Abstract: An anchoring device can be used to secure a vascular rivet to the wall of a blood vessel. The anchoring device has a catheter with a rivet chamber that can be positioned at a desired location within a blood vessel. The rivet can be driven through a graft and the wall of the blood vessel by either a mechanical pusher or a blast of fluid, such as carbon dioxide gas. The rivet has an optional leg with a thermal memory that curls to secure the rivet in place when it warms to body temperature. An optional elastic rivet disk holds the graft tightly to the wall of the blood vessel during the geometric changes that occur during cardiac cycles.

Abstract: Laparoscopic apparatus and method for insertion into a space or potential space in a body including an introducer device having a tubular member with a bore extending therethrough. A tunneling shaft assembly is provided and is slidably mounted in the bore of the introducer device. The tunneling shaft assembly includes a tunneling shaft having proximal and distal extremities. A tunneling member is mounted on the distal extremity of the tunneling shaft. A balloon assembly is provided which is removably secured to the tunneling shaft. The balloon assembly includes a balloon wrapped about said tunneling shaft. A sheath is provided which encloses the balloon on the tunneling shaft. The sheath has a slit extending longitudinally thereof permitting the sheath to be removed whereby the balloon can be released and inflated. A tubular member is provided which has a balloon inflation lumen thereon and is coupled to the balloon for inflating said balloon.

Abstract: Methods and apparatus are provided for removing emboli during an angioplasty, stenting, or surgical procedure comprising apparatus for occluding a branch artery to prevent reversal of flow during carotid artery stenting, the apparatus comprising a retrieval sheath configured to reduce the risk of potentially dangerous interaction with the stent during retrieval.

Abstract: A medical device comprises an inner tube and an outer tube disposed about at least a portion of the inner tube. A balloon extends from the distal end of the outer tube. Within the balloon is a first expandable diaphragm, one end of which is attached to the inner tube. The first expandable diaphragm is covered by a retractable sheath disposed about the inner tube. Upon retraction of the retractable sheath, the diaphragm expands to sealingly contact the interior of the balloon in a first contact region and form at least a first compartment and a second compartment in the balloon.

Abstract: A medical device delivery apparatus has an inner tube with a medical device receiving region at the distal end, a balloon assembly movably disposed about the inner tube and a medical balloon displaceable from the medical device receiving region. A retractable outer sheath is diposed about the inner tube and is movable relative to the inner tube to expose the medical device receiving region. An inflation lumen capable of fluid communication with the medical balloon extends proximally from the balloon. Disposed about the distal portion of the inner tube is an expandable medical device that is distal to the medical balloon. The balloon may be moved within the medical device to expand the medical device.

Abstract: A balloon catheter for use with a guidewire is disclosed. The catheter has a body with a balloon located thereon, preferably at the distal end. A lumen within the catheter body communicates with the interior of the balloon which can be inflated by known methods with saline solution. A series of sleeve members of predetermined lengths and sizes are coupled to and positioned along the length of the catheter body. One or more of the sleeve members can span the length of the balloon. Each sleeve member has a passageway and both an exit and entry port so that the guidewire can pass therethrough. Instead of a balloon, the catheter can include a device member that forms a chamber which can store medicine until discharged at the desired site within the blood vessel. Apertures or pores on the catheter body allow for the perfusion of blood or the delivery of medicine to the site of the blood vessel. A method of operation is also disclosed.

Abstract: An apparatus and method is provided for stenting bifurcated vessels. A main-vessel stent and delivery system is provided for implanting a stent in the main vessel of a bifurcated vessel, wherein the main-vessel stent has an aperture bordered by closed stent cells that aligns with the opening to a side-branch vessel to permit substantially unobstructed blood flow between the main vessel and the side-branch vessel. The delivery system includes a catheter assembly having distal and proximal balloons separated by a positioning guide wire exit port located at the distal end of the catheter. The catheter assembly is advanced over a pair of guide wires for delivering, appropriately orienting, and implanting the main-vessel stent.

Abstract: A protector sleeve is disclosed for protecting an expandable member disposed on a catheter during pre-deployment handling. In one embodiment, the protector sleeve includes a tubular member with proximal and distal portions and preferably an elastomer seal therebetween, wherein the proximal portion of the tubular member is designed to slidably engage the expandable member in its collapsed state, while the distal portion permits fluid access to a catheter lumen, e.g., a guidewire lumen, without exposing the protected expandable member to the fluid.

Abstract: An intravascular device having an elongate shaft and a proximal hub assembly. The proximal hub assembly includes an interference fit member (IFM) which forms an interference fit with a carrier tube to reduce the tendency of the device to fall out of the carrier tube during handling and to provide for easy removal of the device when ready for use.

Abstract: A catheter used for treatment of complex vasculature, such as a bifurcated aneurysm, is provided with an inflatable balloon at a distal portion thereof. The shape, location and material of the inflatable balloon are selected such that when inflated, the balloon conforms to the shape of the complex vasculature, or at least a portion thereof, without appreciably deforming the vessel walls. In this manner, the balloon can be used to control flow in the vasculature, for example occluding a selected branch of the vasculature during introduction of material in order concentrate the material and minimize its disbursement by blood flow.

Abstract: A dilation catheter device comprising a shroud tube having a total preselected diameter effective for use in a preselected body lumen, the shroud tube having a strain relief tube extending therethrough which is adapted to reversibly form a flared, funnel-shape and a collapsed shape for contacting the surface of a dilation balloon, whereby the configuration of the balloon can be altered by altering the position of contact of the distal end of the strain relief tube with the surface of the balloon. Methods for use of the device and articles of manufacture containing the device are also taught.

Abstract: A regrooming device for a balloon catheter, comprising a tubular member having a proximal section, a distal section, and an inner lumen extending therein configured to receive a balloon of a balloon catheter; and a mandrel disposed within the inner lumen and having a proximal end configured to enter a guide wire lumen at a distal section of the balloon catheter to facilitate guiding the distal section of the catheter into the inner lumen of the regrooming device, and a distal end secured to the distal section of the tubular member.

Abstract: A system used in a blood vessel when an interventional procedure is being performed in a stenosed or occluded region, which is capable of treating an entire affected area in a blood vessel while preventing adverse effects for healthy tissue. The system includes a catheter which is positionable in a blood vessel at the interventional procedure site. The system further includes an expandable interventional instrument such as an expandable stent which is expandable and which may be deployed in the blood vessel at the interventional procedure site, which includes an unexpanded axial dimension. The system also includes an expandable member such as an expandable balloon, for expanding the expandable stent. The expandable balloon is capable of expanding so as to expand and deploy the expandable stent, and to substantially retain the unexpanded axial dimension of the expandable stent.

Abstract: An improved catheter assembly and method are provided for delivering angulated stents to a diseased vessels. The assembly allows for the precise delivery of an angulated stent into a side branch vessel that is at varying angles with respect to a main vessel. The assembly includes a single balloon Y-shaped balloon catheter having a restraining member attached to the distal section of the catheter to assist in proper delivery of the angulated stent. The restraining member of the catheter assembly of the present invention is configured to prevent the deployment of an angulated stent unless proper orientation of catheter assembly is first achieved. Because a pre-mounted stent is oriented to coincide with the diseased side branch vessel, once proper orientation of the catheter assembly is achieved, deployment of the angulated stent will be precise.

Abstract: Medical devices that are configured for insertion into a body lumen, such as the male urethra, are provided with one or more inflatable balloons having elastic sleeves, wherein each elastic sleeve is adapted to inflate in response to inflation of a respective balloon, and to deflate in response to deflation of the respective balloon. When a balloon is in a deflated condition, a respective elastic sleeve exerts a circumferentially compressive force against the balloon to cause a smooth, reduced cross-sectional profile of the balloon along an axial extent thereof. This smooth, reduced cross-sectional profile can facilitate passage of the medical device through a body lumen during both insertion and extraction of the medical device. A thin layer of fluid may be disposed between a treatment balloon and a respective elastic sleeve to facilitate heat transfer from a treatment balloon to a surrounding elastic sleeve or to administer a therapeutic agent to localized tissue.

Abstract: A method of inducing liver regeneration in a damaged liver tissue region of an individual is provided. The method including the step of providing at least two distinct growth factors to the damaged liver tissue region of the individual, at least one of the at least two distinct growth factors being an angiogenic factor.

Abstract: A high pressure dilation medical device delivery catheter having a proximal and distal end comprising two tubes mounted generally concentrically about an inner tube. The balloons being characterized as a relatively short inner tube which is inflated with high pressure and a longer outer tube which is inflated with low pressure. The balloons have independent inflation lumens which extend toward the proximal end of the inner tube. A medical device mounting region is disposed about at least a portion of the outer balloon and may have a stent or other medical device mounted thereupon. A retractable outer sheath is further disposed about the medical device mounting region and is operatively connected near the proximal end of the catheter.

Abstract: Laparoscopic apparatus and method for insertion into a space or potential space in a body comprising an introducer device having a tubular member with a bore extending therethrough. A tunneling shaft assembly is provided and is slidably mounted in the bore of the introducer device. The tunneling shaft assembly includes a tunneling shaft having proximal and distal extremities. A tunneling member is mounted on the distal extremity of the tunneling shaft. A balloon assembly is provided which is removably secured to the tunneling shaft. The balloon assembly includes a balloon wrapped about said tunneling shaft. A sheath is provided which encloses the balloon on the tunneling shaft. The sheath has a slit extending longitudinally thereof permitting the sheath to be removed whereby the balloon can be released and inflated. A tubular member is provided which has a balloon inflation lumen thereon and is coupled to the balloon for inflating said balloon.

Abstract: A combination dilatation and drug delivery device includes a flexible catheter, a drug delivery sheath mounted to a distal end region of the catheter and a dilatation balloon also mounted to the catheter and contained within a compartment formed by the sheath. The sheath is radially expandable by supplying a liquid therapeutic agent to the compartment under a moderate pressure. The dilatation balloon is expandable by providing a dilatation fluid to the balloon under a much higher pressure. The sheath can be formed of a highly elastic material or can be made quite thin, and in either case is mounted independently of the dilatation balloon. Thus when radially expanded, the sheath is moved into a conforming contact with surrounding vascular tissue. The conforming contact protects tissue and the therapeutic agent from exposure to blood, and more effectively confines the therapeutic agent to the intended treatment area.

Abstract: Method for developing an anatomic space for laparoscopic hernia repair comprising separating a first layer of tissue from a second layer of tissue for creating an anatomic operating space for the performance of a surgical procedure by making an incision through the first layer of tissue. A non-elastomeric deflated balloon is introduced into the incision. The balloon is inflated to cause separation of the first layer of tissue from the second layer of tissue to thereby produce an anatomic operating space. The balloon is then deflated and removed from the incision. The anatomic operating space is inflated with insufflation gas. A surgical procedure in then performed in the anatomic operating space.

Abstract: Medical devices including a substrate that are expandable from a compressed state to an expanded state; a coating on the substrate, the coating having a drug agent incorporated therein; and a sheath over the coating. The sheath is expandable from a compressed state to an expanded state and has at least one perforation therein. The medical devices are configured such that when the substrate is in a compressed state, the sheath is also in a compressed state and the perforation is substantially closed. When the substrate is in an expanded state, the sheath is also in an expanded state and the perforation is substantially open. The invention also includes a method of using the medical devices for the controlled, localized delivery of a drug agent to a target location within a mammalian body.

Abstract: A dilating and support apparatus with disease inhibitors and methods for use is disclosed that is particularly useful for repairing and/or serving as a conduit for body passageways that require reinforcement, dilatation, disease prevention or the like. Such apparatuses are utilized to deliver a therapy, that therapy being from a family of devices, drugs, or any of a variety of other elements to a specific location within the body. The instant disclosure provides a system of combining a novel radial deployment and/or drug delivery therapy with existing balloon dilatation therapy into one device. This combination will yield a significant decrease in cost to the healthcare system as well as providing a therapy to the patient with increased safety and efficacy. Further, the instant invention provides a novel and improved platform for synthetic/tissue interface between the device and the body.