes a cutout configured to hold the pre-manufactured membrane. The trimming guide can function as a guide for marking or cutting the pre-manufactured membrane through the opening while the pre-manufactured membrane is held in the cutout.

[0066] In some examples, a hole-opening template can be generated to create one or more holes in a pre-manufactured membrane after trimming. The holes can be arranged or configured to secure the device to bone adjacent to the anatomical feature being repaired. The pre-manufactured membrane can be selected from a catalog of membranes based on its suitability to the size and shape of the flattened version of the simulated membrane. The modeling system can include a list of available membranes and associated specifications and can select a membrane for trimming based on suitability. Optimal suitability can be determined based on the overall dimensions of the membrane, the dimensions of the reinforcing binder, the constituent materials, and other reasons. The three-dimensional model may be generated using a measurement system, a scanning system, an imaging system, and / or a processing system. A manufacturing system or another device may generate a simulated membrane using the three-dimensional model, and the simulated membrane can be configured to cover the anatomical feature being repaired.

[0067] FIG. 14 is a conceptual diagram showing a simplified example of a hardware aspect for an apparatus 1400 employing a processing circuit 1402 that may be configured to perform one or more functions disclosed herein. For example, apparatus 1400 may include, or be implemented in, a manufacturing system, and processing circuit 1402 may be configured to control certain operations or processes related to the manufacturing system. According to various aspects of the present disclosure, an element disclosed herein, or any portion of an element, or any combination of elements, can be implemented using processing circuit 1402. Processing circuit 1402 can include one or more processors 1404 controlled by a certain combination of hardware modules and software modules. Examples of processors 1404 include microprocessors, microcontrollers, digital signal processors (DSPs), ASICs, field programmable gate arrays (FPGAs), programmable logic devices (PLDs), state machines, sequencers, gate logic, discrete hardware circuits, and other suitable hardware configured to perform various functions described throughout the present disclosure. The one or more processors 1404 can include dedicated processors for performing specific functions and can be configured, enhanced, or controlled by one of the software modules 1416. The one or more processors 1404 may be configured through a combination of software modules 1416 loaded during initialization and may be further configured by loading or unloading one or more software modules 1416 during operation.

[0068] In the illustrated example, the processing circuit 1402 can be implemented in a bus architecture generally shown by bus 1410. Bus 1410 can include any number of interconnecting buses and bridges depending on the specific application of the processing circuit 1402 and overall design constraints. Bus 1410 links various circuits including one or more processors 1404 and a storage medium 1406. The storage medium 1406 can include memory devices and mass storage devices and is also referred to herein as a computer-readable medium and / or a processor-readable medium. Bus 1410 can also link various other circuits such as a timing source, a timer, peripherals, a voltage regulator, and a power management circuit. The bus interface 1408 can provide an interface between bus 1410 and one or more line interface circuits 1412. The line interface circuits 1412 may be provided for each networking technology supported by the processing circuit. In some cases, multiple networking technologies can share some or all of the circuits or processing modules found in the line interface circuit 1412. Each line interface circuit 1412 provides means for communicating with various other devices via a transmission medium. Also, depending on the nature of the device 1400, a user interface 1418 (e.g., keypad, display, speaker, microphone, joystick) can also be provided and communicatively coupled directly to bus 1410 or via bus interface 1408.

[0069] The processor 1404 can be responsible for managing the bus 1410 and overall processing including the execution of software stored in a computer-readable medium including the storage medium 1406. In this regard, the processing circuitry 1402 including the processor 1404 can be used to implement any of the methods, functions, and techniques disclosed herein. The storage medium 1406 can be used to store data that is manipulated by the processor 1404 during the execution of software, and the software can be configured to execute any one of the methods disclosed herein.

[0070] One or more processors 1404 of the processing circuit 1402 can execute software. Software is broadly interpreted as meaning instructions, instruction sets, code, code segments, program code, programs, subprograms, software modules, applications, software applications, software packages, routines, subroutines, objects, executable files, execution threads, procedures, functions, algorithms, etc., whether called software, firmware, middleware, microcode, hardware description language, or the like. The software may be present in the storage medium 1406 in a computer-readable form or may be present in an external computer-readable storage medium. The external computer-readable storage medium can include a non-transitory computer-readable storage medium. Non-transitory computer-readable storage media can include, for example, magnetic storage devices (e.g., hard disks, floppy disks, magnetic strips), optical disks (e.g., compact discs (CDs), digital versatile discs (DVDs)), smart cards, flash memory devices (e.g., "flash drives", cards, sticks, key drives), random access memory (RAM), read-only memory (ROM), programmable ROM (PROM), erasable PROM (EPROM), electrically erasable PROM (EEPROM), registers, removable disks, and any other suitable medium for storing software and / or instructions that can be accessed and read by a computer. Also, the computer-readable storage medium and / or other storage medium 1406 can include, for example, carrier waves, transmission lines, and any other suitable medium for transmitting software and / or instructions that can be accessed and read by a computer. The computer-readable storage medium and / or storage medium 1406 may be present within the processing circuit 1402, within the processor 1404, external to the processing circuit 1402, or distributed among a plurality of entities including the processing circuit 1402.The computer-readable memory medium and / or other memory medium 1406 may be embodied in a computer program product. As an example, the computer program product can include a computer-readable medium within a package material. Those skilled in the art will recognize the best way to implement the described functionality presented throughout this disclosure in light of the particular application and overall design constraints imposed on the overall system.

[0071] The memory medium 1406 can maintain software maintained and / or organized in loadable code segments, modules, applications, programs, etc., also referred to herein as software modules 1416. Each of the software modules 1416 can include instructions and data that, when installed or loaded into the processing circuitry 1402 and executed by one or more processors 1404, contribute to a runtime image 1414 that controls the operation of the one or more processors 1404. Specific instructions, when executed, can cause the processing circuitry 1402 to perform functions in accordance with the specific methods, algorithms, and processes described herein.

[0072] Some of the software modules 1416 may be loaded during the initialization of the processing circuit 1402, and those software modules 1416 can configure the processing circuit 1402 to enable the execution of various functions disclosed herein. For example, some software modules 1416 can configure the internal devices and / or logic circuits 1422 of the processor 1404 and can manage access to external devices such as the line interface circuit 1412, the bus interface 1408, the user interface 1418, the timer, and the numeric coprocessor. The software modules 1416 can include control programs and / or operating systems that interact with interrupt handlers and device drivers and control access to various resources provided by the processing circuit 1402. The resources can include memory, processing time, access to the line interface circuit 1412, the user interface 1418, and the like.

[0073] One or more processors 1404 of the processing circuit 1402 are multifunctional, whereby some of the software modules 1416 are loaded and configured to execute different functions or different instances of the same function. Further, the one or more processors 1404 may be adapted to manage background tasks, for example, initiated in response to input from the user interface 1418, the line interface circuit 1412, and the device driver. To support the execution of multiple functions, the one or more processors 1404 may be configured to provide a multitasking environment, whereby each of the multiple functions is implemented as a set of tasks provided by the one or more processors 1404 as needed. In one example, the multitasking environment may be implemented using a time-sharing program 1420 that transfers control of the processor 1404 between different tasks, whereby each task returns control of the one or more processors 1404 to the time-sharing program 1420 upon completion of the outstanding operation and / or in response to an input such as an interruption. When a task has control of the one or more processors 1404, the processing circuit is effectively specialized for the purpose addressed by the functions associated with the control task. The time-sharing program 1420 can include an operating system, a main loop that transfers control on a round-robin basis, a function that assigns control of the one or more processors 1404 according to the priority of the functions, and / or an interrupt-driven main loop that responds to external events by providing control of the one or more processors 1404 to the processing function.

[0074] In one embodiment, the memory medium 1406 provides a non-transitory processor-readable memory medium that, when executed, has code that causes the processing circuitry 1402 to receive or generate a three-dimensional model or scan indicative of an anatomical feature to be repaired, and the code can be received by a manufacturing system. The three-dimensional model can be generated using a measurement system, a scanning system, an imaging system, and / or a processing system. The code can cause the processing circuitry 1402 to generate a simulated membrane using the three-dimensional model or scan, and the simulated membrane can be configured to cover the anatomical feature to be repaired. The code can cause the processing circuitry 1402 to manufacture a device to match the physical structure of the simulated membrane. The code can cause the processing circuitry 1402 to generate a drilling template for making one or more holes in the device for use in fixing the device to bone adjacent to the anatomical feature to be repaired. In some examples, the manufacturing system can use the drilling template generated from the three-dimensional model to make holes.

[0075] The code can cause the processing circuitry 1402 to generate a digital two-dimensional flattened version of the simulated membrane and generate a 3D printed or milled trimming guide that includes an opening corresponding to the flattened version of the simulated membrane. The code can cause the processing circuitry 1402 to use the trimming guide to trim a pre-manufactured membrane. The code can cause the processing circuitry 1402 to select a pre-manufactured membrane from a catalog of membranes based on the suitability of the pre-manufactured membrane to the size and shape of the flattened version of the simulated membrane and cause the trimming guide to provide a cutout configured to hold the pre-manufactured membrane. The pre-manufactured membrane may be cut or marked through the opening while the pre-manufactured membrane is held in the cutout.

[0076] In one example, a manufacturing system can manufacture a device by manufacturing a template corresponding to a simulated film and cutting a pre-manufactured film according to the template to obtain the device. In another example, a manufacturing system can manufacture a device by using template information obtained from a simulated film to print at least one layer of material and joining at least one layer of material to one or more other layers of material to obtain the device. The manufacturing system can optionally include a 3D printer.

[0077] In one example, a manufacturing system can generate a two-dimensional flattened version of a simulated film, generate a trimming guide that includes an opening corresponding to the flattened version of the simulated film, and use the trimming guide to trim a pre-manufactured film. The manufacturing system can select a pre-manufactured film from a catalog of films based on the suitability of the size and shape of the flattened version of the simulated film, provide a cutout in the trimming guide, and mark or cut the pre-manufactured film through the opening while the pre-manufactured film is held in the cutout. The cutout can be configured to hold the pre-manufactured film.

[0078] In some examples, a manufacturing system can manufacture a device, or a component of a device, that includes a first layer configured to contact bone and including ePTFE and a second layer including high-density cell-occlusive PTFE configured to substantially prevent fibrous connective tissue from growing into a bone defect. The device can include at least one layer having collagen, a bioabsorbable polymer, animal tissue, or human tissue.

[0079] In one example, the device has a size, density, or spacing defined by a simulated membrane and calculated by a modeling system based on one or more properties of the materials included in the finished device, the thickness of the finished device, or the size of the finished device.

[0080] In a particular example, the reinforcement binder is configured to attach the device to bone adjacent to the anatomical feature to be repaired. The reinforcement binder can include a plurality of elongated members extending from the junction, including a first elongated member having a free end extending away from the junction. The reinforcement binder can include a hole formed in the first elongated member, the hole being configured to receive a fastener that holds the device in place at the bone defect through a first layer and a second layer of the device. The fastener can include a pin, staple, suture, or screw. The reinforcement binder can be disposed between a first layer and a second layer of the device. The reinforcement binder can be composed of titanium. One or more holes of the device may be drilled using a drilling template generated using a three-dimensional model.

[0081] In some cases, the membrane can be manufactured by generating a template corresponding to the simulation and cutting a pre-manufactured membrane according to the template to obtain the membrane. The manufacture of the membrane can include printing one or more layers of material using information obtained from the simulation and joining one or more layers of material to obtain the membrane.

[0082] In another embodiment, the memory medium 1406 is configured to have code that, when executed, causes the processing circuit 1402 to receive a three-dimensional representation that simulates the anatomical feature to be repaired, generate one or more templates and / or control codes used to control or enable the manufacture of a membrane that matches the physical structure of the simulation, and generate code that generates one or more templates and / or control codes used to control a machine that makes one or more holes in the membrane to secure the membrane to the bone adjacent to the anatomical feature to be repaired. The three-dimensional representation can include a simulation of a membrane configured to cover the anatomical feature to be repaired.

[0083] The membrane can have a first layer configured to contact the bone, the first layer including ePTFE, and a second layer including high-density cell-occlusive PTFE configured to substantially prevent fibrous connective tissue from growing into the bone defect. The membrane can include at least one layer having collagen, a bioabsorbable polymer, animal tissue, or human tissue. The size, density, or spacing defined by the simulation can be calculated by the modeling system based on one or more properties of the material included in the membrane, the thickness of the membrane, or the size of the membrane.

[0084] The membrane can include a reinforcing binder configured to couple the membrane to the bone adjacent to the anatomical feature to be repaired. The reinforcing binder can comprise a plurality of elongated members extending from a junction, the plurality of elongated members including a first elongated member having a free end extending away from the junction. The reinforcing binder can have holes formed in the first elongated member, the holes being configured to receive fasteners that hold the membrane in place in the bone defect through the first layer and the second layer of the membrane. The fastener can be a pin, a staple, a suture, or a screw. The reinforcing binder can be disposed between the first layer and the second layer of the membrane. The reinforcing binder can be a titanium reinforcing binder.

[0085] The processor-readable storage medium can be configured to comprise code that causes the processing circuit 1402 to generate a template corresponding to the simulation, and can provide an instruction to the cutting device to cut a pre-manufactured film according to the template to obtain a film. The processor-readable storage medium may be configured to comprise code that causes the processing circuit 1402 to print one or more layers of a material using information obtained from the simulation and bond one or more layers of the material to obtain a film.

[0086] In another embodiment, the memory medium 1406, when executed, causes the processing circuitry 1402 to receive a three-dimensional digital model or scan indicative of the anatomical feature to be repaired, generate a simulated membrane using the 3D model, and generate a digital two-dimensional (2D) flattened version of the simulated membrane. The simulated membrane may be configured to cover the anatomical feature to be repaired. The processor-readable storage medium is configured to cause the processing circuitry 1402 to generate code or instructions that cause a 3D printer or milling device to manufacture a trimming guide that includes an aperture corresponding to the flattened version of the simulated membrane and further includes a cutout configured to hold a premanufactured membrane. The trimming guide can be used as a guide to mark or cut the premanufactured membrane through the aperture while the premanufactured membrane is held in the cutout. The processor-readable storage medium may be configured to include code that causes the processing circuitry 1402 to generate a drilling template for drilling one or more holes in the premanufactured membrane after trimming, the holes being configured to secure a device to bone adjacent the anatomical feature to be repaired. The processor-readable storage medium may be configured to include code that causes the processing circuitry 1402 to select a premanufactured membrane from a catalog of membranes based on the suitability of the premanufactured membrane for the size and shape of the flattened version of the simulated membrane. The processor-readable storage medium may be configured to include code that causes the processing circuitry 1402 to receive a three-dimensional digital model or scan indicative of the anatomical feature to be repaired.

[0087] The systems and methods of the present disclosure are described in detail for the purpose of explanation based on what is currently considered to be the most practical and preferred embodiments, but such details are for that purpose only, and the present disclosure is not limited to the disclosed embodiments, and it should be understood that modifications and equivalent configurations within the spirit and scope of the appended claims are intended to be included. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. A method for manufacturing a device configured to induce bone and tissue regeneration, comprising: receiving, by a processing circuit, a three-dimensional digital model or scan showing an anatomical feature including a defect to be repaired; modifying, by the processing circuit, the three-dimensional digital model to simulate the effect of adding a filling material to the defect; generating, by the processing circuit, a simulated membrane using the three-dimensional model or scan, the simulated membrane being configured to cover the anatomical feature to be repaired and the filling material; manufacturing, by the processing circuit, the device to match the physical structure of the simulated membrane; generating, by the processing circuit, a drilling template for making one or more holes in the device for use in fixing the device to bone adjacent to the anatomical feature to be repaired.

2. The method according to claim 1, wherein modifying the three-dimensional digital model includes reproducing the properties and attributes of autologous bone, allografts, xenografts or particulate particles of bioabsorbable hydroxyapatite.

3. The method according to claim 1, further comprising: generating, by the processing circuit, a digital two-dimensional flattened version of the simulated membrane; creating, by the processing circuit, a 3D printed or milled trimming guide including an opening corresponding to the flattened version of the simulated membrane; trimming, by the processing circuit, a pre-manufactured membrane using the trimming guide.

4. The method according to claim 3, further comprising: selecting, by the processing circuit, a pre-manufactured membrane from a catalog of membranes based on the suitability of the size and shape of the flattened version of the simulated membrane; providing, by the processing circuit, a cutout in the trimming guide, the cutout being configured to hold the pre-manufactured membrane; marking or cutting, by the processing circuit, the pre-manufactured membrane through the opening while the pre-manufactured membrane is held in the cutout.

5. The method according to claim 1, wherein Manufacturing the device comprises embossing the device in a pattern selected based on the type, size, and composition of the filling material, a method characterized by that. **Claim 6** In the method according to claim 1, manufacturing the device comprises printing or cutting at least one layer of material using template information obtained from a simulated membrane, and joining at least one layer of the material to one or more other layers of the material to obtain the device, a method characterized by that. **Claim 7** In the method according to claim 1, the device is a first layer configured to contact bone, the first layer comprising expanded polytetrafluoroethylene (ePTFE), and a second layer comprising high-density cell-occluding polytetrafluoroethylene (PTFE) configured to substantially prevent fibrous connective tissue from growing into the bone defect, a method characterized by that. **Claim 8** In the method according to claim 1, the device comprises at least one layer having collagen, a bioabsorbable polymer, animal tissue, or human tissue, a method characterized by that. **Claim 9** In the method according to claim 1, one or more of the size, density, or spacing defined by the simulated membrane are configured such that the device exerts a maximum or minimum pressure on the filling material applied to the defect, a method characterized by that. **Claim 10** In the method according to claim 1, further, the manufacturing system comprises attaching a reinforcement binder to the device for attachment to bone adjacent to the anatomical feature to be repaired, a method characterized by that. **Claim 11** In the method according to claim 10, the reinforcement binder comprises a plurality of elongated members extending from a junction, the plurality of elongated members including a first elongated member having a free end extending away from the junction, a hole formed in the first elongated member is configured to receive a fastener that holds the device in place in the bone defect through a first layer of the device and a second layer of the device, the fastener including a pin, staple, suture, or screw, a method characterized by that. **Claim 12** In the method according to claim 10, A method, characterized in that the reinforcing binder is a titanium reinforcing binder and is disposed between a first layer and a second layer of the device.

13. A processor-readable storage medium configured to have code, wherein when the code is executed by a processor, the processor receives a three-dimensional digital model showing an anatomical feature including a defect to be repaired; modifies the three-dimensional digital model to simulate the effect of adding a filling material to the defect; generates a simulated membrane using the three-dimensional model, the simulated membrane being configured to cover the anatomical feature to be repaired and the filling material; generates a digital two-dimensional flattened version of the simulated membrane; generates code or instructions configured to cause a three-dimensional printer (3D printer) or a milling device to manufacture a trimming guide, the trimming guide including an opening corresponding to the flattened version of the simulated membrane and further including a cutout configured to hold a pre-manufactured membrane; the trimming guide being operable as a guide for marking or cutting the pre-manufactured membrane through the opening while the pre-manufactured membrane is held in the cutout; A processor-readable storage medium, characterized in that a digital two-dimensional flattened version of the simulated membrane is used to manufacture a device that matches the physical structure of the simulated membrane.

14. In the processor-readable storage medium according to claim 13, the processor is further configured to include code for generating a drilling template for drilling one or more holes in the pre-manufactured membrane after trimming, the holes being configured to fix the device to bone adjacent to the anatomical feature to be repaired.

15. In the processor-readable storage medium according to claim 13, A processor-readable storage medium, further configured to cause the processor to select a pre-fabricated film from a film catalog based on the compatibility of the size and shape of the flattened version of the simulated film.

16. The processor-readable storage medium according to claim 13, A processor-readable storage medium, further configured to cause the processor to include code for reproducing the characteristics and attributes of the filling material.

17. The processor-readable storage medium according to claim 16, A processor-readable storage medium, wherein the filling material includes particulate particles of autologous bone, allograft, xenograft, or bioabsorbable hydroxyapatite.

18. The processor-readable storage medium according to claim 13, further configured to cause the processor to include code for embossing the surface of the device in a pattern selected based on the type, size, and composition of the filling material.

19. The processor-readable storage medium according to claim 13, A processor-readable storage medium, further configured to cause the processor to include code for printing or cutting a plurality of layers from one or more materials using template information obtained from a simulated film, and joining the plurality of layers to obtain the device.

20. The processor-readable storage medium according to claim 13, A processor-readable storage medium, wherein the device includes a first layer configured to contact bone, the first layer including expanded polytetrafluoroethylene (ePTFE), and a second layer including high-density cell-occluding polytetrafluoroethylene (PTFE) configured to substantially prevent fibrous connective tissue from growing into the bone defect.

21. The processor-readable storage medium according to claim 13, A processor-readable storage medium, wherein the device includes at least one layer having collagen, a bioabsorbable polymer, animal tissue, or human tissue.

22. The processor-readable storage medium according to claim 13, A processor-readable storage medium, further configured to comprise code that causes the processor to form a simulated membrane in dimensions configured such that the device exerts a maximum or minimum pressure on the filling material applied to the defect.

23. The processor-readable storage medium according to claim 13, wherein the device is further configured to be attached to bone adjacent to an anatomical feature to be repaired using a reinforcing binder. A processor-readable storage medium, characterized in that it is further configured as such.

24. The processor-readable storage medium according to claim 23, wherein the reinforcing binder comprises a plurality of elongated members extending from a joint, the plurality of elongated members including a first elongated member having a free end extending away from the joint, a hole formed in the first elongated member being configured to receive a fastener that holds the device in place at the bone defect through a first layer of the device and a second layer of the device, the fastener including a pin, a staple, a suture or a screw. A processor-readable storage medium, characterized in that it is configured as such.

25. The processor-readable storage medium according to claim 23, wherein the reinforcing binder is a titanium reinforcing binder and is disposed between a first layer of the device and a second layer of the device. A processor-readable storage medium, characterized in that it is configured as such.

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