Abstract: The present invention relates in general to implantable flexible bone composites, and method for preparing the same. The flexible bone composite includes at least one polymeric layer and at least one calcium-containing layer. The polymeric layer can be a polymeric layer including a synthetic polymer. The calcium-containing layer can include a calcium compound such as ?-Ca3(PO4)2. The flexible bone composites of the invention are useful as bone void fillers and have improved handling characteristics.

Abstract: A bone anchor (100) for attaching a rod (108) to a bone has an anchor member (106) for attachment to the bone and an anchor head (104) having a U-shaped opening for receiving the rod. The bone anchor also includes a locking cap (102) that has a main body (900) and a set screw (1000). Advantageously, in one embodiment the locking cap preferably is designed such that a single tool can be used to lock the locking cap in place on the anchor body preferably with a 90° turn and preferably then drive the set screw to clamp the rod. The locking cap also preferably non-threadingly engages the anchor body. The anchor body preferably has an inclined surface on its top surface which elastically deflects extending tabs on the main body to secure the locking cap to the anchor body. A method of implantation and assembly of the bone anchor are also described.

Abstract: A fastener assembly for a spinal fixation system that is particularly useful in treatment of pediatric and small-statured patients includes a fastener, an attachment member, and a locking member. The fastener has a lower portion for contacting a bone and an upper portion integral with the lower portion. The upper portion has two open channels. Each channel is configured and dimensioned to receive a portion of a longitudinal or connecting member along its circumference. The attachment member is positionable on the fastener and at least partially covers the channel that receives the longitudinal or connecting member. The locking member is operatively associated with the upper portion of the fastener and secures the attachment member and the longitudinal or connecting member to the fastener.

Abstract: An expandable interspinous process spacer implant for insertion and/or implantation between a spinous process of a superior vertebral body and a spinous process of an inferior vertebral body, the implant comprising multiple pairs of legs joined in a scissor-like fashion and pivotally coupled to each other by one or more pins, where each leg has multiple slots along its longitudinal axis. The implant further may include a pair of bearing surfaces coupled between the legs via cross pins and a first plate and second plate each of which is coupled to a pair of roller pins disposed between a pair of slots on the legs where rotation of a fastener in the fastener holes of the first and second plate results in the first plate and the second plate being drawn toward each other causing the expansion of the height of the implant.

Abstract: A bone screw is provided having first and second threaded portions of different diameter separated by a middle portion that is unthreaded so that the bone screw may be inserted into a pair of adjacent bone fragments and used to compress the fragments together by driving the screw into a hole drilled in the fragments. An installation tool is also disclosed for threadably engaging one end of the bone screw and is used to initially drive the screw into the bone hole. Thereafter, a screwdriver may be inserted through the tool and into engagement with a recess in the bone screw and may be used to drive the screw fully into the bone and to separate the bone screw from the installation tool. A method of installation is further provided.

Abstract: A bone fixation device includes an intramedullary pin having a longitudinal axis, a proximal end, and a distal tip configured and dimensioned for insertion into a medullary canal of a bone and a bone plate disposed at the proximal end of the intramedullary pin, wherein the bone plate includes an angled tab configured and dimensioned to have a center of gravity lying on a radius of a cross-sectional area of the intramedullary pin taken orthogonally to the intramedullary pin's longitudinal axis.

Abstract: The device for performing osteosynthesis includes a fixation element, such as a bone plate having a bottom surface designed to bear against the bone, a top surface, and at least one through hole extending from the bottom surface to the top surface, the though hole having a central axis and configured and dimensioned to receive a multiaxially pivotal insert or bushing for a bone screw. A bushing insertable into the through hole, includes a central bore designed to receive a bone screw, the central bore having a longitudinal axis, and a peripheral outer surface designed to be in contact with the through hole. The bushing is configured and dimensioned to be radially compressible and radially expansible, and the cross section of the through hole, which is orthogonal to the central axis, is non-circular. The cross section of the bushing that is orthogonal to the longitudinal axis has a shape that corresponds substantially to the cross section of the through hole of the bone plate.

Abstract: An intervertebral implant comprises a number of components including upper and lower endplates and one or more inserts configured to be disposed between the upper and lower endplates. Complimentary curved articulation surfaces are defined on the insert-facing surfaces of the upper and lower endplates and on the corresponding upper and lower surfaces of each of the inserts. The components of the implant articulate with respect to each other along shared articulation surfaces. At least two pairs of shared articulation surfaces are defined, each pair having a different length radius. The components of the implant can be configured with retainers, such that the implant is retained in an assembled configuration when disposed within an intervertebral space.

Abstract: The method for producing resorbable or degradable polymeric medical devices by applying compressive forces on solid polymeric objects containing liquid or solid additives, is characterized in that: A) the additives are able to promote the slip-page of the polymeric objects through the forming device, facilitate transient chain mobility and promote chain orientation; B) said additives are present in an amount of 0.005 to 20% of the dry weight of said polymeric objects; C) the solubility parameters of said additives being selected in such a way that after absorbing by said polymeric objects the additives do not dissolve more than 0.01 to 1% of the total mass of said polymeric objects; D) said applying of compressive forces is performed minimally at a temperature of Tmin=Tg?50° C., Tg being the glass transition temperature of the polymer the said object is made of polymer; and E) said applying of compressive forces is performed maximally at a temperature Tmax=Tm?5° C.

Abstract: Described herein is a balloon catheter with a zero-profile tip—that is, a balloon catheter having a distal tip that does not extend beyond the boundary of the cavity that will be created by the balloon when inflated—and further described herein are methods for the manufacturing of same. Several embodiment feature a method for inverting the distal end of an inflatable balloon structure, said inflatable balloon structure having a middle region, a first end region with a first opening, and a second end region with a second opening, said method comprising: (1) centrally inverting the second end region of the inflatable balloon structure and passing it through the first opening; (2) permanently fixing the inverted second end region to prevent un-inversion; and (3) returning the second end region back through the first opening.

Abstract: A medical implant comprises a biodegradable magnesium-based alloy of which at least a part of its surface layer comprises a magnesium carbonate. A method for the manufacture of a biocompatible, corrosion-inhibiting protective surface layer on a medical implant comprising a magnesium-based alloy, comprises: providing an implant comprising a magnesium-based alloy to be coated; placing the implant into a reactor chamber; exposing at least part of the surface of said implant to an atmosphere comprising humid carbon dioxide to produce a coating on the surface of the implant comprising a magnesium carbonate of the formula x MgCO3·y Mg (OH)2, whereby x+y=1; removing the implant from the reactor chamber; and drying the surface of the implant.

Abstract: A fracture mobility testing system is provided for use in surgical procedures for augmenting vertebral bodies having collapsed due to compression fractures. The testing system is utilized to determine if the cortical shell of the vertebral body has begun to heal over the fracture lines to the point at which height restoration is not possible. Depending on the feedback provided by the testing system, the surgeon may elect to proceed with any of a variety of known height restoration techniques if the fractured portions of the vertebral body are still mobile, or may elect for a simple vertebroplasty procedure without height restoration if the feedback from the testing system determines that the cortical outer portions of the fractured vertebral body have fused to one another to the point at which height restoration is no longer an option.

Abstract: A surgical implant comprises a body having a compressed state and an uncompressed state. An envelope contains the body in at least the compressed state. The envelope forms an air-tight seal around the body in the compressed state and is water-soluble or degradable in body fluids.

Abstract: A loading station for loading an implant into an insertion device comprises two holders. Each holder is adapted to receive an endplate of the implant, e.g., in a slot of the holder. The loading station may include a distraction block that is disposed on or integrated within one of the holders. The distraction block is adapted to receive the distal ends of the blades of the insertion device, and maintain the insertion device in a particular position. The distraction block is configured to distract the blades from each other, so that the user may insert the implant into the insertion device. Alternatively, each holder of the loading station may have recess guides to receive the blades of the insertion device, and separate the blades from each other as the insertion device is pushed towards the loading station.

Abstract: A novel coplanar X-ray guided method and aiming arm device for insertion of distal locking screws in intramedullary bone nails. Radiopaque target markers in the aiming arm enable the easy positioning of an X-ray source such that an X-ray beam is coplanar with the aiming arm transverse holes. After the X-ray source is accurately oriented, a single X-ray snapshot is enough to assess the exact distortion of the implanted intramedullary nail. The X-ray beam need not be coaxial with the nail holes. The aiming arm includes a mobile portion and a fixed portion fastened to the nail, and the aiming arm can be adjusted, displacing the mobile portion over the fixed portion, to compensate for the distortion of the intramedullary nail caused by implantation in bone.

Abstract: Methods and devices are shown for forming polymer fasteners into bone by expelling the polymer from a cannula. Devices and methods shown allow a user to form multiple fasteners of various sizes without re-loading a device. Devices and methods shown further provide temperature profiles during fastener formation that reduce or eliminate thermal necrosis. Devices and methods shown further provide fasteners with increased strength.

Abstract: The present invention is directed to an adjustable self drilling tap assembly and method for drilling and tapping bores in bone for use in orthopedic procedures to treat bone. The adjustable length tap assembly includes a shaft having cutting threads for drilling holes in bone, a stop collar configured and dimensioned to be translatable along the longitudinal axis of the shaft, and a locking collar comprising a member configured and dimensioned to be received over at least a portion of the stop collar. The locking collar preferably is configured and dimensioned to engage with the stop collar to adjustably set the effective length for the cutting threads and to prevent movement of the stop collar along the longitudinal axis of the shaft.

Abstract: An apparatus for connecting a bone anchor to a support rod includes a connector body and a cap. The connector body has a channel to receive and locate the support rod relative to the bone anchor. The cap is moveable longitudinally into a partially installed position in the channel, and snaps into non-threaded engagement with the connector body by rotating from the partially installed position to an installed position without moving axially relative to the connector body. In some embodiments, a sleeve fits over a socket portion of the connector body in a temporary position in which the sleeve permits insertion of the bone anchor into the socket. The sleeve engages the connector body so as to be restrained from axial and rotational movement relative to the connector body when in the temporary position. Tools are provided for installing the connector body, sleeve, cap, and support rod.

Abstract: A nucleus pulposus of an intervertebral disc is supplemented or replaced by a physiologically fully hydrated solid hydrogel intervertebral body comprising a polyvinyl alcohol copolymer, wherein the solid hydrogel intervertebral body exhibits an osmotic pressure of from 0.1 to 0.3 megapascals prior to insertion into a patient, the solid hydrogel intervertebral body having a ratio of length to principal transverse dimension not less than about 5:1.

Abstract: A system for stabilizing a superior vertebra relative to an inferior vertebra includes a plate having a first surface for mating with the superior and inferior vertebra and a second surface opposite the first surface. The plate has a first hole configured for overlying the superior vertebra and a second hole configured for overlying the inferior vertebra. An alignment instrument has a leading portion and a trailing portion. The leading portion has a securing mechanism configured for removable attachment to a fastening mechanism of the plate. The alignment instrument also includes an alignment prong extending past the first surface of the plate when the plate is attached to the fastening mechanism. The alignment prong provides tactile information to the trailing portion of the alignment instrument for use in positioning the plate with respect to the superior and inferior vertebra.