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Publication numberWO2009111624 A2
Publication typeApplication
Application numberPCT/US2009/036159
Publication date11 Sep 2009
Filing date5 Mar 2009
Priority date6 Mar 2008
Also published asCA2717697A1, CA2717697C, EP2262450A2, EP2262450A4, US8043375, US8092530, US8152847, US8177842, US8591581, US8876901, US8876902, US20090228104, US20090228106, US20100121451, US20100121452, US20120116510, US20120203342, US20120203343, WO2009111624A3
Publication numberPCT/2009/36159, PCT/US/2009/036159, PCT/US/2009/36159, PCT/US/9/036159, PCT/US/9/36159, PCT/US2009/036159, PCT/US2009/36159, PCT/US2009036159, PCT/US200936159, PCT/US9/036159, PCT/US9/36159, PCT/US9036159, PCT/US936159, WO 2009/111624 A2, WO 2009111624 A2, WO 2009111624A2, WO-A2-2009111624, WO2009/111624A2, WO2009111624 A2, WO2009111624A2
InventorsPeter Strzepa, Stephen D. Cook
ApplicantMoirai Orthopedics, Llc
Export CitationBiBTeX, EndNote, RefMan
External Links: Patentscope, Espacenet
Implants and methods of use
WO 2009111624 A2
Abstract
Implant devices, and method of using the same, are provided. The implant devices have circular, or oblong, articular ends. The articular ends have a convex upper face and a concave lower face, the convex upper face blending to the concave lower face, and the concave lower face having a curvature less than the curvature of the convex upper face. The implant devices further have a stem extending from the concave lower face away from the upper face, the stem having a maximum radius at the convex lower face and tapering to lesser radius along the length of the stem.
Claims  (OCR text may contain errors)
1) An implant comprising: an articular end having a circular perimeter approximately defined by a diameter, a convex upper face, and a concave lower face, the convex upper face having a first spherical radius and the concave lower face having a second spherical radius, wherein the first spherical radius is relatively small if the diameter is relatively large; and a stem extending from the concave lower face away from the convex upper face along a vertical axis, the stem having a maximum stem circular perimeter at the intersection of the stem and the concave lower face, the maximum stem circular perimeter less than the articular end circular perimeter.
2) The implant of Claim 1 , wherein the stem circular perimeter decreases from a maximum stem circular perimeter to a lesser stem circular perimeter along the vertical axis of the stem.
3) The implant of Claim 1, wherein the stem has a cylindrical portion extending from the concave lower face away from the convex upper face along the vertical axis, and a conical portion extending from the cylindrical portion away from the convex upper face along the vertical axis.
4) The implant of Claim 3, wherein the cylindrical portion has a length ranging from about one millimeter to about five millimeters; and the conical portion has a length ranging from about two millimeters to about fifteen millimeters.
5) The cartilage implant of Claim 1, wherein the diameter of the articular end circular perimeter ranges from about 10 millimeters to about 20 millimeters, the convex upper face having a spherical radius of about 32 millimeters, the concave lower face having a spherical radius of about 30 millimeters, the cylindrical portion of the stem having a diameter of from about 4 millimeters to about 8 millimeters, and the stem having a length from about 10 millimeters to about 20 millimeters.
6) The cartilage implant of Claim 5, wherein the maximum diameter of the articular end circular perimeter is selected from the group consisting of about 12.5 millimeters, about 15 millimeters, about 17.5 rnillimeters, and about 20 millimeters, the cylindrical portion of the stem having a maximum diameter selected from the group consisting of about 5.5 millimeters, about 6.25 millimeters, about 7 millimeters, and about 7.75 millimeters, and the implant having an overall vertical length selected from the group consisting of about 13 millimeters, about 14.1 millimeters, about 15,2 millimeters, and about 16.5 millimeters.
7) The implant of Claim 1, wherein the diameter ranges from about 17.5 millimeters to about 20 millimeters and the first spherical radius ranges from about 25 millimeters to about 30 millimeters, preferably about 28 millimeters.
8) The implant of Claim 1, wherein the first spherical radius is relatively large if the diameter is relatively small.
9) The implant of Claim 8, wherein the diameter ranges from about 10 millimeters to about 15 millimeters and the first spherical radius ranges from about 30 millimeters to about 40 millimeters, preferably about 32 millimeters.
10) The implant of Claim 1, wherein the first spherical radius is lesser than the second spherical radius if the diameter is relatively large.
11) The implant of Claim 10, wherein the first spherical radius is about 28 millimeters, the second spherical radius is about 29.5 millimeters and the diameter is greater than about 17 millimeters.
12) The implant of Claim 1, wherein the first spherical radius is greater than the second spherical radius if the diameter is relatively small.
13) The implant of Claim 12, wherein the first spherical radius is about 32 millimeters, the second spherical radius is about 29.5 millimeters and the diameter is less than about 17 millimeters.
14) The implant of Claim I5 wherein the diameter is relatively large, the first spherical radius is about 28 millimeters, the second spherical radius is about 29.5, the convex upper face and the concave lower face are separated by about 2.5 millimeters along a vertical axis of symmetry of the implant, and the center of curvature of the first spherical radius and a center of curvature of the second spherical radius align with the vertical axis of symmetry of the implant.
15) The implant of Claim 1, wherein the diameter is relatively small, the first spherical radius is about 32 millimeters, the second spherical radius is about 29.5 and the first spherical radius is about concentric with the second spherical radius.
16) The implant of Claim 3, wherein a portion of the conical portion of the stem is comprised of circumferential grooves. 17) The implant of Claim 16, wherein the circumferential grooves are defined by a partial torus having a tubular radius of from about 0.25 millimeters to about 1.5 millimeters, and the circumferential grooves are spaced apart at a distance of from about 1 millimeter to about 3 millimeters from each other.
18) The implant of Claim 1, wherein the articular end and the stem comprise graphite and pyrocarbon.
19) The implant of Claim 18, wherein the articular end and the stem comprise a graphite core and a pyrocarbon coating, the pyrocarbon coating having an elastic modulus from about 15 GPa to about 22 GPa, the pyrocarbon coating having an average thickness ranging from about 100 to about 1000 microns.
20) The implant of Claim 19, wherein the pyrocarbon coating has an elastic modulus of about 20 GPa and a strength of at least 400 MPa.
21) The implant of Claim 20, wherein the upper face and circular perimeter of the articular end are polished, and the lower face and stem are coated with hydroxyapatite.
22) An implant comprising: an articular end having an oval perimeter, a convex upper face, and a concave lower face, the convex upper face having a first circular pitch radius and a first circular roll radius, at least a portion of the concave lower face having a first spherical radius, the convex upper face blending into a rim, wherein at least a first and second portion of the rim extends at least a first distance along the vertical axis and a third and fourth portion of the rim tapers inward along the vertical axis, the rim blending into the concave lower face; and a stem extending from the concave lower face away from the convex upper face, the stem having an oval shaped perimeter in planes perpendicular to the vertical axis.
23) The implant of Claim 22, wherein the concave lower facing has a first surface comprising a second circular pitch radius and a second circular roll radius, and at least two second surfaces both external to the first surface and each other and both tangent to the first surface, each second surface having a third circular pitch radius and a third circular roll radius.
24) The implant of Claim 22, wherein the oval articular end has a maximum length, along the horizontal axis of from about 15 millimeters to about 40 millimeters; the oval articular end has a maximum length, along the depth axis, ranging from about 10 millimeters to about 30 millimeters; and the implant has a maximum length along the vertical axis ranging from about 10 millimeters to about 35 millimeters.
25) The cartilage implant of Claim 23, wherein the first, second and third circular pitch radii are each independently selected from the group consisting of from about 15 millimeters to about 30 millimeters, from about 20 millimeters to about 25 millimeters, about 22 millimeters, and about 19.5 millimeters, the first, second, and third circular roll radii are each independently selected from the group consisting of from about 20 millimeters to about 40 millimeters, from about 25 millimeters to about 35 millimeters, about 32 millimeters, about 29.5 millimeters, and about 19.5 millimeters.
26) The cartilage implant of Claim 25, wherein the maximum roll radius of the first surface of the concave lower face is bounded by an angle selected from the group consisting of from about 5 degrees to about 25 degrees and from about 10 degrees to about 20 degrees,
27) The implant of Claim 22, wherein the stem has a first portion and a second portion, the first portion extending from the lower concave face a length in the vertical direction away from the upper convex face, the second portion extending from the first portion a length in the vertical direction away from the upper convex face, wherein the first portion tapers inward along its horizontal axis in the vertical direction and has a uniform length along its depth axis in the vertical direction, the second portion tapers inward along its horizontal axis and its depth axis in the vertical direction, the first and second portion blend into each other, the length of the first portion along the vertical is selected from the group consisting of 2 millimeters to about 10 millimeters and from about 2 millimeters to about 8 millimeters, the length of the second portion along the vertical is selected from the group consisting of from about 2 millimeters to about 25 millimeters, from about 5 millimeters to about 20 millimeters, and from about 5 millimeters to about 10 millimeters.
28) The implant of Claim 27, wherein the second portion of the stem comprises grooves.
29) The implant of Claim 28, wherein the grooves are defined by a partial, oval, non-planar torus having a tubular radius of from about 0.25 millimeters to about 1.5 millimeters, and the grooves are spaced apart at a distance of from about 1 millimeter to about 3 millimeters from each other. 30) The implant of Claim 29, wherein the articular end and the stem comprise graphite and pyrocarbon.
31) The implant of Claim 30, wherein the articular end and the stem comprise a graphite core and a pyrocarbon coating, the pyrocarbon coating having an elastic modulus from about 15 GPa to about 22 GPa, the pyrocarbon coating having an average thickness ranging from about 100 to about 1000 microns.
32) The implant of Claim 31, wherein the pyrocarbon coating has an elastic modulus of about 20 GPa and a strength of at least 400 MPa.
33) The implant of Claim 32, wherein the upper face and oval perimeter of the articular end are polished, and the lower face and stem are coated with hydroxyapatite.
34) A method of repair of articular cartilage comprising : locating articular cartilage having a lesion; utilizing an implant having dimensions compatible with the lesion, wherein the implant comprises; an articular end having a circular perimeter approximately defined by a diameter, a convex upper face, and a concave lower face, the convex upper face having a first spherical radius and the concave lower face having a second spherical radius, wherein the first spherical radius is relatively small if the diameter is relatively large; and a stem extending from the concave lower face away from the convex upper face along a vertical axis, the stem having a maximum stem circular perimeter at the intersection of the stem and the concave lower face, the maximum stem circular perimeter less than the articular end circular perimeter forming a cavity in the cartilage and subchondral bone and cancellous bone; and engaging the implant with the cavity so that the lower surface abuts against the prepared subchondral bone and the stem abuts against the prepared cancellous bone.
35) The method of Claim 34, wherein forming the cavity includes placement of autograft, allograft bone, or various bone graft substitute material into the lesion.
36) A method of repair of articular cartilage comprising: locating articular cartilage having a lesion; utilizing an implant of having dimensions compatible with the lesion, wherein the implant comprises; an articular end having an oval perimeter, a convex upper face, and a concave lower face, the convex upper face having a first circular pitch radius and a first circular roll radius, at least a portion of the concave lower face having a first spherical radius, the convex upper face blending into a rim, wherein at least a first and second portion of the rim extends at least a first distance along the vertical axis and a third and fourth portion of the rim tapers inward along the vertical axis, the rim blending into the concave lower face; and a stem extending from the concave lower face away from the convex upper face, the stem having an oval shaped perimeter in planes perpendicular to the vertical axis; forming a cavity in the cartilage and subchondral bone and cancellous bone; and engaging the implant with the cavity so that the lower surface abuts against the prepared subchondral bone and the stem abuts against the prepared cancellous bone. 37) The method of Claim 36, wherein forming the cavity includes placement of autograft, allograft bone, or various bone graft substitute material into the lesion.
Description  (OCR text may contain errors)

IMPLANTS AND METHODS OF USE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims the benefit of U.S. Pat. App. No. 12/074,770, filed March 6, 2008 and U.S. Pat. App. No 12/396,872, filed March 3, 2009.

FIELD OF THE INVENTION

[0002] This invention relates generally to devices and methods for the repair of articular cartilage defects. More particularly, this invention relates to implants that serve as a replacement for diseased cartilage in joints such as human knees, hips and shoulders.

BACKGROUND OF THE INVENTION

[0003] Cartilage acts as a pad between bones to reduce friction and prevent the bones from grinding against one another. Cartilage covers the articular surface of many, if not all, joints in the body. The smoothness and thickness of the cartilage are factors that determine the load- bearing characteristics and mobility of the joints. Over time, due to injury or heredity, however, lesions such as fissures, cracks or crazes can form in the cartilage. In some cases, osteochondral, the lesion penetrates to the subchondral surface of the bone. In other cases, chondral, the lesion does not penetrate to the subchondral surface of the bone. In any event, lesions generally do not repair themselves — and if any repair is made it is insufficient to heal — leading to significant pain and disability, either acutely or over time.

[0004] One approach for regenerating new cartilage is autologous chondrocyte transplantation. However, this technique is complex and relatively costly. Other techniques, aimed at repair instead of regeneration, include debridement, lavage, rnicrofracturing, drilling, and abrasion arthroplasty. These procedures generally involve penetrating the region of vascularization in the subchondral bone with an instrument until bleeding occurs. Formation of a fibrin clot differentiates into fibrocartilage, which then covers the defect site. Some have found, however, that the resulting repair tissue is relatively weak, disorganized, and lacks the biomechanical properties of normal hyaline cartilage that typically covers the bone ends. Additionally, this technique can generally only be used on chondral defects in the presence of normal joint congruity.

[0005] An alternative approach has been to undergo a total replacement of the joint. Such total replacements, however, are costly, high risk, and involve a long recovery time. Accordingly, there is a need for alternative treatments.

[0006] The above-identified prior art devices and methods, as well as alternative devices and methods, are illustrated in greater detail in the following patents and patent publications:

[0007] U.S. Patent Pub. No. 2005/0137708 to Clark discloses, inter alia, a knee joint resurfacing implant that may include femoral implant and tibial implant components. The femoral implant components may be attached to the femur using screws or other fixation devices, and may be configured to share loads between cortical and cancellous bone material. The tibial implant components are formed in modular portions which may be assembled within the knee joint and may be free-floating or fixed to the tibial surface.

[0008] U.S. Patent Pub. No, 2007/0032876 to Clark discloses, inter alia, a knee joint prosthesis including femoral and tibial components. The bodies of the components may possess a network of channels which may be used to deliver bone cement to the component bone interface after the components are implanted.

[0009] U.S. Patent Pub. No. 2007/0250169 to Lang discloses, inter alia, methods and devices for repairing articular surfaces. The devices of Lang are customizable, or patient specific, implants configured for placement between joint surfaces formed by inserting a hollow device having an aperture and a lumen into a target joint, and injecting material into the hollow device to form an implant.

[00010] U.S. Patent No. 6,679,917 to Ek discloses, inter alia, an implant for installation into a portion of an articular surface including a protrusion configured to cover an un-excised portion of articular surface proximate to the implant. [00011] U.S. Patent No. 6,814,757 to Kopylov, et al. discloses, inter alia, a joint surface replacement or joint prosthesis for the distal radioulnar joint.

SUMMARY OF THE INVENTION

Definitions

[00012] In various illustrative embodiments, the terms "vertical axis" or "vertical" mean a direction from the top of a three-dimensional object to the bottom of the three-dimensional object.

[00013] In various illustrative embodiments, the term "yaw" means a direction of rotation around the vertical axis.

[00014] In various illustrative embodiments, the terms "horizontal axis" or "horizontal" mean a direction from right of the three-dimensional object to the left of the three- dimensional object.

[00015] In various illustrative embodiments, the term "pitch" means a direction of rotation around the horizontal axis.

[00016] In various illustrative embodiments, the terms "depth axis" or "depth" mean a direction from the front of the three-dimensional object to the back of the three-dimensional object.

[00017] In various illustrative embodiments, the term "roll" means a direction of rotation around the depth axis.

[00018] In various illustrative embodiments, the term "spherical radius" means the curvature of a surface formed by a sphere having a particular radius. Accordingly, when a surface is referred to as having a spherical radius, it is meant that the surface has a curvature equal to the curvature of the surface of a sphere having a particular radius. [00019] In various illustrative embodiments, the term "circular yaw radius" means the maximum curvature about yaw of a surface formed by a circle having a particular radius rotated about yaw.

[00020] In various illustrative embodiments, the term "circular roll radius" means the maximum curvature about roll of a surface formed by a circle having a particular radius rotated about roll.

[00021] In various illustrative embodiments, the term "circular pitch radius" means the maximum curvature about pitch of a surface formed by a circle having a particular radius rotated about pitch,

[00022] In various illustrative embodiments, the term "oval" means two semi-circles connected by two straight line segments that do not intersect and that each are tangent to each semi-circle, alternatively the term "oval" means an oblong three-dimensional closed curve having no straight segments.

[00023] In various illustrative embodiments, the term "torus" means the surface of a toriod.

[00024] In various illustrative embodiments, the term "tubular radius" refers to the radius of the tube of a torus, as opposed to the radius from the center of the torus to the center of the tube.

[00025] In various illustrative embodiments, geometric terms such as "oval", "circle", "sphere", "cylinder", and the like are used as references and for clarity of understanding, as would be understood by one of ordinary skill in the art. Accordingly, these terms should not be limited to strict Euclidean standards.

[00026] Various illustrating embodiments of the present invention provides an implant, preferably for use in human joints, including knees. In accordance with one aspect of an illustrating embodiment of the present invention an implant is provided which includes an articular end having a circular perimeter, a convex upper face, and a concave lower face. The convex upper face may have a spherical radius and the concave lower face may have a spherical radius. The implant additionally may include a stem extending from the concave lower face away from the convex upper face along a vertical axis. The stem may have a circular perimeter which is a maximum at the intersection of the stem and the concave lower face, and which decreases to a lesser circular perimeter along the vertical axis of the stem. Preferably, the maximum stem circular perimeter is less than the articular end circular perimeter.

[00027] In accordance with another aspect of an illustrating embodiment of the present invention, an implant is provided, which includes an articular end having an oval perimeter, a convex upper face and a concave lower face. The convex upper face of the oval articular end may have a first circular pitch radius and a first circular roll radius. The concave lower face of the oval articular end may have a spherical radius. Alternatively, the concave lower face of the oval articular end may have a first surface comprising a second circular pitch radius and a second circular roll radius, and at least two second surfaces both external to the first surface and each other and both tangent to the first surface and each having a third circular pitch radius and a third circular roll radius. Preferably, the convex upper face blends into a rim, wherein at least first and second portions of the rim extend at least a first distance along the vertical axis and third and fourth portions of the rim taper inward along the vertical axis, and the rim further blends into the concave lower face. The implant further may include a stem extending from the concave lower face away from the convex upper face. Preferably, the stem has an oval shaped perimeter in a plane perpendicular to the vertical axis.

[00028] Those skilled in the art will further appreciate the above-mentioned advantages and superior features of the invention together with other important aspects thereof upon reading the detailed description which follows in conjunction with the drawings, in which like parts are given like reference numerals, and the vertical, horizontal and depth orientations of a given embodiment are specified explicitly in at least one drawing of the embodiment. BRIEF DESCRIPTION OF THE DRAWINGS

[00029] The drawing figures are not necessarily to scale and certain features of the invention may be shown exaggerated in scale or in somewhat schematic form in the interest of clarity and conciseness, wherein:

FIG. 1 is a front view of one embodiment of an implant;

FIG.2 is a top-down view of the embodiment of FIG. 1;

FIG. 3 is a cut-away view of the implant of FIG. 1 taken along line 3-3;

FIG. 4 is an exploded view of a portion of the front view of FIG. 1;

FIG. 5 is a front view of an alternative embodiment of an implant;

FIG. 5a is an alternative front view of an alternative embodiment of an implant

FIG. 6 is a side view of the embodiment of FIG. 5;

FIG. 6a is an alternative side view of the embodiment of FIG 5a;

FIG. 7 is a top-down view of the embodiment of FIG. 6;

FIG. 8 is a cut-away view of the implant of FIG. 5 taken along line 8-8;

FIG. 8a is an alternative cut-away view of the implant of FIG. 5a taken along line 8a-

8a;

FIG. 9 is a cut-away view of the implant of FIG. 6 taken along line 9-9; FIG. 9a is an alternative cut-away view of the implant of FIG. 6a taken along line 9a-

9a; and FIG. 10 is an exploded view of a portion of the cut-away view of FIG. 8.

DISCLOSURE OF ALTERNATIVE EMBODIMENTS

[00030] FIG. 1 is an illustrative embodiment of an implant 100, in which the vertical, V, horizontal, H, and depth, D, orientations of this embodiment are depicted. The implant 100 preferably has an articular end 105 and a stem 130. The articular end 105 may be a disk of uniform thickness in the vertical or a cylinder of uniform length in the vertical. Preferably, the articular end 105 has a convex upper face 110, which blends 125 into, and is bounded by, a circular perimeter portion 120, which — after some length — itself blends 125 into a concave lower face 115. [00031] In this embodiment, the circular pitch radius of the convex upper face 110 is about the same as the circular roll radius of the convex upper face 110. The circular pitch radius and the circular roll radius of the convex upper face 110 may be from about 25 to about 40 millimeters, alternatively from about 30 to about 35 millimeters, alternatively from about 28 to about 32 millimeters. In an embodiment, the circular pitch radius and the circular roll radius of the convex upper face 110 are approximately equal, i.e., the convex upper face 110 may have a spherical radius. The convex upper face 110 may blend, as at 125, into the circular perimeter 120, with the blend 125 having an edge radius of from about 0.1 millimeters to about 1 millimeter. Alternatively, the blend may be about 0.5 millimeters.

[00032] The circular perimeter 120 may extend some distance along the vertical axis, thereby forming a cylinder between the convex upper face 110 and the concave lower face 115. The length of the cylinder formed by the circular perimeter 120 may range from about one millimeter to about 5 millimeters, and alternatively from about 2 millimeters to about 3 millimeters. Referring to FIG. 2, the diameter of the circular perimeter 120 may be of any length, and may range from about 10 millimeters to about 30 millimeters, alternatively from about 12 millimeters to about 20 millimeters. Alternative diameters of the circular perimeter 120 include about 12.5 millimeters, about 15 millimeters, about 17.5 millimeters, and about 20 millimeters.

[00033] In alternative embodiments, implants 100 having circular perimeters with relatively large diameters may have convex upper faces with relatively small spherical radii. In an embodiment, relatively large diameters of circular perimeters are greater than about 17 millimeters. In an embodiment, relatively small spherical radii of convex upper faces are less than about 30 millimeters. Conversely, in alternative embodiments, implants 100 having circular perimeters with relatively small diameters may have convex upper faces with relatively large spherical radii, m an embodiment, relatively small diameters of circular perimeters are less than about 17 millimeters. In an embodiment, relatively large spherical radii of convex upper faces are greater than about 30 millimeters. In embodiments wherein the diameter of the circular perimeter 120 ranges from about 10 millimeters to about 15 millimeters, the convex upper face 110 may have a spherical radius ranging from about 30 millimeters to about 40 millimeters, preferably about 32 millimeters. In embodiments wherein the diameter of the circular perimeter 120 ranges from about 17.5 millimeters to about 20 millimeters the convex upper face 110 may have a spherical radius ranging from about 25 millimeters to about 30 millimeters, preferably about 28 millimeters. Continuing with respect to FIG. 1, in a further embodiment, the circular perimeter 120 may blend 125 into the concave lower face 115. Alternatively, the blend 125 is an edge radius of from about 0.1 millimeters to about 1 millimeter, alternatively about 0.5 millimeters.

[00034] The circular pitch radius of the concave lower face 115 may be about the same as the circular roll radius of the concave lower face 115. In this embodiment, the circular pitch radius and the circular roll radius of the concave lower face 115 may be of any length, and may range from about 20 to about 40 millimeters, alternatively from about 25 to about 35 millimeters. An alternative circular pitch radius and circular roll radius of the concave lower face 115 is about 29.5 millimeters, hi embodiments wherein the diameter of the circular perimeter 120 is relatively small, the circular pitch and roll radii of the convex upper face 110 may be greater than the circular pitch and roll radii of the concave lower face 115. Further, in embodiments wherein the diameter of the circular perimeter 120 is relatively small, the convex upper face 110 may have a spherical radius of about 32 millimeters and the concave lower face may have a spherical radius of about 29.5 millimeters. In embodiments wherein the diameter of the circular perimeter 120 is relatively large, the circular pitch and roll radii of the convex upper face 110 may be lesser than the circular pitch and roll radii of the concave lower face 115. Further, in an embodiment wherein the diameter of the circular perimeter 120 is relatively large, the convex upper face 110 may have a spherical radius of about 28 millimeters and the concave lower face may have a spherical radius of about 29.5 millimeters.

100035] hi an embodiment, the circular pitch and roll radii of the convex upper face 110 are about concentric with the circular pitch and roll radii of the concave lower face 115. In an embodiment, wherein the diameter of the circular perimeter 120 is relatively small, the convex upper face 110 and the concave lower face 115 may have spherical radii of about 32 millimeters and about 29.5 millimeters, respectively, hi this embodiment, spherical radii of the convex upper face 110 and the concave lower face 115 may be approximately concentric, and the centers of the spherical radii of the convex upper face 110 and the concave lower face 115 both may lie on the central vertical axis of symmetry of the implant 100, at the same point or nearly the same point. In an embodiment, wherein the diameter of the circular perimeter 120 is relatively large, the convex upper face 110 and the concave lower face 115 may have spherical radii of about 28 millimeters and about 29.5 millimeters, respectively. In this embodiment, the convex upper face 100 and the concave lower face 115 may not be concentric and may be separated by a distance along the central vertical axis of symmetry of the implant 100 and the respective centers of the spherical radii of the convex upper face 110 and the concave lower face 115 may lie on the central vertical axis of symmetry of the implant 100. The distance of separation between the convex upper face 100 and the concave lower face 115 along the central vertical axis of symmetry may range from about 2 millimeters to about 4 millimeters and may alternatively be about 2.5 millimeters.

[00036] A stem 130 may extend from the concave lower face 115 in the vertical direction away from the convex upper face 110. Alternatively, the stem 130 blends 150 into the concave lower face 115. Alternatively, the blend 150 is a fillet radius of from about 0.1 millimeters to about 1.5 milUmeters, alternatively about 0.8 millimeters. The center of the stem 130 about its yaw may be concentric with the center of the circular perimeter 120 about its yaw. The stem 130 may have a maximum stem yaw radius at the intersection of the stem 130 and the concave lower face 115. The maximum stem yaw radius may be less than the circular perimeter 120 yaw radius, hi this embodiment, the stem yaw radius tapers from its maximum to a lesser stem yaw radius along the vertical length of the stem 130. In this embodiment, the stem 130 may be generally conical along its entire vertical length. In a still further embodiment, the overall vertical length of the stem 130 may be at least 50% of the diameter of the circular perimeter 120.

[00037] Alternatively, the stem 130 has a cylindrical portion 135 extending from the concave lower face 115 in the vertical direction away from the concave upper face 110, and a conical portion 140 further extending from the end of the cylindrical portion 135 in the vertical direction away from the concave upper face 110. The cylindrical portion 135 may be of any length and may have a length along its vertical axis of from about one millimeter to about 5 millimeters, alternatively from about 2 millimeters to about 3 millimeters. The cylindrical portion 135 may have a circular yaw radius of any length, alternatively from about 1 rnillimeter to about 5 millimeters, alternatively from about 2 millimeters to about 4 millimeters. More preferred circular yaw radii of the cylindrical portion 135 include about 2.75 millimeters, about 3.125 millimeters, about 3.5 millimeters, and about 3.875 millimeters. Without wishing to be bound by the theory, the cylindrical portion 135 is preferable as it allows for ease of manufacturing, i.e., it provides a physical structure to clamp during manufacturing.

[00038] The conical portion 140 may be of any length and preferably ranges along its vertical length from about 2 millimeters to about 15 millimeters, alternatively from about 5 millimeters to about 15 millimeters, and alternatively from about 8.5 millimeters to about 11 millimeters. In this embodiment, the maximum circular yaw radius of the conical portion 140 may be located at the intersection between the conical portion 140 and the cylindrical portion 135, and is equal to the circular yaw radius of the cylindrical portion 135. The conical portion 140 may have a yaw radii that decreases from the maximum to a minimum along its vertical axis in the direction away from the upper convex face 110. The circular yaw radii of the conical portion 140 may be of any length, and may range from about one millimeter to about 5 millimeters, alternatively from about 2 millimeters to about 3 millimeters.

[00039] With respect to FIG. 4, the conical portion 140 may have circumferential grooves 145 around its perimeter. The shape of the circumferential grooves 145 may be defined by a partial torus having a tubular radius of any length, and may range from about 0.25 millimeters to about 2 millimeters, more preferably from about 0.5 millimeters to about 1 millimeter, alternatively about 1 millimeter. The circumferential grooves 145 may be spaced apart at any distance, and may be spaced apart at a distance from about 1 to about 3 millimeters from each other along the vertical, alternatively from about 2 to about 2.5 millimeters.

[00040] FIGs. 5, 5a, 6, and 6a illustrate alternative embodiments of an implant 200. The vertical, V, horizontal, H, and depth, D, orientations of this alternative embodiment of the implant 200 are depicted in FIGs. 5 and 5a. The implant 200 may have an articular end 205 and a stem 230. The articular end 205 may be an oval column of uniform thickness in the vertical having planar surfaces at its upper and lower faces. Alternatively, however, with respect to FIGs. 5, 5a, 6, 6a, and 7, the articular end 205 has a convex upper face 210, which blends, as at, 225 into, and is bounded by, an oval perimeter 220, which — after some lengths — itself blends 225 into a concave lower face 215. The blends 225 may have an edge radius from about 0.1 millimeters to about 1 millimeter. Alternatively the blends 225 may have an edge radius of about 0.5 millimeters.

[00041] With respect to FIGs. 5 and 5a, and in alternative embodiments the maximum length of the articular end 205 along the horizontal axis may be any length and may range from about 15 millimeters to about 40 millimeters, alternatively from about 20 millimeters to about 35 millimeters. Preferred maximum lengths of the articular end 205 along the horizontal axis include about 20 millimeters, about 22.5 miUimeters, about 25 millimeters, about 27.5 millimeters, and about 30 millimeters. The maximum length of the articular end 205 along the depth axis may be of any length and may range from about 10 millimeters to about 30 millimeters, alternatively from about 15 millimeters to about 25 millimeters. Alternative maximum lengths of the articular end 205 along the depth axis include about 15 millimeters, about 17.5 millimeters, and about 20 millimeters. In this embodiment the maximum length of the implant 200 along the vertical axis may be of any length and may range from about 10 millimeters to about 35 millimeters, alternatively from about 10 millimeters to about 20 millimeters. In one illustrative embodiment, the maximum length of the implant 200 along the vertical axis is about 15 millimeters.

[00042] With respect to FIGs. 5 and 5a, the circular pitch radius of the convex upper face 210 may be of any length and may range from about 15 millimeters to about 30 millimeters, alternatively from about 20 millimeters to about 25 millimeters. An alternative length of the circular pitch radius of the convex upper face 210 is about 22 millimeters. The circular roll radius of the convex upper face 210 may be of any length and may range from about 20 rnillimeters to about 40 millimeters, alternatively from about 25 millimeters to about 35 millimeters. An alterative length of the circular roll radius of the convex upper face 210 is about 32 millimeters. The convex upper face 210 may have a circular pitch radius and a circular roll radius, which may be different values. [00043] In an embodiment the curvature of the concave lower face 215 may be described as a single spherical radius. In an embodiment, the spherical radius of the concave lower face 215 ranges from about 20 to about 40 millimeters, alternatively from about 25 to about 35 millimeters, alternatively about 29.5 millimeters.

[00044] In an alternative embodiment, with respect to FIGs. 5a, 6a, 8a, and 9a, the concave lower face 215 may have one region of curvature, and in an alterative embodiment the concave lower face 215 may have at least three distinct regions of curvature. Preferably, a first region of curvature may be approximately bounded by the lines shown in FIG. 5a forming angle C. Angle C may be any amount of degrees, and may range from about 5 degrees to about 25 degrees, alternatively from about 10 degrees to about 20 degrees, hi this first region of curvature there may be a second circular pitch radius and a second circular roll radius, which may have the same or different values, alternatively ranging from about 15 millimeters to about 40 millimeters, alternatively from about 20 millimeters to about 25 millimeters. Alternative values for the second circular pitch radius include about 19.5 millimeters and for the second circular roll radius include about 29.5 millimeters. In the second and third regions of curvature, which may occupy that portion of the concave lower face 215 not occupied by the first region, there may be a third circular pitch radius and a third circular roll radius, which may have the same or different values preferably ranging from about 15 millimeters to about 40 millimeters, alternatively from about 20 millimeters to about 25 millimeters. An alternative value of the third circular pitch radius and the third circular roll radius is about 19.5 millimeters.

[00045] The stem 230 may have two portions, which may be both generally oval in cross- section in planes perpendicular to the vertical axis. The first portion 235 may extend from the concave lower face 215 a length along the vertical in a direction away from the convex upper face 210, and the second portion 240 extends from the end of the first portion 235 a length along the vertical in a direction away from the convex upper face 210. The stem 230 may blend 250 into the concave lower face 215 of the articular end 205. In an embodiment, the blend 250 is a fillet radius of from about 0.1 millimeters to about 1.5 millimeters, alternatively about 0.8 millimeters. The first portion 235 may be of a uniform length along the depth and of a decreasing length along the horizontal as it extends in the vertical. The first portion 235 may be of any length along the depth and may range from about 2 millimeters to about 25 millimeters, alternatively from about 5 raillimeters to about 20 millimeters, alternatively from about 5 millimeters to about 10 millimeters. An alternative length along the depth of the first portion 235 is about 6.25 millimeters. The length along the horizontal of the first portion 235 may decrease from a maximum length at the intersection with the concave lower face 215 to a lesser length as it extends along the vertical. The maximum length of the first portion 235 along the horizontal may be of any length, and may range from about 5 millimeters to about 20 millimeters, alternatively from about 10 millimeters to about 15 millimeters. With respect to FIG. 8, the first portion 235 may be of any length in the vertical direction, and preferably ranges from about 2 millimeters to about 10 millimeters, alternatively from about 2 millimeters to about 8 millimeters; an alternative length of the first portion 235 in the vertical direction is about 3.6 millimeters. Without wishing to be bound by the theory, the first portion 235 is preferable as it allows for ease of manufacturing, i.e., it provides a physical structure to clamp during manufacturing.

[00046] The second portion 240 may decrease from a maximum horizontal length to lesser horizontal length as it extends in the vertical direction. The maximum horizontal length of the second portion 240 may be the same as the horizontal length of the first portion 235 at the intersection of the first 235 and second 240 portions. The second portion may decrease from a maximum length along the depth to lesser length along the depth as it extends in the vertical direction. The maximum length along the depth of the second portion 240 may be the same as the length along the depth of the first portion 235 at the intersection of the first 235 and second 240 portions, and thus may range in value as recited above with respect to the depth length of the first portion 235. With respect to FIG. 8, the second portion 240 may be of any length along the vertical direction, and may range from about 2 millimeters to about 25 millimeters, alternatively from about 5 millimeters to about 20 millimeters, alternatively from about 5 millimeters to about 10 millimeters; an alternative length of the second portion 240 along the vertical direction is about 9.1 millimeters. [00047] As shown in Figure 10, the second portion 240 may have grooves 245 about its perimeter. Hie shape of the grooves 245 may be defined by a partial, oval, non-planar torus having a tubular radius of any length, alternatively from about 0.25 millimeters to about 2 millimeters, alternatively from about 0.5 millimeters to about 1 millimeter. The tubular radius of the partial, oval, non-planar torus of the grooves 245 may be about 1 millimeter. Alternatively the grooves 245 are spaced apart at any distance, and may be from about 1 to about 3 millimeters from each other along the vertical, alternatively from about 2 to about 2.5 millimeters.

[00048] The implant 100 or 200 may be manufactured from a variety of suitable materials, including any of the following, individually or in combination, graphite, pyrocarbon, ceramic, aluminum oxide, silicone nitride, silicone carbide or zirconium oxide; metal and metal alloys, e.g., CO— CR- W— Ni, Co— Cr-Mo, CoCr alloys, CoCr molybdenum alloys, Cr- Ni- Mn alloys; powder metal alloys, 316L or other stainless steels, Ti and Ti alloys including Ti 6Al -4 V ELI; polymers, e.g., polyurethane, polyethylene, polypropylene, thermoplastic elastomers, polyaryletherketones such as polyetherehterketone (PEEK) or polyetherketoneketone (PEKK); biomaterials such as polycaprolactone; and diffusion hardened materials such as Ti-13-13, zirconium and niobium. Moreover, the implant 100 or 200 may be coated with a variety of suitable materials, including any of the following, individually or in combination, porous coating systems on bone-contacting surfaces, hydrophilic coatings on load-bearing surfaces, hydroxyapaite coatings on bone-contacting surfaces, and tri-calcium phosphate on bone- contacting surfaces. Other suitable coatings include growth factors and other biological agents such as bone morphogenetic proteins (BMP's), transforming growth factor beta, among others. Additionally, components of the invention may be molded or cast, hand-fabricated or machined.

[00049] In one illustrative embodiment, the implant 100 or 200 is composed of graphite and pyrocarbon. The implant 100 or 200 may be graphite and may include a coating of pyrocarbon. The pyrocarbon coating may have an average thickness of from about 100 to about 1000 microns, alternatively from about 200 microns to about 500 microns, alternatively from about 250 to about 500 microns, alternatively about 350 microns. The pyrocarbon coating may have an elastic modulus from about 15 gigapascals ("GPa") to about 22 GPa, alternatively about 20 GPa. The pyrocarbon coating may further have a strength of at least 200 megapascals ("MPa"), alternatively at least about 300 MPa, alternatively at least about 400 MPa. The pyrocarbon elastic modulus and strength may be tested using a four-point bend, third-point-loading substrated specimens of dimensions 25 millimeters by 6 millimeters by 0.4 millimeters. In an embodiment, the pyrocarbon is pyrolytic carbon as described in Pure Pyrofytic Carbon: Preparation and Properties of a New Material, On-X Carbon for Mechanical Heart Valve Prostheses, Ely et al, J. Heart Valve Dis., Vol. 7, No. 6, A00534 (November 1998), alternatively pyrocarbon is pyrolytic carbon as described in the before-mentioned J. Heart Valve Dis. publication, but includes additional silicon.

[00050] The above-described implants may be used to repair damaged articular cartilage in humans, including knees, wrists, elbows, shoulders, and the like joints. In an illustrative method, a patient having articular cartilage damage is identified. The patient is fully informed of the risks associated of surgery, and consents to the same. An incision may be made near the damaged articular cartilage. The lesion to be repaired is identified, and an implant having dimensions compatible with the lesion is selected. The implant may be slightly smaller or slightly larger than the lesion. In these embodiments, the implant is from about 0.1 percent to about 20 percent smaller or larger than the lesion. A hole is then formed, i.e., drilled, punched, or broached, through the cartilage and the subchondral bone into the cancellous bone. Preferably, the dimensions of the hole are slightly less than the horizontal and depth dimensions of the stem of the implant. This may be achieved, for example, by using a tapered dill bit. Preferably the minimum length of the hole is equal to or slightly greater than the length of the stem of the implant, along the vertical. An amount of healthy and damaged cartilage may be removed near the lesion so that the lower portion of the implant's articular end may rest against the patient's bone. In this manner, however, it is preferable to remove as little healthy cartilage as possible. The stem of the implant may be inserted into the hole, and the lower portion of the implant's articular end may rest against the bone. The incision is then sutured by any of several known methods.

[00051] While specific alternatives to steps of the invention have been described herein, additional alternatives not specifically disclosed but known in the art are intended to fall within the scope of the invention. Thus, it is understood that other applications of the present invention will be apparent to those skilled in the art upon reading the described embodiment and after consideration of the appended claims and drawings.

Non-Patent Citations
Reference
1None
2See also references of EP2262450A4
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US869095611 Aug 20118 Apr 2014Fellowship Of Orthopaedic Researchers, Inc.Talar implants and methods of use
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US887690113 Apr 20124 Nov 2014Moirai Orthopaedics, LlcArticular cartilage implants
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US89204992 Apr 201330 Dec 2014Fellowship Of Orthopaedic Researchers, Inc.Method of use of trochlear implants
US966886516 Sep 20146 Jun 2017Fellowship Of Orthopaedic Researchers, Inc.Trochlear implants and methods of use
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