Abstract: A suture-free clamp for sealing body tissue during introduction of medical devices, such as a cannula, aspirator, stent, endoscope, and pressure monitor. The clamp may be used in a patient's vascular tissues, such as the right atrium and the aorta. The clamp comprises a generally cone-shaped housing which includes a lumen for receiving a medical device, and a collar having a central opening for passage of a medical device, the collar connected to a proximal end of the housing by a plurality of struts. The proximal end of the housing and the collar each has an annular surface. The two surfaces are opposed, and are operable to clamp tissue therebetween, and to thereafter release the tissue by releasing the clamp. Methods are also disclosed for using the suture-free clamp for sealing body tissues during introduction of a medical device.

Abstract: A modular blood filter device and delivery system, comprising a hollow vessel insertion device with a modular filter apparatus. The insertion device, which can be an introducer, includes a distal end adapted to enter an artery, and a proximal end adapted to receive a modular filter apparatus. When the insertion device is a cannula, the modular filter apparatus is received through a side port. The modular filter apparatus includes a shaft and an adjustable filter device or a removable filter associated with the shaft. The adjustable filter includes filter mesh, an adjustable frame capable of assuming enlarged and contracted conditions and a frame sizing mechanism associated with the frame. Certain embodiments include a filter cartridge, and the shaft is inserted into the cartridge, thereby protecting the adjustable filter device therein. The cartridge may then be removably received by the insertion device. An expandable obturator may be used to ease the entry of the insertion device into the vessel.

Abstract: A trocar introducer system having a trocar slideably inserted into a lumen of a cannula. The trocar has an elongate member which comprises a proximal end and a distal end. An actuating mechanism is mounted at the proximal end of the trocar and operates a surgical blade which is mounted on the distal end of the trocar. The cannula may have a suture flange, drainage ports, a balloon occluder, and/or threads to facilitate delivery of medical therapies to a body tissue. Methods of using the devices herein are also disclosed.

Abstract: The invention provides a device having first and second balloons. Each of the first and second balloons communicates with an inflation lumen. A differential pressure gauge communicates with both inflation lumens. Each of the inflation lumens also communicates independently with a pump for inflating the balloon. The pressure gauge may include a shut-off valve for terminating inflation in the second balloon when the pressure within the first balloon exceeds the pressure in the second balloon. The pressure gauge may also include a pressure limiter. Methods of using the devices for measuring diameter and pressure of a balloon occluder deployed in a vessel or body cavity are disclosed.

Abstract: Devices and methods for filtering blood. The devices generally comprise: a mesh for filtering blood flowing within a blood vessel, particularly within an artery such as the aorta; a structure adapted to open and close the mesh within the blood vessel; and a means to actuate the structure. The methods generally include the following steps: introducing a mesh into a blood vessel to entrap embolic material; adjusting the mesh, if necessary, during the course of filtration; and removing the mesh and the entrapped foreign matter from the blood vessel. Additionally, visualization techniques are used to ensure effective filtration.

Abstract: A cannula system having an internally slidable elongate tubular member frictionally anchored within a trocar, and optionally including a flange which acts as a positive stop against the trocar, that can be deployed for various treatments, including aortic cannulation during cardiopulmonary bypass, for example during CABG surgery. The tubular member has a proximal end, a lumen, and a flexible distal end which carries a preformed angled configuration relative to its proximal region and is bendable to a substantially linear configuration. The rigid trocar maintains the cannula in a substantially linear configuration. When the cannula is advanced through the lumen beyond the distal end of the trocar, the tubular member regains its angled configuration. Methods for using the devices herein are also disclosed.

Abstract: Devices and methods for filtering blood. The devices generally comprise: a mesh for filtering blood flowing within a blood vessel, particularly within an artery such as the aorta; a structure adapted to open and close the mesh within the blood vessel; and a means to actuate the structure. The methods generally include the following steps: introducing a mesh into a blood vessel to entrap embolic material; adjusting the mesh, if necessary, during the course of filtration; and removing the mesh and the entrapped foreign matter from the blood vessel. Additionally, visualization techniques are used to ensure effective filtration.

Abstract: An intravascular device for venting an inflatable chamber and methods for using the device are disclosed. The intravascular device generally includes three components, namely a catheter or cannula, an inflatable member, and a selective degassing element. The inflatable member is typically a balloon. The catheter or cannula is typically hollow with a first lumen extending between an inflation port and the interior of the inflatable member and a second lumen extending between the interior of the inflatable member and an exhaust port. The selective degassing element is typically positioned between the inflatable member and the exhaust port and occupies the entire cross-sectional area of the second lumen. When in a closed position, the selective element prevents the passage of liquid from the interior of the inflatable member, through the exhaust port. When in an open position, the selective element permits gas entrained within the inflatable member to be expelled from the device, via the exhaust port.

Abstract: A probe having the ability to deliver cardioplegia solution to the coronary sinus under direct visualization and to provide venous drainage from the right atrium for cardiopulmonary bypass. The probe has an elongate tubular member, including a distal end, a proximal end, and a lumen. A membrane, optionally perforated, mounted within the lumen of the tubular member partitions the lumen and is removable or penetrable by a cardioplegia catheter. The distal end comprises a toroidal balloon or a circumferential recessed vacuum manifold. A vacuum port communicates with the distal end of the tubular member or the vacuum manifold. Methods of using the cardioplegia access view probe for catheterization of the coronary sinus and for venous return as herein described are also disclosed.

Abstract: An introducer system having an elongate shaft with proximal and distal ends. A flexible sleeve is mounted on the distal end of the shaft and is adapted to circumferentially cover the outer surface of a distal end of a cannula when the shaft is positioned within a lumen of the cannula. The introducer system has dilation capabilities which facilitates insertion of a medical device into a vessel or organ. Methods of using the devices herein are also disclosed.

Abstract: A balloon arterial cannula and methods for filtering blood. The devices generally include a mesh for filtering blood flowing within a blood vessel, particularly within an artery such as the aorta, a structure adapted to open and close the mesh within the blood vessel, a means to actuate the structure, and a balloon occluder which typically includes a flexible material enclosing a chamber. The methods generally include the steps of introducing a mesh into a blood vessel to capture embolic material, adjusting the mesh, if necessary, during the course of filtration, inflating the balloon occluder to occlude the vessel upstream of the mesh, and thereafter deflating the balloon occluder and removing the mesh and the captured foreign matter from the blood vessel. Additionally, visualization techniques are used to ensure effective filtration.

Abstract: Devices and methods for filtering blood. The devices generally comprise: a mesh for filtering blood flowing within a blood vessel, particularly within an artery such as the aorta; a structure adapted to open and close the mesh within the blood vessel; and a means to actuate the structure. The methods generally include the following steps: introducing a mesh into a blood vessel to entrap embolic material; adjusting the mesh, if necessary, during the course of filtration; and removing the mesh and the entrapped foreign matter from the blood vessel. Additionally, visualization techniques are used to ensure effective filtration.

Abstract: An expansion mechanism which includes an elongate instrument and a plurality of struts arranged around the elongate instrument provides radial expansion of a medical device. Each strut has a first end pivotally connected to the elongate instrument and a second strut which expands radially outward. Each strut further carries a flexible line which has a proximal end and a distal end. The distal end of each line passes beyond the second end of the strut which carries it and is attached to the strut immediately adjacent the strut which carries it. Methods of using such an expansion mechanism are also disclosed, particularly to provide deployment of medical devices within a patient's blood vascular system.

Abstract: A vessel plug having a handle which include a proximal end and a distal end, a flange attached to the distal end of the handle, and a tip extending distally beyond the flange. In use, the flange and the tip are shaped to engage an opening of a blood vessel, provide occlusion to the opening of the vessel to block the blood flow, thereby achieving hemostasis. The plug may be sutureless, providing a seal by the operation of a flange which includes vacuum ports or adhesive material. Alternatively, sutures may be placed around the flange. Methods of using the sutureless vessel plug are also disclosed herein.

Abstract: A shunt and method of use for maintaining distal blood flow during an arteriotomy procedure is disclosed. The shunt includes a first tubular member having a proximal end, a distal end, and a lumen therebetween. The proximal end has an opening in communication with the lumen, and the proximal opening is adapted to receive blood from a first region of an artery. The distal end has an opening in communication with the lumen, and the distal opening is adapted to release blood into a second region of the artery. The shunt includes a second tubular member having a proximal end, a distal end, and a lumen therebetween which either merges and communicates at its distal end with the lumen of the first tubular member, or rides separate and parallel to it.

Abstract: A cannula possessing a distal region and a proximal region, a slider mounted on the cannula, and a manipulator wire connecting the distal region and the slider, is articulated by proximal and distal displacements of the slider with respect to the distal end of the cannula.

Abstract: The invention provides a nested tubing cannula which comprises outer and inner elongate tubular members, each having a proximal end, a distal end, and a lumen therebetween. The inner tubular member is sealed at its distal end and is nested substantially coaxially within the lumen of the outer tubular member, so that the gap between the inner and the outer tubular member defines a second lumen whereas the first lumen is the lumen of the inner tubular member. A tubular sleeve is disposed coaxially between the inner and outer tubular members. A balloon is mounted on a distal region of the outer tubular member and is in communication with the first lumen. The cannula further comprises a port proximal or distal the balloon occluder and is in communication with the second lumen. Methods for making the devices herein are disclosed.

Abstract: A percutaneous filtration catheter used to entrap emboli from a patient's aorta and heart during cardiac surgery. The catheter has an elongate member, a proximal end, and a distal end. A balloon occluder is mounted on the distal end of the elongate member and an expandable filter is mounted on the elongate member distal the balloon occluder. Methods for using the devices are also disclosed herein.

Abstract: A modular blood filter device and delivery system, comprising an arterial cannula with a modular filter device. The arterial cannula includes a distal end adapted to enter an artery, and a side port for receiving a modular filter cartridge. The modular filter cartridge includes a tubular cartridge, and a shaft having a handle on one end and an expandable filter device on the other end. The expandable filter device includes filter mesh and an expansion frame capable of assuming enlarged and contracted conditions. The shaft is inserted into the cartridge, thereby containing the expandable filter device therein. The cartridge may then be removably received by the side port on the cannula. The cannula may be introduced into a blood vessel, and the expandable filter device may be deployed through the cannula into the vessel. The expansion frame may be expanded to the enlarged condition to capture embolic material in the mesh, may be collapsed to the contracted condition, and may be removed from the vessel.

Abstract: A cardioplegia occluder and methods of using the device during cardiac surgery are disclosed. The system typically includes a substantially rigid cannula with an occluder mounted on the distal region of the cannula that expands upon activation to occlude the aorta downstream of an infusion port which delivers cardioplegia solution to arrest the heart. Systems including cutting blades, blade guards, flanges, radiopaque markers and occluder aligners are also disclosed. In use, the distal end of the cannula is inserted through an incision into the aorta, the occluder is expanded and cardioplegia solution is infused upstream of the aorta to arrest the heart. The infusion port can alternately be used to aspirate cardioplegia or embolic debris or other unwanted material from the aorta.