Abstract: A method and apparatus for fluidly coupling a reservoir containing a flowable biomaterial to a mold. The flow of the flowable biomaterial into the mold is controlled in accordance with a first operating parameter. At least one injection condition is monitored. The flow of the flowable biomaterial is controlled in accordance with a second operating parameter in response to one or more of the injection conditions reaching a threshold level. The second operating parameter is maintained during at least a portion of the curing of the flowable biomaterial. In some embodiments, the second operating parameter may optionally include permitting a portion of the flowable biomaterial to be expelled from the mold.

Abstract: A method of stabilizing adjacent vertebrae including the steps of forming at least one annulotomy in an annulus. At least a portion of the nucleus material is removed through the annulotomy to form a cavity in an intervertebral disc space between the adjacent vertebrae. A reservoir containing a flowable biomaterial is fluidly coupled to the intervertebral disc space. A flowable biomaterial is delivered to the cavity. The delivery of the flowable biomaterial into the intervertebral disc space is controlled in accordance with at least a first operating parameter. The biomaterial is at least partially cured to stabilize the adjacent vertebrae.

Abstract: A non-rigid system and method for stabilizing displaced bony members include a flexible unit of tethering material coupled to the displaced bony members so as to restore a desired shape, curvature of or relationship between the bony members without excessively limiting mobility of bony members located adjacent to the displaced members the rest of the portions of the motion bony segment during a restoration process.

Abstract: A catheter holder designed to deliver a curable biomaterial to an intervertebral disc space. By securing the catheter to the catheter holder, the depth of insertion of the catheter into the disc space can be accurately controlled. The catheter holder optionally helps with insertion of a optional mold through the annulotomy and into the disc space created by the nuclectomy. The catheter holder helps keep the mold from being drawn too far into the disc space or pushed too far out of the disc space during polymer injection.

Abstract: A multi-lumen mold is for the in situ formation of a prosthesis in an annulus located in an intervertebral disc space of a patient. The annulus has at least two openings formed by minimally invasive techniques and at least a portion of the nucleus pulposus is removed to form a nuclear cavity. The multi-lumen mold includes a mold adapted to be located in the nuclear cavity. A first lumen having a distal end is fluidly coupled to a flexible mold at a first location. At least a second lumen having a distal end fluidly coupled to the flexible mold at a second location. The first and second lumens are adapted to extend out through the openings in the annulus when the mold is positioned in the nuclear cavity. One or more securing members can be used to secure the mold in the intervertebral disc space. The securing members can engage with the annulus, the end plates, and/or another surface of a vertebrate.

Abstract: A nuclectomy method for creating a nuclear cavity in an annulus located in an intervertebral disc space and for preparing the nuclear cavity to receive an intervertebral prosthesis. An annulotomy is formed in the annulus along an annular axis to provide access to a nucleus. A portion of the nucleus is removed in a first region surrounding the annular axis using at least a first surgical tool. Another portion of the nucleus is removed from a second region using at least a second surgical tool. An evaluation mold is positioned in the nuclear cavity and a fluid is delivered to the evaluation mold so that the mold substantially fills the nuclear cavity. The amount of nucleus removed from the annulus is estimated. One or more of the removing steps are optionally repeated as necessary until an adequate amount of the nucleus is removed from the annulus.

Abstract: A plurality of differently configured bone spinal implants for insertion in a spine have a cylindrical bore for receiving an insertion head stud. A plurality of instruments are disclosed each of which have a first connection element which is either a male or female member such as e.g., a ball and socket, a cylinder and socket and so on for forming either a stationary or articulating interchangeable joint for a plurality of disc processing heads or implant insertion heads. The plurality of disc space processing heads or implant insertion heads have a complementary second joint member for interchangeable attachment to the first connection element. The implant insertion heads or disc processing heads have different configurations for different shaped implants.

Abstract: A chisel with U.V-shaped, saw tooth or other shaped opposing blades is used to form channels in adjacent vertebrae. The chisel has a projection extending from at least one of the top and bottom surfaces to limit depth of penetration into the vertebrae. A guide member may be attached to the forward tip of the chisel to guide the chisel into the disc space to uniformly chisel both adjacent vertebrae simultaneously to form a channel in the vertebrae. The so formed channels serve as sa guide for a second chisel having no guide member. The second chisel, which may be a box chisel, is used to complete the channels to the desired depth to receive an associated implant, typically of cortical bone. Other embodiments are disclosed in which a two step box chisel has a retractable guide member for initially guiding the chisel as it forms partial channels in the vertebrae disc space. The guide member is then retracted and the channels formed to the desired depth.

Abstract: A bone fastener for stabilizing bone fragments includes a single or multiple components coupleable with one another and displaceable to a locked position of the bone fastener.

Abstract: A method and apparatus for fluidly coupling a reservoir containing a flowable biomaterial to a mold. The flow of the flowable biomaterial into the mold is controlled in accordance with a first operating parameter. At least one injection condition is monitored. The flow of the flowable biomaterial is controlled in accordance with a second operating parameter in response to one or more of the injection conditions reaching a threshold level. The second operating parameter is maintained during at least a portion of the curing of the flowable biomaterial. In some embodiments, the second operating parameter may optionally include permitting a portion of the flowable biomaterial to be expelled from the mold.

Abstract: Intervertebral implant system for intervertebral implantation, are disclosed. An intervertebral implant system according to the present disclosure includes a frame having a peripheral wall defining a space therein, and a settable material introducible into the space of the frame. The settable material is a biocompatible load bearing material including and not limited to bone, composites, polymers of bone growth material, collagen, and insoluble collagen derivatives. The settable material is injectable into the space defined by the frame. The settable material may have an initial fluid condition wherein the fluid settable material cures to a hardened condition.

Abstract: A method and apparatus for fluidly coupling a reservoir containing a flowable biomaterial to a mold. The flow of the flowable biomaterial into the mold is controlled in accordance with a first operating parameter. At least one injection condition is monitored. The flow of the flowable biomaterial is controlled in accordance with a second operating parameter in response to one or more of the injection conditions reaching a threshold level. The second operating parameter is maintained during at least a portion of the curing of the flowable biomaterial. In some embodiments, the second operating parameter may optionally include permitting a portion of the flowable biomaterial to be expelled from the mold.

Abstract: A cortical bone implant is formed of two or more planks of bone which are connected with one or more offset pins. The pins may be right circular cylinders inserted into a corresponding offset bore which offset bends the inserted pin. The bending creates compression and tensile loads in the pin which loads creates friction compression forces on the planks connecting them to the pins by friction. The pins may have different shapes to form offset configurations in place of the offset bores for friction attachment to the planks. The implants may be formed of flat or L-shaped planks or bones formed into other shapes including interlocking arrangements. Processes and fixtures are disclosed for forming the pins, planks and implants. Various embodiments of the pins, planks, implants and processes are disclosed.

Abstract: A chisel with distal cutting edges, used to form channels in adjacent vertebrae, includes a shank having a longitudinal axis and a cutting head coupled to the distal end of the shank. The cutting head includes distal cutting edges, which may be linear, arcuate, or V-shaped, and a guide member, which may be hollow or formed as two spaced members, to guide the chisel into the disc space to uniformly chisel both adjacent vertebrae simultaneously to partially form a channel in the vertebrae. The guide member and cutting head may have openings for distributing cut debris to the top and bottom surfaces of the head. The guide member may also include distal transverse, longitudinal side and/or vertical cutting edges, some of which may be in stepped relationship, for further cutting the endplates and removing disc material from between adjacent vertebrae, and for scraping of endplates. Other embodiments are disclosed.

Abstract: Various instrumentation, implants and methodology are disclosed for implanting bone implants in the TLIF approach. The implants are preferably cortical bone of various shapes. The instruments include chisels, rasps, trials, inserters, spreaders, adjustors, curettes, rongeurs, and impactors. The instruments have straight and bent shafts. The implants may have recesses or notches in their sides for receipt of a mating insertion instrument. Some of the implants have a threaded hole for receiving a mating threaded stud of an implant insertion instrument. The implants may have saw tooth vertebral gripping surfaces which are lordotic or parallel, may be C-shaped, multi-faceted or annular.

Abstract: A C-shaped or ring shaped implant formed of cortical bone has its C-shaped or inner channel filled with a bone promoting material which is preferably demineralized bone fibers formed as a flexible wet sheet or may be cancellous bone, pressed bone fibers formed from demineralized cortical bone chips soaked in acid, or a flex material formed of demineralized bone growth promoting bone fibers. The discrete bone filler element may be secured by a bonding agent, pins or screws, metal, polymer or bone material. The bone filler material is preferably bonded by filling a section of a long bone medullary cavity with wet bone fibers and then drying the fibers to bond them to the outer bone. A filled bone ring may be sliced to form annular filled sections which are then divided into mirror image C-shaped halves each forming an implant. Flex material of compressed bone fibers may be formed with an opening shaped to receive a cortical bone implant element having a C-shaped channel.

Abstract: An insertion tool for a C-shaped bone spinal wedge shaped intervertebral implant comprises an outer shank with a hollow core in which is placed a shaft with a threaded stud which passes through a bore in the shank at an implant insertion end of the shank. A flat extension member defines a plane and extends from the shank overlying the stud, the stud for receiving a threaded bore of the spinal implant. The shaft has a knob distal the stud for rotatably attaching the stud to the implant. The extension member abuts the implant at mating flat surfaces which are spaced by a medial recess formed by a portion of the medullary canal of a long bone. A cap slides over the shank at an end opposite the extension member to capture the shaft in the shank core. A guide rod is attached to a collar on the shank normal to the plane of the extension member to assist the surgeon in orienting the implant to the disc space orientation during insertion of the implant.

Abstract: Spinal and other implants may be bone or synthetic material shaped as rings, C-shaped or rectangular and so on and also may have serrated wedge shaped top and bottom surfaces to match the disc space lordosis of adjacent ertebra and so on. The implants have one or more recesses aligned in an insertion direction at either or both outer peripheral sides of the implant. In a ring implant, e.g., formed from a transverse slice of the diaphysis of a long bone or otherwise, the recesses are aligned overlying the opposing sides of the ring parallel to the insertion direction, which sides are stronger than the more central region overlying and aligned with a central chamber in the implant. The alignment ith the opposing sides minimizes damage to the implant at the weaker more central region in response to implant insertion forces.

Abstract: An insertion tool for a C-shaped bone spinal wedge shaped intervertebral implant comprises an outer shank with a hollow core in which is placed a shaft with a threaded stud which passes through a bore in the shank at an implant insertion end of the shank. A flat extension member defines a plane and extends from the shank overlying the stud, the stud for receiving a threaded bore of the spinal implant. The shaft has a knob distal the stud for rotatably attaching the stud to the implant. The extension member abuts the implant at mating flat surfaces which are spaced by a medial recess formed by a portion of the medullary canal of a long bone. A cap slides over the shank at an end opposite the extension member to capture the shaft in the shank core. A guide rod is attached to a collar on the shank normal to the plane of the extension member to assist the surgeon in orienting the implant to the disc space orientation during insertion of the implant.

Abstract: A spinal implant tool comprises a steel shaft bifurcated into shaft portions at one end at which a pair of extensions extend from the bifurcated shaft portions. The extensions are flat members which extend from an implant impact element at the end of each of the shaft portions. A spinal bone implant is inserted between the extensions. A shaft portion displacement member has a stud threaded to one of the shaft portions and a knob head for capturing the other shaft portion to the member threaded stud. When the knob is rotated the shaft members are moved apart or closer together. A stop member limits the spread apart distance of the shaft portions.