Laser-produced porous structure
11660195 · 2023-05-30
Assignee
Inventors
Cpc classification
B33Y10/00
PERFORMING OPERATIONS; TRANSPORTING
A61F2/30767
HUMAN NECESSITIES
A61F2310/00023
HUMAN NECESSITIES
B23K2103/26
PERFORMING OPERATIONS; TRANSPORTING
A61F2310/00017
HUMAN NECESSITIES
A61F2/30771
HUMAN NECESSITIES
A61F2002/30329
HUMAN NECESSITIES
B33Y80/00
PERFORMING OPERATIONS; TRANSPORTING
A61F2002/30915
HUMAN NECESSITIES
B23K26/082
PERFORMING OPERATIONS; TRANSPORTING
A61F2002/30594
HUMAN NECESSITIES
A61F2310/00413
HUMAN NECESSITIES
A61F2220/0025
HUMAN NECESSITIES
B22F10/80
PERFORMING OPERATIONS; TRANSPORTING
B23K2103/50
PERFORMING OPERATIONS; TRANSPORTING
Y02P10/25
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
A61F2002/3028
HUMAN NECESSITIES
A61F2002/3417
HUMAN NECESSITIES
A61F2310/00544
HUMAN NECESSITIES
B23K26/402
PERFORMING OPERATIONS; TRANSPORTING
A61F2002/30243
HUMAN NECESSITIES
A61F2310/00407
HUMAN NECESSITIES
B23K26/40
PERFORMING OPERATIONS; TRANSPORTING
A61F2002/30736
HUMAN NECESSITIES
A61F2/30907
HUMAN NECESSITIES
B22F10/38
PERFORMING OPERATIONS; TRANSPORTING
A61F2002/3092
HUMAN NECESSITIES
C23C4/02
CHEMISTRY; METALLURGY
C23C24/10
CHEMISTRY; METALLURGY
B23K2103/08
PERFORMING OPERATIONS; TRANSPORTING
A61F2310/00029
HUMAN NECESSITIES
A61F2/4455
HUMAN NECESSITIES
A61F2310/00401
HUMAN NECESSITIES
B22F10/28
PERFORMING OPERATIONS; TRANSPORTING
B22F3/1109
PERFORMING OPERATIONS; TRANSPORTING
A61F2002/3425
HUMAN NECESSITIES
International classification
B22F3/105
PERFORMING OPERATIONS; TRANSPORTING
B22F3/11
PERFORMING OPERATIONS; TRANSPORTING
B23K26/082
PERFORMING OPERATIONS; TRANSPORTING
B23K26/40
PERFORMING OPERATIONS; TRANSPORTING
B23K26/402
PERFORMING OPERATIONS; TRANSPORTING
B33Y10/00
PERFORMING OPERATIONS; TRANSPORTING
B33Y80/00
PERFORMING OPERATIONS; TRANSPORTING
C23C24/10
CHEMISTRY; METALLURGY
C23C4/02
CHEMISTRY; METALLURGY
Abstract
The present invention disclosed a method of producing a three-dimensional porous tissue in-growth structure. The method includes the steps of depositing a first layer of metal powder and scanning the first layer of metal powder with a laser beam to form a portion of a plurality of predetermined unit cells. Depositing at least one additional layer of metal powder onto a previous layer and repeating the step of scanning a laser beam for at least one of the additional layers in order to continuing forming the predetermined unit cells. The method further includes continuing the depositing and scanning steps to form a medical implant.
Claims
1. A method of producing an orthopedic implant comprising the steps of: depositing a layer of a metal powder onto a substrate; scanning an energy beam so as to melt the metal powder layer deposited onto the substrate to form a plurality of points having a cross-sectional area, the points forming a first portion of a plurality of predetermined irregular unit cells within the metal powder layer deposited onto the substrate; depositing at least one additional layer of the metal powder onto the metal powder layer deposited onto the substrate; and performing additional scanning steps to form a plurality of additional points, the additional points forming additional portions of the plurality of predetermined irregular unit cells, the first portion and the formed additional portions collectively including one or more struts having a length and a substantially uniform cross-section along the length, wherein the one or more struts extend in an oblique direction with respect to the substrate, and wherein the geometries of the predetermined irregular unit cells vary.
2. A method of producing an orthopedic implant comprising the steps of: depositing a layer of a metal powder onto a substrate; scanning an energy beam so as to melt the metal powder layer deposited onto the substrate to form a first portion of a plurality of predetermined irregular unit cells within the metal powder layer deposited onto the substrate; depositing at least one additional layer of the metal powder onto the metal powder layer deposited onto the substrate; and performing additional scanning steps to form additional portions of the plurality of predetermined irregular unit cells, the first portion and the additional portions collectively forming one or more struts having a length and a substantially uniform cross-section along the length, wherein the one or more struts extends in an oblique direction with respect to the substrate, wherein the geometries of the predetermined irregular unit cells vary.
3. A method of producing an orthopedic implant comprising the steps of: depositing a layer of a metal powder onto a substrate; scanning an energy beam so as to melt the metal powder layer deposited onto the substrate to form a portion of a plurality of predetermined irregular unit cells within the metal powder layer deposited onto the substrate; depositing at least one additional layer of the metal powder onto the metal powder layer deposited onto the substrate; and performing additional scanning steps to form the plurality of predetermined irregular unit cells, wherein the geometries of the predetermined irregular unit cells vary.
4. The method of producing an orthopedic implant according to claim 3, wherein the energy beam is an electron beam.
5. The method of producing an orthopedic implant according to claim 3, wherein the energy beam is a laser beam.
6. The method of producing an orthopedic implant according to claim 3, wherein any one of the layers of metal powder have a thickness in the range of 5 μm to 2000 μm.
7. The method of producing an orthopedic implant according to claim 3, wherein the substrate is a base or core made of a metal selected from the group consisting of titanium, titanium alloys, stainless steel, cobalt chrome alloys, tantalum and niobium.
8. The method of producing an orthopedic implant according to claim 3, wherein the substrate is a base or core separated from the scanned metal powder layers.
9. The method of producing an orthopedic implant according to claim 3, wherein the substrate is integral with the scanned metal powder layers.
10. The method of producing an orthopedic implant according to claim 3, further comprising placing a solid or a semi-pervious layer between the substrate and the metal powder layers.
11. The method of producing an orthopedic implant according to claim 3, further comprising acid etching portions of the scanned metal powder layers to remove satellites.
12. The method of producing an orthopedic implant according to claim 3, wherein at least some of the portions of the predetermined irregular unit cells lie at an exterior surface of the orthopedic implant and lack struts to provide a barb effect.
13. The method of producing an orthopedic implant according to claim 3, wherein the energy beam is a laser beam having a power (P) for a period of exposure time (μsec) with a point distance (μm).
14. The method of producing an orthopedic implant according to claim 13, wherein the energy beam is a laser beam in which the power is 90.5 W, the exposure time is 1000 μsec, and the point distance is 90 μm.
15. The method of producing an orthopedic implant according to claim 3, wherein the predetermined irregular unit cells include a plurality of intersecting struts and at least some of the struts have a circular cross-section.
16. The method of producing an orthopedic implant according to claim 3, wherein the predetermined irregular unit cells include a plurality of intersecting struts and at least some of the struts have a rectangular cross-section.
17. The method of producing an orthopedic implant according to claim 3, wherein the plurality of the predetermined irregular unit cells include a plurality of intersecting struts, and wherein during the step of scanning the deposited metal powder layers, the energy beam is adjusted to modify at least one of a length and cross-section of the struts of the predetermined irregular unit cells.
18. The method of producing an orthopedic implant according to claim 3, wherein the plurality of the predetermined irregular unit cells includes a plurality of intersecting struts, and wherein at least some of the predetermined irregular unit cells are offset from one another to allow at least some of the struts of at least one of the predetermined unit cells to overlap some of the struts of at least one other predetermined unit cell of the predetermined unit cells.
19. The method of producing an orthopedic implant according to claim 3, wherein the orthopedic implant has a porosity which falls within a predetermined porosity range.
20. The method of producing an orthopedic implant according to claim 3, wherein the orthopedic implant is produced using a file, for use by a rapid manufacturing machine, of a computer-generated model prepared by: populating a component design with modeled unit cells; and perturbing vertices of the modeled unit cells to form a three-dimensional construct corresponding to the orthopedic implant.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) Methods of forming the porous surface of the present invention can be performed in many ways and some embodiments will now be described by way of example and with reference to the accompanying drawings in which:
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DETAILED DESCRIPTION OF THE INVENTION
(45) This invention relates to a method of forming porous and partially porous metallic structures which are particularly but not exclusively applicable for use in hard or soft tissue interlock structures for medical implants and prosthesis. The method makes use of laser technology by employing a variety of scanning strategies. Typical metal and metal alloys employed include stainless steel, cobalt chromium alloys, titanium and its alloys, tantalum and niobium, all of which have been used in medical device applications. This invention can be used for such medical device applications where bone and soft tissue interlock with the component is required, or where a controlled structure is required to more closely match the mechanical properties of the device with surrounding tissue.
(46) The intention of the present invention is to produce a three-dimensional structure using a laser remelting process, for example, for building structures utilizing unit cells with or without a solid base or core. When applied to an orthopedic prosthesis, the three-dimensional structure could be used to provide a porous outer layer to form a bone in-growth structure. Alternatively, the porous structure, when applied to a core, could be used to form a prosthesis with a defined stiffness to both fulfill the requirement of a modulus match with surrounding tissue and provide interconnected porosity for tissue interlock. A further use could be to form an all-porous structure with grade pore size to interact with more than one type of tissue. Again, the process can be used to build on a solid base or core with an outer porous surface, the porosity of which is constant or which varies. The base or core materials to which the process is applied may be either titanium and its alloys, stainless steel, cobalt chrome alloys, tantalum or niobium as well as any other suitable material. The preferred surface coatings are titanium, cobalt chrome and tantalum but both stainless steel and niobium can also be used as well as any other suitable material. Fully porous structures may be built from any of the materials tested, with the preferred material being titanium. The intention of the invention is to produce a method which can be exploited on a commercial basis for the production of, for example, bone interlock surfaces on a device although it has many other uses.
(47) According to the present invention, a method of forming a three-dimensional structure includes building the shape by laser melting powdered Ti and alloys, stainless steel, cobalt chrome alloys, Ta or Nb using a continuous or pulsed laser beam. Individual layers of metal are scanned using a laser. Each layer or portion of a layer is scanned to create a portion of a plurality of predetermined unit cells, as will be described below. Successive layers are deposited onto previous layers and also may be scanned. The scanning and depositing of successive layers continues the building process of the predetermined unit cells. As disclosed herein, by continuing the building process refers not only to a continuation of a unit cell from a previous layer but also a beginning of a new unit cell as well as the completion of a unit cell.
(48) The method can be performed so that the structure is porous and if desired, the pores can be interconnecting to provide an interconnected porosity.
(49) If desired, the method can include using a base or core of cobalt chrome alloy, titanium or alloy, stainless steel, niobium and tantalum, on which to build a porous layer of any one of the aforementioned metals and alloys by laser melting using a continuous or pulsed laser beam. Thus, a mixture of desired mixed materials can be employed.
(50) The method can be applied to an existing article made from cobalt chrome, titanium or alloy, stainless steel, tantalum or niobium, such as an orthopedic implant, to produce a porous outer layer from any of the aforementioned metals or alloys to provide a bone in-growth structure.
(51) The invention can, therefore, include a laser melting process which precludes the requirement for subsequent heat treatment of the structure, thereby preserving the initial mechanical properties of the core or base metal. The equipment used for the manufacture of such a device could be one of many currently available including the MCP Realiszer, the EOS M270, Trumpf Trumaform 250, the Arcam EBM S12 and the like. The laser may also be a custom produced laboratory device.
(52) The method can be applied to produce an all-porous structure using any of the aforementioned metal or metal alloys. Such structures can be used as final products, or further processed to form a useful device for bone or soft tissue in-growth, or as some other function such as that of a lattice to carry cells, for example.
(53) The pore density, pore size and pore size distribution can be controlled from one location on the structure to another. It is important to note that successive powder layers can differ in porosity by varying factors used for laser scanning powder layers. Additionally, the porosity of successive layers of powder can be varied by either creating a specific type of unit cell or manipulating various dimensions of a given unit cell.
(54) To produce a porous surface structure, the nature of the material formed as a result of laser melting of powdered beads is principally dependent on the thermal profile involved (heating rate, soaking time, cooling rate); the condition of the raw material (size and size distribution of powder particles); and atmospheric conditions (reducing, inert or oxidizing chamber gas).
(55) There have been a number of studies to determine the optimum pore structure for maximization of bone in-growth on prostheses. The general findings suggest that optimum porosity is between approximately 20% and 40%, and aim to mid value with a mean volume percent of voids of about 70%. The preferred pore structure is interconnected, with a minimum pore size between about 80 μm and 100 μm and a maximum pore size between 80 μm and 800 μm. The structured thickness for in-growth is 1.4-1.6 mm, but can be larger or smaller depending on the application.
(56) In the present invention porous structures are built in the form of a plurality of unit cells. Many designs of unit cells are possible to give the shape, type, degree, and size of porosity required. Such unit cell designs can be dodecahedral, octahedral, diamond, as well as many other various shapes. Additionally, besides regular geometric shapes as discussed above the unit cells of the present invention may be configured to have irregular shapes where various sides and dimensions have little if any repeating sequences. The unit cells can be configured to constructs that closely mimic the structure of trabecular bone for instance. Unit cells can be space filling, all the space within a three-dimensional object is filled with cells, or interconnected where there may be some space left between cells but the cells are connected together by their edges.
(57) The cells can be distributed within the construct a number of ways. Firstly, they may be made into a block within a computer automated design system where the dimensions correspond to the extent of the solid geometry. This block can then be intersected with the geometry representing the component to produce a porous cellular representation of the geometry. Secondly, the cells may be deformed so as to drape over an object thus allowing the cells to follow the surface of the geometry. Thirdly, the cells can be populated through the geometry following the contours of any selected surface.
(58) The unit cell can be open or complete at the surface of the construct to produce a desired effect. For instance, open cells with truncated lattice struts produce a surface with a porosity and impart the surface with some degree of barb.
(59) Modifying the lattice strut dimensions can control the mechanical strength of the unit cell. This modification can be in a number of key areas. The lattice strut can be adjusted by careful selection of build parameters or specifically by changing the design of the cross-section of each strut. The density of the lattice can similarly be adjusted by modification of the density of the unit cells as can the extent and shape of porosity or a combination thereof. Clearly the overall design of the unit cell will also have a significant effect of the structural performance of the lattice. For instance, dodecahedral unit cells have a different mechanical performance when compared to a tetrahedral (diamond) structure.
(60) As shown in
(61) Each carbon atom in the diamond is surrounded by four nearest neighbors. They are connected together by bonds that separate them by a distance of 1.5445 angstroms. The angles between these bonds are 109.5 degrees. As a result, the central atom and its neighbors form a tetrahedron. This geometry as in the case discussed herein may then be scaled to appropriate value for the pore construct required.
(62) The two key parameters used to define the relations regarding height, surface area, space height, volume of tetrahedron, and the dihedral angle of a tetrahedron are the strand length of the tetrahedron and, i.e., the diameter or height and width, cross section area of the strand i.e., strut. These two parameters control the pore size and porosity of the structure. The parameter editor and relation editor within a typical CAD system can be used to control these parameters. Hence, by changing the parameters one can change the fundamental properties of the porous structure. As shown in
(63) To create the mesh as shown in
(64) TABLE-US-00001 TABLE 1 edge laser point length diameter power exposure distance Part build on SLM μm μm Watts μsec μm Diamond Structure 2000 200 90.5 1000 90 Diamond Structure 2000 200 90.5 1000 90 with compensation Dodecahedron 1500 200 68.3 1000 90 Structure Dodecahedron 1500 200 68.3 1000 90 Structure with compensation Modified Truncated 1500 200 90.5 1000 90 Octahedron
(65) As shown in
(66) In a method of use, a sweep feature is first used to model the dodecahedron structure by driving a profile along a trajectory curve. The trajectory curves are constructed from datum points corresponding to the vertices of the dodecahedron connected by datum curves. The type of profile remains constant along the sweep producing the model shown in
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(68) As shown in
(69) In a method of use, a CAD model of the truncated octahedron is constructed using the sweep feature and calculations and dimensions are incorporated using basic trigonometry. Two tessellate the unit cell, the unit cell is first reoriented to enable easy tessellation and to reduce the number of horizontal struts in the model. Further, the model can be modified to remove all of the horizontal struts as shown in
(70) As shown in
(71) TABLE-US-00002 TABLE 2 Length Width of of Part Strand strand strand Laser Point build on length c/s c/s Power Exposure distance SLM μm μm μm Watts μsec μm Truncated 3000 50 50 90.5 500 90 Octahedron Truncated 3000 50 50 90.5 300 90 Octahedron Truncated 3000 50 50 90.5 100 90 Octahedron Truncated 1000 50 50 90.5 500 90 Octahedron Truncated 1000 50 50 90.5 300 90 Octahedron Truncated 1000 50 50 90.5 100 90 Octahedron Diamond 700 50 50 90.5 500 90 Structure Diamond 700 50 50 90.5 300 90 Structure Diamond 700 50 50 90.5 100 90 Structure
(72) Random representative geometries may be made from the current regular unit cells by applying a random X, Y, Z perturbation of the vertices of the unit cells. Perturbation to the vertices of the unit cells inherently forms irregular unit cells. One such example can be seen in
(73) TABLE-US-00003 TABLE 3 Equipment/Software Description Magics V8.05 (Materialise) CAD software package used for manipulating STL files and preparing builds for Rapid Manufacture (RM) Python Programming language MCP Realizer SLM machine using 100 w fibre laser 316 L gas atomized metal Metal powder with an mean particle size of powder Osprey Metal approximately 40 μm Powders Ltd
(74) In one example of this procedure an STL file of hip component 50 is loaded into an engineering design package such as Magics, as shown in
(75) Jacket 56 is processed via a bespoke application that populates STL shapes with repeating open cellular lattice structures (OCLS). The OCLS used in this instance is a repeating unit cell of size 1.25 millimeters and strand diameter 200 μm.
(76) TABLE-US-00004 TABLE 4 Slice height Power Exposure Feature (μm) (watts) (μs) P.sub.dist (μm) H.sub.dist (mm) Solid layer 100 90.5 800 80 0.125 Porous layer 100 90.5 3500 N/a (spot) N/a
(77) Although the present invention has been described with regard to the femoral hip component as shown in
(78) In other aspect of the present invention an existing product may be coated with various metal layers and then scanned with a laser in order to produce a finished product. In order to apply coating to existing products having either concave and/or convex profiles the present invention i.e., SLM requires the design of a special powder lay system. One such example was conducted and is shown in
(79) In an alternate embodiment of the present invention, the process can be parallelized by addition of many pistons and cylinder pairs around a central laser beam. Optimal laser alignment to the surface can be achieved by a number of methods, including inclining the piston and cylinder pairs so the powder surface and the part surface are correctly aligned normal to the laser beam. Typical operating parameters are shown in Table 5 below.
(80) TABLE-US-00005 TABLE 5 Slice height Exposure (μm) Power (watts) (μs) P.sub.dist (μm) H.sub.dist (mm) 100 90.5 700 80 0.125
(81) In another aspect of the present invention the laser produced porous structure system may be used to manufacture a porous shell which then can be inserted over a substrate and sintered in order to fix permanently to the same. Some examples include the preparation of an acetabular cup component, a tibia knee insert component, and a femoral insert as well as many additional products. In order to illustrate this aspect of the present invention, reference will be made to the outer profile of an acetabular component which serves as an inner profile of a “cap” to insure that an accurate fit is achieved when the cap is set on the substrate (acetabular shell). The cup is built to a thickness of 1.5 millimeters for example using a diamond configured construct to develop the interconnecting porosity. The metal powder used in one example is stainless steel. The processing parameters are shown in Table 6 listed below:
(82) TABLE-US-00006 TABLE 6 Slice height Exposure (μm) Power (watts) (μs) P.sub.dist (μm) H.sub.dist (mm) 100 90.5 2000 N/a N/a
However, the process parameters are dependent on the metal used and if a different metal, say for example, titanium was used, the parameters would be different.
(83) In order to achieve a better and tighter fit of the cap over the component, some adjustments to the geometry of the cap may be considered. For example, the inclusion of a rim 70 on the inner surface of the cap that interfaces with the groove 72 on the outer surface of the acetabular cup component 68 may be included. This mechanism acts a simple lock and gives both security and extra rigidity during the sintering process. Additional modifications may be utilized to improve closeness of the fit and stability. For instance, the introduction of “snap-fits” which are apparent in everyday plastic components may be employed to provide a more reliable attachment mechanism between the two elements. Typical pads or center pads for both the femoral and tibial knee components can be produced by the SLM process and dropped or snapped fit into place to the components and then sintered to attach firmly to the underlying substrate. As previously stated, this technique can apply to other components where a porous outer surface is required to interface with either soft or hard tissue.
(84) A further improvement in the mechanical and microstructural properties of the porous construct may be achieved by either conventional sintering under vacuum or inert atmosphere and/or hot isostatic pressing using temperature regimes known in the state of the art. As the constructs possess high density properties throughout their strands minimal degradation in the structure of the construct is apparent.
(85) In another aspect of the present invention, the appearance of the porous construct can be changed by the alteration of the processing conditions or by the introduction of an acid etch process. For example, the laser power or laser residence time may be reduced or a combination of both which creates struts of the porous construct having a coating with layers of unmelted metal particles firmly adhered to the strut surfaces. This has the effect of producing additional porous features that offer a new dimension to the overall porous structure of the construct. Such features are able to interact with cells in a different manner than the microstructure imparted by the lattice construct and provide extra benefits. A typical example of such construct with this satellite appearance as depicted in
(86) It is also possible to remove these satellites by an acid etching process and a strong acid. The acid may consist of a mixture of 10 milliliters of hydrogenfloride (HF), 5 milliliters of nitric acid (HNO.sub.3) and 85 milliliters of H.sub.2O. the HF and HNO.sub.3 were respectively 48% and 69% concentrated.
(87) Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.