# Patent

## Title
Dual modulus hip stem

## Abstract

An orthopaedic prosthesis for use in a hip replacement surgery. The orthopaedic prosthesis includes a metallic foam shell and a metallic core. The metallic core includes a neck configured to receive a femoral head component and a stem extending through the metallic foam shell.

## Background
This application is a continuation-in-part of U.S. patent application Ser. No. 13/526,032, which was filed on Jun. 18, 2012 and is expressly incorporated herein by reference.


TECHNICAL FIELD
The present disclosure relates generally to orthopaedic prostheses, and particularly to orthopaedic prostheses for use in hip replacement surgery.
BACKGROUND
Joint arthroplasty is a well-known surgical procedure by which a diseased and/or damaged natural joint is replaced by a prosthetic joint. The prosthetic joint may include a prosthesis that is implanted into one or more of the patient's bones. Many hip prostheses include a femoral prosthesis that is implanted into a patient's femur. A femoral prosthesis typically includes an elongated stem component that is received in the medullary canal of the patient's femur and a spherically-shaped head component that bears against the patient's acetabulum or a prosthetic replacement acetabular cup.
Many femoral prostheses are formed from metallic materials or a combination of metallic and polymeric materials. According to Wolff's law, a patient's bone tissue will remodel in proportion to the stress applied it. Because elongated stem components formed from metal typically have an elastic modulus greater than the elastic modulus of the patient's bone, metallic stem components may shield the patient's bone from stress such that the proximal femoral bone does not remodel to an effective degree, possibly resulting in a loss of support for the implant and/or implant failures.
SUMMARY
According to one aspect of the disclosure, an orthopaedic prosthesis is disclosed. The orthopaedic prosthesis includes a metallic foam shell and a metallic core. The foam shell includes a sheath and a cover layer. The metallic core includes a neck positioned proximal of the sheath, the neck being configured to receive a femoral head component, a first core segment positioned in the sheath, and a second core segment positioned distal of the sheath. The cover layer of the foam shell extends distally from the sheath, and the cover layer engages only a lateral surface of the second core segment.
In some embodiments, the first core segment of the metallic core may have a medial surface and a lateral surface positioned opposite the medial surface. In some embodiments, the sheath may have a medial surface and a lateral surface positioned opposite the medial surface. Additionally, in some embodiments, when the orthopaedic prosthesis is viewed in a transverse plane, a first thickness may be defined between a medial-most point of the medial surface of the sheath and a medial-most point of the medial surface of the first core segment and a second thickness may be defined between a lateral-most point of the lateral surface of the sheath and a lateral-most point of the lateral surface of the first core segment. The first thickness may be less than the second thickness.
In some embodiments, the transverse plane may be a first transverse plane extending through the orthopaedic prosthesis between a proximal end of the sheath and a distal end of the sheath. When the orthopaedic prosthesis is viewed in a second transverse plane extending through the orthopaedic prosthesis at the distal end of the sheath, a third thickness may be defined between a medial-most point of the medial surface of the sheath and a medial-most point of the medial surface of the first core segment. The third thickness may be less than the first thickness.
In some embodiments, the third thickness may be less than 1.5 millimeters. Additionally, in some embodiments, when the orthopaedic prosthesis is viewed in the second transverse plane, a fourth thickness may be defined between a lateral-most point of the lateral surface of the sheath and a lateral-most point of the lateral surface of the first core segment. The fourth thickness may be greater than five millimeters.
In some embodiments, when the orthopaedic prosthesis is viewed in the second transverse plane, the medial surface of the first core segment may be convex, and the lateral surface of the first core segment may be convex. In some embodiments, when the orthopaedic prosthesis is viewed in the second transverse plane, the medial surface of the first core segment may be defined by a first radius, and the lateral surface of the first core segment may be defined by a second radius that is greater than the first radius.
Additionally, in some embodiments, the cover layer of the metallic foam shell may have a body that extends from a proximal end attached to the sheath to a distal end. The body may have a first thickness at the proximal end and a second thickness at the distal end. The second thickness may be less than the first thickness. In some embodiments, the first thickness of the body may be greater than three millimeters.
In some embodiments, the sheath of the metallic foam shell may have a porous outer surface. Additionally, in some embodiments, the cover layer of the metallic foam shell may have a non-porous outer surface.
In some embodiments, the metallic foam shell may have a first elastic modulus, and the metallic core may have a second elastic modulus. The first elastic modulus may be approximately one-twentieth of the second elastic modulus. In some embodiments, the metallic foam shell may be shaped to engage a surgically-prepared proximal end of a patient's femur. Additionally, in some embodiments, the first elastic modulus may be approximately one-tenth of the second elastic modulus. In some embodiments, the metallic foam shell may be shaped to engage a surgically-prepared proximal end of a patient's femur.
According to another aspect, an orthopaedic prosthesis includes a metallic foam shell having a first elastic modulus. The metallic foam shell has an outer surface that engages a patient's bony anatomy. The orthopaedic prosthesis also includes a metallic core including a neck positioned proximal of the shell and a body that extends through the shell. The core has a second elastic modulus greater than the first elastic modulus of the shell. When the orthopaedic prosthesis is viewed in a transverse plane extending through the shell and the core, a first thickness is defined between a medial-most point of the outer surface of the shell and a medial-most point of a medial surface of the core, and a second thickness is defined between a lateral-most point of the outer surface of the shell and a lateral-most point of a lateral surface of the core. The first thickness is less than the second thickness.
In some embodiments, the metallic core may be formed from a cobalt-chromium alloy. Additionally, in some embodiments, the metallic foam shell may be formed from titanium. In some embodiments, the metallic foam shell may be formed from a cobalt-chromium alloy. Additionally, in some embodiments, the metallic foam shell may be formed from titanium alloy.
In some embodiments, the body of the metallic core may include a first core segment coupled to the neck and positioned in the metallic foam shell and a second core segment positioned distal of the metallic foam shell. In some embodiments, the metallic foam shell may include a cover layer attached to only a lateral surface of the second core segment.
According to another aspect, a method of manufacturing an orthopaedic prosthesis for a patient is disclosed. The method includes producing a shell from a metallic foam material having a first elastic modulus, producing a stem core from a metallic material having a second elastic modulus greater than the first elastic modulus. The stem core includes a neck configured to receive a femoral head component. The method also includes securing the shell to the stem core such that the shell is positioned over a proximal segment of the stem core, and a cover layer of the shell extends along a lateral surface of a distal segment of the stem core.
In some embodiments, producing the shell may include forming a sheath over the proximal segment of the stem core such that the proximal segment of the stem core is encased therein. Additionally, in some embodiments, forming the sheath may include setting a medial thickness of the shell to between one millimeter and 1.5 millimeters at a distal end of the sheath.
In some embodiments, securing the shell to the core may include sintering the shell to the core. Additionally, in some embodiments, producing the shell from the metallic foam material may include compressing the metallic foam material around the stem core, and machining the metallic foam material to form the shell. In some embodiments, producing the shell from the metallic foam material may include compressing the metallic foam material to form an outer geometry of the shell, and machining a channel in the metallic foam material sized to receive the stem core.
According to another aspect, an orthopaedic prosthesis includes a metallic foam shell including a sheath, and a metallic core including a neck positioned proximal of the sheath a first core segment positioned in the sheath, and a second core segment positioned distal of the sheath. The neck of the metallic core is configured to receive a femoral head component. The metallic foam shell further includes a cover layer extending distally from the sheath that engages only a lateral surface of the second core segment. When the orthopaedic prosthesis is viewed in a transverse plane extending through the cover layer of the metallic foam shell, the cover layer defines a first cross-sectional area, the cover layer and the second core segment define a second cross-sectional area, and a ratio of the first cross-sectional area to the second cross-sectional area is greater than 0.30.
In some embodiments, the ratio of the first cross-sectional area to the second cross-sectional area may be between 0.35 and 0.47. In some embodiments, the ratio of the first cross-sectional area to the second cross-sectional area may be less than 0.56.
In some embodiments, when the orthopaedic prosthesis is viewed in a second transverse plane extending through the sheath of the metallic foam shell, the sheath may define a third cross-sectional area, the sheath and the first core segment may define a fourth cross-sectional area, and a ratio of the third cross-sectional area to the fourth cross-sectional area may be greater than 0.38. In some embodiments, the ratio of the third cross-sectional area to the fourth cross-sectional area may be between 0.46 and 0.54.
Additionally, in some embodiments, the ratio of the third cross-sectional area to the fourth cross-sectional area may be less than 0.70. In some embodiments, the ratio of the third cross-sectional area to the fourth cross-sectional area may be greater than the ratio of the first cross-sectional area to the second cross-sectional area.
In some embodiments, the cover layer of the metallic foam shell may extend distally from a proximal end attached to the sheath, and the transverse plane extends through the proximal end of the cover layer. When the orthopaedic prosthesis is viewed in the transverse plane, the cover layer has a first thickness, the second core segment has a second thickness, and a ratio of the first thickness to the second thickness may be greater than 0.46.
In some embodiments, the first thickness may be greater than three millimeters. When the orthopaedic prosthesis is viewed in the transverse plane, a medial surface of the first core segment may be convex and a lateral surface of the first core segment may be convex.
In some embodiments, when the orthopaedic prosthesis is viewed in the transverse plane, the medial surface of the first core segment may be defined by a first radius, and the lateral surface of the first core segment may be defined by a second radius that is greater than the first radius.
In some embodiments, the first core segment of the metallic core may have a medial surface and a lateral surface positioned opposite the medial surface of the first core segment, and the sheath may have a medial surface and a lateral surface positioned opposite the medial surface of the sheath. When the orthopaedic prosthesis is viewed in the transverse plane, a first thickness may be defined between a lateral-most point of the lateral surface of the sheath and a lateral-most point of the lateral surface of the first core segment, a second thickness may be defined between a medial-most point of the medial surface of the sheath and a medial-most point of the medial surface of the first core segment, and a ratio of the second thickness to the first thickness may be greater than 0.14.
According to another aspect, an orthopaedic prosthesis for a patient includes an elongated femoral stem component having a longitudinal axis. The stem component includes a metallic foam shell having a first elastic modulus, and a metallic core including a neck positioned proximal of the shell and a body that extends through the shell. The core has a second elastic modulus greater than the first elastic modulus. The metallic foam shell defines a first cross-sectional area at a first point on the longitudinal axis, the stem component defines a second cross-sectional area at the first point, and a ratio of the first cross-sectional area to the second cross-sectional area is greater than 0.38. The metallic foam shell defines a third cross-sectional area at a second point on the longitudinal axis that is distal of the first point, the stem component defines a fourth cross-sectional area at the second point, and a ratio of the third cross-sectional area to the fourth cross-sectional area is greater than the ratio of the first cross-sectional area to the second cross-sectional area.
In some embodiments, the metallic foam shell may define a fifth cross-sectional area at a third point on the longitudinal axis. The third point may be distal of the second point. The stem component may define a sixth cross-sectional area at the third point, and a ratio of the fifth cross-sectional area to the sixth cross-sectional area may be less than the ratio of the third cross-sectional area to the fourth cross-sectional area.
In some embodiments, the ratio of the fifth cross-sectional area to the sixth cross-sectional area may be between 0.30 and 0.56.
In some embodiments, the metallic foam shell may include a cover layer attached to only a lateral surface of the metallic core at the third point on the longitudinal axis.
In some embodiments, the ratio of the third cross-sectional area to the fourth cross-sectional area may be less than 0.70.
According to another aspect, an orthopaedic prosthesis includes an elongated femoral stem component having a longitudinal axis. The stem component includes a metallic foam shell including a sheath, and a metallic core including a neck positioned proximal of the sheath that is configured to receive a femoral head component, a first core segment positioned in the sheath, and a second core segment positioned distal of the sheath. The metallic foam shell further includes a cover layer extending distally from the sheath and engaging only a lateral surface of the second core segment. The cover layer defines a first cross-sectional area at a first point on the longitudinal axis. The cover layer and the second core segment define a second cross-sectional area at the first point, and a ratio of the first cross-sectional area to the second cross-sectional area is greater than 0.30.
In some embodiments, the sheath may define a third cross-sectional area at a second point on the longitudinal axis, the sheath and the first core segment may define a fourth cross-sectional area at the second point, and a ratio of the third cross-sectional area to the fourth cross-sectional area may be greater than 0.38.



BRIEF DESCRIPTION OF THE DRAWINGS
The detailed description particularly refers to the following figures, in which:
FIG. 1 is a perspective view of an orthopaedic implant;
FIG. 2 is a perspective view of a core of the orthopaedic implant of FIG. 1;
FIG. 3 is a cross-sectional view of the orthopaedic implant taken along the line 3-3 in FIG. 1;
FIG. 4 is a cross-sectional view of the orthopaedic implant taken along the line 4-4 in FIG. 3;
FIG. 5 is a cross-sectional view of the orthopaedic implant taken along the line 5-5 in FIG. 3;
FIG. 6 is a cross-sectional view of the orthopaedic implant taken along the line 6-6 in FIG. 3;
FIG. 7 is a cross-sectional view of the orthopaedic implant taken along the line 7-7 in FIG. 3;
FIG. 8 is a simplified block diagram of a process for manufacturing the orthopaedic implant of FIGS. 1-7; and
FIG. 9 is a table showing cross-sectional areas of various components of the orthopaedic implant of FIG. 1 at various points along the length of the implant.



DETAILED DESCRIPTION OF THE DRAWINGS
While the concepts of the present disclosure are susceptible to various modifications and alternative forms, specific exemplary embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit the concepts of the present disclosure to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.
Terms representing anatomical references, such as anterior, posterior, medial, lateral, superior, inferior, transverse, coronal, etcetera, may be used throughout the specification in reference to the orthopaedic implants or prostheses and surgical instruments described herein as well as in reference to the patient's natural anatomy. Such terms have well-understood meanings in both the study of anatomy and the field of orthopaedics. Use of such anatomical reference terms in the written description and claims is intended to be consistent with their well-understood meanings unless noted otherwise.
Referring to FIG. 1, an orthopaedic prosthesis is illustratively embodied as a femoral orthopaedic implant 10 of a hip prosthesis. The femoral orthopaedic implant 10 (hereinafter implant 10) includes a head component 12 and an elongated stem component 14 that is configured to be inserted into an intramedullary canal of a patient's surgically-prepared femur (not shown). The head component 12 includes a spherical outer surface 16 configured to engage a patient's natural acetabulum (not shown) or a prosthetic acetabular cup implanted into the patient's pelvic bone. The head component 12 also includes a distal surface 18 having an opening 20 defined therein, and an inner wall (not shown) extends inwardly from the opening 20 to define an aperture 22 in the head component 12.
The stem component 14 of the implant 10 includes a core 24 having a neck 26 configured to be coupled to the head component 12. In the illustrative embodiment, the neck 26 includes a plurality of external threads 28 that are configured to engage with a plurality of internal threads (not shown) lining the aperture 22 of the head component 12. It should be appreciated that in other embodiments the neck and the head component may be configured to be press fit, taper fit, or secured together by other fastening means.
As shown in FIG. 2, the core 24 of the stem component 14 also includes a collar 30 and a core body 32 extending distally from the collar 30. As shown in FIG. 1, the neck 26 extends medially and proximally from the collar 30. In the illustrative embodiment, the neck 26, the collar 30, and the core body 32 are formed as a monolithic structure (e.g., a single molded or cast part). It should be appreciated that in other embodiments the components of the core 24 (e.g., the neck 26, the collar 30, and the core body 32) may be formed as separate components secured to one another by a mechanical fastener (e.g., screw, bolt, taper fit, etc.), adhesive, or other suitable fastener.
The stem core 24 is formed from an implant grade metallic material having a high tensile strength and a high elastic modulus (i.e., a high material stiffness). As used herein, the term “high tensile strength” refers to a tensile strength that is greater than 650 MPa. Additionally, as used herein, the term “high elastic modulus” refers to an elastic modulus or modulus of elasticity that is greater than or equal to 100 GPa. In the illustrative embodiment, the core 24 is formed from cobalt-chromium alloy (“CoCr”) having a minimum ultimate tensile strength of 650 MPa and an elastic modulus of approximately 195 GPa. It should be appreciated that in other embodiments the core 24 may be formed any material having a high tensile strength and a high elastic modulus, including, for example, a titanium alloy such as Ti-6Al-4V, which has a minimum ultimate tensile strength of 750 MPa and an elastic modulus of approximately 105 GPa.
As described above, the core 24 of the stem component 14 includes a core body 32, which lies generally in the coronal plane of a patient's body when the implant 10 is secured to the patient's femur. As shown in FIG. 2, the core body 32 of the core 24 extends from a proximal end 34 attached to the collar 30 to a distal end 36, and the core body 32 has a longitudinal axis 74 that extends through the ends 34, 36. The core body 32 includes a medial surface 38 and a lateral surface 40 positioned opposite the medial surface 38. When the core 24 of the stem component 14 is viewed in the coronal plane, the core body 32 has a thickness 42 at the proximal end 34, which is defined between the surfaces 38, 40 of the core body 32. The core body 32 has another thickness 44 defined between the surfaces 38, 40 at the distal end 36. In the illustrative embodiment, the thickness 44 is less than the thickness 42, and the core body 32 tapers to decrease in thickness between the proximal end 34 and the distal end 36. In the illustrative embodiment, the thickness 42 is equal to approximately 18.0 millimeters, and the thickness 44 is equal to approximately 3.5 millimeters. It should be appreciated that in other embodiments, the thicknesses 42, 44 may vary depending on the patient's anatomy and the performance requirements of the implant 10.
In the illustrative embodiment, the medial surface 38 of the core body 32 is convex. As described in greater detail below, the medial surface 38 is defined by a radius 46 (see FIGS. 4-7) that decreases in magnitude as the medial surface 38 extends from the proximal end 34 of the core body 32 to the distal end 36. The lateral surface 40 is also convex in the illustrative embodiment. The lateral surface 40, like the medial surface 38, is defined by a radius 48 (see FIGS. 4-7) that decreases in magnitude as the lateral surface 40 extends from the proximal end 34 of the core body 32 to the distal end 36. While the radii 46, 48 decrease in magnitude, the magnitude of the radius 48 of the lateral surface 40 at each point along the longitudinal axis 74 of the core body 32 is greater than the magnitude of the radius 46 of the medial surface 38.
Returning to FIG. 1, the stem component 14 of the implant 10 also includes a shell 50 that is secured to the core 24. The shell 50 has a sheath 52 that has a proximal end 54 attached to the collar 30 and a distal end 56 positioned between the collar 30 and the distal end 36 of the core 24. The shell 50 also includes a cover layer 58 that extends distally from the sheath 52 to the distal end 36 of the core body 32. In the illustrative embodiment, the sheath 52 and the cover layer 58 are formed as a monolithic structure. It should be appreciated that in other embodiments the components of the shell 50 (e.g., sheath 52 and the cover layer 58) may be formed as separate components. The separate components may be secured to one another by a mechanical fastener (e.g., screw, bolt, taper fit, etc.), adhesive, or other suitable fastener or secured separately to the core 24.
The shell 50 of the stem component 14 is formed from a metallic foam matrix having a low elastic modulus. As used herein, a “low elastic modulus” refers to an elastic modulus or modulus of elasticity similar to that of a patient's natural femur (i.e., between 10 GPa and 20 GPa). In the illustrative embodiment, the shell 50 is formed from a foam matrix of titanium having an elastic modulus of approximately 10 GPa and an ultimate tensile strength of the foam matrix of titanium is approximately 35 MPa. In that way, the shell 50 has an elastic modulus that is closer to that of a patient's femur. It should be appreciated that in other embodiments the shell 50 may be formed any metallic foam matrix having a low elastic modulus, such as, for example, a CoCr foam matrix having an elastic modulus of approximately 19 GPa, a CoCr alloy foam matrix, a titanium foam alloy matrix, or other foam matrix.
As described above, the core 24 of the stem component 14 in the illustrative embodiment is formed from CoCr having an elastic modulus of approximately 195 GPa while the shell 50 is formed from a foam matrix of titanium having an elastic modulus of approximately 10 GPa. Thus, in the illustrative embodiment, the elastic modulus of the shell 50 is approximately 1/20 of the elastic modulus of the core 24. In still other embodiments, the core may be formed from CoCr having an elastic modulus of approximately 195 GPa and the shell may be formed from a CoCr foam matrix having an elastic modulus of approximately 19 GPa. In such embodiments, the elastic modulus of the shell is approximately 1/10 of the elastic modulus of the core. In other embodiments, the core may be formed from Ti-6Al-4V having an elastic modulus of approximately 105 GPa and the shell may be formed from a titanium foam matrix having an elastic modulus of approximately 10 GPa. In such embodiments, the elastic modulus of the shell is approximately 1/10 of the elastic modulus of the core.
As shown in FIG. 1, the sheath 52 of the shell 50 has an outer surface 60, and the cover layer 58 has an outer surface 62. The outer surfaces 60, 62 define a portion of the external geometry of the implant 10. As such, the outer surfaces 60, 62 engage the portion of the patient's femur defining the intramedullary canal when the implant 10 is inserted into the proximal end of the patient's surgically-prepared femur. In the illustrative embodiment, the outer surface 60 of the sheath 52 is porous to enable bone ingrowth fixation, and the outer surface 62 of the cover layer 58 is non-porous. It should be appreciated that in other embodiments the cover layer 58 may also be porous.
As shown in FIG. 3, the core body 32 of the stem core 24 extends through the sheath 52 of the shell 50. The core body 32 includes a core segment 64 that is positioned in the sheath 52, and a core segment 66 that is positioned distal of the sheath 52. The sheath 52 is attached to and encases a medial surface 68 and a lateral surface 70 of the core segment 64. The surfaces 68, 70 form proximal sections of the medial surface 38 and lateral surface 40, respectively, of the core body 32. In the illustrative embodiment, each of the surfaces 68, 70 extends from an outer anterior surface 84 of the core body 32 to an outer posterior surface 86 of the core body 32.
The core body 32 (i.e., the core segments 64, 66) and the shell 50 (i.e., the sheath 52 and cover layer 58) cooperate to define a longitudinal axis 72 of the stem component 14, which extends between the proximal end 34 and the distal end 36. As described above, the core body 32 has a longitudinal axis 74 that is defined between the ends 34, 36, and the axis 74 is offset from the axis 72. In the illustrative embodiment, the axis 74 is offset in the medial direction from the axis 72 such that the core body 32 is biased toward the medial side 80 of the stem component 14 and away from the lateral side 82 of the stem component 14. Additionally, the thickness (referred to herein as the “lateral thickness”) of the shell 50 on the lateral side 82 of the stem component 14 is greater than the thickness (referred to herein as the “medial thickness”) of the shell 50 on the medial side 80 of the stem component 14.
As described above, the sheath 52 of the foam shell 50 has a proximal end 54 and a distal end 56. In the illustrative embodiment, the ratio of the medial thickness of the shell 50 to the lateral thickness of the shell 50 is between 0.80 and 0.17 at each point along the longitudinal axis 72 between the ends 54, 56 of the sheath 52. In other words, at any point between the ends 54, 56 of the sheath 52, the medial thickness may be 17% to 80% of the lateral thickness. In other embodiments, the ratio at each point may be between 0.95 and 0.14.
For example, as shown in FIG. 4, the sheath 52 has a lateral thickness 90 and a medial thickness 92 when viewed in a transverse plane extending through the stem component 14 at a point 88 on the axis 72 between the proximal end 54 and the distal end 56 of the sheath 52. The lateral thickness 90 of the sheath 52 is defined between a lateral-most point 94 of the lateral surface 70 of the core segment 64 and a lateral-most point 96 of the outer surface 60 of the sheath 52. The medial thickness 92 of the sheath 52 is defined between a medial-most point 98 of the medial surface 68 of the core segment 64 and a lateral-most point 100 of the outer surface 60 of the sheath 52. Each of the points 94, 96, 98, 100 lies in the coronal plane, as indicated by an imaginary line 102.
As shown in FIG. 4, the lateral thickness 90 is greater than the medial thickness 92 at the point 88 on the longitudinal axis 72. In other words, the thickness 90 of the shell 50 on the lateral side 82 of the stem component 14 is greater than the thickness 92 of the shell 50 on the medial side 80 of the stem component 14. In the illustrative embodiment, the lateral thickness 90 is greater than 5.0 millimeters, and the medial thickness 92 is between 2.0 and 4.5 millimeters. The ratio of the medial thickness 92 to the lateral thickness 90 is less than or equal to 0.40 at the point 88. In one particular embodiment, the ratio of the medial thickness 92 to the lateral thickness 90 is about 0.37 at the point 88.
As shown in FIGS. 3-5, the thickness of the sheath 52 of the shell 50 on the medial side 80 of the stem component 14 generally decreases from the proximal end 54 and the distal end 56 of the sheath 52. As shown in FIG. 5, the sheath 52 has a lateral thickness 110 and a medial thickness 112 when viewed in a transverse plane extending through the stem component 14 at a point 108 on the longitudinal axis 72 at the distal end 56 of the sheath 52. The lateral thickness 110 of the sheath 52 is defined between a lateral-most point 114 of the lateral surface 70 of the core segment 64 and a lateral-most point 116 of the outer surface 60 of the sheath 52. The medial thickness 112 of the sheath 52 is defined between a medial-most point 118 of the medial surface 68 of the core segment 64 and a lateral-most point 120 of the outer surface 60 of the sheath 52. Each of the points 114, 116, 118, 120 lies in the coronal plane, as indicated by the imaginary line 102.
As shown in FIG. 5, the lateral thickness 110 of the sheath 52 is greater than the medial thickness 112 of the sheath 52 at the point 108 on the longitudinal axis 72. In the illustrative embodiment, the lateral thickness 110 is greater than 5.0 millimeters. Additionally, the medial thickness 112 at the distal end 56 of the sheath 52 is less than the medial thickness 92 (see FIG. 4). As described above, the medial thickness 92 of sheath 52 in the illustrative embodiment is between 2.0 and 4.5 millimeters, and, in the illustrative embodiment, the medial thickness 112 of the sheath 52 is between 1.0 and 1.5 millimeters. The ratio of the medial thickness 112 to the lateral thickness 110 is less than or equal to 0.30 at the point 108. In other embodiments, the ratio of the medial thickness 112 to the lateral thickness 110 may be about 0.17 at the point 108.
Returning to FIG. 3, the outer surface 60 of the sheath 52 has a curved or rounded distal surface section 130 at the distal end 56 of the sheath 52. The distal surface section 130 has an edge 132 that extends around the core body 32 of the stem core 24 and the cover layer 58 of the shell 50. As described above, the core body 32 also includes a core segment 66 that is positioned distal of the end 56 of the sheath 52. The core segment 66 extends from the edge 132 of the sheath 52 to the distal end 36 of the core body 32.
The core segment 66 has a medial surface 134 that forms a distal section of the medial surface 38 of the core body 32. The core segment 66 also has a lateral surface 136 that forms a distal section of the lateral surface 40 of the core body 32. The medial surface 134 and the lateral surface 136 extend from the outer anterior surface 84 of the core body 32 to the outer posterior surface 86 of the core body 32. As shown in FIG. 3, the cover layer 58 of the shell 50 is attached to only the lateral surface 136 of the core segment 66. The medial surface 134 of the core segment 66 forms a portion of the external geometry of the implant 10 such that the medial surface 134 may engage the patient's bone when the implant 10 is inserted into the intramedullary canal.
As shown in FIG. 3, the cover layer 58 has a body 140 that extends from a proximal end 142 attached to the sheath 52. The cover layer body 140 extends to a distal end 144 connected to a tip 128 of the cover layer 58. The tip 128 extends to the distal end of the stem component 14. In the illustrative embodiment, the tip 128 is shaped to provide relief during insertion of the stem component 14 into the proximal end of the patient's femur. It should be appreciated that in other embodiments the tip 128 may be omitted and the body 140 of the cover layer 58 may extend to the distal end of the stem component 14.
The stem component 14 has a medial-lateral thickness that is the sum of the thickness of the cover layer body 140 and the thickness of the lower core segment 66. In the illustrative embodiment, the ratio of the thickness of the cover layer body 140 to the thickness of the segment 66 is between 0.80 and 0.57 at each point along the longitudinal axis 72 between the ends 142, 144 of the cover layer body 140. In other words, at any point between the ends 142, 144 of the body 140, the cover layer body thickness may be 57% to 80% of the thickness of the core segment 66. In other embodiments, the ratio at each point may be between 0.96 and 0.46. As shown in FIG. 3, the tip 128 of the cover layer 58 is tapered such that the thickness of the cover layer 58 decreases from the distal end 144 of the cover layer body 140 to the distal end of the stem component 14.
As shown in FIGS. 3 and 6-7, the cover layer 58 makes up a significant percentage of the overall thickness of stem component 14. The ratio of the thickness of the cover layer body 140 to the overall thickness of the stem component 14 is between 0.45 and 0.36 at each point between the ends 142, 144 of the cover layer body 140. In other words, the cover layer body 140 may be 36% to 45% of the overall thickness of the stem component 14 between the ends 142, 144. In other embodiments, the ratio of the thickness of the cover layer body 140 to the overall thickness may be between 0.54 and 0.29.
In the illustrative embodiment, the thickness of the cover layer body 140 decreases along the longitudinal axis 72 between the ends 142, 144. For example, as shown in FIG. 6, the cover layer body 140 has a lateral thickness 150 when viewed in a transverse plane that extends through the stem component 14 between the ends 142, 144 at the point 138 on the axis 72. The lateral thickness 150 of the cover layer body 140 is defined between a lateral-most point 152 of the lateral surface 136 of the core segment 66 and a lateral-most point 154 of the outer surface 62 of the cover layer 58. As shown in FIG. 6, the lateral thickness 150 is greater than 4.5 millimeters.
As shown in FIG. 6, the core segment 66 at the point 138 has a thickness 146 defined between the lateral-most point 152 of the core segment 66 and a medial-most point 148 of the core segment 66. The thickness 146 in the illustrative embodiment is greater than 7.0 millimeters. The ratio of the lateral thickness 150 to the core thickness 146 at the point 138 is between 0.65 and 0.57. In one particular embodiment, the ratio may be about 0.59 at the point 138. Additionally, at the point 138, the ratio of the lateral thickness 150 to the overall thickness of the stem component 14 may be between 0.39 and 0.29. In one particular embodiment, the ratio of the lateral thickness 150 to the overall thickness may be about 0.37 at the point 138.
As shown in FIG. 7, the cover layer body 140 has a lateral thickness 158 when viewed in a transverse plane extending through the stem component 14 at a point 164 on the axis 72 at the distal end 144 of the cover layer 58. The lateral thickness 158 of the body 140 is defined between a lateral-most point 160 of the lateral surface 136 of the core segment 66 and a lateral-most point 162 of the outer surface 62 of the cover layer 58. In the illustrative embodiment, the lateral thickness 158 of the body 140 is between 3.0 millimeters and 4.0 millimeters. In other words, the lateral thickness 158 of the cover layer body 140 at the distal end 144 of the cover layer 58 is less than the lateral thickness 150 of the body 140 between the ends 142, 144.
The core segment 66 at the point 164 has a thickness 166 defined between the lateral-most point 160 of the core segment 66 and a medial-most point 168 of the core segment 66. The thickness 166 in the illustrative embodiment is greater than 3.5 millimeters. The ratio of the lateral thickness 158 to the core thickness 166 at the point 164 is between 0.85 and 0.57. In one particular embodiment, the ratio is about 0.80 at the point 164 along the longitudinal axis 72. Additionally, at the point 164, the ratio of the lateral thickness 158 to the overall thickness of the stem component 14 is between 0.40 and 0.29; in one particular embodiment, the ratio of the lateral thickness 158 to the overall thickness is about 0.45 at the point 164.
As shown in FIGS. 3-7, the foam shell 50 comprises a significant portion of the stem component 14, as illustrated by the ratio between the cross-sectional area of the foam shell 50 (designated α in FIGS. 4-7) to the total cross-sectional area of the stem component 14 (designated ι in FIGS. 4-7). It should be appreciated that in the illustrative embodiment the total cross-sectional area of the stem component comprises the cross-sectional area of the foam shell 50 and the cross-sectional area of the core body 32. In the illustrative embodiment, the ratio of the cross-sectional area of the foam shell 50 (designated α in FIGS. 4-7) to the cross-sectional area of the stem component 14 (designated β in FIGS. 4-7) is between 0.55 and 0.37 at each point along the longitudinal axis 72 of stem component 14 above the tip 128 of the foam shell 50. In other words, the foam shell 50 may form 37% to 55% of the cross-sectional area of the stem component 14 at each of those points. In other embodiments, the ratio at each point may be between 0.70 and 0.30.
As shown in FIG. 9, a table 170 shows the illustrative values for the cross-sectional area α of the foam shell 50, the cross-sectional area β of the core body 32, and the cross-sectional area ι of the stem component 14 at each of the points 88, 108, 138, 164 along the axis 72. In the illustrative embodiment, the total cross-sectional area ι of the stem component 14 is equal to the sum of the cross-sectional area α of the foam shell 50 and the cross-sectional area β of the core body 32 at each point along the axis 72 above the tip 128 of the foam shell 50. As shown in the table 170, the ratio of cross-sectional area a to the cross-sectional area ι ranges from 0.46 to 0.54. Between the ends 54, 56 of the foam sheath 52, the ratio of cross-sectional area α to the cross-sectional area ι is between 0.55 and 0.47. In other embodiments, the ratio of cross-sectional area α to the cross-sectional area β between the ends 54, 56 of the sheath 52 may be between 0.70 and 0.38.
Between the ends 142, 144 of the cover layer body 140, the ratio of cross-sectional area α to the cross-sectional area β is between 0.47 and 0.37. In other embodiments, the ratio of cross-sectional area α to the cross-sectional area ι between the ends 142, 144 of the cover layer body 140 may be between 0.56 and 0.30.
In use, the implant 10 is inserted into a proximal end of a patient's surgically-prepared femur. The elongated stem component 14 is received in the intramedullary canal and the sheath 52 and the cover layer 58 of the shell 50 engage the portion of the patient's femur surrounding the canal. The core 24 is sized and shaped to meet the minimum strength requirements of the implant 10, while the shell 50 is configured to possess the external geometry necessary to fit into the intramedullary canal. The combination of the high tensile strength/high elastic modulus core 24 with the low modulus shell 50 results in a reduced stiffness for the implant 10 such that stress shielding of the patient's bone is reduced.
Referring now to FIG. 8, a method 200 of manufacturing the elongated stem component 14 of the implant 10 is illustrated. In the illustrative method, the performance requirements of the stem component 14 are determined and the stem core 24 of the stem component 14 is procured. The stem core 24 and the shell 50 may then be assembled to form the stem component 14.
In block 210, the performance requirements of the stem component 14 are determined. The performance requirements for the stem component 14 may vary between different patients such that a customized stem component 14 may be required. The performance requirements include the external geometry and the minimum endurance and performance requirements, such as, for example, the minimum tensile strength and the minimum stiffness of the stem component 14.
In block 212, the core 24 of the stem component 14 is selected. The core 24 may be an off-the-shelf, generic core that may be used with multiple implant sizes. The core 24 may be a customized, patient-specific component designed to satisfy the performance requirements of a particular patient. Whether the core 24 is generic or custom, the selected core 24 of the component 14 is sized and shaped to provide the minimum strength of the implant 10. The minimum strength of the core 24 is determined in accordance with International Organization for Standardization Standard No. 7206-4:2010 “IMPLANTS FOR SURGERY—PARTIAL AND TOTAL HIP JOINT PROSTHESES—PART 4: DETERMINATION OF ENDURANCE PROPERTIES AND PERFORMANCE OF STEMMED FEMORAL COMPONENTS” and Standard No. 7206-6:1992 “IMPLANTS FOR SURGERY—PARTIAL AND TOTAL HIP JOINT PROSTHESES—PART 6: DETERMINATION OF ENDURANCE PROPERTIES OF HEAD AND NECK REGION OF STEMMED FEMORAL COMPONENTS.”
In block 214, the stem component 14 is assembled. To do so, a metallic foam matrix, which will form the shell 50 of the stem component 14, is procured. The metallic foam matrix may be compressed around the core 24 such that the core 24 is received in a channel within the foam matrix. The foam matrix may then be machined to the required external geometry of the shell 50. Alternatively, the metallic foam matrix may be compressed separately into the shape of shell 50. After the matrix is compressed, a channel sized to receive the core 24 may be machined in the shell 50 before the shell 50 is assembled with the core 24.
A sintering operation may be used to secure the shell 50 to the core 24. It should also be appreciated that the shell 50 and the core 24 may be secured via a brazing operation, a press-fit, or other securing means.
While the disclosure has been illustrated and described in detail in the drawings and foregoing description, such an illustration and description is to be considered as exemplary and not restrictive in character, it being understood that only illustrative embodiments have been shown and described and that all changes and modifications that come within the spirit of the disclosure are desired to be protected.
There are a plurality of advantages of the present disclosure arising from the various features of the method, apparatus, and system described herein. It will be noted that alternative embodiments of the method, apparatus, and system of the present disclosure may not include all of the features described yet still benefit from at least some of the advantages of such features. Those of ordinary skill in the art may readily devise their own implementations of the method, apparatus, and system that incorporate one or more of the features of the present invention and fall within the spirit and scope of the present disclosure as defined by the appended claims.

## Claims

1. An orthopaedic prosthesis, comprising:
a metallic foam shell including a sheath, and
a metallic core including (i) a neck positioned proximal of the sheath, the neck being configured to receive a femoral head component, (ii) a first core segment positioned in the sheath, and (iii) a second core segment positioned distal of the sheath,
wherein the metallic foam shell further includes a cover layer extending distally from the sheath, the cover layer engaging only a lateral surface of the second core segment,
wherein when the orthopaedic prosthesis is viewed in a transverse plane extending through the cover layer of the metallic foam shell, (i) the cover layer defines a first cross-sectional area, (ii) the cover layer and the second core segment define a second cross-sectional area, and (iii) a ratio of the first cross-sectional area to the second cross-sectional area is greater than 0.30.

2. The orthopaedic prosthesis of claim 1, wherein the ratio of the first cross-sectional area to the second cross-sectional area is between 0.35 and 0.47.

3. The orthopaedic prosthesis of claim 1, wherein the ratio of the first cross-sectional area to the second cross-sectional area is less than 0.56.

4. The orthopaedic prosthesis of claim 1, wherein when the orthopaedic prosthesis is viewed in a second transverse plane extending through the sheath of the metallic foam shell,
the sheath defines a third cross-sectional area,
the sheath and the first core segment define a fourth cross-sectional area, and
a ratio of the third cross-sectional area to the fourth cross-sectional area is greater than 0.38.

5. The orthopaedic prosthesis of claim 4, wherein the ratio of the third cross-sectional area to the fourth cross-sectional area is between 0.46 and 0.54.

6. The orthopaedic prosthesis of claim 4, wherein the ratio of the third cross-sectional area to the fourth cross-sectional area is less than 0.70.

7. The orthopaedic prosthesis of claim 4, wherein the ratio of the third cross-sectional area to the fourth cross-sectional area is greater than the ratio of the first cross-sectional area to the second cross-sectional area.

8. The orthopaedic prosthesis of claim 4, wherein:
the first core segment of the metallic core has a medial surface and a lateral surface positioned opposite the medial surface of the first core segment,
the sheath has a medial surface and a lateral surface positioned opposite the medial surface of the sheath, and
when the orthopaedic prosthesis is viewed in the second transverse plane, a first thickness is defined between a lateral-most point of the lateral surface of the sheath and a lateral-most point of the lateral surface of the first core segment, (ii) a second thickness is defined between a medial-most point of the medial surface of the sheath and a medial-most point of the medial surface of the first core segment, and (iii) a ratio of the second thickness to the first thickness is greater than 0.14.

9. The orthopaedic prosthesis of claim 1, wherein:
the cover layer of the metallic foam shell extends distally from a proximal end attached to the sheath, and
the transverse plane extends through the proximal end of the cover layer, and when the orthopaedic prosthesis is viewed in the transverse plane: (i) the cover layer has a first thickness, (ii) the second core segment has a second thickness, and (iii) a ratio of the first thickness to the second thickness is greater than 0.46.

10. The orthopaedic prosthesis of claim 9, wherein the first thickness is greater than three millimeters.

11. The orthopaedic prosthesis of claim 4, wherein when the orthopaedic prosthesis is viewed in the second transverse plane, a medial surface of the first core segment is convex and a lateral surface of the first core segment is convex.

12. The orthopaedic prosthesis of claim 10, wherein when the orthopaedic prosthesis is viewed in the second transverse plane, the medial surface of the first core segment is defined by a first radius, and the lateral surface of the first core segment is defined by a second radius that is greater than the first radius.

13. The orthopaedic prosthesis of claim 1, wherein the sheath and the cover layer of the metallic foam shell have a first elastic modulus and the first core segment and the second core segment of the metallic core have a second elastic modulus, the first elastic modulus being approximately one-twentieth of the second elastic modulus.

14. An orthopaedic prosthesis, comprising:
an elongated femoral stem component having a longitudinal axis, the stem component comprising:
a metallic foam shell including a sheath, and
a metallic core including (i) a neck positioned proximal of the sheath, the neck being configured to receive a femoral head component, (ii) a first core segment positioned in the sheath, and (iii) a second core segment positioned distal of the sheath,
wherein (i) the metallic foam shell further includes a cover layer extending distally from the sheath, the cover layer engaging only a lateral surface of the second core segment and defining a first cross-sectional area at a first point on the longitudinal axis, (ii) the cover layer and the second core segment define a second cross-sectional area at the first point, and (iii) a ratio of the first cross-sectional area to the second cross-sectional area is greater than 0.30.

15. The orthopaedic prosthesis of claim 14, wherein (i) the sheath defines a third cross-sectional area at a second point on the longitudinal axis, (ii) the sheath and the first core segment defines a fourth cross-sectional area at the second point, and (iii) a ratio of the third cross-sectional area to the fourth cross-sectional area is greater than 0.38.

16. An orthopaedic prosthesis for a patient, comprising:
an elongated femoral stem component having a longitudinal axis, the stem component comprising:
a metallic foam shell having a first elastic modulus, and
a metallic core including a neck positioned proximal of the shell and a body that extends through the shell, the core having a second elastic modulus greater than the first elastic modulus,
wherein (i) the metallic foam shell defines a first cross-sectional area at a first point on the longitudinal axis, (ii) the stem component defines a second cross-sectional area at the first point, and (iii) a ratio of the first cross-sectional area to the second cross-sectional area is greater than 0.38,
wherein (i) the metallic foam shell defines a third cross-sectional area at a second point on the longitudinal axis, the second point being distal of the first point, (ii) the stem component defines a fourth cross-sectional area at the second point, and (iii) a ratio of the third cross-sectional area to the fourth cross-sectional area is greater than the ratio of the first cross-sectional area to the second cross-sectional area,
wherein (i) the metallic foam shell defines a fifth cross-sectional area at a third point on the longitudinal axis, the third point being distal of the second point, (ii) the stem component defines a sixth cross-sectional area at the third point, and (iii) a ratio of the fifth cross-sectional area to the sixth cross-sectional area is less than the ratio of the third cross-sectional area to the fourth cross-sectional area,
wherein the metallic foam shell includes a cover layer attached to only a lateral surface of the metallic core at the third point on the longitudinal axis.

17. The orthopaedic prosthesis of claim 16, wherein the ratio of the fifth cross-sectional area to the sixth cross-sectional area is between 0.30 and 0.56.

18. The orthopaedic prosthesis of claim 16, wherein the ratio of the third cross-sectional area to the fourth cross-sectional area is less than 0.70.