阅读说明：本技术 用于脊柱植入物的系统和制造方法 (System and method for manufacturing spinal implant ) 是由 D·A·坦普科 于 2019-02-05 设计创作，主要内容包括：一种构建板系统包含限定至少一个空腔的主体。插入件的大小和形状设计成适合装配在所述至少一个空腔内,以使所述至少一个空腔将所述插入件定向成通过使用增材制造设备的制造方法在其上形成螺钉轴的至少一部分。在一些实施例中,公开了系统、脊柱构建体、外科手术器械和方法。(A build plate system includes a body defining at least one cavity. The insert is sized and shaped to fit within the at least one cavity such that the at least one cavity orients the insert to form at least a portion of a bolt shaft thereon using a manufacturing method of the additive manufacturing apparatus. In some embodiments, systems, spinal constructs, surgical instruments, and methods are disclosed.)

1. A build plate system comprising:

a body defining at least one cavity, an

An insert sized and shaped to fit within the at least one cavity such that the at least one cavity orients the insert to form at least a portion of a bolt shaft thereon using a manufacturing method of an additive manufacturing apparatus.

2. The build plate of claim 1, wherein the insert is separate from and attachable to a surface.

3. The build plate of claim 1, wherein the insert is removable from the surface.

4. The build plate of claim 1, wherein the cavity comprises a pocket extending a depth within the body.

5. A build plate as recited in claim 1, wherein the cavity comprises a plurality of spaced apart pockets.

6. The build plate of claim 1, wherein the cavity comprises a plurality of pockets oriented in rows along the surface.

7. The build plate of claim 1, wherein the surface comprises a plurality of connecting segments.

8. The build plate of claim 1, wherein the at least one cavity is selectively oriented to control distal portion thread formation, material deposition timing, and/or material heating.

9. The build plate of claim 1, wherein the surface comprises a planar surface configured as a powder bed of the additive manufacturing apparatus.

10. The build plate of claim 1, wherein the additive manufacturing apparatus comprises a housing defining a working chamber configured to receive the body.

11. The build plate of claim 10, wherein the surface is movable in a plurality of directions relative to the housing.

12. A build plate in accordance with claim 10, wherein the additive manufacturing apparatus comprises a processor that controls movement of the surface relative to the housing in operation of the apparatus.

13. The build plate of claim 1, wherein the insert includes a distal face disposed in a flush orientation with a planar surface of the surface when the method of manufacturing is performed.

14. The build plate of claim 1, wherein the insert comprises a distal face having a planar configuration.

15. The build plate of claim 1, wherein the insert includes a distal face having an angled configuration.

16. A method of manufacturing a bone screw, the method comprising the steps of:

disposing a build plate within a working chamber of an additive manufacturing apparatus, the plate comprising at least one cavity;

orienting an insert within the at least one cavity such that the at least one cavity orients the insert to form at least a portion of a bolt shaft thereon based on the selected configuration parameters using the additive manufacturing apparatus; and

forming the at least a portion of the bolt shaft by adding material layer by layer.

17. The method of claim 16, wherein the additive manufacturing apparatus includes a laser device that melts the material into a selected three-dimensional shape that forms the at least a portion of the bolt shaft.

18. The method of claim 16, wherein the forming step includes: the at least one cavity orients the insert to selectively laser melt the material onto the insert using a powder bed process to form the at least a portion of the screw.

19. An additive manufacturing apparatus comprising:

a housing defining a working chamber;

a laser device; and

a build plate disposed in the work chamber, the plate defining at least one cavity, an

An insert sized and shaped to fit within the at least one cavity such that the at least one cavity orients the insert to form at least a portion of a bolt shaft thereon by selective laser melting of a material onto the insert to form the at least a portion of the bolt shaft by a powder bed process.

20. The additive manufacturing apparatus of claim 19, wherein the plate comprises a plurality of connecting sections, each of the sections comprising at least one cavity configured to receive an insert.

Technical Field

The present disclosure relates generally to medical devices for treating spinal disorders, and more particularly, to a spinal implant system having a spinal implant manufactured by a method that includes additive manufacturing techniques.

Background

Spinal pathologies and disorders such as scoliosis, kyphosis and other curvature abnormalities, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, tumors, and fractures may result from factors such as trauma, disease, and degenerative conditions resulting from injury and aging. Spinal disorders often result in symptoms that include deformity, pain, nerve damage, and partial or complete loss of mobility.

Non-surgical treatments such as drug therapy, rehabilitation, and exercise may be effective, but may not alleviate the symptoms associated with these conditions. Surgical treatment of these spinal disorders includes orthotics, fusion, fixation, discectomy, laminectomy, and implantable repair. As part of these surgical treatments, spinal constructs containing bone fasteners are often used to provide stability to the treated area. Such bone fasteners have traditionally been manufactured using medical machining techniques. The present disclosure describes improvements over these prior art techniques.

Disclosure of Invention

In one embodiment, a build plate system is provided. The build plate system includes a body defining at least one cavity. The insert is sized and shaped to fit within the at least one cavity such that the at least one cavity orients the insert to form at least a portion of a bolt shaft thereon using a manufacturing method of the additive manufacturing apparatus. In some embodiments, systems, spinal constructs, spinal implants, surgical instruments, and methods are disclosed.

In one embodiment, a method of manufacturing a bone screw is provided. The method comprises the following steps: disposing a build plate within a working chamber of an additive manufacturing apparatus, the plate comprising at least one cavity; orienting an insert within the at least one cavity such that the at least one cavity orients the insert to form at least a portion of a bolt shaft thereon based on the selected configuration parameters using the additive manufacturing apparatus; and forming the at least a portion of the bolt shaft by adding material layer by layer.

In one embodiment, an additive manufacturing apparatus is provided. The additive manufacturing apparatus includes a housing defining a working chamber and a laser device. A build plate is disposed in the work chamber. The plate defines at least one cavity. The insert is sized and shaped to fit within the at least one cavity such that the at least one cavity orients the insert to form at least a portion of the bolt shaft thereon by selective laser melting of a material onto the insert to form the at least a portion of the bolt shaft by a powder bed process.

Drawings

The present disclosure will become more apparent from the detailed description set forth below when taken in conjunction with the drawings.

FIG. 1 is a side view of components of one embodiment of a system according to the principles of the present disclosure;

FIG. 2 is a side view of components of the system shown in FIG. 1;

FIG. 3 is a side view of a component of the system shown in FIG. 1;

FIG. 4 is a perspective view of components of one embodiment of a system according to the principles of the present disclosure;

FIG. 5 is a side view of components of one embodiment of a system according to the principles of the present disclosure;

FIG. 6 is a side view of components of one embodiment of a system according to the principles of the present disclosure;

FIG. 7 is a side view of components of one embodiment of a system according to the principles of the present disclosure;

FIG. 8 is a flowchart illustrating representative steps for manufacturing components of one embodiment of a system according to the principles of the present disclosure;

FIG. 9 is a side view of components of one embodiment of a system according to the principles of the present disclosure;

FIG. 10 is a side view of components of one embodiment of a system according to the principles of the present disclosure;

FIG. 11 is a perspective view of a separate piece of a component of one embodiment of a system according to the principles of the present disclosure;

FIG. 12 is a top perspective view of components of one embodiment of a system according to the principles of the present disclosure;

FIG. 13 is a perspective view of components of one embodiment of a system according to the principles of the present disclosure;

FIG. 14 is a partial cross-sectional side view of a component of one embodiment of a system according to the principles of the present disclosure;

FIG. 15 is a partial cross-sectional side view of a component of one embodiment of a system according to the principles of the present disclosure;

FIG. 16 is a partial cross-sectional side view of a component of one embodiment of a system according to the principles of the present disclosure;

FIG. 17 is a partial cross-sectional side view of a component of one embodiment of a system according to the principles of the present disclosure; and

fig. 18 is a partial cross-sectional side view of a component of one embodiment of a system according to the principles of the present disclosure.

Detailed Description

Exemplary embodiments of the disclosed surgical systems and associated methods of use are discussed in terms of medical devices for treating musculoskeletal disorders, and more particularly, in terms of spinal implant systems having spinal implants manufactured by methods involving a variety of manufacturing techniques. In some embodiments, a spinal implant system includes a spinal implant that includes bone screws that include a hybrid medical device. In some embodiments, the spinal implant comprises a bone screw having at least a portion manufactured by an additive manufacturing technique.

In some embodiments, spinal implant systems of the present disclosure include spinal implants, surgical instruments, and/or medical devices manufactured using the manufacturing systems in conjunction with manufacturing methods that include one or more additive manufacturing features and materials and/or one or more conventional manufacturing features and materials. In some embodiments, the manufacturing system includes as a portion thereof, for example, a build plate used in conjunction with additive molding techniques. In some embodiments, the build plate comprises an additive manufacturing build plate. In some embodiments, the build plate comprises an insert. In some embodiments, the inserts are disposed through one or more cavities of a build plate and are oriented to form at least a portion of a spinal implant, surgical instrument, and/or medical device thereon by a manufacturing process that includes an additive manufacturing apparatus. In some embodiments, the build plate comprises one or more pockets and/or recesses configured for receiving inserts.

In some embodiments, the manufacturing system of the present invention includes modular build plates for powder melt bed additive manufacturing. In some embodiments, the build plate is modular such that at least a portion of the spinal implant, surgical instrument, and/or medical device is connected to an insert in the build plate. This configuration avoids having to directly attach a portion of the spinal implant, surgical instrument, and/or medical device to the build plate. In some embodiments, a manufacturing system includes a build plate for use in power melt bed additive manufacturing, wherein a spinal implant, surgical instrument, and/or medical device is melted onto an insert of the build plate. In some embodiments, this configuration avoids having to remove the entire plate from the additive manufacturing machine. In some embodiments, after additive manufacturing, the insert may be removed from the build plate and the spinal implant, surgical instrument, and/or medical device separated from the insert. In some embodiments, the spinal implant, surgical instrument, and/or medical device are coupled to the insert, for example, by a friction fit, press fit, threaded engagement, fusion, bolting, clamp, screw, and/or dovetail configuration mechanism. In some embodiments, a portion of a spinal implant, surgical instrument, and/or medical device is formed and/or manufactured from an insert. In some embodiments, the spinal implant, surgical instrument, and/or medical device may be removed from and/or separated from the insert by, for example, manual disengagement to overcome a friction fit, manual disengagement to overcome a press fit, unscrewing, snapping, chemically reacting, bolting off, sawing, electrical discharge machining (wire cutting), or other methods.

In some embodiments, the manufacturing system of the present invention includes inserts that are attachable to the build plate and allow for quick and efficient removal of spinal implants, surgical instruments, and/or medical devices from the build plate individually, in groups, and/or in series. In some embodiments, the insert may be made of various shapes, such as circular, rectangular, or square. In some embodiments, the insert may be precisely ground to a configuration flush with the top surface of the build plate. In some embodiments, the insert may be attached to the build plate and secured to the build plate, for example, by friction fit, press fit, threaded engagement, fusing, bolting, clamps, screws, and/or dovetail configured mechanisms.

In some embodiments, the manufacturing system of the present invention improves the efficiency of manufacturing spinal implants, surgical instruments, and/or medical devices. In some embodiments, the manufacturing system of the present invention increases safety and reduces the risk of injury to the operator by eliminating the need to remove the entire build plate from the additive manufacturing machine to remove the manufactured spinal implant, surgical instrument, and/or medical device. In some embodiments, the manufacturing system of the present invention reduces and/or eliminates the surface reprocessing costs of build plates. In some embodiments, the insert may be surface retreated and/or filled.

In some embodiments, spinal implant systems of the present disclosure include spinal implants, surgical instruments, and/or medical devices having hybrid configurations that incorporate, for example, one or more conventional manufacturing features and materials and, for example, one or more additive manufacturing features and materials. In some embodiments, the additive manufacturing comprises 3D printing. In some embodiments, additive manufacturing includes fused deposition modeling, selective laser sintering, direct metal laser sintering, selective laser melting, electron beam melting, layered object manufacturing, and stereolithography. In some embodiments, additive manufacturing includes rapid prototyping, desktop manufacturing, direct digital manufacturing, just-in-time manufacturing, and on-demand manufacturing. In some embodiments, the spinal implant systems of the present disclosure include spinal implants, such as bone screws manufactured by additive manufacturing methods.

In some embodiments, bone screws are manufactured by applying an additive manufacturing material in areas of the bone screw that may benefit from the materials and properties of the additive manufacturing. In some embodiments, the bone screw is manufactured by additive manufacturing such that a distal portion of the bone screw is manufactured by additive manufacturing while the insert described herein comprises a proximal portion of the bone screw. In some embodiments, the proximal portion of the bone screw is manufactured and/or separated from the insert by conventional methods and materials, such as subtractive manufacturing. In some embodiments, the proximal portion is manufactured by forging or from other materials having enhanced physical properties relative to the additive material. In some embodiments, creating the distal portion of a bone screw using additive manufacturing may provide an in-bone growth surface along with complex internal and external features.

In some embodiments, the manufacturing system of the present disclosure includes additive manufacturing to manufacture spinal implants, such as hybrid bone screws that facilitate bone fixation, bone in-growth, and fastening of bone and tissue. In some embodiments, the hybrid bone screw can improve the stability of the bone screw when the distal portion is engaged with tissue. In some embodiments, the bone screws may be placed through tissue in a cantilevered configuration that supports the load on the hybrid bone screws in an evenly distributed manner. For example, the proximal portion of a bone screw made by conventional manufacturing methods may include strength and stability features for supporting loads, such as in connection with spinal rods. The distal portion of a bone screw manufactured by the additive manufacturing method may include fixation features, bone in-growth features, and porosity features, for example, to facilitate securing bone to tissue. In some embodiments, application of the hybrid manufacturing techniques of the present invention for producing surgical instruments allows for the addition of additive features to the surgical instruments such that the surgical instruments include selected features and/or features having complex internal geometries.

In some embodiments, the proximal portion of the bone screw is manufactured and/or separated from the insert by a manufacturing process that employs a lathe, swiss lathe, milling machine, spinning, grinding, and/or roll forming. In some embodiments, the proximal portion is positioned through the insert in conjunction with an additive forming technique, as described herein. In some embodiments, the build plate comprises one or more openings configured for seating inserts. In some embodiments, the opening is threaded to facilitate connection of the insert to the build plate. In some embodiments, the threaded surface is used to control the timing and/or heating of the thread orientation and deposition. In some embodiments, the opening is selectively shaped to facilitate connection with the insert. In some embodiments, the build plate comprises a cavity, e.g., a pocket, that is selectively shaped to facilitate connection with the insert. In some embodiments, the distal face of the insert engages one of the openings such that the distal face is disposed in a flush orientation with the surface of the build plate. In some embodiments, the proximal portion of the bone screw is disposed perpendicular to the build plate. In some embodiments, the proximal portion of the bone screw may be disposed in various orientations relative to the build plate.

In some embodiments, the method of manufacturing a distal portion of a bone screw comprises the step of connecting an insert comprising a proximal portion of a bone screw with a build plate. In some embodiments, the method of manufacturing the distal portion comprises the step of providing a heat source to heat powder deposited on a distal face of the insert comprising the proximal portion. In some embodiments, the method of making the distal portion comprises the step of leveling the powder to a consistent thickness. In some embodiments, the method of manufacturing the distal portion comprises the step of melting the powder. In some embodiments, the method of manufacturing the distal end portion comprises the step of translating the build plate, e.g., in a downward direction, to facilitate application of the additional layer of powder. In some embodiments, the method of manufacturing comprises the steps of separating the insert from the build plate and separating the bone screw from the insert.

In some embodiments, the spinal implant systems of the present disclosure include threaded pedicle screws that include a porous portion for enhancing bone fixation, bone in-growth, and bone fastening when implanted in bone. In some embodiments, the porous portion is fabricated on a distal surface of the insert containing a proximal portion of the pedicle screw. In some embodiments, the porous portion is formed by 3D printing. In some embodiments, the distal portion of the pedicle screw may contain regular or irregular needle-like protrusions and/or lattice structures and/or protrusion/depression features. In some embodiments, the material used to make the pedicle screw comprises stainless steel, titanium, cobalt chromium, polymers, silicone, biologicals, and/or tissue. In some embodiments, the pedicle screws may be manufactured using forged, cast, metal injection molded, roll formed, injection molded, and/or machined materials, as described herein. In some embodiments, the distal portion is manufactured by additive manufacturing and connected to the proximal portion. In some embodiments, the distal portion is manufactured by additive manufacturing and mechanically attached with the proximal portion by, for example, welding, screwing, gluing, and/or riveting.

In some embodiments, the spinal implants, surgical instruments, and/or medical devices of the present disclosure can be used to treat spinal disorders, such as degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumors, and bone fractures. In some embodiments, the spinal implants, surgical instruments, and/or medical devices of the present disclosure can be employed with other bone and bone related applications, including those associated with diagnosis and therapy. In some embodiments, the spinal implants, surgical instruments, and/or medical devices of the present disclosure can alternatively be used to surgically treat a patient in a prone or supine position, and/or employ various surgical approaches to the spine and in other body regions (e.g., maxillofacial and limbs), including anterior, posterior, dorsal midline, lateral, posterolateral, and/or anterolateral approaches. The spinal implants, surgical instruments, and/or medical devices of the present disclosure may also alternatively be employed in procedures to treat the lumbar, cervical, thoracic, sacral, and pelvic regions of the spine. The spinal implants, surgical instruments, and/or medical devices of the present disclosure may also be used on animals, bone models, and other inanimate substrates, for example, in training, testing, and demonstrations.

The present disclosure may be understood more readily by reference to the following detailed description of embodiments taken in conjunction with the accompanying drawings, which form a part hereof. It is to be understood that this application is not limited to the particular devices, methods, conditions or parameters described and/or illustrated herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting. In some embodiments, as used in the specification and including the appended claims, the singular forms "a," "an," and "the" include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from "about" or "approximately" one particular value, and/or to "about" or "approximately" another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. It should also be understood that all spatial references, such as horizontal, vertical, top, upper, lower, bottom, left side, and right side, are for illustrative purposes only and may vary within the scope of the present disclosure. For example, references to "upper" and "lower" are relative and are used only in relative context, and not necessarily "above" and "below".

As used in the specification, including the appended claims, "treatment" of a disease or condition refers to performing surgery, and may include administering one or more drugs to a patient (normal or abnormal human or other mammal), using an implantable device, and/or using a device for treating the disease, such as a mini-discectomy device for removing a bulge or herniated disc and/or bony spurs, in an effort to alleviate signs or symptoms of the disease or condition. Remission may occur before and after the appearance of signs or symptoms of a disease or condition. Thus, treatment includes preventing or preventing a disease or an adverse condition (e.g., preventing the occurrence of a disease in a patient who may be predisposed to the disease but has not yet been diagnosed as having the disease). In addition, treatment does not require complete relief of signs or symptoms, does not require a cure, and specifically involves surgery that has only a minor impact on the patient. Treatment may comprise inhibiting the disease, e.g. arresting its development; or relieving the disease, e.g., causing regression of the disease. For example, treatment may include reducing acute or chronic inflammation; relief of pain and reduction and induction of regrowth of new ligaments, bone and other tissues; as an aid to surgery; and/or any revision surgery. Also, unless explicitly indicated otherwise, as used in the specification and including the appended claims, the term "tissue" includes soft tissue, ligaments, tendons, cartilage and/or bone.

The following discussion includes descriptions of spinal implants, methods of manufacturing spinal implants, related components, and methods of employing surgical systems according to the principles of the present disclosure. Alternative embodiments are disclosed. Reference will now be made in detail to the exemplary embodiments of the present disclosure, examples of which are illustrated in the accompanying drawings. Turning to fig. 1-3, components of a spinal implant system 10 including a spinal implant, surgical instruments, and medical devices are shown.

The components of the spinal implant system 10 may be made of biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics, and bone materials and/or composites thereof. For example, the components of the spinal implant system 10 may be made of the following materials, either individually or collectively: such as stainless steel alloys, aluminum, commercially pure titanium, titanium alloys, grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, superelastic metal alloys (e.g., Nitinol), superelastic metals, such as GUM) Ceramics and composites thereof (such as calcium phosphates (e.g.,SKELITE^TM) Thermoplastics (e.g., Polyaryletherketones (PAEKs), including Polyetheretherketones (PEEK), Polyetherketoneketones (PEKK), and Polyetherketones (PEK), carbon-PEEK composites, PEEK-BaSO)₄Polymeric rubber, polyethylene terephthalate (PET)), fabric, silicone, polyurethane, silicone-polyurethane copolymer, polymeric rubber, polyolefin rubber, hydrogel, semi-rigid and rigid materials, elastomers, rubber, thermoplastic elastomers, thermoset elastomers, elastomer composites, rigid polymers (including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy), bone materials (including autogenous, allogeneic, xenogeneic or transgenic cortical and/or cortical spongious bone and tissue growth or differentiation factors), partially resorbable materials (e.g., composites of metal and calcium-based ceramics, composites of PEEK and resorbable polymers), fully resorbable materials (e.g., calcium-based ceramics, such as calcium phosphate, calcium oxide, Tricalcium phosphate (TCP), Hydroxyapatite (HA) -TCP, calcium sulfate, or other absorbable polymers, such as polylactide, polyglycolide, polytyrosine carbonate, polycaprolactone), and combinations thereof.

The various components of the spinal implant system 10 can have material composites comprising the above-described materials to achieve various desired characteristics, such as strength, rigidity, flexibility, compliance, biomechanical properties, durability and radiolucency or imaging preference. The components of the spinal implant system 10 may also be made of heterogeneous materials, such as a combination of two or more of the above materials, either individually or collectively. As described herein, the components of the spinal implant system 10 may be integrally formed, integrally connected, or incorporate fastening elements and/or instruments.

The spinal implant system 10 includes a spinal implant, such as a bone fastener 12, that defines a longitudinal axis X1. As described herein, the bone fastener 12 includes an elongated screw shaft 18 having a proximal end portion 14 and a distal end portion 16 made by an additive manufacturing process. In some embodiments, proximal portion 14 is manufactured as described herein and connected, such as by threaded engagement, to an insert 250 (fig. 9) that may be positioned by build plate 200 (fig. 12) of an additive manufacturing apparatus (fig. 13) in conjunction with a manufacturing method, as described herein. As part of the manufacturing process or after the manufacturing process, insert 250 may be removed from build plate 200 and bone fastener 12 separated from insert 250, as described herein. In some embodiments, insert 250 may be positioned through build plate 200, and after additive manufacturing distal portion 16, insert 250 is removed from build plate 200 and proximal portion 14 is formed and/or manufactured by conventional manufacturing methods, as described herein.

In some embodiments, the manufacturing method may include conventional machining methods, such as subtractive manufacturing methods, deformation manufacturing methods, or conversion manufacturing methods. In some embodiments, conventional manufacturing methods may include cutting, grinding, rolling, forming, die casting, forging, extruding, spinning, grinding, and/or cold working. In some embodiments, conventional manufacturing methods include forming portion 14 by a medical machining process. In some embodiments, the medical machining process may include using a Computer Numerical Control (CNC) high speed milling machine, a swiss machining device, CNC turning using real time tools, wire cutting 4 th axis, and/or Solid Works^TMCAD and Virtual Gibbs^TMAnd (5) rendering a solid model. In some embodiments, the manufacturing process used to manufacture portion 14 and/or portion 16 includes a finishing process, for example, laser marking, tumbling blasting, bead blasting, micro blasting, and/or powder blasting.

For example, the portion 14 is formed by a manufacturing process that includes feeding a straightened wire W into a machine that cuts the wire W at a specified length to form a screw blank, as shown in fig. 4, and die cutting the head of the screw blank to a selected configuration, as shown in fig. 5. The portion 14 is manufactured to include a head 20, as well as a portion of the bolt shaft 18, as shown in FIG. 2. Portion 14 extends between ends 24 and 26. The end 24 contains the head 20.

As described herein, the portion 14 includes threads 28 that are manufactured by conventional machining methods. Threads 28 extend along all or a portion of portion 14. Threads 28 are oriented through portion 14 and are positioned to engage tissue. In some embodiments, threads 28 include fine pitch features and/or shallow features to facilitate and/or enhance engagement with tissue. In some embodiments, threads 28 include a smaller thread pitch or more thread turns per axial distance to provide a more secure fixation to tissue and/or resist loosening from tissue. In some embodiments, the threads 28 comprise a greater thread pitch and an increased lead between thread turns. In some embodiments, the thread 28 is continuous along the portion 14. In some embodiments, the thread 28 is continuous along the shaft 18 by a selected method of manufacture, as described herein. In some embodiments, the threads 28 may be intermittent, staggered, discontinuous, and/or may comprise a single thread turn or a plurality of discrete threads. In some embodiments, other penetrating elements may be located on and/or manufactured with portion 14, such as nail formations, barbs, expansion elements, raised elements, ribs, and/or spikes, to facilitate engagement of portion 14 with tissue.

End 26 includes a surface 30 defining a distal end face 32. In some embodiments, surface 30 may be disposed along the length of portion 14 or at the distal-most surface of portion 14. In some embodiments, portion 14 is threaded into threaded surface 252 of insert 250 (fig. 9 and 10), and insert 250 is installed through build plate 200 (fig. 12) such that distal end face 32 extends perpendicular to axis X1, as shown in fig. 6. In some embodiments, distal face 32 may be disposed at various orientations, such as transverse and/or angled orientations, such as at acute or obtuse angles, relative to axis X1. In one embodiment, as shown in fig. 7, portion 14 is threaded into threaded surface 252 of insert 250, and insert 250 is mounted by build plate 200 such that distal end face 32 is disposed at an acute angular orientation relative to axis X1.

As shown in fig. 12 and 13 and described herein, distal face 32 is configured to provide a manufacturing platform for forming portion 16 thereon in an additive manufacturing process, as described herein, using an insert 250 secured by build plate 200 that includes proximal end portion 14. Distal face 32 has a substantially planar configuration for enabling material deposition or heating during the additive manufacturing process of portion 16 onto distal face 32. In some embodiments, all or only a portion of distal face 32 may have alternative surface configurations, e.g., angled, irregular, uniform, non-uniform, offset, staggered, tapered, arcuate, undulating, meshed, porous, semi-porous, concave, pointed, and/or textured. In some embodiments, distal face 32 may include nail formations, barbs, expansion elements, raised elements, ribs, and/or spikes, as described herein, to provide a manufacturing platform for forming portion 16 thereon in an additive manufacturing process. In some embodiments, all or only a portion of distal face 32 may have alternative cross-sectional configurations, such as oval, elliptical, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, and/or tapered.

Portion 16 is manufactured in an additive manufacturing process by disposing material M (fig. 14) on distal end face 32, as described herein. As part of the additive manufacturing process, material M is constructed and provided for manufacturing on distal end face 32 such that resulting portion 16 is fused with surface 30. In some embodiments, portion 16 is fabricated by depositing material M onto distal end face 32 one layer at a time, as described herein.

In some embodiments, additive manufacturing includes 3D printing, as described herein. In some embodiments, additive manufacturing includes fused deposition modeling, selective laser sintering, direct metal laser sintering, selective laser melting, electron beam melting, layered object manufacturing, and stereolithography. In some embodiments, additive manufacturing includes rapid prototyping, desktop manufacturing, direct digital manufacturing, just-in-time manufacturing, or on-demand manufacturing. In some embodiments, portion 16 is manufactured by additive manufacturing, and portion 16 is mechanically attached to surface 30 by, for example, welding, threading, bonding, and/or riveting, as described herein.

In one embodiment, as shown in fig. 8, one or more manufacturing methods for manufacturing distal end portion 16, proximal end portion 14, and/or other components of bone fastener 12 include imaging the patient's anatomy using imaging techniques, such as x-ray, fluoroscopy, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), surgical navigation, and/or 2D or 3D images of the patient's anatomy that are available. Selected configuration parameters of distal end portion 16, proximal end portion 14, and/or other components of bone fastener 12 are collected, calculated, and/or determined. Such configuration parameters may include one or more of patient anatomy imaging, surgical treatment, historical patient data, statistical data, treatment algorithms, implant materials, implant dimensions, porosity, and/or manufacturing methods. In some embodiments, the configuration parameters may include the implant material and porosity of distal portion 16 determined based on the patient anatomy and the surgical treatment. In some embodiments, the implant material comprises a selected porosity P of distal portion 16, as described herein. In some embodiments, the selected configuration parameters of distal end portion 16, proximal end portion 14, and/or other components of bone fastener 12 are patient-specific. In some embodiments, the selected configuration parameters of distal end portion 16, proximal end portion 14, and/or other components of bone fastener 12 are based on a common or standard configuration and/or size, rather than patient-specific. In some embodiments, the selected configuration parameters of the distal end portion 16, proximal end portion 14, and/or other components of the bone fastener 12 are based on one or more configurations and/or sizes of the components of the kit of the spinal implant system 10, rather than patient-specific.

For example, based on one or more selected configuration parameters, as described herein, digital renderings and/or data (which may include 2D or 3D digital models and/or images) of selected distal end portions 16, proximal end portions 14, and/or other components of bone fasteners 12 are collected, calculated, and/or determined, and generated for display on a graphical user interface, as described herein, and/or stored on a database attached to a computer and processor (not shown), as described herein. In some embodiments, the computer provides the ability to display and save, digitally manipulate or print a hardcopy of the digital rendering and/or data through a monitor. In some embodiments, the selected distal portion 16, proximal portion 14, and/or other components of bone fastener 12 may be virtually designed in a computer using a CAD/CAM program on a computer display. In some embodiments, a processor may execute code stored in a computer-readable memory medium to execute one or more instructions of a computer, e.g., to transmit instructions to an additive manufacturing device, e.g., a 3D printer. In some embodiments, the database and/or computer readable medium may comprise RAM, ROM, EPROM, magnetic, optical, digital, electromagnetic, flash drive, and/or semiconductor technology. In some embodiments, as described herein, the processor may instruct a motor or actuator (not shown) that controls movement (e.g., rotation) of a component of the spinal implant system 10 (e.g., the build plate 200, the insert 250, the distal end face 32, and/or the laser emitting device), including relative component movement.

In some embodiments, the components of the spinal implant system 10 may comprise one or more computer systems. In some embodiments, the components of the spinal implant system 10 may comprise a computer and server of a network having a plurality of computers connected to each other via the network, Wi-Fi, internet, including computers connected via a cloud network or in a data drop box. In some embodiments, the graphical user interface may comprise one or more display devices, such as a CRT, LCD, PDA, WebTV terminal, set-top box, cellular phone, screen phone, smart phone, iPhone, iPad, tablet, wired or wireless communication device.

The portion 14 with the thread 28 is manufactured by a manufacturing method as described herein. In conjunction with the additive forming process and manufacturing method used to manufacture distal portion 16, portion 14 is threaded into threaded surface 252 of insert 250 and the assembly of insert 250 and portion 14 is connected with section 254 of build plate 200, as shown in fig. 9-13. In some embodiments, portion 14 is coupled to insert 250, for example, by a friction fit, press fit, threaded engagement, fusion, bolting, clamping, screw, and/or dovetail configuration mechanism.

The segment 254 includes a body 202 that defines one or more openings, such as pockets 204. In various embodiments, pockets 204 are arranged in rows and spaced apart along body 202. As described herein, each pocket 204 extends a depth within body 202 and is configured for receiving an insert 250 including proximal end portion 14 to orient distal face 32 as a manufacturing platform for forming portion 16 thereon, such as in an additive manufacturing process. Distal face 32 is provided with a pocket 204 that is flush with surface 203 of body 202 to orient distal face 32 for manufacture. In various embodiments, the manufacturing process uses equipment 222 (fig. 13) and includes adding material M as a powder bed covering distal face 32 and body 202, and laser melting material M at distal face 32.

In various embodiments, the section 254 includes a plurality of threaded side openings 260, the plurality of threaded side openings 260 configured for seating screws 262. After the insert 250 containing the portion 14 is placed through the pocket 204, the screw 262 is threaded into the opening 260 to engage the insert 250 to secure the insert 250 with the segment 254. In some embodiments, insert 250 may be attached to segment 254 and secured with segment 254, for example, by friction fit, press fit, threaded engagement, fusing, bolting, clamps, screws, and/or dovetail configured mechanisms.

The build plate 200 includes one or more sections 254 oppositely disposed in a selected configuration, as shown in fig. 12. For example, the build plate 200 includes four sections 254 disposed in adjacent side-by-side relationship. As described herein, the inserts 250 are selectively oriented and configured by the segments 254 of the build plate 200 for manufacturing the selectively configured distal end portions 16 and are disposed by the working chamber 220 of the powder bed additive manufacturing apparatus 222, as shown in fig. 13. As described herein, a plurality of inserts 250 are installed through the build plate 200 to create a plurality of bone fasteners 12. The insert 250 is configured such that the distal end face 32 is flush with the surface 203 of the body 202 of the build plate 200. The housing 221 of the device 222 defines the working chamber 220.

Apparatus 222 includes a heating device, such as a laser device 224 disposed through working chamber 220, that melts material M (which includes a powder, as described herein) to form portion 16 on distal end face 32 piece-by-piece, layer-by-layer. In some embodiments, laser device 224 includes an interactive laser and optical system that generates a laser beam that is scanned over the layer of material M powder disposed on build plate 200 (fig. 13 and 15) to selectively heat the powder according to instructions received from the computer and processor based on digital rendering and/or data of the selected configuration of portion 16. Laser device 224 heats a thin layer of material M powder according to slicing data based on digital rendering or data to fabricate portion 16 layer by layer via additive manufacturing techniques. See, for example, additive manufacturing systems and methods and three-dimensional manufacturing systems and methods described in U.S. patent No. 5,204,055 and U.S. patent application publication No. 2014/0252685, the contents of each of which are incorporated herein by reference in their entirety.

In some embodiments, device 222 includes a radiation source that melts and solidifies material M disposed through distal end face 32 into a desired three-dimensional shape based on selected configuration parameters, as described herein. In some embodiments, the radiation source comprises a laser device 224 comprising a carbon dioxide laser. In some embodiments, laser device 224 may include a visible or ultraviolet beam of any wavelength. In some embodiments, the device 222 emits alternative forms of radiation, such as microwave, ultrasound, or radio frequency radiation. In some embodiments, laser device 224 is configured to focus on a portion of distal end face 32 to sinter material M deposited thereon, as shown in fig. 16. In some embodiments, the laser device 224 emits a beam of light between about 0.01mm and about 0.8mm in diameter. In some embodiments, the diameter of the light beam may be between about 0.1mm and about 0.4 mm. In some embodiments, the diameter of the beam is adjustable to tailor the intensity of the sintering.

In some embodiments, pocket 204 is oriented by plate 200 to selectively orient insert 250 containing portion 14 in conjunction with commands and instructions provided by apparatus 222 for controlling thread orientation and deposition timing as described herein and/or heating material M through distal face 32 to fabricate portion 16 according to selected configuration parameters, as described herein. For example, distal face 32 is disposed in a perpendicular orientation with respect to surface 203 and axis X1 by pocket 204, as shown in fig. 6. In some embodiments, distal face 32 may be disposed in various orientations, such as a transverse orientation and/or an angled orientation, such as an acute or obtuse angle, relative to surface 203 through pocket 204. In one embodiment, as shown in fig. 7, surface 254 is threaded into body 202, and distal end face 32 is disposed by pocket 204 at an acute angle orientation relative to axis X1. In some embodiments, portion 14 may be disposed through pocket 204 in alternative connection configurations, such as a friction fit, a press fit, a locking projection/groove, a locking keyway, and/or an adhesive.

In some embodiments, the plate 200 may be substantially non-conductive. In some embodiments, the plate 200 may be a ceramic, glass, or non-metallic substance. In some embodiments, the plate 200 may be formed of an electrically insulating material that can be used to prevent an external heat control mechanism from heating the plate 200 to a sintering temperature for forming the layer of material M.

As described herein, insert 250 containing portion 14 is mounted by section 254 for assembly with build plate 200, and build plate 200 is mounted by platform 226 of apparatus 222 such that insert 250 and/or build plate 200 can be moved in one or more directions relative to housing 221 to produce distal end portion 16 on distal face 32 layer-by-layer based on digital rendering and/or data, as shown in fig. 14. In some embodiments, one or more inserts 250 and/or build plates 200 may be translated, rotated, pivoted, raised, and/or lowered vertically, horizontally, or diagonally to create distal portion 16. In some embodiments, build plate 200 may be slidably, continuously, incrementally, intermittently, automatically, manually, selectively moved and/or moved via computer/processor control relative to housing 221. In some embodiments, apparatus 222 includes an additive manufacturing device that employs selective laser melting using a powder bed process to produce a 3D object. See, for example, Lasertec 30SLM additive manufacturing machine manufactured by seiko corporation (DMG MORI co. ltd.) located at village area namestations 2-35-16 in 450-.

In some embodiments, apparatus 222 is connected to one or more computer systems, processors, and databases to receive commands and instructions to create distal portion 16 on distal face 32 by selective laser melting with a powder bed process, as described herein. For example, as described herein, the commands and instructions are based on one or more selected configuration parameters of the selected distal portion 16 that are generated for display on a graphical user interface and/or stored on a database. In some embodiments, device 222 and/or one or more computer systems may contain a keyboard (not shown) to receive commands and instructions from a user. In some embodiments, input may also be received from another computer or any suitable computer user interface. In some embodiments, the processor receives the instructions and directs the device 222 to manufacture the portion 16 based on the received instructions.

In various embodiments, the material M powder is introduced into the working chamber 220, as shown in FIGS. 15 and 16. the apparatus 222 comprises a coating arm (not shown) that translates within the working chamber 220 to deposit a layer of the material M powder along the planar surface 228 of the plate 200. in some embodiments, the coating arm comprises a blade that performs a displacement motion to sweep and/or deposit the material M powder across the distal end face 32 and the surface 228. in some embodiments, the material M is introduced over the entire cross-section of the working chamber 220. As described herein, in various embodiments, the material M is flattened by the blade to a uniform and/or consistent thickness according to selected configuration parameters. in some embodiments, a powder bed is formed around the portion 16 by excess powder accumulated during the fabrication of each layer of the portion 16. in some embodiments, the powder bed is configured as a support material during the fabrication of the portion 16 because the configured component is always surrounded by unsintered powder.in some embodiments, the material M may comprise, for example, stainless steel, titanium, cobalt chromium, a polymer, silicone, a biologic, and/or tissue in some embodiments, the volume of 35300 mm of the material M is about 300mm 8584³. In some embodiments, a cartridge supply/collection system for material M is provided to facilitate the transport and recirculation of the powder.

Referring to fig. 15 and 16, laser device 224 focuses a laser beam onto layer M1 of material M powder disposed through surface 228. Based on the digital rendering and/or data of the selected configuration, laser device 224 heats, melts, and/or softens layer M1 in accordance with instructions received from the computer and processor to selectively heat material M powder to create a layer of portion 16. Laser device 224 is hinged relative to plate 200 such that the provided beam is focused on a selected portion of material M deposited on distal face 32. A light beam is focused onto the portion of material M on distal face 32 to melt or sinter material M into a desired shape based on selected construction parameters.

Platform 226 moves plate 200 and/or insert 250 containing portion 14 relative to housing 221. In some embodiments, a motor, actuator, and/or gear mechanism (not shown) is coupled to platform 226 and plate 200 to control movement of plate 200 and/or insert 250 relative to housing 221 in accordance with instructions received from the computer and processor, e.g., to move vertically downward to translate portion 16 during the manufacture of successive layers of portion 16, as described herein.

After one layer of portion 16 is melted, plate 200 and/or insert 250 containing portion 14 and the manufactured layer of portion 16 are translated vertically downward such that the blade moves across surface 228 to sweep/deposit another layer M2 of material M powder across distal end face 32 and the previously manufactured layer on plate 200, as shown in fig. 17. Layer M2 was leveled by the blade to a thickness according to selected construction parameters, as described herein. Laser device 224 heats, melts and/or softens layer M2 in accordance with instructions received from the computer and processor to selectively heat the material M powder to create a continuous layer of portion 16.

The portion 16 is built up layer by layer and the melting process is repeated piece by piece, layer by layer until the last layer of material M is melted and the portion 16 is complete, as shown in fig. 18. In accordance with instructions received from the computer and processor, a portion 16 is formed on distal face 32 that extends between end 40 and end 42 (FIG. 3), and end 40 is fused with surface 30. End 42 includes a distal tip 44. In some embodiments, material M is subjected to direct metal laser sinteringSelective Laser Sintering (SLS), Fused Deposition Modeling (FDM), or fuse fabrication (FFF)) Or Stereolithography (SLA).

Based on the digital rendering and/or data of the selected configuration, the portion 16 is manufactured by the additive manufacturing process described herein to include threads 46 extending between the end 40 and the distal tip 44 according to instructions received from the computer and processor. Threads 46 are formed layer by layer through the manufacture of portion 16, as described herein. Threads 46 are made to extend along all or a portion of portion 16. In some embodiments, threads 46 are fabricated to include fine pitch features and/or shallow features to facilitate and/or enhance engagement with tissue. In some embodiments, threads 46 are made to contain a greater thread pitch and increased lead between thread turns than threads 28, as shown in FIG. 1. In some embodiments, threads 46 are fabricated to include a smaller thread pitch or more thread turns per axial distance than threads 28 to provide a more secure fixation to tissue and/or resist loosening from tissue. In some embodiments, threads 46 are made continuous along portion 16. In some embodiments, the threads 46 are made to be intermittent, staggered, discontinuous, and/or may comprise a single thread turn or a plurality of discrete threads. In some embodiments, portion 16 is configured to contain penetrating elements, such as nail formations, barbs, expansion elements, raised elements, ribs, and/or spikes. In some embodiments, the threads 46 are made to be self-tapping or intermittent at the distal tip 44. In some embodiments, distal tip 44 may be rounded. In some embodiments, distal tip 44 may be self-drilling.

As described herein, each insert 250 is disengaged from a respective section 254 of the plate 200 individually, continuously, or in groups after the portion 16 is manufactured by the additive manufacturing method. For example, the screw 262 is unscrewed from the opening 260, and the insert 250 is removed from the pocket 204. As described herein, portion 14 is separated and removed from insert 250 by unscrewing and/or manufacturing processes such as wire cutting and/or conventional manufacturing methods to provide bone fastener 12. In some embodiments, the portion 14 is separated and removed from the insert 250 by, for example, manual disengagement to overcome a friction fit, manual disengagement to overcome a press fit, snapping, chemical reaction, and/or sawing. In some embodiments, insert 250 is removed from build plate 200, and proximal portion 14 is formed and/or manufactured from insert 250 by conventional methods as described herein. In some embodiments, portion 14 and/or portion 16 are subjected to a finishing treatment, such as laser marking, tumbling blasting, bead blasting, micro blasting, and/or powder blasting. In some embodiments, the additive manufacturing method may include a 3D print head. In some embodiments, the additive manufacturing method may include a temperature control unit, such as a heating unit or a cooling unit, for controlling the temperature of the distal end face 32. In some embodiments, the computer and processor provide instructions for coordinating the simultaneous and/or orderly movement of the components of the plate 200, insert 250, distal face 32, laser device 224, apparatus 222, and/or the introduction and layering of the material M powder.

In some embodiments, the portion 16 is fabricated in a configuration having a porosity P by an additive manufacturing method, as described herein. In some embodiments, portion 16 is fabricated with porosity P by using spherical, cubic, rectangular, elongated, tubular, fibrous, disk-like, sheet-like, polygonal, or hybrid porogens thereof. In some embodiments, the porosity of portion 16 is based on a plurality of macroporous structures, microporous structures, nanoporous structures, and/or combinations thereof.

In some embodiments, the porogen is configured to diffuse, dissolve, and/or degrade after implantation into portion 16, leaving behind pores. Porogens may be a gas (e.g., carbon dioxide, nitrogen, argon, or air), a liquid (e.g., water, hemolymph, plasma, serum, or bone marrow), or a solid (e.g., crystalline salts, sugars). Porogens may be water-soluble chemical compounds, such as carbohydrates (e.g., polydextrose, dextran), salts, polymers (e.g., polyvinylpyrrolidone), proteins (e.g., gelatin), pharmaceutical agents (e.g., antibiotics), or small molecules. In other aspects, the porous implant comprises a polysaccharide as a porogen, which comprises cellulose, starch, amylose, dextran, poly (dextrose), glycogen, poly (vinyl pyrrolidone), pullulan, poly (glycolide), poly (lactide), and/or poly (lactide-co-glycolide). In other aspects, useful porogens include, but are not limited to, hydroxyapatite or polyethylene oxide, polylactic acid, polycaprolactone. Peptides, proteins of 50 amino acids or less, or parathyroid hormone are also useful porogens.

In some embodiments, the porous construction of portion 16 may exhibit high porosity over a wide range of effective pore sizes. In some embodiments, the porous construction of portion 16 may have both macroporosity, mesoporosity, microporosity, and nanoporosity. Macroporosity is characterized by pores having diameters greater than about 100 microns. The mesoporosity is characterized by a pore diameter of between about 100 microns and about 10 microns; and microporosity occurs when the pore diameter is less than about 10 microns. The microporous implant has pores with diameters less than 9 microns, 8 microns, 7 microns, 6 microns, 5 microns, 4 microns, 3 microns, 2 microns, and 1 micron. The nanoporosity of nanopores is characterized by pore diameters of about 1nm and below.

In some embodiments, portion 16 is made of a material having a porosity P that is created by an additive manufacturing process forming a polymeric material (e.g., a polymer) in a bed of particles that are insoluble in the polymer and that can subsequently be leached by a non-solvent of the polymer, as described herein. In this case the polymer forming part 16 is printed onto a bed of particles such as salt, sugar or polyethylene oxide. After the additive manufacturing process is completed, the portion 16 is removed from the powder bed and placed in a non-solvent for dissolving the implant material of the particles. For example, polylactic acid in chloroform can be 3D printed onto a bed of sugar particles, and then the sugar can be leached out with water.

In some embodiments, portion 16 is made of a material having a porosity P that is created by printing a solution containing the implant material onto a heated bed of polymer by an additive manufacturing process, as described herein. An example is 3D printing of polylactic acid in chloroform onto a bed of PLA granules that have been heated to 100 ℃. The boiling point of chloroform is 60 c and therefore boils when it hits the particle bed, forming a foam. This method of creating porosity is similar to 3D printing a solution containing the implant material onto a bed containing a foaming agent, which is another way to achieve porosity.

In some embodiments, the bone fastener 12 includes an implant receiver (not shown) that is connectable to the head 20. In some embodiments, bone fastener 12 may comprise various configurations, such as, for example, a post screw, a pedicle screw, a bolt, a bone screw for a side plate, an interbody screw, a monoaxial screw, a fixed angle screw, a polyaxial screw, a side-loading screw, a sagittal adjustment screw, a transverse sagittal adjustment screw, a pyramidal tip, a dual-rod polyaxial screw, a midline lumbar fusion screw, and/or a sacral bone screw. In some embodiments, the implant receiver may be attached by manual engagement and/or non-instrumented assembly, which may involve a physician, surgeon, and/or medical personnel grasping the implant receiver and shaft 18, quickly and forcefully fitting the components together. In some embodiments, the spinal implant system 10 includes a kit including a plurality of differently configured bone fasteners 12, as described herein. In some embodiments, the bone fasteners 12 are selected from the set and employed at the time of treatment at the surgical site.

It should be understood that various modifications may be made to the embodiments disclosed herein. Accordingly, the above description should not be construed as limiting, but merely as exemplifications of the various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.