INTREPID ORTHOPEDICS (Richfield, OH)

Removable and/or reversible bone fixation systems, devices, and methods of repairing fractures with a single cut. This includes odontoid-related fractures of the vertebral bodies of C2. These anchoring components are placed externally to fracture sites, and they provide the force of compression and radial force to bone to fix the bone fragment.

In order to effect natural healing for a fractured bone, the fragments that have been fractured of the bone must generally be kept together for a prolonged period of time in order to allow recalcification and bonds of the fractured areas to the rest of the bone. In many instances, adjacent pieces of a fractured bone can be repositioned and maintained in an adjacent relationship (to permit healing of the bone) through clamping or bonded to one another by means by a pin or screw that is driven through the joined parts. Fixing fractures may pose particular difficulties in different parts of the body, such as the cranium and spinal bones. This is due to the specific location of bones blood vessels and nerve tissues, as well as the effect that an injury can have upon the patient’s healing and overall health. A doctor might want to take off the fixation hardware once the anatomy of the bone has healed. In this instance the structure of the device used to fix it or scar tissue may create a challenge or make it impossible to take the device off.

In accordance with various aspects of the invention described herein, devices methods, systems, and techniques are described to treat fractures in the odontoid region of the cervical spine. A flexible tension member may be utilized in a variety of combinations with a rotating distal anchorblock, or “bullet-type fastener” to attach a compressively Odontoid fracture to the rest of the C2 cervical bone.

A specific embodiment describes a distal bullet fixation tool which is designed specifically to treat odontoid bone fractures. It is preferred that the bullet device can be advanced through a passage or channel that is formed between the C2 body as well as the odontoid fragment (desirably traversing the fracture site) and then rotated to present an enlarged cross-section to the channel. A fixation member that is flexible and attached to the bullet could be strained, ideally pulling the odontoid fragment into intimate contact with the rest of the C2 body. The flexible fixation member may also be fixed to the bullet using an proximal anchor button. This secures and tensions it in the way you want using a compression force across an area of fracture.

A portion of the invention is directed at cervical fixation devices that comprise: a “bullet” device that has an elongated profile that allows for movement through a passage that is formed in the C2 body and one or more odontoid pieces. In various configurations the bullet may have various surface patterns toward an odontoid piece, including a concave shaped face for contacting an upper surface of the odontoid fragment. Desirably, the bullet and the system components will draw one or moreodontoid fragments towards the C2 vertebral body and fixate the fragment(s) in an appropriate manner, and then applying compressive and/or radial forces across the fracture location.

The bullet device may contain revision features that permit the bullet and implant to be removed from the body after healing of the wound. One of the revisability features is the use of a flexible cord, or a different feature, that is attached to an opening near one end. This can be used to align the bullet’s longitudinal axis with the passage , and then draw it back through the channel or passageway formed by C2 bodies after the flexible fixation member has been removed and/or detorn.

The disclosed systems including components, devices, and systems can be utilized to treat various types of odontoid-related fractures. Furthermore the disclosed devices may be utilizedto treat odontoid fractures that have significant displacement or angulation, as well as antero-inferior to postero-superior fractures (Type 2C fractures) that are currently untreatable and/or are treated using instrumented C1-C2 fusion.

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