The present invention relates to surgical devices and, in particular, to devices and methods for arthroscopic surgeries.
Partial knee replacement surgery, also called unicompartmental knee arthroplasty, is routinely considered for the treatment of osteoarthritis of the knee joint. Partial knee replacement surgery has generated significant interest because it entails a smaller incision and faster recovery than traditional total joint replacement surgery.
Knee instability caused by either an anterior or posterior cruciate ligament laxity or compromise of the actual ligament due to injury is a contraindication to performing unicompartmental or unicondylar knee resurfacing procedures because of the resultant increased stresses placed upon the resurfacing implants. Having to stage these procedures increases the patient risk to morbidities associate with multiple surgical procedures.
Traditional methods for reconstructing the cruciate ligaments include antegrade drilling of tunnels through the tibial plateau and the femur to accept a tissue graft and implants to fixate the graft securely while it heals.
Unicompartmental and unicondylar knee resurfacing implants are traditionally cemented to a portion of the femoral condyle and tibial plateau bone after removal of the diseased portion of bone and cartilage to provide pain relief and restoration of limb alignment and compartmental kinematics. The implants are located in one of the compartments of the knee that are usually in close proximity to the tunnels drilled for graft placement during cruciate ligament reconstruction procedures.
Undermining the femoral or tibial implants for unicompartmental resurfacing could lead to interruption of the cement mantle and bone and subsequent subsidence of the implants or fracture of the bone leading to failure. Even with the use of targeting guides it has been demonstrated that accurately guiding the trajectory of the drills used to create antegrade drill holes to accept the graft is difficult to control and replicate and could lead to undermining the tibial or femoral bone on which the resurfacing implants will be attached.
There is a need for providing surgeons with instruments, implants, kits and systems to concomitantly perform unicompartmental knee resurfacing and knee ligament reconstruction procedures (such as ACL reconstruction, for example) without compromising either implant construct, as well as reducing overall morbidities associated with multiple staged surgical procedures. Also needed are methods and techniques for simultaneously-conducted cruciate ligament reconstruction and unicompartmental knee resurfacing procedures that provide a functional ACL with normal kinematics of the knee after unicondylar resurfacing/replacement. Methods and techniques that minimize graft damage during bone preparation and enable correct graft placement and tensioning with the joint space restored are also needed.
The present invention fulfills the above needs and objectives by providing improved systems and surgical techniques for arthroscopic procedures. The invention provides medical personnel with instruments and implants to concomitantly perform unicompartmental knee resurfacing and cruciate ligament reconstruction procedures without compromising either implant construct as well as reducing overall morbidities associated with multiple staged surgical procedures. The methods and systems of the present invention allow forming unicompartmental and unicondylar knee resurfacing in conjunction with cruciate ligament replacement concomitantly.
Unicondylar knee resurfacing is conducted with concomitant knee ligament reconstruction (such as, for example, GraftLink® All-Inside ACL Reconstruction using TightRope® ABS) and employing retrograde drilling. Retrograde drilling, which starts at the level of the resurfacing implants and travels away from the joint line and resurfacing implants, allows for more precise placement of the drill holes and also the drill trajectory, to avoid undermining the resurfacing implants. Retrograde drills also allow the surgeon to see the drill hole footprint at the joint line and resurfacing implant level more accurately, so the surgeon can place the starting point of the drill hole away from the resurfacing implants.
Other features and advantages of the present invention will become apparent from the following description of the invention.
The present invention provides advanced preservation and restoration techniques that extend a surgeon's ability to provide a broader continuum of care to treat a patient's knee pathology. The systems and methods of the invention allow the surgeons to offer patients an advanced, yet simple, option to treat the progression of joint degeneration and the underlying injuries they may encounter throughout their lifetime.
An exemplary method of conducting ligament reconstruction concomitantly with unicondylar resurfacing comprises inter alia the steps of: (i) forming femoral and tibial tunnels or sockets, at least the tibial tunnel or socket being formed by retrograde drilling; (ii) installing femoral and tibial components of a knee implant; and (iii) securing a tissue construct within the femoral and tibial tunnels or sockets.
In an exemplary embodiment, the tissue construct is an adjustable suture-button construct that is provided with at least one adjustable, knotless, flexible loop member having an adjustable length, two splices that are interconnected, and at least one button that is adapted for engagement with the adjustable, knotless, flexible loop member and that engages with a ligament.
In another embodiment, the tissue construct is a knotless, adjustable suture loop/button construct with first and second buttons that may have similar or different configuration, a continuous loop of flexible material attached to each button, each of the loops having an adjustable length to allow positioning of a tissue (e.g., ligament) within the tibia and femoral tunnels/sockets, and wherein each loop is provided with two discrete splices that allow adjustment in one direction while locking the construct in the opposite direction, and tissue (soft tissue, ligament, graft, BTB, or combinations thereof) securely attached to each of the two loops for positioning. In an exemplary only embodiment, the tissue construct is a presutured GraftLink® construct employed for an all-inside ACL reconstruction with TightRope® ABS, as detailed and described in U.S. Pat. No. 8,591,578 issued Nov. 26, 2013 (entitled ADJUSTABLE SUTURE-BUTTON CONSTRUCTS FOR LIGAMENT RECONSTRUCTION), the disclosure of which is incorporated by reference in its entirety herewith.
In an exemplary embodiment, the tissue construct is a GraftLink® used in combination with a FlipCutter® that allows independent femoral and tibial retrodrilling to create sockets, while maintaining the cortices to maximize fixation. A single hamstring harvest reduces morbidity and preserves strength. Two suspension TightRope® fixation implants, with a proprietary four-point locking system, make GraftLink® an innovative, reproducible ACL reconstruction.
Another exemplary method of conducting knee ligament reconstruction (for example, ACL reconstruction) concomitantly with unicondylar resurfacing comprises inter alia the steps of: (i) forming femoral and tibial tunnels or sockets, at least the tibial tunnel or socket being formed by retrograde drilling employing a retrocutter, a flip cutter or a dual-sided rotary drill cutter that is configured to cut in both directions, antegrade and retrograde; (ii) resecting tibia at least in horizontal and vertical directions; (iii) resecting femur at least distally and posteriorly; (iv) assessing the fit and position of tibial and femoral implants by employing at least one of a D-ring tibial trial, tibial bearing trials and femoral component trials; and (v) simultaneously (a) implanting the tibial and femoral implants within the tibia and femur and (b) implanting a GraftLink® construct within the femoral and tibial tunnels or sockets. In an exemplary-only embodiment, step (v) further comprises the steps of: installing the tibial trial bearing into the tibial tray; then, shuttling the Graftlink® construct into the femoral and tibial tunnels or sockets in an all-inside intraarticular manner; waiting for the UKA cement to dry; and then replacing the trial bearing with the final bearing of the tibial implant.
Another exemplary method of conducting ACL ligament reconstruction concomitantly with UKA comprises inter alia the steps of (i) forming femoral and tibial tunnels or sockets, at least the tibial tunnel or socket being formed by retrograde drilling employing a retrocutter, a flip cutter or a dual-sided rotary drill cutter that is configured to cut in both directions, antegrade and retrograde; (ii) resecting tibia in horizontal and vertical directions, and next and lateral to, the articular opening of the tibial tunnel or socket; (iii) measuring the flexion space by employing a spacer block into the leg compartment; (iv) resecting the femur at least distally and posteriorly with a distal cutting block and a posterior cutting block; (v) creating anterior and posterior lug holes using a femoral step drill; (vi) assessing the fit and position of tibial and femoral implants by employing at least one of a D-ring tibial trial, tibial bearing trials and femoral component trials; and (vii) simultaneously implanting the tibial and femoral implants within the tibia and femur and implanting a GraftLink® construct within the femoral and tibial tunnels or sockets by conducting the steps of (a) installing the tibial trial bearing into the tibial tray; (b) then, implanting the GraftLink® construct into the tibial and femoral sockets; (c) then, waiting for the UKA cement to harden; and (d) then, replacing trial bearing with final poly bearing of the tibial implant.
Referring now to the drawings, where like elements are designated by like reference numerals,
Straighten the FlipCutter® blade and remove from the joint. Pass a TigerStick® suture 26 into the joint and retrieve both the tibial TigerStick® 26 and the femoral FiberStick™ 16 out the medial portal together with an open Suture Retriever 31. Retrieving both sutures at the same time will help avoid tissue interposition that can complicate graft passing. A PassPort Button Cannula™ may also be used in the medial portal to prevent tangling. Graft passing sutures from femur and tibia will be docked out of the lateral arthroscopy portal in this step to get them out of the way for the unicondylar knee medial incision.
Attach the appropriate (left-medial or right-medial) tibial resection guide to the tibial alignment guide. The curved edge of the tibial resection guide should contact the anterior part of the tibia. The tibial resection should match the anatomic tibial slope. Loosen the screw that allows anterior/posterior motion of the tibial alignment guide relative to the ankle clamp, and adjust the tibial resection guide so that the proximal surface of the tibial alignment guide is parallel to the anatomic slope of the tibia. Tighten the screw to secure tibial slope alignment.
The stylus can then be removed from the cutting block. If additional tibial bone should need to be resected, the tibial alignment guide has markings in 1 mm increments that allow the cutting block to be lowered to accommodate additional bony resection.
Subsequent to the tibial cut, the femoral cut may be conducted and the femur prepared for receiving the femoral component of the UKA implant.
In flexion, the joint space should also open up 1 mm to 2 mm under stress. Another indicator of excess tightness in flexion is if the tibial bearing trial lifts up anteriorly during flexion. Resect additional posterior femoral bone if the joint is tight in flexion but not extension.
Use the tibial peg step drill 226 to drill the two tibial peg holes 226a. The drill bit can be left in the medial hole to add support during punching the keel. Insert the Keel Punch into the designated slot on the Tibial Guide. Mallet the Keel Punch down into the tibial plateau until it stops. The Keel Punch should be impacted until the tip is flush with the guide.
An exemplary graft 100 is shown in
Unfold the blue passing suture of the tibial end of the GraftLink® construct, exposing a loop and two tails. Drop the loop of the TightRope® into the blue loop of the passing suture (
Pass the free end of the TightRope® implant through the TightRope® loop (
The polyethylene implant 230 has a circumferential dovetail 232 that locks into the tibial component. The polyethylene components have a 1.5 inch elliptical radius in the sagittal plane creating an open articulation relationship with the femoral components. The anterior and posterior lip of the polyethylene implant 230 has 5° of clearance built in to allow for ease of insertion.
The methods of the present invention provide surgeons with the instruments and implants to concomitantly perform unicompartmental knee resurfacing and cruciate ligament reconstruction procedures without compromising either implant construct as well as reducing overall morbidities associated with multiple staged surgical procedures
Retrograde drilling, which starts at the level of the resurfacing implants and travels away from the joint line and resurfacing implants allows for more precise placement of the drill holes and also the drill trajectory to avoid undermining the resurfacing implants. Retrograde drills also allow the surgeon to see the drill hole footprint at the joint line and resurfacing implant level more accurately so the surgeon can place the starting point of the drill hole away from the resurfacing implants.
Retrograde cutting and drilling instruments and methods are disclosed, for example, in U.S. Pat. No. 8,652,139 issued Feb. 18, 2014 (disclosing a flip retrograde cutting instrument) or U.S. Pat. No. 8,591,514 issued Nov. 26, 2013 (retrograde cutter with rotating blade) or U.S. Pat. No. 8,038,678 issued Oct. 18, 2011 (dual-sided cutter for forming the femoral trough and tibial socket by retrograde drilling), the disclosure of all of which are incorporated by reference in their entireties herewith.
The rotary drill cutter described in U.S. Pat. No. 8,038,678 is a dual-sided rotary drill cutter that comprises two opposed sides and is provided with cutting surfaces on both sides, such that the rotary drill cutter is configured for cutting in two directions, a cannulation that is threaded such that forward drilling engages the rotary drill cutter to a drill pin, while simultaneously disengaging the cutter from an insertion rod.
The flip cutter instrument detailed in U.S. Pat. No. 8,652,139 is a flip retrograde with a cannulated elongated body having a distal end, a proximal end and a longitudinal axis, the body further comprising a shaft having a blade disposed at its distal end, the blade being securely engaged to the shaft and capable of movement from the straight position to a flip position and vice versa, the blade having a cutting diameter of about 6 mm to about 13 mm, and a locking tube housing the shaft. When the blade is in the straight position, retracting the locking tube allows the blade to articulate and to flip, within the joint space, from the straight position wherein the blade is aligned with the longitudinal axis of the shaft to the flip position which is not aligned with the longitudinal axis of the shaft and with the blade facing the proximal end of the body for retrograde drilling of a bone tunnel or socket. Locking the blade in the flip position by tightening the locking tube allows pulling the retrograde cutter proximally so that the blade in the flip position cuts in a retrograde manner in the bone, from the articular joint space towards an outer surface of the bone, and drills the bone tunnel or socket using the flip retrograde cutter with the blade in the flip position.
The UKA system detailed above is a complete, minimally invasive, instrument and implant platform for the treatment of localized unicondylar cartilage degeneration as a result of osteoarthritis or post-traumatic arthrosis in the medial or lateral compartment of the knee. The UKA system includes highly anatomic femoral and tibial resurfacing implants and a novel and innovative instrument platform that facilitates a highly accurate, efficient and reproducible surgical technique.
The GraftLink® Minimally Invasive ACL Reconstruction technique provides the ultimate in anatomic, minimally invasive and reproducible ACL reconstruction. Its independent tibial and femoral socket preparation with cutters such as the FlipCutter® limits soft tissue dissection, preserves bone/periosteum and facilitates unconstrained placement of the ACL graft in relation to the UKA resurfacing implants without compromising the bone underlying the UKA implants.
As detailed above, the presutured Allograft GraftLink® is a preassembled, sterile allograft tendon that was designed for use with an all-inside ACL technique such as the GraftLink® All-inside® ACL technique. The availability of this presutured allograft provides surgeons with a high quality, consistent, sterile and strong allograft tendon for use in primary or revision ACL procedures and eliminates the time needed to collect and prepare autograft tendon, speeding up the workflow. The tapered graft and adjustable femoral and tibial ACL TightRope® buttons facilitate graft passing, fine tuning of graft depth and graft tensioning from the femoral and tibial sides.
While the present invention is described herein with reference to illustrative embodiments for particular applications, it should be understood that the invention is not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, embodiments and substitution of equivalents all fall within the scope of the invention.