Early Intervention Knee Implant Device and Methods
20200000598 ยท 2020-01-02
Assignee
Inventors
Cpc classification
A61F2002/30878
HUMAN NECESSITIES
A61F2002/30884
HUMAN NECESSITIES
International classification
Abstract
A replacement knee implant has a femoral implant and a tibial implant, each of which are inset in a bone surface. The tibial implant is generally elongated with one end rounded and an opposite end conforming to the shape of the tibia, and is made of a metal alloy or a ceramic. The upper surface is dished while the lower surface is planar and can be parallel or sloped relative to the upper surface, and can have a keel for fixation. The femoral implant for implementation in a femoral condyle is rounded such that, when implemented, the femoral implant is flush at the anterior and posterior sides and protruding away from the femur between the anterior and posterior ends. The femoral implant can have an elongated keel for extending into the femur, and can be made from a highly cross-linked polyethylene.
Claims
1. A tibial resurfacing implant, comprising: a tibial implant structure comprising: a surfacing portion with a tibia-facing surface and a femur-facing surface, wherein the surfacing portion is substantially planar; a keel extending from the tibia-facing surface of the surfacing portion in a direction substantially perpendicular to the surfacing portion, wherein the keel comprises a substantially planar element; and a cylindrical element extending from an anterior end of the keel to a posterior end of the keel.
2. The tibial resurfacing implant of claim 1, wherein the surfacing portion is configured to be implanted along a surface of a resected condyle of a tibia, the surfacing portion having a lateral end that is configured to be positioned along a lateral portion of the tibia and a medial end that is configured to be positioned along a medial portion of the tibia, and wherein the keel extends from the tibia-facing surface along a plane that is between the lateral and medial ends of the surfacing portion.
3. The tibial resurfacing implant of claim 2, wherein the plane along which the keel extends is substantially equidistant from the lateral and medial ends of the surfacing portion.
4. The tibial resurfacing implant of claim 1, wherein the keel comprises a first end portion in contact with the tibia-facing surface and a second end portion that is located opposite to the first end portion, wherein the cylindrical element is located at the second end portion.
5. The tibial resurfacing implant of claim 1, wherein the keel with the cylindrical element is configured to affix the tibial implant structure to a tibia without requiring a cement preparation.
6. The tibial resurfacing implant of claim 1, wherein the cylindrical element has annular notches or extrusions.
7. The tibial resurfacing implant of claim 6, wherein the annular notches or extrusions are between 0.1 and 0.2 mm relative to a diameter of the cylindrical element.
8. The tibial resurfacing implant of claim 1, wherein a diameter of the cylindrical element at the anterior end of the keel approximates a diameter of the cylindrical element at the posterior end of the keel.
9. The tibial resurfacing implant of claim 1, wherein a diameter of the cylindrical element at the anterior end of the keel is greater than a diameter of the cylindrical element at the posterior end of the keel.
10. The tibial resurfacing implant of claim 1, wherein a distance between the tibia-facing surface and the cylindrical element at the posterior end of the keel is greater than a distance between the tibia-facing surface and the cylindrical element at the anterior end of the keel.
11. The tibial resurfacing implant of claim 10, wherein a difference between the distance between the tibia-facing surface and cylindrical element at the anterior end of the keel and the distance between the tibia-facing surface and the cylindrical element at the posterior end of the keel is between about 0.2 mm and 0.5 mm
12. The tibial resurfacing implant of claim 1, wherein the femur-facing surface has a dished morphology.
13. The tibial resurfacing implant of claim 1, wherein the surfacing portion has a thickness of about 5 mm or less at its thinnest point.
14. The tibial resurfacing implant of claim 1, wherein the surfacing portion has a thickness of no more than about 2 mm to allow for mounting the surfacing portion along relatively strong bone tissue of a proximal region of a tibia to provide better strength at an interface of the tibia and the tibia-facing surface.
15. The tibial resurfacing implant of claim 1, wherein the surfacing portion is tapered relative to the keel.
16. The tibial resurfacing implant of claim 15, wherein the surfacing portion is tapered along a frontal plane, the frontal plane being defined with respect to a patient in whom the tibial implant structure is implanted.
17. The tibial resurfacing implant of claim 15, wherein the surfacing portion is tapered along a sagittal plane, the sagittal plane being defined with respect to a patient in whom the tibial implant structure is implanted.
18. The tibial resurfacing implant of claim 15, wherein the surfacing portion is tapered along: a frontal plane, the frontal plane being defined with respect to a patient in whom the tibial implant structure is implanted, and a sagittal plane, the sagittal plane being defined with respect to the patient.
19. A method for implanting a tibial implant structure on a tibia of a patient, the method comprising: removing a portion of a condyle of the tibia to create a resected tibial condyle for mounting the tibial implant structure, the tibial implant structure comprising: a surfacing portion with a tibia-facing surface and a femur-facing surface, wherein the surfacing portion is substantially planar, a keel extending from the tibia-facing surface of the surfacing portion in a direction substantially perpendicular to the surfacing portion, wherein the keel comprises a substantially planar element, and a cylindrical element extending from an anterior end of the keel to a posterior end of the keel; creating a groove along the resected tibial condyle to accommodate the keel of the tibial implant structure; creating an aperture along a length of the groove to accommodate the cylindrical element of the tibial implant structure; and mounting the tibial implant structure on the resected tibial condyle, wherein: the surfacing portion is caused to interface with a surface of the resected tibial condyle, the keel is caused to be disposed within the groove, and the cylindrical element is caused to be disposed within the aperture.
20. The method of claim 19, wherein the surface of the resected tibial condyle is caused to be sloped along: a frontal plane, the frontal plane being defined with respect to a patient in whom the tibial implant structure is implanted, or a sagittal plane, the sagittal plane being defined with respect to the patient.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] These embodiments and other aspects of this invention will be readily apparent from the detailed description below and the appended drawings, which are meant to illustrate and not to limit the invention, and in which:
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DETAILED DESCRIPTION OF THE INVENTION
[0041] Disclosed herein are knee implant devices, surgical cutting guide sets and methods for providing knee resurfacing implants to human patients having degenerative disorders of the bones and soft tissues of the knee, such as osteoarthritis and mechanical wear due to aging. The implant devices include femoral implants and tibial implants, each of which has novel features and aspects. Each of the various devices and their features and uses will be described in turn, and specific embodiments are presented by the figures, which are exemplary only and not meant to be limiting.
[0042] Turning now to the figures,
[0043] A second surgical cutting guide is employed to finish prepaii.ng the implant site. This is illustrated in
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[0048] The invention disclosed herein provides for both femoral implants as described and tibial implants, discussed in turn below.
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[0053] If an isolated metallic tibial plateau is used, the bearing surface should be shaped to give maximum conformity with the femoral condyles. In practice this means that there would be conforming surfaces in early flexion, but less conformity in flexion due to the diminishing sagittal radius of the medial femoral condyle. There is not the benefit, as in the intact knee, of a meniscus that can change its shape according to the shape of the femoral condyle itself. A conforming metallic component can be even more rigid fixation to the tibia than a shallow component, because of the high shear and tilting forces that are likely to occur. Another consideration for the shape of the upper surface of a metallic tibial plateau is the required stability on the one hand, and freedom of motion on the other hand. In the intact knee on the medial side, there are only a few millimeters of AP laxity at all angles of flexion due to the actions of the cruciate ligaments, further augmented. On the medial side, the stability is further augmented by the dishing of the tibial surface, the menisci, and the medial collateral ligament. Hence from this point of view, the medial dishing of a metallic plateau is an advantage regarding wear of the medial femoral condyle. Overall however, for durability and absence of pain, replacement bearing surfaces can be done for both the femur and tibia, and each would need to be rigidly fixed to the bone. For kinematic compatibility, the contours of the artificial surfaces should closely match those of the original femur.
[0054] For the treatment of the medial compartment in early OA, where the emaciated ligaments are intact or if adapted in cases where the anterior cruciate is damaged, and where there is no significant varus deformity, there is an additional aspect. A nonlimiting example of a typical knee which is suitable for this treatment is one where the arthritic lesions are localized on the distal medial femoral condyle, and on the central or anterior regions of the medial tibial plateau. The lateral side of the joint is able to sustain normal weight-bearing while the patello-femoral joint shows only slight arthritic lesions at most such that there is no significant pain deriving from that compartment. The patients benefiting are those who still are pursuing an active lifestyle, with a typical age range from 50-65 years. The procedure is envisaged as performed through small incisions and involve much less trauma than a standard total knee replacement, and even less trauma than a standard unicompartmental knee replacement.
[0055] The femoral implant can have various widths, such as 12 mm, 16 mm, or 20 mm width; and various thicknesses, such 6 or 8 mm. Different materials can be used for the femoral implant, but preferably it is a plastic, such as ultra-high molecular weight polyethylene (UHMWPE), or a more rigid polymer such as polyetheretherketone (PEEK).
[0056] In one embodiment, the femoral component is made from a wear resistant polymer such as highly cross-linked polyethylene, with a thickness of at least 8 mm, an optional keel along the base 2-4 mm wide, where the component is inset into the femoral condyle leaving 2-4 mm of bone on each side. The component is sized to carry load from approximately 5 degrees hyperextension to approximately 40-60 degrees flexion. It is flush with the cartilage at the anterior and posterior locations, and projects 0.5-1 mm above the cartilage in the center, the projection tapering down to zero at each end. The projection causes more of the weight-bearing to be in the component and less in surrounding cartilage at each side. The outer radii of the femoral component in the frontal plane, is about 1-3 mm smaller than that of the tibial component for moderately close conformity and stability. The lower surface of the component can be designed for osseointegration. All edges have a small radius, such as 0.5 mm, to avoid stress concentrations of the bone interfacing with the component.
[0057] An advantage of making the femoral component in a polymer is that the tibial component can be made from metal. A metal implant can be made thinner, thus requiring less tibial bone resection. However there are alternate material choices. A molded polyethylene can be used, or a stiff polymer such as polyetheretherketone (PEEK). It is possible to make the femoral component from metal, interfacing with polymer on the tibial side. These are the materials conventionally used today for unicompartmental replacements.
[0058] The implant can be fixed to the bone with polymethylmethacrylate cement (PMMA), which is commonly used in knee replacements. Another method is to bond a layer of a porous material such as porous tantalum to the base of the plastic component and rely on subsequent bone ingrowth. The lower surface could also be fused with a trabecular metal for ingrowth fixation. The side and lower surfaces can have grooves to help the bonding.
[0059] The tibial implants can have one of several different forms and can have several different shapes. A slot is cut into the tibia from the anterior side, and the implant is introduced anteriorly. The implant is assumed to be bonded to bone (after ingrowth) but not to cartilage. As shown, the device can have different thicknesses, such as 6 mm or 8 mm, can use a single keel or a dual keel for support (1.5-2.5 mm wide and 4-8 mm deep, with lower surface is designed for osseointegration), and can have a width from about 12 to 24 mm, including widths of 10, 12, 14, 16, 20, and 24 mm, or more typically, about 16-24 mm in width. The implant should have a thickness of 2-4 mm at its thinnest point, although higher thicknesses are available, such as 4-10 mm to cope with prevailing bone loss and deformity.
[0060] The tibial component can be made from a metal alloy, such as a CoCr alloy or a surface hardened titanium alloy, or from a ceramic. The tibial component is inset with 2-4 mm peripheral boundary of cartilage, and with meniscus preserved if applicable, where the bone preparation and component insertion is carried out from the anterior. Although not shown in
[0061] The tibial component can be made from different materials. If the femoral component is made from metal, the tibial component can be made from a polymer, such as cross-linked polyethylene or molded polyethylene. It can also have a metal backing to provide greater rigidity and reduce the deformation of the polymer.
[0062] The fixation including PMMA or a porous surface, as well as the rounding of comers, as are used for the femoral component. Also, similar to the femoral component, all edges of the tibial component have a small radius to avoid stress concentrations.
[0063] The inserted tibial component is compatible with preserving the meniscus, which is released anteriorly to allow access to the component. The tibia component can come in different sizes and shapes. The dimensional variables are the sagittal radii, the AP length and the ML width. The component is preferably made from a metal, such as CoCr alloy. Fixation can be with acrylic cement, or with a fused-in porous material. The thickness of tibial component at the center is about 2-3 mm. The tibial component is fixed, ensuring that the boundaries are flush or slightly recessed relative to the surrounding cartilage surfaces (step i). As shown here, the tibial implant is generally elongated with one end rounded and an opposite end designed to conform to the shape of the tibia.
[0064] The compressive stresses and strains on the bone at the base of the recess were calculated using finite element analysis for the normal anatomic knee, and for the different versions of the femoral and tibia components. The criterion was that the strains were the baseline against which to compare the strains after implantation. If the strains were higher, that would imply that there was a possibility of compressive bone failure, which would impair the fixation and durability of the implant. On a comparative basis, implants with lower strains are preferred, all else being equal. The strains for the anatomic knee were less than for all of the implants analyzed, including on the femur and tibia. The strains were approximately inversely proportional to width.
[0065] For the femur, the strains were similar whether plastic or metal was used, for both 6 mm and 8 mm thick components. For the tibia, there was some advantage to using metal for the thinner component. For the tibia, there was a major reduction of stresses using a keel. Using two keels produced a further significant decrease. Rounding the edges of the components, including the keels, avoided stress concentrations at those locations. By insetting components, versus seating on a straight-across resection, was in transmitting shear stresses were transmitted down the peripheral bone contact, hence reducing the strains on the lower surface of the bone.
[0066] Methods of making a patient-specific knee implant set are included in the scope of the invention. This is accomplished by first imaging the knee of a patient having a degenerative knee condition thereby creating one or more three-dimensional maps of the femoral and tibial surfaces of the patient. Standard imaging techniques such as MRI and CT scans permit accurate high-resolution maps of the patient's anatomy, and specifically allow determination of the degree of condyle curvature as well as patient-specific anatomic variations that are within the resurfacing areas. Using standard computer systems with appropriate software, these patient maps are rendered as three dimensional virtual models of the patient's tibia and femur. Systems exist for patient-specific total knee replacement procedures, such as the Signature, Visionaire and ConforMIS systems, and the present invention utilizes similar mapping and rendering technologies. Essentially, the patient specific femoral and tibial maps are provided to a computer system, the computer system having software for rendering the femoral and tibial maps into a 3-dimensional virtual model of the femur and tibia of the patient. The femoral and tibial subregions defining femoral and tibial implant locations are determined from the virtual model. From such models, a femoral and/or a tibial implant is created such that the exterior surfaces of the femoral and/or the tibial implant substantially conforms to the shape of a native femoral condyle or a native tibial surface, respectively. Creation of the implant can be achieved through molding techniques or by direct sculpting techniques, or a combination of these. Patient-specific tibial surgical cutting guides or a patient-specific femoral surgical cutting guide sets are similarly created from the 3-dimensional virtual model.