Surgery – Instruments – Orthopedic instrumentation
Reexamination Certificate
2000-11-27
2004-03-09
McDermott, Corrine (Department: 3738)
Surgery
Instruments
Orthopedic instrumentation
C606S080000
Reexamination Certificate
active
06702822
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to prostheses which are implanted in bone and, in particular, to an improved system for preparing a cavity for receiving the prosthesis and to improved prosthesis configurations for use with such cavities.
BACKGROUND OF THE INVENTION
A variety of prosthesis configurations have been proposed and used to implant prostheses in bone. See, for example, Noiles, U.S. Pat. No. 4,219,893 (see FIGS.
7
-
9
); Meyer, U.S. Pat. No. 4,549,319; Noiles, U.S. Pat. No. 4,790,852; Penenberg et al., U.S. Pat. No. 4,808,185; Noiles, U.S. Pat. No. 4,846,839; Luman, U.S. Pat. No. 5,002,578; and the C-2 Conical Colla™ Hip System of the Kirschner Medical Corporation, Timonium, Md., 21093.
In overview, one or more cavities are prepared at the end of the bone for receiving the prosthesis. The prosthesis is then inserted into the prepared cavity and held in place by a mechanical fit or in some cases by bone cement. The initial fit between the prosthesis and the bone is critical to the long term success of the prosthesis especially with a mechanical fit.
Two fundamental criteria which a prosthesis and its cavity should meet are: (1) proper transfer of force from the prosthesis to the bone (see Meyer, U.S. Pat. No. 4,549,319); and (2) ready formation of the cavity so as to achieve an accurate fit with the prosthesis (see Noiles, U.S. Pat. No. 4,790,852).
With regard to the first criterium, force needs to be effectively transferred from the prosthesis to the cortical (hard/strong) bone and, in particular, to the cortical bone at the extreme end of the bone, e.g., the proximal end of the femur in the case of the femoral component of a hip joint, the distal end of the femur in the case of the femoral component of a knee joint, and the proximal end of the tibia in the case of the tibial component of a knee joint.
In the case of knee joints, instead of directly transferring force to the cortical bone, it is also common practice to have the prosthesis abut primarily cancellous bone and have the cancellous bone transmit force to the cortical bone. In such cases, the cancellous bone must have sufficient structural strength to sustain the loads imposed on it.
The application of forces of physiological magnitudes to bone fosters bone growth in the region where the forces are applied. The transfer of force to the cortical bone at the extreme end of the bone thus leads to bone growth in this critical region. If the end of the bone is not loaded, bone resorption can occur in this region. This leads to a diminished amount of bone which is undesirable in its own right and is particularly troublesome should the prosthesis fail and need to be replaced.
With regard to the second criterium, for repeatable success, the cavity for the prosthesis must be created in a precise and reproducible manner. The cavity preparation procedure preferably accommodates the anatomical variation between patients. Moreover, the surgical site does not favor complex procedures for preparing a cavity for implantation of a prosthesis in bone.
Prior techniques have achieved these two criteria to greater or lesser extents. Loading at the extreme end of the bone has not been a natural consequence of the prosthesis' configuration in many cases. With regard to bone preparation, many prostheses require cavities whose configurations do not lend themselves to precise machining. The loading and bone preparation criteria have often led to compromises regarding other desirable criteria. For example, the ability to provide a one piece prosthesis which can be used in either the right or left hand bones of the patient has been difficult with prior prostheses.
SUMMARY OF THE INVENTION
In view of the foregoing state of the art, it is an object of the invention to provide a prosthesis and cavity configuration which maximize the loading of the patient's hard bone at the extreme end of the bone in which the prosthesis is implanted.
It is an additional object of the invention to provide a cavity whose geometry can be readily machined in the patient's bone with a high degree of precision and which at the same time is a relatively close match to the shape of the patient's hard bone at the end of the bone, as for instance, a close match to the shape of the wall of the femur anterior to the calcar for a femoral hip prosthesis.
It is a further object of the invention to provide a one piece neutral (symmetric) prosthesis which can be used with both right and left bones. It is an additional object of the invention to achieve this goal with the removal of a minimum of hard bone.
It is a still further object of the invention to provide a prosthesis which can be implanted in either an anteverted, neutral, or retroverted orientation. In connection with this object, it is a further object to minimize the removal of bone for each of these orientations.
To achieve these and other objects, the invention provides a prosthesis for implantation in bone which has a bone engaging surface which comprises at least two cone-like bodies, the axes of which are non-collinear. In certain embodiments, the axes are parallel to one another, while in others the axes intersect.
The invention also provides surgical instruments for use in preparing the patient's bone to receive a prosthesis having the inventive configuration of its bone engaging surface.
As discussed in detail below, prostheses having the inventive configuration readily achieve the twin goals of high force transfer to the end of the bone and precise fit to a prepared cavity within the bone.
REFERENCES:
patent: 4219893 (1980-09-01), Noiles
patent: 4473070 (1984-09-01), Matthews et al.
patent: 4549319 (1985-10-01), Meyer
patent: 4790852 (1988-12-01), Noiles
patent: 4808185 (1989-02-01), Penenberg et al.
patent: 4846839 (1989-07-01), Noiles
patent: 4923472 (1990-05-01), Ugolini
patent: 5002578 (1991-03-01), Luman
patent: 5133766 (1992-07-01), Halpern
patent: 5259398 (1993-11-01), Vrespa
patent: 5290315 (1994-03-01), DeCarlo, Jr. et al.
patent: 5342363 (1994-08-01), Richelsoph
patent: 5403320 (1995-04-01), Luman et al.
patent: 5499984 (1996-03-01), Steiner et al.
patent: 5527316 (1996-06-01), Stone et al.
patent: 5580352 (1996-12-01), Sekel
patent: 5725594 (1998-03-01), McTighe et al.
patent: 5908423 (1999-06-01), Kashuba et al.
patent: 6152963 (2000-11-01), Noiles et al.
patent: 1489887 (1977-10-01), None
patent: WO94/12124 (1994-06-01), None
Kirschner Medical Corporation's product brochure and advertisements for its C-2 Conical Collar™ Hip System, Timonium, Maryland, 21093, 1991-1992.
DeCarlo, Jr. Alfred F.
Noiles Douglas G.
Joint Medical Products Corporation
Klee Maurice M.
Stewart Alvin
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