Method and apparatus for an orthopedic fixation system
Inventors
Knight, Adam T. • Cheney, Daniel F. • Marcano, Eric A. • Pancratz, David J.
Assignees
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Publication Number
US-9724146-B2
Publication Date
2017-08-08
Expiration Date
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 orthopedic sizing and fixation system defines a sizing device having a perimeter with a first fixed separation distance and a second fixed separation distance, where the first fixed separation distance is different from the second fixed separation distance. The sizing device extends from its perimeter a first pair of projections with the first fixed separation distance and a second pair of projections with the second fixed separation distance. A first and second shape memory implant each has a first leg and a second leg movable between an implanted position and an insertion position, with a leg-to-leg distance in the insertion position corresponding to the sizing device projection separations.
Using the sizing device, a first bone and a second bone are measured to determine whether the bones require the first shape memory implant or the second shape memory implant. Implanting includes implanting the first shape memory implant into the first and second bones when the sizing device shows the bones require the first shape memory implant, and implanting the second shape memory implant into the first and second bones when the sizing device shows the bones require the second shape memory implant. The sizing device is used to match the insertion position leg distances of the corresponding selected implant to the projection separations of the sizing device.
In packaging-focused embodiments, the orthopedic sizing and fixation system provides a first package containing the first shape memory implant and a second package containing the second shape memory implant, where each package maintains its contained implant sterile after sterilization. The sizing device itself includes perimeter-defined fixed distances aligned with the leg-to-leg insertion position distances of the first and second shape memory implants. The workflow further includes opening the first package and opening the second package and implanting the selected shape memory implant after the measurement step.
Additional embodiments further tie implantation components to the sizing device separations by providing drill guides and insertion devices whose drilling and delivery are based on fixed separation distances. The methods include providing drill guides configured to drill holes into the first bone and the second bone with fixed separation distances matching the sizing device projections, positioning drill guides, drilling holes with corresponding separation distances, inserting implant legs while in the insertion position, and allowing the legs to move to the implanted position.
Claims Coverage
The provided excerpts include three independent claims (clm-00001, clm-00009, clm-00018). Across these, the inventive features center on perimeter-defined sizing projections with two different fixed distances, selecting between two shape memory implants whose insertion-position leg spacing matches the selected distance, and providing sterile packages for the implants.
Perimeter-based sizing device with two different fixed distances
A sizing device defines a perimeter with a first fixed separation distance and a second fixed separation distance, the first fixed separation distance being different than the second fixed separation distance, and extends from its perimeter first and second pairs of projections having the respective fixed separation distances.
Two shape memory implants matched to sizing-device insertion-position distances
A first shape memory implant includes first and second legs movable between implanted and insertion positions such that the distance between the legs in the insertion position equals the first fixed separation distance of the sizing device, and a second shape memory implant includes first and second legs movable between implanted and insertion positions such that the distance between the legs in the insertion position equals the second fixed separation distance of the sizing device.
Measuring first and second bones to select the implant
A method measures a first bone and a second bone using the sizing device to determine whether the first and second bones require the first shape memory implant or the second shape memory implant, and implants the corresponding selected shape memory implant into the first and second bones based on the sizing-device indication.
Sterile implant packaging for first and second shape memory implants
A method provides a first package containing a first shape memory implant and a second package containing a second shape memory implant, where each package maintains its contained implant sterile after sterilization, and includes opening the selected package and implanting the corresponding shape memory implant into the first and second bones after measurement.
Drill guides and implantation tied to fixed separation distances
A method provides drill guides configured to drill holes into the first bone and the second bone with a fixed separation distance equal to a respective fixed separation distance defined by the sizing device projections, positions the drill guides, drills holes with the corresponding separation, inserts the implant legs while the legs are in an insertion position, and allows the legs to move from the insertion position to an implanted position.
The claim coverage centers on using a sizing device defining two different fixed distances via perimeter projections to match the insertion-position leg spacing of two shape memory implants, measuring bones to select between the implants, and implanting accordingly. One independent claim further requires sterile packaging for the implants, and multiple dependent claim refinements add drill guides and implantation steps tied to the same fixed separation distances.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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