Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Bone
Reexamination Certificate
2002-01-18
2003-12-16
O'Connor, Cary E. (Department: 3732)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Bone
C623S023450
Reexamination Certificate
active
06663670
ABSTRACT:
BACKGROUND OF INVENTION
The present invention relates to an orthopedic prosthesis. More specifically, the invention concerns a prosthesis for restoring the functionality of an extremity, such as an arm of a patient. The invention is particularly suited for the replacement of a long bone of the patient.
The later half of the 20
th
century has seen a proliferation in the number of human skeletal components that can be replaced by a man-made prosthesis. Over the years these prosthesis have evolved from simply a physical substitution for a bone or a joint, to the more sophisticated fully functional prosthesis. For example, prostheses are well known for the replacement of the shoulder joint or the elbow joint. A modular shoulder prosthesis designed according to U.S. Pat. No. 5,314,479, assigned to DePuy, Inc., can be integrated into the existing glenoid cavity of a patient's shoulder. The prosthesis includes a lower stem that is configured to be embedded within the existing humerus bone of the patient. In a like manner, U.S. Pat. No. 6,290,725 (also owned by Depuy, Inc.) discloses a modular elbow prosthesis that includes stems for implantation into the intramedullary canal of the humerus and ulna bones. Similar prosthetic joints exist for replacement of the hip, knee, and ankle joints.
While many devices exists for the replacement of a damaged or defective joint, the substitution of a bone, and particularly a long bone, is much more problematic. While prosthetic phalanges have enjoyed increasing success, the long bones have not been so easily replaced by a prosthesis, particularly to maintain the functionality of the patient's limb.
The problems with long bone replacement are many and varied. Perhaps the greatest difficulty is the extreme load-bearing nature of the long bones. One approach to this problem has been to supplement, rather than replace, the bone its self. For instance, as shown in U.S. Pat. No. 4,384,373, an artificial femoral diaphysis is extended through a longitudinal bore in the femur. The artificial diaphysis is bounded at one end by an artificial knee component and at its opposite end by an artificial hip component. This prosthesis of the '373 patent retains the existing bone and relies upon that bone for a certain amount of load-bearing capability.
A further problem associated with a long bone prosthesis is the variability in length of a particular long bone between patients. The femur, tibia, radius, and humerus bones vary in length as much as patients vary in height. The aforementioned '373 patent dealt with this variation by providing a motion screw and an external threaded sleeve feature for adjusting the overall distance between the hip joint and knee joint components of the prosthesis. Many similar approaches have been implemented for prosthetic joints. It should be noted that with these prostheses, the joint is affixed to an existing long bone, such as by implantation of a stem into the intramedullary canal of the bone. The following patents illustrate a variety of adjustable length features: U.S. Pat. Nos. 4,502,160; 4,892,546; 5,358,524; 5,387,239; and 5,906,644. These adjustable length features range from the bevel gear and external key arrangement of the '160 patent, to the Morse taper pressure lock feature of the device in the '644 patent.
One problem common to all of these prior adjustable length features is that the length of the prosthesis cannot be adjusted in situ. In other words, in each of the prior devices, the required length of the prosthesis is predetermined and the prosthesis adjusted before implantation into the patient. In a typical surgical procedure, the affected limb is x-rayed to determine the desired length for the prosthesis. However, in some cases no matter how accurate the x-ray and resulting measurements, certain errors creep in that make accurate measurement of the length of the long bone difficult. For instance, it is often particularly difficult to obtain an accurate x-ray of the upper arm, or humerus bone, of a patient. In a typical scenario, the bone cannot be oriented perfectly parallel with the x-ray plate due to the presence of muscle and fatty tissue around the bone, and other biomechanical disruptions. Thus, often the humerus bone is frequently oriented in a non-parallel relation to the x-ray photographic plate, and most frequently angled slightly outward form the x-ray plate. With this parallax error, it is virtually impossible to accurately determine the length of the humerus bone.
Inaccurate measurement of the long bone prosthesis of course leads to an improper length of the extremity. This maladjusted length can cause motor and muscular difficulties. Moreover, an incorrect prosthesis length can affect the tightness of the tissue surrounding the prosthesis. If the length is too short, the surrounding tissue is unnecessarily loose. If the prosthesis is too long, the tissue may be too tight, if the prosthesis can be implanted at all.
While the prior prosthetic devices have gone a long way toward helping patients with bone or joint disorders, several needs remain unmet. One need is for a viable long bone prosthesis or substitute. Another need is for an adjustable length prosthesis that allows for easy and ready adjustments in situ once the prosthesis has been implanted within the patient.
SUMMARY OF INVENTION
In order to address these needs, the present invention contemplates an adjustable long bone prosthesis that can be readily adjusted within the patient to account for discrepancies in the measurement of a long bone to be replaced. The inventive prosthesis includes a first elongated component having a first end configured to engage a first prosthetic joint, such as an elbow joint, and an opposite end having a first articulating portion. A second elongated component is provided having a second end configured to engage a second prosthetic joint, such as a shoulder joint, and an opposite end having a second articulating portion. The two articulating portions are adjustably mateable with each other so that the combined length of said first and second components can be adjusted to approximate the length of the long bone to be replaced.
In one feature of the invention, the first articulating portion includes an elongated stem, while the second articulating portion includes a collet having a threaded outer surface and an inner surface arranged for pressure engagement of the stem therein. The prosthesis further includes a lock nut having a tapered inner threaded surface configured for threaded engagement with the threaded outer surface of the collet. With this feature, threading the lock nut onto the collet compresses the collet about the elongated stem therein to fix the relative axial and rotational position of the two components.
In accordance with the invention, the second articulating portion also includes a blind bore sized contiguous with the inner surface of the collet. The blind bore is sized for a close running fit with the elongated stem so that the stem can be freely rotated or translated relative to the bore. In certain embodiments, the stem and bore can define an interdigitating interface therebetween. The interdigitating interface can be configured for indexed rotation or translation of the stem relative to the bore. Alternatively, the interdigitating interface can be configured to prevent or limit relative rotation or translation between the components. In a specific embodiment, the interdigitating interface includes a number of axial ribs on the stem and the bore.
The inner surface of the collet and the outer surface of the stem can collectively include a surface treatment configured to enhance the pressure fixation or engagement of the collet about the stem. This surface feature can be in the form of an interdigitating interface between the components or in the form of deformable projections.
It is one object of the invention to provide a prosthesis that is readily adapted as a long bone replacement. A further object resides in features of the invention that allow for easy
Martin Troy D.
Rhoades Joel C.
Rogers James R.
DePuy Orthopaedics, Inc.
Maginot Moore & Beck
Melson Candice C.
O'Connor Cary E.
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