Patent Application
20150230839
The present invention relates to an internal fixation widely used in orthopedic surgery to maintain reduction of osteotomy, fracture or arthrodesis site and provide compression and stability across surfaces of bone for successful ossification and healing.
Typically multiple screws and potentially a plate is used in conjunction with screws for orthopedic surgery to maintain reduction of osteotomy, fracture or arthrodesis site and provide compression and stability, especially for procedures on the lower extremities. However, the technique of application for these components are complex, with a steep learning curve and are not without inherent limitations and complications. Practitioners have noticed that in case of lower extremity surgery, when multiple screws with or without a plate, there is rarely a consensus on optimal placement of plate and screws to obtain desired stability and compression.
Also, when using screws without a plate, the screws are never working in tandem but individually. Thus, there exists a problem of non-union, delayed union as well as hardware becoming excessive resulting in stiffness of the foot. In the times of placing bone grafts, screws need to cross the bone graft versus host interface, resulting in significantly diminished surface area contact and therefore delayed healing. Also when placing a screw across any osteotomy or fracture, endosteal blood flow is interrupted as well resulting in delayed healing.
Also, in many different hindfoot and midfoot procedures the actual placement of the screws is difficult because of operating table and patient positioning issues.
Thus, there is a need for a medical device for a lower extremity bone fixation device which provides extra focal compression (much like an external fixator). Further, there is a need for a lower extremity bone fixation device which preserves maximal surface to surface contact of tissue therefore, maximizing the potential for healing of the arthrodesis, osteotomy or fracture.
One example of a prior art approach is shown in the Wright CLAW II polyaxial compression plating system. This system teaches the use of multiple locking screws using a variety of different plate configurations. Such a system does not teach the use of a single, integrated system, nor a standardize plate configuration, and does not address several of the problems which are addressed by the present invention.
Another discussion of a prior art approach may be found in the Integra UNI-CP Plate compression plate system. This system teaches the use of various 2 or 4 screw plate designs, with insertable screws and Surfix® Locking Technology. As with the Wright system, this reference system does not teach the use of a single, integrated system, nor a standardize plate configuration, and does not address several of the problems which are addressed by the present invention.
The following terms are used in the claims of the patent as filed and are intended to have their broadest plain and ordinary meaning consistent with the requirements of the law.
A plate refers to a metallic plate used in orthopedics for internal fixation of bone, typically after fractures, the plate being designed to exert pressure between the bone fragments to be transfixed.
As used herein, the term pins refers to metal pins anchored in bone.
Where alternative meanings are possible, the broadest meaning is intended. All words used in the claims set forth below are intended to be used in the normal, customary usage of grammar and the English language.
The apparatus and method of the present invention generally includes an improved internal compression plate and method of use thereof with lower extremity bone surgical procedures. Specifically, the present invention includes the use of a single, integrated unit compression plate including a plurality (preferably four) pins. The pins being part of a single unit are then functioning simultaneously and synergistically which is different, fundamentally from all other internal fixation options. The pins, in addition to being fixed to the plate, preferably include double reverse barbs also allow for maximal “bite” into bone further increasing the staple's stability and preventing any micromotion subsequent to bone resorption through the course of healing. One template allows to safely and accurately pre drill guide holes for the pins on the plate, coupled with the use of a reverse plier system by the surgeon to facilitate controlled and measured compression according the requirement of the procedure. This preferred feature provides dynamic compression with selective compression of the staple bridges under direct visualization at time of surgery, as opposed to current internal fixation which is limited to “all or none” type of compression. This will reduce the potential for inaccurate placement of the fixation, as well as facilitating appropriate compression/stabilization, ease of application and maximizing bone to bone contact without sacrifice of the interface surface area.
The immediate application of the present invention will be seen in providing an improved internal compression plate that provides extra focal compression (much like an external fixator).
A further object of the present invention is to provide improved internal compression plate that preserves maximal surface to surface contact of tissue therefore, maximizing the potential for healing of the arthrodesis, osteotomy of fracture.
Still another object of the present invention is to provide an improved internal compression plate that offers ease of application by eliminating the need for measuring other than direct visualization of the bone to bone placement
Yet another object of the present invention is to provide an improved internal compression plate that enables improved placement of the fixation, as well as facilitating appropriate compression/stabilization, ease of application and maximizing bone to bone contact without sacrifice of the interface surface area.
It should be noted that not every embodiment of the claimed invention will accomplish each of the objects of the invention set forth above. In addition, further objects of the invention will become apparent based the summary of the invention, the detailed description of preferred embodiments, and as illustrated in the accompanying drawings. Such objects, features, and advantages of the present invention will become more apparent in light of the following detailed description of a best mode embodiment thereof, and as illustrated in the accompanying drawings.
a-d show perspective, top, side and pin detail drawings, respectively, of a contoured, long barb embodiment of the present invention.
a-d show perspective, top, side and pin detail drawings, respectively, of a contoured, short barb embodiment of the present invention.
a-d show perspective, top, side and pin detail drawings, respectively, of a square plate, long barb embodiment of the present invention.
a-d show perspective, top, side and pin detail drawings, respectively, of a square plate, short barb embodiment of the present invention.
Set forth below is a description of what is currently believed to be the preferred embodiment or best examples of the invention claimed. Future and present alternatives and modifications to this preferred embodiment are contemplated. Any alternatives or modifications which make insubstantial changes in function, in purpose, in structure or in result are intended to be covered by the claims in this patent.
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The above description is not intended to limit the meaning of the words used in the following claims that define the invention. Rather, it is contemplated that future modifications in structure, function or result will exist that are not substantial changes and that all such insubstantial changes in what is claimed are intended to be covered by the claims. For instance, those of skill will understand that the instant invention can also apply to other designs of plates, as well as various locking mechanisms for the pins integrated with such plates. Likewise, it will be appreciated by those skilled in the art that various changes, additions, omissions, and modifications can be made to the illustrated embodiments without departing from the spirit of the present invention. All such modifications and changes are intended to be covered by the following claims.
