Surgery – Instruments – Orthopedic instrumentation
Reexamination Certificate
2002-07-12
2004-03-30
Reip, David O. (Department: 3731)
Surgery
Instruments
Orthopedic instrumentation
C606S075000, C606S076000, C606S213000
Reexamination Certificate
active
06712821
ABSTRACT:
TECHNICAL FIELD
The present invention is directed to a surgical device and method, and more particularly, to a sternum closure device that helps maintain a predetermined space between parts of the severed sternum after closure.
BACKGROUND OF THE INVENTION
Thousands of open-heart operations are performed in the United States each year. In order to perform most of them, the chest is opened through a mid-line sternotomy (the sternum of the chest bone is longitudinally split with an electrical saw). After the procedure is complete, the sternum is closed by a conventional method such as stainless steel wire or a clamping mechanism. However, the heart and other organs often become edematous, swollen, and generally larger than their original size. As a result, while closing the sternum and after the closure, the pressure exerted by the sternum over the enlarged organs may cause post-procedure complications such as low blood pressure, arythmias, and possibly even fatality.
Further, one conventional clamping closure device typically does not involve the perforation of the sternum for insertion of the stainless steel wire. The large needle utilized to perforate the sternum for insertion of the wire can cause major bleeding complications, infections, and needless destruction of the sternal tissue. This conventional clamping device achieves easy and strong closure of the sternum without the destruction caused by use of the wire.
SUMMARY OF THE INVENTION
The following presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the invention. It is intended to neither identify key or critical elements of the invention nor delineate the scope of the invention. Its sole purpose is to present some concepts of the invention in a simplified form as a prelude to the more detailed description that is presented later.
In accordance with one aspect of the present invention, an apparatus maintains a predetermined distance between two parts of a severed sternum of a patient, such as after closure of the severed sternum. The apparatus includes an elongate spacer member, such as a plate formed of plastic, surgical steel, or a bone-substitute material, and an element for securing the elongate member to each of the two parts of the severed sternum. The elongate member has a length approximately equal to the length of the sternum. The elongate member has longitudinally extending edges dimensioned and configured to space apart the two parts of the severed sternum the predetermined distance (e.g., the width of the plate defines the predetermined distance). The vertical surfaces of the severed sternum abut the longitudinally extending edges of the elongate member and are fastened there by the securing element to maintain the predetermined distance.
In accordance with another aspect of the present invention, an apparatus maintains a desired space between a vertical surface of a first member and a vertical surface of a second member (e.g., parts of the severed sternum). The apparatus includes an elongate spacer plate, at least one shaft fastened to the elongate plate, and a retaining element for securing the elongate plate to the first member. The elongate plate has a first end portion and a second end portion opposite the first end portion. The elongate plate further has a first longitudinally extending lateral edge portion and a second longitudinally extending lateral edge portion opposite the first lateral edge portion. The elongate plate further has upper and lower opposed surfaces. The shaft extends away from the upper surface of the elongate plate. The retaining element engages the shaft such that the first member is fixed between the retaining element and a projection of the elongate plate. The retaining element is adapted to engage an upper surface of the first member. The projection of the elongate plate engages a lower surface of the first member. The projection has a first part and a second part. The first part of the projection extends downward away from the lower surface of the elongate plate. The second part of the projection extends laterally away from the first lateral edge portion of the elongate plate and the first part of the projection. The elongate plate can thus be fixed in abutting engagement with the vertical surface of the first member and in engagement with the upper and lower surfaces of the first member, such that the first member is clamped between the retaining element and the projection of the elongate plate.
In accordance with still another aspect of the present invention, a method maintains a post-closure space between opposite parts of a longitudinally severed sternum of a patient. The method includes implanting an elongate spacer member between the opposite parts of the longitudinally severed sternum, such as following an open-heart procedure. The severed sternum is closed such that vertical surfaces of the opposite parts of the longitudinally severed sternum each engage the elongate member. The elongate member can then be secured to the opposite parts of the severed sternum such that a lateral dimension of the elongate member provides the post-closure space for enlarging the volume of the patient's chest cavity to mitigate pressure on the organs of the patient.
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Reip David O.
Tarolli, Sundheim Covell & Tummino L.L.P.
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