Abstract: The present invention relates to a method of making clips which can be used to engage body tissue for the purpose of closing wounds. Such clips are generally annular in shape and have radially inwardly extending tines. The present invention first forms a precursor which, in one embodiment, has the tines extending radially outwardly from the annular body and then forms the clip by inverting the precursor such that the tines extend radially inwardly. In an alternate embodiment, the precursor is formed with an over-sized lateral dimension and then compressed inwardly to bring the tines closer A together and to reduce the lateral dimension of the precursor. It is preferred to manufacture such clips from a superelastic alloy such as nickel-titanium, in which case the inverted or compressed precursor must be heated and quenched to heat set the clip in its final shape.

Abstract: A clip for engaging tissue includes a generally annular-shaped body defining a plane and disposed about a central axis extending normal to the plane. The body includes alternating inner and outer curved regions, defining a zigzag pattern about a periphery of the clip. The body is biased towards a planar configuration lying in the plane and deflectable towards a transverse configuration extending out of the plane. Tines extend from the inner curved regions, the tines being oriented towards the central axis in the planar configuration, and parallel to the central axis in the transverse configuration. The tines include primary tines and secondary tines that are shorter than the primary tines. The primary tines may be disposed on opposing inner curved regions and oriented towards one another.

Abstract: A system for treating a septal defect having an implantable treatment apparatus and devices for delivering the implantable treatment apparatus and methods for treating a septal defect are provided. The implantable treatment apparatus is preferably implantable through a septal wall or portion thereof. The treatment system can include a flexible elongate body member, a delivery device configured to deliver the implantable apparatus, a stabilization device configured to stabilize the body member and a positioning device configured to position the delivery device in a desired location.

Abstract: An apparatus for sealing a passage through tissue communicating with a blood vessel includes a bioabsorbable plug member coupled to the distal end of a carrier member. The plug member includes a lumen extending therethrough that communicates with a lumen extending through the carrier member. A sealing member is disposed in the plug member lumen for sealing the lumen. A guide member is slidable into the lumen such that edges of a groove extending between proximal and distal portions of the guide member engage a wall of the lumen to define a bleed back lumen. The guide member is inserted into the passage until the distal portion enters the vessel. The plug member is advanced over the guide member until the plug member enters the vessel, whereupon blood enters the bleed back lumen to identify the location of the vessel relative to the plug member.

Abstract: This invention relates to apparatus and methods for use in sealing a vascular puncture site, particularly sites of punctures that are the result of catheterization or other interventional procedures. In several of the preferred embodiments, the sealing device includes a sealing member and a tether. The sealing member generally performs the function of occupying a space in an incision, puncture, or other wound and sealing the space in the incision, puncture, or wound that it occupies, to prevent further blood flow. The tether is typically attached in some manner to the sealing member, and provides the user with the ability to withdraw the sealing member if necessary. In a particularly preferred form, the sealing device further includes a restraining member associated with the sealing member. The restraining member provides the ability to more securely restrain the sealing member to prevent it from migrating from the deployment location within a tissue tract.

Abstract: A delivery system having a steerable delivery device and an elastic clip for treating an internal tissue defect, such as septal defects and the like, is provided. The clip can be deformable between a relaxed state and a stressed state and biased towards the relaxed state. The delivery device can include a flexible tubular needle with a lumen for housing the clip while in the stressed state. When used to treat a septal defect, the needle is advancable through overlapping tissue flaps and a pusher member is advancable within the needle lumen to push the clip distally such that one end of the clip is deployed and engages a tissue flap. The needle can then be retracted allowing the clip to deploy over both flaps of tissue, where the biasing force returns the clip to the relaxed state drawing the tissue flaps together and closing the septal defect.

Abstract: An apparatus for sealing a passage through tissue includes a plug including external threads, a lumen extending between its proximal and distal ends, and an annular collet slidably disposed within the lumen. The plug is carried on a distal end of a handle device that includes an inner member with a distal end that is slidable axially within the lumen of the body for moving the collet into a reduced cross-sectional region of the lumen, thereby compressing the collet to seal the lumen, and for deploying the plug from the handle device. During use, the plug is delivered into a passage through tissue over a guide wire. Once a desired location is reached, the plug is deployed from the handle device, thereby compressing the collet and sealing the lumen. The guide wire and handle device are removed, leaving the plug to seal the passage.

Abstract: Prosthetic valves and their component parts are described, as are prosthetic valve delivery devices and methods for their use. The prosthetic valves are particularly adapted for use in percutaneous aortic valve replacement procedures. The delivery devices are particularly adapted for use in minimally invasive surgical procedures.

Abstract: Prosthetic valves and their component parts are described, as are prosthetic valve delivery devices and methods for their use. The prosthetic valves are particularly adapted for use in percutaneous aortic valve replacement procedures. The delivery devices are particularly adapted for use in minimally invasive surgical procedures.

Abstract: Prosthetic valves and their component parts are described, as are prosthetic valve delivery devices and methods for their use. The prosthetic valves are particularly adapted for use in percutaneous aortic valve replacement procedures. The delivery devices are particularly adapted for use in minimally invasive surgical procedures.

Abstract: An apparatus for sealing a passage through tissue includes a bioabsorbable, threaded plug carried by a delivery device. A guide wire is receivable through lumens in the plug and delivery device that includes wings on a bioabsorbable distal portion. With the wings collapsed, the guide wire is advanced through the passage into a blood vessel, the wings expanding once located within the vessel, and the guide wire is withdrawn until the wings contact the vessel wall. The plug is threaded into the passage over the guide wire until the plug is disposed adjacent the wings. The distal portion of the guide wire is secured to the plug, e.g., by compressing a collet within the plug lumen that seals the lumen, and is severed from a proximal portion thereof. Thus, the plug and distal portion are deployed with the plug sealing the passage.

Abstract: A lung-assist apparatus includes a tubular housing, a tubular nozzle therein, and a first valve disposed between the housing and nozzle. The housing is implanted across a bifurcation such that the nozzle extends from a first branch communicating with a healthy region of a lung towards a main passage, and terminates proximate a lateral opening in the housing that is disposed within a second branch communicating with a damaged region of the lung. During inhalation, the first valve opens to allow air flow into the first branch, and closes during exhalation to force air through the nozzle, thereby inducing a vacuum for drawing air from the damaged region. A second valve in the second branch opens during exhalation to draw air from the diseased region, and closes during inhalation to prevent air from being drawn into the damaged region.

Abstract: A clip for engaging tissue includes a generally annular-shaped body defining a plane and disposed about a central axis extending normal to the plane. The body includes alternating inner and outer curved regions, defining a zigzag pattern about a periphery of the clip. The body is biased towards a planar configuration lying in the plane and deflectable towards a transverse configuration extending out of the plane. Tines extend from the inner curved regions, the tines being oriented towards the central axis in the planar configuration, and parallel to the central axis in the transverse configuration. The tines may include primary tines and secondary tines that are shorter than the primary tines. The primary tines may be disposed on opposing inner curved regions and oriented towards one another such that they overlap in the planar configuration.

Abstract: This invention relates to apparatus and methods for use in sealing a vascular puncture site and to apparatus and methods for properly locating and deploying a sealing device. The locating apparatus comprises a lumen which extends from an opening in the distal region of the apparatus but located proximally of the sealing device, which lumen extends to another opening in the proximal region of the device. When the distal opening is in communication with blood in a blood vessel, blood flow through the lumen and out of the proximal opening signifies such location to the user. When the sealing device is withdrawn such that the sealing device is deployed such that it blocks the blood flow into the distal port, the user will know the location of the sealing device. In a preferred embodiment, the sealing device is then withdrawn proximally a predetermined distance to assure that no part of the sealing device extends into the blood vessel lumen. The sealing device is then detached from the delivery device.

Abstract: This invention relates to apparatus and methods for use in sealing a vascular puncture site and to apparatus and methods for properly locating and deploying a sealing device. The locating apparatus comprises a lumen which extends from an opening in the distal region of the apparatus but located proximally of the sealing device, which lumen extends to another opening in the proximal region of the device. When the distal opening is in communication with blood in a blood vessel, blood flow through the lumen and out of the proximal opening signifies such location to the user. When the sealing device is withdrawn such that the sealing device is deployed such that it blocks the blood flow into the distal port, the user will know the location of the sealing device. In a preferred embodiment, the sealing device is then withdrawn proximally a predetermined distance to assure that no part of the sealing device extends into the blood vessel lumen. The sealing device is then detached from the delivery device.

Abstract: A minimally invasive technique for harvesting saphenous veins and the like for use as autografts in coronary artery bypass grafting surgery include a microsurgical instrument adapted to be demountably secured to the distal end of an endoscope. The instrument is inserted through an entry incision in the patient's skin, at the end of the endoscope which is used by a surgeon to advance the instrument along the saphenous vein, using the vein as a guide for the instrument. The instrument is tapered to provide initial separation of surrounding tissues from the vein, and cutting means supported by the instrument and viewed via the endoscope allow dissection of all tissues and side branch vessels from the saphenous vein. The instrument further provides a protective hood which prevents tissues or skin from blocking the endoscope. The desired length of saphenous vein is transected and is extracted via the entry incision. The technique minimizes trauma to the patient and to the saphenous vein graft.

Abstract: Methods and devices for revascularization of a patient's coronary artery system which obviate the need to place the patient on cardiopulmonary bypass. A method is provided for revascularizing a patient while the-heart is beating, and includes performing at least one minimally invasive coronary artery bypass graft procedure, or other cardiac surgical procedure, and contemporaneously performing at least one catheter-based procedure in at least one coronary artery. The catheter-based procedure(s) may be either therapeutic or diagnostic or both, and may involve delivering at least one catheter to a coronary artery via a surgical or percutaneous opening in the thoracic cavity or via a percutaneous opening at a location peripheral to the thoracic cavity. The catheter-based procedure or procedures is performed contemporaneously with the bypass graft procedure, and specifically prior to, during, or after anesthetizing the patient for purposes of the bypass graft procedure.

Abstract: A minimally invasive technique for harvesting saphenous veins and the like for use as autografts in coronary artery bypass grafting surgery include a microsurgical instrument adapted to be demountably secured to the distal end of an endoscope. The instrument is inserted through an entry incision in the patient's skin, at the end of the endoscope which is used by a surgeon to advance the instrument along the saphenous vein, using the vein as a guide for the instrument. The instrument is tapered to provide initial separation of surrounding tissues from the vein, and cutting means supported by the instrument and viewed via the endoscope allow dissection of all tissues and side branch vessels from the saphenous vein. The instrument further provides a protective hood which prevents tissues or skin from blocking the endoscope. The desired length of saphenous vein is transected and is extracted via the entry incision. The technique minimizes trauma to the patient and to the saphenous vein graft.

Abstract: The present invention provides improvement usable with an intravascular catheter having a single common distal lumen with a reduced profile connected to two or more proximal lumens. The catheter will be loadable over a guidewire into a region of interest within a patient's vascular system. According to one aspect of the present invention, means are provided to ensure that the guidewire enters into a desired one of the proximal lumens. In a preferred embodiment, a special tool is provided to achieve this. According to a second aspect of the present invention, the catheter is provided with a proximal housing and an axially expandable member to shield the rotating parts at the proximal end of the catheter and to allow for convenient movement of a work element within the catheter body.

Abstract: The present invention provides improvement usable with an intravascular catheter having a single common distal lumen with a reduced profile connected to two or more proximal lumens. The catheter will be loadable over a guidewire into a region of interest within a patient's vascular system. According to one aspect of the present invention, means are provided to ensure that the guidewire enters into a desired one of the proximal lumens. In a preferred embodiment, a special tool is provided to achieve this. According to a second aspect of the present invention, the catheter is provided with a proximal housing and an axially expandable member to shield the rotating parts at the proximal end of the catheter and to allow for convenient movement of a work element within the catheter body.