Embodiments of the present disclosure relate generally to medical prosthetic devices, including prosthetic hip joint components, and associated methods of implantation and treatment.
The present disclosure relates to devices, apparatus, and systems for replacing at least some of the functionality of the natural hip joint and methods of implanting such devices, apparatus, and systems. The natural hip joint is a ball-and-socket joint formed by the articulating interaction of the rounded head of the femur with the acetabulum of the pelvis. The articulating surfaces of both the head of the femur and the acetabulum are covered with articular cartilage. Various conditions can cause damage to the hip joint resulting in debilitating pain, arthritis, and/or limited mobility. In some instances, hip arthroplasty has been used to treat such conditions.
Although existing devices and methods associated with prosthetic hip joint components have been adequate in some respects, they have not been satisfactory in all respects. The present disclosure overcomes one or more of the shortcomings of the existing devices and methods.
In one embodiment, a prosthetic device for positioning within a hip joint is disclosed.
In some instances, the prosthetic device is comprised of two components: a thin metal shell and a pliable articulating component. In some embodiments, the pliable articulating component is made of a pliable structural material validated for medical devices used in vivo and having mechanical properties characterized by a non-linear stress-strain relationship defined by a polynomial mathematical curve having more than two coefficients, such as the Mooney Rivlin coefficients. In some instances, the material has strength and/or elasticity substantially similar to human cartilage. In some instances, the material is a polyurethane based material, which may be polycarbonate polyurethane in some embodiments, and may be a Bionate Polyurethane in some embodiments. The material of the metal shell and the pliable articulating component operate together to dissipate bone stress and strain associated with the hip joint during the life of the device to help preserve and/or regenerate bone strength.
In another embodiment, a prosthetic device for implantation into a hip joint is disclosed. The prosthetic device includes a first component comprising an outer surface for securely engaging a bony portion of an acetabulum and an opposing inner surface for receiving a second component. The outer surface has a generally semi-spherical profile. The inner surface also has a generally semi-spherical profile concentric with the outer surface. The first component has a substantially uniform thickness less than about 1.0 mm between the outer surface and the inner surface. The first component also includes at least one annular protrusion extending circumferentially from the inner surface. The at least one annular protrusion has a height less than about 1.0 mm relative to the inner surface. The first component comprises a substantially rigid first material. The prosthetic device also includes a second component. The second component includes an outer surface having a generally semi-spherical profile for engagement with the inner surface of the first component. In that regard, the outer surface includes at least one annular recess extending circumferentially into the outer surface with a depth less than about 1.0 mm. The at least one annular recess is shaped to receive the at least one annular protrusion of the first component. The second component also includes an inner surface for mating with a femoral head. The inner surface has a generally semi-spherical profile concentric with the outer surface. The second component has a substantially uniform thickness less than about 3.0 mm between the outer surface and the inner surface. The second component comprising a pliable second material. In some instances, the first and second components have a total thickness between the outer surface of the first component and the inner surface of the second component that is approximately equal to a thickness of a native articular cartilage of the acetabulum adjacent the bony portion of the acetabulum. In some instances, the prosthetic device also includes a prosthetic femoral head for mating with the inner surface of the second component.
In another embodiment, a prosthetic acetabular cup system is disclosed. The system includes a metal shell comprising an outer surface for securely engaging a prepared portion of an acetabulum, an opposing inner surface for receiving a pliable articulating component, and at least one snap-fit engagement feature associated with the inner surface. The metal shell has a thickness less than about 1.0 mm between the outer surface and the inner surface. The system also includes a pliable articulating component. The pliable articulating component includes an outer surface for engaging the inner surface of the metal shell, including at least one snap-fit engagement feature associated sized and shaped to snap-fittingly engage the at least one snap-fit engagement feature of the metal shell. The pliable articulating component also includes an inner surface for receiving a femoral head. The pliable articulating component has a thickness less than about 3.0 mm between the outer surface and the inner surface. In some instances, the at least one snap-fit engagement feature of the metal shell comprises at least one recess and the at least one snap-fit engagement feature of the pliable articulating component comprises at least one projection. In some instances, the at least one snap-fit engagement feature of the metal shell comprises at least one projection and the at least one snap-fit engagement feature of the pliable articulating component comprises at least one recess. In some instances, the metal shell and the pliable articulating component have a total thickness between the outer surface of the metal shell and the inner surface of the pliable articulating component that is approximately equal to a thickness of a native articular cartilage of the acetabulum.
In another embodiment, a method of implanting an artificial acetabular component is disclosed. The method includes removing at least a portion of an articular cartilage of an acetabulum to access a bony portion of the acetabulum and engaging an outer surface of a metal shell with the bony portion of the acetabulum, where the metal shell has an opposing inner surface and a thickness of less than about 1.0 mm between the outer surface and the inner surface. The method also includes snap-fitting a pliable articulating component into engagement with the inner surface of the metal shell, where the pliable articulating component has a thickness less than about 3.0 mm between an outer engagement surface and an inner articulating surface such that when snap-fittingly engaged the metal shell and the pliable articulating component have a total thickness between the outer surface of the metal shell and the inner articulating surface of the pliable articulating component that is approximately equal to a thickness of the removed articular. In some instances, snap-fitting the pliable articulating component into engagement with the inner surface of the metal shell comprises snap-fitting at least one projection extending from the inner surface of the metal shell with at least one recess extending into the outer engagement surface of the pliable articulating component. In some instances, the method also includes wetting at least the outer engagement surface of the pliable articulating component prior to snap-fitting the pliable articulating component into engagement with the metal shell.
Other features and advantages of the present disclosure will become apparent in the following detailed description of embodiments of the disclosure with reference to the accompanying of drawings, of which:
For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is intended. Any alterations and further modifications in the described devices, instruments, methods, and any further application of the principles of the disclosure as described herein are contemplated as would normally occur to one skilled in the art to which the disclosure relates. In particular, it is fully contemplated that the features, components, and/or steps described with respect to one embodiment may be combined with the features, components, and/or steps described with respect to other embodiments of the present disclosure.
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From a center point 126, the substantially semi-spherical outer surface 112 is defined by a radius of curvature 128. Similarly, the substantially semi-spherical inner surface 116 is defined by a radius of curvature 130. The radius of curvature 128 is generally between about 24.0 mm and about 30.0 mm, but in some instances may be larger or smaller. Accordingly, the radius of curvature 130 is generally between about 23.0 mm and about 29.5 mm, but also may be larger or smaller in some instances.
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In some embodiments, the articulating component 108 does not include recesses 134, 136 and the shell 106 does not include protrusions 118, 120, such that the articulating component 108 is anchored to the shell 106 via engagement of the protrusion or rim 122 with the taper or rim 138 of the articulating component. In that regard, the diameter of the opening defined by the protrusion or rim 122 is less than a maximum diameter of the articulating component 108, such that the articulating component is held within the shell 106 by the protrusion 122. In such embodiments, the articulating component 108 may have a substantially smooth outer surface for interfacing the with the shell 106. In one such embodiment, the articulating component 108 may also be anchored to the shell 106 via a liquid adhesion bond. In such instances, the liquid adhesion bond prevents separation of the articulating component 108 from the shell 106 while the protrusion 122 limits rotation of the articulating component 108 relative to the shell 106.
The articulating component 108 also includes an inner surface 140 opposite the outer surface 132. In the present embodiment, the outer surface 132 is substantially semi-spherical. Similarly, the inner surface 140 is also substantially semi-spherical and concentric relative to the outer surface 132. The outer surface 132 and the inner surface 140 are separated by a thickness 142 of the articulating component 108. Generally, the thickness 142 is between about 6.0 mm and about 1.5 mm. In some embodiments, the thickness 142 is less than about 3.0 mm and, in some further embodiments, is about 1.5 mm. The articulating component 108 also has a thickness 144 between the inner surface 140 and the trough or lowest point of each of the recesses 134, 136. In that regard, the thickness 144 is generally between about 5.0 mm and about 0.5 mm. In some embodiments, the thickness 144 is less than about 2.0 mm. As discussed below, however, in other embodiments the protrusions 118, 120, 122 may have various other profiles instead of the illustrated rounded profiles.
From a center point 146, the substantially semi-spherical outer surface 132 is defined by a radius of curvature 148. Similarly, the substantially semi-spherical inner surface 140 is defined by a radius of curvature 150 extending from the center portion 146. The radius of curvature 148 is generally between about 23.0 mm and about 29.5 mm, but in some instances may be larger or smaller. Accordingly, the radius of curvature 150 is generally between about 17.0 mm and about 28.5 mm, but also may be larger or smaller in some instances.
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When assembled, the shell 106 and the articulating component 108 have a combined thickness 152 adjacent the apex of the components between the outer surface 112 of the shell 106 and the inner surface 140 of the articulating member 108. When assembled, the shell 106 and the articulating component 108 also have a combined thickness 154 adjacent the rim of the components between the outer surface 112 of the shell 106 and the inner surface 140 of the articulating member 108. In the present embodiment, the thicknesses 152, 154 are substantially equal such that when assembled the shell 106 and articulating component 108 define a substantially constant thickness between the outer surface 112 and the inner surface 140. In that regard, the mating of the protrusions 118, 120 with the recesses 134, 136 and the mating of the protrusion 122 with the taper 138 results in the constant thickness. In other embodiments, the combined thickness extending between the outer surface 112 and the inner surface 140 is not substantially constant. In one particular embodiment, the thickness 154 adjacent the rim of the components is larger than the thickness 152 adjacent the apex of the components. In that regard, an increased thickness 154 adjacent the rim of the components is utilized to at least partially retain a femoral head within the articulating component in some instances.
In some instances, the combined thicknesses 152, 154 are substantially equal to or less than a thickness of the native cartilage of the acetabulum in some instances. In that regard, in some instances the combined thicknesses 152, 154 are substantially equal to or less than a desired or normal amount of articular cartilage, but not necessarily less than the articular cartilage of a particular patient. For example, in the case where a patient's articular cartilage has been damaged or removed, the thicknesses 152,154 may be greater than the thickness of the patient's articular cartilage. In some instances the combined thicknesses 152, 154 are substantially equal to or less than the actual articular cartilage of the patient. In that regard, in some instances the shell 106 and articulating component 108 are sized to substantially replace the space created by removal of articular cartilage and/or bone from the acetabulum prior to insertion of the shell 106 and articulating component 108. In some instances the shell 106 and articulating component 108 are sized to replace less than the space created by removing articular cartilage and/or bone from the acetabulum prior to insertion of the shell 106 and articulating component 108, such that a femoral head larger than the natural femoral head may be utilized.
While the shell 106 is shown as having protrusions 118, 120, and 122, in other embodiments the shell may have other engagement features for mating the with the articulating component 108. Similarly, while the articulating component 108 is shown as having recesses 134, 136 and taper 138, in other embodiments the articulating component may have other engagement features for mating with the shell. In that regard, each of the shell 106 and articulating component 108 may include projections, recesses, and combinations thereof sized and shaped to engage corresponding projections, recesses, and combinations thereof of the other component. In some instances the engagement features are similar to the engagement features of one or more of the prosthetic devices described in U.S. patent application Ser. No. 10/289,126 titled “ONE PIECE SNAP FIT ACETABULAR CUP,” U.S. patent application Ser. No. 10/497,897 titled “CUSHION BEARING IMPLANTS FOR LOAD BEARING APPLICATIONS,” U.S. patent application Ser. No. 10/515,486 titled “IMPLANTS,” U.S. patent application Ser. No. 11/688,153 titled “CERAMIC-ON-CERAMIC PROSTHETIC DEVICE COUPLED TO A FLEXIBLE BONE INTERFACE,” or PCT Application No. PCT/IL2006/000343 titled “IMPLANT DEVICES” (published as WO 2006/097932), each incorporated by reference in its entirety. It is recognized that the various combinations of projections and recesses described as being formed in the acetabulum by these references can instead by formed in one of the shell 106 and/or articulating component 108 in accordance with the present disclosure.
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When assembled together the outer component 182 and the inner component 184 have a thickness 198 between the outer surface of the outer component and the inner surface of the inner component between the interface of the projection 196 and recess 194 and the apex of the components. When assembled together the outer component 182 and the inner component 184 have a thickness 200 between the outer surface of the outer component and the inner surface of the inner component between the interface of the projection 196 and recess 194 and the rim of the components. In that regard, the thickness 198 is substantially equal to the thickness 200 in the present embodiment. Thus, the difference between the thicknesses 186 and 188 of the outer component and the difference between the thicknesses 190 and 192 of the inner component are substantially equal. In other instances, the differences between the thickness 186, 188 and 190, 192 are not substantially equal such that the thicknesses 198, 200 of the assembled components is not equal.
Generally, the shell or outer components of the present disclosure are formed of a material that is more rigid than the material of the articulating or inner components. For example, in some embodiments the shell is formed of a medical grade metal suitable for implantation, including but not limited to stainless steel alloys, cobalt-chrome alloys, titanium alloys, nickel-titanium alloys, and other suitable metals. In other embodiments, the shell is formed of a composite material, including but not limited to polyetheretherketone (PEEK), carbon-reinforced PEEK, Dyneema, and other suitable composites.
In some instances, the prosthetic devices of the present disclosure are fiber reinforced, include one or more deformation control elements, or comprise a material or combination of materials particularly suited for positioning within an articulating joint. In some embodiments, the prosthetic devices are formed of materials or combinations of materials as described in U.S. patent application Ser. No. 10/497,897 titled “CUSHION BEARING IMPLANTS FOR LOAD BEARING APPLICATIONS” and U.S. patent application Ser. No. 12/100,090 titled “MANUFACTURING AND MATERIAL PROCESSING FOR PROSTHETIC DEVICES”, each hereby incorporated by reference in its entirety.
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The foregoing outlines features of several embodiments so that those skilled in the art may better understand the aspects of the present disclosure. Those skilled in the art should appreciate that they may readily use the present disclosure as a basis for designing or modifying other processes and structures for carrying out the same purposes and/or achieving the same advantages of the embodiments introduced herein. Those skilled in the art should also realize that such equivalent constructions do not depart from the spirit and scope of the present disclosure, and that they may make various changes, substitutions and alterations herein without departing from the spirit and scope of the present disclosure. Also, it will be fully appreciated that variations of the above-disclosed and other features and functions, or alternatives thereof, may be combined into other methods, systems, apparatus, or applications. Similarly, various presently unforeseen or unanticipated alternatives, modifications, and/or variations of the present disclosure subsequently made by those skilled in the art are also encompassed by the present disclosure and the following claims.
This application is a United States national phase application of co-pending international patent application number PCT/US2008/064352, filed May 21, 2008, which claims priority to U.S. Provisional patent application No. 60/946,522, filed Jun. 27, 2007 and U.S. Provisional patent application No. 60/939,327, filed May 21, 2007, the disclosures of which are incorporated herein by reference.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US08/64352 | 5/21/2008 | WO | 00 | 3/3/2010 |
Number | Date | Country | |
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60939327 | May 2007 | US | |
60946522 | Jun 2007 | US |