WO2016100526A1

WO2016100526A1 - A guide for re-cutting tibial resections for total knee replacement

Info

Publication number: WO2016100526A1
Application number: PCT/US2015/066117
Authority: WO
Inventors: James Matthew HARTFORD; Mario Michael PELELLA
Original assignee: Hartford James Matthew; Pelella Mario Michael
Priority date: 2014-12-17
Filing date: 2015-12-16
Publication date: 2016-06-23

Abstract

A re-cutting guide for making calibrated tibial re-cuts for total knee replacement when the depth of an initial tibial resection is insufficient. The re-cutting guide includes a top element and a bottom element parallel to each other and connected by a spacer. The top element further including at least two reference arms extending perpendicularly from underneath the top element, where the reference arms are shorter than that of the spacer. The reference arms are disposed on the top element at a second end opposite the first end. The bottom element is shorter in length than the top element. In use, the reference arms sit atop the cut tibia plateau while a side of the bottom element contacts a tibial side. A pre-calibrated height is based on the distance between the reference arms and the bottom element and measures out the height of a subsequent cut.

Description

A GUIDE FOR RE-CUTTING TIBIAL RESECTIONS FOR TOTAL KNEE REPLACEMENT

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims priority to U.S. Provisional Application No. 62/092,996, filed on December 17, 2014, entitled "A Pre-calibrated Guide for Re-cutting Tibial resections for Total Knee Replacement", the disclosure of which is incorporated by reference in its entirety.

INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

FIELD

[0003] The present invention relates to tools and guides for use in joint replacement surgery. In particular, the device and methods described are directed towards guides for re-cutting a tibial plateau that has at least been re-sectioned once.

BACKGROUND

[0004] Knee replacement surgery is a common joint replacement procedure. A knee replacement surgery procedure is needed when a patient's knee is damaged by physical trauma or by disease affecting the knee joint. In some cases, the doctor is able to repair or replace part of the patient's knee, but in other cases, the damage is too extensive and a total knee replacement may be required.

[0005] For a total knee replacement surgery, the surface of the tibia is prepared to receive the corresponding tibial implants that will ultimately become part of the new knee joint. Exemplary total knee replacement components can be found in U.S. Patent 8,337,564 to Shah. FIGS. 1A and IB, taken from Shah, show a side view of the various components that are typically needed for total knee replacement. As can be gathered from these two figures, the tibial implant base plate will sit on top a cut tibia surface and the interfacing element of the tibial implant will eventually be anchored into the tibial plateau. Thus the surface of the tibia must be made flat and level in order for the tibial implant to properly seat into the patient's tibia. In preparation for receiving the tibial implant, the surgeon will resect the tibial surface, removing the intercondylar tubercles to create a flat surface and make other necessary cavities for accepting the tibial implant. Because the implantable joint components used in a total knee replacement require a certain amount of clearance to function properly, the proximal methaphyseal area of the tibia is often resected to accommodate these implant components. Thus, a surgeon must determine the amount of anterior surface of the tibia to remove.

[0006] In some cases, after performing an initial resection of the tibia, the surgeon may find that the space between the femur and the tibia is still not large enough to accommodate the entire knee replacement implant throughout the arc of motion. Under these circumstances, the simpler choice is for the surgeon to re-cut the tibial plateau. The tool initially used for resecting the patient's tibia may no longer be useful for re-cutting the tibial plateau; many knee alignment guides for initial resection of the patient's tibia are specific to that patient and specific for the landscape of the intact tibia (which includes the lateral and medial intercondylar tubercles). It would also be unfeasible to have on hand patient- specific guides or tools in anticipation of having to re-cut an already resected tibial surface because not every tibial resection will require re-cutting. Finally, "eye-balling" or estimating how much more of the tibial plateau to remove is also ill-advised for obvious reasons, primarily lack of accuracy.

[0007] As previously alluded to, in order for all the components of the total knee replacement to work in synchrony, not only do the components have to fit with the space between the femoral end and the tibial end, the individual components, such as the tibia implant, must fit perfectly within the tibial end. If the tibial end is not level, the tibial implant would also be uneven. If the tibial implant is uneven, it may not properly fit with the other knee replacement components. The improperly-fitted tibial implant could then cause the entire knee replacement to be misaligned, which may cause a host of potential problems for the patient in the future such as excessive wear in certain regions of the implant, overall discomfort in the knee joint, and so forth. Thus, there exists a need for a tool that will guide a surgeon in re-cutting an already resected tibia.

[0008] Most prior tibial cutting guides are used to guide the first cut of the tibia. In the majority of the prior tibial resecting tools, the trend has been going towards patient-specific resecting tools. While patient-specific tibial resection guides may cut down on the uncertainty and time in a total knee replacement procedure, there is much additional upfront cost and time required. For instance, in prior patient-specific tibial guides, each piece of the tibial resection guide assembly is uniquely tailored to the particular patient's anatomy. Making custom resection guides will often require taking images or scans of the patient's anatomy, followed by creating specific molds. Thus, not only does the patient have to go in for additional appointments, there are additional costs associated with the additional time and labor required for customizing the cutting guide for every patient. While the prospect of performing a more perfect initial tibia resection makes using patient-specific desirable, in other scenarios such as when the tibia has to be re-cut, having a patient-specific tool in the total knee replacement procedure is unfeasible or simply unnecessary. A patient-specific re-cutting guide for performing a secondary cut of an already resected tibia is unnecessary because in all of the cases, the tibial top profile will be flat from the first resection, and any patient-specific feature of the resected tibial end will not enter into determining how much more of the tibia end needs to be removed in order to properly fit the knee implants with an accurate depth of resection.

[0009] Thus, there is a need for a generic tibial re-cutting guide for surgeons performing total joint replacement, specifically total knee replacement surgeries, in the event re-cutting the already resected tibia is required. It would be useful if such a generic re-cutting guide is available during every total knee replacement procedure in case the surgeon needs to re-cut the tibial plateau. SUMMARY OF THE DISCLOSURE

[0010] The present invention relates to re-cutting guides used in total knee replacement procedures. The re-cutting guide is used in resecting a tibia plateau of a patient where tibia already possesses a flat surface from an initial tibial resection. The re-cutting guide may be used with most patients under these circumstances. The re-cutting guide is used to remove additional amount of tibial plateau so that the various components of the total knee replacement will fit within the space between the femoral end and the tibial end of the patient's leg.

[0011] The re-cutting guide includes a spacer from which a top element may extend and having a first distance from the spacer to the distal end of the top element. The re-cutting guide also includes a bottom element extending from the spacer in a position parallel to, and spaced from the top element, where the bottom element extends from the spacer to the distal end of the bottom element having a second distance which is less than the first. The bottom element is sized and adapted to be inserted through a cutting aperture of a standard tibial alignment tool. The re-cutting guide also includes two reference arms that each extend down from the top element from positions a distance from the spacer greater than the second distance. The distance between the free distal ends of the two reference arms and the top surface of the bottom element defining a thickness for resecting.

[0012] In some examples of the re-cutting guide, the spacer and the reference arms are of fixed in their heights, but in other instances, the spacer and/or the reference arms may be of variable or adjustable height. Where the spacer is adjustable, the spacer may include markings for determining the amount of adjustments made. The spacers may be adjustable in any reasonable increments such as one millimeter, two millimeters and so forth, or also in one-sixteenth or one-eighth of an inch increments. In some instances, the reference arms are fixed relative to each other, but in other instances, the reference arms may be adjustable relative to each other. The two reference arms may each also include markings for determining the amount of adjustment made, where the markings may be in millimeter increments, in one-sixteenth of an inch increments, or other suitable increment.

[0013] The re-cutting guide may also include a level. The level may be useful to show the operator/surgeon that the cut they are taking will make the tibial plateau level, which is crucial for the knee replacement components to properly fit.

[0014] The re-cutting guide described herein may also be provided as part of a kit, wherein a plurality of re-cutting guides have different, but fixed distances between the distal ends of the reference arms and the top surface of the bottom element. This would allow the user to select different re-cutting guides based on the different amounts of tibial thicknesses the user wishes to remove.

[0015] In other embodiments, the re-cutting guide has the following features. A top element extending from an adjustable spacer, where the top element extends a first distance from the spacer to a top element distal end. A bottom element extending from the spacer in a position parallel to and spaced from the top element, where the bottom element extends a second distance from the spacer to a bottom element distal end, where the second distance is less than the first distance. The adjustable spacer may be adjustable in millimeter or fractions of an inch increments. The spacer may also include markings to show the amount of adjustment made to the spacer. The re-cutting guide also includes a first adjustable reference arm extending perpendicularly from a first location underneath the top element distal side towards the bottom element, and a second adjustable reference arm positioned opposite from the first adjustable reference arm underneath the top element distal side and extending perpendicularly toward the bottom element. The first and the second reference arms may also be adjustable in millimeter or fractions of an inch increments, and include markings for showing the amount of adjustments made to each reference arm. The markings may be disposed on each respective reference arm. The re-cutting tool may also include one or more levels to show the user that the resulting surface after the cut made with the aid of the re-cutting guide will be a level plane. The re-cutting guide is designed to couple with a standard tibial alignment tool/cutting jigand align the standard alignment tool for performing the re-cut of the initial tibial resection.

(0016] Also disclosed herein are methods for using the re-cutting guide for resecting a tibia of a patient where the tibia has already undergone an initial proximal cut. The steps include determining an initial amount of bone to remove after the initial tibial resection. This may then be followed by inserting the bottom element of the re-cutting guide through a standard cutting tool guide cutting aperture. Next, the surgeon would place the reference arms of the re-cutting guide on the flat surface of the initial tibial resection, such that the reference arms extend downward from a top element, where the top element is spaced from and parallel to a bottom element. Then the joined re-cutting guide and the standard tibal alignment tool is attached to the patient's tibia. The re-cutting guide is then removed so that only the standard tibial alignment guide is coupled to the patient's tibia. Finally, a saw may be inserted into the cutting aperture of the standard tibial alignment tool to make the subsequent cut within the cutting aperture. This was where the bottom element was initially coupled but then removed. The surgeon may make incremental adjustments to the height of the tibial plateau by making additional cuts to the tibial resection. Depending on whether the re-cutting guide is adjustable or not, the surgeon may use re-cutting tools of different distances between the distal ends of the reference arms and the top surface of the bottom element or simply adjust the reference arms and/or spacer to achieve the desired thickness for resecting.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

[0018] FIG. 1 A is a side view of a total knee replacement implant.

[0019] FIG. IB is a second, perspective view of the total knee replacement implant.

[0020] FIG. 2 is a perspective drawing of a re-cutting guide.

[0021] FIG. 3 is a drawing showing the re-cutting guide coupled to a standard tibial cutting guide as it would be used in re-cutting a tibial plateau.

[0022] FIG. 4 is a side view of the re-cutting guide. [0023] FIG. 5A is a drawing of the re-cutting guide having adjustable reference arms and coupling spacer.

[0024] FIG. 5B is a drawing of the re-cutting guide having an alternative mode of adjusting the heights of the reference arms.

[0025] FIG. 6 is a top view of the re-cutting guide showing a level disposed on a top side.

DETAILED DESCRIPTION

[0026] The present disclosure provides a generic re-cutting guide and methods of using the re- cutting guide with standard tibial alignment or cutting tools. The detailed description and figures provide merely examples of the various inventions described herein. Those skilled in the art will appreciate that the disclosed examples of the may be varied, modified, and altered without departing from the scope of the inventions described herein. Many variations are contemplated for different applications and design considerations; however, for the sake of brevity, each and every contemplated variation is not individually described in the following detailed description.

[0027] The generic nature of the re-cutting guide allows it be used on practically all patients undergoing total a knee replacement procedure. Thus, it would be useful to have the re-cutting guide on hand at every total knee replacement surgery performed in case the surgeon has to perform a subsequent cut of the tibial plateau after an initial resection and does not wish to estimate or guess how much more of the tibia to remove.

[0028] The re-cutting guide described herein addresses a need in the area of total knee replacement, or more generally, in joint replacement, where the tibia or the bone being resected requires additional resecting. While there are a plethora of tibial resecting guides known in the field, there is little in the way of a re-cutting guide for such a situation.

]0029] The re-cutting guide described herein is a simple and easy-to-use device that will guide a surgeon in accurately and precisely removing only the necessary additional portion of the tibia in order to accommodate the knee replacement implant components. Because of its simple design, those skilled in the art will intuitively discern how to employ the re-cutting guide in removing additional bone from the tibia or other bone surface. Unlike some of the devices used for resecting the tibia, the re-cutting guide does not require additional elements for attaching itself to the tibia, nor does it require any associated programs or applications for its use.

[0030] Turning to FIG. 2, a generic tibial re-cutting guide 100 for is shown. The term generic used herein is used to describe something (e.g. a device or tool) that is not specific to any one person and may be used with the majority of cases (e.g. with patients) for its intended purpose. In this present case, the generic tibial re-cutting guide can be used with most total knee replacement procedures where a surgeon needs to make additional cuts to the tibia after an initial tibial resection. This can be contrasted with patient-specific devices or tools that are only intended to be used with one person.

[0031] As can be seen for the drawing in FIG. 2, the tibial re-cutting guide 100 shown is a simple device, generally having a top element 101 spaced from and parallel to a bottom element 105. A spacer 1 10, such as post, maintains the relative positions of top element 101 and bottom element 105. The top element 101 includes a top element proximal side 102 and a top element distal side 103. The bottom element 105 includes a bottom element proximal side 106 and a bottom element distal side 107. The term proximal side is used herein to indicate the side of the re-cutting guide 100 that is closer to the operator/surgeon. The term distal side is used herein to indicate the side of the re-cutting guide 100 that is in contact with the tibia, be it the top element of the tibia or the side surface. FIG. 3 shows the re- cutting guide 100 coupled to a standard tibial alignment tool 150. The re-cutting guide 100 contacts a flat surface 160 of a cut tibia. As can be seen from this figure, the bottom element 105 interfaces with a cutting aperture 151 of the standard tibial alignment tool 150.

[0032] In the illustrated embodiment, both the top element 101 and the bottom element 105 are generally planar. The bottom element 105 extends from the spacer 1 10 a shorter distance than the top element 101. In use, this shorter distance allows the top element 101 to extend over the tibial plateau when the distal end 107 of the bottom element 105 is adjacent to the side surface of the patient's tibia, as shown in FIG. 3.

[0033] In the embodiment shown in FIG. 2, the top element 101 has a cut out 104 at its distal side 103. In other embodiments, the distal end of the top element has a straight edge. The top element 101 is rigid enough (due to, e.g., a combination of material, thickness and cross-sectional shape) to support the device while maintaining the parallel spacing between the top element and the bottom element. The thickness of the bottom element 105 should only be a few millimeters because in use, the bottom element 105 of the re-cutting guide 100 is intended to insert into a cutting aperture of the standard tibial alignment tool.

[0034] Staying with FIG. 2, the spacer 1 10 connects the top element 101 with the bottom element 105 at their proximal sides 102 and 106, respectively. In the illustrated embodiment, the spacer 1 10 attaches to both the top element 101 and the bottom element 105 at perpendicular angles. While the spacer 1 10 in the figures is largely cylindrical in form, it may also be other geometric shapes (e.g. cuboid, triangular prism, hexagonal prism, and so forth) that can support the top and bottom elements. The spacer 1 10 may be of a fixed height as shown in FIGS. 2-4, but an example of a variation of the re-cutting guide 100 having an adjustable spacer will be discussed below.

[0035] The re-cutting guide 100 also includes a first and second reference arms 120. Having two reference arms is preferable to re-cutting guides than only have one point of contact with the resected tibial plateau because the two points of contact offer a more accurate guide for having a resulting parallel, planar tibial resection. In this primary embodiment, the first and second reference arms 120 may be essentially identical in form. The first reference and the second reference arms 120 are disposed on opposite ends of the top element distal side 103. The first and the second reference arms 120 both extend downward from the top element 101 but never contact the bottom element 105 because the bottom element 105 is shorter than the top element 101. From the side view of the re-cutting guide 100 shown in FIGS. 2 and 4, the first and the second reference arms 120 have the same height of approximately between approximately one and two centimeters. In use, the first and the second reference arms 120 sit atop a cut tibial surface that need to be further resected. As can be seen from the side view of the re- cutting guide 100 in FIG. 4, the difference in distance from the free ends of the first and the second reference arms 120 and a plane extending from the top face of the bottom element 105 is a few millimeters (FIG. 4 shows a distance of approximately 3mm). In use, the distance between the free ends of the reference arms 120 and a plane extending from the top side of the bottom element 105 is the additional amount of bone to be removed from the tibia. In some examples, it is conceivable to have a set of re-cutting guides having different distances between the free ends of the reference arms and the plane extending from the top side of the bottom element. Having available re-cutting guides that measure different heights from the tibial plateau to a depth where a subsequent cut needs to be made would be useful for quick correction of the space between the femoral and tibial plateaus during the total knee replacement procedure. Distances may range from approximately one millimeter up to approximately 5 mm. While the first and the second reference arms 120 shown in FIGS. 2 and 4 are fixed in height, it is conceivable that the two reference arms may be adjustable in height. A re-cutting guide having adjustable reference arms will be discussed in more detail below.

[0036] The re-cutting guide 100 described herein provides a simple way to guide surgeons in removing additional layer or layers of tibia during a total knee replacement where the initial resection was not sufficient. The surgeon will first need to decide how much more of the tibia plateau need to be removed. Ideally, the surgeon will have at his or her disposal a set of re-cutting guides having different calibrated distances as alluded to in the previous paragraph. For example, re-cutting guides that define heights of 0.5 mm, 1mm, 2mm, 3mm, 4mm, 5mm and so forth. In use, a surgeon may decide to initially use a re-cutting guide having a 3 mm distance to guide in removing 3mm of the tibial plateau. He or she may then turn to a 1 mm re-cutting guide if fine tuning of the tibia plateau height is needed. Thus the re- cutting guides may be used in succession or in combination (when re-cutting guides having different distances are available) to achieve a perfect tibial length.

[0037] More specifically, a surgeon may first initially use the re-cutting guide 100 to decide how much more of the tibial plateau has to be removed. Once this amount has been determined, the re-cutting guide 100 may interface with a standard tibial alignment tool by, e.g., inserting the bottom element 105 of the re-cutting guide 100 through a cutting aperture of the standard tibial alignment tool. Once coupled, the surgeon may then place the bottom surfaces of the reference arms 120 of the re-cutting guide 100 on a flat tibia surface where the re-cutting tool 100 positions the cutting aperture of the standard tibia alignment tool with respect to the patient's tibia. The standard tibial alignment tool than can be securely coupled to the tibia. The re-cutting guide 100 is then removed and a cut can be made with a saw through the cutting aperture of the standard tibia alignment tool.

[0038] As suggested earlier, the re-cutting guide described herein may also be adjustable. Turning to FIGS. 5A and 5B, a variation of the re-cutting guide 100 is shown. First of all, the re-cutting guide 200 in FIGS. 5A and 5B may include an adjustable spacer 210. Having an adjustable spacer 210 allows the surgeon to more easily adjust the re-cutting guide 200 for deciding the thickness of tibia plateau to cut. Being able to adjust the distance between the reference arm ends and the bottom element provides a simpler way of achieving the correct thickness of tibial surface to remove. The spacer 210 may be adjusted in a number of ways. For example, the spacer 210 may come in two pieces where a top piece 211 fits over a bottom piece 212 and wherein the top and bottom pieces 21 1 and 212 are coupled through corresponding arrays of teeth that fit together and adjustable along the length of the spacer. Another potential mechanism for adjusting the height of the spacer may be where the top piece 21 1 and bottom piece 212 possess corresponding threads that allow the bottom piece 212 to thread into the top piece 21 1. By turning the bottom piece 212 one direction when the bottom piece 212 is coupled to the top piece 21 1 would decrease the overall height of the spacer 210, while turning the bottom piece 212 in the opposite direction when coupled with the top piece 21 1 would increase the overall height of spacer 210. Yet another method of adjusting the height of the spacer may be where the bottom piece can slide into top piece and a lock for maintaining the desired height of the overall spacer is determined. The lock may be any suitable lock or locking mechanism known in the art. The adjustable spacer may also include markings 213 to show the user the adjustment in distance to the spacer and the overall re-cutting guide. The markings may be in increments of millimeters, fractions of an inch, or other pre-defined amount. In some instances, each turn or click of the bottom piece with respect to the top piece may correspond to a pre-determined distance value (e.g. one turn or click may correspond to one millimeter).

[0039] In addition to the spacer being adjustable, the first and the second reference arms may also be adjustable. Having adjustable reference arms has several advantages. For one thing, being able to adjust the overall heights of the two reference arms can make adjusting the overall distance between the reference arm ends and the top surface of the bottom element easier. Adjustable reference arms also allow for a greater flexibility in determining where the tibia should be re-cut. For example, in some instances, the first resection of the tibia may not be even, meaning that the cut resulted in a tibial plateau that is tilted or slanted. In that instance, placing a re-cutting guide with reference arms having the same height would result in a secondary cut that was also be slanted. Being able to individually adjust the reference arms with respect to each other would correct the slant and result in providing a level guide for the saw to follow in performing the subsequent cut.

[0040] FIG. 5A further shows the first and the second reference arms in an adjustable configuration. The first reference arm 220 would include a top piece 221 and a bottom piece 222, and identically, the second reference arm 220 would include a top piece 221 and a bottom piece 222. Similar to the adjustable spacer 210, the first and the second reference arms 220 may include a top piece and a bottom piece where the top and bottom pieces fit together through an adjustable threading mechanism. The first and the second reference arms may also be adjustable through corresponding arrays of teeth disposed on the top and the bottom pieces of the reference arms that fit together and are able to extend and retract to adjust the height. In yet other examples, the top piece and the bottom piece of the reference arms may be adjustable by way of the bottom piece sliding within the top piece and locking the position of the bottom piece with respect to the top piece when a desired height is reached. Similarly also, markings 213 may be include on the first and the second reference arms 220 to help the surgeon or user keep track of the adjustments made. Similar to the markings described for the adjustable spacer, the markings 213 for the first and the second reference arms 220 may be in a millimeter scale, in one-eighth of an inch, in one- sixteenth of an inch, or any other suitable scale.

[0041] Turning to FIG. 5B, a variation on the adjustable reference arms is shown. Instead of having a top and a bottom piece that fit together and where the height is adjustable by inserting a portion of the lower piece of the reference arm into the top portion of the reference arm and thereby reducing the height, or by retracting a portion of the lower piece from the top piece thereby increasing the overall height of the reference arm, here, both reference arms include a series of stackable tabs 225. The stackable tabs 225 may have known thicknesses such as one or two millimeters each or one-sixteenth of an inch or one eighth of an inch thickness for each stackable tab. A surgeon may add or take away the removable tabs to adjust the heights of each of the reference arms to the same degree or to different heights based on the situation. For this particular adjustment configuration, it may also be useful to have a tool for releasing the stackable tabs 225 from each other. In one example, each tab may include an indentation where a tool may be inserted to pry the stackable tab 225 from one another.

[0042] In yet other examples of adjustable reference arms, the reference arms distal ends may also be set to a known tilt angle in instances where the subsequent cut needs to provide an angle correction to an initial tibial resection, where the initial resection was not truly planar. In this case, to match the angle of the distal ends of the reference arms, the spacer may also be configured to include a tilt of a particular angle. A tilt may be introduced into the spacer by having a spacer that comes apart (e.g. into two pieces) and where an angled piece, of known tilt angle, may be inserted such that the angle is then translated into the re-coupled spacer pieces and then to the bottom element. The result would be a tilted plane defined by the distal ends of the reference arms and the tilted bottom element.

[0043] The re-cutting guides aligning a standard tibia alignment guide may also include a level. As alluded to earlier, in certain instances, the initial resection of the tibia may not have been even. A tilt in any direction in the tibial plateau may result in the tilt being translated to the other components of the knee replacement (e.g. between the tibial implant and the joint liner, between the joint liner, the patellar implant and the femoral implant, and so forth). A tilt in the tibial implant can also easily translate to uneven pressure or wear to the other components of the knee replacement. For example, looking back at FIGS. 1A and IB, if the final tibial plateau is uneven, that would translate to the joint liner also being uneven. Then, depending upon the amount of tilt the joint liner experiences, the piece protruding from the joint liner may not pivot properly within the femoral implant cavity, possibly resulting in blocked range of motion or uneven wearing of the joint liner, the femoral implant, or both. Thus, the re-cutting guides described here may further include a level 130 (such as a standard bubble level) as shown in FIG. 6. While FIG. 6 only shows a level for one axis, it is conceivable to more than one level or a multi-axes level to ensure that the entire surface is even.

[0044] An adjustable generic re-cutting guide is used in largely the same manner as the fixed generic re-cutting guide. A surgeon may first determine the amount of the tibia surface that needs to be removed through use of the re-cutting guide. After determining the additional amount of the tibial end that needs to be removed, the surgeon may first adjust the spacer and the first and the second reference arms. With the aid of the level or levels, the surgeon may determine how best to adjust the spacer and reference arms to guide the standard tibia alignment tool in making an even cut that reduces the tibia by the necessary level. Upon arriving at the desired adjustments for the re-cutting guide, the surgeon may then couple the re-cutting guide with the standard tibia alignment tool by inserting the bottom element of the re-cutting guide into the cutting aperture of the standard tibia alignment tool. The surgeon can now place reference arms of the re-cutting guide against the tibial plateau and fasten the standard tibia alignment tool to the tibia. Once the standard tibia alignment tool is secured to the tibia, the surgeon can now remove the re- cutting guide and perform the cut through the cutting aperture.

[0045] Finally, the generic re-cutting guide described herein can be formed from various suitable materials. Suitable materials may include plastics and other hard, synthetic polymers. Other suitable materials may be metals, metal alloys, or even wood.

[0046] When a feature or element is herein referred to as being "on" another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0047] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as "/".

[0048] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0049] Although the terms "first" and "second" may be used herein to describe various

features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.

[0050] Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising" means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0051] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or

"approximately," even if the term does not expressly appear. The phrase "about" or "approximately" may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/- 0.1 % of the stated value (or range of values), +/- 1 % of the stated value (or range of values), +/- 2% of the stated value (or range of values), +/- 5% of the stated value (or range of values), +/- 10% of the stated value (or range of values), etc. Any numerical range recited herein is intended to include all sub-ranges subsumed therein.

[0052] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

[0053] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term "invention" merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

CLAIMS What is claimed is:

1. A re-cutting guide for use in resecting a tibia of a patient, the tibia having a flat surface from an initial tibial resection, the re-cutting guide comprising:

a top element extending from a spacer, the top element extending a first distance from the spacer to a top element distal end;

a bottom element extending from the spacer in a position parallel to and spaced from the top element, the bottom element extending from the spacer to a bottom element distal end a second distance less than the first distance; and

two reference arms each extending down from the top element from positions a distance from the spacer greater than the second distance.

2. The re-cutting guide of claim 1 , wherein a distance between free distal ends of the two reference arms and a top surface of the bottom element defines a thickness for resecting.

3. The re-cutting guide of claim 1 , wherein the bottom element has a size and shape adapted to be inserted through an aperture of a standard tibial alignment tool,

4. The re-cutting guide of claim 1 , wherein the spacer is fixed in height.

5. The re-cutting guide of claim 1, wherein the spacer is adjustable in height.

6. The re-cutting guide of claim 5, wherein the spacer further includes markings for determining the amount of adjustment made to the spacer.

7. The re-cutting guide of claim 5, wherein the spacer is adjustable in increments of one millimeter.

8. The re-cutting guide of claim 5, wherein the spacer is adjustable in one-sixteenth inch increments.

9. The re-cutting guide of claim 1 , wherein the at least two reference arms are fixed in height relative to each other.

10. The re-cutting guide of claim 1 , wherein the at least two reference arms are adjustable in height with respect to each other.

1 1. The re-cutting guide of claim 10, wherein the at least two reference arms each include markings for determining the amount of adjustment the at least two reference arms.

12. The re-cutting guide of claim 10, wherein the at least two reference arms are adjustable in increments of one millimeter.

13. The re-cutting guide of claim 10, wherein the at least two reference arms are adjustable in one- sixteenth inch increments.

14. The re-cutting guide of claim 1 further comprising a level.

15. A kit comprising a plurality of re-cutting guides as recited in any of claims 1-4 and 9, wherein the plurality of re-cutting guides each having fixed but different distances between a distal end of the at least two reference arms and a top face of the bottom element.

16. A re-cutting guide for use in resecting a tibia of a patient, the tibia having a flat surface from an initial tibial resection, the re-cutting guide comprising:

a top element extending from an adjustable spacer, the top element extending a first distance from the spacer to a top element distal end;

a bottom element extending from the spacer in a position parallel to and spaced from the top element, the bottom element extending from the spacer to a bottom element distal end a second distance less than the first distance;

a first adjustable reference arm extending perpendicularly from a first location underneath the top element distal side towards the bottom element; and

a second adjustable reference arm positioned opposite from the first adjustable reference arm underneath the top element distal side and extending perpendicularly towards the bottom element.

17. The re-cutting guide of claim 16, wherein the adjustable spacer is adjustable by millimeter increments.

18. The re-cutting guide of claim 16, wherein the adjustable spacer further comprising markings to show the amount of adjustment made to the adjustable spacer.

19. The re-cutting guide of claim 16, wherein the first adjustable reference arm and the second adjustable reference arm are adjustable by millimeter increments.

20. The re-cutting guide of claim 16, wherein the first adjustable reference arm and the second adjustable reference arm further comprising a first and a second visual guide for determining the amount of adjustment made to either the first adjustable reference arm or the second adjustable reference arm.

21. The re-cutting guide of claim 16 further comprising a level disposed on the top element.

22. The re-cutting guide of claim 16, wherein the bottom element is configured to couple with a standard tibial alignment tool and align the standard tibial alignment tool for performing a re-cut of the initial tibial re-section.

23. A method of guiding resection of a tibia of a patient, the tibia having a flat surface from an initial tibial resection, the method comprising: determining an additional amount of bone to remove after the initial tibial resection;

inserting a bottom element of a re-cutting guide through a standard cutting tool guide cutting aperture;

placing first and second reference arms of the re-cutting guide on the flat surface of the initial tibial resection, the references arms extending downward from a top element, the top element being spaced from and parallel to a bottom element;

coupling the standard cutting tool guide to the patient's tibia;

removing the re-cutting guide such that only the standard cutting tool guide is coupled to the patient's tibia; and

performing the re-cut of the tibial re-section through the standard cutting tool guide's cutting aperture.

24. The method of claim 23, further comprising using the re-cutting guide a second or third time to make additional cuts of the tibial resection.

25. The method of claim 23, further comprising using the re-cutting guide to incrementally remove portions from the patient's tibia.

26. The method of claim 23, further comprising adjusting a height of a reference arm.

27. The method of claim 23, further comprising adjusting a distance between the top element and the bottom element.