Abstract: An embolic protection system and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. The embolic protection system includes a guide catheter, a multi-lumen tube having a sealing surface on the distal end and an interventional device. A method of treating a blood vessel includes providing a guide catheter and a multi-lumen elongate member having proximal and distal ends, evacuation and inflation lumens extending therebetween and a sealing surface on the distal end. The elongate member is advanced through the guide catheter into a blood vessel that supplies blood to the heart proximal a lesion. The sealing surface is expanded to engage the endoluminal surface of the blood vessel and stop antegrade flow. An interventional device is advanced through the evacuation lumen to treat the lesion.

Abstract: The various embodiments disclosed herein relate to implantable devices for the treatment of a structural bone and deformity. More specifically, the various embodiments include systems, devices, and methods for implantation of a flexible or tension band for treating such a deformity, including hallux valgus.

Abstract: A steerable guide wire includes a core wire having a proximal end and a distal end. A multi-filament bundle is affixed to the distal end of the core wire. An outer coil surrounds at least a portion of the core wire and the multi-filament bundle. A proximal end of the multi-filament bundle is secured to a distal end of the coil. By locating the multi-filament bundle in the distal tip portion of the guide wire, a guide wire is provided that is highly flexible, has a high degree of tensile integrity, and is highly steerable, even in tortuous vasculature.

Abstract: A method of treating diseased ethmoid sinuses in a patient with a therapeutic agent includes providing an injection device comprising an elongate member having a proximal end, a distal tip or end, and a lumen extending between the distal tip and the proximal end, the proximal end being operatively coupled to a source of the therapeutic agent. The distal tip of the injection device is inserted at least partially within an interior portion of an ethmoid air cell. The therapeutic agent is then injected into the interior portion of the ethmoid air cell using the injection device, the therapeutic agent being delivered via the lumen in the elongate member.

Abstract: A method of treating a constricted sinus passageway of a patient includes traversing the canine fossa region of the patient so as to form a passageway in the sinus cavity. An elongate member is inserted through the passageway, the elongate member having an inflation member such as a balloon disposed thereon. The inflation member is positioned within the constricted passageway. The inflation member is expanded so as to expand at least a portion of the constricted sinus passageway.

Abstract: An evacuation sheath assembly and method of reducing or removing a blockage within a vessel without permitting embolization of particulate matter is provided. The evacuation sheath assembly includes a first elongate tubular member, having proximal and distal ends and a main lumen configured to be placed in fluid communication with a blood vessel. An expandable member is provided on a distal portion of the tubular member and is configured to form a seal with the blood vessel. The evacuation assembly further includes a second elongate tubular member having proximal and distal ends and an inflation lumen configured to be placed in fluid communication with the expandable member and a gas inflator. The gas inflator includes a high pressure gas source and a mechanism for regulating the pressure of the gas delivered by the gas inflator.

Abstract: A method of treating a constricted sinus passageway of a patient includes traversing the canine fossa region of the patient so as to form a passageway in the sinus cavity. An elongate member is inserted through the passageway, the elongate member having an inflation member such as a balloon disposed thereon. The inflation member is positioned within the constricted passageway. The inflation member is expanded so as to expand at least a portion of the constricted sinus passageway.

Abstract: Devices, systems and methods are described by which the blood pressure, nervous system activity, and neurohormonal activity may be selectively and controllably reduced by activating baroreceptors. A baroreceptor activation device is positioned near a baroreceptor, preferably a baroreceptor located in the carotid sinus. A control system may be used to modulate the baroreceptor activation device. The control system may utilize an algorithm defining a stimulus regimen which promotes long term efficacy and reduces power requirements/consumption. The baroreceptor activation device may utilize electrodes to activate the baroreceptors. The electrodes may be adapted for connection to the carotid arteries at or near the carotid sinus, and may be designed to minimize extraneous tissue stimulation.

Abstract: The various embodiments disclosed herein relate to methods and devices for treating a bone deformity such as hallux valgus. The various methods and devices relate to first and second anchors that are configured to be anchored in adjacent bones such that the two anchors, and thus the two bones, can be urged toward each other to treat the bone deformity.

Abstract: A method of treating a constricted sinus passageway of a patient includes traversing the canine fossa region of the patient so as to form a passageway in the sinus cavity. A cannula is positioned in the passageway. A visualization tool such as an endoscope is passed through a lumen or channel in the cannula to aid in visualization of the anatomical site of interest. A balloon dilation catheter is then deployed through or along the cannula so as to place the balloon within or across the constricted anatomical space (e.g., ostium). The balloon is then expanded so as to expand at least a portion of the constricted anatomical space. Alternative embodiments include the use of an optional guide wire and incorporating a endoscope lumen through the balloon dilation catheter.

Abstract: A system for manipulating a guide catheter within a patient's nasal passages or sinus cavities includes a guide catheter formed from an elongate flexible member having a lumen passing there through. A wire guide is slidably disposed within the lumen of the guide catheter. The system further includes a steering member fixedly secured to a proximal end of the wire guide and a proximal hub secured to a proximal end of the guide catheter. The system further includes a recessed handle having a first recess for fixedly receiving the proximal hub of the guide catheter and a second recess for receiving the steering member, the second recess being dimensioned to permit axial and rotational movement of the steering member while disposed in the second recess.

Abstract: A method and implantation tools for placing a transventricular splint including a tension member. The method includes gaining access to the patient's hearts and identifying entry or exit points for the tension member, marking those locations and delivering the tension member. Anchors for the tension member are also delivered. The length of the tensions member is measured and the walls of the heart drawn together. The pads are secured to the tension member and the tension member is trimmed to length. The pads are secured to the heart surface.

Abstract: An evacuation sheath assembly and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. A method of treating a lesion within a blood vessel, includes providing an evacuation sheath assembly having a multi-lumen tube with proximal and distal ends, first and second lumens therebetween, and at least one sealing surface mounted on the distal end of the multi-lumen tube. The evacuation sheath assembly is advanced to a region of interest within a blood vessel. The sealing surface is deployed upstream of the region of interest to occlude antegrade flow adjacent to the lesion to be treated. A dilation catheter is advanced through the multi-lumen tube such that the dilation balloon is positioned across the lesion and the lesion is dilated. Suction is applied to induce retrograde blood flow to carry dislodged embolic material into a lumen of the evacuation sheath assembly.

Abstract: Devices and methods for treating a damaged intervertebral disc to reduce or eliminate associated back pain. The present invention provides disc reinforcement therapy (DRT) which involves implanting one or more reinforcement members in and preferably around the annulus of the disc. The reinforcement members may be used to stabilize the annulus and/or compresses a portion of the annulus so as to reduce a bulge and/or close a fissure. The implantable devices and associated delivery tools may incorporate heating capabilities to thermally treat the annular tissue. Alternatively or in combination, other devices may be specifically employed for such thermal treatment.

Abstract: The various embodiments disclosed herein relate to implantable devices for the treatment of structural bone and joint deformity, including hallux valgus. More specifically, the various embodiments include systems, devices, and methods for implantation of a flexible or tension band for treating such deformity.

Abstract: A method and implantation tools for placing a transventricular splint including a tension member. The method includes gaining access to the patient's hearts and identifying entry or exit points for the tension member, marking those locations and delivering the tension member. Anchors for the tension member are also delivered. The length of the tensions member is measured and the walls of the heart drawn together. The pads are secured to the tension member and the tension member is trimmed to length. The pads are secured to the heart surface.

Abstract: Devices and methods for sealing a passageway formed by a patent foramen ovale (PFO track) in the heart are provided. One method includes providing an abrading device to the PFO track and abrading the tissue within the PFO track. The abraded tissue forming the PFO track is then held together under pressure, either via lowering right atrial pressure or via applying suction to the septum primum to pull it into apposition against the septum secundum. After a sufficient period of time, the pressure is released and the abraded tissue heals to form a robust seal over the PFO track. Additionally, several devices are provided which can be placed into the PFO track to apply adhesive to the walls of the PFO track. The devices may or may not be left within the PFO track. If the devices are not left within the PFO track, the walls of the PFO track, covered with adhesive, are brought into apposition with one another and adhered together.

Abstract: An evacuation sheath assembly and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. A method of treating a blood vessel, includes providing an elongate member having proximal and distal ends, a lumen therebetween, the distal end having a braided sheath expandable between a reduced and expanded diameter, and a fluid-tight covering. The elongate member is advanced into a blood vessel that supplies blood to the heart. The braided sheath is expanded to engage the endoluminal surface of the blood vessel and stop antegrade flow.

Abstract: Devices, systems and methods are disclosed by which the blood pressure, nervous system activity, and neurohormonal activity may be selectively and controllably reduced by activating baroreceptors. A baroreceptor activation device is positioned near a baroreceptor, preferably a baroreceptor located in the carotid sinus. A control system may be used to modulate the baroreceptor activation device. The control system may utilize an algorithm defining a stimulus regimen which promotes long term efficacy and reduces power requirements/consumption. The baroreceptor activation device may utilize RF-coupled or other electrodes to activate the baroreceptors. The electrodes may be adapted for connection to the carotid arteries at or near the carotid sinus, and may be designed to minimize extraneous tissue stimulation.

Abstract: Methods are provided for partial aortic obstruction for cerebral perfusion augmentation in patients suffering from global or focal cerebral ischemia. Alternatively, the methods can be used to partially obstruct aortic blood flow to condition the spinal cord to secrete neuroprotective agents prior to abdominal aortic aneurysm repair. Partial obstruction of a vessel can be accomplished by a device comprising an elongate catheter and a distally mounted expandable member. The expandable member may comprise one or two balloons. Other medical devices, such as an angioplasty, stent, or atherectomy catheter, can be inserted distal the expandable member to provide therapeutic intervention.