US20170027624A1 - Dmls orthopedic intramedullary device and method of manufacture - Google Patents

Dmls orthopedic intramedullary device and method of manufacture Download PDF

Info

Publication number
US20170027624A1
US20170027624A1 US15/302,899 US201515302899A US2017027624A1 US 20170027624 A1 US20170027624 A1 US 20170027624A1 US 201515302899 A US201515302899 A US 201515302899A US 2017027624 A1 US2017027624 A1 US 2017027624A1
Authority
US
United States
Prior art keywords
intramedullary nail
nail
section
wall
intramedullary
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US15/302,899
Other languages
English (en)
Inventor
Darren James Wilson
David Bradford Harness
Henry Faber
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Smith and Nephew Inc
Original Assignee
Smith and Nephew Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Smith and Nephew Inc filed Critical Smith and Nephew Inc
Priority to US15/302,899 priority Critical patent/US20170027624A1/en
Assigned to SMITH & NEPHEW, INC. reassignment SMITH & NEPHEW, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: FABER, HENRY, HARNESS, DAVID B., WILSON, DARREN J.
Assigned to SMITH & NEPHEW, INC. reassignment SMITH & NEPHEW, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: FABER, HENRY, HARNESS, DAVID B., WILSON, DARREN J.
Publication of US20170027624A1 publication Critical patent/US20170027624A1/en
Abandoned legal-status Critical Current

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B22—CASTING; POWDER METALLURGY
    • B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
    • B22F10/00—Additive manufacturing of workpieces or articles from metallic powder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
    • A61B17/7216—Intramedullary pins, nails or other devices for bone lengthening or compression
    • A61B17/7225—Intramedullary pins, nails or other devices for bone lengthening or compression for bone compression
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
    • A61B17/7233—Intramedullary pins, nails or other devices with special means of locking the nail to the bone
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B22—CASTING; POWDER METALLURGY
    • B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
    • B22F10/00—Additive manufacturing of workpieces or articles from metallic powder
    • B22F10/20—Direct sintering or melting
    • B22F10/28—Powder bed fusion, e.g. selective laser melting [SLM] or electron beam melting [EBM]
    • B22F3/1055—
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B22—CASTING; POWDER METALLURGY
    • B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
    • B22F3/00—Manufacture of workpieces or articles from metallic powder characterised by the manner of compacting or sintering; Apparatus specially adapted therefor ; Presses and furnaces
    • B22F3/12—Both compacting and sintering
    • B22F3/14—Both compacting and sintering simultaneously
    • B22F3/15—Hot isostatic pressing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B22—CASTING; POWDER METALLURGY
    • B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
    • B22F5/00—Manufacture of workpieces or articles from metallic powder characterised by the special shape of the product
    • B22F5/10—Manufacture of workpieces or articles from metallic powder characterised by the special shape of the product of articles with cavities or holes, not otherwise provided for in the preceding subgroups
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
    • B23K—SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
    • B23K26/00—Working by laser beam, e.g. welding, cutting or boring
    • B23K26/08—Devices involving relative movement between laser beam and workpiece
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
    • B23K—SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
    • B23K26/00—Working by laser beam, e.g. welding, cutting or boring
    • B23K26/08—Devices involving relative movement between laser beam and workpiece
    • B23K26/10—Devices involving relative movement between laser beam and workpiece using a fixed support, i.e. involving moving the laser beam
    • B23K26/103—Devices involving relative movement between laser beam and workpiece using a fixed support, i.e. involving moving the laser beam the laser beam rotating around the fixed workpiece
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
    • B23K—SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
    • B23K26/00—Working by laser beam, e.g. welding, cutting or boring
    • B23K26/352—Working by laser beam, e.g. welding, cutting or boring for surface treatment
    • B23K26/354—Working by laser beam, e.g. welding, cutting or boring for surface treatment by melting
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B24—GRINDING; POLISHING
    • B24C—ABRASIVE OR RELATED BLASTING WITH PARTICULATE MATERIAL
    • B24C1/00—Methods for use of abrasive blasting for producing particular effects; Use of auxiliary equipment in connection with such methods
    • B24C1/08—Methods for use of abrasive blasting for producing particular effects; Use of auxiliary equipment in connection with such methods for polishing surfaces, e.g. smoothing a surface by making use of liquid-borne abrasives
    • B24C1/086—Descaling; Removing coating films
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y10/00—Processes of additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22C—ALLOYS
    • C22C14/00—Alloys based on titanium
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22F—CHANGING THE PHYSICAL STRUCTURE OF NON-FERROUS METALS AND NON-FERROUS ALLOYS
    • C22F1/00—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working
    • C22F1/16—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working of other metals or alloys based thereon
    • C22F1/18—High-melting or refractory metals or alloys based thereon
    • C22F1/183—High-melting or refractory metals or alloys based thereon of titanium or alloys based thereon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526—Methods of manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B22—CASTING; POWDER METALLURGY
    • B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
    • B22F10/00—Additive manufacturing of workpieces or articles from metallic powder
    • B22F10/30—Process control
    • B22F10/36—Process control of energy beam parameters
    • B22F10/364—Process control of energy beam parameters for post-heating, e.g. remelting
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B22—CASTING; POWDER METALLURGY
    • B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
    • B22F10/00—Additive manufacturing of workpieces or articles from metallic powder
    • B22F10/30—Process control
    • B22F10/36—Process control of energy beam parameters
    • B22F10/366—Scanning parameters, e.g. hatch distance or scanning strategy
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B22—CASTING; POWDER METALLURGY
    • B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
    • B22F10/00—Additive manufacturing of workpieces or articles from metallic powder
    • B22F10/60—Treatment of workpieces or articles after build-up
    • B22F10/64—Treatment of workpieces or articles after build-up by thermal means
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B22—CASTING; POWDER METALLURGY
    • B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
    • B22F10/00—Additive manufacturing of workpieces or articles from metallic powder
    • B22F10/60—Treatment of workpieces or articles after build-up
    • B22F10/66—Treatment of workpieces or articles after build-up by mechanical means
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B22—CASTING; POWDER METALLURGY
    • B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
    • B22F3/00—Manufacture of workpieces or articles from metallic powder characterised by the manner of compacting or sintering; Apparatus specially adapted therefor ; Presses and furnaces
    • B22F3/24—After-treatment of workpieces or articles
    • B22F2003/248—Thermal after-treatment
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B22—CASTING; POWDER METALLURGY
    • B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
    • B22F2998/00—Supplementary information concerning processes or compositions relating to powder metallurgy
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B22—CASTING; POWDER METALLURGY
    • B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
    • B22F2998/00—Supplementary information concerning processes or compositions relating to powder metallurgy
    • B22F2998/10—Processes characterised by the sequence of their steps
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
    • Y02P10/00—Technologies related to metal processing
    • Y02P10/25—Process efficiency

Definitions

  • the present invention relates generally to implants for use in orthopedic surgeries or procedures, and more particularly but not exclusively relates to an orthopedic intramedullary device, such as, for example, an orthopedic intramedullary nail, for internal fixation of a bone and a method of manufacturing the same.
  • an orthopedic intramedullary device such as, for example, an orthopedic intramedullary nail
  • Orthopedic fixation devices may be used, for example, to stabilize an injury, to support a bone fracture, to fuse a joint, and/or to correct a deformity.
  • the orthopedic fixation device may be attached permanently or temporarily, and may be attached to the bone at various locations, including implanted within a canal or other cavity of the bone, implanted beneath soft tissue and attached to an exterior surface of the bone, or disposed externally and attached by fasteners such as screws, pins, and/or wires.
  • Some orthopedic fixation devices allow the position and/or orientation of two or more bone pieces, or two or more bones, to be adjusted relative to one another.
  • Orthopedic fixation devices are generally machined or molded from isotropic materials, such as metals including, for example, titanium, titanium alloys, stainless steel, cobalt-chromium alloys, and tantalum.
  • an intramedullary (IM) nail is to stabilize the fracture fragments, and thereby enable load transfer across the fracture site while maintaining anatomical alignment of the bone.
  • the effect of altered fixation stiffness, in terms of torsion and bending, on fracture healing may provide insight into the pathogenesis and ideal treatment of fractures and non-unions.
  • similar implants are used for both simple and complex fractures. Consequently, finding a relatively optimal solution in terms of axial bending and torsional stiffness, that is closer to bone rather than titanium or stainless steel, is likely to accelerate fracture healing for a specific type of fracture.
  • An aspect of the present invention is a method for manufacturing an orthopedic device that includes forming from a medical grade powder, and via an additive manufacturing process, an additive manufactured orthopedic component. The method further includes heat treating the additive manufactured orthopedic component and machining the heat treated additive manufactured orthopedic component to form the orthopedic device.
  • an intramedullary nail that includes a wall comprising one or more laser sintered layers of a medical grade powder.
  • the wall has an outer portion and an inner portion, the inner portion generally defining an inner cannulated region of the intramedullary nail.
  • the intramedullary nail further includes an internalized channel for housing a miniaturized sensor probe that extends into at least a portion of the wall. Additionally, the internal sensor probe channel does not extend through the outer portion of the wall.
  • an aspect of the present invention is an intramedullary nail that has a first section coupled to a second section by a telescopic portion.
  • the telescopic portion has an outer diameter that sized to be slidingly received in an inner region of at least one of the first and second sections to accommodate adjustments in the relative axial positions of the first and second sections.
  • the first and second sections are structure for implantation into a bone.
  • the intramedullary nail also includes a mechanical actuator that is adapted to provide a biasing force to bias the relative axial positions of the first and second sections.
  • an intramedullary nail that includes a wall having an outer portion and an inner portion, the inner portion generally defining an inner region of the intramedullary nail.
  • the intramedullary nail further includes a first screw hole and a second screw hole, the first and second screw holes extending through at least the outer portion of the wall.
  • the intramedullary nail includes one or more protrusions in the wall between the first and second screw holes, the one or more protrusions not extending through at least the outer portion of the wall. Further, the one or more protrusions are structured to alter the torsional and flexural moduli of the intramedullary nail.
  • intramedullary nail having a first section having a wall, the wall generally defining an inner region of the first section.
  • the intramedullary nail also includes a second section that is coupled to an inner section, the inner section being sized for lateral displacement in at least a portion of the inner region of the first section. Further, the inner section is selectively detachable from the first section by a locking screw to selectively alter the mechanical properties of the intramedullary nail.
  • FIG. 1A illustrates an isometric view of a three-dimensional (3D) model of a hypothetical build program having a vertical stack of 143 nails.
  • FIG. 1B illustrates a top view of a three-dimensional (3D) model of a hypothetical build program having a vertical stack of 143 nails.
  • FIG. 1C illustrates a side view of a three-dimensional (3D) model of a hypothetical build program having a vertical stack of 143 nails
  • FIG. 2A illustrates a microscopic view of a distal mid-shaft location of a direct metal laser sintering (DMLS) intramedullary nail having 30% porosity.
  • DMLS direct metal laser sintering
  • FIG. 2B illustrates a nail fracture site at a distal location of an intramedullary nail following 4 point bend fatigue testing
  • FIG. 3A illustrates an ALM nail manufactured with minimal post-machining requirements, i.e. all design features turned on in the CAD file.
  • FIG. 3B illustrates an ALM nail manufactured with all design features turned off in the CAD file and a support structure for holding the part in the chuck of a CNC machine.
  • FIG. 3C illustrates an ALM nail manufactured with the design features turned off at the distal end in the CAD file.
  • FIG. 4 illustrates the time taken to build a nail on an SLM500, which scales approximately linearly with size (length) of nail
  • FIG. 5 illustrates a comparison of example build times for 16 test bars, including interpolation of time and cost to build 280 millimeter (mm) tall intramedullary nails using different machines.
  • FIG. 6A illustrates a perspective view of the manufacture of intramedullary nails using a vertical orientation.
  • FIG. 6B illustrates a perspective view of the manufacture of intramedullary nails using a horizontal orientation.
  • FIG. 7A illustrates a three-dimensional (3D) CAD intramedullary nail model that includes a tapered inner wall section in cross-section view.
  • FIG. 7B illustrates a three-dimensional (3D) CAD intramedullary nail model in partial phantom view and which includes a porous or channel inner structure in the wall of the intramedullary nail.
  • FIG. 7C illustrates a three-dimensional (3D) CAD intramedullary nail model in a perspective, partial cut away view that includes a detachable inner section.
  • FIG. 7D illustrates a three-dimensional (3D) CAD intramedullary nail model in a partial cutaway view that includes an internal fluted section.
  • FIG. 8 illustrates examples of optimal cross-sectional geometries for an intramedullary nail.
  • FIG. 9 illustrates a schematic representation of last sintering additive manufacturing process parameters, layer by layer, reproduced from a build carried out on a Renishaw SLM250.
  • FIG. 10A illustrates a transverse section of an intramedullary nail highlighting a batch area in the wall section that is associated with a double scan strategy.
  • FIG. 10B illustrates uni-directional X and Y scanning associated with a double scan strategy for re-melting of laser sintered layers of a build.
  • FIG. 10C illustrates multi-directional X and Y scanning associated with a double scan strategy for re-melting of a laser sintered layers of a build.
  • FIG. 10D illustrates parameters for re-melting sintered layers of a build utilizing a double scan strategy.
  • FIG. 11A illustrates a transverse section of an intramedullary nail highlighting a wall section of the intramedullary nail that is associated with an X and Y alternating hatch laser raster for a double scan strategy for re-melting of laser sintered layers of a build.
  • FIG. 11B illustrates X and Y alternating hatch laser raster associated with a double scan strategy for re-melting of laser sintered layers of a build.
  • FIG. 11C illustrates a transverse section of an intramedullary nail highlighting a wall section of the intramedullary nail that is associated with a circumferential laser raster for a double scan strategy for re-melting of laser sintered layers of a build.
  • FIG. 11D illustrates circumferential laser raster associated with a double scan strategy for re-melting of laser sintered layers of a build.
  • FIG. 12 illustrates peen stress distribution for a Ti-64 additive layer machined (“ALM”) part.
  • FIG. 13 illustrates a three-dimensional model of an ALM test part with attempts to clone a distal end of a standard intramedullary nail.
  • FIG. 14 illustrates an example of the effect of laser power on porosity as a function of position along an ALM sample.
  • FIG. 15 illustrates an SEM image captured from a fracture surface of an ALM part laser sintered to 400 Watts (W).
  • FIG. 16 illustrates a table depicting results of four-point bend testing conducted at 5 hertz(Hz).
  • a machine Ti 6-4 nail was cut to a similar length and tested using the 300 to 3000 Newton (N) method to validate the use of the test rig with short nails. The nail survived 10 6 cycles with no sign of damage and did not move on the test rig.
  • the ALM samples were tested using the same method but using 200 to 2000 Newton (N) loading conditions.
  • FIG. 17 illustrates the effect of laser power on four-point bend fatigue properties to Ti-64 ALM parts conducted at step load of 2000:200 Newton's (N) at 5 hertz (Hz).
  • FIG. 18 provides a table of a listing of example machine suppliers for laser sintering and electron beam melting of Ti-64 material.
  • FIG. 19A illustrates a 2D drawing of a simplified test coupon geometry.
  • FIG. 19B Photograph of the cannulated Ti-64 coupons post-machining/heat treatment
  • FIG. 20 illustrates four-point bend fatigue performance of laser sintered and e-beam melted coupons as a function of machine suppliers. Tests conducted at 200 to 2000 Newton's at 5 Hertz (Hz)
  • FIGS. 21A and 21B illustrate micro sections of an EOS sample at different magnifications, and etched with Kroll's reagent to visualize the grain structure.
  • FIG. 22 illustrates four-point bend fatigue performance of HIPPED laser sintered and e-beam melted coupons as a function of machine suppliers. Tests conducted at 300 to 3000 Newton's at 5 Hertz (Hz)
  • FIG. 23A illustrates the crystal structure of a Grade 23 titanium produced, as an as-built part, on an EOS M280 machine prior to a Hot Isostatically Pressing treatment.
  • FIG. 23B illustrates the crystal structure of the Grade 23 titanium produced part of FIG. 21A after the part has been subjected to a Hot Isostatically Pressing treatment.
  • FIG. 24 illustrates a generally typical ordered structure of conventional lamella type Ti-6Al-4V titanium wrought alloy heated to the ⁇ transus temperature of 1005° C. and cooled at a rate of 100° C. min ⁇ 1 to 700 C, stabilized for 2 hours then allowed to cool in the oven
  • FIG. 25 provides a table of surface finish or roughness of as-built parts that were subjected to post-machining.
  • FIG. 26 provides average measured thickness of the ⁇ lamella in the ALM samples studied.
  • FIG. 28 illustrates four-point bend fatigue performance of surface polished and HIPPED laser sintered and e-beam melted coupons as a function of machine suppliers. Tests conducted at 400 to 4000 Newton's at 5 Hertz (Hz)
  • FIG. 29 illustrates Load Extension curves for heat-treated and non-heat treated ALM parts. Points F and J represent performance of non-heat treated parts. These parts are strong, but brittle
  • FIG. 30 illustrates strength (UTS) and ductility (% Elongation) data captured from wrought and ALM Ti-64 parts
  • FIG. 31 illustrates calculations for the production of 100 pieces of fully dense intramedullary nails at normal scanning speed using single, twin, and quad lasers.
  • FIG. 32 illustrates calculations for the production of 100 pieces of fully dense intramedullary nails at hyper-scanning speeds.
  • FIG. 33B illustrates the production costs shown in FIG. 27A as a percentage cost per manufacturing step.
  • FIG. 34A illustrates an exemplary breakdown of production costs for making 100 intramedullary nails using scanning conditions higher than those associated with the example depicted in FIGS. 31A-32A .
  • FIG. 34B illustrates the production costs shown in FIG. 34A as a percentage cost per manufacturing step.
  • FIG. 35 illustrates a proximal end of a Trigen Meta tibial nail, and highlights the concept of boundary layer scanning.
  • FIG. 36A illustrates a model of an orthopedic intramedullary nail after a boundary scan and which is dimensionally adjusted to account for dimensional shrinkages.
  • FIG. 36B illustrates a model of an orthopedic intramedullary nail after HIPPING, which indicates a fully densified part that meets the required CAD file part specification.
  • FIG. 37A illustrates a photograph showing powder cores produced by 5% boundary scanning “In situ shelling”
  • FIG. 37B CAD illustrates a CAD file highlighting the distal extruded section used to prevent the residual powder from escaping from the core after removal form build plate
  • FIG. 38 illustrates optical images acquired from the polished face of the wall section at the distal tip after heat treatment.
  • the measured porosity and average pore size was approximately 0.25%, and 3.4 microns respectively.
  • FIG. 39A illustrates a model of an orthopedic intramedullary nail after a hyper-laser scan, and which is dimensionally adjusted to account for dimensional shrinkages.
  • FIG. 39B illustrates a model of an orthopedic intramedullary nail after HIPPING, and which indicates a fully densified part that meets the required CAD file part specification.
  • FIG. 40 illustrates the four point bend fatigue performance of ALM parts produced by SLM solutions subjected to variable scanning strategies (full skin, no core, full skin, partial core).
  • FIG. 41 illustrates a sagittal section through the HIPPING oven highlighting the exposure of an ALM part to silver vapor.
  • FIG. 42 illustrates a schematic illustration of a bead blast procedure highlighting the deposition of silver onto a working part during a finishing operation.
  • FIG. 43A illustrates a three-dimensional (3D) model of an intramedullary nail with an internalized channel that extends generally parallel to the cannulation for temporarily housing a sensor probe.
  • FIG. 43B illustrates a microCT image of a nail with an internalized channel (1.5 mm diameter) highlighting no residual powder residing in the channel after the build.
  • FIG. 44 illustrates a three-dimensional (3D) model of a removable sensor probe that may be designed to operate in the internalized sensor probe channel of the intramedullary nail depicted in FIG. 43 .
  • FIGS. 45A and 45B illustrate a model of an intramedullary nail having an open channel created at a proximal end, and in an outside surface, of an intramedullary nail, which is amenable to traditional manufacturing techniques.
  • FIG. 46A illustrates an end view of exemplary geometry for an internal sensor probe channel that may be created using additive manufacturing.
  • FIG. 46B illustrates an isometric view of an exemplary geometry for an internal sensor probe channel that may be created using additive manufacturing.
  • FIG. 47 additive manufactured nail that includes an internal sensor probe channel.
  • FIG. 48 illustrates a perspective view of a proximal end of an intramedullary nail that was constructed via additive manufacturing, and which includes an internalized probe channel that is adapted to receive the insertion of a removable sensor probe.
  • FIG. 49 illustrates a perspective view of a distal end of a dynamizing intramedullary nail according to an illustrated embodiment of the present invention.
  • FIGS. 50A, 50B, and 50C illustrate dynamizing intramedullary nails having a telescopic section at a distal, midsection, and a proximal region of the intramedullary nail respectively.
  • FIG. 51 illustrates an example of linear and non-linear spring force-displacement relationships.
  • FIGS. 52A and 52B provide schematic illustrations of the degradation of a resorbable polymer of a dynamizing, actuated-loaded intramedullary nail that is positioned in a long bone fracture.
  • FIGS. 53A and 53B illustrate dynamizing intramedullary nails having telescopic sections that are structured to provide the intramedullary nails with unidirectional and bi-directional translation, respectively.
  • FIGS. 54 and 55 illustrate a dynamizing intramedullary nail having a telescopic section that includes a protrusion in the form of a pin.
  • FIG. 56 illustrates the effect of wall thickness on the mechanical stiffness measurements of an intramedullary nail.
  • FIG. 57 illustrates perspective views of examples of three bushings that are structured for use with an intramedullary nail to create cyclic loading locally at a fracture site.
  • FIG. 58A illustrates a exterior longitudinal view of an end of a intramedullary nail having an activatable shape memory sleeve or collar.
  • FIGS. 58B and 58C illustrate perspective views of an inner portion of the intramedullary nail shown in FIG. 58A that includes an activatable shape memory sleeve or collar in active and inactive states respectively.
  • FIG. 59 illustrates a schematic of views of various portions of a dynamizing intramedullary nail that includes a pair of opposing, encapsulated biasing elements.
  • FIG. 60 illustrates a standard circular cross section intramedullary nail and examples of cross sectional geometries of intramedullary nails that may reduce bending stiffness in the anterior-posterior plane while relatively preserving the stiffness in the orthogonal medial-lateral plane.
  • FIGS. 61A and 61B illustrate torsional and bending stiffness data based on a standard 10 millimeter outside diameter Trigen Meta tibial nail and 10 millimeter outside diameter Trigen Meta tibial nails that have different sized slots on an outer surface of the nails.
  • FIG. 62 illustrates a three-dimensional (3D) CAD intramedullary nail model in a cross sectional view that includes a tapered inner wall at a mid-section of the nail.
  • FIG. 63 illustrates a table identifying theoretical bending and torsional stiffness in the mid-section of an intramedullary nail that has a tapered inner wall.
  • FIG. 64A illustrates a three-dimensional (3D) CAD model of an intramedullary nail in partial perspective and cut away view, the intramedullary nail being equipped with circumferentially arranged internal flutes in an inner wall section of the nail.
  • FIG. 64B illustrates a cross sectional view of a portion of the mid-section of the intramedullary nail shown in FIG. 65A .
  • FIG. 65 illustrates three-dimensional (3D) CAD model of an intramedullary nail in a partial phantom view, the intramedullary nail including an ordered porous or channel inner structure in the wall of the intramedullary nail.
  • FIG. 66 illustrates an end view of a portion of the intramedullary nail shown in FIG. 65 taken from a mid-section of the intramedullary nail.
  • FIG. 67 illustrates a comparison of the theoretical bending and torsional stiffness of a standard intramedullary nail and an intramedullary nail having a porous or channel inner structure, as shown in FIGS. 66 and 65 .
  • FIG. 68 illustrates an elastic modulus versus density diagram that provides data for cancellous bone, collagen, Ti 40% porosity, cortical bone, TI-6Al-4V 40% porosity, Ti alloys, CO—Cr alloy, steels, and Ti-6A-4V.
  • FIG. 69 illustrates a perspective, partial cut away view of a portion of three-dimensional (3D) model of an intramedullary nail that includes a detachable inner section.
  • FIG. 70 illustrates a table that provides a comparison between the bending and torsional stiffness of standard Trigen Meta tibial nails and a nail having a detachable inner section similar to that shown in FIG. 69 .
  • Orthopedic devices require certain material properties and/or tolerances for both optimal manufacturing and performance under stress loading conditions within the human body.
  • fixation devices such as, for example, intramedullary (IM) nails
  • properties or characteristics may include four-point bend fatigue, flexural modulus, torsional rigidity, tensile strength/ductility/yield strength, porosity, surface finishes, and geometrical tolerances/part accuracy.
  • IM intramedullary
  • properties or characteristics may include four-point bend fatigue, flexural modulus, torsional rigidity, tensile strength/ductility/yield strength, porosity, surface finishes, and geometrical tolerances/part accuracy.
  • RMT rapid manufacturing technologies
  • additive manufacturing has the advantage of providing near net-shaped products/parts to multiple markets without having to rely on a highly skilled labor force. Additionally, given its design freedom, using additive manufacturing in designing and manufacturing implant devices, such as, for example, intramedullary ails, may open up the possibility of developing an implant, which is specific to the characteristics of the patient, including, for example, the patient's age, bone quality, and injury type, among other characteristics.
  • RMT technologies include, but are not limited to, direct metal fabrication (DMF), direct metal laser sintering (DMLS), electron beam welding (EBM) and solid free-form fabrication. These technologies have been used in various industries including orthopedics for reconstructive, trauma and rehabilitation devices.
  • DMLS may use a three-dimensional (3D) computer-aided design (CAD) model, which may be created through programs, such as, for example, Magics® by Materialise®, to produce a three-dimensional metal sintered model that is created layer-by-layer through irradiating metal powder with a laser.
  • CAD computer-aided design
  • 1A-1C illustrate isometric, top, and side views, respectively, of a three-dimensional (3D) model of a hypothetical build program created by the Magic® program having a vertical stack of 143 nails across a 25 centimeter by 25 centimeter (x by y) build plate.
  • DMLS can create a number of issues relating to material performance and functionality that cannot be tolerated in orthopedic devices, including porosity, part tolerance, part design, and surface finish, which require additional post-processing, each of which will be summarized in turn below.
  • FIG. 2A illustrates a distal mid-shaft of a DMLS intramedullary nail with 30% porosity at a distal mid-shaft location
  • FIG. 2B illustrates an associated nail fracture site at a distal location of the intramedullary nail as result of 4 point bend fatigue testing.
  • Sub-optimal laser beams can create devices with specifications outside the required tolerances. For instance, with respect to intramedullary nails, such areas that are outside required tolerances that may be produced by sub-optional laser beams include the internal/external portions of the nail, as well as areas associated with an internal screw diameter.
  • FIG. 3A illustrates a part which has all the design features switched on during the build phase.
  • the design features at the distal end of the part are particular sensitive to fatigue stress given that the wall is thinner.
  • the parts are typically build in a vertical orientation and so the microstructure around the transverse screws holes are particularly prone to defects due to the nature of the heat dissipating out of the part. Consequently, this part design did not produce satisfactory mechanical fatigue properties despite requiring the least amount of post-machining.
  • FIG. 3B outlines a more conservative design given that all the design features (transverse screw holes, key-ways slot, etc.) have been switched off during the build phase/
  • the part is also equipped with a boss at the proximal end to secure the pare in the chuck of a CNC machine.
  • this design produced satisfactory mechanical properties, the post-machining phase was very intensive.
  • FIG. 3C outlines an implant design provides a balance between the post machining requirements and the required mechanical performance. The distal features are turned off in the most vulnerable part of the nail, which reduces the post-machining time but addresses the risk of early fatigue failure
  • DMLS can create a number of issues relating to cost of goods and productivity.
  • the cost of metal powder which may be around $200-$400/kg depending on the grade of Ti-6AL4V powder purchased, e.g. Plasma Rotating Electrode Process (PREP), gas atomized, and EL1 grade 23.
  • PREP Plasma Rotating Electrode Process
  • machine cost/build time may be around $97/hour depending on the size of the manufacturing cell, the capital equipment and level of depreciation, and the staff.
  • part throughput which may be 100 nails per build
  • part throughput can take around 109 hours to complete (65.4 minutes per nail), compared to, for example, 600 nails per day (2.4 minutes per nail), which may be attained using highly developed subtractive machining operations that are carried out in medical device manufacturing cells.
  • the efficiency of the additive manufacturing process can be improved using a laser sintering machine with a bigger footprint and equipped with 4 scanners, e.g. SLM 500 quad scanner.
  • 800 nails sized 20 cm long ⁇ 10 mm OD
  • boundary scanning “in situ shelling” strategy The SLM500 is capable of producing around 40,000 nails per year, if run to full capacity and adopting the boundary scanning strategy.
  • FIG. 4 illustrates the time taken to build a nail on an SLM500, which scales approximately linearly with size (length) of the nail. For example, the 320 mm nail requires an average per nail build time of 25 minutes, FIG. 4 .
  • the cost of metal powder is typically controlled by suppliers who may charge a premium given the limited number of suppliers available in certain market places.
  • European supply companies, and more specifically UK suppliers often offer radically cheaper and environmentally benign powder compared with existing titanium production methods, such as, for example, the energy-intensive gas-atomized and toxic Kroll process, which constitutes a costly and labor-intensive four-step process.
  • Such suppliers may take rutile and transform it directly into powdered titanium using electrolysis, which is cost-effective and thus generally essential to the supply chain.
  • the low-cost titanium powder can be used in a variety of new applications, whereas previously the metal has been excessively expensive for use in mass production of lower value items.
  • gas atomized powder directly from bar stock is a potential route for reducing Ti-64 power cost to around £30/Kg.
  • FIG. 5 illustrates an example of comparison of build times for 16 test bars, including interpolation to time and cost to build 280 millimeter (mm) tall intramedullary nails using different machines, identified as Arcam S12, Concept M2, EOS M270, Realizer, Renishaw AM250, and SLM Solutions 280HL.
  • Build time of parts may be influenced by a number of inter-related variables, including, for example, DMLS machine specification, as well as operating costs, such as, for example, gas, electricity, and capital equipment, among other costs, as shown in the illustrated example table depicted in FIG. 5 .
  • DMLS machine specification as well as operating costs, such as, for example, gas, electricity, and capital equipment, among other costs, as shown in the illustrated example table depicted in FIG. 5 .
  • operating costs such as, for example, gas, electricity, and capital equipment
  • the present invention provides an optimal DMLS manufacturing route for orthopedic devices with material performances matching those for wrought/cast/machined titanium parts.
  • a method of manufacturing an elongated orthopedic device via direct laser sintering including the steps of: a) producing a virtual three-dimensional (3D) elongated device model; b) manufacturing an elongated device in an appropriate build direction via direct metal sintering according to the three-dimensional (3D) model utilizing a laser power of at least 300 Watts (W), and using a powder of at least Grade 5 quality, such as, for example, a TiAl6v4 powder; c) subjecting the elongated device to Hot Isostatically Pressing (HIP) utilizing a temperature of at least 1000 degrees with a cooling rate of between 0.24 and 72 degrees C. min ⁇ 1; d) machining and polishing the HIP processed elongated device; and e) wherein the mechanical performance is equivalent to the four-point bend performance of wrought titanium.
  • HIP Hot Isostatically Pressing
  • an orthopedic implant such as, for example, an intramedullary nail, is manufactured via the following steps and processes:
  • A Creation of a CAD File: An appropriate file type, such as, for example, a .stl formatted file, is uploaded into a three-dimensional (3D) software provider such as, for example, Magics® by Materialise®, among others, in an orientation that is suitable for manufacturing.
  • 3D three-dimensional
  • Such files may include, for example, a non-supported vertical build structure of an intramedullary (IM) nail, among other components or devices.
  • IM intramedullary
  • FIGS. 6A and 6B illustrate a three-dimensional (3D) CAD file highlighting the manufacture of intramedullary nails using a vertical orientation ( FIG. 6A ) and a horizontal orientation ( FIG.
  • FIG. 6A illustrates building parts in a vertical configuration/orientation, and can be made more economical by designing supports structures that allow the parts to be stacked in layers.
  • FIG. 6B illustrates building parts in a configuration/orientation at an angle between 0 and 90 degrees, and can facilitate reducing their anisotropic behavior. However, lower numbers of devices can be made in a single build run.
  • FIGS. 7A-7D illustrate three-dimensional (3D) CAD intramedullary nail models in cross-section and which highlight a tapered wall section ( FIG. 7A ), a porous inner structure ( FIG. 7B ), a detachable inner section ( FIG. 7C ), and an internal fluted section ( FIG. 7D ). Additionally, FIG.
  • D Kuntscher nails
  • K Universal nails
  • RMT can also be used to produce patient matched implants through optimization of the curvature of the intramedullary nail. This may avoid a mismatch in the radius of curvature between the intramedullary nail and the bone, particular the distal femur, which could otherwise lead to anterior cortical perforation.
  • the radius of curvature of the femur is estimated to be 120 cm (+/ ⁇ 36 cm).
  • femoral nail designs typically have less curvature, with a radius ranging from 186 to 300 cm.
  • nails can also be designed to suit each individual fracture. According to such an embodiment, a computer model of each individual fracture can be created, and this model can then be used to test different fixation strategies in order to select a system that will create a specific mechanical environment for assumed load-bearing requirements.
  • the intramedullary nails can be built using various commercial machines from suppliers such as, for example, SLM Solutions, Renishaw, Realizer, EOS, Concept Laser and Arcam.
  • the relative merits of each technology are generally based upon: (a) machine productivity (i.e., size of the chamber (along the x, y, and z axes), scanning speed, and number of lasers); (b) part quality (i.e., accuracy, surface finish, tolerances/resolution); and (c) capital and running costs (e.g., consumption of gas and electricity).
  • Hard re-coaters such as, for example, the EOS M270/M280/M290 from EOS, may produce parts with superior mechanical properties and reduced porosity given that any weakly-bound, partially sintered material is more likely to be removed at each build layer.
  • Soft re-coaters may produce parts that may also be contaminated with silicone blade debris, which would in turn need to be investigated to satisfy regulations. The soft re-coater blades can potentially wear out after one build, which in turn adds additional cost to the manufacturing process.
  • Hard re-coater blades can be made from high speed steel, and the debris released from these arms into the part is perceived to be less of a problem than soft re-coater blades.
  • Hard re-coater blades are also more economical as to powder use.
  • Modern laser sintering machines supplied by SLM Realizer can produced focused beam spot sizes of 30 microns, which can produce parts with superior grain structure and resolution that enables novel design features to be realized, e.g. internalized channels.
  • (F) Powder Specification Medical grade Ti-64 powder is available in a number of different formats depending on the end application and the selection of the three-dimensional (3D) printer.
  • Grade 5 gas or plasma atomized powders are typically used in laser sintering, may have a particle size range of either 15 to 45 microns ( ⁇ m) or 20 to 63 microns ( ⁇ m), and are typically supplied at a cost of £50/kilogram.
  • Grade 23 ELI powder may be either a gas-atomized or centrifugal PREP powder with a particle size range of between 45 and 100 microns ( ⁇ m), and is typically supplied at £250/kilogram, and may contain reduced levels of oxygen, nitrogen, carbon and/or iron.
  • FIG. 9 provides a schematic diagram of build parameters that may be used for a Renishaw SLM250 to produce intramedullary nails. Specifically, FIG.
  • FIG. 9 is a schematic representation of laser sintering additive manufacturing process parameters, layer by layer, reproduced from a build carried out on a Renishaw SLM250, wherein the laser power is between 50 watts (W) and 280 watts (W), the point distance is between 30 and 90 microns ( ⁇ m), the hatch distance is 65 microns ( ⁇ m), the layer thickness if 50 microns ( ⁇ m), and the exposure (Ex) is 50 to 500 microseconds ( ⁇ s).
  • SLM selective layer melting
  • Post-processing of RMT parts may include, but is not limited to the following steps or processes.
  • Heat treating the parts that are built via an additive manufacturing process can involve any combination of the steps of HIPPING (Hot Isostatically Pressed System), stress relief, and annealing, among other steps.
  • HIPPING Hot Isostatically Pressed System
  • manufacturing of an orthopedic implant may utilize optimal processing conditions during formation of the part.
  • manufacturing of an orthopedic implant includes optimized fatigue performance of three-dimensional (3D) printed Ti-64 parts.
  • (A) Laser Power The mechanical properties of additive manufactured parts may be dependent upon how much power is used to build them, such as, for example, the energy density of the laser beam that was used to produce the parts. As a general rule, the greater the energy density used to manufacture the part, the rougher the part surface finish will be. This phenomenon may be caused by heat from the part “leaking” into the surrounding powder material and encouraging the powder to fuse to the surface of the part. Therefore, increasing the energy density of the laser beam may increase the surface roughness and the overall strength or the parts.
  • a batch of twelve (12) additive manufactured Ti-64 samples resembling the distal section of a tibial nail was formed via laser sintering.
  • the following processing conditions were implemented using a Renishaw 250 ALM: (a) scanning speed of 150 millimeters/second (mm/s); (b) focus offset of 0 millimeters (mm); (c) a point distance of 65 microns ( ⁇ m); (d) an exposure time of 250 ⁇ s; and, (e) a laser power varied between 120 watts (W) and 400 watts (W).
  • Such processing included, and provided related information regarding, the following:
  • FIG. 18 (B) Standard Fatigue Performance of Laser Sintered and E-beam Melted Coupons: In order to determine whether there is any accrued benefit in using a particular machine supplier to build Ti-64 nails, as listed in FIG. 18 , a part geometry may be created that is related to the final device, which in turn allows direct comparisons to be made. Specifically, FIG. 18 lists machine suppliers identified for laser sintering and electron beam melting of Ti-64 material, and FIG. 19A illustrates a 2D drawing of simplified test coupon geometry. FIG. 19B illustrates a photohrao of a simplified test coupon geometry
  • FIG. 20 illustrates four-point bend fatigue performance of laser sintered and e-beam melted Ti-64 coupons as a function of machine suppliers.
  • FIGS. 21A and 21B illustrated therein is a typical crystal structure of a laser sintered Ti-64 part comprised of bands ⁇ within a matrix ⁇ , and being of a Widmanstatten type.
  • FIGS. 21A and 21B illustrate micro sections of an EOS sample at different magnifications, and etched with Kroll's reagent. This is very similar to wrought microstructures produced after heating to 1000° Celsius and forced air cooled. Grain size is in the region of 100 microns ( ⁇ m). This type of structure may not yield good mechanical properties, and may require appropriate solution and ageing heat treatments to produce a material with acceptable mechanical properties.
  • the EOS Ti-64 part etched with Kroll's reagent shows the crystal structure at low magnification ( FIG. 21A ) and a higher magnification ( FIG. 21B ), with showing the Widmanstatten type structure of individual grains.
  • (C) HIPPING Hipping can be very effective at increasing the fatigue performance of ALM Ti-64 parts, as illustrated in FIG. 22 .
  • fatigue performance may be improved 100% when the ALM Ti-64 parts are HIPPED at a temperature of 980° Celsius for 4 hours at a pressure of 200 MPa, and with an initial cooling rate of 10° Celsius/minute.
  • ultimate failure occurred at 26,891 cycles when loaded between 4000 newton (N) and 400 newton (N) at 5 hertz (Hz) (not shown).
  • FIG. 22 illustrates four-point bend fatigue performance of HIPPED laser sintered and e-beam melted coupons as a function of machine suppliers with the following parameters: part geometry of 100 millimeter (mm) long, an outer diameter of 10 millimeter (mm), and an inner diameter of 4.7 millimeter (mm); test conditions of 3000 newton (N) to 300 newton (N) at 5 hertz (Hz) according to ASTM 1264; HIPPED at a temperature of 980° Celsius for four (4) hours at a pressure of 200 MPa and with an initial cooling rate of 10° Celsius/minute. Failure typically occurred at around 200,000 cycles with the HIPPED part produced from the Realizer running out a 1M cycles, FIG. 22 .
  • HIP treatment may refine the crystal structure to produce a lamella structure, with some similarity to conventionally manufactured titanium when heated above the ⁇ transus temperature and cooled slowly.
  • FIGS. 23A and 23B illustrated the effect of HIP treatment on Grade 23 titanium produced on an EOS machine, with FIG. 23A showing the as-built part and FIG. 23B illustrating the part after HIP treatment.
  • the illustrations are typical of the type of modification observed with the samples from other machines, although the width of the lamella and the overall grain size varied with the other samples.
  • the main difference from conventional Ti-6Al-4V titanium is the rather disordered nature of the lamella observed in all of these samples.
  • the microstructures observed with the laser sintered parts comprises bands of ⁇ separated by very small regions of ⁇ .
  • FIG. 24 shows the typical ordered structure of conventional lamella type Ti-6Al-4V titanium alloy.
  • the HIP treated samples ( FIG. 23B ) are far more disordered than the conventional lamella type Ti-6Al-4V titanium alloy shown in FIG. 24 . This contributes to the lower fatigue performance of these samples during fatigue testing. It can also be seen that definite crystal boundaries are present in the conventional sample, but these are hard to define in the test samples examined, as there appeared to be no clear distinction between lamella colonies and grain boundaries. More specifically, FIG.
  • FIG. 24 illustrates Ti-6Al-4V titanium alloy that is conventionally wrought and heated to the ⁇ transus temperature of 1005° Celsius (C), cooled at a rate of 100° C min ⁇ 1 to 700° C., stabilized for 2 hours, and then allowed to cool in the oven.
  • the ALM samples were given an HIP treatment at 980° Celsius, so it is likely that the ⁇ transus was not reached, and therefore the phase change to ⁇ was not achieved. This incidence, combined with the slow rate of cooling of 10° C. min ⁇ 1, explains the difference between the wrought microstructure and the studied ALM samples.
  • a ⁇ transus temperature must be reached. This will then allow an ordered lamella structure to be produced on cooling.
  • the width of the lamella is dictated by the cooling rate, with a finer structure being achieved at faster rates of cooling. It has been found that the width of the lamella (t) should be microns, and the size of the colonies of parallel lamella (d) should be 30 microns for maximum fatigue strength.
  • a more ordered, parallel structure should be achieved if the HIP temperature is increased to 1000° Celsius so that full ⁇ transus is achieved.
  • cooling rates from the ⁇ transus temperature should be between 0.24° C. min ⁇ 1 and 72° C. min ⁇ 1, with the faster cooling rate producing smaller lamella.
  • the cooling rate in the HIP furnace used for the current batch of ALM parts is 10° C. min ⁇ 1, and the lamella produced had widths of between 4.05 microns and 6.12 microns, FIG. 26 . This is not far from the optimum size for maximum fatigue strength. Therefore, a more ordered, parallel structure should be achieved if the HIP temperature was increased to 1000° Celsius so that full ⁇ transus is achieved.
  • (D) HIPPING & Machining/Polishing Post-machining of the external surface of the part has a significant improvement in fatigue performance. For example, techniques such as abrasive fluid machining results in the flattening out of the surface and a reduction in the number of crack initiation sites in the test part. As illustrated in FIG. 25 , the surface finish or roughness of the external geometry of the as-build parts that were subjected to such post-machining experienced increases from 5.43 ⁇ m (Realizer)-23.4 ⁇ m Ra (Arcam), to 0.4 ⁇ m Ra after abrasive fluid machining.
  • FIGS. 29-30 illustrates the Load Extension curves for heat-treated and non-heat treated ALM parts. Points F and J represent performance of non-heat treated parts. These parts are strong, but brittle
  • the present invention provides at least the following advantages over the prior art: (1) mechanical properties similar to wrought parts; (2) Grade 5 Ti powder can be used, which in turn may provide an economic advantage; and, (3) improved part tolerance.
  • mechanical properties similar to wrought parts (2) Grade 5 Ti powder can be used, which in turn may provide an economic advantage; and, (3) improved part tolerance.
  • these advantages are exemplary and do not in any way limit the scope of the present invention.
  • Embodiments of the present invention further provide an optimal DMLS manufacturing route for orthopedic devices, with a potential six-fold reduction in manufacturing time.
  • a method of manufacturing en elongated orthopedic device via direct laser sintering including the following steps:
  • This scanning strategy assumes the following: (a) any residual porosity left in the part after building is removed after heat treatment; (b) a standard heat treatment cycle is used; (c) dimensional changes resulting from part shrinkage are factored into the original design of the CAD file or are controlled by the Magic® program; and, (d) the mechanical properties of the hyper-scanned speed parts are equivalent to a normal scan.
  • FIGS. 33A-34B illustrate a breakdown of costs for making an additive-manufactured Ti-64 nail.
  • the fixed costs include the cost of powder (assuming current supply chain options for qualified powder without access to lower cost metal spray equipment), post machining, and packaging/sterilization.
  • the total cost of making an ALM nail using this manufacturing route is $149.50.
  • the cost for operating at a hyper-scan speed has a significant impact on build time costs, reducing it from 62% to 25.6% of the overall manufacturing cost, as illustrated FIGS. 33B and 34B . Further, the cost of producing a “hyper scanned” part is reduced from $149.50 to $75.90, which is aligned with the cost of manufacturing a machined part of equivalent geometry.
  • the production costs for making 100 nails using standard scanning conditions (scanning speed ⁇ 1000 mm/s) for an SLM DMLS machine is shown in FIG. 33A as cost breakdown (dollars/manufacturing step), and FIG. 33B as a percentage cost per manufacturing step, and with the following assumptions: cost of running the ALM is $97/hour; cost of implant grade powder is $255/kg; and, build time is 96 hours to manufacture 100 nails.
  • FIGS. 34A and 34B illustrate production costs for making 100 nails using “higher speed” scanning conditions (scanning speed ⁇ 1000 mm/s) for an SLM DMLS machine showing cost breakdown in dollars per manufacturing step ( FIG. 34A ), and percentage cost per manufacturing step ( FIG. 34B ), and using the following assumptions: cost of running the ALM is $97/hour; cost of implant grade powder is $255/kg; build time is 96 hours to manufacture 100 nails; and, heat treatment cycle is HIPPED at 1050° Celsius for 6 hours, with all heat treatments carried out in an inert argon atmosphere.
  • Boundary Scan A second approach for reducing the cost of building the parts in the DMLS chamber is to use a scanning strategy which restricts the sintering to the boundary layers (i.e., the outside and inside surface of a cannulated part), aptly termed the “Baked Bean Can or in situ shelling” model. This scanning strategy omits the hatch or core scan of the part.
  • a three dimensional model of the proximal end of a Trigen Meta tibial nail highlighting the concept of boundary layer scanning is illustrated in FIG. 359 . With this scanning approach, only 5% of the total volume of the part is sintered on the build platform. Specifically, FIG.
  • 35 illustrates the concept of a boundary or “Baked Bean Can” scanning strategy for densifying the outer and inner layers of a Trigen Meta tibial nail (proximal tapered region) to reduce build time in the DMLS chamber.
  • the core of the part contains free-flowing powder which is densified after heat treatment.
  • certain part design features such as, for example, keyway and slot screw holes, have been turned off.
  • an intramedullary nail or other types of implants are manufactured via the following steps and processes.
  • FIGS. 36A and 36B illustrate a cross section of an intramedullary nail 110 including an additive manufactured component 100 subsequent to a boundary scan highlighting the dimensionally adjusted part to account for shrinkage effects ( FIG. 36A ), and HIP processed additive manufactured component indicating the final “stabilized” nail 110 dimensions after heat treatment ( FIG. 36B ).
  • FIG. 36A illustrates an additive manufactured component 100 that will provide the orthopedic intramedullary nail 1100 before a boundary scan indicating a dimensionally adjusted CAD file to account for dimensional shrinkages (typically ⁇ 5%)
  • FIG. 36B illustrates an orthopedic intramedullary nail 110 after HIPPING and which indicates a fully densified part with the specified geometry.
  • the additive manufactured component 100 is manufactured using DMLS technology with a boundary scan only approach.
  • various scan strategies are used to produce a sintered model representing the complete intramedullary nail device 110 .
  • a “Baked Bean Can” of the additive manufactured component 100 is produced by laser sintering the three dimensional model, and more specifically the external surface 102 and the internal surface 104 to a desired thickness, which could be, for example, in the range of about 100 microns ( ⁇ m).
  • the internal cannulation 106 would be maintained with this scanning approach in addition to an un-sintered powder core 108 . Referring to FIG.
  • the nail 110 becomes densified by the heat treatment with some accompanying dimensional changes, which reflect the amount of shrinkage experienced by the additive manufactured component 100 during the heat treatment step.
  • nails are supplied with a powder core using a boundary scanning strategy as indicated in FIG. 37 a .
  • the parts are densified at either 5% in the build chamber.
  • the bottom surface of the nail is extruded in the Magics software to 3 mm to prevent the powder from escaping from the distal end of the part after removal from the platform, FIG. 37 b .
  • FIG. 38 illustrates the degree of porosity remaining in the cross-section of the part.
  • the measured porosity is 0.3%, FIG. 38 .
  • the average pore size is approximately 3.4 microns, FIG. 38 .
  • FIGS. 39A and 39B illustrate a cross section of an intramedullary nail 206 including an additive manufactured component 200 after a hyper-laser scan producing 50% densification in the part.
  • the figure highlights the dimensionally adjusted nail 206 that accounts for shrinkage effects to the additive manufactured component 200 , which may occur after heat treatment ( FIG. 39A ), and a HIP processed nail 210 indicating the final “stabilized” part dimensions after heat treatment ( FIG. 39B ).
  • FIG. 339A illustrates an additive manufactured component 200 that will be used to form the orthopedic intramedullary nail 210 after a hyper-scan which indicates a dimensionally adjusted CAD file to account for dimensional shrinkages
  • FIG. 39B illustrates an orthopedic intramedullary nail 210 after HIPPING which indicates a fully densified part with the required geometry.
  • the additive manufactured component 200 is manufactured using DMLS technology with a hyper laser scan.
  • various scan strategies are used to produce a sintered model representing the complete intramedullary nail device 210 .
  • a cannulation 202 is surrounded by a semi-sintered core 204 .
  • FIG. 39B after HIPPING, the nail 206 becomes densified by heat treatment with some accompanying dimensions changes which reflect the amount of shrinkage experienced by the part during the heat treatment step.
  • Hyper-scanned parts supplied by SLM solutions were subjected to heat treatment only, and the number of cycles to failure compared to standard scanned parts produced after the same step in the process, FIG. 40 .
  • the hyper-scanned parts consisted of three groups of parts: full skin with powder core, full skin with powder core, with extruded distal end to allow parts to be heat treated off the build platform, and parts with a full skin and partially powder core.
  • the mean cycles to failure after the heat treatment step when loaded between 3000 & 300 N were 1,161+/ ⁇ 288 for the parts with the full skin and powder core.
  • the corresponding mean cycles to failure after the heat treatment step were 34.7+/ ⁇ 9.6k for the parts with the full skin and powder core, which had the extruded distal end.
  • the corresponding mean cycles to failure after the heat treatment step were 180,068+/ ⁇ 38.7k for the parts with the full skin and partially scanned core, which had the extruded distal end.
  • the improvement observed in the fatigue performance from the powder core samples after inclusion of the extruded distal end was believed to be due to the benefits accrued from heat treating the part away from the build plate.
  • the extruded ‘floor’ prevented the powder from coming out.
  • the nails were positioned over the platform and then dropped by 2 mm, (in CAD space).
  • an anti-microbial nail may be provided.
  • the cost saving realized from the scanning strategies discussed above may enable other cost effective processes to be included within the process map.
  • a silver hip implant may be provided.
  • silver is deposited onto a hip implant during the HIPPING step, and may use the following approaches: (a) a silver plated/coated work-piece, and (b) a modified compression media (argon gas-silver vapor). Both approaches produce a silver coated product using a non-line-of-sight process, which is known to have anti-microbial properties.
  • FIG. 41 illustrates a sagittal section through the HIPPING oven highlighting the exposure of the ALM part to silver vapor. This coating technology assumes that the deposited silver lay is thicker than 0.1 millimeters (mm) to accommodate any post machining operations.
  • a silver-coated bead blast treatment may be provided.
  • such an embodiment may constitute a one step process that involves the use of silver-coated ceramic particles produced from either silver plating or silver nitrate coating that is fired at the surface.
  • the particles produce a hardened layer of silver-titania that has anti-microbial properties.
  • FIG. 42 is a schematic illustration of a bed blast procedure highlighting the deposition of silver onto a working part during a finishing operation sing silver coated grid or bead blast.
  • the present invention provides significant savings in terms of cost of goods over prior implants and methods of manufacture. However, it should be understood that these advantages are exemplary and do not in any way limit the scope of the present invention.
  • an orthopedic implant device such as, for example, an intramedullary nail that has the design freedom of additive manufacturing, and which includes a longitudinal internal channel that is capable of housing a removable sensor probe that is configured to register distal and proximal locking holes.
  • the orthopedic implant device may also have an internal geometry that facilitates variable stiffness in the anterior-posterior (A/P) plane and medial lateral (M/L) plane and/or an internal geometry that offers a lower stiffness implant for larger patients.
  • a further embodiment of the present invention provides a minimally invasive method for auto-dynamization so as to provide biomechanical loading to the healing fracture.
  • embodiments of the present invention include a longitudinal internal channel created in the wall section of an orthopedic device, such as an intramedullary nail, using additive manufacturing for housing a removable sensor probe for registration of the distal and proximal screw holes.
  • FIG. 43 a illustrates an intramedullary nail 300 with an internal sensor probe channel 302 running parallel to the cannulation 304 .
  • FIG. 43 b illustrates a microCT image captured from an ALM part with an internalized channel in the wall section. The longitudinal cross-section through the part shows that there is no residual powder residing in the channel after the build phase.
  • FIG. 48 illustrates a proximal end of an intramedullary nail 300 that was constructed via additive manufacturing, and which includes an internal sensor probe channel 302 ( FIG. 43 a ) in a wall section 306 that is adapted to receive the insertion of a sensor probe 308 .
  • the inclusion of a removable sensor probe in the channel 302 may facilitate proximal locking, as the sensor probe is not located in the cannulation of the nail, thereby allowing surgeons to drill for, and insert screws into, the nail 300 .
  • the shape of the internal sensor probe channel 302 may be created using additive manufacturing based upon the constraints imposed by the geometry of the intramedullary nail 300 .
  • the internal sensor probe channel 302 is located within the wall section 306 of the intramedullary nail 300 to ensure that the probe that may be received in the channel 302 does not become incarcerated in the intramedullary canal during removal.
  • the longitudinal channel is approximately 1.5 mm in diameter extending the length of the nail and terminating just above superior distal screw hole. Locating the internal sensor probe channel 302 within the wall section 306 will avoid the need for a welded lid, which otherwise can add complexity and cost to the manufacturing process.
  • FIG. 44 illustrates an embodiment of a removable sensor probe designed to operate in this channel 302 .
  • Typical probe and sensor dimensions may include, but are not limited to, a 1.422 millimeter (mm) outer diameter, a 1.22 millimeter (mm) inner diameter, a 1.12 millimeter (mm) height, a 0.61 millimeter (mm) width, and a 30 millimeter (mm) length.
  • the sensor probe may be constructed from a variety of different materials, including, for example, stainless steel, or another rigid or semi-rigid metallic material. It can also include a potting compound such as a medical grade silicone rubber or epoxy resin to protect the electronic components from moisture and vibrational forces. Further, the configuration of the sensor components on the printed circuit board (PCB), i.e.
  • PCB printed circuit board
  • the two coiled ferrites also referred to as the six degree of freedom tracking sensors, are preferentially arranged at 180 degrees to each other.
  • Such a configuration may minimize the overall diameter of the sensor unit, such as, for example to 1 millimeter (mm), and which may be positioned in an internal sensor probe channel 302 having a diameter in the wall of the nail that is less than 1.5 mm.
  • the location of the channel also allows the nail to be locked at either the distal or proximal end first providing more options for the Surgeon.
  • the probe is also designed to be removed after the nail has been locked within the bone channel 302 .
  • 45A and 45B illustrate a model of an intramedullary nail 400 having a channel 402 created in the outside surface 404 of the nail 400 at the proximal end that is amenable to traditional manufacturing techniques.
  • the channel in FIG. 45B includes a removable sensor probe 406 .
  • This design requires a welded plate to prevent the probe from becoming incarcerated during extraction from the bone canal.
  • FIGS. 46A and 46B illustrates an exemplary geometry for an internal sensor probe channel 302 that may be created using additive manufacturing, and highlights the position of the channel 302 relative to the neutral axis.
  • the size dimensions of the internal sensor probe channel 302 may be minimized to mitigate the risk of adverse fatigue failure.
  • the inclusion of a channel 302 may constitute around an 11% reduction in bending stiffness in the plane of the channel 302 , which is unlikely to cause any problems clinically.
  • the “x” axis which is in the plane of the channel 302 , experienced about an 11% reduction in moment of inertia.
  • the “y” axis which is perpendicular to the channel 302 , may experience an approximately a 1% reduction in moment of inertia.
  • the moment of inertia with and without the channel 302 is calculated to be X: 878.8 mm 4 ; Y: 990.5 mm 4 and X: 993.9 mm 4 ; Y: 993.9 mm 4 respectively.
  • the intramedullary nail 300 depicted in FIG. 43 a can be manufactured in a variety of different manners, including, for example, by use of a laser or electron beam three-dimensional (3D) printing. Examples of the laser scanning conditions for a Realiser SLM100 system are outlined in the table shown in FIG. 47 . Additionally, the thickness of the wall 306 of the intramedullary nail 300 may be increased, such as, for example, increasing the outer diameter of the wall 306 of the intramedullary nail 300 so as to at least attempt to prevent the internal sensor probe channel 302 from being distorted during heat treatment (HIPPING).
  • HIPPING heat treatment
  • the wall 306 of the intramedullary nail may be increased such that the outer diameter of the intramedullary nail is increased by 0.5 millimeters (mm).
  • the additional thickness of the wall 306 may be sacrificed during the post-machining operations.
  • the use of additive manufacturing may permit the intramedullary nail 300 to be manufactured without the use of an exit point or opening that may be associated with the removal of non-sintered powder from the internal sensor probe channel 302 . More specifically, micro CT images acquired from testing intramedullary nails 300 after three-dimensional (3D) printing indicated that the internal sensor probe channel 302 did not become contaminated with residual, non-sintered powder, FIG. 43 b . Thus, according to certain designs, the intramedullary nail 300 may not include such a removal point or exit that is in fluid communication with the internal sensor probe channel 302 . The absence of a removal point or exit that may otherwise be adapted at least for the removal of residual, non-sintered powder may assist in simplifying the design of the internal sensor probe channel 302 , as well as the manufacturing of the intramedullary nail 300 .
  • Conventional axial dynamization of statically locked intramedullary nails involves the removal of one or more interlocking screws two to three months after initial surgery in an outpatient setting.
  • This approach requires an invasive procedure, and typically has a resolution of around 1 to 5 millimeters (mm), which is often dictated by the width of the slot in the intramedullary nail, and may only be available in one section of the intramedullary nail.
  • a self-dynamizing intramedullary nail would overcome some of these shortfalls, and provide a step-wise improvement in accelerating bone healing through continuous adjustment of the loading share applied to the fracture site.
  • a self-dynamizing intramedullary nail may help prevent the occurrence of delayed healing or non-union of the fracture by permitting appropriate axial movement of the fractured ends of the bone towards each other.
  • developing a self-dynamizing intramedullary nail may include the following:
  • FIG. 49 illustrates a perspective view of a distal end of a dynamizing intramedullary nail 500 according to an illustrated embodiment of the present invention.
  • the dynamizing intramedullary nail 500 includes a first section 502 a and a second section 502 b .
  • the dynamizing intramedullary nail 500 is structured so that the axial position of at least one of the first section 502 a and the second section 502 b may be adjusted relative to at least the other of the first section 502 a and the second section 502 b .
  • Such relative changes in the axial positions of the first section 502 a and/or the second section 502 b may be adapted to at least adjust an overall length of the dynamizing intramedullary nail 500 .
  • the dynamizing intramedullary nail 500 includes a telescopic section 504 that is adapted to both facilitate relative axial displacement of the first section 502 a and/or the second section 502 b of the dynamizing intramedullary nail 500 and retain a connection between the first and second sections 502 a , 502 b .
  • a telescopic section 504 that is adapted to both facilitate relative axial displacement of the first section 502 a and/or the second section 502 b of the dynamizing intramedullary nail 500 and retain a connection between the first and second sections 502 a , 502 b .
  • the telescopic section 504 may be a sleeve that extends from an end of the first section 502 a or the second section 502 b , and which is received in an inner region 506 a , 506 b of the other of the first and second sections 502 a , 502 b .
  • an end portion 503 of the outer wall 505 of the first section 502 a may be reduced in size so that a portion of the outer wall 505 is sized to be received in the inner region 506 b of the second section 502 b .
  • a diameter of the outer wall 505 at the end portion 503 of the first section 502 a may be reduced by 1.5 millimeter (mm) diameter so that the outer wall 505 at the end portion 503 has a diameter no greater than 15 millimeters (mm), which may be less than the diameter of at least the portion of the inner region 506 b in which the end portion 503 is to be received.
  • the telescopic section 504 ′ may be a separate component that is slidingly received in the inner regions 506 a , 506 b of both the first and second sections 502 a , 502 b.
  • the telescopic section 504 may be located at a variety of different positions along the dynamizing intramedullary nail 500 .
  • the telescopic section 504 may be in the distal region ( FIG. 50A ), the midsection ( FIG. 50B ), or the proximal region ( FIG. 50C ). Such various positioning may facilitate continuous dynamic loading for different types of fractures.
  • a distal end 508 a and/or proximal end 508 b of the telescopic section 504 , 504 ′ may include one or more guides or feet 510 that may assist in retaining the first section 502 a or the second section 502 b in alignment along a central longitudinal axis 512 of the dynamizing nail 500 .
  • the guides or feet 510 extend from an inner wall 514 of the first or second section 502 a , 502 b in which the telescopic section 504 is slidingly received.
  • an outer wall 516 of the telescopic section 504 , 504 ′ may be sized relative to the mating inner region 506 a , 506 b into which the telescopic section 504 is slidingly received so as to prevent misalignment of the first and second sections 502 a , 502 b along the central longitudinal axis 512 .
  • the inner region 506 a , 506 b in which the telescopic section 504 is slidingly received may include one or more protrusions 518 that are configured to limit axial displacement of the telescopic section 504 .
  • the protrusions 518 may be positioned to at least limit the degree to which the first and/or second sections 502 a , 502 b may be axially displaced in a manner that decreases the length of the dynamizing nail 500 .
  • one more protrusions 518 may be positioned within the inner region 506 a , 506 b in a manner that limits the degree to which one or both of the first and second sections 502 a , 502 b may increase the length of the dynamizing nail 500 .
  • the protrusions 518 may take a variety of different forms, including, for example, being a washer that is retained in position by a mechanical fastener 520 , such as, for example, a screw or pin, among other protrusions 518 and fasteners 520 . According to the embodiment illustrated in FIGS.
  • the protrusion 518 may be a pin that extends through one of the first and second sections 502 a , 502 b , and which is received in a slot 522 of the outer wall 516 of the telescopic section 504 , 504 ′.
  • a size of the slot 522 such as a length, may limit the distance that one or both of the first and second sections 502 a , 502 b may be displaced relative to each other. Further, as indicated by FIG.
  • axial displacement may be limited by a shoulder 524 of the first or second section 502 a , 502 b that is larger than the size of the adjacent inner region 506 a , 506 b of the other section 502 a , 502 b.
  • the dynamizing nail 500 can be equipped with at least one mechanical actuator 526 that may bias and/or influence the orientation of the dynamizing nail 500 .
  • the actuator 526 may be a spring that exerts a force against opposing regions of the first and second sections 506 a , 506 b to extend or compress the length of the dynamizing nail 500 .
  • the actuator 526 may be a spring that is configured to extend a force against the shoulder 524 of the first section 502 a , and against an end wall 528 of the second section 502 b .
  • the actuator 526 may exert a force against end walls 528 a , 528 b of the first and second sections 502 a , 502 b , respectively.
  • the actuator 526 may be a spring that can be linear or non-linear in nature, as indicated in FIG. 51 .
  • non-linear or variable rate springs may offer enhanced control and support to shield against excessive impact forces that apply to the bone ends.
  • non-linear springs include, but are not limited to, conical springs, as well as variable pitch or variable diameter wire springs. Equation 1 represents the general non-linear spring force displacement relationship:
  • the actuator 526 may further include a dash pot, which, for example, may be used along with the spring to provide more uniform and steady displacement to stabilize the bone ends displacement during weight bearing.
  • the actuator 526 may facilitate or otherwise allow axial movement that is comparable to displacement that may be cause by conventional dynamization of the distal screw.
  • the actuator(s) 526 may facilitate axial displacement of around 1 to 5 millimeters (mm).
  • on-board actuator(s) 526 may also provide controlled, cyclic compression forces, control the size of a gap between the ends of the fractured bone, and provide adjustable intramedullary nail stiffness, thereby at least assisting in making the nail 500 more compliant with the surrounding bone as healing progresses.
  • FIGS. 52A and 52B provide schematic illustrations of an actuated-loaded dynamizing nail 600 in a long bone fracture highlighting the degradation of a resorbable polymer.
  • the degradation of the resorbable polymer may also, simultaneously, allow an embedded actuator 626 to engage over time and release one or more bioactive agents capable of stimulating fracture healing and/or reducing infection.
  • the actuator 626 may be a spring (constant or variable rate) that is housed in a resorbably biocompatible polymer encapsulate that simultaneously controls spring compression or a glassy non-resorbably polymer such as polyethylene that relaxes on exposure to an externally applied inductive heater.
  • suitable resorbably biocompatible polymers may include, but are not limited to, poly(caprolactone), poly(lactic acid), and poly(glycolic acid), among other resorbably biocompatible polymers.
  • Degradation of the polymer may place the actuator 626 in the actuator's 626 relaxed state, thereby providing a continuous cyclic loading to the fractured bone 632 a , 632 b .
  • relaxation of a glassy polymer through inductive heating will also allow the spring to respond under cyclical forces. According to such situations, the ends 630 a , 630 b of the fractured bone 632 a , 632 b may be supported when forces are applied to the construct.
  • the bone segments 632 a , 632 b may then move relative to each other when the polymer encapsulate is no longer capable of carrying a load as a consequence of either inductive heating or degradation.
  • the glassy non-resorbable polymer can prevent the movement of the spring if the inductive heater is removed from the limb allowing the polymer to crystallize and stiffen.
  • the mechanism may be optimized to facilitate just compression of the fracture gap 634 so as to not impede bone healing, which could be delayed if the fracture gap 634 were to be stretched and the bone ends 630 a , 630 b were pulled apart.
  • the actuator 626 could be encapsulated in its extended state, allowing the two bone fragments 632 a , 632 b to be pulled together as the polymer encapsulate degrades away.
  • the actuator 626 and/or the polymer encapsulate can also be filled with active agents or molecules to help facilitate fracture healing and/or reduce bacterial colonization of the implant 600 using growth factors.
  • active agents may include, but are not limited to, heavy metal ions, such as, for example, gold and silver.
  • the polymer encapsulated actuator 626 is activated periodically by an external application of physical energy, such as, for example, heat, ultrasound, or electricity. Such activation may facilitate an altering of physical properties of the polymer encapsulate, such as, for example, like Young's Modulus of flexural modulus, among other properties. Such alteration of physical properties of the polymer encapsulate may change the polymer encapsulate from being in a condition in which the polymer encapsulate at least assists in impeding or otherwise resisting relative axial displacement of first and/or second portions 602 a , 602 b of the nail 600 that may otherwise result in compression or expansion of the length of the dynamizing nail 600 . Thus, movement of the actuator 626 can be provided on-demand.
  • physical energy such as, for example, heat, ultrasound, or electricity.
  • Such activation may facilitate an altering of physical properties of the polymer encapsulate, such as, for example, like Young's Modulus of flexural modulus, among other properties.
  • the telescopic section 504 , 604 of the dynamizing intramedullary nail 500 , 600 can be developed so that it offers either unidirectional or bi-directional translation, as illustrated, for example, in FIGS. 53A and 53B , respectively. Further, rotation of the telescopic section 504 , 604 , as well as other components of the nail 500 that are coupled to the telescopic section 504 , 604 , may be presented by flutes 530 on medial and lateral aspects of the inner portion or sleeve 532 of the telescopic section 504 , 604 . An example of a similar flute 820 and the mating recess 822 is also shown in FIG. 58A .
  • the insertion of the previously discussed protrusion 518 such as, for example, screw or pin, that extends through a machined slot 522 in an inner section of the intramedullary nail 500 , 600 can be used to prevent rotation of the first and second sections 502 a , 502 b while keeping the mechanical actuator 526 located within the recessed region of the nail 500 .
  • the protrusion 518 could also be mechanically adjusted by a surgeon to control the displacement of the mechanical actuator 526 .
  • the protrusion 518 may be located in the nail 500 to prevent the fracture gap from increasing.
  • FIG. 56 illustrates the effect of wall thickness on the mechanical stiffness measurements of three intramedullary nails, namely (1) a standard nail, (2) a nail having a machined recess in a section of the outside diameter of the nail that provides a 25% reduction in the recessed section of the nail, and (3) a nail having a machined section in a portion of the inner diameter of the nail that provides a 25% increase in the size of the inner diameter of the nail at that machined section the nail. More specifically, FIG. 56 illustrates measured stiffness for each of the three above-identified nails for four external diameters, namely, diameters of 13, 11.5, 10, and 8.9 millimeters (mm).
  • housing an actuator such as, for example, the actuator 526 , 626 , shown in FIGS. 52A-53B , in an inner portion of the intramedullary nail 500 , 600 may, compared to actuators that are positioned on the external surface of the nail 500 , 600 , have a smaller impact on fatigue performance, and may be constructed via use of additive manufacturing.
  • the actuator 526 , 626 may be a bushing that is structured to create cyclic loading locally at the fracture site.
  • the bushing may be constructed from a variety of materials, including, for example, an elastomeric material, such as, for example rubber, among other materials.
  • the bushing may be a substitute for at least certain types of actuator 526 , 626 , such as variable rate springs. Further, as demonstrated by FIG.
  • the bushing 700 a - c may have a wall 702 that generally defines an inner region 704 of the bushing 700 , and which is size to receive at least a portion of the first and/or second sections 502 a , 502 b , 602 a , 602 b of the nail 500 , 600 .
  • an outer portion of the wall 702 may have a variety of shapes and sizes.
  • a dynamizing intramedullary nail 800 may further include a activatable shape memory sleeve or collar 802 , as shown in FIG. 58A-58C , that is structured to control displacement of an actuator 804 , such as, for example, control the displacement experienced by spring actuator and the resultant forces exerted on the bone.
  • the sleeve or collar 802 may be positioned about a telescopic section 806 of the nail 800 that is sized to be received in the inner region 812 of the first section 810 a and/or second section 810 b of the nail 800 .
  • a first end 814 a of the sleeve or collar 802 may be positioned to abut against an adjacent end of the actuator 804
  • a second end 814 b of the sleeve or collar 802 may be positioned to abut against an adjacent portion of the second section 810 b
  • the sleeve or collar 802 and actuator 804 are located in the distal region of the nail 800 .
  • the sleeve or collar 802 , along with the actuator 804 may be positioned at a variety of other locations along the nail 800 .
  • the sleeve or collar 802 may be a shape memory collar, such as, for example, a shape memory polymer or metal allow that is trained to contract when activated, such as, for example, upon being heated above body temperature, to accommodate fixed translation of the actuator 804 .
  • the sleeve or collar 802 may be constructed from a piezoelectric material that, upon being activated from an inactive state to an active state, deforms in response to an externally applied voltage in a manner that increases or decreases a size of the sleeve or collar 802 .
  • the sleeve or collar 802 may provide a locking mechanism for the self dynamizing nail 800 as the sleeve or collar 802 is adjusted from being in an active or inactive state.
  • the sleeve or collar 802 may have a first size, such as a length (as indicated by “L” in FIG. 58A ) when in one of the active or inactive state that is larger than a second size of the collar or sleeve 802 when the collar or sleeve 802 is in the other of the active or inactive state.
  • the overall length of the sleeve or collar 802 and the actuator 804 assembly or combination may be generally constant in regardless of whether the sleeve or collar 802 is in the inactive state and or active state. Such differences in the size of the sleeve or collar 802 when the sleeve or collar 802 is in the active or inactive state may alter whether the actuator 804 is in a compressed or at least partially uncompressed state.
  • the actuator 804 may be in its compressed state when the shape memory sleeve or collar 802 has a first size or length that at least assists in compressing the actuator 804 to a compressed state.
  • the spring actuator 804 may expand from the compressed state to an extended, or partially extended state, and thereby at least assist in accommodating an adjustment, even if temporary, in a corresponding length of the dynamizing nail 800 .
  • displacement of the actuator 804 may be controlled by the use of an adjustable controller 816 , such as, for example, a pin or screw.
  • the adjustable controller 816 may be received in an aperture 817 in the second section 810 b , as well as in a slot 818 in the outer wall 808 of the first section 810 a that is sized to be received in the inner region 812 of the second section 810 b .
  • the controller 816 may be mechanically adjustable by a surgeon, and may be configured to prevent fractured bone segments from becoming pulled apart during motion of the actuator 804 . Additionally, according to certain embodiments, the controller 816 may be tightened so as to prevent the relative displacement of the first and second sections 810 a , 810 b.
  • the dynamizing intramedullary nail 900 may include one or more biasing elements 902 a , 902 b , such as, for example, springs, which are each encapsulated in resorbably housings 904 .
  • the purpose of the counterbalancing springs is to shield the fractured bone from excessive and impact forces that may disturb the healing process.
  • the encapsulated biasing elements 902 a , 92 b and intermediary element 906 may be sized to be positioned within a slot 906 in the nail 900 .
  • This slot can be located at either the proximal, mid shaft or distal region of the nail
  • the resorbable housing 904 may prevent activation of the biasing elements 902 a , 902 b .
  • the biasing elements 902 a , 902 b may exert, via the resorbably housings 904 , a force against an intermediary element 906 , such as for example, a portion of a screw, which is positioned between the resorbable housings 904 .
  • the associated biasing element 902 a , 902 b of the degraded resorbably housing(s) 904 may be able to be in an active state in which the biasing element(s) 902 a , 902 b extend toward, and/or to, partial or full expanded or relaxed states, and wherein the biasing elements 902 a , 902 b may provide support only for compression of the fracture gap.
  • the use of such biasing elements 902 a , 902 b is advantageous in making the nail 900 self-adjusting and controlled, and shielding the fracture from excessive and impact forces that may disturb the healing process.
  • C Variable Stiffness Nail in the Anterior-Posterior (A/P) and Medial-Lateral (M/L) Planes: the ability to independently control bending or torsional stiffness in either the A/P or M/L plane may permit an intramedullary nail to be structured to attain optimal fracture healing or reduced the incidence of periprosthetic fracture. A localized reduction in bending stiffness at the distal end of the nail could prevent the risk of per-prosthetic fracture if the patient received a joint replacement.
  • the various cross sections shown in items B-H in FIG. 60 may provide the following reductions in moment of inertia in the A/P plane: 11% for item B; 17-28% for item C; 7% for item D; 8% for item E; 14% for item P; 7% for item G; and, 10% for item H.
  • FIGS. 61A and 61B provide torsional and bending stiffness data based on a standard 10 millimeter Trigen Meta tibial nail and 10 millimeter Trigen Meta tibial nails that have different sized slots on an outer surface of the nails. Moreover, FIGS. 61A and 61B illustrate the sensitivity of cross-sectional geometry on mechanical performance. As depicted, compared to a standard nail, the inclusion of a narrow (1.5 millimeter), a wide (3 millimeter), or stepped slot (1.5-3 millimeter) on the outside of the nails in the A/P plane reduced torsional stiffness from 3.5 Nm/Degree to less than 1 Nm/Degree.
  • FIG. 62 illustrates a cross section view of an intramedullary nail 1000 having a tapered inner wall 1002 at a mid-section 1004 of the nail 1000 that is located between the distal and proximal screw holes of the nail 1000 .
  • the tapered mid-section 1002 may be dovetail shaped.
  • Such a tapered configuration on the inside surface 1006 of the cannulation of the nail 1000 may have a pronounced effect on torsional stiffness, which could have a beneficial impact if this design feature intersects the fracture site. Further, such a nail 1000 could allow rapid uptake of load during the early stage of fracture healing without comprising the fatigue properties of the nail 1000 .
  • FIG. 63 provides a table identifying theoretical bending and torsional stiffness in the mid-section 1004 of the intramedullary nail 1000 (“Custom wall thickness”) with a tapered inner wall 1002 and an outer diameter 1008 .
  • the theoretical values for the Trigen Meta tibial nail (“Standard”) is also included in the table in FIG. 63 .
  • the reduction in theoretical bending and torsional stiffness for the intramedullary nails 1000 having a tapered inner wall 1002 for the three identified outer diameter 1008 sizes, namely an outer diameter of 10 millimeter (mm), 11.5 millimeter, and 13 millimeter, assuming a constant wall thickness of 1.5 millimeter, is 17%, 27% and 21.3% respectively.
  • the theoretical bending stiffness for a 10 millimeter (mm) outer diameter nail 1000 equipped with a customized, tapered inner wall 1002 in the mid-section 1004 is calculated to be 42.5 N.m 2 .
  • This customized section of the nail 1000 has a bending stiffness comparative to: a solid profile AO Universal Tibial Nail (Synthes) having a 9 millimeter outer diameter, which was determined to be 40 N.m 2 ; an un-slotted profile nail, e.g. a B&K nail, which is determined to be 34 N.m 2 ; and, a slotted profile nail having a wall thickness 1.2 millimeter, e.g. a K&S nail, which is determined to be 40 N.m 2 .
  • a solid profile AO Universal Tibial Nail (Synthes) having a 9 millimeter outer diameter, which was determined to be 40 N.m 2
  • an un-slotted profile nail e.g. a B&K nail, which is determined
  • the theoretical torsional stiffness of a customized nail 1000 having a tapered inner wall 1002 in the mid-section 1004 , a 1.5 millimeter (mm) wall thickness, and 10 millimeter outer diameter is 29.8 N.m 2 .
  • This stiffness is comparable to a 9.0 millimeter (mm) outer diameter Russell Taylor Delta Nail (22.5 N.m 2 ) and an 8.5 millimeter (mm) outer diameter Trigen Meta tibial nail (18.4 N.m 2 ).
  • FIGS. 7A-7D, 64A-66 and 69 provide additional implant designs that offer reduced stiffness for larger patients. Such designs may include recesses into or though the wall of the nail.
  • FIG. 64A illustrates a cutaway view
  • FIG. 64B illustrates a cross sectional view of a portion, of a mid-section 1102 of an intramedullary nail 1000 that is equipped with circumferentially arranged internal flutes 1104 in an inner wall section 1106 of the nail 1100 .
  • the flutes 1104 may be positioned in the mid-section 1102 of the nail 1100 between the distal and proximal screw holes 1108 a , 1108 b .
  • the inclusion of flutes 1104 may reduce the theoretical bending stiffness of the nail 1100 .
  • a standard 10 millimeter outer diameter, 4.8 millimeter internal diameter nail having a circular cross sectional shape may have a bending stiffness of 51.2 N.m 2 .
  • the inclusion of flutes 1104 to such a nail may reduce the bending stiffness to 48.5 N.m 2 .
  • an intramedullary nail 1200 may include a series of circumferentially arranged open channels 1202 that extend within, and through, the wall 1204 of the nail 1200 .
  • the wall 1204 may include an inner wall section 1203 that generally defines a hollow inner region 1205 of the nail 1200 .
  • the channels 1202 may extend along a mid-section 1206 of the intramedullary nail 1200 , such as, for example, in a region between distal and proximal screw holes 1208 a , 1208 b in the nail 1200 . Further, the channels 1202 may be generally parallel to a central longitudinal axis 1210 of the nail 1200 .
  • the channels 1202 may also be arranged along one or more diameters. For example, as shown in FIG. 66 , according to certain embodiments, at least a portion of the channels 1202 may be arranged about a first, outer diameter 1212 a while other channels are arranged about a second, smaller inner diameter 1212 b .
  • the channels 1202 may also have a variety of different shapes and sizes, such as, for example, being cylindrical in shape. While the above example, has been discussed in terms of the mid-section 1206 of the nail, the discussed channel 1202 structure may also be used with other portions of the implant so as to ensure that the fracture site can intersect with a low modulus portion of the nail 1200 .
  • the nail 1200 shown in FIGS. 65 and 66 may include 35 circumferentially arranged channels 1202 that have approximately a 1 millimeter diameter circular cross-sectional shape.
  • the inclusion of such channels 1202 in the wall 1204 of a nail 1200 that has a 13 millimeter outside diameter and a 4.8 millimeter diameter inner wall section 1200 may reduce the volume fraction of material, such as, for example, titanium, in the wall 1204 of the implant from 100% to 76%, with the volume fraction of the voids in the wall 1204 provided by the channels 1202 being 24%, thereby creating a lower porosity structure.
  • the theoretical bending and torsional stiffness of the nail 1200 may be reduced from 155.9.N.m 2 /119.2 N.m 2 to 110.1/83.4 N.m 2 respectively.
  • FIG. 68 provides an elastic modulus versus density diagram that may be used to estimate the degree of porosity required to match the elastic modulus of cortical bone.
  • the Elastic Moduli for nonporous Titanium-64, 316 stainless steel, and cobalt chromium are 114 gigapascal (GPa), 193 GPa and 235 GPa, respectively.
  • the density of bone, Ti-64 and 316 stainless steel may be 2.4 g/cm 3 , 4.7 g/cm 3 and 8.8 g/cm 3 , respectively.
  • a porous titanium implant may help reduce the stiffness mismatch between the implant, such as an intramedullary nail, and bone tissue, and thereby reduce stress shielding.
  • increasing porosity and pore size may result in a reduction of the implant mechanical properties.
  • the balance between mechanical properties and biological performance may vary for different implant applications.
  • the elastic modulus of an intramedullary nail 1300 can also be modulated by housing a detachable inner section 1302 in at least a portion of an outer section 1304 of the nail 1300 .
  • the inner section 1302 may be fixed to the inside surface 1306 of the intramedullary nail 1300 at one of the proximal end 1308 a and distal end 1308 b of the nail, but is detachable via a locking screw (not shown) at the other of the proximal end 1308 a or distal end 1308 b of the nail 1300 .
  • the inner section 1302 includes a wall 1310 having an outer portion 1312 and an inner portion 1314 , the inner portion 1314 of the wall 1310 generally defining a hollow inner region of the inner section 1302 .
  • the outer portion 1312 of the wall 1310 is sized to accommodate lateral displacement of the inner section 1302 about the outer section 1304 of the nail 1300 , as well as displacement of at least connected portions of the proximal end 1308 a and the nail 1300 relative to distal end 1308 b of the nail 1300 , or vice versa.
  • Such a variable modulus nail 1300 may enable the implant to present a higher stiffness during fracture healing, which may be useful for at least severely comminuted fractures where greater nail stiffness and stabilization are required during initial healing.
  • the configuration of intramedullary nail 1300 may enable, once the fractured bone has healed, a reduction in the elastic modulus of the nail 1300 in a minimally invasive fashion and without the need for removing the nail 1300 .
  • loading on the bone could increase significantly, which could lead to re-fracture in situations where there was significant patient activity.
  • Such situations may include osteoporotic fractures where high-rigidity nails, such as, for example, nails having approximately 300% of the bending rigidity of an osteoporotic femur, can reduce bone strength.
  • a low-rigidity nail such as, for example, the intramedullary nail 1300 of FIG. 69 with the detachable inner section 1302 , may reduce the effects of stress shielding, and may result in less bone resorption than relatively stiffer nails.
  • FIG. 70 illustrates a table that provides a comparison between the bending and torsional stiffness of standard Trigen Meta tibial nails having 8.5 millimeter (mm) and 10 mm outer diameters, and a “custom” nail similar to the nail 1300 illustrated in FIG. 69 that has a 10 millimeter outer section. Further, the “custom” nail referenced in FIG. 70 has an inner section 1302 having wall 1310 that includes an outer portion 1312 having a 7.6 millimeter diameter and an inner portion 1314 having a 4.8 mm diameter. As shown in FIG. 70 , the torsional and bending stiffness of such a nail may be 8.5/26.2 N.m 2 and 12.1/37.3 N.m 2 respectively.
US15/302,899 2014-04-11 2015-04-10 Dmls orthopedic intramedullary device and method of manufacture Abandoned US20170027624A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US15/302,899 US20170027624A1 (en) 2014-04-11 2015-04-10 Dmls orthopedic intramedullary device and method of manufacture

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201461978804P 2014-04-11 2014-04-11
US201461978806P 2014-04-11 2014-04-11
US15/302,899 US20170027624A1 (en) 2014-04-11 2015-04-10 Dmls orthopedic intramedullary device and method of manufacture
PCT/US2015/025429 WO2015157703A2 (en) 2014-04-11 2015-04-10 Dmls orthopedic intramedullary device and method of manufacture

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2015/025429 A-371-Of-International WO2015157703A2 (en) 2014-04-11 2015-04-10 Dmls orthopedic intramedullary device and method of manufacture

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US16/560,703 Continuation US20190388128A1 (en) 2014-04-11 2019-09-04 Dmls orthopedic intramedullary device and method of manufacture

Publications (1)

Publication Number Publication Date
US20170027624A1 true US20170027624A1 (en) 2017-02-02

Family

ID=53005701

Family Applications (2)

Application Number Title Priority Date Filing Date
US15/302,899 Abandoned US20170027624A1 (en) 2014-04-11 2015-04-10 Dmls orthopedic intramedullary device and method of manufacture
US16/560,703 Pending US20190388128A1 (en) 2014-04-11 2019-09-04 Dmls orthopedic intramedullary device and method of manufacture

Family Applications After (1)

Application Number Title Priority Date Filing Date
US16/560,703 Pending US20190388128A1 (en) 2014-04-11 2019-09-04 Dmls orthopedic intramedullary device and method of manufacture

Country Status (8)

Country Link
US (2) US20170027624A1 (ja)
EP (1) EP3129175A2 (ja)
JP (1) JP2017520282A (ja)
CN (2) CN112869855A (ja)
AU (3) AU2015243170A1 (ja)
CA (1) CA2945347A1 (ja)
RU (1) RU2016143164A (ja)
WO (1) WO2015157703A2 (ja)

Cited By (40)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160262786A1 (en) * 2015-03-10 2016-09-15 Ethicon Endo-Surgery, Llc Surgical blades with fatigue resistant properties
US20170020571A1 (en) * 2007-12-07 2017-01-26 Nexus Spine, LLC Additive manufacturing for spinal implants
US20170370005A1 (en) * 2016-06-28 2017-12-28 Delavan Inc Additive manufacturing processing with oxidation
US20180085830A1 (en) * 2016-09-28 2018-03-29 General Electric Company Grain boundary engineering for additive manufacturing
US20190049921A1 (en) * 2016-03-17 2019-02-14 Siemens Aktiengesellschaft Method for determining the orientation of a part to be additively manufactured, and computer-readable medium
US10239218B1 (en) 2018-01-30 2019-03-26 Disney Enterprises, Inc. Structural frame for covered and animated segments of a robotic figure
US20200029980A1 (en) * 2018-07-24 2020-01-30 DePuy Synthes Products, Inc. Intramedullary nail with wire or magnet for targeting of a bone-anchor locking hole
US10779848B2 (en) 2006-01-20 2020-09-22 Ethicon Llc Ultrasound medical instrument having a medical ultrasonic blade
US10828057B2 (en) 2007-03-22 2020-11-10 Ethicon Llc Ultrasonic surgical instruments
US10828059B2 (en) 2007-10-05 2020-11-10 Ethicon Llc Ergonomic surgical instruments
US10835768B2 (en) 2010-02-11 2020-11-17 Ethicon Llc Dual purpose surgical instrument for cutting and coagulating tissue
US10842580B2 (en) 2012-06-29 2020-11-24 Ethicon Llc Ultrasonic surgical instruments with control mechanisms
US10856896B2 (en) 2005-10-14 2020-12-08 Ethicon Llc Ultrasonic device for cutting and coagulating
US10869700B2 (en) * 2011-07-15 2020-12-22 Smith & Nephew, Inc. Fiber-reinforced composite orthopaedic device having embedded electronics
US10875250B2 (en) * 2017-01-15 2020-12-29 Hexcel Corporation Method for analytically determining laser power for laser sintering
US10874418B2 (en) 2004-02-27 2020-12-29 Ethicon Llc Ultrasonic surgical shears and method for sealing a blood vessel using same
US10921238B2 (en) 2018-02-02 2021-02-16 Concept Laser Gmbh Device for determining at least one component parameter of a plurality of, particularly additively manufactured, components
US20210053261A1 (en) * 2016-08-12 2021-02-25 Smith & Nephew, Inc. Forming of additively manufactured product
US10952759B2 (en) 2016-08-25 2021-03-23 Ethicon Llc Tissue loading of a surgical instrument
US10966744B2 (en) 2016-07-12 2021-04-06 Ethicon Llc Ultrasonic surgical instrument with piezoelectric central lumen transducer
US11000707B2 (en) 2009-06-24 2021-05-11 Ethicon Llc Ultrasonic surgical instruments
US11006971B2 (en) 2004-10-08 2021-05-18 Ethicon Llc Actuation mechanism for use with an ultrasonic surgical instrument
US11020140B2 (en) 2015-06-17 2021-06-01 Cilag Gmbh International Ultrasonic surgical blade for use with ultrasonic surgical instruments
US11033292B2 (en) 2013-12-16 2021-06-15 Cilag Gmbh International Medical device
USD924400S1 (en) 2016-08-16 2021-07-06 Cilag Gmbh International Surgical instrument
US11058447B2 (en) 2007-07-31 2021-07-13 Cilag Gmbh International Temperature controlled ultrasonic surgical instruments
US11167375B2 (en) 2018-08-10 2021-11-09 The Research Foundation For The State University Of New York Additive manufacturing processes and additively manufactured products
US11253288B2 (en) 2007-11-30 2022-02-22 Cilag Gmbh International Ultrasonic surgical instrument blades
US11272952B2 (en) 2013-03-14 2022-03-15 Cilag Gmbh International Mechanical fasteners for use with surgical energy devices
US11280324B2 (en) * 2016-01-05 2022-03-22 Gibson Elliot Matrix controlled shape memory actuator array
US11350959B2 (en) 2016-08-25 2022-06-07 Cilag Gmbh International Ultrasonic transducer techniques for ultrasonic surgical instrument
US11369402B2 (en) 2010-02-11 2022-06-28 Cilag Gmbh International Control systems for ultrasonically powered surgical instruments
US11407034B2 (en) 2017-07-06 2022-08-09 OmniTek Technology Ltda. Selective laser melting system and method of using same
US11428614B2 (en) * 2015-03-24 2022-08-30 Textron Innovations Inc. Notch treatment methods for flaw simulation
US11439426B2 (en) 2007-11-30 2022-09-13 Cilag Gmbh International Ultrasonic surgical blades
US11553954B2 (en) 2015-06-30 2023-01-17 Cilag Gmbh International Translatable outer tube for sealing using shielded lap chole dissector
US11607268B2 (en) 2007-07-27 2023-03-21 Cilag Gmbh International Surgical instruments
US11666784B2 (en) 2007-07-31 2023-06-06 Cilag Gmbh International Surgical instruments
US11690641B2 (en) 2007-07-27 2023-07-04 Cilag Gmbh International Ultrasonic end effectors with increased active length
US11877734B2 (en) 2007-07-31 2024-01-23 Cilag Gmbh International Ultrasonic surgical instruments

Families Citing this family (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10687956B2 (en) 2014-06-17 2020-06-23 Titan Spine, Inc. Corpectomy implants with roughened bioactive lateral surfaces
TWI726940B (zh) 2015-11-20 2021-05-11 美商泰坦脊柱股份有限公司 積層製造整形外科植入物之方法
JP6914266B2 (ja) * 2015-11-20 2021-08-04 タイタン スパイン インコーポレイテッドＴｉｔａｎ Ｓｐｉｎｅ，Ｉｎｃ． 整形外科インプラントを付加製作するための方法
WO2018026448A1 (en) 2016-08-03 2018-02-08 Titan Spine, Llc Titanium implant surfaces free from alpha case and with enhanced osteoinduction
US10631935B2 (en) 2016-10-25 2020-04-28 Biosense Webster (Israel) Ltd. Head registration using a personalized gripper
CN107377976B (zh) * 2017-07-06 2021-07-16 苏州恒久光电科技股份有限公司 金属料浆3d打印无模凝胶成形方法
US11701557B2 (en) 2017-08-10 2023-07-18 Taylor Made Golf Company, Inc. Golf club heads
US11224940B2 (en) * 2018-02-05 2022-01-18 General Electric Company Powder bed containment systems for use with rotating direct metal laser melting systems
CN111902373B (zh) * 2018-02-26 2022-07-15 康宁公司 用于电缆线的支撑设备
FR3079151B1 (fr) * 2018-03-23 2020-10-30 Safran Aircraft Engines Optimisation des supportages pour la fabrication additive de piece avec un evidement
WO2019210285A2 (en) 2018-04-26 2019-10-31 San Diego State University Selective sintering-based fabrication of fully dense complex shaped parts
JP7433011B2 (ja) * 2018-10-16 2024-02-19 テイラー メイド ゴルフ カンパニー， インコーポレーテッド ゴルフクラブヘッド
JP6964797B2 (ja) 2018-11-01 2021-11-10 三菱電機株式会社 空調システム及び空調管理システム
CN112656498A (zh) * 2020-05-27 2021-04-16 北京科仪邦恩医疗器械科技有限公司 钉棒系统表面处理方法及钉棒系统
CN114309642B (zh) * 2020-09-29 2024-01-12 中国航发商用航空发动机有限责任公司 航空发动机部件的增材制造方法和可读存储介质
CN112404433B (zh) * 2020-10-30 2023-03-10 嘉思特华剑医疗器材(天津)有限公司 含氧化层锆铌合金分区骨小梁单间室胫骨平台及制备方法
CN112404432B (zh) * 2020-10-30 2023-03-31 嘉思特华剑医疗器材(天津)有限公司 含氧化层锆铌合金骨小梁单间室股骨髁假体及制备方法
CN112296342B (zh) * 2020-10-30 2023-03-10 嘉思特华剑医疗器材(天津)有限公司 含氧化层锆铌合金分区骨小梁单间室股骨髁及制备方法
CN112404431B (zh) * 2020-10-30 2023-03-10 嘉思特华剑医疗器材(天津)有限公司 含氧化层锆铌合金髋关节假体系统及制备方法
CN112472370A (zh) * 2020-11-13 2021-03-12 天衍医疗器材有限公司 一种单髁膝关节假体及其制造方法
CN112570718A (zh) * 2020-11-13 2021-03-30 天衍医疗器材有限公司 一种胫骨平台及其制备方法
CN113146164B (zh) * 2021-04-30 2022-12-02 宁波兆盈医疗器械有限公司 一种胫骨髓内钉加工工艺
CN114433873B (zh) * 2022-02-25 2023-06-06 鑫精合激光科技发展（北京）有限公司 一种增材制造方法
CN115635082A (zh) * 2022-10-12 2023-01-24 北京科技大学 一种可降解多孔金属骨钉及其增材制造方法
JP7404566B1 (ja) * 2023-01-06 2023-12-25 株式会社スギノマシン 外科用インプラントの表面処理方法、及び外科用インプラント

Citations (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4475545A (en) * 1982-12-06 1984-10-09 Ender Hans G Bone-nail
US4784127A (en) * 1986-01-18 1988-11-15 Kernforschungszentrum Karlsruhe Gmbh Device for fixing the fractured ends of a bone
US4877019A (en) * 1986-12-02 1989-10-31 Pierre Vives Intramedullary nail and apparatus for its insertion
US5573536A (en) * 1991-08-09 1996-11-12 Howmedica Gmbh Locking nail for treating femoral fractures
US5993456A (en) * 1997-03-19 1999-11-30 Howmedica Gmbh Device for manufacturing a lateral bore in a tubular bone
US20030069581A1 (en) * 2001-10-04 2003-04-10 Stinson David T. Universal intramedullary nails, systems and methods of use thereof
US6558388B1 (en) * 1999-08-30 2003-05-06 Sulzer Orthopedics Ltd. Intramedullary nail for the humerus
US20050203517A1 (en) * 2003-09-24 2005-09-15 N Spine, Inc. Spinal stabilization device
US20070100343A1 (en) * 2003-05-17 2007-05-03 Cole Dean J Intramedullary nail assembly
US20070118243A1 (en) * 2005-10-14 2007-05-24 Vantus Technology Corporation Personal fit medical implants and orthopedic surgical instruments and methods for making
US20070233064A1 (en) * 2006-02-17 2007-10-04 Holt Development L.L.C. Apparatus and method for flexible spinal fixation
US20080262496A1 (en) * 2004-06-30 2008-10-23 Sythes (U.S.A.) Surgical Nail
US20080269745A1 (en) * 2007-04-24 2008-10-30 Osteolign, Inc. Thermo-chemically activated intramedullary bone stent
US20090028919A1 (en) * 2000-10-06 2009-01-29 Michael Dancu Systems and methods of promoting engraftment of a hybrid lower limb artery bypass vascular graft in a mammal
US20110178520A1 (en) * 2010-01-15 2011-07-21 Kyle Taylor Rotary-rigid orthopaedic rod
US20120245700A1 (en) * 2011-03-24 2012-09-27 Sidebotham Christopher G Load bearing implants
US20140228845A1 (en) * 2013-02-08 2014-08-14 Jonathan Feibel Systems, methods, and apparatuses for fusion, stabilization, or fixation of bones
US9072545B2 (en) * 2008-05-06 2015-07-07 Biedermann Technologies Gmbh & Co. Kg Rod-shaped implant, in particular for the dynamic stabilization of the spine

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5477864A (en) * 1989-12-21 1995-12-26 Smith & Nephew Richards, Inc. Cardiovascular guidewire of enhanced biocompatibility
US5344494A (en) * 1993-01-21 1994-09-06 Smith & Nephew Richards, Inc. Method for cleaning porous and roughened surfaces on medical implants
CN2343985Y (zh) * 1998-09-01 1999-10-20 常州市康辉医疗器械有限公司 带远端定位平台的交锁髓内钉
JP3943315B2 (ja) * 2000-07-24 2007-07-11 松下電工株式会社 三次元形状造形物の製造方法
BR0318345A (pt) * 2003-06-12 2006-07-11 Synthes Ag pino cirúrgico
US7771428B2 (en) * 2004-06-11 2010-08-10 Synthes Usa, Llc Intramedullary rod with spiraling flutes
US20060009857A1 (en) * 2004-07-08 2006-01-12 Gibbs Phillip M Method and apparatus for surface hardening implants
US8486070B2 (en) * 2005-08-23 2013-07-16 Smith & Nephew, Inc. Telemetric orthopaedic implant
CN2902213Y (zh) * 2006-03-01 2007-05-23 南方医科大学 早期坚强固定的弹性交锁髓内钉
GB0618612D0 (en) * 2006-09-21 2006-11-01 Smith & Nephew Medical device
EP1913887A1 (en) * 2006-10-20 2008-04-23 Vassilis Kostopoulos Intramedullary leg lengthening nail using shape memory alloys
US8814868B2 (en) * 2007-02-28 2014-08-26 Smith & Nephew, Inc. Instrumented orthopaedic implant for identifying a landmark
US9095391B2 (en) * 2007-06-11 2015-08-04 Aeolin Llc Osseointegration and biointegration coatings for bone screw implants
US8457930B2 (en) * 2009-04-15 2013-06-04 James Schroeder Personalized fit and functional designed medical prostheses and surgical instruments and methods for making
CN102548509B (zh) * 2009-08-19 2016-09-21 史密夫和内修有限公司 多孔植入物结构
US8574273B2 (en) * 2009-09-09 2013-11-05 Innovision, Inc. Bone screws and methods of use thereof
JP5960057B2 (ja) * 2009-11-12 2016-08-02 スミス アンド ネフュー インコーポレーテッド 制御された無作為性の多孔性構造を製作するための方法
JP2011206420A (ja) * 2010-03-30 2011-10-20 Kobayashi Pharmaceutical Co Ltd 髄内釘
EP2575686B1 (en) * 2010-06-03 2019-10-16 Smith & Nephew, Inc. Orthopaedic implants
US8876821B2 (en) * 2010-11-24 2014-11-04 Kyle Kinmon Intramedullary nail, system, and method with dynamic compression
TR201202105A2 (tr) * 2012-02-24 2012-12-21 İstemi̇ Alp Yücel İrşadi̇ Manyetik uzayan çivi.
CN104363860B (zh) * 2012-04-13 2016-04-13 康复米斯公司 用于植入物部件的添加制造的装置和方法
ES2670977T3 (es) * 2013-02-14 2018-06-04 Renishaw Plc. Aparato de solidificación selectiva por láser y método

Patent Citations (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4475545A (en) * 1982-12-06 1984-10-09 Ender Hans G Bone-nail
US4784127A (en) * 1986-01-18 1988-11-15 Kernforschungszentrum Karlsruhe Gmbh Device for fixing the fractured ends of a bone
US4877019A (en) * 1986-12-02 1989-10-31 Pierre Vives Intramedullary nail and apparatus for its insertion
US5573536A (en) * 1991-08-09 1996-11-12 Howmedica Gmbh Locking nail for treating femoral fractures
US5993456A (en) * 1997-03-19 1999-11-30 Howmedica Gmbh Device for manufacturing a lateral bore in a tubular bone
US6558388B1 (en) * 1999-08-30 2003-05-06 Sulzer Orthopedics Ltd. Intramedullary nail for the humerus
US20090028919A1 (en) * 2000-10-06 2009-01-29 Michael Dancu Systems and methods of promoting engraftment of a hybrid lower limb artery bypass vascular graft in a mammal
US20030069581A1 (en) * 2001-10-04 2003-04-10 Stinson David T. Universal intramedullary nails, systems and methods of use thereof
US20070100343A1 (en) * 2003-05-17 2007-05-03 Cole Dean J Intramedullary nail assembly
US20050203517A1 (en) * 2003-09-24 2005-09-15 N Spine, Inc. Spinal stabilization device
US20080262496A1 (en) * 2004-06-30 2008-10-23 Sythes (U.S.A.) Surgical Nail
US20070118243A1 (en) * 2005-10-14 2007-05-24 Vantus Technology Corporation Personal fit medical implants and orthopedic surgical instruments and methods for making
US20070233064A1 (en) * 2006-02-17 2007-10-04 Holt Development L.L.C. Apparatus and method for flexible spinal fixation
US20080269745A1 (en) * 2007-04-24 2008-10-30 Osteolign, Inc. Thermo-chemically activated intramedullary bone stent
US9072545B2 (en) * 2008-05-06 2015-07-07 Biedermann Technologies Gmbh & Co. Kg Rod-shaped implant, in particular for the dynamic stabilization of the spine
US20110178520A1 (en) * 2010-01-15 2011-07-21 Kyle Taylor Rotary-rigid orthopaedic rod
US9730739B2 (en) * 2010-01-15 2017-08-15 Conventus Orthopaedics, Inc. Rotary-rigid orthopaedic rod
US20120245700A1 (en) * 2011-03-24 2012-09-27 Sidebotham Christopher G Load bearing implants
US20140228845A1 (en) * 2013-02-08 2014-08-14 Jonathan Feibel Systems, methods, and apparatuses for fusion, stabilization, or fixation of bones

Cited By (53)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10874418B2 (en) 2004-02-27 2020-12-29 Ethicon Llc Ultrasonic surgical shears and method for sealing a blood vessel using same
US11730507B2 (en) 2004-02-27 2023-08-22 Cilag Gmbh International Ultrasonic surgical shears and method for sealing a blood vessel using same
US11006971B2 (en) 2004-10-08 2021-05-18 Ethicon Llc Actuation mechanism for use with an ultrasonic surgical instrument
US10856896B2 (en) 2005-10-14 2020-12-08 Ethicon Llc Ultrasonic device for cutting and coagulating
US10779848B2 (en) 2006-01-20 2020-09-22 Ethicon Llc Ultrasound medical instrument having a medical ultrasonic blade
US10828057B2 (en) 2007-03-22 2020-11-10 Ethicon Llc Ultrasonic surgical instruments
US11607268B2 (en) 2007-07-27 2023-03-21 Cilag Gmbh International Surgical instruments
US11690641B2 (en) 2007-07-27 2023-07-04 Cilag Gmbh International Ultrasonic end effectors with increased active length
US11666784B2 (en) 2007-07-31 2023-06-06 Cilag Gmbh International Surgical instruments
US11058447B2 (en) 2007-07-31 2021-07-13 Cilag Gmbh International Temperature controlled ultrasonic surgical instruments
US11877734B2 (en) 2007-07-31 2024-01-23 Cilag Gmbh International Ultrasonic surgical instruments
US10828059B2 (en) 2007-10-05 2020-11-10 Ethicon Llc Ergonomic surgical instruments
US11690643B2 (en) 2007-11-30 2023-07-04 Cilag Gmbh International Ultrasonic surgical blades
US11766276B2 (en) 2007-11-30 2023-09-26 Cilag Gmbh International Ultrasonic surgical blades
US11266433B2 (en) 2007-11-30 2022-03-08 Cilag Gmbh International Ultrasonic surgical instrument blades
US11439426B2 (en) 2007-11-30 2022-09-13 Cilag Gmbh International Ultrasonic surgical blades
US11253288B2 (en) 2007-11-30 2022-02-22 Cilag Gmbh International Ultrasonic surgical instrument blades
US20170020571A1 (en) * 2007-12-07 2017-01-26 Nexus Spine, LLC Additive manufacturing for spinal implants
US11000707B2 (en) 2009-06-24 2021-05-11 Ethicon Llc Ultrasonic surgical instruments
US11179582B2 (en) 2009-06-24 2021-11-23 Cilag Gmbh International Ultrasonic surgical instruments
US10835768B2 (en) 2010-02-11 2020-11-17 Ethicon Llc Dual purpose surgical instrument for cutting and coagulating tissue
US11369402B2 (en) 2010-02-11 2022-06-28 Cilag Gmbh International Control systems for ultrasonically powered surgical instruments
US10869700B2 (en) * 2011-07-15 2020-12-22 Smith & Nephew, Inc. Fiber-reinforced composite orthopaedic device having embedded electronics
US10842580B2 (en) 2012-06-29 2020-11-24 Ethicon Llc Ultrasonic surgical instruments with control mechanisms
US11602371B2 (en) 2012-06-29 2023-03-14 Cilag Gmbh International Ultrasonic surgical instruments with control mechanisms
US11272952B2 (en) 2013-03-14 2022-03-15 Cilag Gmbh International Mechanical fasteners for use with surgical energy devices
US11033292B2 (en) 2013-12-16 2021-06-15 Cilag Gmbh International Medical device
US20160262786A1 (en) * 2015-03-10 2016-09-15 Ethicon Endo-Surgery, Llc Surgical blades with fatigue resistant properties
US11428614B2 (en) * 2015-03-24 2022-08-30 Textron Innovations Inc. Notch treatment methods for flaw simulation
US11020140B2 (en) 2015-06-17 2021-06-01 Cilag Gmbh International Ultrasonic surgical blade for use with ultrasonic surgical instruments
US11553954B2 (en) 2015-06-30 2023-01-17 Cilag Gmbh International Translatable outer tube for sealing using shielded lap chole dissector
US11280324B2 (en) * 2016-01-05 2022-03-22 Gibson Elliot Matrix controlled shape memory actuator array
US10908589B2 (en) * 2016-03-17 2021-02-02 Siemens Aktiengesellschaft Method for determining the orientation of a part to be additively manufactured, and computer-readable medium
US20190049921A1 (en) * 2016-03-17 2019-02-14 Siemens Aktiengesellschaft Method for determining the orientation of a part to be additively manufactured, and computer-readable medium
US20170370005A1 (en) * 2016-06-28 2017-12-28 Delavan Inc Additive manufacturing processing with oxidation
US9988721B2 (en) * 2016-06-28 2018-06-05 Delavan, Inc. Additive manufacturing processing with oxidation
US10966744B2 (en) 2016-07-12 2021-04-06 Ethicon Llc Ultrasonic surgical instrument with piezoelectric central lumen transducer
US11883055B2 (en) 2016-07-12 2024-01-30 Cilag Gmbh International Ultrasonic surgical instrument with piezoelectric central lumen transducer
US20210053261A1 (en) * 2016-08-12 2021-02-25 Smith & Nephew, Inc. Forming of additively manufactured product
USD924400S1 (en) 2016-08-16 2021-07-06 Cilag Gmbh International Surgical instrument
US11350959B2 (en) 2016-08-25 2022-06-07 Cilag Gmbh International Ultrasonic transducer techniques for ultrasonic surgical instrument
US10952759B2 (en) 2016-08-25 2021-03-23 Ethicon Llc Tissue loading of a surgical instrument
US11925378B2 (en) 2016-08-25 2024-03-12 Cilag Gmbh International Ultrasonic transducer for surgical instrument
US10639719B2 (en) * 2016-09-28 2020-05-05 General Electric Company Grain boundary engineering for additive manufacturing
US20180085830A1 (en) * 2016-09-28 2018-03-29 General Electric Company Grain boundary engineering for additive manufacturing
US10875250B2 (en) * 2017-01-15 2020-12-29 Hexcel Corporation Method for analytically determining laser power for laser sintering
US11407034B2 (en) 2017-07-06 2022-08-09 OmniTek Technology Ltda. Selective laser melting system and method of using same
US10239218B1 (en) 2018-01-30 2019-03-26 Disney Enterprises, Inc. Structural frame for covered and animated segments of a robotic figure
US10921238B2 (en) 2018-02-02 2021-02-16 Concept Laser Gmbh Device for determining at least one component parameter of a plurality of, particularly additively manufactured, components
US11457934B2 (en) * 2018-07-24 2022-10-04 DePuy Synthes Products, Inc. Intramedullary nail with wire or magnet for targeting of a bone-anchor locking hole
US20200029980A1 (en) * 2018-07-24 2020-01-30 DePuy Synthes Products, Inc. Intramedullary nail with wire or magnet for targeting of a bone-anchor locking hole
US11426818B2 (en) 2018-08-10 2022-08-30 The Research Foundation for the State University Additive manufacturing processes and additively manufactured products
US11167375B2 (en) 2018-08-10 2021-11-09 The Research Foundation For The State University Of New York Additive manufacturing processes and additively manufactured products

Also Published As

Publication number Publication date
AU2015243170A1 (en) 2016-10-27
CA2945347A1 (en) 2015-10-15
AU2022204447A1 (en) 2022-07-14
WO2015157703A3 (en) 2015-12-17
WO2015157703A2 (en) 2015-10-15
RU2016143164A (ru) 2018-05-14
AU2020227095A1 (en) 2020-09-24
EP3129175A2 (en) 2017-02-15
CN106457394A (zh) 2017-02-22
CN112869855A (zh) 2021-06-01
US20190388128A1 (en) 2019-12-26
CN106457394B (zh) 2020-10-02
JP2017520282A (ja) 2017-07-27

Similar Documents

Publication Publication Date Title
US20190388128A1 (en) Dmls orthopedic intramedullary device and method of manufacture
Singla et al. Selective laser melting of Ti6Al4V alloy: Process parameters, defects and post-treatments
Nouri et al. Additive manufacturing of metallic and polymeric load-bearing biomaterials using laser powder bed fusion: A review
Pandey et al. Metallic implants with properties and latest production techniques: a review
Davoodi et al. Additively manufactured metallic biomaterials
Moghadasi et al. A review on biomedical implant materials and the effect of friction stir based techniques on their mechanical and tribological properties
Depboylu et al. Titanium based bone implants production using laser powder bed fusion technology
EP2116210B1 (en) Knee implant
Bartolomeu et al. Additive manufacturing of NiTi-Ti6Al4V multi-material cellular structures targeting orthopedic implants
Dhiman et al. Mechanobiological assessment of Ti-6Al-4V fabricated via selective laser melting technique: a review
EP3936634B1 (en) Preparation method of a medical implant by application of oxidized ceramic layer on surface of zirconium
JP2018534116A (ja) 整形外科インプラントを付加製作するための方法
JP2018535811A (ja) 整形外科インプラントを付加製作するための方法
Al-Tamimi et al. Topology optimised metallic bone plates produced by electron beam melting: a mechanical and biological study
Campanelli A review on the recent advances concerning the fatigue performance of titanium alloys for orthopedic applications
Wu et al. Wear mechanism and tribological characteristics of porous NiTi shape memory alloy for bone scaffold
Mondal et al. Biomedical porous scaffold fabrication using additive manufacturing technique: Porosity, surface roughness and process parameters optimization
Ryniewicz et al. Microstructural and micromechanical tests of titanium biomaterials intended for prosthetic reconstructions
Fashanu et al. Review of surface finishing of additively manufactured metal implants
Stepanov et al. Effect of annealing on the structure and properties of titanium alloy with cellular architecture for medical applications
Mondal et al. Fabrication of Ti-6Al-4V porous scaffolds using selective laser melting (SLM) and mechanical compression test for biomedical applications
Tipan et al. Magnesium based alloys for biodegradable implants applications using additive manufacturing technique: a review
Lietaert et al. Porous metals in orthopedics
RU2338811C1 (ru) Способ получения изделий из титановых сплавов и изделия, полученные этим способом (варианты)
Kumar Emerging trend in manufacturing of 3D biomedical components using selective laser sintering: A review

Legal Events

Date Code Title Description
AS Assignment

Owner name: SMITH & NEPHEW, INC., TENNESSEE

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:WILSON, DARREN J.;HARNESS, DAVID B.;FABER, HENRY;REEL/FRAME:040418/0898

Effective date: 20161017

Owner name: SMITH & NEPHEW, INC., TENNESSEE

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:WILSON, DARREN J.;HARNESS, DAVID B.;FABER, HENRY;REEL/FRAME:040418/0871

Effective date: 20161017

STPP Information on status: patent application and granting procedure in general

Free format text: RESPONSE TO NON-FINAL OFFICE ACTION ENTERED AND FORWARDED TO EXAMINER

STPP Information on status: patent application and granting procedure in general

Free format text: FINAL REJECTION MAILED

STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION