Apparatus for an orthopedic fixation system
Inventors
Knight, Adam T. • Cheney, Daniel F. • Marcano, Eric A. • Pancratz, David J.
Assignees
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Abstract
An orthopedic fixation system includes a sterile packaged implant kit and a sterile packaged instrument kit. The sterile packaged implant kit includes at least one surgical implant, an insertion device, and an implant package adapted to receive the at least one surgical implant and the insertion device therein. The implant package maintains the at least one surgical implant and the insertion device sterile after sterilization of the sterile packaged implant kit. The sterile packaged instrument kit includes one or more instruments necessary to use the sterile packaged implant kit and an instrument package adapted to receive the one or more instruments therein. The instrument package maintains the one or more instruments sterile after sterilization of the sterile packaged instrument kit.
Core Innovation
The invention relates to an orthopedic sizing and fixation system. A sizing device extends from its perimeter a first pair of projections with a fixed separation distance to determine the appropriate size of surgical implant required for a surgical procedure. A first shape memory implant includes legs movable between an implanted position and an insertion position, where the distance between the legs in their insertion position is equal to the fixed separation distance between the first pair of projections of the sizing device.
The system further includes a first package adapted to receive the sizing device, whereby the package maintains the sizing device sterile after sterilization. A second package adapted to receive the first shape memory implant maintains the first shape memory implant sterile after sterilization. The packages are provided as part of the orthopedic sizing and fixation system to keep both the sizing device and the shape memory implant sterile after sterilization.
In an embodiment, a sterile packaged sizing guide includes perimeter projections whose spacing corresponds to implant leg spacing to select proper implant size. The orthopedic fixation system is provided as two sterile-packaged kits, including a sterile implant kit and a sterile instrument kit, stored in respective implant and instrument trays covered by an outer cover and sterile seal.
Claims Coverage
Independent claim clm-00001 defines an orthopedic sizing and fixation system with four core inventive elements: a sizing device with a fixed separation projection pair, a sterile-maintaining package for the sizing device, a first shape memory implant matched by equal leg separation in an insertion position, and a sterile-maintaining package for the implant. Dependent claims refine the system by adding additional matched projection pairs and corresponding implants, and by adding instruments such as an insertion device and a drill guide with fixed separation relationships.
Sizing device with fixed separation projections
A sizing device determines the appropriate size of surgical implant required for a surgical procedure, wherein the sizing device includes extending from its perimeter a first pair of projections with a fixed separation distance.
Sterile package for the sizing device
A first package adapted to receive therein the sizing device, whereby the package maintains the sizing device sterile after sterilization.
First shape memory implant matched to projection separation
A first shape memory implant, comprising legs movable between an implanted position and an insertion position, wherein the distance between the legs of the first shape memory implant in their insertion position is equal to the fixed separation distance between the legs of the first pair of projections of the sizing device.
Sterile package for the shape memory implant
A second package adapted to receive therein the first shape memory implant, whereby the second package maintains the first shape memory implant sterile after sterilization.
Across the independent claim and its listed refinements, coverage is centered on pairing a sizing device with fixed separation perimeter projections to an implant having equal leg separation in an insertion position, while maintaining both the sizing device and the implant sterile via respective packages. Dependent refinements add additional matched projection pairs and additional shape memory implants, and include instruments such as an insertion device and a drill guide with hole separation determined by the fixed separation distances.
Stated Advantages
Maintains the sizing device sterile after sterilization.
Maintains the shape memory implant sterile after sterilization.
Determines the appropriate size of surgical implant required for a surgical procedure using a sizing device matched to the implant leg separation.
Documented Applications
Sizing and fixation in a surgical procedure using a sizing device to determine appropriate implant size and a first shape memory implant matched by leg separation in an insertion position.
Using the system with a drill guide to drill parallel bone holes with correct separation, inserting/releasing the implant, and tamping it flush.
Selecting proper implant size using a sterile packaged sizing guide having perimeter projections whose spacing corresponds to implant leg spacing.
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