Medical device

Abstract

and a femoral reference instrument having a first complementary femoral engaging member and configured to engage the first complementary femoral engaging member, wherein the assembly has an engaged configuration when the first femoral engaging member is engaged with the first complementary femoral engaging member and a disengaged configuration when the first femoral engaging member is not engaged with the first complementary femoral engaging member.

Description

Technical Field

[0001] (Reference to Related Applications) This application claims priority to U.S. Patent Application No. 17 / 455,945, filed Nov. 22, 2021, which is incorporated by reference, and which claims priority to U.S. Provisional Patent Application No. 63 / 248,059, filed Sep. 24, 2021, and U.S. Provisional Patent Application No. 63 / 122,115, filed Dec. 7, 2020, each of which is incorporated by reference.

[0002] The present disclosure generally relates to the field of knee arthroplasty, and more specifically to a kinematic alignment tibial guide delivery instrument and method configured to accurately position components of an internal prosthesis knee implant.

Background Art

[0003] Total knee arthroplasty is a procedure in which an orthopedic surgeon replaces a diseased portion of the knee joint with an artificial internal prosthesis implant intended to restore joint function and reduce pain. The procedure itself generally consists of the surgeon making a vertical midline anterior incision over the bent knee (i.e., the knee in a flexed state). The surgeon then continues to incise the tissue to access the joint capsule. After the joint capsule is perforated, the patella is moved out of the way, and the distal condyles of the femur, the cartilaginous menisci, and the proximal tibial plateau are exposed.

[0004] Next, the surgeon removes the cartilaginous meniscus and uses measuring instruments to independently measure and excise the distal femur and proximal tibia to accommodate the internal prosthesis knee implant. The excision itself often involves removing areas of diseased bone and modifying the bone shape to better accommodate the complementary shapes of the respective implant components. That is, the excised distal femur will ultimately fit into a complementary femoral implant component, and the excised proximal tibia will ultimately support a complementary tibial implant component. The surgeon selects from different sized implant components to match the size of the patient's bone.

[0005] There are several concepts regarding the angles at which the distal femur and proximal tibia should be excised. The excision angle can substantially determine how the implant components will be positioned within the joint and can affect how the artificial joint will function over time.

[0006] One such concept is the kinematic alignment principle. Using kinematic alignment, the surgeon attempts to restore the patient's pre - diseased natural joint line based on data available to the surgeon both pre - operatively and intra - operatively.

[0007] It is not surprising that surgical approaches can vary even among surgeons practicing kinematic alignment techniques. Some surgeons prefer to use calipers or other measuring instruments to independently measure the dimensions of the distal femur and proximal tibia relative to each other. This approach generally provides the greatest amount of autonomy and thus allows for the greatest amount of subjectivity and variability in the placement of the excision plane (and ultimately, the placement of the implant components). Therefore, this independently referenced approach can result in a large amount of trial and error. Summary of the Invention Problems to be Solved by the Invention

[0008] Accordingly, this technique generally lengthens the time during which a patient is under general anesthesia. This technique also increases the risk that the final placement of the joint line will not align precisely with the natural joint line prior to affliction. In extreme cases, the misalignment can foster supplementary or corrective procedures that otherwise would have been avoidable. Even when finally placing the joint line completely, the amount of time necessary to calculate, resect, install, and test a kinematically aligned joint lengthens the time the surgical area is exposed. Surgeons typically make every effort to maintain a sterile surgical environment, but nonetheless, a lengthy procedure can increase the risk of infection, prolong blood loss, and cause more damage to surrounding tissue.

[0009] Other surgeons can use tools such as those disclosed in U.S. Patent Application Publication No. 2019 / 0231365 to improve accuracy and reduce surgical time. While an improvement, these tools preserve elements of subjectivity and risks associated with subjectivity. Setting up the tools and properly adjusting them also adds additional steps to the procedure. Overall, these additional steps can affect the number of patients a surgeon can see in a day. Instruments with several moving parts can also increase the time necessary to sterilize the instrument between procedures.

[0010] Accordingly, there is a need to overcome the drawbacks of the prior art, which have long been felt but remain unresolved. The instruments, assemblies, kits, systems, and methods disclosed herein are intended to be used to overcome the drawbacks of the prior art.

[0011] Problems with inaccurate placement of resection surfaces in knee replacement surgery and increased procedure time associated with techniques that rely heavily on subjective placement of resection surfaces are addressed by a distal reference linkage drill guide assembly comprising a femur portion configured to engage a first femur engagement member, a tibia portion configured to engage a first tibia engagement member, and a body connecting the femur portion to the tibia portion, and a femur reference instrument having a first complementary femur engagement member configured to engage the first femur engagement member, wherein the distal reference linkage drill guide assembly has an engagement configuration and a disengagement configuration, the engagement configuration including a first femur engagement member engaging a first complementary engagement member, and the disengagement configuration including a first femur engagement member not engaging the first complementary femur engagement member.

[0012] The exemplary embodiments described herein are intended to be able to provide improved kinematic knee devices and methods.

[0013] It is further contemplated that the exemplary embodiments described herein can provide a distal reference option for transmitting alignment to a tibial resection guide.

[0014] The above object can be achieved by providing a kinematic alignment tibial guide transmission device and method having the features described herein.

[0015] The above and other objects, features, aspects, and advantages of the present invention will become more apparent from the following detailed description of the present invention when considered in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0016] The above will become apparent from the following more specific description, as shown in the accompanying drawings, of exemplary embodiments of the present disclosure. The drawings are not necessarily to scale, and instead emphasis is placed on showing the disclosed embodiments.

[0017] Figures 1-10 generally depict method steps, as well as exemplary devices and assemblies, that may involve the use of a femoral trial including a complimentary femoral engagement member.

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[0018] Figs. 11 - 15 generally show method steps, exemplary devices, and assemblies, including another embodiment of an exemplary connecting drill guide, which may involve the use of a distal reference guide having complementary femoral engagement members.

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[0019] Figures 16 - 28 generally include other embodiments of the exemplary connecting drill guide and depict method steps as well as exemplary devices and assemblies that may involve the use of a distal femoral resection guide.

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DETAILED DESCRIPTION OF THE INVENTION

[0020] The following detailed description of the preferred embodiments is presented for illustrative purposes only to aid understanding and is not intended to be exhaustive or to limit the scope and spirit of the invention. The embodiments are selected and described to best explain the principles of the invention and its practical applications. Those skilled in the art will recognize that many variations can be made to the invention disclosed herein without departing from the scope and spirit of the invention.

[0021] Unless otherwise specified, like reference numerals indicate corresponding parts throughout the several figures. The drawings represent embodiments of various features and components according to the present disclosure, but the drawings are not necessarily to scale and certain features may be exaggerated to better illustrate embodiments of the present disclosure, and such illustrations should not be construed as limiting the scope of the present disclosure.

[0022] Except as otherwise expressly stated herein, the following rules of interpretation apply to this specification: (a) All terms used in this specification shall be construed to be of such gender or number (singular or plural) as may be required in such context. (b) The singular terms "a", "an", and "the" as used in this specification and the appended claims shall include plural references unless the context clearly indicates otherwise. (c) The antecedent "about" as applied to a recited range or value indicates an approximation having a deviation from the range or value known or expected in the art from measurement. (d) Unless otherwise specified, the words "herein", "hereby", "hereto", "hereinbefore", "hereinafter", and words of similar import refer to the entire specification and not to any particular paragraph, claim, or other subdivision. (e) Headings are for convenience only and do not control or affect the meaning of any part of this specification. (f) "Or" and "any" are not exclusive, and "include", "including" are not limiting. Further, "comprising", "having", "including", and "containing" should be construed as terms of inclusion (i.e., meaning "including but not limited to").

[0023] References in this specification to "one embodiment", "an exemplary embodiment", etc., indicate that the described embodiment may include a particular feature, structure, or characteristic, but not that every embodiment necessarily includes the particular feature, structure, or characteristic. Further, such phrases do not necessarily refer to the same embodiment. Moreover, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is contemplated that it may affect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described, within the knowledge of one of ordinary skill in the art.

[0024] To the extent necessary to provide descriptive support, the subject matter and / or text of the appended claims are hereby incorporated by reference in their entirety into this specification.

[0025] The recitation of a range of values herein is merely intended to serve as a shorthand method of referring individually to each separate value that falls within the range, unless otherwise expressly indicated herein. Each separate value within the recited range is incorporated herein or in the claims as if it were individually recited herein. When specific ranges of values are provided, each intervening value, to the tenth of the unit of the lower limit between the upper and lower limits of that range, and any other recited value or intervening value within the recited range of the subrange, is understood to be included herein unless the context clearly dictates otherwise. All subranges are also included. The upper and lower limits of these smaller ranges are also included, subject to any specific and expressly excluded limitations within the recited range.

[0026] Note that some of the terms used herein are relative terms. For example, the terms "upper" and "lower" are spatially relative to each other, i.e., an upper component is positioned higher than a lower component in each orientation, but these terms can change if the orientation is reversed. The terms "inlet" and "outlet" are with respect to a fluid flowing through a given structure, e.g., the fluid flows into the structure through the inlet and then out of the structure through the outlet. The terms "upstream" and "downstream" are with respect to the direction in which the fluid flows through various components before flowing through a downstream component.

[0027] The terms "horizontal" and "vertical" are used to indicate absolute reference, i.e., the direction with respect to the ground level. However, these terms should not be construed as requiring structures that are absolutely parallel or absolutely perpendicular to each other. For example, a first vertical structure and a second vertical structure are not necessarily parallel to each other. The terms "upper" and "lower" or "base" are used to indicate that the upper part refers to a place or surface that is always higher than the lower part or the base with respect to an absolute reference, i.e., the surface of the earth. The terms "upward" and "downward" are also with respect to an absolute reference. An upward flow always opposes the gravity of the earth.

[0028] There are many reasons why a patient may undergo total knee arthroplasty ("TKA"). Such reasons may include trauma, progression of bone degenerative diseases, and excessive wear due to time and strenuous use. Common bone degenerative diseases include rheumatoid arthritis and osteoarthritis.

[0029] In primary TKA (i.e., TKA in which a surgeon operates on a knee joint that has not been surgically treated before), the surgeon generally makes a vertical midline incision on the anterior side of the knee to be operated on. The incision is generally made at or below the tibial tuberosity with the knee in a flexed state and may extend several inches above the patella. The surgeon then continues to incise the adipose tissue to expose the anterior surface of the joint capsule. A medial parapatellar arthrotomy may be performed to pierce the joint capsule and excise the medial patellar retinaculum. Then, a retractor is generally used to move the patella laterally to expose the cartilaginous meniscus resting on the distal femoral condyle and the proximal tibial plateau. The surgeon then removes the meniscus and uses measuring instruments to measure and excise the distal femur and proximal tibia. The excised distal femur and the excised proximal tibia will ultimately accommodate an internal prosthesis knee implant.

[0030] The types of measurement and resection instruments used can be influenced by a surgeon's preference for a particular joint alignment philosophy. These joint alignment philosophies can potentially affect the design of available knee implants and their related instruments. The three main knee joint alignment principles are known as anatomical alignment, mechanical alignment, and kinematic alignment, respectively.

[0031] The oldest alignment philosophy is the anatomical alignment principle. In anatomical alignment, the surgeon attempts to resect the tibia with 3 degrees of varus, regardless of the orientation of the patient's pre - morbid actual joint line. Femoral resection and ligament release are also performed to maintain the straight hip - knee - ankle axis of the limb. Releasing the anterior cruciate ligament (ACL) to accommodate the implant can result in a sense of weakness in the patient, as will be further explained below. Additionally, the implant technology at the time was not yet prepared to address the effects of a 3 - degree varus resection of the tibia. For example, the varus angle created shear forces between the tibial implant, the meniscal insert, and the femoral implant, contributing to implant failure.

[0032] The resection angle of the distal femur essentially sets the angle of the axis of the prosthesis. Anatomical alignment does not allow for the resection angle to vary ambiguously. This can result in a resection angle that is not aligned with the patient's pre - morbid joint's native angle. As a result, anatomical alignment can lead to patient discomfort, weakening of the surrounding soft tissues (e.g., ligaments and muscles), and early wear of the prosthesis.

[0033] In mechanical alignment, the surgeon excises the tibia perpendicular to the mechanical axis of the tibia. The mechanical axis of the tibia generally refers to an axis extending from the center of rotation of the proximal head of the associated femur, through the center of the knee, to the center of the ankle. A perpendicular resection of the proximal surface of the tibia with respect to the mechanical axis results in a resection that is in the same plane as the cross-section placed in the resection area. Many tibial prostheses designed for mechanical alignment are positioned on the resected tibial plateau and have an articular surface configured to place a new joint line parallel to the cross-section of the resection. That is, the reconfigured joint line is also perpendicular to the mechanical axis. Approaching the same concept from a different perspective, the mechanically reconstructed joint line can generally be visualized as being parallel to a flat floor when the knee is in an extended position and the patient is standing. In contrast, the position of the natural joint line varies from person to person, but on average, the natural joint line has a slight varus inclination with respect to the cross-section of the patient's body.

[0034] Mechanical alignment techniques can provide good stability when the patient's leg is in an extended position (e.g., when the patient is standing), and sometimes this technique is required due to trauma or severe disease progression. However, implants commonly used with mechanical alignment often require release of the ACL. In certain situations, the posterior cruciate ligament (PCL) can also be released. The ACL normally prevents the tibia from sliding excessively forward and rotating excessively with respect to the femur. The absence of any of these ligaments can result in a sense of vulnerability when the leg is in a flexed position. Furthermore, changing the position of the patient's natural joint line can cause discomfort. Patients who change their walking to accommodate the new joint line can chronically stress the remaining muscles, which can further exacerbate the discomfort and potentially contribute to additional musculoskeletal problems in the future.

[0035] The resection of the ACL also encourages the use of the "gap balance" technique in which the surgeon applies counterforces to the tibia and femur using a distractor, while applying symmetric tension to the remaining collateral ligaments and setting the distal cut surface of the femur parallel to the proximal cut surface of the tibia. The remaining collateral ligaments are typically the lateral collateral ligament ("LCL") that connects the femur to the outer fibula, and the medial collateral ligament ("MCL") that connects the femur to the inner tibia. By setting the distal cut surface of the femur parallel to the resected tibial plateau while evenly balancing the stretching force on the remaining collateral ligaments, it is considered possible to easily insert a prosthesis into the gap disposed between the femur and the tibia. The forces of the knee in the flexed and extended states are evenly distributed through the prosthesis, thereby making it possible to avoid uneven wear and other complications.

[0036] However, after the distal femur cut is made, the pre-profile of the gap is generally trapezoidal. Surgeons are generally taught to form a rectangular gap to accommodate the internal prosthesis implant. To do this, the surgeon generally releases the MCL if the knee is a varus knee and the LCL if the knee is a valgus knee. Valgus knees exist in a small number of patients. The release of these ligaments creates scar tissue when the reattached ligaments begin to heal after a successful surgery. The healed ligaments are often subject to contracture as a result of scarring. Ligament release also exposes the tissue to trauma, creating a cause for further bleeding and generally lengthening the patient's recovery time.

[0037] The latest alignment concept is the kinematic alignment principle. The kinematic alignment principle recognizes that the physiology of all patients is slightly different and aims to restore the natural joint line of the patient before the onset of the disease by performing actual measurements of surgical physiology and confirming the position of the natural joint line. There is nothing that excludes the use of the devices of the present invention in mechanical alignment or anatomical alignment, but the inventors recognized the drawbacks of mechanical alignment and anatomical alignment and invented a device that is also compatible with kinematic alignment.

[0038] There are various methods for performing kinematic alignment techniques, all of which start by referring to the distal condyle of the femur. Most methods involve an assessment of the thickness of the articular cartilage on the distal surface of the femoral condyles. The surgeon may use calipers, such as a cartilage thickness gauge as disclosed in U.S. Patent Application Publication No. 2019 / 0231365, or other instruments to measure the amount of cartilage wear. The position of the pre-onset native joint line is approximately set by the interaction between the soft tissue (e.g., articular cartilage) on the femoral condyles and the tibial plateau supported by the underlying bone (e.g., the neck bone). In the absence of bone loss, knowing the pre-disease cartilage thickness ultimately enables the measurement of the pre-disease joint line. For example, if the surgeon measures 2 millimeters ("mm") of wear on the medial condyle and no wear on the lateral condyle, and the surgeon plans to use a 10 mm internal artificial implant, the surgeon can set a femoral resection guide on the anterior surface of the femur for the purpose of performing a distal cut of the distal surface of the femoral condyles. The femoral resection guide can be angled to remove 10 mm of the distal surface of the lateral condyle and 8 mm of the distal surface of the medial condyle. Thus, adding the 2 mm of cartilage loss measured in the 8 mm resection of the medial condyle results in accommodating a 10 mm implant medially. Similarly, the 10 mm resection of the lateral condyle results in accommodating a 10 mm implant laterally.

[0039] Next, the surgeon determines the size of the implant using a sizing guide or sizing caliper. The surgical kit typically includes several implant size options to accommodate variations in the patient population. Once the sizing guide is used to inform the surgeon of the appropriate implant size, the surgeon removes the sizing guide and places the 4-in-1 cutting block on the resected distal surface of the femur. The 4-in-1 cutting block has saw slots that allow the surgeon to perform a front cut, a back cut, and two chamfer cuts (see Figure 1).

[0040] Next, a femoral implant trial (see Figure 15a) is placed on the resected distal end 12 of the femur 10. The femoral implant trial 15a desirably matches the sizing dimensions of the internal prosthesis implant that will be installed later. Next, a distraction device or traction device (e.g., a gap spacer (see 25a in Figure 4)) is inserted into the joint gap 3 (Figure 3A) to measure the inner and outer dimensions of the joint gap 3.

[0041] To determine the amount of proximal tibia resection, the measured dimensions of the inner and outer surfaces of the joint gap are subtracted from the desired thickness of the resection. For example, if the surgeon plans to use a 10 mm tibial implant, the inner gap is 3 mm, and the outer gap is 1 mm, the surgeon will orient the tibia resection guide to resect 7 mm on the inner side of the tibial plateau and 9 mm on the outer side of the tibial plateau. In kinematic alignment techniques, it will be appreciated that release of the MCL or LCL is typically not required. If the distal cut surface is not initially parallel to the proximal tibia cut surface, the surgeon will typically re-cut the tibia until the surgeon achieves the desired rectangular joint gap.

[0042] Adjusting the position of a tibial resection guide based on measurements of an extension device or a traction device generates a resection angle calculated based on a patient's specific anatomical structure. Based on these measurements, the tibial resection guide is typically oriented at a varus angle with respect to the cross-section, but in some patients, this angle may be valgus or close to 0°. Due to the shape of the femoral component of the meniscal insert and the internal prosthesis implant assembly, the reconstructed joint line is substantially parallel to the plane of the tibial resection. Replicating the natural joint line before disease is an important step in restoring the balanced natural movement of the knee. A kinematically balanced knee avoids problems of mechanical and anatomical thinking.

[0043] Disclosed herein are instruments, assemblies, kits, systems, and methods that can be configured for use in a primary total knee arthroplasty ("TKA").

[0044] Linking drill guide techniques with engaging femoral trials Figures 1-10 generally illustrate method steps, exemplary devices, and assemblies that may involve the use of a femoral trial including an exemplary linking drill guide 30 and having a first complementary femoral engaging member 13 and a second complementary femoral engaging member 13z.

[0045] FIG. 1 is a perspective view depicting the resected distal end 12 of the femur 10. As shown in FIG. 1, the femur 10 is prepared using a preferred resection technique. The distal cut, anterior / posterior cut, and chamfer cut are made to form a distal resection surface 5, a posterior resection surface 6, an anterior resection surface 2, and chamfer resection surfaces 8a, 8b, respectively (see also FIG. 7B). The chamfer resection surfaces 8a, 8b include an anterior chamfer resection surface 8a and a posterior chamfer resection surface 8b. A 4-in-1 cutting block may desirably be used to create the posterior resection surface 6, the anterior resection surface 2, and the chamfer resection surfaces 8a, 8b, but it will be understood that other instruments may be used instead of, or in addition to, the 4-in-1 cutting block, depending on the preference of the surgeon. A femur reference instrument 15 is provided. The depicted femur reference instrument 15 is a femur trial 15a having a first complementary femur engaging member 13 and a second complementary femur engaging member 13z in the form of a femur reference hole 13a. A trial implant such as the depicted femur trial 15a is a test internal prosthesis that generally has the same functional dimensions as the actual internal prosthesis, but the trial implant is designed to be temporarily installed and easily removed for the purpose of evaluating the fit of the actual internal prosthesis and for the purpose of evaluating the kinematics of the knee joint. The surgeon generally removes the trial implant and installs the actual implant when satisfied with the sizing of the trial implant and the kinematics of the knee joint.

[0046] In other exemplary embodiments, the femur reference instrument 15 can be the distal reference guide 15b (FIG. 12A), the femur distal resection guide 15c (FIG. 16), the pin 15d (FIG. 17A), or any other instrument that is placed on the distal end 12 or, preferably, is closely associated with the distal end 12 of the surgically resected surface 5 of the femur 10. These instruments can be used directly or indirectly to confirm the position of the resected distal surface of the femur 10 relative to the proximal surface of the tibia 20 of the femur 10 being operated on. When these instruments are used with the exemplary distal reference linkage drill guide assembly 1, in the engaged configuration, information regarding the orientation of the distal resection surface 5 of the femur is mechanically transmitted directly or indirectly to the tibia 20. Stated another way, when the exemplary distal reference linkage drill guide assembly 1 is in the engaged configuration, the femur reference instrument 15 can be used to mechanically transmit information regarding the orientation of the distal resection surface 5 of the femur directly (or indirectly through an intermediate instrument such as the pivotal neck resection guide 40) to the tibia 20.

[0047] As shown in FIG. 2, each of the femur reference holes 13a (i.e., the exemplary first complementary femur engagement member 13 and the second complementary femur engagement member 13z) receives a femur connecting pin 17. The distal ends of these femur connecting pins 17 (see the distal end 11 of the flared fixing pin 34 in FIG. 9) are then placed into the distal portion of the resected femur 10. In the described embodiment, the femur connecting pins 17 function as the first femur engagement element 19 and the second femur engagement element 19z.

[0048] The femoral linking pin 17 may be a common pin, headless nail, drill bit, post, or other connectable fastener that is compatible with standard pin slots of related instruments such as the distal femur resection guide 15c (FIG. 16), the pivotable tibia resection guide 40 (FIG. 7A), the linking drill guide 30, other drill guides, and other surgical instruments. It will be understood that in other exemplary embodiments, the femoral linking pin 17 may have visual or tactile indicators to reduce surgeon error. Visual indicators can include different colors and markings. Visual and tactile indicators can include raised or recessed portions of the femoral linking pin 17.

[0049] The exemplary embodiments of FIGS. 1-10 show the first complementary femoral engagement member 13 and the second complementary femoral engagement member 13z in the form of the femoral reference hole 13a, but it will be understood that other exemplary embodiments may include one complementary femoral engagement member 13. Still other exemplary embodiments may include three or more complementary femoral engagement members 13, 13z, etc. Complementary femoral engagement members 13 may take the form of holes, slots, recesses, protrusions, clamps, lips, magnets, spikes, or any other structure known in the art used to selectively (directly or indirectly) fixedly engage and disengage one component with another component, as well as any combination thereof. In a particular exemplary embodiment, the complementary femoral engagement member 13 may be present on the distal femur 10 itself, and it will be understood that the femoral engagement member 19 of the linking drill guide 30 may be configured to engage a complementary femoral engagement member 13 disposed directly on the distal femur 10. In such an exemplary embodiment, the complementary femoral engagement member 13 is likely to be a drilled hole disposed directly on the distal femur 10 created by a drill bit guided by a drill guide.

[0050] As shown in FIG. 2, the femur connecting pin 17 is screwed through the femur reference hole 13a of the femur trial 15a. In certain exemplary embodiments, the femur connecting pin 17 may be threaded. In such embodiments, the femur connecting pin 17 is desirably threaded at its tip (see FIG. 9) to fixedly engage the femur connecting pin 17 within the bone. The femur connecting pin 17 is retained in the femur trial 15a.

[0051] As shown in FIGS. 3A and 3B, an expansion device 49 in the form of a gap spacer 25 is inserted medially and laterally so as to fill the joint gap 3 defined by the region between the distal surface of the femur 10 and the proximal surface of the tibia 20. The gap spacer 25 can refer to any instrument that can be inserted into the space between the proximal surface of the tibia and the distal surface of the femur 10 and that is used to measure or otherwise evaluate the size of the joint gap 3 (i.e., the height of the medial and lateral joint gaps 3). In this way, such an expansion device is "configured to be placed" between the resected distal femur 10 and proximal tibia 20 to confirm the distance between the distal femur 10 and proximal tibia 20. It will be appreciated that the expansion device 49 can be placed within the joint gap 3 when the knee is in a flexed or extended position.

[0052] In the embodiment depicted in FIGS. 3A and 3B, the gap spacer 25 is a spoon gap spacer 25a. The measuring element 26 of the spoon gap spacer 25a is desirably curved so as to closely abut the curved surface of the femur trial 15a. It will be appreciated that a number of gap spacers 25 with measuring elements 26 of different dimensions are typically provided for the procedure. The measuring elements 26 of different sizes are typically provided in 1 mm height increments, although other increments are contemplated. FIG. 3B shows the measuring element 26 of the medial gap spacer 25 (i.e., the gap spacer 25 depicted on the left side of the image) which is thicker than the measuring element 26 of the adjacent lateral gap spacer 25 (i.e., the gap spacer 25a depicted on the right side of the image).

[0053] The spoon gap spacer 25a may be provided for the left and right feet. Different embodiments of the gap spacer 25 include the snap-on spacer 25b shown in FIG. 6A, trays or plugs of different dimensions configured to be inserted into the joint space 3, and spacers having removable measurement elements 26. In the present disclosure, there is no limitation on the types of gap spacers 25 that are compatible with the exemplary embodiments of the present disclosure.

[0054] Furthermore, it will be understood that the distraction device 49 can include other ligament tensioning devices such as the gap spacer 25, laminar spreader, ratchet tensioner, or gap balance device. In certain exemplary methods, a traction device may be used instead of or in addition to the distraction device. The distraction device is typically inserted into the surgical area of the knee to separate the distal femur 10 from the proximal tibia 20 in the joint space 3, while the tensioning device is typically placed outside the surgical area, for example, on the patient's ankle or on the patient's leg, pulling on the surgical leg, thereby providing traction to separate the distal femur 10 from the proximal tibia 20 in the joint space 3. It should be understood that the tensioning device can include a boot configured to enclose a portion of the patient's leg, ankle, or foot on the surgical leg, the hand of the surgeon or technician, or other device configured to apply a traction force to the surgical leg.

[0055] After distal femur resection, the surgeon will selectively insert different sized spoon gap spacers 25a inside and outside the joint gap 3 until the measuring end of the spoon gap spacer 25a provides a secure fit. Without being bound by theory, the use of an expansion device 49 (e.g., spoon gap spacer 25a), in combination with the use of the connecting drill guide 30, as further described below, can obviate the need for "gap balance" and release of either the MCL or LCL at the engagement position, thereby avoiding the risk of hematoma, unnecessary trauma to the ligaments, scarring, and increased healing time that would otherwise result from conventional mechanical alignment techniques. The expansion device 49 effectively sets the joint gap 3 to a desired distance, while the connecting drill guide 30 transmits information regarding the orientation of the distal femur resection to a tibial resection guide (which may be a pivoting tibial resection guide), enabling the surgeon to quickly perform a tibial resection that is preferably parallel to the distal femur resection. The distal femur resection and proximal tibial resection effectively define a "rectangle" into which an internal prosthesis implant will be inserted.

[0056] Previously, in mechanical alignment techniques, the MCL or LCL would have been released (i.e., cut) to define the "rectangle" into which an internal prosthesis implant would be inserted. In this way, it is contemplated that the connecting drill guide 30 can be used to avoid the need for "gap balance", release of the MCL or LCL, and associated scarring, hematoma, trauma, and increased healing time of conventional methods. These improvements can be particularly significant when an exemplary connecting drill guide 30 is used in mechanical alignment techniques.

[0057] It is contemplated that the exemplary embodiments described herein can be used in combination with mechanical alignment techniques, anatomical alignment techniques, kinematic alignment techniques, or any other techniques practiced by a qualified orthopedic surgeon.

[0058] FIG. 4 shows an exemplary distal reference linkage drill guide assembly 1 in an engaged configuration. The exemplary distal reference linkage drill guide assembly 1 generally comprises a femur reference instrument 15 and a linkage drill guide 30.

[0059] The exemplary linkage drill guide 30 has a femur portion 32 which is configured to engage a first femur engaging member 19. The first femur engaging member 19 is in turn configured to engage a first complementary femur engaging member 13 of the femur reference instrument 15. The depicted linkage drill guide 30 is further configured to engage a second femur engaging member 19z. The second femur engaging member 19z is configured to engage a second complementary femur engaging member 13z (FIG. 1) of the femur reference instrument 15. The linkage drill guide 30 may optionally be referred to as a “yoke”.

[0060] The femur portion 32 of the linkage drill guide 30 has a region defining a femur connection hole 22 (FIG. 5A), a femur connection hole 22z. The femur connection hole 22 is an exemplary structure that enables the femur portion 32 of the linkage drill guide 30 to engage the first femur engaging member 19. By having the femur connection hole 22 which can be disposed around a femur connection pin 17, the linkage drill guide 30 can be said to “indirectly engage” the femur reference instrument 15 via the first femur engaging member 19, which takes the form of a femur connection pin 17 in the depicted embodiment, and the first complementary femur engaging member 13, which takes the form of a first femur reference hole 13a (FIG. 1) in the depicted embodiment. In such an exemplary manner, the femur portion 32 can thereby be said to be “configured to engage the first femur engaging member 19”.

[0061] Similarly, the second femoral connection hole 22z is an exemplary structure that enables the femoral portion 32 to engage with the second femoral engagement member 19z. By having the second femoral connection hole 22z that can be disposed around the second femoral connection pin 17, the connection drill guide 30 can be said to "indirectly engage" with the femoral reference instrument 15 via the second femoral engagement member 19z (which takes the form of the femoral connection pin 17 in the depicted embodiment), and the second complementary femoral engagement member 13 (which takes the form of the second femoral reference hole 13z in the depicted embodiment). In such an exemplary manner, the femoral portion 32 can thereby be said to be "configured to engage with the second femoral engagement member 19z".

[0062] The femoral connection pin 17 and the femoral connection hole 22 are provided as examples of what the femoral portion 32 can be configured to engage with femoral engagement members 19, 19z, etc., but it will be understood that any mechanical engagement mechanism designed to selectively engage one component with another component is considered within the scope of the present disclosure. Further, the first and second femoral reference holes 13a receive the distal ends of the femoral connection pin 17 (e.g., femoral engagement members 19, 19z, etc.) and are thereby provided as examples of the first complementary femoral engagement member 13 and the second complementary femoral engagement member 13z that are "configured to engage" with the femoral engagement member, but it will be understood that any mechanical engagement mechanism designed to selectively engage one component with another component is considered within the scope of the present disclosure.

[0063] In other exemplary embodiments, it will also be appreciated that the first femoral engagement member 19 is an integral part of the connecting drill guide 30. For example, the first femoral engagement member 19 may be permanently engaged with the femoral portion 32 and may extend directly from the femoral portion 32 of the connecting drill guide 30 (see blade 19c in FIGS. 13A and 17B). In embodiments where the connecting drill guide 30 comprises a first femoral engagement member 19 that is permanently engaged with the femoral portion 32, such embodiments may likewise be said to be "configured to engage the first femoral engagement member 19". The same can be said for an exemplary connecting drill guide 30 that even includes a second or more permanently engaged femoral engagement members 19z, etc. A connecting drill guide 30 comprising permanently fixed femoral engagement members 19, 19z, etc. can further be said to "directly engage" the femoral reference instrument 15 via the first femoral engagement member 19 and the first complementary femoral engagement member 13.

[0064] Similarly, in embodiments where the connecting drill guide 30 comprises a second femoral engagement member 19z, such embodiments may likewise be said to be "configured to engage the second femoral engagement member 19". A connecting drill guide 30 comprising a second femoral engagement member 19z can further be said to "directly engage" the femoral reference instrument 15 via the second femoral engagement member 19z and the second complementary femoral engagement member 13z.

[0065] In the described embodiments, the first femoral engagement member 19 and the second femoral engagement member 19z are femoral connecting pins 17, 17z, and the first complementary femoral engagement member 13 and the second complementary femoral engagement member 13z of the distal femoral reference instrument 15 are femoral reference holes 13a.

[0066] In other exemplary embodiments, the first femoral engagement member 19 or the second femoral engagement member 19z can comprise a slot, a lip, a clamp, a hook, a protrusion, a recess, a spike, a magnet, an alignment pin 19b (FIG. 13B), a blade 19c (FIG. 17B), or any other structure known in the art used to selectively fixedly engage and disengage one component directly or indirectly with another component, as well as any combination thereof. In certain exemplary embodiments, the first femoral engagement member 19 or the second femoral engagement member 19z physically contacts the first complementary femoral engagement member 13 without an intermediate element. In such embodiments, the first femoral engagement member 19 or the second femoral engagement member 19z can be said to "directly engage" the first complementary femoral engagement member 13 or the second complementary femoral engagement member 13z. Similarly, if an intermediate element is present, the first femoral engagement member 19 or the second femoral engagement member 19z can be said to "indirectly engage" the first complementary femoral engagement member 13 or the second complementary femoral engagement member 13z.

[0067] The connecting drill guide 30 further includes a tibial portion 31. The tibial portion 31 has a region that defines two tibial reference holes 23. It will be understood that in certain exemplary embodiments, only one tibial reference hole 23 may be provided. In still other exemplary embodiments, three or more tibial reference holes 23, 23z may be provided. The body 36 connects the femoral portion 32 to the tibial portion 31. The substantially parallel arrangement of the body 36 of the connecting drill guide 30 and the reference marks (e.g., femoral connection holes 22, 22z and tibial reference holes 23, 23z) on each of the femoral portion 32 and the tibial portion 31 transmits information regarding the orientation of the distal resection plane (which is in the same plane as the distal resection plane 5) to the tibial portion 31 of the connecting drill guide 30. In certain exemplary embodiments, the body 36 may have a fixed length. A plurality of connecting drill guides 30 may be provided, each including a body 36 having a length different from that of another body 36 of another connecting drill guide 30 provided in the kit. In such exemplary embodiments, the surgeon can select one of the plurality of provided connecting drill guides 30 to transmit information regarding the distal resection plane 5 of the femur 10 to the tibial resection guide 40 (FIG. 7A) for the purpose of setting the plane of tibial resection. In a particular procedure, it is desirable for the plane of tibial resection to be parallel to the plane of distal resection.

[0068] In other exemplary embodiments, the body 36 can have an adjustable length dimension with respect to the femoral portion 32, with respect to the tibial portion 31, or with respect to both the femoral portion 32 and the tibial portion 31. In still other exemplary embodiments, the length of the femoral portion 32 or the tibial portion 31 can be adjustable with respect to the body 36. In any embodiment that includes adjustment of the length of the connecting drill guide 30, the adjustable component is preferably capable of being locked at the desired length. It is contemplated that a kit featuring such an adjustable-length connecting drill guide may include fewer connecting drill guides 30 than a kit that includes a plurality of connecting drill guides 30 having a plurality of different lengths.

[0069] In certain exemplary embodiments, the connecting drill guide 30 is provided as a single member. It is contemplated that a single member may be easier to sterilize between procedures and may prevent the risk of mechanical failure as compared to exemplary embodiments where the connecting drill guide 30 is not a single member but rather includes a plurality of components. The connecting drill guide 30 is preferably sized to be disposed anterior to the knee exposed to the surgical area. The exemplary connecting drill guide 30 described herein can reduce the overall instrumentation required to perform a TKA while enabling the surgeon to resect the proximal tibia more quickly than what can be safely achieved using existing instrumentation.

[0070] Similar to the femoral connecting holes 22, 22z provided in the femoral portion 32, the first tibial reference hole 23 of the tibial portion 31 enables the tibial portion 31 to engage with the first tibial engagement member 77 (FIG. 5A). The described embodiment includes a first tibial engagement member 77 and a second tibial engagement member 77z in the form of tibial connecting pins 27. By having the first tibial reference hole 23 that can be disposed around the tibial connecting pin 27, the connecting drill guide 30 can be said to be "configured to engage with the first tibial engagement member 77".

[0071] Similarly, the second tibial reference hole 23z is an exemplary structure that enables the tibial portion 31 to engage with the second tibial engagement member 17z. By having the second tibial reference hole 23z that can be disposed around the second tibial engagement member 77z, the tibial portion 31 can thereby be said to be "configured to engage with the second tibial engagement member 77z".

[0072] In the described embodiment, the first tibial engagement member 77 and the second tibial engagement member 77z are the tibial connecting pins 27, 27z.

[0073] In other exemplary embodiments, the first tibial engagement member 77 or the second tibial engagement member 77z can include slots, lips, clamps, hooks, protrusions, recesses, spikes, magnets, alignment pins, blades, or any other structure known in the art used to selectively fixedly engage and disengage one component directly or indirectly with another component, and any combination thereof. It will be understood that in certain exemplary embodiments, the first tibial engagement member 77 physically contacts the tibia 20 without an intermediate element. In such embodiments, the first tibial engagement member 77 can be said to "directly engage" the tibia 20. In certain exemplary embodiments, it is contemplated that an intermediate element can be disposed between the tibial portion 31 and the tibia 20. In such embodiments, the first tibial engagement member 77 and the second tibial engagement member 77z can engage an intermediate component, and the intermediate component itself can directly engage the tibia 20. In such embodiments, the first tibial engagement member 77 and the second tibial engagement member 77z can be said to "indirectly engage" the tibia 20.

[0074] The exemplary linkage drill guide 30 according to the present disclosure can be manufactured (or coated therewith) from any clinically proven biocompatible material, including a plastic polymer such as stainless steel, cobalt chromium alloy, or ultra-high molecular weight polyethylene ("UHWPE"). In certain exemplary embodiments, the linkage drill guide 30 can be a single-use disposable linkage drill guide. In other exemplary embodiments, the linkage drill guide 30 can be designed for use in multiple surgical procedures. Regardless of the embodiment, the exemplary linkage drill guide 30 is preferably sterilized prior to entering the surgical field.

[0075] As shown in FIG. 4, the connecting drill guide 30 can be slid on the femoral connecting pin 17 until the tibial portion 31 of the connecting drill guide 30 contacts the anterior tibial cortex 21 of the proximal tibia 20. The sliding of the femoral connecting hole 22 of the femoral portion 32 on the connecting pin 17 extending through the femoral reference hole 13a of the femoral trial 15a in the depicted embodiment defines the engagement configuration of the distal reference connecting drill guide assembly 1. Similarly, it will be understood that the distal reference connecting drill guide assembly 1 is in a disengaged configuration when the femoral engagement member 19 is not directly or indirectly engaged with the complementary femoral engagement member 13. For example, in the depicted embodiment, the distal reference connecting drill guide assembly 1 is in a disengaged configuration when the femoral connecting hole 22 of the femoral portion 32 is not disposed around the connecting pin 17.

[0076] Although the femoral connecting hole 22 is provided as an example, it will be understood that the femoral connecting hole 22 can take the form of a slot, recess, tube, protrusion, clamp, lip, magnet, spike, or any other structure known in the art used to selectively (directly or indirectly) fixedly engage and disengage one component with another component, as well as any combination thereof. It will also be understood that in embodiments where the femoral engagement members 19, 19z, etc. are integrally engaged with the connecting drill guide 30 (see, e.g., FIGS. 13B and 17B), there may be no femoral connecting hole 22.

[0077] An expansion device 49, such as the gap spacer 25, may be in a fixed position before sliding the connecting drill guide 30 on the femoral connecting pin 17, or the expansion device 49 may be disposed within the joint gap 3 after the connecting drill guide 30 has been slid on the femoral connecting pin 17.

[0078] As shown in FIGS. 5A and 5B, with the spoon gap spacer 25a in a fixed position, the tibial connecting pin 27 is disposed within each of the tibial reference holes 23, 23z of the connecting drill guide 30. In the depicted embodiment, the tibial reference holes 23, 23z are the tibial drill holes 23a. In other exemplary embodiments, the tibial reference hole 23 can take the form of a hole, slot, tube, recess, protrusion, clamp, lip, magnet, spike, or any other structure known in the art used to selectively (directly or indirectly) fixedly engage and disengage one component with another component, as well as any combination thereof. In embodiments where the tibial engagement member is integrally engaged with the connecting drill guide 30, it will be understood that the tibial reference holes 23, 23z may not exist. In certain exemplary embodiments, only one tibial reference hole 23 may be present. The tibial connecting pin 27 is fixed to the tibia 20. In certain exemplary embodiments, the tibial connecting pin 27 is threaded. In such an exemplary embodiment, it is desirable for the tibial connecting pin 27 to be threaded at the tip 11 in order to fixedly engage the tibial connecting pin 27 within the tibia 20 (see the tip 11 of the flared retaining pin 34 in FIG. 9 for reference).

[0079] Alternatively, as shown in FIGS. 6A and 6B, a snap-on spacer 25b can be used in place of the gap spoon 25a to fill the joint gap 3. It will be understood that the measuring element 26 of the snap-on spacer 25b can occupy substantially the same area as the snap-on spacer 25b itself. FIG. 6B provides an exemplary example of an inner snap-on spacer 25b1 that is thicker than the adjacent outer snap-on spacer 25b2 disposed therewith.

[0080] As shown in FIG. 7A, the connecting drill guide 30 is removed, and the femoral connecting pin 17 is placed at a fixed position within the femur 10 and the tibial connecting pin 27 is placed at a fixed position within the tibia 20. The receiving slot 87 of the pivotal tibial resection guide 40 is slidable over the tibial connecting pin 27. In the described embodiment, the receiving slot 87 extends generally front-to-back through the body 40a of the pivotal tibial resection guide 40. The receiving slot 87 is desirably sized to closely encompass the medial-lateral width of the tibial connecting pin 27, while having a generally vertical (i.e., up-and-down) length dimension that enables the pivotal tibial resection guide 40 to pivot around the tibial connecting pin 27, as further described below.

[0081] FIG. 30 is a front cross-sectional view of an exemplary pivotal tibial resection guide 40. The pivotal tibial resection guide 40 can include a pivotal tibial resection guide body 40a. The body 40a defines a generally linear resection slot 46 disposed above the pivot recess 78. The pivot assembly 55 can be dimensioned to rotate about an axis within the pivot recess 78. The pivot assembly 55 itself is preferably disposed above a lock mechanism recess 79 dimensioned to closely surround the lock mechanism 48. The body 40a further has a region defining a plurality of standard holes 33, a +2 mm standard pin hole 33, and a flared fixed pin receiving hole 35.

[0082] The described locking mechanism 48 includes a cam 73, a cam follower 74, a shaft 71 oriented substantially perpendicular to the pivot guide 66, and a spring 75 disposed between the cam follower 74 and the shaft 71. The pivot assembly 55 includes a pivot guide 66 and end screws 43 disposed at both ends of the pivot guide 66 to prevent the pivot guide 66 from sliding from the pivot tibial resection guide 40. The pivot guide 66 preferably has one or more complementary tibial engagement members 68 that can receive a tibial engagement member associated with the drill connection guide 30. The complementary tibial engagement members 68 may include a slot 68b sized to receive the connection tab 64 of the spike plate 67 (see the embodiment depicted in FIG. 20B) and tibial engagement holes 68a disposed adjacent to both outer sides of the slot 68b. However, in certain exemplary embodiments, one or more tibial engagement holes 68a may be provided instead of the slot 68b, and vice versa.

[0083] As shown in the side view of FIG. 7B, the tibial resection level is automatically set to accommodate the 10 mm tibial component (or construct) of an internal prosthesis assembly that can include a tibial trial base 93 (FIG. 29) and a meniscal trial insert 95 (FIG. 29). In embodiments, the connection drill guide 30 can be fabricated to allow other resection levels required or desired by the surgeon, such as by a plurality of connection drill guides 30, a plurality of pin holes on the connection drill guide 30, a plurality of connection holes on the pivot tibial resection guide 40, or an adjustable connection drill guide 30.

[0084] As shown in FIG. 8, the posterior tibial slope PS can be adjusted as needed to conform to the natural anatomical structure. The pivotable tibial resection guide 40 is configured such that the pivotable tibial resection guide 40 can be adjusted relative to the placement of the tibial connecting pin 27 within the tibia 20. The posterior tibial slope PS generally extends anteroposteriorly, medially, and laterally and can be envisioned as a plane passing through the resection slot 46. In FIG. 8, a side view of this plane is depicted as a line. The intersection of the posterior tibial slope PS with a transverse plane TP that extends generally horizontally through the tibia 20 defines the posterior slope angle θ. The placement of the transverse plane TP can be measured from any reference frame useful for defining the posterior slope angle θ. In the depicted embodiment, the transverse plane TP is disposed in the same plane as the tibial connecting pin 27 that extends into the tibia 20. In the side view of FIG. 8, the transverse plane TP is represented as a line. In an embodiment, the pivotable tibial resection guide 40 can be adjusted from approximately minus 3 degrees to approximately plus 10 degrees relative to the tibial connecting pin 27. Once the desired posterior tibial slope PS is reached, the pivotable tibial resection guide 40 can be locked in place using the lock mechanism 48 of the pivotable tibial resection guide 40.

[0085] As shown in FIG. 9, once the posterior slope PS is set to the desired posterior slope angle θ, the pivoting tibial resection guide 40 is pinned in place by inserting the pin 37 through the standard pinhole 33 and into the tibia 20. The described standard pinhole 33 includes a 10 mm pinhole that is positioned below and slightly offset from the +2 mm standard pinhole 33. The pin 37 extends through the standard pinhole 33 of FIG. 9. The +2 mm standard pinhole 33 can be used if the sizing guide indicates that the patient's anatomy will require a tibial construct larger than the standard 10 mm (i.e., the meniscal trial insert 95 and tibial trial base 93, see FIG. 29). However, in general practice, if the amount of tibial resection is insufficient to allow for a 10 mm tibial construct, the pivoting tibial resection guide 40 is more likely to be returned onto the pin 37 within the +2 mm standard pinhole 33. It will be understood that other exemplary pivoting tibial resection guides 40 may have more than four pinholes 33. All feasible increments between the standard pinholes 33 are considered to be within the scope of the present disclosure.

[0086] In FIG. 9, the tibial connecting pin 27 has been removed from the receiving slot 87 of the pivoting tibial resection guide 40. The pin 37 extends through the standard pinhole 33 and into the tibia 20, generally preventing further pivoting. Rather, these pins 37 can be used to fix the pivoting tibial resection guide 40 in the desired orientation. As shown, if desired, a flaring fixation pin 34 can be used to add stability. The tip 11 of the flaring fixation pin 34 extends into the anterior tibial cortex 21 of the proximal tibia 20.

[0087] As shown with reference to FIG. 9, other resection levels of the proximal tibia 20 can also be achieved using a plurality of standard pin holes 33 arranged at different resection levels. Sliding the standard pin holes 33 arranged at different heights of the pivotal tibial resection guide 40 across the resection level changes the position of the resection slot 46 upward and downward relative to the top of the tibial plateau, thereby enabling the surgeon to adjust the amount of resection to accommodate different sizes of internal prosthesis implant assemblies.

[0088] As shown in FIG. 10, the femoral trial 15a is removed and the proximal tibial resection is performed through the resection slot 46 of the pivotal tibial resection guide 40. The surgeon typically performs the resection using a hand-held surgical saw inserted through the resection slot 46. In other exemplary embodiments, the surgeon can use the top of the pivotal tibial resection guide 40 as a plane to align the proximal tibial resection.

[0089] Once the tibial resection is complete, the surgeon selects a tibial trial base 93 and meniscal trial insert 95 of the appropriate size. The femoral trial 15a is then repositioned on the resected distal end 12 of the femur 10 and a trial reduction is performed. The femoral groove, peg prep, and tibial keel prep can be performed according to kinematic alignment techniques or surgeon preference.

[0090] Distal referencing technique FIGS. 11-15 generally show method steps and exemplary devices and assemblies including another exemplary linkage drill guide 30, and the femur referencing instrument 15 is a distal referencing guide 15b having a complementary femur engaging member 13.

[0091] Figure 11 is a perspective view of a knee in an extended position, with the distal femur 10 resected, and spoon gap spacers 25a inserted medially and laterally to fill the joint space between the resected femur 10 and the intact tibia 20 and to determine the medial and lateral gap distances. The surgeon or technician then selects a snap-on spacer 25b from among the many available snap-on spacers 25b. Here, the first snap-on spacer has a thickness different from that of another available snap-on spacer 25b. Once the thickness of the snap-on spacer 25b of the appropriate thickness is selected, the fully assembled distal reference guide 15b will match the gap distance d determined in the step of using the spoon gap spacer 25a (see Figure 11).

[0092] In a particular exemplary method, the use of the spoon gap spacer 25a can be omitted, and a distal reference guide 15b having a selectively selected snap-on gap spacer 25b that matches the distances of the medial and lateral dimensions of the joint gap 3 can be used in place of the spoon gap spacer 25a.

[0093] In a particular exemplary method, the pivoting tibial resection guide 40 can also be used in distal referencing techniques. At the start of the distal referencing technique, the distal end 12 of the femur 10 is resected. Distal cuts, anterior cuts, posterior cuts, and chamfer cuts are made to form a distal resection surface 5, a posterior resection surface 6, an anterior resection surface 2, and chamfer resection surfaces 8a, 8b, respectively (see also Figure 14B). U.S. Patent Application Publication No. 2019 / 0231365 (A1), which is incorporated herein by reference, provides an example of how a surgeon can orient the distal cut, anterior cut, posterior cut, and chamfer cut portions. As shown in Figure 12B, after the distal resection, the knee is placed in an extended position and the distal reference guide 15b is inserted into the joint space 3. In the depicted embodiment, the distal reference guide 15b comprises a distal reference portion 44, a modular handle 41, and a snap-on gap spacer 25b disposed on the bottom side of the distal reference portion 44.

[0094] As shown in FIG. 12A, the snap-on gap spacer 25b is affixed to the distal reference portion 44 of the distal reference guide 15b. The surgeon uses the modular handle 41 to insert the reference portion 44 medial and lateral between the distal surface of the resected femur 10 and the proximal surface of the tibia 20, fill the joint space 3, and determine the medial gap distance md (FIG. 12B) and the lateral gap distance ld (FIG. 13B). Unlike the techniques described above, during the connection transfer step, the femoral trial 15a is not placed on the resected femur 10.

[0095] The distal reference technique is performed using the distal reference guide 15b. An exemplary embodiment of the assembled distal reference guide 15b is shown in FIG. 12A. The distal reference guide 15b has a femoral reference portion 44 having an inner local condylar portion 45M and an outer local condylar portion 45L. Each condylar portion 45M, 45L has a complementary femoral engagement member 13. In the exemplary embodiment depicted, the complementary femoral engagement member 13 is a pin hole perforation 13b formed to penetrate from front to back. Each pin hole perforation 13b can be accessed from the front for use in orienting the connection drill guide 30 as shown in FIG. 13A. The modular handle 41 is configured to be easily removable from the femoral reference portion 44 for use in manipulating the distal reference guide 15b into and within the joint space 3. The distal portion of each of the condylar portions 45M, 45L is configured to receive the snap-on spacer 25b. A plurality of thicknesses of snap-on spacers 25b are provided. The appropriate thickness of the snap-on spacer 25b is selected such that the fully assembled distal reference guide 15b matches the gap distance d determined in the previous step using the spoon gap spacer 25a (see FIG. 11).

[0096] FIG. 12B shows the use of the modular handle 41 for sliding the distal reference guide 15b into the joint space 3. As shown in FIG. 12C, the modular handle 41 can be removed from the distal reference guide 15b after insertion, if desired.

[0097] As shown in FIG. 13A, with the distal reference guide 15b in a fixed position within the joint space 3, the connecting drill guide 30 is inserted into the incision. The depicted exemplary embodiment of the connecting drill guide 30 has a recess 39 in the femoral portion 32 of the connecting drill guide 30, and a modular handle 41 is inserted through the recess 39 to engage, if desired, the distal reference portion 44 of the distal reference guide 15b. A pair of femoral engagement members 19, 19z in the form of alignment pins 19b are formed on or adjacent to the femoral portion 32 of the connecting drill guide 30. In other exemplary embodiments, it will be appreciated that femoral connection holes 22, 22z, or other femoral engagement members 19 may be used instead of, or in addition to, the alignment pins 19b shown in FIG. 13A. The alignment pins 19b are inserted into the pin holes 13b of the condylar portions 45M, 45L until the tibial portion 31 of the connecting drill guide 30 contacts the anterior tibial cortex 21. In this way, the exemplary distal reference connecting drill guide assembly 1 is arranged in an engaged configuration. The connecting drill guide 30 includes a pair of tibial reference holes 23, 23z on or adjacent to the tibial portion 31 of the connecting drill guide 30.

[0098] Modified embodiments of the connecting drill guide 30 and related assemblies, systems, and methods described with reference to FIG. 13A are further contemplated. In such embodiments, the alignment pins 19b of the connecting drill guide 30 can be inserted directly into drill holes formed in the distal femur 10. The exemplary connecting drill guide 30 can be sized to have alignment pins 19b that extend into drill holes formed via a distal femoral resection guide 8 (see 15c in FIG. 16). In certain exemplary embodiments, the alignment pins 19b can be spikes configured to engage drill holes in the distal femur 10. In such exemplary embodiments, the spike is a femoral engagement member 19, and the drill hole in the distal femur 10 is a complementary femoral engagement member 13.

[0099] As shown in FIG. 13B, the tibial connecting pin 27 is disposed in each of the tibial reference holes 23, 23z of the connecting drill guide 30. As shown in FIG. 13C, the modular handle 41 can optionally be used in this step for stability. The tibial connecting pin 27 is inserted into the tibia 20. In a particular embodiment, the tibial connecting pin 27 is threaded at the tip 11 (see FIG. 15).

[0100] As shown in FIG. 14A, the connecting drill guide 30 and the distal reference guide 15b are removed from the joint and the tibial connecting pin 27 is left in a fixed position within the proximal tibia 20. The receiving slot 87 of the pivoting tibial resection guide 40 is slid over the tibial connecting pin 27. From this point forward, the technique is the same as the technique described above, except that the femoral trial 15a is not on the resected distal femur 10. It should be noted that once the connecting pin 27 is placed in the tibia 20, the femoral trial 15a does not need to remain in a fixed position for any of the embodiments described herein.

[0101] As shown in the side view of FIG. 14B, the instrument can be sized such that the tibial resection level automatically aligns with a 10 mm tibial implant construct (i.e., the tibial trial base 93 plus the meniscal trial insert 95). In an embodiment, the connecting drill guide 30 can be made to allow other resection levels as required or desired by the surgeon, such as, for example, a plurality of connecting guides, a plurality of pin holes, or an adjustable guide.

[0102] As shown in FIG. 14C and referring to FIG. 8, the posterior tibial slope PS can be adjusted as needed to conform to the natural anatomical structure in the manner described above. The pivotal tibial resection guide 40 is configured such that the pivotal tibial resection guide 40 can be adjusted relative to the placement of the tibial connecting pin 27. In an embodiment, the pivotal tibial resection guide 40 can have a posterior tilt angle θ in the range of about minus 3 degrees to about plus 10 degrees relative to the connecting pin 27. Once the posterior tilt angle θ is set, the pivotal tibial resection guide 40 can be locked at the selected posterior tilt angle θ.

[0103] As described above with reference to FIG. 9, the pivotal tibial resection guide 40 is pinned in place through the standard pin holes 33. If desired, a flaring fixation pin 34 can be used to add stability. The tibial connecting pin 27 is removed.

[0104] As shown in FIG. 15, the proximal tibial resection is performed through the resection slot 46 of the pivotal tibial resection guide 40. Unlike the techniques described above, there is no femoral trial 15a to be removed prior to performing the tibial resection.

[0105] Once the tibial resection is complete, the surgeon selects an appropriately sized tibial base and tibial insert trial. The femoral trial 15a is placed on the previously resected distal femur 10. If distal reference techniques as described herein are used, the femoral trial 15a may not have a complementary femoral engagement member 13 such as the complementary femoral engagement member 13 disclosed in FIGS. 1-9. A trial reduction is performed (see FIG. 29). The femoral groove, peg prep, and tibial keel prep can be performed according to kinematic alignment techniques or surgeon preference.

[0106] Distal Femoral Resection Guide Reference Techniques FIGS. 16-28 generally show exemplary alternative embodiments of the connecting drill guide 30, method steps that can involve the use of the distal femoral resection guide 15c, as well as exemplary devices and assemblies.

[0107] Figure 16 is a perspective view of a bent knee. In the embodiments depicted in these figures, the femur reference instrument 15 is the distal femur resection guide 15c. The distal femur resection guide 15c is slidable over the femur connecting pin 17 that extends into the femur 10. In this embodiment, the femur connecting pin 27 is a standard pin that is otherwise used to identify the position of the distal femur resection guide. The distal femur resection guide 15c is positioned using kinematic alignment techniques known to surgeons. For example, the distal femur resection guide assembly disclosed in U.S. Patent Application Publication No. 2019 / 0231365 (A1) may have been used to orient the distal femur resection guide 15c. Once oriented, the surgeon uses the femur connecting pin 17 to lock the position and orientation of the distal femur resection guide relative to the distal femur 10. The surgeon then inserts a surgical saw through the resection slot 57 to resect the distal surface of the femur 10 and create the distal resection surface 5 through the distal cut.

[0108] In the exemplary connection drill guide 30 depicted in Figure 17A, the distal femur resection guide 15c is then removed and the leg is placed in the extended state. It will be understood that the exemplary embodiments of the connection drill guide 30 used may affect which instrument functions as the femur reference instrument 15. For example, in Figure 17A, the femur resection guide 15c has been removed and the femur connecting pins 17, 15d remain positioned in the femur 10. The femur connecting pin 17 can be used to mechanically transmit information regarding the orientation of the distal resection surface 5 of the femur 10 to the tibia resection guide 40 with the depicted embodiments of the connection drill guide 30, so the femur connecting pin 17 in the depicted embodiments functions as a kind of femur reference instrument 15. Similarly, in Figure 17B where the slot 57 of the distal femur resection guide 15c engages the blade 19c of the exemplary connection drill guide 30 to mechanically transmit information regarding the orientation of the distal resection surface 5 of the femur 10 to the tibia resection guide 40, the distal femur resection guide 15c is a kind of femur reference instrument 15.

[0109] The exemplary connecting drill guide 30 shown in FIG. 17A includes a femoral portion 32. The femoral portion 32 includes a tube 24 that can receive a first femoral engagement member 19 and a second femoral engagement member 19z in the form of a femoral connecting pin 17. That is, each tube 24 defines a connecting hole 22 (see FIG. 5A). The tube 24 and the connecting hole 22 can receive the femoral connecting pin 17 in substantially the same manner as described above with reference to FIGS. 4 and 5A. In this way, the described embodiment is configured to engage the first femoral engagement member 19 and the second femoral engagement member 19z. In the described embodiment, the first complementary femoral engagement member 13 and the second complementary femoral engagement member 13z are drill holes made directly in the distal femur 10. In FIG. 17A, the femoral connecting pin 17 also functions as the first femoral engagement member 19 and the second femoral engagement member 19z. The distal femoral resection guide 15c has been removed, and the placement of the femoral connecting pin 17 on the distal surface of the femur 10 holds information regarding the plane of distal resection that is coplanar with the distal resection surface 5. That is, the imaginary shortest possible line connecting the two femoral connecting pins 17 can function as a reference line parallel to the plane of distal resection of the femur 10.

[0110] The exemplary connecting drill guide 30 further includes a tibial portion 31 having tubes 24 that define tibial reference holes 23, 23z, and a body 36 that connects the femoral portion 32 to the tibial portion 31. A handle 38 may be optionally provided to facilitate attachment and removal of the connecting drill guide 30. The handle 38 may be removable, or the handle 38 may be a permanent and integral part of the connecting drill guide 30. The body 36 of the connecting drill guide 30 communicates information regarding the orientation of the plane of distal resection (coplanar with the distal resection surface 5) for the tibial portion 31 of the connecting drill guide 30.

[0111] As best seen in FIGS. 18, 19A, and 19B, the distal ends 16 of the tubes 24 define the tibial reference holes 23, 23z. Each distal end 16 of the tubes 24 preferably retracts from the posterior distal end 18 of the tibial portion 31 of the connecting drill guide 30. When the connecting drill guide 30 is in the engaged configuration, the lower surface 53 (FIG. 19B) of the tibial portion 31 is aligned with the tibial resection plane. This feature allows the surgeon to visualize the tibial resection cut before it is made. The recess 39 further enables direct marking of the tibia 20 by creating a line that connects two opposing lower surfaces 53 at the distal end 18 of the tibial portion 31. Direct marking is generally performed using a surgical-grade single-use marker or through a cautery device. Optionally, a line may be made that is drawn through the recess 39 that separates the opposing lower surfaces 53 at the distal end 18 of the tibial portion 31.

[0112] FIG. 18 further shows an expansion device 49, such as a gap spacer 25 inserted into the joint gap 3, to confirm and verify the medial and lateral distances between the resected distal condyles of the femur 10 and the adjacent proximal tibial plateau 20 of the same leg, between the medial and lateral condyles. Instead of the distal reference gap spacer 25, a lamina spreader or other tensioning device may be used to apply tension to the joint. Once determined, the surgeon inserts the tibial connecting pin 27 as depicted in FIG. 19A.

[0113] Figure 20A shows the tibial connecting pin 27 that remains disposed on the proximal surface of the anterior cortex 21 of the tibia 20 after the connecting drill guide 30 has been removed. As seen in FIGS. 21A and 22, the receiving slot 87 of the pivotable tibial resection guide 40 can then be slid over the remaining tibial connecting pins 27. The locking mechanism 48 is in the unlocked position. A visual indicator can be provided on the front surface of the locking mechanism 48 to inform the surgeon of the position of the locking mechanism 48. In the described embodiment, the indicator disposed at the 9 o'clock position indicates that the locking mechanism 48 is unlocked. Next, the posterior slope PS (see FIG. 8) can be adjusted, and the proximal surface of the tibia 20 can be resected as described above (generally see also FIGS. 23-28).

[0114] Referring to FIG. 17B, another exemplary embodiment of the connecting drill guide 30 is provided. In the described embodiment of the associated distal reference connecting drill guide assembly 1, the distal femoral resection guide 15c can be seen to function as the femoral reference instrument 15. The femoral resection slot 57 also functions as the first complementary femoral engaging member 13 of the femoral reference instrument 15. The first femoral engaging member 19 on the femoral portion 32 of the connecting drill guide 30 is a blade 19c dimensioned to closely fit into the femoral resection slot 57. In the described embodiment, a recess 39 may be present in the tibial portion 31 of the connecting drill guide 30. The recess 39 allows the connecting drill guide 30 to be slid over the stem portion 51 of the distal femoral resection guide 15c.

[0115] The blade 19c of the connecting drill guide 30 is slid into the femoral resection slot 57 of the distal femoral resection guide 15c with the leg in the extended position. FIG. 19B shows the tibial connecting pin 27 inserted into the tibial reference hole 23. Then, as outlined in FIGS. 21A and 22 and as described above, progression is possible.

[0116] Figure 20B shows a spike plate 67 used as a reference instrument for the pivotal tibial resection guide 40 instead of the tibial connecting pin 27. As shown in FIGS. 19A and 19B, the tibial connecting pin 27 is inserted through the tibial reference holes 23, 23z in the tibial portion 31 of the connecting drill guide 30 and threaded into the anterior cortex 21 of the proximal tibia 20. In FIG. 20B, both the connecting drill guide 30 and the tibial connecting pin 27 have been removed, leaving drill holes in the anterior cortex 21 of the proximal tibia 20. A spike plate 67 is provided that includes a first spike member 61 and a second spike member 62, connected by a body portion 63 and having a connecting tab 64 to facilitate selective engagement with the pivotal tibial resection guide 40. As will be further described below, the connecting tab 64 can represent an orientation of a differently formed plane by the composite axis of the tibial connecting pin 27. The first spike member 61 and the second spike member 62 of the spike plate 67 are inserted into the tibial drill holes left by the connecting tibial pin 27.

[0117] In certain exemplary embodiments, the spike plate 67 may be a single-use disposable item. In other exemplary embodiments, the spike plate may be made of stainless steel or any other clinically proven biocompatible material having sufficient strength and durability.

[0118] As shown in FIG. 21B, the pivotal tibial resection guide 40 having the reference slot 41 is slidable on the connection tab 64 of the spike plate 67. The connection tab 64 can be seen through the open resection slot 41. The connection tab 64 is oriented parallel to the resection slot 46, thereby indicating the orientation of a plane otherwise formed by the composite axis of the tibial connection pin 27 (see PS in FIG. 8). In order to better facilitate the surgeon's pre-visualization of the tibial resection cut performed on a parallel plane above the plane otherwise formed by the composite axis of the tibial connection pin 27, the connection tab 64 may optionally be provided with a visual indicator such as a color different from that of the surrounding instruments. The surgeon can lock the connection tab 64 to the reference slot 41 using the lock mechanism 48 on the front end of the pivotal tibial resection guide 40. In FIG. 21B, the lock mechanism 48 is shown in the unlocked position.

[0119] The spike plate 67 allows for the medial and lateral positioning of the pivotal tibial resection guide 40 and the inward and outward rotation of the pivotal tibial resection guide 40, while the use of the tibial connection pin 27 eliminates the medial and lateral positioning of the pivotal tibial resection guide 40.

[0120] FIGS. 23-25 show a tibial visual tilt gauge 60 that can optionally be disposed within the resection slot 47 of the pivotal tibial resection guide 40. The posterior tilt angle θ of the tibial resection guide 40 can be adjusted from about -3° to about +10° with respect to the placement of the tibial connection pin 27 or, in embodiments involving the use of the spike plate 67, with respect to the placement of the spike plate 67. Once the desired tilt and orientation are achieved, the pivotal movement may be locked by rotating the lock mechanism 48.

[0121] The locking mechanism 48 depicted in the cross-sectional views of FIGS. 21B and 30 is in the unlocked position. The locking mechanism 48 may be a friction locking mechanism such as that depicted in FIG. 30, but other locking mechanisms configured to selectively fix the orientation of the pivotal tibial resection guide 40 are considered to be within the scope of the present disclosure. For example, a mechanical locking mechanism 48 may be provided in certain exemplary embodiments.

[0122] Referring to the locking mechanism of FIG. 30 and further to FIG. 27, a surgeon or technician can lock the locking mechanism by inserting a keyed instrument through the interface of the locking mechanism 48. The keyed instrument may be a wrench, a hex key, or any other keyed instrument having a keyed end dimensioned to closely engage a complementary key shape within an interface that is rotatably communicative with the cam 73. Rotating the keyed instrument rotates the interface in the same direction, which rotates the cam 73. The cam 73 converts the rotational force into a linear force by pushing the cam follower 74 against the spring 75. The spring 75 then transmits the linear force to the shaft 71, which in turn transmits the linear force as friction to the pivotal guide 66. Thereby, the application of this friction prevents the pivotal assembly 55 from rotating about the axis. In this way, it can be said that the surgeon or technician "locks" the pivotal tibial resection guide at the desired posterior tilt angle θ.

[0123] In embodiments comprising the tibial connecting pin 27, it will be appreciated that the tibial connecting pin 27 extends through the tibial engagement hole 68a of the pivotal guide 66 to selectively engage the pivotal tibial resection guide 40 with the tibia 20. The tibial engagement hole 68a is generally aligned with the receiving slot 87 of the pivotal tibial resection guide 40. Similarly, in embodiments including the connection tab 64, it is desirable that the slot 68b of the pivotal guide 66 be dimensioned to receive the connection tab 64 of the spike plate 67.

[0124] As shown in FIG. 26, the inclination gauge is removed after the inclination of the pivotable tibial resection guide 40 is set. Next, the standard pin 37 is placed through the standard pin hole 33 in the pivotable tibial resection guide 40. The pivotable tibial resection guide 40 may be moved up to a position +2 mm from the standard hole, if desired. The locking mechanism 48 is shown in the locked position. In the described embodiment, a visual indicator at the 12 o'clock position indicates that the locking mechanism 48 is locked. Other visual indicators indicating the position of the locking mechanism are considered to be within the scope of the present disclosure.

[0125] FIG. 27 shows the pivotable tibial resection guide 40 disposed at the desired posterior slope PS (see FIG. 8), and further depicts the flared fixation pin 34 extending through the pivotable tibial resection guide 40 to further secure the pivotable tibial resection guide 40 to the tibia 20 at the desired inclination. The resection slot 46 of the pivotable tibial resection guide 40 orients the resection plane of the proximal end 29 of the proximal tibia 20.

[0126] FIG. 28 depicts the pivotable tibial resection guide 40 disposed at the desired posterior slope PS (see FIG. 8), with the proximal end 29 (FIG. 27) of the proximal tibia 20 resected.

[0127] FIG. 29 is a perspective view of a femur trial 15a, a tibial trial base 93, and a meniscus trial insert 95 selected based on size criteria. Without being bound by theory, the exemplary distal reference linkage drill guide 30 and / or the exemplary distal reference linkage drill guide assembly 1 described herein can directly link the orientation of the distal cut (resulting in the distal resection surface 5 of the distal femur 10) to the orientation of the proximal cut of the proximal tibia 20, thereby significantly reducing the potential for surgeon error while further eliminating one or more additional steps required by conventional kinematic alignment techniques that independently reference or indirectly link. The minimum size of the exemplary distal reference linkage drill guide 30 and the exemplary distal reference linkage drill guide assembly 1 allows the linkage drill guide 30 and the drill guide assembly 1 to fit within the surgical area without requiring additional instruments that extend significantly outside the incision. It is contemplated that the minimal amount of instrumentation may facilitate resterilization of the instruments between procedures.

[0128] The instrument can be provided in the form of a kit. The components of the kit are preferably arranged in a convenient form such as a surgical tray or case. However, the kit components need not be packaged or delivered together so long as they are assembled or collected together in the operating room for use during the surgery. Exemplary kits can include any suitable embodiment of the connecting drill guide 30, variations of the connecting drill guide 30 described herein, and any other connecting drill guide 30 according to one embodiment. While it is contemplated that exemplary kits may further include one or more femoral engagement members 19, 19z, etc., one or more tibial engagement members 77, 77z, etc., and one or more femoral reference instruments 15, it will be understood that a particular kit may lack some or all of these elements. Any suitable embodiment of the femoral engagement member 19, variations of the femoral engagement member 19 described herein, and any other femoral engagement member 19 according to one embodiment are considered to be within the scope of the present disclosure. Any suitable embodiment of the tibial engagement member 77, variations of the tibial engagement member 77 described herein, and any other tibial engagement member 77 according to one embodiment are considered to be within the scope of the present disclosure. Any suitable embodiment of the femoral reference instrument 15, variations of the femoral reference instrument 15 described herein, and any other femoral reference instrument 15 according to one embodiment are considered to be within the scope of the present disclosure.

[0129] The appropriate number or type of connecting drill guide 30, femoral engagement member 19, tibial engagement member 77, and femoral reference instrument 15 to include in a kit according to a particular embodiment can be based on various considerations such as the procedure that is intended to be performed using the components included in the kit.

[0130] An exemplary medical device can comprise a femoral portion configured to engage a first femoral engagement member, a tibial portion configured to engage a first tibial engagement member, and a body connecting the femoral portion to the tibial portion.

[0131] In such an exemplary medical device, the first femoral engagement member can be selected from the group consisting essentially of a femoral connecting pin, a blade, a slot, a lip, a clamp, a hook, a protrusion, a recess, a spike, a magnet, an alignment pin, and combinations thereof.

[0132] In such an exemplary medical device, the first tibial engagement member can be selected from the group consisting essentially of a hole, a slot, a recess, a protrusion, a clamp, a lip, a magnet, a spike, and combinations thereof.

[0133] An exemplary distal reference connecting drill guide assembly can include a connecting drill guide having a femoral portion configured to engage a first femoral engagement member, a tibial portion configured to engage a first tibial engagement member, and a body connecting the femoral portion to the tibial portion; and a femoral reference instrument having a first complementary femoral engagement member configured such that the first complementary femoral engagement member engages the first femoral engagement member, wherein the distal reference connecting drill guide assembly has an engaged configuration when the first femoral engagement member engages the first complementary engagement member and a non-engaged configuration when the first femoral engagement member does not engage the first complementary engagement member.

[0134] Such an exemplary assembly may further include an expansion device configured to be disposed between the resected distal femur and the proximal tibia to confirm the distance between the distal femur and the proximal tibia. The expansion device is selected from the group consisting essentially of a gap spacer, a laminar spreader, a ratchet tensioner, or other knee ligament tensioning device.

[0135] Such an exemplary assembly may have a femur portion further configured to engage a second femur engaging member, and the femur reference instrument may further comprise a second complementary femur engaging member configured to engage the second femur engaging member. The second femur engaging member can be configured to selectively engage the second complementary femur engaging member.

[0136] Such an exemplary assembly can have a femur reference instrument selected from the group consisting essentially of a femur trial, a distal reference guide, a pin, and a femur distal cut guide.

[0137] Such an exemplary assembly may have a tibia portion of a connecting drill guide further configured to engage a second tibia engaging member.

[0138] Such an exemplary assembly can have an engagement configuration that includes a first femur engaging member that directly engages a first complementary femur engaging member.

[0139] Such an exemplary assembly can have an engagement configuration that includes a first femur engaging member that indirectly engages a first complementary femur engaging member.

[0140] Such an exemplary assembly may have a first femur engaging member selected from the group consisting essentially of a femur connecting pin, a blade, a slot, a lip, a clamp, a hook, a protrusion, a recess, a spike, a magnet, an orientation pin, and combinations thereof.

[0141] Such an exemplary assembly may have a first tibia engaging member selected from the group consisting essentially of a hole, a slot, a recess, a protrusion, a clamp, a lip, a magnet, a spike, and combinations thereof.

[0142] An exemplary medical device can include a femur portion having a blade sized to closely fit within a femur resection slot of a distal femur resection guide, a tibia portion having a tube defining a tibia reference hole, and a body connecting the femur portion to the tibia portion.

[0143] Such an exemplary assembly may further include a handle engaged to the body.

[0144] Such an exemplary assembly may have a tube defining a tibia reference hole that retracts from a posterior distal end of the tibia portion of the connecting drill guide.

[0145] Such an exemplary assembly may have a lower surface of the tibia portion that aligns with a tibia resection plane when the connecting drill guide is in an engaged configuration.

[0146] Another exemplary medical device can include a femur portion having a first femur engagement member, a tibia portion configured to engage the first tibia engagement member, and a body connecting the femur portion to the tibia portion.

[0147] Yet another exemplary medical device can include a femur portion having a first femur engagement member, a tibia portion having a first tibia engagement member, and a body connecting the femur portion to the tibia portion.

[0148] An exemplary method can include engaging a femur reference instrument to the distal femur, engaging a first femur engagement member directly or indirectly to the distal femur, and engaging a connecting drill guide directly or indirectly to the first femur engagement member, where the connecting drill guide includes a femur portion configured to engage the first femur engagement member, a tibia portion configured to engage a first tibia engagement member, and a body connecting the femur portion to the tibia portion.

[0149] In an exemplary method, the step of directly engaging the first femoral engagement member with the distal femur can include physically contacting the first femoral engagement member with the anterior cortex of the distal femur.

[0150] In an exemplary method, the step of indirectly engaging the first femoral engagement member with the distal femur can include physically contacting the first femoral engagement member with a first complementary engagement member on an intermediate femoral device, where a portion of the intermediate femoral device physically contacts the distal femur.

[0151] In an exemplary method, the step of indirectly engaging the first femoral engagement member with the distal femur can further include physically contacting the first femoral engagement member with a first complementary engagement member on an intermediate device. A portion of the intermediate device can physically contact a subsequent intermediate device, and a portion of the subsequent intermediate device can physically contact the distal femur.

[0152] An exemplary method can further include inserting an expansion device into the joint space defined by the distal femur and proximal femur of the surgical leg to confirm the distance between the distal femur and the proximal tibia. The distance can include an inner distance and an outer distance.

[0153] An exemplary method can further include using a traction device to pull on the surgical leg and apply a traction force to the proximal tibia or the distal femur to expand the joint space.

[0154] An exemplary method may further include directly or indirectly engaging the first tibial engagement member with both the proximal tibia and the tibial portion of the connecting drill guide.

[0155] In an exemplary method, the step of directly engaging the first tibial engagement member with the proximal tibia can include physically contacting the first tibial engagement member with the anterior cortex of the proximal tibia.

[0156] In an exemplary method, the step of indirectly engaging the first tibial engagement member with the proximal tibia can include physically contacting the first tibial engagement member with an intermediate tibial device. A portion of the intermediate tibial device can physically contact the proximal tibia.

[0157] In an exemplary method, the step of indirectly engaging the first tibial engagement member with the proximal tibia can further include physically contacting the first tibial engagement member with an intermediate tibial device. A portion of the intermediate tibial device can physically contact a subsequent intermediate tibial device, and a portion of the subsequent intermediate tibial device can physically contact the proximal tibia.

[0158] The exemplary method may further include removing the connecting drill guide from the first tibial engagement member while the first tibial engagement member remains directly or indirectly engaged with the proximal tibia.

[0159] The exemplary method may further include engaging a tibial resection guide with the first tibial engagement member.

[0160] The exemplary method may further include adjusting the posterior tilt angle of the tibial resection guide relative to the position of the first tibial engagement member to define a desired resection tilt.

[0161] The exemplary method may further include fixedly locking the tibial resection guide to the proximal tibia at a desired resection tilt.

[0162] The exemplary method may further include resected the tibial plateau of the proximal tibia at a desired resection tilt.

[0163] The exemplary method may further include adjusting the height of the tibial resection guide relative to the upper portion of the proximal tibia to accommodate the height of the internal prosthesis implant assembly.

[0164] The exemplary method may further include adjusting the medial / lateral angle of the tibial resection guide relative to the first tibial engagement member to define a desired medial / lateral resection angle.

[0165] The exemplary method can further include fixedly locking the tibial resection guide to the proximal tibia at a desired medial / lateral resection angle.

[0166] The exemplary method may further include resected the tibial plateau of the proximal tibia at a desired medial / lateral resection angle.

[0167] The exemplary method may further include adjusting the medial / lateral position of the tibial resection guide relative to the first tibial engagement member to define a desired medial / lateral resection position.

[0168] The exemplary method can further include fixedly locking the tibial resection guide to the proximal tibia at a desired medial / lateral resection position.

[0169] The exemplary method may further include resected the tibial plateau of the proximal tibia at a desired medial / lateral resection position.

[0170] It should be understood that the present invention is not limited to the specific configurations and method steps disclosed herein or shown in the drawings, but also includes any modifications or equivalents within the scope of the claims known in the art. It will be understood by those skilled in the art that the devices and methods disclosed herein will find utility.

Claims

1. A medical device comprising a blade that engages with and extends from the posterior distal end of the femur portion, the blade being sized to fit snugly within the femur resection slot of a distal femur resection guide, a femur portion, a tibia portion having a tube that protrudes from the lower surface of the tibia portion, the tube defining a tibial reference hole, a tibia portion, a body that connects the femur portion to the tibia portion, the distal ends of the respective tubes being recessed from the posterior distal end of the tibia portion of the medical device, a body, and a medical device comprising the same.

2. The medical device according to claim 1, further comprising a handle that engages with the body.

3. The medical device according to claim 1, wherein the lower surface of the tibia portion coincides with the tibia resection surface when the medical device is in the engaged configuration.

4. a femur portion configured to engage with a first femur engagement member, a first arm disposed on the opposite side of the second arm, the first arm being a recess that extends from the posterior distal side of the tibia portion, the recess defining a separation of the first arm from the second arm, and each of the first arm and the second arm having a tube that protrudes from the lower surface of the first arm and the second arm of the tibia portion, the tube defining a tibial reference hole, a tibia portion, a body that connects the femur portion to the tibia portion, and a medical device comprising the same, wherein the distal ends of the respective tubes are recessed from the posterior distal end of the tibia portion of the medical device, and the lower surfaces of the first arm and the second arm of the tibia portion coincide with the tibia resection surface when the medical device is in the engaged configuration.

5. The medical device according to claim 4, wherein the first femur engagement member is selected from the group consisting essentially of a femur connecting pin, a blade, a slot, a lip, a clamp, a hook, a protrusion, a recess, a spike, a magnet, an orientation pin, and combinations thereof.

6. The medical device according to claim 4, further comprising a handle that engages with the body.

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