Surgery – Instruments – Orthopedic instrumentation
Reexamination Certificate
1998-09-28
2002-04-09
Reip, David O. (Department: 3731)
Surgery
Instruments
Orthopedic instrumentation
C606S071000, C606S075000, C606S074000, C606S232000
Reexamination Certificate
active
06368326
ABSTRACT:
FIELD OF THE INVENTION
This invention pertains to the field of fixation devices for bones.
BACKGROUND OF THE INVENTION
Simple fractures of bones are readily treated by bringing the fracture surfaces together and holding them in the desired orientation with respect to one another through the use of splints, casts and the like. Bones in general have dense outer, strong cortical portions and interior, non-cortical portions that may include cancellous bone.
Comminuted fractures and fractures involving the breakage of a bone into numerous bone fragments are more difficult to deal with since one must attempt to reposition each bone fragment in an orientation relative to each other bone fragment so that the fragments may knit together properly. For this purpose, physicians have often used metal plates that attach to the outer cortical surfaces of the bones and which utilize bone screws to hold the bone fragments in position.
Another method involves the use of cerclage procedures in which a wire is, in effect, wrapped about a broken bone to hold the fragments in place, the cerclage wire occasionally penetrating through the bone. Reference is made to Johnson et al., U.S. Pat. No. 4,146,022. Yet another method taught in Berger, U.S. Pat. No. 5,658,310, involves anchoring the balloon portion of a balloon catheter in the medullary cavity at one end of a long bone having a transverse fracture, and stretching the remaining portion of the elastic catheter across the fracture interface within the bone to maintain the fracture interface in compression. It would appear that unless the elastic catheter traverses the precise center of the bone at the fracture site (which may be difficult to accomplish, considering the bowed or curved nature of most bones), compressive forces will be uneven across the fracture site. That is, the compressive forces on the side of the bone nearest the catheter will be greater than the compressive forces on the opposite side of the bone, generating an unwanted bending moment across the fracture site.
Surgical procedures used to mount bone plates and cerclage elements to a bone often require supportive tissue that is normally joined to the bone to be cut from the bony tissue to enable direct visual access to the bone. With cerclage procedures, one must entirely encircle a bone in order to hold the bony parts together.
Procedures using bone plates and cerclage elements often tend to interrupt blood flow to the damaged bone fragments, and thus hinder the healing process. Moreover, the use of bone plates and cerclage elements, particularly the former, can lead to stress shielding of the fracture site. It is well known (Wolff's law) that bone growth is stimulated when stress is applied. However, continuous, excessive pressure applied to a bone may cause unwanted resorption of bone at the pressure site. In order to promote healing of bone fractures, the fracture surfaces that are brought together during reduction of the fracture should be subject to cyclic or periodic compressive forces so as to stimulate the growth of new bone across the fracture interface without causing bone resorption. When a fracture interface is immobilized, as by a cast, the bone material that is deposited at the fracture interface may have a collagen fiber matrix that is random rather than aligned with the fiber matrix of bone on either side of the fracture, the healed fracture interface being weaker in tension than bone on either side of the interface.
Some bone fractures result in the production of many bone fragments, and proper reduction of the fracture requires the fragments to be carefully reassembled next to each other with their fracture surfaces in contact. Bone screws and bone plate devices commonly are used for this purpose. Using bone screw techniques, two bone fragments may be joined together, and these two fragments as a unit may be moved into approximation with a third fragment and joined to it, and so on. Fragments that are thus joined together by rigid screws cannot move with respect to other fragments, and mismatching of the fracture surfaces as the first several fragments are joined together can have a compounding effect, causing mal-union or non-union of fracture surfaces and resulting in far less than perfect bone fragment assembly and healing.
SUMMARY OF THE INVENTION
The invention involves an orthopedic fixation system for fixing a bone to an element which is a bone fragment or a prosthesis. The system includes a length of flexible, inelastic cord, a first fastener for attaching the cord to the element; and a second fastener for fastening the cord to the bone. At least one of the fasteners has an opening through which the cord may pass from the interior of the bone to the exterior to enable the element to be securely mounted to the bone.
In one embodiment, the invention involves a fracture relief system in which bone fragments are brought together by internal, inelastic flexible cords to counter forces tending to widen the fracture interfaces when the bone is stressed through normal, though often restricted, physical activity of a patient. Movement of fracture surfaces away from each other thus is prevented, but the flexible, inelastic cords do not restrict the transfer of compressive stress from one fragment to another across fracture interfaces during physical activity. That is, the cords do not prevent the bone fragments forming a fracture interface from converging slightly to enable stress transfer. Due to their inelastic nature, the flexible cords do not maintain the fracture interface in compression during rest, and thus resorption of bone due to excessive constant compressive force is largely avoided.
In another embodiment, the invention relates to a bone fracture reduction system for positioning bone fragments with respect to each other to reduce a fracture and promote healing. The system comprises a flexible, inelastic cord having an end portion, a fastener attached to the end portion of the cord and adapted for attachment to a bone fragment in a direction generally coaxial to the axis of the end portion, and a second fastener attachable to the other bone fragment and having an opening through which the cord can be drawn to place the cord in tension. The second fastener includes a lock for locking the cord to the second fastener to restrain separation of the bone fragments.
In a further embodiment, the invention provides a bone fracture reduction system for reducing and promoting healing of a bone fracture. The fracture reduction system comprises a fractured bone normally having an exterior cortical portion and a non-cortical interior, the bone having bone fragments with confronting fracture surfaces. An internal fastener is attached from within the bone interior to a first bone fragment with a length of flexible, inelastic cord extending within the bone interior and attached to said fastener and passing outwardly through an opening in a second bone fragment. The fastener and cord are so positioned as to draw respective fracture surfaces together to reduce the fracture upon tensioning of the cord extending outwardly through said opening. A second, external fastener desirably is attached to the bone opening, this fastener including an open bore to receive the cord and a lock to secure the cord to this fastener.
The invention also relates to a method for positioning fragments of a bone fracture with respect to each other to reduce the fracture and promote healing of a bone which normally has an exterior cortical portion and a non-cortical interior, the bone fragments having confronting fracture surfaces forming a fracture interface. The method comprises attaching from within the interior of the bone to a first bone fragment an internal fastener to which is attached a length of flexible, inelastic cord, and drawing the cord through an opening formed in a second bone fragment to draw the fragments together in a direction to reduce the fracture. The cord preferably is secured to the second bone fragment to maintain the bone fragments in a predetermined position to t
Dakin Edward B.
Lippincott, III Albert L.
Daos Limited
Fredrikson & Byron , P.A.
Reip David O.
Woo Julian W
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