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 bendable shape-retaining cannula and methods of use. The bendable shape-retaining cannula comprises a tubular member having a proximal region, a distal region adapted to enter a blood vessel or heart chamber, a lumen therebetween, and a flexible region positioned proximal the distal region. A suture flange may be disposed about the cannula distal the flexible region. The flexible region can be bent and retains its bent configuration until a positive force is applied.

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 steps of introducing a mesh into a blood vessel to entrap embolic material, and removing the mesh and the entrapped foreign matter from the blood vessel.

Abstract: A catheter apparatus for use in a body passage. The catheter comprises a catheter shaft and an expandable conduit defined by a filter mesh material of varying porosity mounted on said catheter shaft. The expandable conduit has an upstream end and a downstream end, the expandable conduit having a collapsed position in which the expandable conduit is collapsed toward the catheter shaft and an expanded position in which the upstream end of the expandable conduit is open to fluid flow. The expandable conduit has an upstream sealing member at the upstream end of the expandable conduit for creating a seal between the upstream end of the expandable conduit and an internal wall of the body passage.

Abstract: A filter comprising a porous material is arranged in a generally conical shape having an expandable base and a vertex. A reservoir tip is located at the vertex for collecting filtered embolic material. The tip communicates with a distal port and lumen of an aspiration tube for removing embolic material under vacuum. A vessel occluding device comprising a non-permeable material having an expandable conical shape and communicating with an aspiration tube is also disclosed. Methods of using the filter and occluding devices for protecting a patient from embolization during cardiovascular procedures are described.

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 steps of introducing a mesh into a blood vessel to entrap embolic material, and removing the mesh and the entrapped foreign matter from the blood vessel.

Abstract: An expansion mechanism that 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 that 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 modular blood filter apparatus and methods of use. The modular filter apparatus includes 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 to protect the adjustable filter device therein. The cartridge may be removably introduced into a blood vessel, and the adjustable filter device may be deployed through the device into the vessel. The adjustable frame may be self-adjusting or externally adjusted to fit the vessel and to capture embolic material in the filter. The frame may be collapsed to the contracted condition, and may be removed from the vessel.

Abstract: Modular systems comprising a cannula and at least one clip-on access port adjacent to a distal end of the cannula to provide insertion of one or more therapeutic or diagnostic devices into a vessel or cardiac tissue through a single incision site. The access port can be removably attached to a distal region of the cannula in a fixed orientation or in any desired orientation. The devices can be operated in combination or independently. The systems can be employed to provide multiple therapies, including blood perfusion, filtration, aspiration, vessel occlusion, atherectomy, and endoscopic devices. Methods of using the system for vessel cannulation are also disclosed herein.

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: An introducer having an elongate tubular member and a device connector releasably attached to a proximal end of the tubular member. The introducer allows exchange of medical instruments, such as a blood filter and cardioplegia catheter, through a single lumen. An obturator having a retractable blade for making incision on a tissue is insertable through the lumen of the introducer. Methods of using the obturator and the introducer for introducing medical device(s) into body cavity, such as a vessel or cardiac tissue, are also disclosed.

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: The invention provides a nested tubing cannula which comprises outer and inner elongate tubular members, both 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 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. The adjustable frame may be self-adjusting or externally adjusted to fit the vessel and to capture embolic material in the mesh. The frame may be collapsed to the contracted condition, and may be removed from the vessel or embolic debris may be removed by an aspiration tube.

Abstract: The invention provides a nested tubing cannula which comprises outer and inner elongate tubular members, both 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 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 that 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: 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: The invention provides devices and methods for endoscopically cannulating the aorta, right atrium, and other body tissues to establish cardiopulmonary bypass for minimally invasive coronary artery bypass grafting surgery, and for other surgeries. After inserting the suction support through a minimal access port, the suction support having an arcuate member with suction ports provides countertraction to the aorta by creating a vacuum seal between its suction ports and the aorta, therefore facilitating aortic incision and cannulation. In one embodiment, the suction support allows aorta stabilization, incision, and insertion with an introducer to be achieved sequentially. Methods for using the devices herein are also disclosed.

Abstract: A balloon occlusion device for aspirating embolic material from a blood vessel, such as from the aorta during cardiac surgery. The device includes an arterial cannula having a proximal end adapted to receive blood from a bypass-oxygenator machine, a distal end adapted to enter an artery, and a blood flow lumen extending between the proximal end and an outlet on the distal end. The cannula has an aspiration port proximate to the outlet, which communicates with an aspiration lumen. The cannula also includes an inflatable balloon attached to the cannula between the outlet and the aspiration port and capable of assuming an inflated condition for occluding a blood vessel. To use the device, the distal end of the cannula is introduced into a blood vessel, such as the aorta, the outlet is oriented downstream for delivering blood, and the balloon is inflated to occlude the vessel.