Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Bone
Reexamination Certificate
2002-01-25
2004-03-30
Robert, Eduardo C. (Department: 3732)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Bone
C623S019140
Reexamination Certificate
active
06712854
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a acromial-humeral prosthesis, and more particularly, to a acromial-humeral prosthesis for use in preventing superior migration of the humeral head after massive rotator cuff tears while helping retard rotator cuff arthropathy.
2. Description of the Prior Art
The loss of integrity of the rotator cuff muscle/ligament group often results in pain, generally due to superior migration of the humeral head causing non-anatomical articulation with the inferior surface of the acromion, as well as other inappropriate gleno-humeral kinematics. These losses of cuff integrity are generally caused by massive, irreparable tears of the rotator cuff. Following such tears, secondary development of cuff arthropathy often follows.
Presently, surgical corrective techniques include a massive debridement, typically including excising back the torn, irreparable portions of the cuff as well as any associated inflammatory bursitis. These procedures then often include sub-acromial decompression and distal clavicle resection. Such procedures, intended primarily for pain relief, do not address the mechanical abnormalities associated with torn rotator cuffs. Rarely, after such a procedure, is there any improvement in function. In addition, the results of such procedures typically have unpredictable, mixed outcomes.
Another approach to the torn rotator cuff problem is to perform an over-sized humeral hemi-arthoplasty. Like the debridement procedure, these procedures do not address the abnormal mechanics associated with an incompetent rotator cuff and the consequent potential superior migration of the prosthetic head through the tear. Total constrained or unconstrained shoulder replacements are also used to treat irreparable rotator cuff tears.
Other surgical techniques such as allograft tissue or transfer of local autogenous tissue to the affected area have also not proven to be reliable surgical techniques.
Such prior art techniques are taught in several United States patents.
U.S. Pat. No. 3,979,778, for SHOULDER PROSTHESIS, issued Sep. 14, 1976, to Jerome H. Stroot teaches a two-component (i.e., a humeral and a glenoid component) prosthesis having spherical articulation thereby allowing a relatively wide range of joint movement. In addition, a novel humeral component may be used alone as a partial prosthesis. However, STROOT does not address a torn rotator cuff.
U.S. Pat. No. 4,550,450, for TOTAL SHOULDER PROSTHESIS SYSTEM, issued Nov. 5, 1985, to James G. Kinnett, teaches a three-component prosthesis. In addition the traditional humeral and glenoid components, a third, acromial component is added to replace the acromial-clavicular articulation which, helps prevent superior displacement of the humerus.
U.S. Pat. No. 4,990,161, for IMPLANT WITH RESORBABLE STEM, issued Feb. 5, 1991, to Stanley L. Kampner teaches a joint prosthesis suitable for knee, finger, hip or shoulder implantation, the prosthesis having a biodegradable anchor pin.
U.S. Pat. No. 5,032,132, for GLENOID COMPONENT, issued Jul. 16, 1991, to Frederick A. Matsen, III, et al. teaches a glenoid component for shoulder arthoplasty. The component is attached to the scaplua by anchor pins.
U.S. Pat. No. 5,080,673, for GLENOID PROSTHESIS AND METHOD OF USE, issued Jan. 14, 1992, to Walter Z. Burkhead, et al., teaches another pin-attached glenoid component for use in shoulder arthoplasty. Detailed steps of a method for attaching the component are provided.
U.S. Pat. No. 5,593,448, for GLENOID COMPONENT FOR SHOULDER PROSTHESIS AND IMPLANT METHOD, issued Jan. 14, 1997, to Nicholas N. G. Dong teaches a glenoid component utilizing a series of pins for securing the component to the scaplua. A method for implanting the glenoid component is also provided.
U.S. Pat. No. 5,944,757, for TOTAL TROCHITERO-ACROMIAL SHOULDER PROSTHESIS, issued Aug. 31, 1999, to Paul Marie Grammont teaches a one-piece, sub-acromial element adapted for interaction with a trochiterian element. The acromial element is cemented to the inferior surface of an acromion after it has been appropriately sectioned. The trochiterian element has a substantially spherical shape and is composed of high-density polyethylene.
The prosthesis of the present invention differs substantially from that of GRAMMONT. First, the inventive prosthesis consists only of a acromial element. The two-piece construction of the inventive acromial element allows for a metallic backed component to encourage bone growth and a modular polymeric lower portion optimized for articulation with the humeral head, not a trochiterian element as taught by GRAMMONT. The inventive prosthesis eliminates the need for a trochiterian element by specially engineering the polyethylene component to accept the humeral head directly. By molding the polyethylene in the appropriate shape the polyethylene component can eliminate the entire need of any additional component. The inventive acromial element is affixed to the acromion by porous ingrowth backing and supplemental screw fixation, not cement.
None of the aforementioned United States patents teach or suggest an apparatus or method similar to that of the present invention. The subject matter of each of these patents is directed to glenoid and/or humeral components for use in a shoulder joint prosthesis and not to a acromial-humeral prosthesis intended to control superior migration of the humeral head after a massive, irreparable rotator cuff tear.
None of the above inventions and patents, taken either singly or in combination, is, however, seen to anticipate or suggest the instant invention as claimed.
SUMMARY OF THE INVENTION
The present invention relates to a acromial-humeral prosthesis for use in performing acromial-humeral arthoplasty. The prosthesis is useful for cases where massive, irreparable tears to the rotator cuff have occurred. The principle function of the inventive prosthesis is to provide pain relief by preventing superior migration of the humeral head. A metal, porous coated acromial tray is inserted using an insertion tool using a typical anterior, anterior-lateral or mini-lateral surgical approach. The acromial tray is held in place against a prepared inferior surface of the acromion by a pair of trans-acromial screws inserted from above the acromion. A concave, disc-like component, typically made from ultra high density polyethylene, is affixed to the bottom of the acromial tray by sliding the component onto one or more matching rails on the inferior surface of the acromial tray. Other methods of fixation of the polyethylene component to the metal tray could be envisioned. This component, designed for direct articulation with the humeral head, is relieved to accept the long head of the biceps tendon (if intact) anteriorly and the greater trochanter laterally. An insertion tool adapted for implantation of the prosthesis as well as other tools such as a drill guide are also provided. The inventive prosthesis helps prevent non-anatomical articulations of the humerus and other inappropriate glenohumeral kinematics. In addition, secondary development of rotator cuff arthropathy is minimized. The inventive prosthesis also increases tension on associated shoulder musculature, resulting in increased strength and range of motion.
Accordingly, it is a principal object of the invention to provide a humeral-acromial prosthesis for use in patients having massive, irreparable rotator cuff tears.
It is another object of the invention to provide a humeral-acromial prosthesis which provides pain relief in patients having massive, irreparable rotator cuff tears.
It is a further object of the invention to provide a humeral-acromial prosthesis which may easily be implanted using either arthroscopically assisted or open surgical techniques.
Still another object of the invention is to provide a humeral-acromial prosthesis which is formed from an acromial tray having a porous surface for fixation against the inferior surface of a prepared acromion, and a concave, polymer disk shaped component for attach
Ramana Anuradha
Robert Eduardo C.
Siemens Patent Services LC
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