Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Bone
Reexamination Certificate
2001-06-07
2002-03-12
Isabella, David J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Bone
C623S023180
Reexamination Certificate
active
06355068
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to the medical field of orthopaedics and joint replacement, in particular. Modular artificial joints have several components that must be assembled and placed in the patient to reconstruct a joint. While modular joints provide the ability to custom fit an artificial joint to a patient's anatomy, the connection between the components must be without relative movement after implantation. This invention is directed to a modular artificial joint construction and method which provide a locking mechanism to secure the components immovably together and a visual indication that the components are properly assembled.
BACKGROUND OF THE INVENTION
In replacing a hip joint, the head of the femur is removed along with the ball. The trochanter portion of the femur is shaped and prepared for receiving the prosthesis so that the artificial joint will closely approximate the natural hip.
Earlier artificial hip joints were made of one-piece construction requiring a large inventory of prosthesis to accommodate the various sized patients. The modular artificial joint has two or three or more elements which replace the natural hip. By manufacturing these components with interchangeable connections but different external sizes, inventories may be smaller because of the ability to mix and match components. Also, the modular prosthesis provides more flexibility in customizing the various components of a joint to the various parts of a patient's natural joint.
In a three piece artificial hip joint, the various sized components of the joint that may be selected are the intramedullary rod, the trochanter and the neck. The intramedullary rod is inserted into the end of the femur. The rod acts as a stabilizer in maintaining the artificial joint in the axis of the femur. The upper portion of the rod which extends toward the proximal end of the femur is fitted into a trochanter element which is shaped like the removed broad head of the femur which it replaces. This element, along with the rod, is used to adjust the length of the prosthesis to approximate the natural length of the femur.
The natural trochanter is the broadened area offset from the end of the femur. The natural trochanter may be at any radial angle about the axis of the femur. This natural angular relationship must be reproduced by the intramedullary rod and the artificial trochanter. The artificial trochanter is seated on the end of the patient's femur and is the main load bearing element of the prosthesis. It is important that this load, which is mostly compression, is transmitted along the axis of the femur.
A neck element is inserted into the trochanter element and carries an extension onto which the ball joint will be fixed. The horizontal angle between the trochanter and the neck extension is variable to reproduce the anteversion angle of the patient's natural joint. The neck carries cantilevered forces in torque and compression between the acetabulum and the trochanter. It is also important that these forces do not result in relative movement between the trochanter and the neck.
All these elements have a central bore and are permanently secured together by a compression screw which is inserted into the neck element, extends through the trochanter element, and is threaded into the upper end of the rod. In some cases, the intramedullary rod may be attached to the bone with bone cement while, in other cases the cement is omitted.
When the cement is omitted, the placement and fixation of the intramedullary rod becomes more critical to pain free usage of the prosthesis. Further, it is most important that the intramedullary rod not be disturbed after insertion since this would corrupt the union between the rod and the interior of the femur.
In order to maintain the original union between the femur and the intramedullary rod, modular prosthesis have been developed to allow rotational adjustment of the several parts or elements about the rod before the placement of the prosthesis to more closely reproduce the natural structure of the hip. The modular concept also allows the selection of different sized elements, before or during surgery, to more closely approximate the natural joint.
With the advantage of flexibility gained by modular prosthesis, there comes the requirement that there be no movement between the several parts or elements after implantation. These movements may cause misalignment of the joint resulting in increased pain, trauma to the joint and, even, dislocation of the joint.
In a modular hip prosthesis, the neck is subjected to cantilevered forces of torque and compression which are transmitted to the body of the prosthesis at the junction between the neck and body. If there is any angular movement between the neck and body at this junction, these forces are magnified and transmitted to the junction between the body and the bone thereby degrading the entire prosthesis. Prosthesis which have line seals or screw thread unions between these elements of the prosthesis are subject to relative movement between the elements. For example, when two cones are telescoped together the junction is a circular line seal about the circumference of the cones. This union can pivot about the line seal. Similarly, when a bolt or screw is used to tighten a connection between two pieces, the leading threads take most of the stress which is not evenly distributed along the shaft of the bolt.
DESCRIPTION OF THE PRIOR ART
The prior art is replete with artificial prosthesis and hip joints, in particular.
Illustrative of the state of the art are U.S. Pat. No. 5,725,592 to White et al, U.S. Pat. No. 5,876,459 and U.S. Pat. No. 5,506,644 to Powell which disclose modular hip joints having a stem, one end of which is inserted in the intramedullary canal. The other end of the stem is tapered to fit within a second, neck, element. The neck ultimately supports the ball joint. A sleeve element is placed over the junction of the first two-elements. All three elements are rotationally movable relative to each other. A bolt is driven through the bore of the neck and stem to fix the elements together.
In the Powell patents the bolt deforms a portion of the interconnected elements for a friction fit between the neck and the stem. These prior art patents disclose that the sleeve may have a polygonal shaped bore with the articulating elements having corresponding shaped portions. The interconnected elements of these hip joints do not form a static lock between each other but require a deformation of one or more elements before a friction fit is established. The deformation and friction fit is between the stem and the neck rather than the sleeve and the stem.
U.S. Pat. No. 5,653,765, to McTighe et al discloses a modular hip joint with a stem, an intermediate shoulder portion, and a proximal shoulder piece which attaches to the ball. The stem and the intermediate shoulder portion have interengaging teeth on the corresponding ends of each by which they are connected. This end-to-end connection allows for rotational movement of the elements relative to each other. The proximal shoulder piece and the intermediate shoulder piece also have an end-to-end toothed connection for rotational adjustment. This construction has two movable end-to-end connections which provide good flexibility for rotation of the elements but have small surface areas of fixation to each other limited to the surfaces of the interengaged teeth.
U.S. Pat. No. 4,851,007 to Gray discloses a modular hip prosthesis with a tapered fit between the intramedullary rod and the neck. In this prosthesis, there is no bolt used to fix the elements together.
SUMMARY OF THE INVENTION
In the instant invention a modular prosthesis is taught which has an intramedullary rod element which is to be inserted in a bone. The rod has a shaped proximal portion which is telescoped into one end of a bore in a body or trochanter element. The mating surfaces of the shaped rod and the body bore form a rotationally immovable connection. A neck element is telescoped into
Doubler Robert L.
Hammill, Sr. John E.
Hammill Manufacturing Co.
Isabella David J.
McHale & Slavin
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