Abstract: Instrumentation for implanting an artificial intervertebral disc includes static trials and a dynamic trial for determining the appropriate size of disc to be implanted, static trial holders for manipulating the static trials, inserter/impactors for inserting and removing the static trials and for inserting the artificial intervertebral discs, repositioners/extractors for repositioning and extracting the static trials or the artificial intervertebral discs, and a leveler for setting the proper position of the artificial intervertebral disc. Methods for using the same are also disclosed. Features for artificial intervertebral discs and intervertebral spacer devices useful for manipulation by the instrumentation are also disclosed.

Abstract: A method of inserting an intervertebral disc implant into a disc space includes accessing a spinal segment having a first vertebral body, a second vertebral body and a disc space between the first and second vertebral bodies. The method includes securing a first pin to the first vertebral body and a second pin to the second vertebral body, using the first and second pins for distracting the disc space, and providing an inserter holding the intervertebral disc implant. The method also desirably includes engaging the inserter with the first and second pins, and advancing the inserter toward the disc space for inserting the intervertebral disc implant into the disc space, whereby the first and second pins align and guide the inserter toward the disc space.

Abstract: A wedge plate inserter/impactor instrument is provided primarily for holding, inserting, repositioning, removing, impacting, extracting, and otherwise manipulating an artificial intervertebral disc having features suitable for being manipulated thereby. A spring-loaded holding pin of the instrument can be used to engage a corresponding hole on the disc and confront the angled surfaces of the disc to enable the holding and manipulation of the disc. A forward wedge extension of the inserter/impactor has upper and lower surfaces that engage inwardly facing surfaces of the disc to hold the baseplates of the disc at a preferred lordosis angle with respect to one another. The instrument can engage the disc from a variety of surgical approach angles.

Abstract: A method of inserting an intervertebral disc implant into a disc space includes accessing a spinal segment having a first vertebral body, a second vertebral body and a disc space between the first and second vertebral bodies. The method includes securing a first pin to the first vertebral body and a second pin to the second vertebral body, using the first and second pins for distracting the disc space, and providing an inserter holding the intervertebral disc implant. The method also desirably includes engaging the inserter with the first and second pins, and advancing the inserter toward the disc space for inserting the intervertebral disc implant into the disc space, whereby the first and second pins align and guide the inserter toward the disc space.

Abstract: Instrumentation for implanting an artificial intervertebral disc includes repositioners/extractors for repositioning and extracting the static trials or the artificial intervertebral discs, each of the repositioners/extractors including a shaft and at least two pins coupled to the shaft distal end and extending in a same direction and perpendicular to a plane passing through the shaft longitudinal axis, each pin being parallel to all others of the pins, wherein the disc includes at least two holes, at least two of the pins being sized, directed, and spaced for simultaneous engagement with at least two of the holes, and wherein such simultaneous engagement enables repositioning of the implant via application of pressure to the shaft.

Abstract: Apparatus and methods for preparing a disc space and inserting an intervertebral disc implant therein are disclosed. Among the various instruments disclosed are a midline marker, a reference pin drill and insertion guide, a pin drill guide, a chisel guide, a sizer, a serrated broach, an implant dispenser, and an implant insertion tool. Methods of utilizing these tools are also disclosed.

Abstract: Instrumentation for implanting an artificial intervertebral disc includes a leveler for setting the proper position of the artificial intervertebral disc, the leveler including at least two tines extending parallel to one another from the leveler shaft distal end, wherein the tines are spaced and sized to be insertable and fittable between baseplates of the disc and to substantially fill at least a height of a separation space volume between the baseplates, and to straddle a central coupling of the baseplates during the insertion and when so fitted, such that when the baseplates are substantially non-parallel to one another in the intervertebral space, insertion of the tines into the intervertebral space between the baseplates and straddling the central coupling forces the baseplates into a substantially parallel orientation relative to one another.

Abstract: An artificial disc having a pair of opposing baseplates, for seating against opposing vertebral bone surfaces, separated by a ball and socket joint that includes a solid ball mounted to protrude from one of the baseplates. The ball is captured within a curvate socket formed in a peak of a convex structure integral with the other of the baseplates. The socket is formed by opposing curvate pockets, one on the convex structure and one on a retaining cap that is secured to the other of the baseplates. The ball rotates and angulates in the socket. The ball and socket joint therefore permits the baseplates to rotate and angulate relative to one another.

Abstract: Devices, systems, and methods for treating gastro-esophageal reflux disease (GERD) include anti-reflux valves and retainers for securing them within the lumen of the esophagus, stomach, or a hiatal hernia. The retainers contain inflatable balloons, some of which may be enveloped by a flexible shell that is used to secure the balloon to tissue. Methods are described for treating GERD patients who (1) have no hiatal hernia, (2) have a hiatal hernia that is fixed in place, or (3) have a hiatal hernia that slides above and below the diaphragm. Methods are also described for delivering GERD-treatment devices to their target locations within the patient's gastrointestinal tract.

Abstract: Apparatus and methods for preparing a disc space and inserting an intervertebral disc implant therein are disclosed. Among the various instruments disclosed are a midline marker, a reference pin drill and insertion guide, a fin drill guide, a chisel guide, a sizer, a serrated broach, an implant dispenser, and an implant insertion tool. Methods of utilizing these tools are also disclosed.

Abstract: Instrumentation for implanting an artificial intervertebral disc includes static trials and a dynamic trial for determining the appropriate size of disc to be implanted, static trial holders for manipulating the static trials, inserter/impactors for inserting and removing the static trials and for inserting the artificial intervertebral discs, repositioners/extractors for repositioning and extracting the static trials or the artificial intervertebral discs, and a leveler for setting the proper position of the artificial intervertebral disc. Methods for using the same are also disclosed. Features for artificial intervertebral discs and intervertebral spacer devices useful for manipulation by the instrumentation are also disclosed.

Abstract: Instrumentation for implanting a cervical disc replacement device includes cervical disc replacement trials for determining the appropriate size of replacement device to be implanted, an insertion plate for maintaining the elements of the replacement device in fixed relation to one another for simultaneous manipulation, an insertion handle for attachment to the insertion plate for manipulation of the elements, an insertion pusher for releasing the insertion handle from the insertion plate, a drill guide that cooperates with the insertion plate to guide the drilling of tap holes for bone screws to be placed through bone screw holes in the flanges of the replacement device, clips that are applied to the flanges after placement of the bone screws to resist screw backout, and a clip applicator for applying the clips to the flanges.

Abstract: An artificial intervertebral disc having a pair of opposing baseplates, for seating against opposing vertebral bone surfaces, uses a semispherical, bored bearing that is secured to the baseplates with compression locking posts and one or more retaining caps. The compression locking posts extend through the bearing bore and baseplate apertures such that the bearing is between the baseplates' inwardly facing surfaces. Retaining caps are attached to the compression locking posts, securing the baseplates to the bearing. Bearing surfaces on the inwardly facing side of each baseplate allow each baseplate to rotate relative to the bearing, however, rotation of each baseplate is limited by the interference of each baseplate and its respective retaining cap. Rotation of the baseplates about the longitudinal axis of the spine can be limited via a notch in the retaining caps and a groove in the baseplates, or vice versa.

Abstract: Instrumentation for implanting an artificial intervertebral disc includes static trials and a dynamic trial for determining the appropriate size of disc to be implanted, static trial holders for manipulating the static trials, inserter/impactors for inserting and removing the static trials and for inserting the artificial intervertebral discs, repositioners/extractors for repositioning and extracting the static trials or the artificial intervertebral discs, and a leveler for setting the proper position of the artificial intervertebral disc. Methods for using the same are also disclosed. Features for artificial intervertebral discs and intervertebral spacer devices useful for manipulation by the instrumentation are also disclosed.

Abstract: Instrumentation for implanting an artificial intervertebral disc includes static trials, the static trials including first and second trial baseplates immovably coupled to one another via a trunk extending therebetween, each trial baseplate having an outwardly facing surface approximating a contour of a corresponding outwardly facing surface of an artificial intervertebral disc baseplate, at least one of the trial baseplates having a plurality of engagement holes extending into the at least one of the trial baseplates in a direction substantially perpendicular to each of a plurality of a surgical approach directions used to insert the trial into the intervertebral space, each of the plurality of engagement holes being disposed on the at least one of the trial baseplates to correspond to a respective one of the surgical approach directions such that selection for use of one of the plurality of engagement holes corresponds to, selection of the respective surgical approach.

Abstract: An adjustable pin drill guide and method for using an adjustable pin drill guide to prepare a vertebral body space to receive an implant are disclosed. The method includes providing an adjustable pin drill guide, producing a gap by removing tissue between a first vertebral body and a second vertebral body, inserting into the gap first and second extensions of the guide in a first position, moving the first extension and the second extension to a second position, drilling a first hole in the first vertebral body through a first opening in the guide, drilling a second hole in the second vertebral body through a second opening in the guide, placing a first pin into the first hole, and placing a second pin into the second hole. The first and second extensions are preferably in parallel planes when in the first and second positions.

Abstract: Instrumentation for implanting an artificial intervertebral disc includes static trials and a dynamic trial for determining the appropriate size of disc to be implanted, static trial holders for manipulating the static trials, inserter/impactors for inserting and removing the static trials and for inserting the artificial intervertebral discs, repositioners/extractors for repositioning and extracting the static trials or the artificial intervertebral discs, and a leveler for setting the proper position of the artificial intervertebral disc. Methods for using the same are also disclosed. Features for artificial intervertebral discs and intervertebral spacer devices useful for manipulation by the instrumentation are also disclosed.

Abstract: Instrumentation for implanting a cervical disc replacement device includes cervical disc replacement trials for determining the appropriate size of replacement device to be implanted, an insertion plate for maintaining the elements of the replacement device in fixed relation to one another for simultaneous manipulation, an insertion handle for attachment to the insertion plate for manipulation of the elements, an insertion pusher for releasing the insertion handle from the insertion plate, a drill guide that cooperates with the insertion plate to guide the drilling of tap holes for bone screws to be placed through bone screw holes in the flanges of the replacement device, clips that are applied to the flanges after placement of the bone screws to resist screw backout, and a clip applicator for applying the clips to the flanges.

Abstract: Devices, systems, and methods for treating gastro-esophageal reflux disease (GERD) include anti-reflux valves and retainers for securing them within the lumen of the esophagus, stomach, or a hiatal hernia. The retainers contain inflatable balloons, some of which may be enveloped by a flexible shell that is used to secure the balloon to tissue. Devices with more than one balloon, a low-profile leaf valve, and a sleeve valve are used to treat reflux in patients with a hiatal hernia. The leaf valve may also be configured for its control by constriction by gastrointestinal lumen muscle, through radial compression of the valve's flange. Bi-directional combination valves are used to treat or diagnose patients with reflux due to transient lower esophageal sphincter relaxations (TLESR). Those valves pass reflux through a channel in which gas and liquid reflux are separated.

Abstract: Instrumentation for implanting a cervical disc replacement device includes cervical disc replacement trials for determining the appropriate size of replacement device to be implanted, an insertion plate for maintaining the elements of the replacement device in fixed relation to one another for simultaneous manipulation, an insertion handle for attachment to the insertion plate for manipulation of the elements, an insertion pusher for releasing the insertion handle from the insertion plate, a drill guide that cooperates with the insertion plate to guide the drilling of tap holes for bone screws to be placed through bone screw holes in the flanges of the replacement device, clips that are applied to the flanges after placement of the bone screws to resist screw backout, and a clip applicator for applying the clips to the flanges.