Tibial resection guide

Abstract

To provide kinematic alignment tibial guide transfer instruments and methods.SOLUTION: An assembly includes a distally referencing linking drill guide assembly 1. The distally referencing linking drill guide assembly 1 includes: a linking drill guide 30 comprising a femoral portion 32, the femoral portion 32 configured to engage a first femoral engagement member 19, a tibial portion 31, the tibial portion 31 configured to engage a first tibial engagement member 77, and a body connecting the femoral portion 32 to the tibial portion 31; and a femoral referencing instrument 15a, the femoral referencing instrument 15a having a first complementary femoral engagement member, wherein the first complementary femoral engagement member is configured to engage the first femoral engagement member 19. The assembly has an engaged configuration when the first femoral engagement member 19 engages the first complementary femoral engagement member, and the assembly has a disengaged configuration when the first femoral engagement member 19 does not engage the first complementary femoral engagement member.SELECTED DRAWING: Figure 5A

Description

[Background technology]

[0001] (Reference to Related Application) This application claims priority to U.S. Patent Application No. 17 / 455,945, filed November 22, 2021, which is incorporated by reference, which in turn claims priority to U.S. Provisional Patent Application No. 63 / 248,059, filed September 24, 2021, and U.S. Provisional Patent Application No. 63 / 122,115, filed December 7, 2020, which are incorporated by reference. [Technical Field]

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

[0003] Total knee replacement is a procedure in which an orthopedic surgeon replaces severely diseased portions of the knee joint with an artificial endoprosthetic implant intended to restore joint function and relieve pain. The procedure itself generally consists of the surgeon making a vertical midline anterior incision in a bent knee (i.e., the knee in flexion). The surgeon then continues to dissect tissue to access the joint capsule. After the capsule is perforated, the patella is moved out of the way, exposing the distal femoral condyles, cartilaginous meniscus, and proximal tibial plateau.

[0004] The surgeon then removes the cartilaginous meniscus and uses measuring instrumentation to independently measure and resect the distal femur and proximal tibia to accommodate the endoprosthetic knee implant. The resection itself often removes diseased bone regions and modifies the bone shape to better accommodate the complementary shapes of the respective implant components. That is, the resected distal femur will ultimately fit into a complementary femoral implant component, and the resected proximal tibia will ultimately support a complementary tibial implant component. The surgeon selects from different sizes of implant components to match the patient's bone size.

[0005] There are several schools of thought regarding the angle at which the resections of the distal femoral condyle and proximal tibia should be made. The angle of the resections largely determines how the implant components will sit within the joint and can affect how the prosthesis will function over time.

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

[0007] It is not surprising that surgical approaches vary even among surgeons who practice kinematic alignment techniques. Some surgeons prefer to use calipers or other measuring instrumentation to measure the dimensions of the distal femur and proximal tibia independently of one another. This approach generally offers the greatest amount of autonomy, and thus allows for the greatest amount of subjectivity and variability in the placement of the resection plane (and ultimately, the placement of the implant components). Therefore, this independently referencing approach may result in the greatest amount of trial and error.

[0008] Therefore, this technique generally increases the time the patient remains under general anesthesia. This technique also increases the risk that the final alignment of the joint line will not precisely align with the natural, pre-injury joint line. In extreme cases, misalignment may prompt supplemental or revision procedures that would otherwise be avoidable. Even if the final alignment of the joint line is perfect, the amount of time required to calculate, resect, place, and test the kinematically aligned joint prolongs the time the surgical field is exposed. Although surgeons typically make every effort to maintain a sterile surgical environment, prolonged procedures can nonetheless increase the risk of infection, prolong blood loss, and cause more damage to surrounding tissue.

[0009] Other surgeons may use tools such as those disclosed in U.S. Patent Application Publication No. 2019 / 0231365 to improve accuracy and reduce surgical time. While certainly an improvement, these tools introduce an element of subjectivity and the associated risks. 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 may also increase the time required to sterilize the instruments between procedures. Summary of the Invention

[0010] Thus, there is a long-felt but unresolved need to overcome the shortcomings of the prior art. It is contemplated that the instruments, assemblies, kits, systems, and methods disclosed herein may be used to overcome the shortcomings of the prior art.

[0011] Problems of inaccurate placement of resection planes in knee replacement surgery and increased procedure times associated with procedures that are highly dependent on subjective placement of the resection planes are alleviated by a distal reference coupled drill guide assembly comprising: a femoral portion configured to engage a first femoral engaging member; a tibial portion configured to engage the first tibial engaging member; and a body connecting the femoral portion to the tibial portion; and a femoral reference instrument having a first complementary femoral engaging member configured to engage the first femoral engaging member, wherein the distal reference coupled drill guide assembly has an engagement configuration and a disengagement configuration, wherein the engagement configuration includes the first femoral engaging member engaging the first complementary femoral engaging member and the disengagement configuration includes the first femoral engaging member not engaging the first complementary femoral engaging member.

[0012] It is contemplated that the exemplary embodiments described herein may provide improved kinematic knee devices and methods.

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

[0014] The above objectives may be achieved by providing a kinematic alignment tibial guide transfer instrument 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 invention when considered in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0016] The foregoing will be apparent from the following more particular description of exemplary embodiments of the disclosure, as illustrated in the accompanying drawings, in which the drawings are not necessarily to scale, emphasis instead being placed upon illustrating the disclosed embodiments.

[0017] 1-10 generally depict method steps and exemplary devices and assemblies that may involve the use of femoral trials having complementary femoral engaging members, including exemplary interlocking drill guides. [Figure 1] 1 shows a femoral trial placed on the distal end of a resected femur. [Figure 2] 2 depicts a threaded femoral linking pin being inserted through a reference hole in the femoral trial shown in FIG. 1; [Figure 3A] FIG. 3 is a perspective view of the elements of FIG. 2, further including spoon gap spacers inserted medially and laterally between the femoral trial and the tibial plateau of the proximal tibia. [Figure 3B] FIG. 3 is a perspective view of the elements of FIG. 2, further including spoon gap spacers inserted medially and laterally between the femoral trial and the tibial plateau of the proximal tibia. [Figure 4] FIG. 3C is a perspective view of the elements from FIGS. 3A and 3B, further depicting the linking drill guide sliding over the femoral linking pin with the gap spacer present. [Figure 5A] FIG. 5 is a perspective view of the elements of FIG. 4, further showing a tibial linking pin positioned in a tibial reference hole in the linking drill guide. [Figure 5B] FIG. 5 is a perspective view of the elements of FIG. 4, further showing a tibial linking pin positioned in a tibial reference hole in the linking drill guide. [Figure 6A] FIG. 5C is a perspective view showing the elements of FIGS. 5A and 5B, except that a snap-on spacer has been placed between the femoral trial and the tibial plateau instead of the spoon gap spacer. [Figure 6B] FIG. 5C is a perspective view showing the elements of FIGS. 5A and 5B, except that a snap-on spacer has been placed between the femoral trial and the tibial plateau instead of the spoon gap spacer. [Figure 7A] FIG. 6C is a perspective view of the elements of FIGS. 6A and 6B with the articulating drill guide removed and the pivoting tibial resection guide slid onto the tibial articulating pin. [Figure 7B]FIG. 7B is a side view of the element depicted in FIG. 7A. [Figure 8] FIG. 7B is another side view of the elements depicted in FIG. 7A, with the tibial posterior slope of the tibial resection guide adjusted to match the natural slope of the patient's tibia. [Figure 9] FIG. 7B is a perspective view of the elements depicted in FIG. 7A with the tibial linking pin removed and the pivoting tibial resection guide secured to the proximal tibia through the fixation pin in the fixation pin hole. [Figure 10] 9, except that the femoral trial has been removed and the proximal tibial resection has been performed through a slot in the pivoting tibial resection guide. 11-15 generally illustrate method steps and exemplary devices and assemblies, including another embodiment of an exemplary interlocking drill guide, which may involve the use of a distal reference guide having a complementary femoral engaging member. [Figure 11] FIG. 1 is a perspective view of a knee placed in extension with the distal femur resected and distal reference gap spacers inserted medially and laterally to fill the joint space between the resected femur and intact tibia and determine the medial and lateral gap distances. [Figure 12A] FIG. 1 is a perspective view of a distal reference guide having a removable handle connected to a femoral portion having a medial condylar portion and a lateral condylar portion, the distal portion of each condylar portion being configured to receive a snap-on spacer. [Figure 12B] FIG. 10 is a perspective view showing a distal reference guide inserted into the gap. [Figure 12C] FIG. 10 is a perspective view of the distal reference guide positioned within the gap with the handle removed. [Figure 13A] FIG. 12D is a perspective view of the element of FIG. 12C, further comprising an exemplary articulated drill guide having an orientation pin inserted into the condylar portion of the distal reference guide. [Figure 13B] FIG. 13B is a perspective view of the elements shown in FIG. 13A, further depicting a tibial linking pin inserted into a tibial reference hole in the linking drill guide. [Figure 13C]FIG. 13C is a perspective view of the elements shown in FIG. 13B, further depicting the removable handle reattached to the femoral portion of the distal reference guide. [Figure 14A] FIG. 10 is a perspective view showing a pivoting tibial resection placed over a tibial linking pin remaining in the tibia with the distal gap spacer assembly and linking drill guide removed. [Figure 14B] FIG. 14B is a side view of the element shown in FIG. 14A. [Figure 14C] FIG. 14C is a side view of the elements depicted in FIG. 14B, with the tibial posterior slope of the tibial resection guide adjusted to match the natural slope of the patient's tibia. [Figure 15] 14C, except that the tibial linking pin has been removed, a standard pin has been inserted into the standard fixation pin hole to fix the orientation of the pivoting tibial resection guide, and the proximal tibial resection is performed through a slot in the pivoting tibial resection guide. Figures 16-28 generally depict method steps and exemplary devices and assemblies, including other embodiments of exemplary linking drill guides, that may involve the use of a distal femoral resection guide. [Figure 16] FIG. 1 is a perspective view of a knee in flexion with a distal femoral resection guide oriented on the distal femur after a distal cut has been made. [Figure 17A] FIG. 1 is a perspective view of a knee in extension, providing an exemplary embodiment of a linking drill guide configured to be engaged with a previously used pin to secure a distal femoral resection guide in a resection orientation. [Figure 17B] FIG. 10 is a perspective view of a knee in extension, where another exemplary embodiment of an interlocking drill guide is provided that includes a blade configured to fit securely within a femoral resection slot of a distal femoral resection guide. [Figure 18] FIG. 12 is a perspective view of a knee in extension with a gap spacer inserted into the joint space between the resected distal femur and proximal tibia, where an embodiment of an articulated drill guide is provided. [Figure 19A]FIG. 19 is a perspective view of the elements depicted in FIG. 18, further comprising a tibial linking pin extending through the tibial portion of the linking drill guide and into the tibia. [Figure 19B] FIG. 17C is a perspective view of the elements depicted in FIG. 17B, further comprising a tibial linking pin extending through the tibial portion of the linking drill guide and into the tibia. [Figure 20A] FIG. 10 is a perspective view of the tibial linking pin remaining in the tibia after all other elements have been removed. [Figure 20B] 10 is a perspective view of an exemplary spike plate remaining in the borehole left by the tibial linking pin after the pin and all other elements have been removed. FIG. [Figure 21A] FIG. 20B is a perspective view of a pivoting tibial resection guide positioned on the tibial linking pin depicted in FIG. 20A. [Figure 21B] FIG. 20C is a perspective view of a pivoting tibial resection guide positioned on the connecting tab of the spike plate depicted in FIG. 20B. [Figure 22] FIG. 10 is a side view of a pivoting tibial resection guide positioned on a tibial linking pin. [Figure 23] FIG. 21C is a perspective view of the elements depicted in FIG. 21B, further comprising a tibial visual tilt gauge with the locking cam in the unlocked position. [Figure 24] FIG. 24 is a side view of the element depicted in FIG. 23. [Figure 25] FIG. 24 is a side view of the elements depicted in FIG. 23, with pivoting resection guide 40 pivoted to adjust the posterior tilt of the resection plane. [Figure 26] FIG. 12 is a perspective view of a pivoting tibial resection guide positioned in a desired posterior tilt with the locking cam in a locked position. [Figure 27] FIG. 10 is a perspective view of a pivoting tibial resection guide positioned at a desired posterior tilt, further showing a flared fixation pin extending through the pivoting tibial resection guide to further secure the pivoting tibial resection guide to the tibia at the desired tilt. [Figure 28] FIG. 10 is a perspective view of a pivoting tibial resection guide positioned at a desired posterior tilt with the tibial plateau resected. [Figure 29]FIG. 12 is a perspective view of a femoral trial, a tibial base trial, and a meniscal insert based on size standards. [Figure 30] 1 is a cross-sectional anterior view of an exemplary pivoting tibial resection guide. DETAILED DESCRIPTION OF THE INVENTION

[0018] The following detailed description of 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 have been chosen and described in order to best explain the principles of the invention and its practical application. Those skilled in the art will recognize that many modifications can be made to the invention disclosed herein without departing from the scope and spirit of the invention.

[0019] Unless otherwise stated, like reference numerals designate corresponding parts throughout the several views. While the drawings depict embodiments of various features and components according to the present disclosure, 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.

[0020] Except as otherwise expressly stated herein, the following rules of interpretation apply herein: (a) all words used herein shall be construed with such gender or number (singular or plural) as required by the context; (b) as used in this specification and the appended claims, the singular terms "a," "an," and "the" include plural references unless the context clearly dictates otherwise; (c) the antecedent "about" applied to a listed range or value indicates an approximation with deviations from that range or value known in the art or expected from measurements; (d) unless otherwise specified, the words "herein," "hereby," "hereinbefore," and "hereinafter," and words of similar import, refer to this specification as a whole and not to any particular paragraph, claim, or other subdivision; (e) description headings are for convenience only and do not control or affect the meaning of any portion of this specification; (f) "or" and "any" are not exclusive, and "include," "including," etc. are not limiting. Furthermore, the terms "comprising," "having," "including," and "containing" are to be construed as open-ended terms (i.e., meaning "including, but not limited to").

[0021] References herein to "one embodiment," "an embodiment," "exemplary embodiment," and the like indicate that the described embodiment may include a particular feature, structure, or characteristic, but not all embodiments necessarily include the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is implied that it is within the knowledge of one of ordinary skill in the art to affect such feature, structure, or characteristic in connection with other embodiments, whether or not explicitly stated.

[0022] To the extent necessary to provide narrative support, the subject matter and / or text of the appended claims are incorporated herein by reference in their entirety.

[0023] The recitation of ranges of values ​​herein is merely intended to serve as a shorthand method of individually referring to each separate value within any subrange therebetween, unless expressly stated otherwise herein. Each separate value within a recited range is incorporated into the specification or claims as if each separate value were individually recited herein. When a specific range of values ​​is provided, it is understood that each intervening value, to the nearest tenth of the unit of the lower limit between the upper and lower limits of that range, and any other stated or intervening value within the stated range of that subrange, is 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 therein, subject to any specific and explicitly excluded limit in the stated range.

[0024] It should be noted that some of the terms used herein are relative terms. For example, the terms "upper" and "lower" are relative to one another in location, i.e., an upper component is higher than a lower component in each orientation, but these terms may change if the orientation is reversed. The terms "inlet" and "outlet" are relative to the fluid flowing therethrough with respect to a given structure, e.g., fluid flows into a structure through an inlet and then out of the structure through an outlet. The terms "upstream" and "downstream" are relative to the direction in which fluid flows through various components before flowing through downstream components.

[0025] The terms "horizontal" and "vertical" are used to indicate directions relative to an absolute reference, i.e., Earth's surface level. However, these terms should not be interpreted as requiring structures to be absolutely parallel or absolutely perpendicular to one another. For example, a first vertical structure and a second vertical structure are not necessarily parallel to one another. The terms "top" and "bottom" or "base" are used to refer to a place or surface where the top is always higher than the bottom or base relative to an absolute reference, i.e., the Earth's surface. The terms "upward" and "downward" are also relative to an absolute reference. An upward flow always opposes the Earth's gravity.

[0026] There are many reasons why a patient may undergo total knee arthroplasty ("TKA"). Such reasons may include trauma, the development of degenerative bone disease, and excessive wear over time and hard use. Common degenerative bone diseases include rheumatoid arthritis and osteoarthritis.

[0027] In a primary TKA (i.e., a TKA performed by a surgeon on a knee joint that has not previously been operated on), the surgeon generally makes a vertical midline incision on the anterior side of the knee to be operated on. The incision is generally made with the knee in flexion at or below the tibial tuberosity and may extend several inches above the patella. The surgeon then proceeds to dissect the fatty tissue to expose the anterior surface of the joint capsule. A medial parapatellar arthrotomy may be performed to perforate the joint capsule and resect the medial patellar retinaculum. Retractors are then typically used to move the patella laterally, exposing the cartilaginous meniscus resting on the distal condyles of the femur and the proximal tibial plateau. The surgeon then removes the meniscus and measures and resects the distal femur and proximal tibia using measuring instrumentation. The resected distal femur and resected proximal tibia will ultimately house the endoprosthetic knee implant.

[0028] The type of measurement and resection instrumentation used may be influenced by the surgeon's preference for particular joint alignment philosophies. These joint alignment philosophies may influence the design of available knee endoprostheses and their associated instrumentation. The three primary knee alignment principles are known as anatomical alignment, mechanical alignment, and kinematic alignment.

[0029] The oldest alignment concept is the anatomical alignment principle. In anatomical alignment, surgeons attempt to resect the tibia with 3 degrees of varus, regardless of the patient's actual pre-existing joint line orientation. Femoral resections and ligament releases are also performed to maintain a straight hip-knee-ankle axis of the limb. Releasing the anterior cruciate ligament (ACL) to accommodate the implant can result in a feeling of weakness in the patient, as explained further below. Furthermore, 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, meniscal insert, and femoral implant, which contributed to implant failure.

[0030] The resection angle of the distal femur essentially sets the angle of the axis of the prosthesis. Anatomical alignment does not allow the angle of the resection to vary indefinitely. This can result in a resection angle that is not aligned with the natural angle of the patient's pre-diseased joint. The resulting anatomical alignment can lead to patient discomfort, weakening of the surrounding soft tissues (e.g., ligaments and muscles), and premature wear of the prosthesis.

[0031] In mechanical alignment, the surgeon resects the tibia perpendicular to its mechanical axis. The mechanical axis of the tibia generally refers to the axis extending from the center of rotation of the associated proximal femoral head through the center of the knee to the center of the ankle. Perpendicular resection of the proximal surface of the tibia relative to the mechanical axis results in a resection that is flush with the transverse plane placed in the resection area. Many tibial prostheses designed for mechanical alignment have articular surfaces configured to sit on the resected tibial plateau and position a new joint line parallel to the transverse plane of the resection. That is, the reconstructed 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 extension and the patient is standing. In contrast, the location of the natural joint line varies from person to person, but on average, the natural joint line has a slight varus tilt relative to the transverse plane of the patient's body.

[0032] Mechanical alignment techniques can provide good stability when a patient's leg is in extension (e.g., when the patient is standing). While this technique is sometimes required due to trauma or severe disease progression, implants commonly used with mechanical alignment often require release of the ACL. In some situations, the posterior cruciate ligament (PCL) may also be released. The ACL normally prevents the tibia from sliding too far forward and from excessively rotating relative to the femur. The absence of either of these ligaments can result in a feeling of weakness when the leg is in flexion. Furthermore, altering the position of the patient's natural joint line can cause discomfort. Patients who alter their gait to accommodate the new joint line can chronically stress remaining muscles, which can further exacerbate discomfort and contribute to additional musculoskeletal problems in the future.

[0033] Resection of the ACL also encourages the use of a "gap balancing" technique, in which the surgeon uses distractors to apply opposing forces to the tibia and femur in an attempt to set the distal cut surface of the femur parallel to the proximal cut surface of the tibia while symmetrically tensioning the remaining collateral ligaments. The remaining collateral ligaments are typically the lateral collateral ligament (LCL), which connects the femur to the lateral fibula, and the medial collateral ligament (MCL), which connects the femur to the medial tibia. By setting the distal cut surface of the femur parallel to the resected tibial plateau while evenly balancing distraction forces on the remaining collateral ligaments, it is believed that the prosthesis can be easily inserted into the gap between the femur and tibia. Knee forces in flexion and extension are evenly distributed through the prosthesis, thereby avoiding uneven wear and other complications.

[0034] However, after a distal femoral resection is performed, the anterior profile of the gap is generally trapezoidal. Surgeons are generally taught to create a rectangular gap to accommodate an endoprosthetic implant. To do this, surgeons typically release the MCL if the knee is varus and the LCL if the knee is valgus. Knee valgus is present in a minority of patients. These ligament releases generate scar tissue as the reattached ligaments begin to heal after successful surgery. Healed ligaments often undergo contracture as a result of scarring. Ligament releases also expose tissue to trauma, creating additional bleeding opportunities and generally prolonging the patient's recovery time.

[0035] The latest alignment philosophy is the kinematic alignment principle. The kinematic alignment principle recognizes that every patient's physiology is slightly different and aims to restore the patient's pre-symptomatic natural joint line by making actual measurements of surgical physiology to confirm the location of the natural joint line. While nothing precludes the use of the present device in mechanical or anatomical alignment, the inventors have recognized the shortcomings of mechanical and anatomical alignment and have devised a device that is also compatible with kinematic alignment.

[0036] There are various methods for performing kinematic alignment procedures, but all begin by referencing the distal condyle of the femur. Most methods involve assessing the thickness of the articular cartilage on the distal surface of the femoral condyle. The surgeon may use a caliper, a cartilage thickness gauge, such as that disclosed in U.S. Patent Application Publication No. 2019 / 0231365, or other device to measure the amount of cartilage wear. The location of the pre-morbid natural joint line is approximately determined by the interaction between the soft tissue (e.g., articular cartilage) on the femoral condyle and the tibial plateau as supported by the underlying bone (e.g., the tibia). In the absence of bone loss, knowing the pre-morbid cartilage thickness ultimately allows for the measurement of the pre-morbid 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 if the surgeon plans to use a 10 mm endoprosthetic implant, the surgeon can set a femoral resection guide on the anterior surface of the femur with the intent of performing a distal resection on the distal surface of the femoral condyle. The femoral resection guide can be angled to resect 10 mm of the distal aspect of the lateral condyle and 8 mm of the distal aspect of the medial condyle. Therefore, 8 mm of resection of the medial condyle plus 2 mm of measured cartilage loss will accommodate a 10 mm implant medially. Similarly, a 10 mm resection of the lateral condyle will accommodate a 10 mm implant laterally.

[0037] The surgeon then sizes the implant using a sizing guide or sizing calipers. Surgical kits typically include several implant size options to accommodate variations in patient populations. Once the sizing guide is used to inform the surgeon of the appropriate implant size, the surgeon removes the sizing guide and places a 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 make an anterior cut, a posterior cut, and two chamfer cuts (see Figure 1).

[0038] A femoral implant trial (see FIG. 15a) is then placed on the resected distal end 12 of the femur 10. The femoral implant trial 15a desirably matches the sizing of the endoprosthetic implant that will be installed later. A distraction or retraction device, such as a gap spacer (see 25a in FIG. 4), is then inserted into the joint gap 3 (FIG. 3A) to measure the medial and lateral dimensions of the joint gap 3.

[0039] To determine the amount of proximal tibial resection, the measured dimensions of the medial and lateral aspects of the joint gap are subtracted from the desired thickness of the resection. For example, if a surgeon plans to use a 10mm tibial implant with a 3mm medial gap and a 1mm lateral gap, the surgeon would orient the tibial resection guide to resect 7mm of the medial side of the tibial plateau and 9mm of the lateral side of the tibial plateau. It will be appreciated that with kinematic alignment techniques, release of the MCL or LCL is typically unnecessary. If the distal resection plane is not initially parallel to the proximal tibial resection plane, the surgeon typically recuts the tibia until the surgeon achieves the desired rectangular joint gap.

[0040] Adjusting the position of the tibial resection guide based on measurements from the extension or traction device generates a calculated resection angle based on the patient's specific anatomy. Based on these measurements, the tibial resection guide is typically oriented at a varus angle relative to the transverse plane; however, in some patients, this angle may be valgus or approach 0°. Due to the geometry of the meniscal insert and the femoral component of the endoprosthetic implant assembly, the reconstructed joint line is nearly parallel to the plane of the tibial resection. Replicating the natural, pre-injury joint line is a critical step in restoring balanced, natural kinematics of the knee. A kinematically balanced knee avoids problems with mechanical and anatomical concepts.

[0041] Described herein are instruments, assemblies, kits, systems, and methods that may be configured for use in primary total knee arthroplasty ("TKA").

[0042] Interlocking Drill Guide Technique with Engaging Femoral Trials 1-10 generally illustrate method steps, exemplary devices, and assemblies that may involve the use of a femoral trial including an exemplary interlocking drill guide 30 and having a first complementary femoral engaging member 13 and a second complementary femoral engaging member 13z.

[0043] FIG. 1 is a perspective view depicting the resected distal end 12 of a femur 10. As shown in FIG. 1, the femur 10 is prepared using a preferred resection technique. Distal cuts, anterior / posterior cuts, and chamfer cuts are made to form distal resection surface 5, posterior resection surface 6, anterior resection surface 2, and chamfer resection surfaces 8a, 8b, respectively (see also FIG. 7B). The chamfer resection surfaces 8a, 8b include anterior chamfer resection surface 8a and posterior chamfer resection surface 8b. While a 4-in-1 cutting block may desirably be used to create posterior resection surface 6, anterior resection surface 2, and chamfer resection surfaces 8a, 8b, it will be understood that other instrumentation may be used in place of or in addition to the 4-in-1 cutting block, depending on the surgeon's preference. A femoral reference instrument 15 is provided. The depicted femoral reference instrument 15 is a femoral trial 15a having a first complementary femoral engaging member 13 and a second complementary femoral engaging member 13z in the form of femoral reference holes 13a. A trial implant, such as the depicted femoral trial 15a, is a trial endoprosthesis that generally has the same functional dimensions as the actual endoprosthesis, but the trial implant is designed to be temporarily installed and easily removed for the purposes of evaluating the fit of the actual endoprosthesis and for the purposes of evaluating the kinematics of the knee joint. Once the surgeon is satisfied with the sizing of the trial implant and the kinematics of the knee joint, the surgeon typically removes the trial implant and installs the actual implant.

[0044] In other exemplary embodiments, the femoral reference instrument 15 may be a distal reference guide 15b (FIG. 12A), a distal femoral resection guide 15c (FIG. 16), a pin 15d (FIG. 17A), or any other instrument disposed on the distal end 12, or preferably in close association with the distal end 12, of the distally resected surface 5 of the surgical femur 10. These instruments may be used directly or indirectly to confirm the position of the distal surface of the resected femur 10 relative to the proximal surface of the tibia 20 of the surgical femur 10. When these instruments are used with the exemplary distal reference coupled drill guide assembly 1, in the engaged configuration, they mechanically convey, directly or indirectly, information regarding the orientation of the distal resection surface 5 of the femur to the tibia 20. In other words, when the exemplary distal reference coupled drill guide assembly 1 is in the engaged configuration, the femoral reference instrument 15 can be used to mechanically transmit information regarding the orientation of the distal resection surface 5 of the femur directly to the tibia 20 (or indirectly through an intermediate instrument such as the pivoting tibial resection guide 40).

[0045] As shown in FIG. 2, each of the femoral reference holes 13a (i.e., exemplary first and second complementary femoral engaging members 13, 13z) receives a femoral linking pin 17. The tips of these femoral linking pins 17 (see tips 11 of flared fixation pins 34 in FIG. 9) are then placed into the distal portion of the resected femur 10. In the depicted embodiment, the femoral linking pins 17 function as first and second femoral engaging elements 19, 19z.

[0046] It will be appreciated that 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 associated instrumentation, such as the distal femoral resection guide 15c (FIG. 16), pivoting tibial resection guide 40 (FIG. 7A), linking drill guide 30, other drill guides, and other surgical instrumentation. It will also be appreciated that in other exemplary embodiments, the femoral linking pin 17 may have visual or tactile indicators to reduce surgeon error. Visual indicators may include different colors and markings. Visual and tactile indicators may include raised or recessed portions of the femoral linking pin 17.

[0047] While the exemplary embodiment of FIGS. 1-10 illustrates a first complementary femoral engaging member 13 and a second complementary femoral engaging member 13z in the form of femoral reference holes 13a, it will be understood that other exemplary embodiments may include one complementary femoral engaging member 13. Still other exemplary embodiments may include three or more complementary femoral engaging members 13, 13z, etc. The complementary femoral engaging member 13 may take the form of a hole, slot, recess, protrusion, clamp, lip, magnet, spike, or any other structure known in the art used to selectively (directly or indirectly) securely engage and disengage one component from another component, as well as any combination thereof. It will be understood that in certain exemplary embodiments, the complementary femoral engaging member 13 may be present on the distal femur 10 itself, and the femoral engaging member 19 of the coupled drill guide 30 may be configured to engage a complementary femoral engaging member 13 disposed directly on the distal femur 10. In such an exemplary embodiment, the complementary femoral engaging member 13 is likely to be a drill hole placed directly in the distal femur 10 created by a drill bit guided by a drill guide.

[0048] As shown in FIG. 2, the femoral linking pin 17 is threaded through the femoral reference hole 13a of the femoral trial 15a. In certain exemplary embodiments, the femoral linking pin 17 may be threaded. In such embodiments, the femoral linking pin 17 is desirably threaded at its distal end (see FIG. 9) to securely engage the femoral linking pin 17 in the bone. The femoral linking pin 17 is placed in the femoral trial 15a.

[0049] As shown in FIGS. 3A and 3B , a distraction device 49 in the form of a gap spacer 25 is inserted medially and laterally to fill the joint gap 3 defined by the area between the distal surface of the femur 10 and the proximal surface of the tibia 20. It will be understood that gap spacer 25 may 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 to measure or otherwise assess the size of the joint gap 3 (i.e., the height of the medial and lateral joint gap 3). In this manner, such a distraction device is “configured to be placed” between the resected distal femur 10 and the proximal tibia 20 to ascertain the distance between the distal femur 10 and the proximal tibia 20. It will be understood that the distraction device 49 can be placed within the joint gap 3 when the knee is in flexion or extension.

[0050] In the embodiment depicted in FIGS. 3A and 3B, the gap spacer 25 is a spoon gap spacer 25a. The measuring elements 26 of the spoon gap spacer 25a are desirably curved to closely abut the curved surface of the femoral trial 15a. It will be understood that a number of gap spacers 25 having different sized measuring elements 26 are typically provided for a procedure. The different sized measuring elements 26 are typically provided in 1 mm height increments, although other increments are also contemplated. FIG. 3B shows the measuring elements 26 of the medial gap spacer 25 (i.e., the gap spacer 25 depicted on the left side of the image) as being thicker than the measuring elements 26 of the adjacent lateral gap spacer 25 (i.e., the gap spacer 25a depicted on the right side of the image).

[0051] A spoon gap spacer 25a may be provided for the left and right legs. Different embodiments of the gap spacer 25 include a snap-on spacer 25b shown in FIG. 6A, different sized trays or plugs configured to be inserted into the joint space 3, and spacers having a removable measuring element 26. Nothing in this disclosure limits the types of gap spacers 25 that are compatible with exemplary embodiments of the present disclosure.

[0052] It will further be understood that the distraction device 49 can include other ligament tensioning devices, such as gap spacers 25, lamina spreaders, ratchet tensioners, or gap balancing devices. In certain exemplary methods, a traction device may be used instead of or in addition to a distraction device. While a distraction device is typically inserted into the surgical area of ​​the knee to separate the distal femur 10 from the proximal tibia 20 at the joint space 3, a tensioning device is typically placed outside the surgical area, for example, on the patient's ankle or on the patient's leg, to pull on the surgical leg, thereby providing traction and separating the distal femur 10 from the proximal tibia 20 at the joint space 3. It will be understood that the tensioning device can include a boot configured to encapsulate a portion of the patient's leg, ankle, or foot on the surgical leg, a surgeon's or technician's hand, or other device configured to apply traction to the surgical leg.

[0053] After the distal femoral cut is made, the surgeon would selectively insert different sized spoon gap spacers 25a medially and laterally into 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 the distraction device 49 (e.g., spoon gap spacer 25a), in combination with the use of the articulating drill guide 30, can eliminate the need for “gap balancing” and release of either the MCL or LCL in the engaged position, as described further below, thereby avoiding the risk of hematoma, unnecessary trauma to ligaments, scarring, and increased healing time that would otherwise result from conventional mechanical alignment techniques. The distraction device 49 effectively sets the joint gap 3 at the desired distance, while the articulating drill guide 30 communicates information regarding the orientation of the distal femoral cut to the tibial resection guide (which may be a pivoting tibial resection guide), allowing the surgeon to quickly make a tibial cut that is typically and desirably parallel to the distal femoral cut. The distal femoral cut and the proximal tibial cut effectively define a "rectangle" into which the endoprosthetic implant will be inserted.

[0054] Previously, in mechanical alignment techniques, the MCL or LCL would be released (i.e., cut) to define a "rectangle" into which the endoprosthetic implant would be inserted. In this manner, it is contemplated that the coupled drill guide 30 may be used to avoid the need for "gap balancing," releasing the MCL or LCL, and the associated scarring, hematoma, trauma, and increased healing time of conventional methods. These improvements may be particularly noticeable when the exemplary coupled drill guide 30 is used in mechanical alignment techniques.

[0055] It is contemplated that the exemplary embodiments described herein can be used in conjunction with mechanical alignment techniques, anatomical alignment techniques, kinematic alignment techniques, or any other techniques practiced by a qualified orthopedic surgeon.

[0056] 4 illustrates an exemplary distal reference and coupled drill guide assembly 1 in an engaged configuration. The exemplary distal reference and coupled drill guide assembly 1 generally includes a femoral reference instrument 15 and a coupled drill guide 30.

[0057] The exemplary coupled drill guide 30 has a femoral portion 32 configured to engage a first femoral engaging member 19. The first femoral engaging member 19, in turn, is configured to engage a first complementary femoral engaging member 13 of the femoral reference instrument 15. The depicted coupled drill guide 30 is further configured to engage a second femoral engaging member 19z. The second femoral engaging member 19z is configured to engage a second complementary femoral engaging member 13z (FIG. 1) of the femoral reference instrument 15. The coupled drill guide 30 may be referred to as a "yoke" if desired.

[0058] The femoral portion 32 of the coupled drill guide 30 has an area defining a femoral coupling hole 22 (FIG. 5A). The femoral coupling hole 22 is an exemplary structure that allows the femoral portion 32 of the coupled drill guide 30 to engage with the first femoral engaging member 19. By having the femoral coupling hole 22 that can be positioned around the femoral coupling pin 17, the coupled drill guide 30 can be said to “indirectly engage” the femoral reference instrument 15 via the first femoral engaging member 19, which in the depicted embodiment takes the form of the femoral coupling pin 17, and the first complementary femoral engaging member 13, which in the depicted embodiment takes the form of the first femoral reference hole 13a (FIG. 1). In such an exemplary manner, the femoral portion 32 can thereby be said to be “configured to engage the first femoral engaging member 19.”

[0059] Similarly, the second femoral coupling hole 22z is exemplary structure that allows the femoral portion 32 to engage the second femoral engaging member 19z. By having the second femoral coupling hole 22z that can be positioned around the second femoral coupling pin 17, the coupling drill guide 30 can be said to "indirectly engage" the femoral reference instrument 15 via the second femoral engaging member 19z, (which in the depicted embodiment takes the form of the femoral coupling pin 17), and the second complementary femoral engaging member 13 (which in the depicted embodiment takes the form of the second femoral reference hole 13z). In such an exemplary manner, the femoral portion 32 can thereby be said to be "configured to engage the second femoral engaging member 19z."

[0060] While femoral linking pin 17 and femoral linking hole 22 are provided as examples of what femoral portion 32 may be provided to be configured to engage with femoral engaging members 19, 19z, etc., it will be understood that any mechanical engagement mechanism designed to selectively engage one component with another is considered to be within the scope of this disclosure. Furthermore, while first and second femoral reference holes 13a are provided as examples of first and second complementary femoral engaging members 13, 13z that are "configured to receive" the distal end of femoral linking pin 17 (e.g., femoral engaging members 19, 19z, etc.) and thereby "engage" with a femoral engaging member, it will be understood that any mechanical engagement mechanism designed to selectively engage one component with another is considered to be within the scope of this disclosure.

[0061] It will also be appreciated that in other exemplary embodiments, the first femoral engaging member 19 is an integral part of the coupled drill guide 30. For example, the first femoral engaging member 19 may be permanently engaged to the femoral portion 32 and may extend directly from the femoral portion 32 of the coupled drill guide 30 (see blade 19c in FIGS. 13A and 17B). In embodiments in which the coupled drill guide 30 includes a first femoral engaging member 19 that is permanently engaged to the femoral portion 32, such embodiments may similarly be said to be "configured to engage the first femoral engaging member 19." The same is true for exemplary coupled drill guides 30 that include a second, or even three or more permanently engaged femoral engaging members 19z, etc. The interlocking drill guide 30, which includes permanently fixed femoral engaging members 19, 19z, etc., can further be said to "directly engage" the femoral reference instrument 15 via the first femoral engaging member 19 and the first complementary femoral engaging member 13.

[0062] Similarly, in embodiments in which the coupled drill guide 30 includes a second femoral engaging member 19z, such embodiments may similarly be said to be "configured to engage the second femoral engaging member 19z." The coupled drill guide 30 including the second femoral engaging member 19z may further be said to "directly engage" the femoral reference instrument 15 via the second femoral engaging member 19z and the second complementary femoral engaging member 13z.

[0063] In the depicted embodiment, the first femoral engaging member 19 and the second femoral engaging member 19z are femoral connecting pins 17, 17z, and the first complementary femoral engaging member 13 and the second complementary femoral engaging member 13z of the distal femoral reference instrument 15 are femoral reference holes 13a.

[0064] It will be appreciated that in other exemplary embodiments, the first femoral engaging member 19 or the second femoral engaging member 19z can comprise a slot, lip, clamp, hook, protrusion, recess, spike, magnet, orientation pin 19b (FIG. 13B), blade 19c (FIG. 17B), or any other structure known in the art used to selectively securely engage and disengage one component directly or indirectly with another component, as well as any combination thereof. In certain exemplary embodiments, the first femoral engaging member 19 or the second femoral engaging member 19z physically contacts the first complementary femoral engaging member 13 without an intermediate element. In such embodiments, the first femoral engaging member 19 or the second femoral engaging member 19z can be said to "directly engage" the first complementary femoral engaging member 13 or the second complementary femoral engaging member 13z. Similarly, when an intermediate element is present, the first femoral engaging member 19 or the second femoral engaging member 19z can be said to "indirectly engage" the first complementary femoral engaging member 13 or the second complementary femoral engaging member 13z.

[0065] The interlocking drill guide 30 further includes a tibial portion 31. The tibial portion 31 has an area defining 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 body 36 of the interlocking drill guide 30 and the generally parallel arrangement of the reference markings on the respective femoral and tibial portions 32, 31 (e.g., the femoral interlocking holes 22, 22z and the tibial reference holes 23, 23z) convey information regarding the orientation of the distal resection surface (coplanar with the distal resection surface 5) to the tibial portion 31 of the interlocking drill guide 30. In certain exemplary embodiments, the body 36 may have a fixed length. Multiple interlocking drill guides 30 may be provided, each having a body 36 having a different length than the body 36 of another interlocking drill guide 30 provided in the kit. In such an exemplary embodiment, a surgeon may select one interlocking drill guide 30 of the multiple provided interlocking drill guides 30 to transfer information regarding the distal resection surface 5 of the femur 10 to the tibial resection guide 40 ( FIG. 7A ) for purposes of setting the plane of the tibial resection. In certain procedures, it is desirable for the plane of the tibial resection to be parallel to the plane of the distal resection.

[0066] In other exemplary embodiments, the body 36 can have an adjustable length dimension relative to the femoral portion 32, relative to the tibial portion 31, or relative to both the femoral portion 32 and the tibial portion 31. In yet other exemplary embodiments, the length of the femoral portion 32 or the tibial portion 31 can be adjustable relative to the body 36. In any embodiment that includes adjustment of the length of the linked drill guide 30, the adjustable component desirably can be locked at a desired length. It is contemplated that a kit featuring such an adjustable-length linked drill guide may include fewer linked drill guides 30 than a kit that includes multiple linked drill guides 30 having multiple different lengths.

[0067] In certain exemplary embodiments, the linked drill guide 30 is provided as a single piece. It is contemplated that, compared to exemplary embodiments in which the linked drill guide 30 is not a single piece but rather includes multiple components, a single piece may be easier to sterilize between procedures and may obviate the risk of mechanical failure. The linked drill guide 30 is desirably sized to be placed anteriorly of the knee exposed to the surgical field. It is contemplated that the exemplary linked drill guide 30 described herein may reduce the overall instrumentation required to perform a TKA while allowing a surgeon to resect the proximal tibia more quickly than can be safely achieved with existing instrumentation.

[0068] Similar to the femoral coupling holes 22, 22z provided in the femoral portion 32, the first tibial reference hole 23 in the tibial portion 31 allows the tibial portion 31 to engage a first tibial engagement member 77 (FIG. 5A). The depicted embodiment includes a first tibial engagement member 77 in the form of a tibial coupling pin 27 and a second tibial engagement member 77z. By having the first tibial reference hole 23 that can be positioned around the tibial coupling pin 27, the coupling drill guide 30 can be said to be "configured to engage a first tibial engagement member 77."

[0069] Similarly, the second tibial reference hole 23z is an exemplary structure that allows the tibial portion 31 to engage the second tibial engagement member 17z. By having the second tibial reference hole 23z that can be positioned about the second tibial engagement member 77z, the tibial portion 31 can thereby be said to be "configured to engage the second tibial engagement member 77z."

[0070] In the depicted embodiment, the first tibial engaging member 77 and the second tibial engaging member 77z are tibial linking pins 27, 27z.

[0071] It will be understood that in other exemplary embodiments, the first tibial engaging member 77 or the second tibial engaging member 77z can include slots, lips, clamps, hooks, protrusions, recesses, spikes, magnets, orientation pins, blades, or any other structure known in the art used to selectively securely engage and disengage one component, directly or indirectly, with another component, and any combination thereof. In certain exemplary embodiments, the first tibial engaging member 77 physically contacts the tibia 20 without an intermediate element. In such embodiments, the first tibial engaging 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 engaging member 77 and the second tibial engaging member 77z can engage an intermediate component, which itself can directly engage the tibia 20. In such an embodiment, the first tibial engaging member 77 and the second tibial engaging member 77z can be said to "indirectly engage" the tibia 20.

[0072] It is contemplated that the exemplary coupler drill guide 30 according to the present disclosure may be fabricated from (or coated with) any clinically proven, biocompatible material, including stainless steel, cobalt-chromium alloy, or a plastic polymer such as ultra-high molecular weight polyethylene ("UHWPE"). In certain exemplary embodiments, the coupler drill guide 30 may be a single-use, disposable coupler drill guide. In other exemplary embodiments, the coupler drill guide 30 may be designed for use in multiple surgical procedures. Regardless of the embodiment, the exemplary coupler drill guide 30 is desirably sterilized before entering the surgical field.

[0073] As shown in FIG. 4 , the coupling drill guide 30 is slid over the femoral coupling pin 17 until the tibial portion 31 of the coupling drill guide 30 contacts the anterior tibial cortex 21 of the proximal tibia 20. In the depicted embodiment, the sliding of the femoral coupling holes 22 of the femoral portion 32 over the coupling pin 17, which extends through the femoral reference holes 13a of the femoral trial 15a, defines the engaged configuration of the distal reference coupling drill guide assembly 1. Similarly, it will be understood that the distal reference coupling drill guide assembly 1 is in the 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 coupling drill guide assembly 1 is in the disengaged configuration when the femoral coupling holes 22 of the femoral portion 32 are not positioned around the coupling pin 17.

[0074] While femoral coupling hole 22 is provided as an example, it will be understood that femoral coupling hole 22 may 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) securely engage and disengage one component from another, as well as any combination thereof. It will also be understood that in embodiments in which femoral engagement members 19, 19z, etc. are integrally engaged to coupled drill guide 30 (see, e.g., FIGS. 13B and 17B), femoral coupling hole 22 may be absent.

[0075] The expansion device 49, such as the gap spacer 25, may be in place before the connecting drill guide 30 is slid onto the femoral connecting pin 17, or the expansion device 49 may be placed in the joint gap 3 after the connecting drill guide 30 has been slid onto the femoral connecting pin 17.

[0076] As shown in FIGS. 5A and 5B , with the spoon gap spacer 25a in place, a tibial linking pin 27 is placed into 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 tibial drill holes 23a. In other exemplary embodiments, the tibial reference holes 23 can take the form of holes, slots, canals, recesses, protrusions, clamps, lips, magnets, spikes, or any other structure known in the art used to selectively (directly or indirectly) securely engage and disengage one component from another, as well as any combination thereof. It will also be understood that in embodiments in which the tibial engagement member is integrally engaged to the connecting drill guide 30, the tibial reference holes 23, 23z may not be present. In certain exemplary embodiments, only one tibial reference hole 23 may be present. The tibial linking pin 27 is fixed to the tibia 20. In certain exemplary embodiments, the tibial linking pin 27 is threaded. In such an exemplary embodiment, the tibial linking pin 27 is preferably threaded at the tip 11 to fixedly engage the tibial linking pin 27 within the tibia 20 (see tip 11 of flared fixation pin 34 in FIG. 9 for reference).

[0077] Alternatively, as shown in Figures 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 appreciated that the measuring element 26 of the snap-on spacer 25b can occupy substantially the same area as the snap-on spacer 25b itself. Figure 6B provides an illustrative example of an inner snap-on spacer 25b1 that is thicker than an adjacently positioned outer snap-on spacer 25b2.

[0078] 7A , the articulating drill guide 30 is removed, leaving the femoral linking pin 17 in place within the femur 10 and the tibial linking pin 27 in place within the tibia 20. The receiving slot 87 of the pivoting tibial resection guide 40 is slid over the tibial linking pin 27. In the depicted embodiment, the receiving slot 87 extends generally anterior-posterior through the body 40a of the pivoting tibial resection guide 40. The receiving slot 87 is desirably sized to closely encompass the medial-lateral width of the tibial linking pin 27, while having a generally vertical (i.e., up-down) length dimension that allows the pivoting tibial resection guide 40 to pivot about the tibial linking pin 27, as described further below.

[0079] 30 is an anterior cross-sectional view of an exemplary pivoting tibial resection guide 40. The pivoting tibial resection guide 40 can include a pivoting tibial resection guide body 40a. The body 40a defines a substantially linear resection slot 46 disposed above a pivot recess 78. The pivot assembly 55 can be precisely sized to rotate about an axis within the pivot recess 78. The pivot assembly 55 itself is preferably positioned above a locking mechanism recess 79 sized to closely surround the locking mechanism 48. The body 40a further includes regions defining a plurality of standard holes 33, a +2 mm standard pin hole 33, and a flared fixation pin receiving hole 35.

[0080] The depicted 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 on both ends of the pivot guide 66 to prevent the pivot guide 66 from sliding from the pivoting tibial resection guide 40. The pivot guide 66 desirably has one or more complementary tibial engagement members 68 capable of receiving the tibial engagement members associated with the drill connection guide 30. The complementary tibial engagement members 68 may include slots 68b sized to receive the connection tabs 64 of the spike plate 67 (see the embodiment depicted in FIG. 20B ) and tibial engagement holes 68a disposed adjacent the outside of both slots 68b. However, in certain exemplary embodiments, one or more tibial engagement holes 68a may be provided in place of slots 68b, or vice versa.

[0081] As shown in the side view of FIG. 7B, the tibial resection level is automatically set to accommodate a 10 mm tibial component (or construct) of an endoprosthesis assembly, which may include a tibial trial base 93 (FIG. 29) and a meniscal trial insert 95 (FIG. 29). In embodiments, the interlocking drill guide 30 may be fabricated to allow for other resection levels as needed or desired by the surgeon, such as with multiple interlocking drill guides 30, multiple pin holes on the interlocking drill guide 30, multiple interlocking holes on the pivoting tibial resection guide 40, or an adjustable interlocking drill guide 30.

[0082] As shown in FIG. 8 , the tibial posterior slope PS can be adjusted as needed to match the natural anatomy. The pivoting tibial resection guide 40 is configured so that it can be adjusted relative to the placement of the tibial linking pin 27 within the tibia 20. The tibial posterior slope PS can be envisioned as a plane extending generally anterior-posterior, medial, and lateral, and passing through the resection slot 46. In FIG. 8 , a side view of this plane is depicted as a line. The intersection of the tibial posterior slope PS with a transverse plane TP extending approximately horizontally through the tibia 20 defines the posterior slope angle θ. The placement of the transverse plane TP can be measured from any frame of reference useful for defining the posterior slope angle θ. In the depicted embodiment, the transverse plane TP is positioned coplanar with the tibial linking pin 27 extending into the tibia 20. In the side view of FIG. 8 , the transverse plane TP is depicted as a line. In embodiments, the pivoting tibial resection guide 40 can be adjusted from approximately minus 3 degrees to approximately plus 10 degrees relative to the tibial linking pin 27. Once the desired tibial posterior slope PS is reached, the pivoting tibial resection guide 40 can be locked into place using the locking mechanism 48 of the pivoting tibial resection guide 40.

[0083] 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 pins 37 through the standard pin holes 33 and into the tibia 20. The depicted standard pin holes 33 include 10 mm pin holes that are positioned below and slightly offset from the +2 mm standard pin holes 33. The pins 37 extend through the standard pin holes 33 in FIG. 9 . The +2 mm standard pin holes 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., meniscus trial insert 95 and tibial trial base 93, see FIG. 29 ). However, in common practice, if the amount of tibial resection was insufficient to allow for a 10 mm tibial construct, the pivoting tibial resection guide 40 would more likely be placed back onto the pins 37 in the +2 mm standard pin holes 33. It will be appreciated that other exemplary pivoting tibial resection guides 40 may have more than four pin holes 33. All feasible increments between standard pin holes 33 are considered within the scope of this disclosure.

[0084] In FIG. 9 , the tibial linking pins 27 have been removed from the receiving slots 87 of the pivoting tibial resection guide 40. The pins 37 extend through standard pin holes 33 into the tibia 20 and generally prevent further pivoting. Rather, these pins 37 can be used to secure the pivoting tibial resection guide 40 in a desired orientation. As shown, a flared fixation pin 34 can be used for added stability, if desired. The tip 11 of the flared fixation pin 34 extends into the anterior tibial cortex 21 of the proximal tibia 20.

[0085] As illustrated with reference to Figure 9, other resection levels of the proximal tibia 20 can also be achieved using multiple standard pin holes 33 located at different resection levels. Sliding the standard pin holes 33 located at different heights of the pivoting tibial resection guide 40 across the resection levels changes the position of the resection slot 46 above and below relative to the top of the tibial plateau, thereby allowing the surgeon to adjust the amount of resection to accommodate different sized endoprosthetic implant assemblies.

[0086] 10, the femoral trial 15a is removed and the proximal tibial resection is performed through the resection slot 46 of the pivoting tibial resection guide 40. The surgeon typically performs the resection using a handheld surgical saw inserted through the resection slot 46. In another exemplary embodiment, the surgeon can use the top of the pivoting tibial resection guide 40 as a plane to align the proximal tibial resection.

[0087] Once the tibial resection is complete, the surgeon selects the appropriately sized tibial trial base 93 and meniscal trial insert 95. The femoral trial 15a is then repositioned onto the resected distal end 12 of the femur 10 and a trial reduction is performed. Femoral groove, peg prep, and tibial keel prep can be performed according to the kinematic alignment technique or surgeon preference.

[0088] Distal referencing technique 11-15 generally illustrate method steps and exemplary devices and assemblies including another exemplary coupled drill guide 30, in which the femoral reference instrument 15 is a distal reference guide 15b having a complementary femoral engaging member 13.

[0089] FIG. 11 is a perspective view of a knee positioned in extension, 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 determine the medial and lateral gap distances. The surgeon or technician then selects a snap-on spacer 25b from many available snap-on spacers 25b, where a first snap-on spacer has a different thickness than another available snap-on spacer 25b. Once the appropriate thickness of the snap-on spacer 25b is selected, the fully assembled distal reference guide 15b will match the gap distance d determined in the step using the spoon gap spacers 25a (see FIG. 11).

[0090] In certain exemplary methods, the use of spoon gap spacer 25a can be omitted and a distal reference guide 15b having snap-on gap spacers 25b selectively selected to match the distance between the medial and lateral dimensions of joint gap 3 can be used in place of spoon gap spacer 25a.

[0091] In a particular exemplary method, the pivoting tibial resection guide 40 can also be used in a distal referencing technique. At the start of the distal referencing technique, the distal end 12 of the femur 10 is resected. Distal, anterior, posterior, and chamfer cuts are made to form distal resection surface 5, posterior resection surface 6, anterior resection surface 2, and chamfer resection surfaces 8a and 8b, respectively (see also FIG. 14B). U.S. Patent Application Publication No. 2019 / 0231365(A1), incorporated herein by reference, provides an example of how a surgeon may orient the distal, anterior, posterior, and chamfer cuts. As shown in FIG. 12B, after the distal resection, the knee is placed in extension and the distal reference guide 15b is inserted into the joint space 3. In the depicted embodiment, the distal reference guide 15b includes 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.

[0092] As seen 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 medially and laterally between the distal surface of the resected femur 10 and the proximal surface of the tibia 20 to 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, the femoral trial 15a is not placed on the resected femur 10 during the joint transfer step.

[0093] The distal referencing technique is performed using a 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 a medial local condylar portion 45M and a lateral local condylar portion 45L. Each condylar portion 45M, 45L has a complementary femoral engagement member 13. In the depicted exemplary embodiment, the complementary femoral engagement member 13 is a pin hole drilling 13b formed therethrough from anterior to posterior. Each pin hole drilling 13b can be accessed anteriorly for use in orienting the interlocking drill guide 30, as shown in FIG. 13A. A modular handle 41 is configured to easily attach and detach from the femoral reference portion 44 for use in maneuvering 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 accept a snap-on spacer 25b. Multiple thicknesses of snap-on spacers 25b are provided, with the appropriate thickness selected so that the fully assembled distal reference guide 15b matches the gap distance d determined in the previous step using spoon gap spacer 25a (see FIG. 11).

[0094] Figure 12B shows the use of modular handle 41 to slide distal reference guide 15b into joint space 3. As shown in Figure 12C, modular handle 41 can be detached from distal reference guide 15b after insertion, if desired.

[0095] As shown in FIG. 13A , with the distal reference guide 15b in place within the joint space 3, the docked drill guide 30 is inserted into the incision. The depicted exemplary embodiment of the docked drill guide 30 includes a recess 39 in the femoral portion 32 of the docked drill guide 30, allowing a modular handle 41 to be inserted through the recess 39 to engage the distal reference portion 44 of the distal reference guide 15b, if desired. A pair of femoral engagement members 19, 19z in the form of orientation pins 19b are formed on or adjacent the femoral portion 32 of the docked drill guide 30. It will be understood that in other exemplary embodiments, femoral docking holes 22, 22z, or other femoral engagement members 19 may be used in place of or in addition to the orientation pins 19b shown in FIG. 13A . The orientation pin 19b is inserted into the pin hole drill holes 13b of the condylar portions 45M, 45L until the tibial portion 31 of the joint drill guide 30 contacts the anterior tibial cortex 21. In this manner, the exemplary distal reference joint drill guide assembly 1 is positioned in an engaged configuration. The joint drill guide 30 includes a pair of tibial reference holes 23, 23z on or adjacent to the tibial portion 31 of the joint drill guide 30.

[0096] Modified embodiments of the coupled drill guide 30 and associated assemblies, systems, and methods described with reference to FIG. 13A are also contemplated. In such embodiments, the orientation pin 19b of the coupled drill guide 30 can be inserted directly into a drill hole formed in the distal femur 10. The exemplary coupled drill guide 30 can be sized to have the orientation pin 19b extend into a drill hole formed through the distal femur resection guide 8 (see 15c in FIG. 16). In certain exemplary embodiments, the orientation pin 19b can be a spike configured to engage a drill hole in the distal femur 10. In such exemplary embodiments, the spike is the femoral engagement member 19, and the drill hole in the distal femur 10 is the complementary femoral engagement member 13.

[0097] As shown in FIG. 13B, a tibial linking pin 27 is placed in each of the tibial reference holes 23, 23z of the linking drill guide 30. As shown in FIG. 13C, a modular handle 41 can optionally be used at this step for stability. The tibial linking pin 27 is inserted into the tibia 20. In certain embodiments, the tibial linking pin 27 is threaded at the tip 11 (see FIG. 15).

[0098] 14A , the linking drill guide 30 and distal reference guide 15b are removed from the joint, leaving the tibial linking pin 27 in place within the proximal tibia 20. The receiving slot 87 of the pivoting tibial resection guide 40 is slid over the tibial linking pin 27. From this point on, the technique is similar to that described above, except that the femoral trial 15a is not on the resected distal femur 10. It should be noted that once the linking pin 27 is placed in the tibia 20, the femoral trial 15a does not need to remain in place for any of the embodiments described herein.

[0099] 14B, the instrument may be sized so that the tibial resection level is automatically set to match the 10 mm tibial implant construct (i.e., the tibial trial base 93 plus the meniscal trial insert 95). In embodiments, the interlocking drill guide 30 can be fabricated to allow for other resection levels as needed or desired by the surgeon, such as with multiple interlocking guides, multiple pin holes, or adjustable guides.

[0100] As shown in FIG. 14C and with reference to FIG. 8, the tibial posterior slope PS can be adjusted as needed to match the natural anatomy in the manner described above. The pivoting tibial resection guide 40 is configured so that the pivoting tibial resection guide 40 can be adjusted relative to the placement of the tibial linking pin 27. In embodiments, the pivoting tibial resection guide 40 can have a posterior slope angle θ ranging from about minus 3 degrees to about plus 10 degrees relative to the linking pin 27. Once the posterior slope angle θ is set, the pivoting tibial resection guide 40 can be locked at the selected posterior slope angle θ.

[0101] As described above with reference to Figure 9, the pivoting tibial resection guide 40 is pinned in place through the standard pin holes 33. If desired, a flared fixation pin 34 can be used for added stability. The tibial linking pin 27 is removed.

[0102] 15, the proximal tibial resection is performed through the resection slot 46 of the pivoting tibial resection guide 40. Unlike the technique described above, there is no femoral trial 15a that is removed before performing the tibial resection.

[0103] Once the tibial resection is complete, the surgeon selects the appropriately sized tibial base and tibial insert trial. A femoral trial 15a is placed on the previously resected distal femur 10. If a distal referencing technique as described herein is used, the femoral trial 15a may not have a complementary femoral engaging member 13, such as the complementary femoral engaging 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 the kinematic alignment technique or surgeon preference.

[0104] Distal femur resection guide reference technique 16-28 generally illustrate exemplary devices and assemblies, as well as method steps that may involve the use of distal femoral resection guide 15c, including other embodiments of exemplary interlocking drill guide 30. FIG.

[0105] FIG. 16 is a perspective view of a knee in flexion. In the embodiment depicted in these figures, the femoral reference instrument 15 is a distal femoral resection guide 15c. The distal femoral resection guide 15c is slid over a femoral linking pin 17 that extends into the femur 10. In this embodiment, the femoral linking pin 27 is a standard pin otherwise used to identify the position of the distal femoral resection guide. The distal femoral resection guide 15c was positioned using kinematic alignment techniques known to surgeons. For example, the distal femoral resection guide assembly disclosed in U.S. Patent Application Publication No. 2019 / 0231365(A1) may have been used to orient the distal femoral resection guide 15c. Once oriented, the surgeon uses the femoral linking pin 17 to lock the position and orientation of the distal femoral resection guide relative to the distal femur 10. The surgeon then inserts a surgical saw through the resection slot 57 and resects the distal surface of the femur 10, creating a distal resection surface 5 via a distal cut.

[0106] In the exemplary coupled drill guide 30 depicted in FIG. 17A , the distal femoral resection guide 15c is then removed and the leg is placed in extension. It will be understood that the exemplary embodiment of the coupled drill guide 30 used may affect which instrument functions as the femoral reference instrument 15. For example, in FIG. 17A , the femoral resection guide 15c has been removed, while the femoral linking pins 17, 15d remain in place on the femur 10. The femoral linking pin 17 in the depicted embodiment functions as a type of femoral reference instrument 15, as the femoral linking pin 17, in conjunction with the depicted embodiment of the coupled drill guide 30, can be used to mechanically transfer information regarding the orientation of the distal resection surface 5 of the femur 10 to the tibial resection guide 40. Similarly, in FIG. 17B , the distal femoral resection guide 15c is a type of femoral reference instrument 15, where the slot 57 of the distal femoral resection guide 15c, when engaged with the blade 19c of the exemplary interlocking drill guide 30, mechanically transfers information regarding the orientation of the distal resection surface 5 of the femur 10 to the tibial resection guide 40.

[0107] The exemplary interlocking drill guide 30 shown in FIG. 17A includes a femoral portion 32. The femoral portion 32 includes a canal 24 capable of receiving a first femoral engaging member 19 and a second femoral engaging member 19z in the form of a femoral interlocking pin 17. That is, each canal 24 defines a interlocking hole 22 (see FIG. 5A). The canal 24 and interlocking hole 22 are capable of receiving a femoral interlocking pin 17 in substantially the same manner as described above with reference to FIGS. 4 and 5A. In this manner, the depicted embodiment is configured to engage the first femoral engaging member 19 and the second femoral engaging member 19z. In the depicted embodiment, the first and second complementary femoral engaging members 13z are drilled holes made directly in the distal femur 10. In FIG. 17A, the femoral interlocking pin 17 also functions as the first femoral engaging member 19 and the second femoral engaging member 19z. The distal femoral resection guide 15c is removed, and the placement of the femoral linking pins 17 on the distal surface of the femur 10 retains information about the plane of distal resection, which is coplanar with the distal resection surface 5. That is, the imaginary shortest possible line connecting the two femoral linking pins 17 can serve as a reference line parallel to the plane of distal resection of the femur 10.

[0108] The exemplary joint drill guide 30 further includes a tibial portion 31 having a canal 24 defining tibial reference holes 23, 23z, and a body 36 connecting the femoral portion 32 to the tibial portion 31. A handle 38 may optionally be provided to facilitate installation and removal of the joint drill guide 30. The handle 38 may be removable, or the handle 38 may be a permanent, integral part of the joint drill guide 30. The body 36 of the joint drill guide 30 conveys information regarding the orientation of the distal resection plane (coplanar with the distal resection surface 5) for the tibial portion 31 of the joint drill guide 30.

[0109] As best seen in FIGS. 18, 19A, and 19B, the distal ends 16 of the tubes 24 define tibial reference holes 23, 23z. The distal ends 16 of each of the tubes 24 are preferably recessed from the posterior distal end 18 of the tibial portion 31 of the coupled drill guide 30. When the coupled drill guide 30 is in the engaged configuration, the inferior surface 53 of the tibial portion 31 (FIG. 19B) aligns with the tibial resection plane. This feature allows the surgeon to visualize the tibial resection cut before it is made. The recesses 39 also allow for direct marking of the tibia 20 by creating a line connecting the two opposing inferior surfaces 53 at the distal end 18 of the tibial portion 31. Direct marking is typically performed using a surgical-grade, single-use marker or via a cauterization device. If desired, a line may be made drawn through the recess 39 separating the opposing inferior surfaces 53 at the distal end 18 of the tibial portion 31 .

[0110] 18 further shows a widening 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 condyle of the femur 10 and the medial and lateral condyles of the adjacent proximal tibial plateau 20 of the same leg. Instead of a distal reference gap spacer 25, a lamina spreader or other tensioning device may be used to tension the joint. Once determined, the surgeon inserts a tibial linking pin 27, as depicted in FIG. 19A.

[0111] FIG. 20A shows the tibial linking pin 27 remaining positioned on the proximal surface of the anterior cortex 21 of the tibia 20 after the linking drill guide 30 has been removed. As seen in FIGS. 21A and 22, the receiving slot 87 of the pivoting tibial resection guide 40 can then be slid over the remaining tibial linking pin 27. The locking mechanism 48 is in the unlocked position. A visual indicator can be provided on the front of the locking mechanism 48 to inform the surgeon of the position in which the locking mechanism 48 is positioned. In the depicted embodiment, an indicator located at the 9 o'clock position indicates that the locking mechanism 48 is unlocked. The posterior slope PS (see FIG. 8) can then be adjusted, and the proximal surface of the tibia 20 can be resected as described above (also see generally FIGS. 23-28).

[0112] 17B, ​​another exemplary embodiment of a coupled drill guide 30 is provided. In the depicted embodiment of the associated distal reference coupled drill guide assembly 1, a distal femoral resection guide 15c can be seen to function as the femoral reference instrument 15. A 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 coupled drill guide 30 is a blade 19c that is sized to fit closely within the femoral resection slot 57. In the depicted embodiment, a recess 39 may be present in the tibial portion 31 of the coupled drill guide 30. The recess 39 allows the coupled drill guide 30 to be slid over the stem portion 51 of the distal femoral resection guide 15c.

[0113] The blade 19c of the linking drill guide 30 is slid into the femoral resection slot 57 of the distal femoral resection guide 15c with the leg in extension. Figure 19B shows the tibial linking pin 27 being inserted into the tibial reference hole 23. Proceeding can then be performed as outlined in Figures 21A and 22 and described above.

[0114] FIG. 20B illustrates a spike plate 67 used as a reference instrument for the pivoting tibial resection guide 40 in place of the tibial linking pin 27. As shown in FIGS. 19A and 19B, the tibial linking pin 27 is inserted through the tibial reference holes 23, 23z in the tibial portion 31 of the linking drill guide 30 and threaded into the anterior cortex 21 of the proximal tibia 20. In FIG. 20B, both the linking drill guide 30 and the tibial linking pin 27 have been removed, thereby leaving a drill hole 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 linking tab 64 for facilitating selective engagement with the pivoting tibial resection guide 40. As will be further described below, the linking tab 64 can assume a planar orientation otherwise defined by the compound axis of the tibial linking 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 .

[0115] 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 from stainless steel or any other clinically proven biocompatible material with sufficient strength and durability.

[0116] As seen in FIG. 21B , the pivoting tibial resection guide 40, having a reference slot 41, is slid over the linking tab 64 of the spike plate 67. The linking tab 64 is visible through the open resection slot 41. The linking tab 64 is oriented parallel to the resection slot 46, thereby indicating the orientation of the plane otherwise formed by the compound axis of the tibial linking pin 27 (see PS in FIG. 8 ). To better facilitate the surgeon's pre-visualization of the tibial resection cut, which will be made in a parallel plane above the plane otherwise formed by the compound axis of the tibial linking pin 27, the linking tab 64 may optionally be provided with a visual indicator, such as a different color from the surrounding instrumentation. The surgeon can lock the linking tab 64 into the reference slot 41 using a locking mechanism 48 on the anterior end of the pivoting tibial resection guide 40. In FIG. 21B , the locking mechanism 48 is shown in the unlocked position.

[0117] The spike plate 67 allows for medial and lateral positioning of the pivoting tibial resection guide 40 as well as inward and outward rotation of the pivoting tibial resection guide 40, while the use of the tibial connecting pin 27 precludes medial and lateral positioning of the pivoting tibial resection guide 40.

[0118] 23-25 ​​show a tibial visual tilt gauge 60 that may optionally be positioned within the resection slot 47 of the pivoting tibial resection guide 40. The posterior tilt angle θ of the tibial resection guide 40 may be adjusted from about −3° to about +10° relative to the placement of the tibial linking pin 27, or relative to the placement of the spike plate 67 in embodiments involving the use of the spike plate 67. Once the desired tilt and orientation is achieved, the pivoting motion may be locked by rotating the locking mechanism 48.

[0119] The locking mechanism 48 depicted in Figures 21B and in the cross-sectional views of Figure 30 is in an unlocked position. The locking mechanism 48 may be a friction locking mechanism such as that depicted in Figure 30, although other locking mechanisms configured to selectively secure the orientation of the pivoting tibial resection guide 40 are considered within the scope of the present disclosure. For example, a mechanical locking mechanism 48 may be provided in certain exemplary embodiments.

[0120] Referring to the locking mechanism in FIG. 30 and with further reference to FIG. 27 , a surgeon or technician can lock the locking mechanism 48 by inserting a keyed instrument through the interface of the locking mechanism 48. The keyed instrument may be a screwdriver, hex wrench, or other keyed instrument having a keyed end of any shape sized to closely engage a complementary key shape in the interface that is in rotational communication with the cam 73. When the keyed instrument is rotated, the interface rotates the cam 73 in the same direction. The cam 73 converts the rotational force into a linear force by pressing 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 pivot guide 66. This application of friction thereby prevents the pivot assembly 55 from rotating about its axis. In this manner, the surgeon or technician is said to “lock” the pivoting tibial resection guide at the desired posterior tilt angle θ.

[0121] It will be appreciated that in embodiments including the tibial linking pin 27, the tibial linking pin 27 extends through the tibial engagement hole 68a in the pivoting guide 66 to selectively engage the pivoting tibial resection guide 40 with the tibia 20. The tibial engagement hole 68a generally aligns with the receiving slot 87 in the pivoting tibial resection guide 40. Similarly, in embodiments including the linking tab 64, the slot 68b in the pivoting guide 66 is desirably sized to receive the linking tab 64 of the spike plate 67.

[0122] As shown in FIG. 26 , the tilt gauge is removed after the tilt of the pivoting tibial resection guide 40 is set. A standard pin 37 is then placed through the standard pin hole 33 in the pivoting tibial resection guide 40. The pivoting tibial resection guide 40 may be moved to a position +2 mm from the standard hole, if desired. The locking mechanism 48 is shown in the locked position. In the depicted embodiment, a visual indicator at the 12 o'clock position indicates that the locking mechanism 48 is locked. Other visual indicators that indicate the position of the locking mechanism are considered within the scope of this disclosure.

[0123] 27 shows the pivoting tibial resection guide 40 positioned at the desired posterior slope PS (see FIG. 8 ) and further depicts the flared fixation pins 34 extending through the pivoting tibial resection guide 40 to further secure the pivoting tibial resection guide 40 to the tibia 20 at the desired slope. The resection slots 46 of the pivoting tibial resection guide 40 orient the resection plane of the proximal end 29 of the proximal tibia 20.

[0124] FIG. 28 depicts the pivoting tibial resection guide 40 positioned at the desired posterior slope PS (see FIG. 8), with the proximal end 29 of the proximal tibia 20 (FIG. 27) resected.

[0125] 29 is a perspective view of the femoral trial 15a, tibial trial base 93, and meniscal trial insert 95 selected based on size criteria. Without being bound by theory, it is contemplated that the exemplary distal reference coupled drill guide 30 and / or exemplary distal reference coupled drill guide assembly 1 described herein can directly couple 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 possibility of surgeon error while also eliminating one or more extra steps otherwise required by conventional independently referenced or indirectly coupled kinematic alignment techniques. The minimal size of the exemplary distal reference coupled drill guide 30 and exemplary distal reference coupled drill guide assembly 1 allows the coupled drill guide 30 and drill guide assembly 1 to fit into the surgical field without requiring additional instrumentation that extends significantly outside the incision. It is contemplated that a minimal amount of instrumentation may facilitate instrument resterilization between procedures.

[0126] The instruments may be provided in the form of a kit. The kit components are preferably arranged in a convenient format, such as a surgical tray or case. However, the kit components need not be packaged or delivered together, provided they are assembled or collected together in the operating room for use during surgery. An exemplary kit may include any suitable embodiment of the coupled drill guide 30, variations of the coupled drill guide 30 described herein, and any other coupled drill guide 30 according to an embodiment. While it is contemplated that the exemplary kit may further include one or more femoral engaging members 19, 19z, etc., one or more tibial engaging 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 engaging member 19, variations of the femoral engaging member 19 described herein, and any other femoral engaging member 19 according to an embodiment are considered within the scope of the present disclosure. Any suitable embodiment of the tibial engaging member 77, variations of the tibial engaging member 77 described herein, and any other tibial engaging member 77 according to an embodiment are considered within the scope of this 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 an embodiment are considered within the scope of this disclosure.

[0127] Selection of the appropriate number or type of interlocking drill guide 30, femoral engaging member 19, tibial engaging 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 intended to be performed using the components included in the kit.

[0128] An exemplary medical device can include 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.

[0129] In such exemplary medical devices, the first femoral engaging member can be selected from the group consisting essentially of a femoral linking 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.

[0130] In such an exemplary medical device, the first tibial engaging member may 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.

[0131] An exemplary distal reference coupled drill guide assembly can include a coupled drill guide comprising: a femoral portion configured to engage a first femoral engaging member; a tibial portion configured to engage a first tibial engaging member; and a body connecting the femoral portion to the tibial portion; and a femoral reference instrument having a first complementary femoral engaging member configured to engage the first femoral engaging member, wherein the distal reference coupled drill guide assembly has an engaged configuration when the first femoral engaging member engages the first complementary engaging member, and the distal reference coupled drill guide assembly has a disengaged configuration when the first femoral engaging member does not engage the first complementary engaging member.

[0132] Such an exemplary assembly may further comprise a distraction device configured to be placed between the resected distal femur and the proximal tibia to confirm the distance between the distal femur and the proximal tibia, the distraction device being selected from the group consisting essentially of a gap spacer, a lamina spreader, a ratchet tensioner, or other knee ligament tensioning device.

[0133] Such an exemplary assembly may include a femoral portion further configured to engage a second femoral engaging member, and the femoral reference instrument may further include a second complementary femoral engaging member configured to engage the second femoral engaging member, which may be configured to selectively engage the second complementary femoral engaging member.

[0134] Such an exemplary assembly can have a femoral reference instrument selected from the group consisting essentially of a femoral trial, a distal reference guide, a pin, and a distal femoral cutting guide.

[0135] Such an exemplary assembly may include a tibial portion of the interlocking drill guide further configured to engage a second tibial engaging member.

[0136] Such an exemplary assembly can have an engagement arrangement that includes a first femoral engaging member that directly engages a first complementary femoral engaging member.

[0137] Such an exemplary assembly can have an engagement arrangement that includes a first femoral engaging member that indirectly engages a first complementary femoral engaging member.

[0138] Such an exemplary assembly may have a first femoral engaging member selected from the group consisting essentially of a femoral linking 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.

[0139] Such an exemplary assembly may have a first tibial engaging member selected from the group consisting essentially of holes, slots, recesses, protrusions, clamps, lips, magnets, spikes, and combinations thereof.

[0140] An exemplary medical device can include a femoral portion having a blade sized to fit closely within a femoral resection slot of a distal femoral resection guide, a tibial portion having a canal defining a tibial reference hole, and a body connecting the femoral portion to the tibial portion.

[0141] Such an exemplary assembly may further include a handle engaged with the body.

[0142] Such an exemplary assembly may have a tube recessed from the posterior distal end of the tibial portion of the interlocking drill guide, the tube defining the tibial reference hole.

[0143] Such an exemplary assembly can have the inferior surface of the tibial portion align with the tibial resection plane when the interlocking drill guide is in the engaged configuration.

[0144] Another exemplary medical device may include a femoral portion having a first femoral engaging member, a tibial portion configured to engage the first tibial engaging member, and a body connecting the femoral portion to the tibial portion.

[0145] Yet another exemplary medical device may include a femoral portion having a first femoral engaging member, a tibial portion having a first tibial engaging member, and a body connecting the femoral portion to the tibial portion.

[0146] An exemplary method may include engaging a femoral reference instrument to a distal femur, directly or indirectly engaging a first femoral engaging member to the distal femur, and directly or indirectly engaging a coupled drill guide to the first femoral engaging member, wherein the coupled drill guide comprises a femoral portion configured to engage the first femoral engaging member, a tibial portion configured to engage the first tibial engaging member, and a body connecting the femoral portion to the tibial portion.

[0147] In an exemplary method, the step of directly engaging the first femoral engaging member to the distal femur can include bringing the first femoral engaging member into physical contact with the anterior cortex of the distal femur.

[0148] In an exemplary method, the step of indirectly engaging the first femoral engaging member to the distal femur can include physically contacting the first femoral engaging member to a first complementary engaging member on the mid-femoral device, where a portion of the mid-femoral device physically contacts the distal femur.

[0149] In an exemplary method, the step of indirectly engaging the first femoral engaging member to the distal femur can further include physically contacting the first femoral engaging member with a first complementary engaging member on an intermediate device, wherein a portion of the intermediate device can be in physical contact with a subsequent intermediate device, and a portion of the subsequent intermediate device can be in physical contact with the distal femur.

[0150] An exemplary method can further include inserting an expansion device into a joint space defined by the distal femur and the proximal femur of the operative leg to ascertain a distance between the distal femur and the proximal tibia, the distance including a medial distance and a lateral distance.

[0151] An exemplary method may further include using a traction device to pull on the operative leg and apply traction to the proximal tibia or distal femur to expand the joint space.

[0152] Exemplary methods may further include directly or indirectly engaging a first tibial engagement member to both the proximal tibia and the tibial portion of the interlocking drill guide.

[0153] In an exemplary method, the step of directly engaging the first tibial engaging member to the proximal tibia can include bringing the first tibial engaging member into physical contact with the anterior cortex of the proximal tibia.

[0154] In an exemplary method, indirectly engaging the first tibial engaging member to the proximal tibia can include physically contacting the first tibial engaging member to a medial tibial device, a portion of which can be in physical contact with the proximal tibia.

[0155] In an exemplary method, the step of indirectly engaging the first tibial engaging member to the proximal tibia can further include physically contacting the first tibial engaging member with a medial tibial device, a portion of which can be in physical contact with the subsequent medial tibial device, and a portion of which can be in physical contact with the proximal tibia.

[0156] Exemplary methods may further include removing the coupled drill guide from the first tibial engaging member while the first tibial engaging member remains directly or indirectly engaged to the proximal tibia.

[0157] Exemplary methods may further include engaging a tibial resection guide to the first tibial engagement member.

[0158] An exemplary method may further include adjusting a posterior inclination angle of the tibial resection guide relative to the position of the first tibial engaging member to define a desired resection inclination.

[0159] An exemplary method may further include fixedly locking a tibial resection guide to the proximal tibia at the desired resection angle.

[0160] An exemplary method may further include resecting the tibial plateau of the proximal tibia at a desired resection slope.

[0161] Exemplary methods may further include adjusting the height of the tibial resection guide relative to the top of the proximal tibia to accommodate the height of the endoprosthetic implant assembly.

[0162] An exemplary method may further include adjusting a medial / lateral angle of the tibial resection guide relative to the first tibial engaging member to define a desired medial / lateral resection angle.

[0163] An exemplary method may further include fixedly locking a tibial resection guide to the proximal tibia at the desired medial / lateral resection angle.

[0164] An exemplary method may further include resecting the tibial plateau of the proximal tibia at a desired medial / lateral resection angle.

[0165] An exemplary method may further include adjusting a medial / lateral position of the tibial resection guide relative to the first tibial engaging member to define a desired medial / lateral resection position.

[0166] An exemplary method may further include fixedly locking a tibial resection guide to the proximal tibia at the desired medial / lateral resection location.

[0167] An exemplary method may further include resecting the tibial plateau of the proximal tibia at a desired medial / lateral resection location.

[0168] It is to be understood that the present invention is not limited to the particular configurations and method steps disclosed herein or illustrated in the drawings, but also includes any modifications or equivalents known in the art within the scope of the claims. Those skilled in the art will appreciate that the apparatus and methods disclosed herein will find utility.

Claims

1. A tibial resection guide (40), comprising: a body (40a) defining a pivot recess (78) extending laterally therein and a generally linear cutting slot (46) disposed above said pivot recess (78) and extending laterally and anteriorly through said body; A plurality of pinholes (33) penetrating the main body (40a) in the front-rear direction; a pivot assembly (55) disposed within the pivot recess (78), the pivot assembly (55) including one or more complementary tibial engagement members (68, 68a, 68b); Equipped with the pivot assembly (55) is precisely dimensioned to rotate axially relative to the body (40a) within the pivot recess (78); the pivot assembly (55) is positioned above a locking mechanism recess (79) in the body (40a) that is sized to closely surround a locking mechanism (48) included in the tibial guide (40); The locking mechanism (48) is locked to prevent the pivot assembly (55) from rotating axially.

2. 2. The tibial resection guide (40) of claim 1, wherein the body (40a) can be rotated relative to the pivot assembly (55) by axial rotation within the pivot recess (78) to define a desired posterior inclination angle (θ) relative to the tibial connecting pin (27) in the range of minus 3 degrees to plus 10 degrees.

3. 2. The tibial resection guide (40) of claim 1, wherein the locking mechanism (48) has a locked configuration and an unlocked configuration, and the locking mechanism (48) is configured to lock the tibial resection guide (40) at a desired posterior inclination angle (θ) in the locked configuration.

4. 4. The tibial resection guide of claim 3, wherein the locking mechanism comprises: a cam; an interface that is rotationally connected to the cam; a cam follower that is linearly connected to the cam, the cam follower having a cam end and an opposite end distal to the cam end; a spring that is disposed at the opposite end of the cam follower, the spring having a cam follower end and a shaft end; and a shaft that is disposed at the shaft end.

5. The tibial resection guide (40) of claim 4, wherein the interface is a keyed interface.

6. 2. The tibial resection guide of claim 1, wherein the locking mechanism further comprises a visual indicator that indicates a position of the locking mechanism,

7. The tibial resection guide (40) of claim 1, wherein the plurality of pin holes (33) further comprises a +2 mm pin hole (33) and a standard pin hole (33).

8. 2. The tibial resection guide (40) of claim 1, wherein the plurality of pin holes (33) further comprises diverging fixation pin receiving holes (35),

9. 2. The tibial resection guide (40) of claim 1, wherein the one or more complementary tibial engagement members (68, 68a, 68b) are selected from the group consisting essentially of one or more tibial engagement holes (68a) sized to receive a tibial linking pin (27) secured to the anterior portion of the tibia, and one or more slots (68b) sized to receive a linking tab (64) of a spike plate (67) secured to the anterior portion of the tibia.

10. The tibial resection guide of claim 1 , further comprising a tibial visual tilt gauge positioned within the resection slot of the swivel tibial resection guide.

Images