Patent Application
20230346390
The present invention relates to a surgical saw blade useful in treating disorders of the knee, termed the stifle in dogs, which facilitates performing Tibial Plateau Leveling Osteotomy (TPLO) with a preset closing wedge angle to compensate for the TPLO induced valgus that results from use of conventional saw blades.
The anterior cruciate ligament (ACL) in the human knee joint, commonly called the cranial cruciate ligament (CrCL) in the canine stifle, is frequently torn in trauma. It also frequently fails, particularly in dogs, after a degenerative process of still unknown etiology.
In human orthopedics, standard procedures replace the failed ACL with an ACL allograft or an autograft made from a part of the patient’s own patellar tendon or a part of the fascia and tendon removed from the hamstring muscles. The procedure results in a stable knee, but the long-term performance of the knee is often unsatisfactory. Roughly, 75-90% of cases result in degenerative arthritis of the joint within 15 years of the procedure.
In dogs, the standard procedure involves either placement of an extra-capsular suture or performance of one of several geometry-modifying surgical techniques. In the extra-capsular procedure, a suture is placed outside of the joint, usually on the lateral side, to approximate the function of the CrCL. The intention of the suture application is to provide stability of the joint for several weeks while waiting for fibrosis to occur around the joint. This fibrosis should then provide for long-term stability. However, the extra-capsular suture technique regularly results in failure. Degenerative arthritis of the joint, after a year or so, is the rule rather than the exception.
Attempts to replace the CrCL in the dog by an anatomically placed, intra-articular artificial ligament have also generally failed in spite of years of research and development of materials, anchor designs, and surgical techniques.
In surgical, geometry-modifying techniques, the tibia is cut and a segment of it is repositioned to change the geometry of the tibia and/or the joint in order to stabilize the stifle. Various techniques have been used, including tibial plateau leveling osteotomy (TPLO; see U.S. Pat. No. 4,677,973 and Slocum and Slocum, Vet. Clin. North Am.23:777-795, 1993), cranial closing wedge osteotomy (CWO; Slocum and Devine, J. Am. Vet. Med. Assoc. 184:564-569, 1984), and tibial tuberosity advancement (TTA; Tepic et al., Biomechanics Of The Stifle Joint, in Proceedings of the 1st World Orthopaedic Veterinary Congress, Munich, Germany, pp. 189-190. 2002; see EP 2854677 B1, Tepic and Hopmans). Of the surgical approaches used in dogs, TTA seems to be associated with less morbidity and faster recovery, and it also provides immediate and durable stability to the joint (Boudrieau, Vet Surg., 38(1):1-22, 2009). TPLO with more than a decade advantage in terms of clinical acceptance is the most commonly used geometry-modifying procedure.
Nevertheless, surgical complications are not uncommon with all these techniques. The most common is post-surgical damage to the medial meniscus caused by excessive, supra-physiological movement between the femur and the tibia. Failure of the fixation of TPLO by special plates and screws is relatively rare, but when it does occur, it is usually on the proximal segment and is very difficult to treat by revision procedure for lack of good bone purchase proximally to the osteotomy.
The present invention provides instruments and methods for surgically treating a partial or complete rupture of the cranial cruciate ligament (CrCL) by TPLO by correcting the valgus deformity at the stifle, which is an unintended consequence of performing TPLO using a conventional saw blade. The mechanical consequence of this valgus deformity is a lateral shift of the joint reaction force, which then causes an even higher tendency towards valgus. The lateral support at the osteotomy is greatly reduced by the TPLO rotation, so much so that the lateral cortices of the proximal and distal tibia segment cross at only two points at the osteotomy. Crushing of the bone at these points leads to even more valgus exposing the fixation by the screws of the TPLO plate to high pullout and bending forces. Even worse, it is mostly the one crossing of the cortices located in the caudal aspect of the saw cut that takes the brunt of the joint load. If a failure does occur, it is typically at the proximal segment of the tibia where the cortical bone is very thin, and the screws engage mostly in weak cancellous bone.
Clear indications of this mode of failure were observed in numerous in vitro experiments we have conducted wherein the hind limbs of dogs were tested to failure comparing intact limbs to those altered by the TPLO procedure. Typically, the TPLO constructs failed at about 50% of contralateral, intact limbs. This is in stark contrast to TTA constructs the strength of which were about 100% of intact. The reason for this major difference is that TTA does not disrupt the congruency of the joint and there is no deviation in position of the stifle in the transverse plane, i.e. the leg remains in the natural position within the sagittal plane.
This observation from experimental studies agrees with observations from clinical failures of TPLO. Even if no failure of the fixation develops, careful examination of TPLO cases frequently shows the partial collapse of the lateral support with the cortices cutting into each other and thus leading to furthering valgus deviation at the stifle. Another potential reason for TPLO-induced valgus is the very different shape of the medial and the lateral tibial condyles. Both condyles are convex, but the lateral condyle’s convexity is much higher. The rotation at the osteotomy by TPLO procedure changes the position of contacts between the femoral and tibial condyles resulting in the relative lowering of the lateral femoral condyle, which in an intact joint, rides on the high section of the tibial lateral condyle. This can also induce forced internal rotation of the tibia.
While it is possible to perform TPLO with so-called double cuts to correct for major varus or valgus deformities, the correction needed for this problem that seems to be a universal consequence of stifle anatomy and mismatch of cortices on the lateral side after TPLO rotation is small and hence difficult to treat with double osteotomies.
The present invention solves the problem by the design of a TPLO saw blade, which is wedge-shaped and leads to a pre-set correction. At the leading edge, the blade is of uniform thickness, generally 1 mm or less. Further away from the leading edge toward the upper end, the blade thickness increases. In certain embodiments, the blade thickness increases not uniformly over its whole breadth - at the side edges the thickness may be the same as at the leading edge, but in the middle, it gains in thickness. At the average depth of the finished cut, the blade has the same radius of the inner and the outer surface, just as in the original Slocum bi-radial saw blade (U.S. Pat. No. 4,955,888, Biradial saw, D. Barclay Slocum, Sept. 11, 1990). For manufacturing reasons, the inner surface of the saw blade may be cylindrical while the outside surface of the blade is 3D-shaped to result in the desired cut geometry and provided with a multitude of teeth to gradually remove the bone as the blade is advanced from the medial towards the lateral aspect of the proximal tibia. In short, to the surgeons familiar with the subject, the blade of this invention can be described as a TPLO saw blade that changes gradually with distance from the leading edge of a conventional saw blade to the Slocum biradial saw blade at the depth of the average full-thickness cut.
With the shape of the cross-section of the tibia at the level of a TPLO where the cortices on the lateral side cross at only two points, at best, it is of less importance that the saw blade is not of Slocum’s biradial type on the lateral side. On the medial side, cortices align over a much longer part of the cut so having better contact resulting from the biradial shape of the saw blade is more consequential.
With the same technical approach to manufacturing, a flat, oscillating saw blade can be made to execute precise planar closing wedge osteotomies. In some cases, involving major deformities, large angles of closing wedge osteotomies are called for and those are best performed by double planar cuts. However, if less than 10 degrees are planned for, making a single cut with a special blade according to the present invention is of real benefit. Such blades can be made with several angles with for example increments of 2 to 3 degrees.
A first aspect of the present invention relates to an oscillating saw blade adapted for use in bone surgery comprising an upper end, a lower end, an outside face, and an inside face, wherein at the lower end a leading edge with cutting teeth is provided. At the upper end, the saw blade may comprise an element, e.g. a roof and a hub for connection to an oscillating saw machine, which may typically comprise a drive unit and a hand grip.
The term “oscillating saw blade” in the context of the present invention refers to a saw blade adapted for an oscillatory movement. The oscillating saw blade is adapted for use in medicine, e.g. in human or veterinary medicine, particularly for use in bone surgery, more particularly for bone surgery in dogs. In certain embodiments, the saw blade is sterilized and optionally packaged.
In particular embodiments, the present invention relates to a saw blade adapted for an oscillatory movement in bone surgery, wherein its thickness increases from the leading edge at its lower end towards its upper end, wherein the blade is of curved shape.
In certain embodiments, the outside face of the saw blade, at least on the portion toward the leading edge is provided with cutting teeth. Further, a plurality of windows may be provided through the full thickness of the blade.
According to the present invention, the thickness of the saw blade, i.e. the distance between the outside face and the inside face increases from the leading edge at its lower end towards the upper end. Thus, in a longitudinal cross-section, the saw blade of the invention has a wedge shape, wherein the narrowest part of the wedge is at the leading edge at its lower end. In certain embodiments, the thickness of the saw blade at the leading edge is about 1 mm or less, preferably about 0.5 to about 0.9 mm and more preferably about 0.7 mm. The angle corresponding to the increase in thickness is in the range of about 2 to about 10 degrees, preferably about 3 to about 8 degrees and more preferably about 5 degrees.
In certain embodiments, the thickness increases in steps, wherein a plurality, e.g. 2 or more, e.g. 5 or more discrete steps are provided on the outside face of the saw blade. At the leading edges of the steps, cutting teeth are provided. The steps may be in the size range of 0.1 to 1.0 mm, preferably in the range of 0.3 to 0.5 mm, most preferably about 0.4 mm.
In certain embodiments, the blade is of curved shape, wherein the outside face is convex and the inside face is concave. The curved shape may be adapted for use in a surgical procedure involving cutting of a bone, e.g. Tibial Plateau Leveling Osteotomy (TPLO) procedure or planar closing wedge osteotomy.
In certain embodiments, the blade thickness at the leading edge is uniform while the blade thickness increases in steps away from the leading edge in its central portion but not along its longitudinal edges, i.e. the edges ranging from the upper end to the lower end of the saw blade. The shape of the cross-section at the trailing end may be of biradial, Slocum type, wherein the radius of curvature of the concave surface is equal to the radius of curvature of the convex surface.
In certain embodiments, the blade is substantially planar or planar.
A further aspect of the invention relates to a Tibial Plateau Leveling Osteotomy (TPLO) procedure, which is performed with an oscillating saw blade as described above.
Still a further aspect of the present invention is a planar closing wedge osteotomy, which is performed with an oscillating blade as described above.
This invention is based, at least in part, on in vitro experiments and clinical observations that have helped us identify the fundamental causes of the mechanical failures of the TPLO procedure.
Our experimental work with dog cadavers, with the hind leg loaded in a testing machine in compression between the femoral head and the hock joint, has shown a strong tendency of the TPLO constructs to a valgus drift at the stifle. Intact legs do not show that tendency and on average need twice the load to failure in comparison to TPLO. With the stifle moving into valgus position the load across the stifle joint shifts laterally and hence creates even higher loading of the weakly supported lateral side. The cortices on the lateral side cut into each other. The TPLO plate is fixed on the medial side and the collapsing support on the lateral side places the plate under bending and the screws under bending and pullout forces. The critical fixation is usually proximally with the weaker, cancellous bone for screw anchorage. Proximal screws are also placed at a short distance to each other. This can result in a pullout of the screws or ripping out of a larger piece of bone from the proximal tibia. Another consequence of the lateral collapse is occasionally observed fracture of the fibula, which is of some real clinically negative impact.
A moderate closing wedge of preferably about 5 degrees on the medial side of the cut results in the medial shift of the joint load sparing the lateral cortices overload. As a practical consequence, the proximal screws pullout loading is much reduced, paving the way for using mono-cortical screws in both proximal and distal segments. This can spare the time in surgery but also reduce some risks of drilling for and using bi-cortical screws. The most cranial screw in the proximal segment of TPLO in many cases exits on the lateral side just under the tendon of the long digital extensor. A long screw can cause damage or even rupture of this tendon.
In many instances, the most caudal screw line of insertion is very close to hitting the fibula. In our in vitro experiments, dissections have shown a number of cases where the drill bits have done damage to the fibula due to uncontrolled penetration of the drill bit past the lateral cortex. This was observed with the surgeries performed by very experienced surgeons and different plate designs.
The further benefit of using mono-cortical screws is the reduced cost of implants with a greatly reduced inventory of the screws of different lengths.
A conventional dome-shaped roof 6 of the saw blade connects the blade to the hub 7 used to attach the blade to the oscillating saw machine.
Having disclosed at least one embodiment of the present invention for a TPLO saw blade and a planar oscillating blade, variations will be understood by one of ordinary skill in the art. Such adaptations, modifications, and improvements are considered part of the invention.
| Number | Date | Country | Kind |
|---|---|---|---|
| 20188448.3 | Jul 2020 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2021/071164 | 7/28/2021 | WO |
