A method for single-stage cranioplasty reconstruction includes prefabricating a clear craniofacial implant, creating a cranial, craniofacial, and/or facial defect, positioning the clear craniofacial implant over the cranial, craniofacial, and/or facial defect, tracing cut lines on the clear craniofacial implant as it lies over the cranial, craniofacial, and/or facial defect, cutting the prefabricated clear custom craniofacial implant along the hand-marked lines for optimal fit of the clear implant within the cranial, craniofacial, and/or facial defect, and attaching the final clear craniofacial implant to the cranial, craniofacial, and/or facial defect with standard fixation methods of today.

A cranial burr hole cover having a single, elongated internal bracing member, a locking external cover member joined by one or more connecting members, and a locking mechanism that precludes movement of the external cover member relative to the connecting members in the proximal direction once the cover is secured onto the skull. The internal bracing member is longer than it is wide. For a given burr hole, the cover will be chosen such that the longitudinal dimension is greater than the diameter of the burr hole and the width dimension is less than the diameter of the burr hole.

A method of affixing a cranial burr hole cover comprising an elongated internal bracing member, a locking external cover member joined by one or more connecting members, and a locking mechanism, whereby the interior bracing member is tilted and one end is inserted through the burr hole and under the skull. The internal bracing member is then moved laterally relative to the burr hole to allow the opposite end of the internal bracing member to clear the opposite edge of the burr hole. The internal bracing member is then centered beneath the burr hole. The external cover member is now moved distally toward the skull to cover the burr hole. The locking mechanism secures the cover in place on the skull and the connecting members extending from the cover member are cut flush with the cover member.

A skull fixing device includes at least a lower fastening member and a movable retainer assembly. The lower fastening member includes a thread rod having a first coupling section formed in an interior thereof. The movable retainer assembly includes at least an upper fastening member and a nut. The upper fastening member includes a sleeve section in which a first rotation section is formed. The nut is screwed to the threaded rod and has an upper end forming a first positioning section and has an outer surface forming a second rotation section mating the first rotation section. Also disclosed is a surgery tool that includes at least a outer barrel having a lower end forming a second positioning section engageable with the first positioning section and an inner guide rod having a lower end forming a second coupling section engageable with the first coupling section.

A mosaic implant conformable to a curved surface, comprising first and second implant sections coupled along a beam portion extending across a length of the implant, each of the implant sections havinga plurality of biocompatible mosaic plates, anda plurality of wires which interconnect the plates with one another. The mosaic implant is configured to be deformable such that at least a portion of the mosaic implant is conformable to a curved surface, with the beam portion providing structural support which resists inward deformation of the curved portion of the implant. A kit for forming a mosaic implant is also provided, along with a method for correcting a bone defect in a patient.

The present disclosure discloses a bone stabilization device (also referred to as a bone tape), which includes a composite flexible construct including a rigidifiable biocompatible sheet structure having first and second opposed surfaces. A biocompatible cement is located on the first surface. In use the composite flexible construct is applied to a bone with the cement contacted directly to the bone. The cement is made of a material that, once adhered to the bone, is curable to mechanically and/or ionically bond to the sheet structure and to chemically bond to the bone to achieve a permanent bond. The bone tape allows simultaneous alignment and stabilization of multiple articulated fragments for successful 3D reconstruction of shattered bones. Initial flexibility and translucency provided by the bone tape can facilitate the temporary stabilization and alignment adjustment of multiple fragments, prior to permanent rigid bonding.

The present disclosure is for a device, tooling, methods of use and kits containing the cranial plates and bur hole covers used for resecuring a cranial flap after a craniotomy. The cranial repair system is meant to reduce the profile of cranial plates or bur hole covers on the external surface of the cranium after a craniotomy is performed. The embodied devices of present disclosure are designed to reside substantially within the kerf or bur holes and thus minimize the surface area of devices resides on the external surface of the cranium. Additional embodiments include kits, tooling and methods to further reduce and/or eliminate the external profile of the cranial plate on the external cranial surface.

The present disclosure provides a burr hole cover (e.g., burr hole cover) and method of manufacturing such apparatus. The burr hole cover disclosed herein may be multi-functional in that it may be used to: (a) form a burr hole which provides access to the brain, and (b) facilitate concealing the burr hole without employing any fastening devices (e.g., surgical screws, wires, etc.). In embodiments, the burr hole cover may include a sleeve having an outer surface, an inner surface, and a hollowed portion. In embodiments, the outer surface of the sleeve may define external serrations. The sleeve may be configured to create a burr hole in a skull, and the external serrations may be configured to secure the sleeve within the burr hole. The burr hole cover may also include a plate configured to fit with the sleeve and conceal the burr hole.

In accordance with one embodiment, a device for performing an angled craniotome includes an elongate handle, a footplate, a stem, and an elongate cutting bit. The elongate handle extends in a vertical direction. The footplate is spaced apart from the elongate handle and defines a plane generally perpendicular to the vertical direction. The footplate is offset from the handle in a horizontal direction where the horizontal direction is perpendicular to the vertical direction. The stem has a proximal end and a distal end. The proximal end is coupled to the handle and the distal end is coupled to the footplate. The stem extends from the handle at an oblique angle in the horizontal direction relative to the handle. The elongate cutting bit is coupled to the handle and extends from the handle toward the footplate at the oblique angle in the horizontal direction relative to the handle.

One or more arrays of flexible, disposable, bone plate sizers with corresponding arrays of permanent bone plates, systems using these bone plate sizers and/or templates, and methodologies using these bone plate sizers and/or templates are embodied. Each array of disposable bone plate sizers has a plurality of sizers having differing configurations and sizes, each of the disposable sizers in a given array corresponding to a particular bone screw size. Each of the disposable bone plate sizers in a given array are mounted upon and easily detachable from a frame member. The disposable bone plate sizers may be malleable such that may be manipulated by the surgeon into the desired three-dimensional shape to match the contour of the bone segments to be joined, thereby providing a template to shape the corresponding permanent bone plate.