Abstract: Devices, systems and methods for dynamically stabilizing the spine are provided. The devices include an expandable spacer having an undeployed configuration and a deployed configuration, wherein the spacer has axial and radial dimensions for positioning between the spinous processes of adjacent vertebrae. The systems include one or more spacers and a mechanical actuation means for delivering and deploying the spacer. The methods involve the implantation of one or more spacers within the interspinous space.

Abstract: A bone fixation system with variable z-axis translation is provided. The system includes an outer tulip coupled to a bone fastener via a screw retainer. An inner tulip is coupled to the outer tulip such that the inner tulip is longitudinally movably relative to the outer tulip. The inner tulip includes a lock that provides a seat for a connecting rod. The inner tulip together with a seated rod is permitted to translate along the z-axis inside the outer tulip when in an unlocked position. Also in the unlocked position, the bone fastener is free to angulate relative to the outer tulip. The z-axis position of the inner tulip and rod relative to the outer tulip is fixed in a locked position. Also, in the locked position, the bone fastener is locked with respect to the outer tulip. The system may be adjusted between the locked and unlocked positions by way of a set screw.

Abstract: A spinal facet bone screw and minimally invasive surgical method of implanting a facet screw to stabilize the spine are provided. The facet screw includes an elongated body portion having a head, a threaded portion and a distal threadless portion. A pair of flutes formed in the elongated body extends from the distal end across the threadless portion and into the distal end of the threaded portion. The flute creates a self-tapping cutting surface that includes a heel edge that is curved with respect to the outer surface. The method of implantation comprises making a minimally invasive incision on the side of the midline contralateral to the target facet joint and delivering the screw across the interspinous process using the adjacent spinous processes as guideposts. The facet screw system fixes juxtaposed facet articular processes to enhance spinal fusion and stability and the method provides for accurate, repeatable and easy implantation.

Abstract: A percutaneous and minimally invasive instrument for inserting an interspinous process spacer into a patient is disclosed. The insertion instrument includes a first assembly connected to a handle assembly. The first assembly includes an inner shaft located inside an outer shaft and configured for relative translational motion with respect to the outer shaft. The relative translation motion causes one of the outer or inner shafts to move with respect to the other and thereby deflect at least one prong formed on one of the inner or outer shafts wherein such deflection causes engagement with a juxtapositioned interspinous spacer. The instrument further includes a driving tool configured for removable insertion into a proximal end of a passageway of the instrument. The driving tool has a distal spacer engaging portion configured to engage that part of the spacer requiring actuation for deployment of the spacer from at least one undeployed configuration to at least one deployed configuration and vice versa.

Abstract: An anterior cervical plate system is provided. The cervical plate includes an actuator and two locks located between two holes adapted to receive fasteners. Each lock includes a pair of fingers oppositely disposed from a fastener retaining flange. The retaining flange face the holes and the fingers face each other with the actuator located between the fingers. The actuator includes an elongated body. As the actuator is rotated from an unlocked to a locked position, the elongated body pushes both locks simultaneously outwardly to retain fasteners placed inside the holes. As the actuator is rotated in the opposite direction to an unlocked position, the elongated body catches hooks on the fingers to pull the locks inwardly away from holes. The locks are configured to prevent bone fasteners from backing out of the plate.

Abstract: An interbody spacer for the spine is provided. The interbody spacer includes a polymer cage and a plurality of bone screws configured to anchor the cage between two vertebrae of the spine. The cage includes a screw receiver configured to receive a metallic plate screw for attaching a plate to cover the proximal ends of the bone screws to prevent them from backing out over time with respect to the cage. The screw receiver has deflectable extensions that snap into cage to retain the screw receiver to the cage. The screw receiver also includes a transverse flanges that provide anti-rotation and alignment to the screw receiver relative to the cage and; furthermore, the screw receiver further includes a self-locking feature that increases purchase on the plate screw providing a secured cover plate for anti-backout protection for the bone screws.

Abstract: A bone fixation system with variable z-axis translation is provided. The system includes an outer tulip coupled to a bone fastener via a screw retainer. An inner tulip is coupled to the outer tulip such that the inner tulip is longitudinally movably relative to the outer tulip. The inner tulip includes a lock that provides a seat for a connecting rod. The inner tulip together with a seated rod is permitted to translate along the z-axis inside the outer tulip when in an unlocked position. Also in the unlocked position, the bone fastener is free to angulate relative to the outer tulip. The z-axis position of the inner tulip and rod relative to the outer tulip is fixed in a locked position. Also, in the locked position, the bone fastener is locked with respect to the outer tulip. The system may be adjusted between the locked and unlocked positions by way of a set screw.

Abstract: An implantable spacer for placement between adjacent spinous processes in a spinal motion segment is provided. The spacer includes a body defining a longitudinal passageway. A first arm and a second arm are connected to the body. Each arm has a pair of extensions and a saddle defining a U-shaped configuration for seating a spinous process therein. An actuator assembly is disposed inside the longitudinal passageway and connected to the body. When advanced, the actuator assembly contacts camming surfaces of the arms to rotate them from an undeployed configuration to a deployed configuration. In the deployed configuration, the distracted adjacent spinous processes are seated in the U-shaped portion of the arms providing sufficient distraction to open the neural foramen. An insertion instrument is provided for implanting the interspinous process spacer. The system is configured for implantation through a small percutaneous incision employing minimally invasive techniques.

Abstract: A dilator that facilitates implantation of an interspinous spacer is provided. The dilator includes a proximal portion and a tapered distal portion interconnected by an elongated body portion. The tapered distal portion is ideally suited for splitting ligamentous tissue for creating a posterior midline pathway through the supraspinous ligament as well as for distracting the adjacent spinous processes. Two oppositely located and longitudinally extending channels or grooves are formed in the outer surface of the dilator for stabilizing the dilator with respect to the spinous processes. An accompanying cannula together with the dilator form a system for the distraction of the adjacent spinous processes, stabilization of the spinous processes with respect to the system and creation of a working channel for the implantation of an interspinous spacer.

Abstract: A bone plate system is provided. The system includes two or more fastener locks stacked on top of each other and located between two holes in a plate adapted to receive bone fasteners. An actuator is provided between the locks. As the actuator is advanced, the locks are moved sequentially into position, firstly, to prevent one or more bone fasteners from backing out of the plate while permitting the fasteners to angulate and, secondly, to lock the angulation of the bone fasteners while still providing back out protection in situ. An expandable bone plate having a top plate interconnected to a bottom plate by a rack and pinion is provided. The rotation of the pinion with a driver lengthens or shortens the plate incrementally for custom length adjustment. The length is fixed in position with the simple removal of the driver and no further step is required to lock the plate length.

Abstract: An implantable spacer for placement between adjacent spinous processes in a spinal motion segment is provided. The spacer includes a body defining a longitudinal passageway. A first arm and a second arm are connected to the body. Each arm has a pair of extensions and a saddle defining a receiving portion configured for seating a spinous process of a scoliotic spine or a spine with misaligned spinous processes. Each arm has a proximal caming surface and is capable of rotation with respect to the body. An actuator assembly is disposed inside the longitudinal passageway and connected to the body. When advanced, a threaded shaft of the actuator assembly contacts the caming surfaces of arms to rotate them from an undeployed configuration to a deployed configuration. In the deployed configuration, the distracted adjacent spinous processes are seated in the superior and inferior arms of the spacer. Variations adapted for scoliotic curves are provided.

Abstract: A bone plate system is provided. The system includes two or more fastener locks stacked on top of each other and located between two holes in a plate adapted to receive bone fasteners. An actuator is provided between the locks. As the actuator is advanced, the locks are moved sequentially into position, firstly, to prevent one or more bone fasteners from backing out of the plate while permitting the fasteners to angulate and, secondly, to lock the angulation of the bone fasteners while still providing back out protection in situ. An expandable bone plate having a top plate interconnected to a bottom plate by a rack and pinion is provided. The rotation of the pinion with a driver lengthens or shortens the plate incrementally for custom length adjustment. The length is fixed in position with the simple removal of the driver and no further step is required to lock the plate length.

Abstract: Devices, systems and methods for dynamically stabilizing the spine are provided. The devices include an expandable spacer having an undeployed configuration and a deployed configuration, wherein the spacer has axial and radial dimensions for positioning between the spinous processes of adjacent vertebrae. The systems include one or more spacers and a mechanical actuation means for delivering and deploying the spacer. The methods involve the implantation of one or more spacers within the interspinous space.

Abstract: An implantable spacer for placement between adjacent spinous processes in a spinal motion segment is provided. The spacer includes a body defining a longitudinal axis and passageway. A first arm and a second arm are connected to the body. Each arm has a pair of extensions and a saddle defining a U-shaped configuration for seating a spinous process therein. Each arm has a proximal caming surface and is capable of rotation with respect to the body. An actuator assembly is disposed inside the passageway and connected to the body. When advanced, a threaded shaft of the actuator assembly contacts the caming surfaces of arms to rotate them from an undeployed configuration to a deployed configuration. In the deployed configuration, the distracted adjacent spinous processes are seated in the U-shaped portion of the arms.

Abstract: A percutaneous and minimally invasive instrument for inserting an interspinous process spacer into a patient is disclosed. The insertion instrument includes a first assembly connected to a handle assembly. The first assembly includes an inner shaft located inside an outer shaft and configured for relative translational motion with respect to the outer shaft. The relative translational motion causes one of the outer or inner shafts to move with respect to the other and thereby deflect at least one prong formed on one of the inner or outer shafts wherein such deflection causes engagement with a juxtapositioned interspinous spacer. The instrument further includes a driving tool configured for removable insertion into a proximal end of a passageway of the instrument.

Abstract: A micro-needle roller infusion system for transdermal or intradermal delivery of active agents, skin-care products, and other topical formulations is provided. The infusion system comprises a needle roller assembly with needles enclosed in a housing with a disposable cartridge having the active agent. The device offers the advantages of creating a path for the active agents to reach or be injected into the desired depth for an easier, more effective interaction with the target skin layer. Apart from the approximation of the agent to the target, the device also provides biological benefits of the needling therapy of collagen generation and skin rejuvenation coupled with superior convenience and ease of use.

Abstract: A spinal facet bone screw and minimally invasive surgical method of implanting a facet screw to stabilize the spine are provided. The facet screw includes an elongated body portion having a head, a threaded portion and a distal threadless portion. A pair of flutes formed in the elongated body extends from the distal end across the threadless portion and into the distal end of the threaded portion. The flute creates a self-tapping cutting surface that includes a heel edge that is curved with respect to the outer surface. The method of implantation comprises making a minimally invasive incision on the side of the midline contralateral to the target facet joint and delivering the screw across the interspinous process using the adjacent spinous processes as guideposts. The facet screw system fixes juxtaposed facet articular processes to enhance spinal fusion and stability and the method provides for accurate, repeatable and easy implantation.

Abstract: A plurality of individual tools is provided where each tool is uniquely configured to perform a step or a portion of a step in a novel procedure associated with the implantation of a stabilizing device (e.g., an interspinous spacer) for stabilizing at least one spinal motion segment. The tools are usable individually, or more preferably as a tooling system in which the tools are collectively employed to implant an interspinous spacer, generally in a minimally invasive manner. For example, each of the tools is arranged with coordinated markings and/or other features to ensure consistent depths of insertion, proper orientation of the tools with respect to each other or an anatomical feature of the patient, and precise delivery of the spacer to maintain safe positioning throughout the implantation procedure.

Abstract: A bone fixation system is provided. The bone fixation system includes a receiver coupled to a bone fastener. The receiver includes an inner bore and channel that provides a seat for an elongate fixation rod. The inner surface of the receiver includes locations for an instrument to securely grasp the receiver from the inside of the receiver without obstructing the inner bore. The instrument is provided with hooks that uniquely grasp the receiver from the inside and outside of the receiver. The instrument also includes flexible prongs configured to engage recesses formed in the outer surface of the receiver. The prongs have prong extensions that conform in shape to the recesses. The prongs and recesses have three separated perimeter surfaces each having a component perpendicular to the longitudinal axis. The bone fixation system provides a strong connection between the screw and the instrument for the demands unique to spinal surgery.

Abstract: Devices, systems and methods for dynamically stabilizing the spine are provided. The devices include an expandable spacer having an undeployed configuration and a deployed configuration, wherein the spacer has axial and radial dimensions for positioning between the spinous processes of adjacent vertebrae. The systems include one or more spacers and a mechanical actuation means for delivering and deploying the spacer. The methods involve the implantation of one or more spacers within the interspinous space.