Abstract: Systems and methods of delivering and deploying a stent into a curvilinear cavity within a vertebral body or other bony or body structure. In some instances, the system can include an elongate shaft for delivering a self-expanding, cement-directing stent and devices that may be used to perform the steps to deliver and deploy the stent.

Abstract: An injector (100) may include a container (102) having a wall (110) with an interior surface (112) and a seal assembly (140) with an interior surface (142), the interior surfaces (110) of the wall (110) and the seal assembly (140) defining a closed sterile reservoir (150) filled with a drug product. The injector (100) may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle (180) having a point (182) disposed only partially through the seal assembly (140) in a storage state, and disposed through the interior surface (142) of the seal assembly (140) into the sterile reservoir (150) in a delivery state. Further, the injection may include an actuator (106) that is adapted to move the container needle from the storage state to the delivery state.

Abstract: An implantable, radially distensible stent includes a tubular structure having opposed open ends. The wall of the stent is made from a shape memory polymeric material. Grooves may be disposed within an outer surface of stent wall to improve flexibility and drainage of the stent.

Abstract: Systems and methods of delivering and deploying a stent into a curvilinear cavity within a vertebral body or other bony or body structure. In some instances, the system can include an elongate shaft for delivering a self-expanding, cement-directing stent and devices that may be used to perform the steps to deliver and deploy the stent.

Abstract: A drug delivery system includes a reservoir and a drug delivery device coupled to the reservoir. The drug delivery device also may include at least one temperature-sensitive component and a lock having locked and unlocked states. The system further includes an output device, and a controller coupled to the lock and the output device. The controller may also include a temperature sensor, or may be coupled to the temperature sensor. The controller is programmed or configured to determine if the temperature of a drug in the reservoir or of the temperature-sensitive component exceeds an upper limit or is below a lower limit, and to activate the lock in either event. The controller is also programmed or configured to determine, directly or indirectly, if the temperature subsequently is between the upper and lower limits, and to unlock lock as a consequence.

Abstract: Endoprostheses are disclosed.

Abstract: An injector may include a container having a wall with an interior surface and a seal assembly with an interior surface, the interior surfaces of the wall and the seal assembly defining a closed sterile reservoir filled with a drug product. The injector may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle having a point disposed only partially through the seal assembly in a storage state, and disposed through the interior surface of the seal assembly into the sterile reservoir in a delivery state. Further, the injection may include an actuator that is adapted to move the container needle from the storage state to the delivery state.

Abstract: An injector may include a container having a wall with an interior surface and a seal assembly with an interior surface, the interior surfaces of the wall and the seal assembly defining a closed sterile reservoir filled with a drug product, including a granulocyte colony-stimulating factor (G-CSF). The injector may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle having a point disposed only partially through the seal assembly in a storage state, and disposed through the interior surface of the seal assembly into the sterile reservoir in a delivery state. Further, the injection may include an actuator that is adapted to move the container needle from the storage state to the delivery state.

Abstract: An injector may include a container having a wall with an interior surface and a seal assembly with an interior surface, the interior surfaces of the wall and the seal assembly defining a closed sterile reservoir filled with a drug product. The injector may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle having a point disposed only partially through the seal assembly in a storage state, and disposed through the interior surface of the seal assembly into the sterile reservoir in a delivery state. Further, the injection may include an actuator that is adapted to move the container needle from the storage state to the delivery state.

Abstract: An injector may include a container having a wall with an interior surface and a seal assembly with an interior surface, the interior surfaces of the wall and the seal assembly defining a closed sterile reservoir filled with a drug product, including a granulocyte colony-stimulating factor (G-CSF). The injector may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle having a point disposed only partially through the seal assembly in a storage state, and disposed through the interior surface of the seal assembly into the sterile reservoir in a delivery state. Further, the injection may include an actuator that is adapted to move the container needle from the storage state to the delivery state.

Abstract: Systems and methods of delivering and deploying a stent into a curvilinear cavity within a vertebral body or other bony or body structure. In some instances, the system can include an elongate shaft for delivering a self-expanding, cement-directing stent and devices that may be used to perform the steps to deliver and deploy the stent.

Abstract: An implantable, radially distensible stent includes a tubular structure having opposed open ends. The wall of the stent is made from a shape memory polymeric material. Grooves may be disposed within an outer surface of stent wall to improve flexibility and drainage of the stent.

Abstract: The present invention generally is directed toward a spinal fixation system whereby a coupling element allows the physician to selectively lock or unlock either the connection between the coupling element and a fastener, such as to allow for repositioning of the coupling element, or the connection between the coupling element and an elongate rod. The locking or unlocking of these connections may be made independently and as desired by the physician.

Abstract: A medical device includes a balloon catheter having an expandable member, e.g., an inflatable balloon, at its distal end and a stent or other endoprosthesis. The stent is, for example, an apertured tubular member formed of a polymer and is assembled about the balloon. The stent has an initial diameter for delivery into the body and can be expanded to a larger diameter by inflating the balloon.

Abstract: An injector (100) may include a container (102) having a wall (110) with an interior surface (112) and a seal assembly (140) with an interior surface (142), the interior surfaces (110) of the wall (110) and the seal assembly (140) defining a closed sterile reservoir (150) filled with a drug product. The injector (100) may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle (180) having a point (182) disposed only partially through the seal assembly (140) in a storage state, and disposed through the interior surface (142) of the seal assembly (140) into the sterile reservoir (150) in a delivery state. Further, the injection may include an actuator (106) that is adapted to move the container needle from the storage state to the delivery state.

Abstract: According to aspects described herein, there is disclosed an improved hot balloon catheter delivery system for shape memory tubular stents. An outer sheath is provided on the delivery system that facilitates stent placement on a balloon during delivery through an endoscope. In one embodiment, the stent may be positioned between radiopaque markers/electrodes and the balloon may be heated. The stent may be prevented from moving proximally relative to the catheter as the delivery system is tracked through the patient's anatomical passageways. The outer sheath may be positioned to ride over the proximal cone of the hot balloon catheter and abut the proximal end of the stent to facilitate proper alignment of the balloon for deployment. Upon deployment of the stent in an appropriate position, the sheath may be pulled away from the stent to expose the proximal cone of the balloon and thereby allow balloon and stent expansion.

Abstract: A medical device includes a balloon catheter having an expandable member, e.g., an inflatable balloon, at its distal end and a stent or other endoprosthesis. The stent is, for example, an apertured tubular member formed of a polymer and is assembled about the balloon. The stent has an initial diameter for delivery into the body and can be expanded to a larger diameter by inflating the balloon.

Abstract: A medical device includes a balloon catheter having an expandable member, e.g., an inflatable balloon, at its distal end and a stent or other endoprosthesis. The stent is, for example, an apertured tubular member formed of a polymer and is assembled about the balloon. The stent has an initial diameter for delivery into the body and can be expanded to a larger diameter by inflating the balloon.

Abstract: According to aspects described herein, there is disclosed an improved hot balloon catheter delivery system for shape memory tubular stents is disclosed. An outer sheath is provided on the delivery system that facilitates stent placement on a balloon during delivery through an endoscope. In one embodiment, the stent may be positioned between radiopaque markers/electrodes and the balloon may be heated. The stent may be prevented from moving proximally relative to the catheter as the delivery system is tracked through the patient's anatomical passageways. The outer sheath may be positioned to ride over the proximal cone of the hot balloon catheter and abut the proximal end of the stent to facilitate proper alignment of the balloon for deployment. Upon deployment of the stent in an appropriate position, the sheath may be pulled away from the stent to expose the proximal cone of the balloon and thereby allow balloon and stent expansion.

Abstract: The present invention generally is directed toward a spinal fixation system whereby a coupling element allows the physician to selectively lock or unlock either the connection between the coupling element and a fastener, such as to allow for repositioning of the coupling element, or the connection between the coupling element and an elongate rod. The locking or unlocking of these connections may be made independently and as desired by the physician.