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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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 fixation system that includes a sterile packaged implant kit and a complementary sterile packaged instrument kit. The sterile packaged implant kit includes an insertion device loaded with an implant and a drill guide, with the implant pre-mounted on the insertion device and maintained sterile in a sealed implant tray or implant cover. The implant comprises legs movable between an insertion position and an implanted position.
The sterile packaged instrument kit includes at least a drill bit, locating pins, an instrument handle, and an implant tamp, maintained sterile in a sealed instrument tray or instrument cover. The drill guide is adapted for drilling holes into bone having a fixed separation distance equal to a fixed separation distance between the legs of the implant in their insertion position. The system further includes a sterile packaged sizing guide to determine implant size or selection based on projection separation corresponding to implant leg spacing.
In use, the method comprises opening the sterile packaged implant kit and the sterile packaged instrument kit, drilling holes in bone using the drill guide and the drill bit, inserting the legs of the implant into the bone using the insertion device, releasing the implant from the insertion device, and pushing a portion of the implant located between the legs flush to the bone. Releasing the implant moves the legs from their insertion position toward their implanted position, thereby compressing the bone.
Claims Coverage
The independent claims are directed to two inventive features: orthopedic fixation using sterile packaged implant and instrument kits with fixed separation drilling tied to implant leg separation, and selection between two sterile packaged implant kits having different fixed leg separation distances. Across these claims, the inventive features center on sterile packaged implant/instrument kits, fixed separation drilling, leg motion and release that compress bone, and kit selection based on bone measurement.
Sterile packaged implant kit with leg-separated drill guidance
Opening a sterile packaged implant kit to access a drill guide and an insertion device loaded with an implant, where the implant comprises legs movable between an implanted position and an insertion position, and the drill guide is adapted for drilling holes into bone that have a fixed separation distance equal to a fixed separation distance between the legs of the implant in their insertion position.
Sterile packaged instrument kit enabling drilling and leg insertion
Opening a sterile packaged instrument kit to access a drill bit, drilling holes in bone using the drill guide and the drill bit, inserting the legs of the implant into the bone using the insertion device, and releasing the implant from the insertion device.
Flush seating and release-driven leg motion compressing bone
Pushing a portion of the implant located between the legs flush to the bone, wherein the legs of the implant move from their insertion position towards their implanted position, thereby compressing the bone.
First and second sterile packaged implant kits with different leg separations
Providing a first sterile packaged implant kit comprising a first implant, a first insertion device, and a first drill guide, where the first implant comprises legs movable between an implanted position and an insertion position and the first drill guide is adapted for drilling holes into bone with a fixed separation distance equal to a fixed separation distance between the legs of the first implant in their insertion position; providing a second sterile packaged implant kit comprising a second implant, a second insertion device, and a second drill guide, where the second implant comprises legs movable between an implanted position and an insertion position and a fixed separation distance between the legs of the second implant in their insertion position is different from the fixed separation distance between the legs of the first implant, and the second drill guide is adapted for drilling holes into bone with the fixed separation distance equal to the fixed separation distance between the legs of the second implant in their insertion position.
Bone measurement determining which sterile kit is used
Measuring bone to determine whether the bone requires the first sterile packaged implant kit or the second sterile packaged implant kit, utilizing the first sterile packaged implant kit to fixate the bone when the measuring determines the bone requires the first kit, and utilizing the second sterile packaged implant kit to fixate the bone when the measuring determines the bone requires the second kit.
The independent claims define orthopedic fixation procedures using sterile packaged implant and instrument kits, drilling bone holes with a drill guide whose fixed separation matches implant leg separation in the insertion position, inserting and releasing the implant legs so they move toward the implanted position, and pushing an inter-leg portion flush to the bone to achieve compression. A second independent claim further covers selecting between two sterile packaged implant kits by measuring bone to match the required kit having different fixed leg separation distances and corresponding drill guidance.
Stated Advantages
Compressing the bone.
Documented Applications
Fixating bone in an orthopedic context using a sterile packaged implant kit and a sterile packaged instrument kit.
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