Patent Application
20240207061
The present subject matter relates to orthopedic prostheses and, more particularly, to tibial baseplates used in constrained knee arthroplasties.
Orthopedic procedures and prostheses are commonly utilized to repair and/or replace damaged bone and tissue in the human body. Generally, the knee is formed by the pair of condyles at the distal portion of the femur, the lower surfaces of which bear upon the correspondingly shaped proximal surface plateau of the tibia. The femur and tibia are connected by means of ligaments such as, the posterior cruciate ligament, the lateral collateral ligament, the medial collateral ligament, and the anterior cruciate ligament. These ligaments provide stability to the knee joint.
Prosthetic knee joints can be considered either constrained or unconstrained. For the purposes of this discussion, constrained prosthetic knee systems include femoral and tibial prostheses, which are mechanically linked or constrained to each other to limit relative movement between the femoral and tibial prostheses. Common mechanisms for such mechanical linkage is by a hinge, band or other linkage structure. An unconstrained prosthetic knee system includes femoral and tibial prostheses which are not mechanically linked. An unconstrained knee utilizes the patient's existing ligaments and other soft tissue to provide joint stability. With this in mind, constrained prosthetic knees have particular applicability to cases in which a patient has experienced ligament loss and/or the existing ligaments do not provide adequate support and stability to the knee.
Various constrained knee designs are known. One such design includes a hinge post. This hinge post configuration is positioned within a tibial baseplate (with an end protruding therefrom) and is connected to the femoral component. One hinge post configuration is the NexGen® Rotating Hinge Knee owned by the applicant, for example.
This disclosure pertains generally to improved constrained knee prostheses, particularly tibial baseplates thereof. It has been recognized for unconstrained prosthetic knee systems that having a medially biased keel can provide benefits including having the keel centered or nearly centered within the intramedullary canal. In this manner, the keel may avoid impinging onto hard, cortical bone around the intramedullary canal, thereby promoting firm and stable long-term fixation of the tibial baseplate to tibia. Furthermore, it has been recognized again for unconstrained prosthetic knee assemblies and systems that a degree of medialization of keel should increase as the tibial baseplates in the system become larger in size. However, medialization of the keel presents design challenges with addition of a hinge post configuration for a constrained knee system. In particular, for larger system sizes with a higher degree of medialization of the keel, if an axis of the hinge post is aligned with a medial/lateral midline of the tibial baseplate, an amount of material on a lateral side of the keel is reduced relative to a medial side. This reduced amount of material on the lateral side of the keel could lead to a possibility of a failure (breakout) of the hinge post from the keel for the larger system sizes with the higher degree of medialization. Thus, a reduction in the amount of material at the lateral side of the keel resulting from the hinge post being aligned with the medial/lateral midline of the tibial baseplate is not acceptable with larger sizes of tibial baseplates.
The present inventors have recognized, among other things, a medialized keel for the tibial baseplate can be achieved for a constrained knee system. Use of a medialized keel can avoid impinging onto hard, cortical bone around the intramedullary canal, thereby promoting firm and stable long-term fixation of tibial baseplate to tibia. The present inventors recognize several techniques that can allow for the medialized keel while also allowing for use of the hinge post configuration to mechanically link the femoral prosthesis and tibial baseplate together. As a first example, the present inventors have recognized that for all sizes of the tibial baseplate or at least for certain larger sizes of the tibial baseplate, a longitudinal axis defined by the hinge post can be medialized from the medial/lateral midline of the tibial baseplate.
According to other examples, which may or may not be combined with the example described above, the present inventors recognize that the femoral prosthesis (and/or other components of the prosthesis system) can be medialized with respect to the tibial baseplate. This can allow the hinge post to be medialized with respect to the medial/lateral midline of the tibial baseplate. Indeed, the present inventors have recognized that the hinge post can be medialized with respect to the medial/lateral midline of the tibial baseplate to such a degree that the hinge post received in the keel can be centralized with respect to the keel without adverse effects to knee joint kinematics. Alternatively, the present inventors recognize a design of the hinge post that creates a medial jog after the hinge post leaves the coupling point with the femoral component and enters the tibial baseplate. This jog can allow the portion of the hinge post received in the keel to be more centralized with respect to the keel even when the keel is medialized with respect to the medial/lateral midline of the tibial baseplate.
Alternatively, according to a second example, the present inventors recognize that a size of the keel can be increased to accommodate the hinge post (with the longitudinal axis of the hinge post positioned along the medial/lateral midline of the tibial baseplate). This increased size for the keel can be for the certain larger sizes of the tibial baseplate and can increase a thickness of the keel to provide for a relatively larger amount of material on the lateral side of the keel, thereby reducing the possibility of a failure in this region.
Additional features and benefits of the various examples provided herein will be discussed and/or will be apparent to one of ordinary skill in the art.
To further illustrate the apparatuses, systems and methods disclosed herein, the following non-limiting examples are provided, and which are referred to below as techniques. Parts or all of these examples/techniques can be combined in any manner.
In some aspects, the techniques described herein relate to a prosthesis assembly for a constrained knee including: a baseplate including: a medial compartment forming a first portion of a distal surface sized and shaped to substantially cover a first portion of proximal resected surface of a tibia and a first portion of a proximal surface opposite the first portion of the distal surface; a lateral compartment forming a second portion of the distal surface sized and shaped to substantially cover a second portion of proximal resected surface of a tibia and a second portion of the proximal surface opposite the second portion of the distal surface; a periphery extending around the medial compartment and the lateral compartment between the proximal surface and the distal surface; a medial/lateral midline extending between the medial compartment and the lateral compartment; and a keel extending distally from the distal surface to define a longitudinal keel axis, wherein longitudinal keel axis is medially biased toward the medial compartment so as to be spaced a first distance medial of the medial/lateral midline; and a hinge post having an longitudinal axis, the hinge post received in a recess in the baseplate including in the keel.
In some aspects, the techniques described herein relate to a prosthesis assembly, wherein the longitudinal axis of the hinge post is medially biased toward the medial compartment so as to be spaced a second distance medial of the medial/lateral midline.
In some aspects, the techniques described herein relate to a prosthesis assembly, wherein the first distance is substantially the same as the second distance.
In some aspects, the techniques described herein relate to a prosthesis assembly, wherein the longitudinal axis of the hinge post and the longitudinal keel axis are substantially coaxially aligned for at least three different standard stock sizes of the baseplate.
In some aspects, the techniques described herein relate to a prosthesis assembly, wherein the longitudinal axis of the hinge post is offset laterally from the longitudinal keel axis for at least three different standard stock sizes of the baseplate.
In some aspects, the techniques described herein relate to a prosthesis assembly, wherein a distance of the offset is between 0.25 mm and 2.5 mm, inclusive.
In some aspects, the techniques described herein relate to a prosthesis assembly, wherein the longitudinal axis of the hinge post is offset medially from the medial/lateral midline for all different standard stock sizes of the baseplate.
In some aspects, the techniques described herein relate to a prosthesis assembly, further including a femoral component connected to the hinge post, wherein a medial-lateral midline of the femoral component is offset medially with respect to the medial/lateral midline of the baseplate.
In some aspects, the techniques described herein relate to a prosthesis assembly, wherein a minimum wall thickness of the keel at a lateral side portion is at least 1.25 mm.
In some aspects, the techniques described herein relate to a prosthesis assembly, wherein a proximal end portion of the hinge post has a jog portion that extends medially from the proximal end portion toward a distal end portion of the hinge post.
In some aspects, the techniques described herein relate to a prosthesis assembly, wherein the hinge post is rotatable relative to the baseplate about the longitudinal axis.
In some aspects, the techniques described herein relate to a tibial prosthesis system including: a plurality of prostheses having a plurality of different standard stock sizes, each of the plurality of prostheses including: a baseplate including: a medial compartment forming a first portion of a distal surface sized and shaped to substantially cover a first portion of proximal resected surface of a tibia and a first portion of a proximal surface opposite the first portion of the distal surface; a lateral compartment forming a second portion of the distal surface sized and shaped to substantially cover a second portion of proximal resected surface of the tibia and a second portion of the proximal surface opposite the second portion of the distal surface; a periphery extending around the medial compartment and the lateral compartment between the proximal surface and the distal surface; a medial/lateral midline extending between the medial compartment and the lateral compartment; and a keel extending distally from the distal surface to define a longitudinal keel axis; one or more hinge posts having an longitudinal axis, the one or more hinge posts configured to be received in a recess in the baseplate including in the keel, wherein when the one or more hinge posts is received in the recess, the longitudinal axis of the hinge post and the longitudinal keel axis are substantially coaxially aligned for at least one of the plurality of the different standard stock sizes, and wherein the longitudinal axis of the hinge post is offset laterally from the longitudinal keel axis for two or more of the plurality of the different standard stock sizes.
In some aspects, the techniques described herein relate to a system, wherein longitudinal keel axis is medially biased toward the medial compartment so as to be spaced a first distance medial of the medial/lateral midline.
In some aspects, the techniques described herein relate to a system, wherein the first distance is between 0.25 mm and 2.5 mm, inclusive.
In some aspects, the techniques described herein relate to a system, wherein the longitudinal axis of the hinge post and the longitudinal keel axis are substantially coaxially aligned for at least three of the plurality of the different standard stock sizes.
In some aspects, the techniques described herein relate to a system, wherein the longitudinal axis of the hinge post is offset medially from the medial/lateral midline for all the plurality of different standard stock sizes.
In some aspects, the techniques described herein relate to a system, further including a femoral component connected to one of the one or more hinge posts, wherein a medial-lateral midline of the femoral component is offset medially with respect to the medial/lateral midline of the baseplate.
In some aspects, the techniques described herein relate to a system, wherein the longitudinal axis of the hinge post is offset laterally from the longitudinal keel axis for at least three of the plurality of the different standard stock sizes.
In some aspects, the techniques described herein relate to a system, wherein a proximal end portion of the one or more hinge posts has a jog portion that extends medially from the proximal end portion toward a distal end portion of the one or more hinge posts.
In some aspects, the techniques described herein relate to a system, wherein the one or more hinge posts is rotatable relative to the baseplate about the longitudinal axis of the hinge post when received in the recess.
In some aspects, the techniques described herein relate to a prosthesis assembly for a constrained knee including: a baseplate including: a medial compartment forming a first portion of a distal surface sized and shaped to substantially cover a first portion of proximal resected surface of a tibia and a first portion of a proximal surface opposite the first portion of the distal surface; a lateral compartment forming a second portion of the distal surface sized and shaped to substantially cover a second portion of proximal resected surface of a tibia and a second portion of the proximal surface opposite the second portion of the distal surface; a periphery extending around the medial compartment and the lateral compartment between the proximal surface and the distal surface; a medial/lateral midline extending between the medial compartment and the lateral compartment; and a keel extending distally from the distal surface to define a longitudinal keel axis, wherein longitudinal keel axis is medially biased toward the medial compartment so as to be spaced a first distance medial of the medial/lateral midline; a hinge post having an longitudinal axis, the hinge post received in a recess in the baseplate including in the keel, wherein the longitudinal axis of the hinge post is medially biased toward the medial compartment so as to be spaced a second distance medial of the medial/lateral midline; and a femoral component connected to the hinge post.
In some aspects, the techniques described herein relate to a prosthesis assembly, wherein at least one of: a medial-lateral midline of the femoral component is offset medially with respect to the medial/lateral midline of the baseplate; or a proximal end portion of the hinge post has a jog portion that extends medially from the proximal end portion toward a distal end portion of the hinge post.
In some aspects, the techniques described herein relate to a prosthesis assembly, wherein the first distance is substantially the same as the second distance.
In some aspects, the techniques described herein relate to a prosthesis assembly, wherein the longitudinal axis of the hinge post and the longitudinal keel axis are substantially coaxially aligned for at least three different standard stock sizes of the baseplate.
In some aspects, the techniques described herein relate to a prosthesis assembly, wherein the longitudinal axis of the hinge post is offset laterally from the longitudinal keel axis for at least three different standard stock sizes of the baseplate.
In some aspects, the techniques described herein relate to a prosthesis assembly, wherein a distance of the offset is between 0.25 mm and 2.5 mm, inclusive.
In some aspects, the techniques described herein relate to a prosthesis assembly, wherein the longitudinal axis of the hinge post is offset medially from the medial/lateral midline for all different standard stock sizes of the baseplate.
In some aspects, the techniques described herein relate to a prosthesis assembly, wherein a minimum wall thickness of the keel at a lateral side portion is at least 1.25 mm.
In the drawings, which are not necessarily drawn to scale, like numerals can describe similar components in different views. Like numerals having different letter suffixes can represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various examples discussed in the present document.
The present application relates to constrained tibial prosthesis assemblies and systems including tibial baseplates and a hinge post among other components. This application focuses on positioning of the hinge post relative to the keel of the tibial baseplate and other solutions for increasing an amount of material on a lateral side of the keel when the hinge post and keel are medialized relative to the remainder of the baseplate as further discussed herein. As discussed previously, proper positioning of the keel with respect to the intermedullary canal of the tibia can improve fixation and the durability of the tibial baseplate among other benefits.
As used herein, the terms “proximal” and “distal” should be given their generally understood anatomical interpretation. The term “proximal” refers to a direction generally toward the torso of a patient, and “distal” refers to the opposite direction of proximal, i.e., away from the torso of a patient. It should be understood that the use of the terms “proximal” and “distal” should be interpreted as though the patient were standing with the knee joint in extension despite the apparatuses described herein generally being used with the knee joint in flexion. The intent is to differentiate the terms “proximal” and “distal” from the terms “anterior” and “posterior”. As used herein, the terms “anterior” and “posterior” should be given their generally understood anatomical interpretation. Thus, “posterior” refers to a rear of the patient, e.g., a back of the knee. Similarly, “anterior” refers to a front of the patient, e.g., a front of the knee. Thus, “posterior” refers to the opposite direction of “anterior”. Similarly, the term “lateral” refers to the opposite direction of “medial”. The term “medial/lateral” means medial to lateral or lateral to medial. The term “proximal/distal” means proximal to distal or distal to proximal. The term “anterior/posterior” means anterior to posterior or posterior to anterior.
As used herein, the “periphery” of a tibial baseplate refers to any periphery as viewed in a top plan view, e.g., in a generally transverse anatomical plane. Alternatively, the periphery of a tibial baseplate may be any periphery as viewed in bottom plan view, e.g., in a generally transverse plane and looking at the distal surface adapted to contact a resected proximal surface of a tibial bone. In the context of a prosthesis, such as tibial baseplate described below, the medial/lateral centerline (sometimes referred to a “home axis” or “anteroposterior axis”) refers to an axis that divides a lateral compartment of the baseplate from a medial compartment. The medial/lateral centerline can extend anterior/posterior (e.g., from an anterior periphery of the baseplate to a posterior periphery of the baseplate) as the medial/lateral centerline extends generally anteriorly and posteriorly when baseplate is implanted upon tibia. The medial/lateral centerline can be positioned equidistant from a medial most point and lateral most point along the periphery. A typical practice upon implantation of the baseplate is to have the baseplate oriented relative to the tibia such that the medial/lateral centerline is substantially aligned with a home axis of tibia. Such orientation allows for a proper rotational and spatial orientation. However, it is contemplated that medial/lateral centerline may be oriented other manners relative to the home axis of tibia. As described below, distal features such as the keel can be oriented relative to the medial/lateral centerline, etc.
The home axis of the tibia can extend from a posterior point to an anterior point. The posterior point is generally disposed in the area where the patient's posterior cruciate ligament (PCL) attaches or would attach to tibia. More specifically, the posterior point is generally disposed at the geometric center of the attachment between the patient's PCL and tibia. The patient's PCL typically attaches to tibia T in two ligament “bundles,” the first bundle having a more anterolateral attachment location and the second bundle having a more posteromedial attachment location. Although the posterior point PP is described at the geometric center of the first bundle, it is contemplated that the posterior point may be located at the geometric center of the second bundle or at the geometric center of the first and second bundles, together. The anterior point can be disposed on the patient's anterior tibial tubercle. The anterior point can be medially spaced from the tubercle midpoint by an amount equal to ⅙ of the overall medial/lateral tubercle width. Stated another way, the anterior point can be laterally spaced from the tubercle medial end by an amount equal to ⅓ of the overall medial/lateral tubercle width, such that the anterior point lies on the “medial third” of the anterior tibial tubercle.
The tibial baseplate 100 can be used as part of a constrained knee prosthesis system or assembly as further discussed herein. The keel 104 extends distally from the distal surface 106 of the tibial baseplate 100. The keel 104 can be integral with (monolithic) or can be attached to (e.g. via thread or another mechanical connection mechanism) a remainder of the tibial baseplate 100. It is contemplated that a core 114 of the keel 104 may have a substantially conical, or have a tapered outer profile. The taper angle may be formed, for example, by tapering the core 114 of the keel 104 from a larger outer diameter at a proximal terminus of keel 104 (i.e., at the junction between keel 104 and distal surface 106 of tibial baseplate 100) to a relatively smaller distal diameter of at the distal terminus of keel 104 at a tip thereof. Exemplary constructs for the keel are discussed in U.S. Pat. Nos. 8,758,444B2 and 9,381,090B2, the entire specification of each of which is incorporated by reference in its entirety.
The keel 104 can be configured to extend distally and can be shaped to fit in an intermedullary canal of a tibia (not show) to provide fixation for the tibial baseplate 100. The keel 104 can include features that extend from the core 114 such as fins and can have a distal aperture to receive a stem extension as known in the art. As shown in
Referring again to
Due to the medialization of the keel 104, a majority of the keel 104 is positioned medial of the medial/lateral centerline MLC and the axis A1 as shown in
The distal surface 106 can include features such as threaded apertures for the connection of pegs, augments or other components as known in the art. The tibial baseplate 100, and hence the distal surface 106, can have a particular asymmetry, with respect to the medial/lateral centerline MLC. This shape is designed to maximize tibial coverage for a large proportion of knee-replacement candidates. The asymmetric shape results in the medial compartment 108 being relatively larger than the lateral compartment 110. Maximized coverage of cortical bone facilitates superior support of tibial baseplate 100. A firm, enduring fixation of tibial baseplate 100 to tibia is facilitated by large-area contact between the cortical and cancellous bone of tibia.
Distal surface 106 (and other features of the tibial baseplate such as the keel 104) can be made of a porous or highly porous material that facilitates an amount of bone ingrowth. A highly porous biomaterial is useful as a bone substitute and as cell and tissue receptive material. A highly porous biomaterial may have a porosity as low as 30%, 55%, or as high as 70%, 80%, 85%, or 90%. The highly porous material can have an average pore size of between 100 microns and 1000 microns, for example. However, use of the highly porous biomaterial is not contemplated in all examples. For example, material such as bone cement can be utilized as an alternative to the highly porous biomaterial.
An example of such porous or highly porous material is OsseoTi® generally available from Zimmer Biomet, Inc., of Warsaw, Ind. The material can include titanium or titanium alloy and can additionally include other materials. Such material (including a base of relatively less porous or non-porous biocompatible material) can be manufactured using additive manufacturing processes such as laser sintering or the like. OsseoTi® is highly biocompatible, has high corrosion resistance and includes a highly interconnected porous architecture that mimics the porous structure of human cancellous bone, which can enhance bone integration and in-growth. The porous or highly porous material can be manufactured to be layered over or otherwise structured with/on a relatively less porous or non-porous biocompatible material such as titanium, titanium alloy, stainless steel or other material as known in the art.
Another example of such a porous or highly porous material is produced using Trabecular Metal™ Technology generally available from Zimmer Biomet, Inc., of Warsaw, Ind. Such a material may be formed from a reticulated vitreous carbon foam substrate which is infiltrated and coated with a biocompatible metal, such as tantalum, by a chemical vapor deposition (“CVD”) process in the manner disclosed in detail in U.S. Pat. No. 5,282,861 to Kaplan, the entire disclosure of which is hereby expressly incorporated herein by reference. In addition to tantalum, other metals such as niobium, or alloys of tantalum and niobium with one another or with other metals may also be used. The porous tantalum structure may be made in a variety of densities in order to selectively tailor the structure for particular applications. In particular, as discussed in the above-incorporated U.S. Pat. No. 5,282,861, the porous tantalum may be fabricated to virtually any desired porosity and pore size, and can thus be matched with the surrounding natural bone in order to provide an improved matrix for bone ingrowth and mineralization.
Generally, the porous material structures contemplated can include a large plurality of ligaments defining open spaces there between, with each ligament generally including a core covered by a thin film of metal. The open spaces between the ligaments form a matrix of continuous channels having no dead ends, such that growth of cancellous bone through the porous tantalum structure is uninhibited. The porous or highly porous material may include up to 70%, 85%, or more void space therein. Thus, porous or highly porous material is a lightweight, strong porous structure which is substantially uniform and consistent in composition, and closely resembles the structure of natural cancellous bone, thereby providing a matrix into which cancellous bone may grow to provide fixation of the tibial baseplate 100 to the patient's bone.
The medial compartment 108 forms a first portion 116 of the distal surface 106. The first portion 116 can be sized and shaped to substantially cover a first portion of proximal resected surface of the tibia. Similarly, the lateral compartment 110 forms a second portion 118 of the distal surface 106. The second portion 118 can be sized and shaped to substantially cover a second portion of proximal resected surface of the tibia.
The periphery 112 extends around the medial compartment 108 and the lateral compartment 110 between the proximal surface 120 (shown in
The prosthesis assembly 122 has the femoral component 134 and the tibial baseplate 100 mechanically linked to one another. This is accomplished by the hinge post 126 and other components of
When assembled, the shackle 142 can be placed between opposing walls of poly box 138. When assembled on the hinge axle 136, the axle bushing 140 additionally resides within an aperture on a proximal portion of the shackle 142. The shackle 142 and hinge post 126 can be formed from suitable materials such as a titanium alloy, a cobalt-chromium alloy, etc. while the axle bushing 140 and the poly box 138 can be formed from a different materials such as plastic, e.g., UHMWPE. The axle bushing 140 acts as a bearing between the shackle 142 and the hinge axle 136. The poly box 138 acts as a bearing between the femoral component 134 and the shackle 142.
Similarly, there can be a distance of medial offset between the longitudinal axis LA (including the axis of rotation/articulation ARA in the examples of
As shown in
As shown in
The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.
In this document, the terms “generally” “substantially” “about” mean within 15 percent of the value provided (±). The terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) can be used in combination with each other. Other examples can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above detailed description, various features can be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter can lie in less than all features of a particular disclosed example. Thus, the following claims are hereby incorporated into the detailed description as examples or embodiments, with each claim standing on its own as a separate example, and it is contemplated that such examples can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 63/434,573, filed on Dec. 22, 2022, the benefit of priority of which is claimed hereby, and which is incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63434573 | Dec 2022 | US |
