Patent Grant
9763791
The present invention relates to a femoral prosthesis for use in hip joint replacement procedures. More specifically the invention relates to a novel modular prosthetic head for a femoral prosthesis.
In one embodiment, the present invention includes as components a hollow ball component having a polymeric filler with a molded tapered socket for connecting the ball component to a prosthetic femoral component stem having a conically tapered trunion.
Artificial joint prostheses are widely used to restore joint mobility to patients affected by a variety of conditions, including degeneration of the joint and bone structure. Typically, the degenerated bone structure is replaced with an orthopedic implant that mimics, as closely as possible, the structure of the natural bone and performs its functions. The satisfactory performance of these implants can be affected not only by the design of the component itself, but also by the surgical positioning of the implanted component and the long-term fixation of the implant. Improper placement or positioning of the implant can adversely affect the goal of satisfactorily restoring the clinical bio-mechanics of the joint as well as impairing adequate fixation of the component when implanted.
Orthopedic implants are constructed from materials that are stable in biological environments and withstand physical stress with minimal or controlled deformation. Such materials must possess strength, resistance to corrosion, biocompatibility, and good wear properties. Also, the implants include various interacting parts, which undergo repeated long-term physical stress inside the body.
For these reasons, among others, the bone/implant interface and the connection between various parts of the implant must be durable and resistant to breakdown. This is especially important since installation of an orthopedic implant often involves an extensive medical procedure, and therefore replacement or revision of the installed implant is typically even more difficult. The requirements for the useful life of the implant continue to grow with the increase in human life expectancy and use in younger patients. As implants improve, more younger patients are considered as implant candidates. It is therefore desirable to develop implants that, while durable in their own right, minimize the difficulty of replacement or revision surgery should the implant eventually fail.
The strength and longevity of implants in large part depend on the bone/implant interface. Various methods of connection are known in the art. For example, a hip joint is a ball-in-socket joint, and includes a rounded femoral head and a cup-like socket (acetabular cup) located in the pelvis. The surfaces of the rounded femoral head and the acetabula cup continually abrade each other as a person walks. The abrasion, along with normal loading, creates stress on the hip joint and adjacent bones. If the natural femoral head or the acetabular cup is replaced with an implant, this stress must be well tolerated by the implant's bearing surfaces to prevent implant failure.
One type of hip prosthesis is a resurfacing femoral head. In this design, the natural bone neck is preserved and a hollow metal shell is implanted on the prepared head area of the femur. The inside or distal surface is covered by cancellous bone. The metal shell replaces diseased natural cartilage. Because the acetabular cartilage will wear out over time, this resurfacing is considered temporary solution and total hip replacement is eventually conducted. Hollow metal shell designs are well-known (UK 719,308, US 2010/0121458 A1). The shell is typically made of CoCr alloy. Especially, UK 719308 discloses a resurfacing prosthesis that is composed of CoCr shell filled with plastic core, where the plastic core directly contacts cancellous bone.
The total hip replacement replaces diseased cartilage with both a prosthetic femoral head and acetabular cup. One design of the femoral head is a one piece component integral with a femoral stem. In this design, the neck length is fixed, however a patient's femoral neck length may vary from person to person. Another femoral prostheses comprises a separate stem part and a head part. The neck length is easily adjusted by different offsets to fit different patient neck lengths. The modular design is easy to use, and has become popular over the past 20 years. The stem part comprises a body section for location in the intramedullary cavity of the patient's femur, and a neck section at its proximal end for carrying the modular head part. The head part comprises an outer bearing surface formed as part of a sphere, which is for articulation in a cup component implanted into the patient's acetabulum. The stem part and the head part usually are separate components. The proximal end of the neck section of the stem part comprises a conically tapered trunion and a distal side of the head part comprises a tapered bore adapted to receive the trunion. This configuration allows for the femoral stem to be more readily implanted into the femur initially, and for a particular head part to then be chosen to suit during the procedure. Multiple femoral prosthetic head parts may be provided with, for example, different offsets and diameters for mating with different diameter acetabular cups. Modular prosthetic heads are typically made of solid metal ground into a spherical shape and include a tapered socket, such as a Morse taper in a distally facing surface thereof. However, the traditional metal-on-metal taper junction may have corrosion and fretting problems, especially with a titanium stem against a CoCr head.
One solution for the taper corrosion is to change the metal head into ceramic head. Because ceramic is non-electric conducting material, there is no galvanic corrosion problem. However, ceramic heads are brittle compared to metal heads.
One purpose of this invention is to provide a modular femoral head that engage a metal trunion on a femoral component which improves the performance and is free of corrosion. The femoral ball head has a polymeric tapered cavity and a metal or ceramic outer shell. The polymer cavity is non-electrically conductive, thus intrinsically eliminating galvanic corrosion when it mates a metallic stem taper. Also, the selected polymer is tough and wear resistant; there is no brittle fracture issue. The metal or ceramic shell provides wear resistance when it articulates against the acetabulum such as against natural cartilage or a prosthetic bearing made of UHMWPE or ceramic. Therefore, the present invention has the overall advantage over the current metal-on-metal and ceramic-on-metal modular design.
Use of a polymer such as Polyetherether ketone (PEEK) produced a low corrosion current of a PEEK-on-metal taper trunion and reduced crevice corrosion in certain conditions. In an alternate embodiment a PEEK sleeve was placed on a Ti6Al4V stem taper. The PEEK sleeve mated with a CoCr female trunion. In another embodiment a PEEK coated Ti6Al4V stem taper was a mirror polished PEEK surface. In another embodiment PEEK was machined into a sleeve and polished.
The above aspects of the invention are provided by a prosthetic head for a femoral component having a hollow, preferably titanium, shell having a thickness between 0.2 and 3.0 mm. The shell has a part-spherical outer surface defining an inner portion terminating in a flange extending inwardly towards a polar axis of the hollow shell. A polymeric material, such as PEEK, fills the inner portion of the hollow titanium shell extending from an inner surface of the shell to an inwardly facing surface of the flange or open end. The polymeric material includes a conically tapered socket formed therein centered about the polar axis intermediate radially spaced ends of the flange on the hollow titanium shell. The hollow shell may have an inner surface with a porous structure for lockingly receiving a portion of the polymeric material. The hollow shell inner surface may have at least one rib extending from an inner surface inwardly toward the conically tapered socket for lockingly receiving the polymer. The outer surface of the hollow titanium shell may be polished or coated with a ceramic. The polymeric material may be polyetheretherketone or polyetherketoneketone or other suitable polymers. The polymeric material may be glass or carbon fiber reinforced such as with chopped fibers. The conically tapered socket may have a polished inner surface or may be molded. The at least one rib on the inner spherical surface of the head may be generally perpendicular to the inner surface of the hollow titanium shell. The ribs may extend in the longitudinal or latitude direction and are spaced at predetermined intervals. The rib may include an inner flange extending perpendicular to the rib, these being “T” shaped.
The above designs can be more expressed in the following table as combination of the options.
As used herein when referring to bones or other parts of the body, the term “proximal” means close to the heart and the term “distal” means more distant from the heart. The term “inferior” means toward the feet and the term “superior” means toward the head. The term “anterior” means toward the front part or the face and the term “posterior” means toward the back of the body. The term “medial” means toward the midline of the body and the term “lateral” means away from the midline of the body.
The invention will be described in more detail below with reference to the embodiments shown in the drawings wherein
In describing the preferred embodiments of the subject matter illustrated and to be described with respect to the drawings, specific terminology will be resorted to for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar purpose.
Referring to the drawings, wherein like reference numerals represent like elements, there is shown in
As best shown in
Various materials can be used in formation of part-spherical shell 16 and inner support 18. Acceptable materials for shell 16 include various metals, such as titanium, CoCr, stainless steel (SS) and titanium alloys, or a ceramic material, such as alumina. Also a metal shell can be coated with ceramic such as alumina. If a polymeric material is used to form support 18, the polymer may be reinforced with carbon or glass fiber, including long, short or micro fibers, as they are known in the art. Preferably, shell 16 is formed from a metal, such as titanium or titanium alloy, CoCr or SS having a thickness between about 0.2 mm and about 3.0 mm. In a preferred embodiment, shell 16 is formed from titanium and has a thickness of about 2 to 3 mm.
Various materials may also be used in the formation of polymeric support 18. Acceptable materials for support 18, include polymeric materials including ULTEX®, PEEK, polycarbonate, polysulphone, XYLAR®, LEXAN® and PEKK. In one embodiment of the present invention, support 18 can be made from a fiber-reinforced polymeric material. Such materials may include PEEK reinforced with carbon fibers, which may comprise long, short or micro fibers. Further, shell 16 is preferably formed with a series of inwardly extending ribs 24 therein. Ribs 24 may increase the overall strength of shell 16 and, thus, of femoral head implant 10, allowing for less-rigid and, possibly, less expensive materials to be used for support 18. Still further, the inclusion of ribs 24 allows the material from which support 18 is formed to have a more uniform thickness. This is advantageous when forming support 18 using an injection molding process because uniform material thickness allows the material throughout the entire part to cool (and thus, shrink) uniformly. This helps prevent the part from warping during cooling.
In a preferred embodiment of implant 10, shell 16 is formed from a metal, preferably titanium or titanium alloy and support 18 is formed from a polymeric material, preferably PEEK. In such an arrangement, shell 16 is more preferably formed using a hydroform process. Hydroforming is a process that is generally known in the art and is useful for imparting complex, three-dimensional (“3D”) shapes into metal. Preferably, shell is formed using a vertical hydraulic hydroforming press. Such a process can be carried out by Aero Trades Manufacturing, located at 65 Jericho Turnpike, Mineola, N.Y. It is preferred that a metal subjected to a hydroform process is thin enough to be accurately formed by the process. It is also preferred that the material be thick enough to retain the shape imparted therein. The ideal thickness for shell in this embodiment will vary by the material and specific geometry used and will be known by those having reasonable skill in the art as indicated above 0.2 to 3 mm is acceptable. The use of a hydroform process to form shell 16 reduces the need for the additional process steps of CNC grinding or polishing, as are needed with a casting process.
Generally, the combination of a shell 16 made from hydroformed metal and a support 18 made from a polymeric material allows for an implant 10 which is appropriately shaped and sufficiently rigid to provide an acceptable femoral component head, while being lightweight and cost-effective from a manufacturing standpoint. Further, the cost-effective manufacture of such implants makes it reasonable to use each of such implants in only one surgical procedure or, alternately, as a trial femoral head. The provision of such disposable trial implants eliminates the need to design such an implant to withstand multiple autoclave cycles, and to withstand multiple trial reductions, further lowering the manufacturing cost thereof.
Shell 16 may be affixed to support 18 by a variety of methods, including using adhesives. Additionally, fixation may be done by providing inner surface of shell 16 with a porous metal coating 28 such as described in U.S. Pat. No. 7,537,664 or U.S. Publication No. 2011/0014081, the disclosures of which are incorporated herein by reference, to secure shell 16 to support 18. Further, in addition to ribs 24, corresponding tabs may be formed in appropriate portions of shell 16 and support 18 to achieve fixation therebetween.
An integral formation of rib or ribs 24 on the inner surface 22 of shell 16 increases the rigidity of shell 16, and accordingly of implant 10 overall. Rib 24 may be formed in a metal shell 16 by hydroforming.
As shown in
Referring to
As stated above, the inner surface of the socket 14, 14′ may be polished to allow the formation of a locking taper with the conically tapered trunion of the femoral component. The locking tapers may be a Morse taper junction within the contacting smooth tapered surfaces providing a sufficient locking force to couple the head to the femoral component trunion. Support 18 is made from polymeric reinforced carbon fiber. Carbon fiber is a reinforcing fiber known for its lightweight, high strength and high stiffness. Carbon fiber is produced by a high-temperature stretching process of an organic precursor fiber based on polyacrylonitrile (“PAN”), rayon, or pitch in an inert atmosphere at temperatures above 1,800 degrees, Fahrenheit. Fibers can be transformed by removing more non-carbon atoms via heat treating above 3,000 degrees Fahrenheit. After these fibers are produced, they can be utilized in many different forms. They can be woven into long, dry fabric, pre-impregnated with PEEK resin, wound onto spools for use in filament winding, or braided and chopped into small fibers. There are several ways in which to produce components using carbon fiber; however, all of such processes require the use of a mold to impart the necessary geometry into the carbon fiber. The mold used in such a process defines the shape of the component. Accordingly, any component that can be molded can be formed from carbon fiber reinforced PEEK.
Molding processes used to form support 18 from carbon fiber include injection molding, autoclave molding, compression molding, bladder molding or resin transfer molding (“RTM”). Any of these methods can be used to produce knee femoral trials for total hip replacement (THR) and hip stem trials for THR. All of these types of molding processes force the carbon and resin to conform to the desired shape using heat and/or pressure. Once the part has cured, it maintains its shape permanently and the composite construction provides sufficient rigidity to allow the implant 10 to perform equivalently to a solid metal prosthetic femoral head having a metal conically tapered bore for receiving a conically tapered trunion on a femoral component neck/stem.
The socket 14, 14′ can be made during the molding operation by placing a conically tapered metal thimble in the mold. The thimble may have a machined surface of may have a polished tapered outer surface. The thimble tapered outer surface which, after injection molding the head/shell with PEEK, forms a socket with a similar surface finish. Alternately, the tapered socket can be machined and optimally polished.
A white light microscopy was used to measure surface roughness profile (
The second finding related to interface hydrolysis. Two metal plugs were bonded with PEEK by melting PEEK film at about 385° C. in between the two metal plug in an Ar atmosphere. After cooling to room temperature, the bonded plugs were soaked in simulated body fluid (Phosphate Buffered Saline) at 37° C. The results are summarized in
Based on the above, a femoral head was designed that has two unique features, a PEEK trunion with as-machined surface roughness and a metal or ceramic shell with mechanical locking feature in the inner surface. The as-machined trunion surface prevents crevice corrosion of the titanium metal stem taper, while the shell inner mechanical locking feature will overcome the hydrolysis issue.
In one embodiment of the invention a shell is made first and then PEEK is molded into the interior space of the shell. The shell may be made of a metal or sintered ceramic with a thickness of 0.2 to 3.0 mm. The metal shell may be made by forging, laser or E-beam additive manufacturing or by Metal Injection Molding (MIM) or hydroforming or any other relatively inexpensive process. The ceramic shell may be made by slip casting, injection molding, and cold isostatic pressing followed by normal sintering or a hot isostatic press sintering process. The outer head surface is ground/machined then polished. The metal surface may be a neat metal alloy that has good biocompatability, good wear resistance, and corrosion resistance, such as CoCr and special stainless steel. If the metal shell does not have good wear resistance such as Titanium alloy and zirconium alloy, the metal shell should be coated with a wear resistant coating. The wear resistant coating may be selected from a ceramic or metal. The ceramic coating may be alumina, zirconia, titanium oxide, chromium oxide, silicon nitride, titanium nitride, chromium nitride, diamond-like coating (DLC), diamond, titanium carbide, zirconium carbide, chromium carbide, etc. The metal coating may be CoCr, stainless steel, chromium. In addition to coating, the outer surface of the metal shell can be transformed to create a ceramic coating with a surface treatment (Sonova LLC, Long Island City, N.Y.)) or transformed with an additional ceramic sprayed or PVD coated with nano-ceramic. A process disclosed in U.S. Pat. No. 5,037,438 or U.S. Pat. No. 7,582,117 may also be used.
The metal or ceramic shell should have a mechanical locking feature. The locking feature should have an average surface roughness of at least 5.0 micrometer, which is the current grit-blasted metal surface roughness. The method to achieve the mechanical locking feature may be selected from selective laser or e-beam additive manufacture process, which can generate a three-dimensional (3D) interlock structure. The 3D structure has interconnected pores that allowed polymer to be molded into it, thus form strong mechanical locking. Another method is physical vapor deposition (PVD). A CoCr, Mo, Ta, Cr, W, Pt, Au, Ag coating can be coated by a PVD method to create two dimensional (2D) surface roughness which has some undercuts to form mechanical interlocks. Grit blasting does not produce undercuts only increased surface area. 2D surface has porosity on its surface only, while the surface pores hold polymer well to form strong mechanical lock. The inner surface may have some anti-rotation fins or ribs around the inside as well. This mechanical locking feature has been disclosed in US 2007/0233266. A 3D porous structure, 2D porous layer, and ribs can provide enough mechanical bonding strength to polymer and overcome hydrolysis issue.
The interlocking feature may vary according to the prosthesis size, shell thickness, and trunion diameter and depth. The 3D porous structure may have interconnected porosity 30-80%, preferably 40-70% and more preferred 50-65%. The 2D locking feature may have a surface roughness minimum of 5 micrometer, preferred more than 10 microns. More preferred more than 20 micrometer. The rib structure can be designed to different patterns. The preferred pattern has T-shape thus that can hold polymer from shrinking back after molding.
No matter what kind of locking feature or design details, the shell-core structure should not have any gap between polymer and shell after manufacturing. It is desirable that the tensile bonding strength between the shell and polymer should more than 35 MPa after soaking in body fluid for life time.
The polymer may be injection molded to form the interior volume and taper junction and the inside of the shell can be textured by grit blasting or left smooth. Advantages are low cost of manufacturing (avoid grinding taper geometry). The polymer taper bore eliminates fretting corrosion concerns at the junction with the trunion on the neck. Light weight saves on shipping and packaging. Burst (fracture) concerns for head are eliminated and fewer metal ions are produced during use. Such a polymer may be selected from polyaryletherketone (PAEK, including PEEK, PEKK, PEK, PEKKEKK), polyphenylene sulfide (PPS), polyacetal (POM), polyamideimide (PAI), liquid crystalline polymers (LCP), polyaryether (PAE), polyarylsulfone (PAS), polyether sulfone, polyetherimide. Of all these polymers, PAEK is the preferred polymer because its semicrystalline nature, POM, and PPS, whose hardness and fracture toughness can be adjusted by controlling crystallinity. The more preferred PAEK polymer is PEEK, which can be sterilized by current popular methods such as gamma ray, X-ray, e-beam, ETO, and autoclave. The desired PAEK polymer will have molecular weight (Mw) more than 80,000 g/mol, more preferred Mw more than 100,000 g/mol, the most preferred Mw more than 110,000 g/mol. The higher the molecular weight, the higher the polymer toughness. Because the polymer socket mates with metal taper, a micromotion and wear may occur at taper junction, high toughness of the polymer is required, which guarantees no catastrophic fracture which can occur with a bulk ceramic head. If the molecular weight is lower than 80,000 g/mol, the polymer will be brittle and is not preferred application for the taper trunion, whose behavior is more similar to ceramic.
For semi-crystalline polymers, the toughness can be as high as metal, or as low as ceramic. The key controlling factor is crystallinity. For a head application, the preferred crystallinity is lower than 50%. The corresponding polymers are LTI 1, LT2, and LT3 (Invibo Ltd, UK) or equivalent PAEK. More preferred crystallinity is lower than 40%, such as LT1 and LT 2 PEEK or equivalent PAEK. The most preferred polymer is less than 31%, which is corresponding to LT1 PEEK or equivalent PAEK.
Because the polymer is used against a metal tapered trunion, a neat polymer is preferred, i.e., not carbon fiber or glass fiber, or Barium sulfate reinforced polymer, especially not reinforced PAEK. The reason is that the reinforcement acts as a third body wear surface, which speeds up the damage to the metal taper in wet and warm corrosive body fluid.
As discussed above, in order to eliminate crevice corrosion, the mold used for injection molding PAEK should have non-polished surface. As-machined mold surface is preferred. This rough mold surface will result in a rough PEEK surface. When mating with a metallic stem taper, the body fluid and oxygen can enter and leave the taper junction freely.
Another embodiment of the invention is to make plastic (PEEK) core first, then applying a metal or ceramic shell second. In this embodiment, the inner shell mechanical locking feature and plastic trunion surface roughness may keep the same of the first embodiment, just manufacturing order was reversed.
Although the various embodiments of the present invention have been discussed as they apply either to the human knee and hip joints, one having reasonable skill in the art upon reading this disclosure would understand that the present invention can be used to form other joints of human or animal bodies. Such joints may include the elbow, wrist, shoulder, etc.
As seen in
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.
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