US20180021136A1 - Rapid manufacturing of porous metal prostheses - Google Patents
Rapid manufacturing of porous metal prostheses Download PDFInfo
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- US20180021136A1 US20180021136A1 US15/721,998 US201715721998A US2018021136A1 US 20180021136 A1 US20180021136 A1 US 20180021136A1 US 201715721998 A US201715721998 A US 201715721998A US 2018021136 A1 US2018021136 A1 US 2018021136A1
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/56—Porous materials, e.g. foams or sponges
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D1/00—Processes for applying liquids or other fluent materials
- B05D1/02—Processes for applying liquids or other fluent materials performed by spraying
- B05D1/12—Applying particulate materials
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D3/00—Pretreatment of surfaces to which liquids or other fluent materials are to be applied; After-treatment of applied coatings, e.g. intermediate treating of an applied coating preparatory to subsequent applications of liquids or other fluent materials
- B05D3/02—Pretreatment of surfaces to which liquids or other fluent materials are to be applied; After-treatment of applied coatings, e.g. intermediate treating of an applied coating preparatory to subsequent applications of liquids or other fluent materials by baking
- B05D3/0254—After-treatment
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D5/00—Processes for applying liquids or other fluent materials to surfaces to obtain special surface effects, finishes or structures
-
- 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
- B22F3/10—Sintering only
- B22F3/105—Sintering only by using electric current other than for infrared radiant energy, laser radiation or plasma ; by ultrasonic bonding
-
- 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
- B22F3/10—Sintering only
- B22F3/11—Making porous workpieces or articles
-
- 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
-
- 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 disclosure relates to porous metal prostheses. More particularly, the present disclosure relates to rapid manufacturing of porous metal prostheses.
- Orthopaedic prostheses are commonly used to replace at least a portion of a patient's bone following traumatic injury or deterioration due to aging, illness, or disease, for example.
- the orthopaedic prosthesis When the orthopaedic prosthesis is implanted into a joint, the orthopaedic prosthesis may be configured to articulate with an adjacent orthopaedic component.
- the orthopaedic prosthesis when the orthopaedic prosthesis is implanted into the patient's hip joint, the orthopaedic prosthesis may be socket-shaped to receive and articulate with an adjacent femoral component.
- the orthopaedic prosthesis may be at least partially porous to promote ingrowth of the patient's surrounding bone and/or soft tissue, which may enhance the fixation between the orthopaedic prosthesis and the patient's surrounding bone and/or soft tissue.
- the porous portion of the orthopaedic prosthesis is attached to a solid component, such as by diffusion bonding. Diffusion bonding, however, requires a significant amount of time to complete and subjects the orthopaedic prosthesis to high temperatures.
- the present disclosure provides an orthopaedic prosthesis having a solid bearing layer, a porous bone-ingrowth layer, and an interdigitating layer therebetween.
- the present disclosure also provides a method for rapidly manufacturing the orthopaedic prosthesis, such as by performing a laser sintering process.
- a method for rapidly manufacturing an orthopaedic prosthesis.
- the orthopaedic prosthesis has a porous substrate, the porous substrate including an outer surface and a plurality of ligaments that define pores beneath the outer surface.
- the method includes the steps of: depositing a plurality of metal powder particles onto the outer surface of the porous substrate; allowing at least a first portion of the plurality of metal powder particles to enter the pores beneath the outer surface of the porous substrate, the first portion of the plurality of metal powder particles being sized to fit within the pores of the porous substrate; and applying an energy source to the first portion of the plurality of metal powder particles to form solid metal, the solid metal interdigitating into the pores of the porous substrate.
- a method for rapidly manufacturing an orthopaedic prosthesis.
- the orthopaedic prosthesis has a solid metal component and a porous metal component, the porous metal component including a plurality of ligaments that define pores.
- the method includes the steps of: depositing a plurality of metal powder particles into the pores of the porous metal component; and directing an energy source into the pores of the porous metal component to convert the plurality of metal powder particles in the pores to solid metal in the pores, the solid metal in the pores coupling the solid metal component to the porous metal component.
- an orthopaedic prosthesis including a solid metal layer having a first thickness, a porous metal layer having a second thickness that is less than or equal to the first thickness, the porous metal layer including a plurality of ligaments that define pores, and an interdigitating layer having a third thickness, the interdigitating layer including a plurality of ligaments that define pores, the pores of the interdigitating layer being substantially filled with solid metal, the interdigitating layer extending between the solid metal layer and the porous metal layer to couple the solid metal layer to the porous metal layer.
- FIG. 1 is a flow chart of an exemplary method for rapidly manufacturing an orthopaedic prosthesis
- FIG. 2 is a schematic diagram of a porous substrate located within a build chamber
- FIG. 3 is another schematic diagram showing a first layer of metal powder deposited into the porous substrate of FIG. 2 ;
- FIG. 4 is another schematic diagram showing a laser selectively converting the first layer of metal powder of FIG. 3 to solid metal;
- FIG. 5 is another schematic diagram showing a second layer of metal powder deposited into the porous substrate of FIG. 4 ;
- FIG. 6 is another schematic diagram showing the laser selectively converting the second layer of metal powder of FIG. 5 to solid metal;
- FIG. 7 is another schematic diagram showing a third layer of metal powder deposited into and atop the porous substrate of FIG. 6 ;
- FIG. 8 is another schematic diagram showing the laser selectively converting the third layer of metal powder of FIG. 7 to solid metal;
- FIGS. 9-11 are schematic diagrams similar to FIG. 8 , further showing the laser selectively converting additional layers of metal powder to solid metal to produce an orthopaedic prosthesis;
- FIG. 12 is a schematic diagram of the orthopaedic prosthesis of FIG. 11 , further including an exploded polymeric liner, and
- FIG. 13 is a schematic diagram of another, patient-specific orthopaedic prosthesis shown implanted in a patient's bone.
- FIG. 1 provides an exemplary method 100 for designing and manufacturing an orthopaedic prosthesis.
- Method 100 is exemplified with reference to FIGS. 2-7 .
- a porous substrate 200 having a large plurality of struts or ligaments 202 that define open spaces or pores 204 therebetween, as shown in FIG. 2 .
- Ligaments 202 may be constructed, at least in part, of a first biocompatible metal, such as tantalum, a tantalum alloy, niobium, a niobium alloy, or another suitable metal, for example.
- pores 204 between ligaments 202 form a matrix of continuous channels having no dead ends, such that growth of cancellous bone and/or soft tissue through porous substrate 200 is uninhibited.
- porous substrate 200 may provide a matrix into which cancellous bone and/or soft tissue may grow to provide fixation of porous substrate 200 to the patient's bone.
- porous substrate 200 is a highly porous biomaterial having a porosity as low as 55%, 65%, or 75% or as high as 80%, 85%, or 90%.
- An example of such a material is produced using Trabecular MetalTM Technology generally available from Zimmer, Inc., of Warsaw, Ind. Trabecular MetalTM is a trademark of Zimmer, Inc.
- Porous substrate 200 may be formed from a reticulated vitreous carbon foam substrate which is infiltrated and coated with the above-described first biocompatible metal (e.g., tantalum) by a chemical vapor deposition (“CVD”) process in the manner disclosed in detail in U.S. Pat. No.
- CVD chemical vapor deposition
- each ligament 202 of porous substrate 200 includes a carbon core covered by a thin film of the first biocompatible metal (e.g., tantalum). It is also within the scope of the present disclosure that porous substrate 200 may be in the form of a fiber metal pad, for example, the ligaments of the fiber metal pad being constructed entirely or substantially entirely of the first biocompatible metal.
- first biocompatible metal e.g., tantalum
- Porous substrate 200 may be fabricated to virtually any desired porosity and pore size in order to selectively tailor porous substrate 200 for a particular application, as discussed in the above-incorporated U.S. Pat. No. 5,282,861.
- porous substrate 200 has an average pore size between 100 micrometers and 1,000 micrometers, and more specifically about 500 micrometers.
- porous substrate 200 may be in a desired shape and size that is suitable for implantation in a patient's body.
- the illustrative porous substrate 200 of FIG. 2 is provided in a hollow hemispherical shape and in a size that is suitable for implantation as an acetabular shell in a patient's hip joint.
- porous substrate 200 may require subsequent shaping or machining after the providing step 102 of method 100 ( FIG. 1 ) and before being implanted in the patient's body.
- the porous substrate 2 is shaped and sized for use as an acetabular shell in the patient's hip joint, it is also within the scope of the present disclosure that the porous substrate may be shaped and sized for use as a femoral component, a tibial component, a humeral component, a spinal component, a dental component, or another orthopaedic component, for example.
- Porous substrate 200 includes a first, bone-engaging surface 206 that interacts with the patient's bone.
- the bone-engaging surface 206 of porous substrate 200 is a regular, stock surface that is shaped to interact with a prepared (e.g., reamed, cut, etc.) bone surface of a patient.
- the bone-engaging surface 206 ′ of porous substrate 200 ′ is a patient-specific surface that is shaped as substantially a negative of the particular patient's bone surface S to conform to the particular patient's bone surface S, even without preparing (e.g., reaming, cutting, etc.) the patient's bone B.
- the patient-specific bone-engaging surface 206 ′ may be designed to be highly irregular, arbitrary, non-parametric, or biologically complex in shape to fill a void or defect in the particular patient's bone B and to accommodate the surrounding anatomy of the particular patient.
- An exemplary method of manufacturing such a patient-specific component is described in U.S. patent application Ser. No. 13/464,069 to Li et al., entitled “Patient-Specific Manufacturing of Porous Metal Prostheses,” filed May 4, 2012, the entire disclosure of which is expressly incorporated herein by reference.
- Porous substrate 200 also includes a second, solid-receiving surface 208 .
- solid-receiving surface 208 is concave in shape and opposes bone-engaging surface 206 of porous substrate 200 .
- porous substrate 200 is placed inside a build chamber 300 , as shown in FIG. 2 .
- Build chamber 300 may be evacuated and flushed with an inert gas (e.g., argon) to avoid oxidation.
- inert gas e.g., argon
- Build chamber 300 may also be heated to improve the efficiency of the remaining process steps.
- a first layer of metal powder 302 is deposited onto porous substrate 200 in build chamber 300 , as shown in FIG. 3 . More specifically, the first layer of metal powder 302 is deposited onto solid-receiving surface 208 of porous substrate 200 . Additionally, the first layer of metal powder 302 may be deposited around porous substrate 200 to support and stabilize porous substrate 200 in build chamber 300 . In an exemplary embodiment, the first layer of metal powder 302 , and each subsequent layer, is about 20 micrometers to about 30 micrometers thick. After depositing each new layer of metal powder 302 into build chamber 300 , the newly deposited layer may be leveled by rolling a roller (not shown) across build chamber 300 , by vibrating build chamber 300 , or by another suitable leveling technique.
- metal powder 302 comprises a second biocompatible metal that differs from the first biocompatible metal of porous substrate 200 .
- ligaments 202 of porous substrate 200 comprise or are coated with tantalum
- particles 304 of metal powder 302 may comprise titanium or a titanium alloy (e.g., Ti-6Al-4V).
- particles 304 of metal powder 302 are sized smaller than pores 204 of porous substrate 200 .
- Particles 304 of metal powder 302 may be less than about 10% the size of pores 204 of porous substrate 200 . More specifically, particles 304 of metal powder 302 may be as little as about 1%, about 2%, or about 3% the size of pores 204 of porous substrate 200 and as much as about 4%, about 5%, or about 6% the size of pores 204 of porous substrate 200 , or within a range defined between any pair of the foregoing values.
- each particle 304 of metal powder 302 may be as small as about 5 micrometers, 10 micrometers, or 15 micrometers in size and as large as about 20 micrometers, 25 micrometers, or 30 micrometers in size.
- a large number of particles 304 may fall into pores 204 of porous substrate 200 , especially pores 204 that are exposed along solid-receiving surface 208 of porous substrate 200 , as shown in FIG. 3 .
- the above-described leveling techniques may also encourage particles 304 to fall into pores 204 of porous substrate 200 .
- select areas of metal powder 302 are exposed to an energy source during step 108 of method 100 ( FIG. 1 ).
- the applied energy source causes localized sintering or melting of particles 304 of metal powder 302 , which converts select areas of metal powder 302 to solid metal 306 .
- Each newly-formed region of solid metal 306 may bond to a previously-formed region of solid metal 306 and to porous substrate 200 , as shown in FIG. 4 . In this manner, solid metal 306 is selectively and rapidly formed upon porous substrate 200 while simultaneously bonding solid metal 306 to porous substrate 200 .
- the applying step 108 of method 100 involves a direct metal laser sintering (DMLS) process, where the energy source is a focused, high-powered laser 400 (e.g., a ytterbium fiber optic laser).
- the DMLS process may also be referred to as a selective laser sintering (SLS) process or a selective laser melting (SLM) process.
- SLS selective laser sintering
- SLM selective laser melting
- Laser 400 may be controlled using a suitable computer processor having, for example, computer-aided design (CAD) software and/or computer-aided manufacturing (CAM) software installed thereon. Such software can be used to rapidly create computer numerical control (CNC) code that will control each individual pass of laser 400 across build chamber 300 .
- CNC computer numerical control
- the CNC code may direct laser 400 side-to-side across build chamber 300 (i.e., along the y-axis) and back-and-forth across build chamber 300 (i.e., along the x-axis).
- laser 400 may be activated at select xy-coordinates.
- laser 400 may be deactivated at other xy-coordinates or may avoid traveling to those xy-coordinates altogether.
- the second biocompatible metal of particles 304 of metal powder 302 has a lower melting point than the first biocompatible metal of ligaments 202 of porous substrate 200 .
- ligaments 202 of porous substrate 200 comprise or are coated with tantalum, which has a melting point above 3,000° C.
- particles 304 of metal powder 302 may comprise titanium or a titanium alloy (e.g., Ti-6Al-4V), which have melting points below 1,700° C.
- the thermally-stable ligaments 202 of porous substrate 200 remain substantially intact without sintering or melting.
- particles 304 may sinter or melt to form solid metal 306 .
- solid metal 306 within each pore 204 of porous substrate 200 may be able to maintain substantially the same elemental content as metal powder 302 , without incorporating material from the thermally-stable ligaments 202 of porous substrate 200 .
- the depositing step 106 and the applying step 108 of method 100 are repeated until solid metal 306 reaches a final, desired shape.
- particles 304 of metal powder 302 begin to substantially fill the exposed pores 204 of porous substrate 200 , as shown in FIG. 5 .
- particles 304 of metal powder 302 begin to accumulate atop solid-receiving surface 208 of porous substrate 200 , as shown in FIGS. 7-11 .
- select areas of the newly-deposited layer are exposed to laser 400 , converting more metal powder 302 to solid metal 306 .
- porous substrate 200 and solid metal 306 form orthopaedic prosthesis 500 that is suitable for implantation in a patient's body.
- the illustrative orthopaedic prosthesis 500 of FIG. 12 is suitable for implantation as an acetabular cup in a patient's hip joint.
- the illustrative orthopaedic prosthesis 500 of FIG. 12 is suitable for implantation as an acetabular cup in the patient's hip joint, it is also within the scope of the present disclosure that the orthopaedic prosthesis may be configured for implantation in a patient's femur, tibia, humerus, spine, or mouth, for example.
- porous substrate 200 and solid metal 306 cooperate to define an interdigitating layer L 1 beneath the solid-receiving surface 208 of porous substrate 200 .
- solid metal 306 metallurgically and/or mechanically interacts with ligaments 202 of porous substrate 200 to create a strong attachment between solid metal 306 and porous substrate 200 .
- the interdigitating layer L 1 may have a thickness of approximately 250 micrometers or more, 500 micrometers or more, 1,000 micrometers (1 millimeter) or more, or 1,500 micrometers (1.5 millimeters) or more, for example.
- Solid metal 306 in the interdigitating layer L 1 may be formed from particles 304 of metal powder 302 that settled into pores 204 of porous substrate 200 before exposure to laser 400 , as shown in FIGS. 3-6 . Additionally, solid metal 306 in the interdigitating layer L 1 may be formed from particles 304 of metal powder 302 that settled atop solid-receiving surface 208 of porous substrate 200 before exposure to laser 400 , but that later settled into pores 204 of porous substrate 200 upon exposure to laser 400 . Depending on the size of pores 204 , the size of particles 304 , and/or the degree to which particles 304 are heated and rendered flowable, solid metal 306 may substantially or completely fill pores 204 in the interdigitating layer L 1 of porous substrate 200 .
- orthopaedic prosthesis 500 further includes a solid bearing layer L 2 and a porous bone-ingrowth layer L 3 , as shown in FIG. 12 .
- Solid metal 306 extends beyond porous substrate 200 and the interdigitating layer L 1 to form the solid bearing layer L 2 .
- the solid bearing layer L 2 may have a thickness of approximately 0.5 inch or more, 1.0 inch or more, 1.5 inches or more, or 2.0 inches or more, for example.
- Porous substrate 200 extends beyond solid metal 306 and the interdigitating layer L 1 to define the porous bone-ingrowth layer L 3 .
- An exemplary orthopaedic prosthesis 500 is predominantly solid, not porous, by weight and/or volume.
- the thickness of the porous bone-ingrowth layer L 3 is less than or equal to the thickness of the solid bearing layer L 2 to arrive at orthopaedic prosthesis 500 that is predominantly solid.
- the solid bearing layer L 2 of orthopaedic prosthesis 500 constitutes more than just a thin surface coating on the porous bone-ingrowth layer L 3 .
- the above-described depositing step 106 and the above-described applying step 108 of method 100 produce orthopaedic prosthesis 500 in a rapid and automated manner.
- the solid bearing layer L 2 of orthopaedic prosthesis 500 may be rapidly and automatically manufactured to strengthen and support orthopaedic prosthesis 500 and/or to interact with an adjacent orthopaedic component.
- the solid bearing layer L 2 of orthopaedic prosthesis 500 is configured to receive a polymeric liner 502 , which in turn interacts with and receives the patient's adjacent femoral head.
- the solid bearing layer L 2 of orthopaedic prosthesis 500 may be rapidly and automatically manufactured in a highly complex geometry, without requiring any subsequent shaping.
- the interdigitating layer L 1 may be rapidly and automatically produced to bond the solid bearing layer L 2 to the underlying porous bone-ingrowth layer L 3 .
- orthopaedic prosthesis 500 is removed from build chamber 300 , leaving behind metal powder 302 that was not converted to solid metal 306 . Also, excess metal powder 302 may be removed from porous substrate 200 by shaking orthopaedic prosthesis 500 and/or by blowing pressurized air into porous substrate 200 , for example. Orthopaedic prosthesis 500 may then be subjected to any necessary cleaning, shaping, processing, sterilizing, or packaging steps. For example, in the illustrated embodiment of FIG. 12 , the polymeric liner 502 may be coupled to solid bearing layer L 2 of orthopaedic prosthesis 500 to facilitate articulation with the patient's adjacent femoral head.
- orthopaedic prosthesis 500 is implanted into the patient's body. Bone-engaging surface 206 of orthopaedic prosthesis 500 is implanted against the patient's bone to encourage bone and/or soft tissue ingrowth into the porous bone-ingrowth layer L 3 of orthopaedic prosthesis 500 . Orthopaedic prosthesis 500 may be secured in place using suitable fasteners (e.g., bone screws) or bone cement, for example.
- suitable fasteners e.g., bone screws
- bone cement bone cement
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Abstract
An orthopaedic prosthesis and a method for rapidly manufacturing the same are provided. The orthopaedic prosthesis includes a solid bearing layer, a porous bone-ingrowth layer, and an interdigitating layer therebetween. A laser sintering technique is performed to manufacture the orthopaedic prosthesis.
Description
- This application claims priority from U.S. Provisional Patent Application Ser. No. 61/507,151, filed Jul. 13, 2011, the disclosure of which is hereby expressly incorporated by reference herein in its entirety.
- The present disclosure relates to porous metal prostheses. More particularly, the present disclosure relates to rapid manufacturing of porous metal prostheses.
- Orthopaedic prostheses are commonly used to replace at least a portion of a patient's bone following traumatic injury or deterioration due to aging, illness, or disease, for example.
- When the orthopaedic prosthesis is implanted into a joint, the orthopaedic prosthesis may be configured to articulate with an adjacent orthopaedic component. For example, when the orthopaedic prosthesis is implanted into the patient's hip joint, the orthopaedic prosthesis may be socket-shaped to receive and articulate with an adjacent femoral component.
- The orthopaedic prosthesis may be at least partially porous to promote ingrowth of the patient's surrounding bone and/or soft tissue, which may enhance the fixation between the orthopaedic prosthesis and the patient's surrounding bone and/or soft tissue. Typically, the porous portion of the orthopaedic prosthesis is attached to a solid component, such as by diffusion bonding. Diffusion bonding, however, requires a significant amount of time to complete and subjects the orthopaedic prosthesis to high temperatures.
- The present disclosure provides an orthopaedic prosthesis having a solid bearing layer, a porous bone-ingrowth layer, and an interdigitating layer therebetween. The present disclosure also provides a method for rapidly manufacturing the orthopaedic prosthesis, such as by performing a laser sintering process.
- According to an embodiment of the present disclosure, a method is provided for rapidly manufacturing an orthopaedic prosthesis. The orthopaedic prosthesis has a porous substrate, the porous substrate including an outer surface and a plurality of ligaments that define pores beneath the outer surface. The method includes the steps of: depositing a plurality of metal powder particles onto the outer surface of the porous substrate; allowing at least a first portion of the plurality of metal powder particles to enter the pores beneath the outer surface of the porous substrate, the first portion of the plurality of metal powder particles being sized to fit within the pores of the porous substrate; and applying an energy source to the first portion of the plurality of metal powder particles to form solid metal, the solid metal interdigitating into the pores of the porous substrate.
- According to another embodiment of the present disclosure, a method is provided for rapidly manufacturing an orthopaedic prosthesis. The orthopaedic prosthesis has a solid metal component and a porous metal component, the porous metal component including a plurality of ligaments that define pores. The method includes the steps of: depositing a plurality of metal powder particles into the pores of the porous metal component; and directing an energy source into the pores of the porous metal component to convert the plurality of metal powder particles in the pores to solid metal in the pores, the solid metal in the pores coupling the solid metal component to the porous metal component.
- According to yet another embodiment of the present disclosure, an orthopaedic prosthesis is provided including a solid metal layer having a first thickness, a porous metal layer having a second thickness that is less than or equal to the first thickness, the porous metal layer including a plurality of ligaments that define pores, and an interdigitating layer having a third thickness, the interdigitating layer including a plurality of ligaments that define pores, the pores of the interdigitating layer being substantially filled with solid metal, the interdigitating layer extending between the solid metal layer and the porous metal layer to couple the solid metal layer to the porous metal layer.
- The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the invention itself will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:
-
FIG. 1 is a flow chart of an exemplary method for rapidly manufacturing an orthopaedic prosthesis; -
FIG. 2 is a schematic diagram of a porous substrate located within a build chamber; -
FIG. 3 is another schematic diagram showing a first layer of metal powder deposited into the porous substrate ofFIG. 2 ; -
FIG. 4 is another schematic diagram showing a laser selectively converting the first layer of metal powder ofFIG. 3 to solid metal; -
FIG. 5 is another schematic diagram showing a second layer of metal powder deposited into the porous substrate ofFIG. 4 ; -
FIG. 6 is another schematic diagram showing the laser selectively converting the second layer of metal powder ofFIG. 5 to solid metal; -
FIG. 7 is another schematic diagram showing a third layer of metal powder deposited into and atop the porous substrate ofFIG. 6 ; -
FIG. 8 is another schematic diagram showing the laser selectively converting the third layer of metal powder ofFIG. 7 to solid metal; -
FIGS. 9-11 are schematic diagrams similar toFIG. 8 , further showing the laser selectively converting additional layers of metal powder to solid metal to produce an orthopaedic prosthesis; -
FIG. 12 is a schematic diagram of the orthopaedic prosthesis ofFIG. 11 , further including an exploded polymeric liner, and -
FIG. 13 is a schematic diagram of another, patient-specific orthopaedic prosthesis shown implanted in a patient's bone. - Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary embodiments of the invention and such exemplifications are not to be construed as limiting the scope of the invention in any manner.
-
FIG. 1 provides anexemplary method 100 for designing and manufacturing an orthopaedic prosthesis.Method 100 is exemplified with reference toFIGS. 2-7 . - Beginning at
step 102 of method 100 (FIG. 1 ), aporous substrate 200 is provided having a large plurality of struts orligaments 202 that define open spaces orpores 204 therebetween, as shown inFIG. 2 .Ligaments 202 may be constructed, at least in part, of a first biocompatible metal, such as tantalum, a tantalum alloy, niobium, a niobium alloy, or another suitable metal, for example. In an exemplaryporous substrate 200, pores 204 betweenligaments 202 form a matrix of continuous channels having no dead ends, such that growth of cancellous bone and/or soft tissue throughporous substrate 200 is uninhibited. Thus,porous substrate 200 may provide a matrix into which cancellous bone and/or soft tissue may grow to provide fixation ofporous substrate 200 to the patient's bone. - According to an exemplary embodiment of the present disclosure,
porous substrate 200 is a highly porous biomaterial having a porosity as low as 55%, 65%, or 75% or as high as 80%, 85%, or 90%. An example of such a material is produced using Trabecular Metal™ Technology generally available from Zimmer, Inc., of Warsaw, Ind. Trabecular Metal™ is a trademark of Zimmer, Inc.Porous substrate 200 may be formed from a reticulated vitreous carbon foam substrate which is infiltrated and coated with the above-described first biocompatible metal (e.g., tantalum) by a chemical vapor deposition (“CVD”) process in the manner disclosed in detail in U.S. Pat. No. 5,282,861 to Kaplan, entitled “Open Cell Tantalum Structures for Cancellous Bone Implants and Cell and Tissue Receptors,” filed Mar. 11, 1992, the entire disclosure of which is expressly incorporated herein by reference. By performing this CVD process, eachligament 202 ofporous substrate 200 includes a carbon core covered by a thin film of the first biocompatible metal (e.g., tantalum). It is also within the scope of the present disclosure thatporous substrate 200 may be in the form of a fiber metal pad, for example, the ligaments of the fiber metal pad being constructed entirely or substantially entirely of the first biocompatible metal. -
Porous substrate 200 may be fabricated to virtually any desired porosity and pore size in order to selectively tailorporous substrate 200 for a particular application, as discussed in the above-incorporated U.S. Pat. No. 5,282,861. In an exemplary embodiment,porous substrate 200 has an average pore size between 100 micrometers and 1,000 micrometers, and more specifically about 500 micrometers. - During the providing
step 102 of method 100 (FIG. 1 ),porous substrate 200 may be in a desired shape and size that is suitable for implantation in a patient's body. For example, the illustrativeporous substrate 200 ofFIG. 2 is provided in a hollow hemispherical shape and in a size that is suitable for implantation as an acetabular shell in a patient's hip joint. However, it is also within the scope of the present disclosure thatporous substrate 200 may require subsequent shaping or machining after the providingstep 102 of method 100 (FIG. 1 ) and before being implanted in the patient's body. Although the illustrativeporous substrate 200 ofFIG. 2 is shaped and sized for use as an acetabular shell in the patient's hip joint, it is also within the scope of the present disclosure that the porous substrate may be shaped and sized for use as a femoral component, a tibial component, a humeral component, a spinal component, a dental component, or another orthopaedic component, for example. -
Porous substrate 200 includes a first, bone-engaging surface 206 that interacts with the patient's bone. In the illustrated embodiment ofFIG. 2 , the bone-engaging surface 206 ofporous substrate 200 is a regular, stock surface that is shaped to interact with a prepared (e.g., reamed, cut, etc.) bone surface of a patient. In the illustrated embodiment ofFIG. 13 , on the other hand, the bone-engaging surface 206′ ofporous substrate 200′ is a patient-specific surface that is shaped as substantially a negative of the particular patient's bone surface S to conform to the particular patient's bone surface S, even without preparing (e.g., reaming, cutting, etc.) the patient's bone B. The patient-specific bone-engaging surface 206′ may be designed to be highly irregular, arbitrary, non-parametric, or biologically complex in shape to fill a void or defect in the particular patient's bone B and to accommodate the surrounding anatomy of the particular patient. An exemplary method of manufacturing such a patient-specific component is described in U.S. patent application Ser. No. 13/464,069 to Li et al., entitled “Patient-Specific Manufacturing of Porous Metal Prostheses,” filed May 4, 2012, the entire disclosure of which is expressly incorporated herein by reference. -
Porous substrate 200 also includes a second, solid-receivingsurface 208. In the illustrated embodiment ofFIG. 2 , solid-receivingsurface 208 is concave in shape and opposes bone-engagingsurface 206 ofporous substrate 200. - Continuing to step 104 of method 100 (
FIG. 1 ),porous substrate 200 is placed inside abuild chamber 300, as shown inFIG. 2 .Build chamber 300 may be evacuated and flushed with an inert gas (e.g., argon) to avoid oxidation.Build chamber 300 may also be heated to improve the efficiency of the remaining process steps. - Next, in
step 106 of method 100 (FIG. 1 ), a first layer ofmetal powder 302 is deposited ontoporous substrate 200 inbuild chamber 300, as shown inFIG. 3 . More specifically, the first layer ofmetal powder 302 is deposited onto solid-receivingsurface 208 ofporous substrate 200. Additionally, the first layer ofmetal powder 302 may be deposited aroundporous substrate 200 to support and stabilizeporous substrate 200 inbuild chamber 300. In an exemplary embodiment, the first layer ofmetal powder 302, and each subsequent layer, is about 20 micrometers to about 30 micrometers thick. After depositing each new layer ofmetal powder 302 intobuild chamber 300, the newly deposited layer may be leveled by rolling a roller (not shown) acrossbuild chamber 300, by vibratingbuild chamber 300, or by another suitable leveling technique. - According to an exemplary embodiment of the present disclosure,
metal powder 302 comprises a second biocompatible metal that differs from the first biocompatible metal ofporous substrate 200. For example, ifligaments 202 ofporous substrate 200 comprise or are coated with tantalum,particles 304 ofmetal powder 302 may comprise titanium or a titanium alloy (e.g., Ti-6Al-4V). - According to another exemplary embodiment of the present disclosure,
particles 304 ofmetal powder 302 are sized smaller thanpores 204 ofporous substrate 200.Particles 304 ofmetal powder 302 may be less than about 10% the size ofpores 204 ofporous substrate 200. More specifically,particles 304 ofmetal powder 302 may be as little as about 1%, about 2%, or about 3% the size ofpores 204 ofporous substrate 200 and as much as about 4%, about 5%, or about 6% the size ofpores 204 ofporous substrate 200, or within a range defined between any pair of the foregoing values. For example, ifpores 204 ofporous substrate 200 are about 500 micrometers in size, eachparticle 304 ofmetal powder 302 may be as small as about 5 micrometers, 10 micrometers, or 15 micrometers in size and as large as about 20 micrometers, 25 micrometers, or 30 micrometers in size. In this embodiment, a large number ofparticles 304 may fall intopores 204 ofporous substrate 200, especially pores 204 that are exposed along solid-receivingsurface 208 ofporous substrate 200, as shown inFIG. 3 . The above-described leveling techniques may also encourageparticles 304 to fall intopores 204 ofporous substrate 200. - After the
depositing step 106 ofmethod 100, select areas ofmetal powder 302 are exposed to an energy source duringstep 108 of method 100 (FIG. 1 ). The applied energy source causes localized sintering or melting ofparticles 304 ofmetal powder 302, which converts select areas ofmetal powder 302 tosolid metal 306. Each newly-formed region ofsolid metal 306 may bond to a previously-formed region ofsolid metal 306 and toporous substrate 200, as shown inFIG. 4 . In this manner,solid metal 306 is selectively and rapidly formed uponporous substrate 200 while simultaneously bondingsolid metal 306 toporous substrate 200. - In an exemplary embodiment, the applying
step 108 of method 100 (FIG. 1 ) involves a direct metal laser sintering (DMLS) process, where the energy source is a focused, high-powered laser 400 (e.g., a ytterbium fiber optic laser). The DMLS process may also be referred to as a selective laser sintering (SLS) process or a selective laser melting (SLM) process. Suitable DMLS systems are commercially available from 3D Systems, Inc., of Rock Hill, S.C. -
Laser 400 may be controlled using a suitable computer processor having, for example, computer-aided design (CAD) software and/or computer-aided manufacturing (CAM) software installed thereon. Such software can be used to rapidly create computer numerical control (CNC) code that will control each individual pass oflaser 400 acrossbuild chamber 300. For example, as each layer ofmetal powder 302 is deposited into build chamber 300 (i.e., along the z-axis), the CNC code may directlaser 400 side-to-side across build chamber 300 (i.e., along the y-axis) and back-and-forth across build chamber 300 (i.e., along the x-axis). To convert select areas ofmetal powder 302 tosolid metal 306,laser 400 may be activated at select xy-coordinates. To leave other areas ofmetal powder 302 as is, without formingsolid metal 306,laser 400 may be deactivated at other xy-coordinates or may avoid traveling to those xy-coordinates altogether. - As shown by comparing
FIGS. 3 and 4 , evenparticles 304 ofmetal powder 302 that settled intopores 204 ofporous substrate 200 during the depositingstep 106 of method 100 (FIG. 1 ) may be converted tosolid metal 306 during the applyingstep 108 of method 100 (FIG. 1 ). According to an exemplary embodiment of the present disclosure, the second biocompatible metal ofparticles 304 ofmetal powder 302 has a lower melting point than the first biocompatible metal ofligaments 202 ofporous substrate 200. For example, ifligaments 202 ofporous substrate 200 comprise or are coated with tantalum, which has a melting point above 3,000° C.,particles 304 ofmetal powder 302 may comprise titanium or a titanium alloy (e.g., Ti-6Al-4V), which have melting points below 1,700° C. In this embodiment, even whenlaser 400 passes over and is absorbed byporous substrate 200, as shown inFIG. 4 , the thermally-stable ligaments 202 ofporous substrate 200 remain substantially intact without sintering or melting. However, whenlaser 400 passes over and is absorbed byparticles 304 ofmetal powder 302,particles 304 may sinter or melt to formsolid metal 306. If the melting points between the first and second biocompatible metals are sufficiently different,solid metal 306 within eachpore 204 ofporous substrate 200 may be able to maintain substantially the same elemental content asmetal powder 302, without incorporating material from the thermally-stable ligaments 202 ofporous substrate 200. - As shown in
FIGS. 5-11 , the depositingstep 106 and the applyingstep 108 of method 100 (FIG. 1 ) are repeated untilsolid metal 306 reaches a final, desired shape. Asmore metal powder 302 is deposited atop the previously-formed regions ofsolid metal 306,particles 304 ofmetal powder 302 begin to substantially fill the exposedpores 204 ofporous substrate 200, as shown inFIG. 5 . As evenmore metal powder 302 is deposited atop the previously-formed regions ofsolid metal 306,particles 304 ofmetal powder 302 begin to accumulate atop solid-receivingsurface 208 ofporous substrate 200, as shown inFIGS. 7-11 . After each new layer ofmetal powder 302 is deposited, select areas of the newly-deposited layer are exposed tolaser 400, convertingmore metal powder 302 tosolid metal 306. - Together,
porous substrate 200 andsolid metal 306 formorthopaedic prosthesis 500 that is suitable for implantation in a patient's body. For example, the illustrativeorthopaedic prosthesis 500 ofFIG. 12 is suitable for implantation as an acetabular cup in a patient's hip joint. Although the illustrativeorthopaedic prosthesis 500 ofFIG. 12 is suitable for implantation as an acetabular cup in the patient's hip joint, it is also within the scope of the present disclosure that the orthopaedic prosthesis may be configured for implantation in a patient's femur, tibia, humerus, spine, or mouth, for example. - Returning to
FIG. 6 ,porous substrate 200 andsolid metal 306 cooperate to define an interdigitating layer L1 beneath the solid-receivingsurface 208 ofporous substrate 200. Within the interdigitating layer L1,solid metal 306 metallurgically and/or mechanically interacts withligaments 202 ofporous substrate 200 to create a strong attachment betweensolid metal 306 andporous substrate 200. The interdigitating layer L1 may have a thickness of approximately 250 micrometers or more, 500 micrometers or more, 1,000 micrometers (1 millimeter) or more, or 1,500 micrometers (1.5 millimeters) or more, for example.Solid metal 306 in the interdigitating layer L1 may be formed fromparticles 304 ofmetal powder 302 that settled intopores 204 ofporous substrate 200 before exposure tolaser 400, as shown inFIGS. 3-6 . Additionally,solid metal 306 in the interdigitating layer L1 may be formed fromparticles 304 ofmetal powder 302 that settled atop solid-receivingsurface 208 ofporous substrate 200 before exposure tolaser 400, but that later settled intopores 204 ofporous substrate 200 upon exposure tolaser 400. Depending on the size ofpores 204, the size ofparticles 304, and/or the degree to whichparticles 304 are heated and rendered flowable,solid metal 306 may substantially or completely fillpores 204 in the interdigitating layer L1 ofporous substrate 200. - In addition to the above-described interdigitating layer L1,
orthopaedic prosthesis 500 further includes a solid bearing layer L2 and a porous bone-ingrowth layer L3, as shown inFIG. 12 .Solid metal 306 extends beyondporous substrate 200 and the interdigitating layer L1 to form the solid bearing layer L2. The solid bearing layer L2 may have a thickness of approximately 0.5 inch or more, 1.0 inch or more, 1.5 inches or more, or 2.0 inches or more, for example.Porous substrate 200 extends beyondsolid metal 306 and the interdigitating layer L1 to define the porous bone-ingrowth layer L3. - An exemplary
orthopaedic prosthesis 500 is predominantly solid, not porous, by weight and/or volume. In one embodiment, the thickness of the porous bone-ingrowth layer L3 is less than or equal to the thickness of the solid bearing layer L2 to arrive atorthopaedic prosthesis 500 that is predominantly solid. In this exemplary embodiment, the solid bearing layer L2 oforthopaedic prosthesis 500 constitutes more than just a thin surface coating on the porous bone-ingrowth layer L3. - Advantageously, the above-described
depositing step 106 and the above-described applyingstep 108 of method 100 (FIG. 1 ) produceorthopaedic prosthesis 500 in a rapid and automated manner. The solid bearing layer L2 oforthopaedic prosthesis 500 may be rapidly and automatically manufactured to strengthen and supportorthopaedic prosthesis 500 and/or to interact with an adjacent orthopaedic component. In the illustrated embodiment ofFIG. 12 , for example, the solid bearing layer L2 oforthopaedic prosthesis 500 is configured to receive apolymeric liner 502, which in turn interacts with and receives the patient's adjacent femoral head. Also, the solid bearing layer L2 oforthopaedic prosthesis 500 may be rapidly and automatically manufactured in a highly complex geometry, without requiring any subsequent shaping. At substantially the same time, the interdigitating layer L1 may be rapidly and automatically produced to bond the solid bearing layer L2 to the underlying porous bone-ingrowth layer L3. - Continuing to step 110 of method 100 (
FIG. 1 ),orthopaedic prosthesis 500 is removed frombuild chamber 300, leaving behindmetal powder 302 that was not converted tosolid metal 306. Also,excess metal powder 302 may be removed fromporous substrate 200 by shakingorthopaedic prosthesis 500 and/or by blowing pressurized air intoporous substrate 200, for example.Orthopaedic prosthesis 500 may then be subjected to any necessary cleaning, shaping, processing, sterilizing, or packaging steps. For example, in the illustrated embodiment ofFIG. 12 , thepolymeric liner 502 may be coupled to solid bearing layer L2 oforthopaedic prosthesis 500 to facilitate articulation with the patient's adjacent femoral head. - Finally, in
step 112 of method 100 (FIG. 1 ),orthopaedic prosthesis 500 is implanted into the patient's body. Bone-engagingsurface 206 oforthopaedic prosthesis 500 is implanted against the patient's bone to encourage bone and/or soft tissue ingrowth into the porous bone-ingrowth layer L3 oforthopaedic prosthesis 500.Orthopaedic prosthesis 500 may be secured in place using suitable fasteners (e.g., bone screws) or bone cement, for example. - While this invention has been described as having exemplary designs, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.
Claims (1)
1. A method of rapidly manufacturing an orthopaedic prosthesis having a porous substrate, the porous substrate including an outer surface and a plurality of ligaments that define pores beneath the outer surface, the method comprising the steps of:
depositing a plurality of metal powder particles onto the outer surface of the porous substrate;
allowing at least a first portion of the plurality of metal powder particles to enter the pores beneath the outer surface of the porous substrate, the first portion of the plurality of metal powder particles being sized to fit within the pores of the porous substrate; and
applying an energy source to the first portion of the plurality of metal powder particles to form solid metal, the solid metal interdigitating into the pores of the porous substrate.
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CA2841889A1 (en) | 2013-01-17 |
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