Surgery – Instruments – Orthopedic instrumentation
Reexamination Certificate
2001-04-23
2003-10-07
Robert, Eduardo C. (Department: 3732)
Surgery
Instruments
Orthopedic instrumentation
Reexamination Certificate
active
06629978
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to methods and tools used in knee arthroplasty. More particularly, the invention relates to methods and tools typically used in revision surgery where an artificial femoral component is removed and replaced.
2. Brief Description of the Prior Art
Total knee arthroplasty involves the replacement of portions of the patella, femur and tibia with artificial components. In particular, a proximal portion of the tibia and a distal portion of the femur are cut away (resected) and replaced with artificial components.
As used herein, when referring to bones or other body parts, the term “proximal” means closest to the heart and the term “distal” means more distant from the heart. When referring to tools and instruments, the term “proximal” means closest to the practitioner and the term “distal” means distant from the practitioner.
There are several types of knee prostheses known in the art. One type is sometimes referred to as a “resurfacing type”. In these prostheses, the articular surface of the distal femur and proximal tibia are “resurfaced” with respective metal and plastic condylar-type articular bearing components. These knee prostheses provide adequate rotational and translational freedom and require minimal bone resection to accommodate the components within the boundaries of the available joint space.
The femoral component is typically a metallic alloy construction (cobalt-chrome alloy or 6A14V titanium alloy) and provides medial and lateral condylar bearing surfaces of multi-radius design of similar shape and geometry as the natural distal femur or femoral-side of the knee joint.
The tibial component usually includes a distal metal base component and a proximal interlocking plastic, e.g. UHMWPE (ultra high molecular weight polyethylene), component or insert. The plastic tibial plateau bearing surfaces are of concave multi-radius geometry to more or less match the articular geometry of the mating femoral condyles. Both the femoral and tibial components are usually provided with intermedullary (IM) stem options.
After preparing the distal surface of the femur and the proximal surface of the tibia, an opening is made into the medullary canal of the femur, and an opening is made into the medullary canal of tibia. The interior surface and the IM stem of the femoral component are usually covered with a polymeric cement and the IM stem is inserted into the medullary canal of the femur until the interior surface of the femoral component meets the distal surface of the femur. The tibial component is similarly usually cemented to the proximal surface and medullary canal of the tibia.
Occasionally, the components are press fit without the use of cement. The use of cement has advantages and disadvantages. Press fit components rely on bone quality to obtain good fixation. Sometimes it is impossible to obtain good fixation with a press fit component and sometimes a press fit component will fail early because of failure of successful biological ingrowth. Cement assures good fixation but puts strain along the component stem. In addition, as described below, cement complicates the removal of a failed component.
Often, due to normal wear over time, the prosthetic knee must be replaced via a procedure known as revision surgery. When the primary cemented prosthetic is removed, the proximal surface of the tibia and the distal surface of the femur typically exhibit cavernous defects. Absent the use of bone graft, the proximal surface of the tibia and the distal surface of the femur must be carefully resected to remove cavernous defects before a replacement knee can be installed.
In addition, the intermedullary (IM) canals must be broached or reamed to remove any remaining cement or cavernous defects existing in the canals before a replacement knee can be installed. In many instances, the replacement femoral component will be provided with an anterior or posterior stabilizer and an anterior or posterior distal portion of the femur will need to be removed in order to accommodate the stabilizer.
The absence of bony landmarks (removed during primary surgery) and the presence of cavernous defects make extramedullary (EM) alignment of cutting jigs difficult even in cases where the primary prosthetic did not use cement.
The state of the art method for accomplishing revision arthroplasty involves the use of several cutting guides which must be aligned with reference to the IM canal.
After the primary prosthetic is removed, the distal femur is resected with a lateral template. The medullary canal is reamed and the reamer is tapped in place with a mallet. A distal resection guide is attached to the reamer and distal resection is completed via slots in the guide. The distal resection guide is removed from the reamer and another cutting guide is attached to the reamer for A/P and chamfer resections.
The rotational alignment of the femoral component is critical to ensure correct patellar tracking. Since the posterior condyles are no longer present, this cutting guide must be carefully aligned relative to the femoral epicondyles where the collateral ligaments are attached.
After anterior/posterior and chamfer resections are completed, the cutting guide is removed and a fourth cutting guide is attached to the reamer in order to accomplish intercondylar box resection. It will be appreciated that the installation and removal of the several cutting guides makes alignment of the cutting guides more difficult.
Following preparation of the femur, similar procedures are performed on the proximal tibia.
Previously incorporated, co-owned application Ser. No. 09/049,705 discloses IM revision tools including:
(a) reamers with depth markings and/or depth stops;
(b) an impactor-extractor with a distal coupling for attaching to other tools which are inserted into and removed from the IM canal;
(c) a resection guide tower to which a cutting guide is accurately attached and which includes a notch which serves as both a witness mark and a holder for a femoral or tibial collar;
(d) a selection of different sized stems attachable to the guide tower;
(e) a selection of different sized femoral and tibial collars;
(f) a reversible cutting guide with a quick-connect clamp attachable to the guide tower for resecting the distal femur;
(g) a right and left cutting guide with quick-connect clamp attachable to the guide tower for resecting the proximal tibia;
(h) a selection of spacer blocks for measuring the space between the tibia and femur to determine the thickness of the tibial component to be installed;
(i) an all-in-one cutting guide for preparing the femur;
(j) a set of 5 and 10 mm trial wedges;
(k) a trial stem valgus adapter;
(l) femoral sizing indicators which include indications of anterior/posterior offset;
(m) a posterior stabilizer box cutting template which is attachable to the all-in-one cutting guide; and
(n) anterior/posterior offset adapters for attaching the femoral component to the IM stem.
The tools are modular and can also be used in primary knee arthroplasty with or without IM fixation.
The methods disclosed in the co-owned application include:
(a) removing the primary femoral component;
(b) reaming an appropriate depth of the femoral IM canal with a reamer of appropriate diameter;
(c) selecting a tool stem (trial stem) of appropriate length and diameter;
(d) attaching the guide tower to the tool stem;
(e) inserting the tool stem into the femoral IM canal;
(f) attaching the impactor/extractor to the proximal end of the tool stem and impacting the stem into the IM canal (or optionally impacting the stem with a mallet);
(g) optionally attaching a stop to the tool stem prior to impacting;
(h) attaching the reversible cutting guide to the tool stem resecting the distal femur;
(i) removing the cutting guide from the tool stem and removing the tool stem with the impactor/extractor;
(j) repeating the procedure with respect to the proximal tibia using one of the left or right tibial cutting guides;
(k) sizing the distal femur and the space between
Collazo Carlos E.
Sanchez Emilio
Schulzki Michael J.
Trimmer Kenneth
Howmedica Osteonics Corp.
Lerner David Littenberg Krumholz & Mentlik LLP
Robert Eduardo C.
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