Abstract: A recanalization catheter for facilitating re-entry into a lumen of a blood vessel from a subintimal space. The catheter includes an inflatable balloon mounted on a distal end region of the catheter shaft of the catheter. The catheter shaft includes a guidewire lumen having a distal opening and a lateral opening in a distal region of the catheter shaft proximal of the distal opening, and an inflation lumen in fluid communication with the balloon. The balloon is configured to be inflated in the subintimal space to a first inflation state at inflation pressures below a threshold inflation pressure to orient the lateral opening toward the lumen of the blood vessel, and inflated to a second inflation state at inflation pressures above the threshold inflation pressure. The catheter includes means for retaining the balloon in the first inflation state at pressures below the threshold inflation pressure.

Abstract: Adjustable balloon catheter including an inner tubular member having a proximal end portion, a distal end portion, an inflation lumen and a fluid lumen defined therein. An expandable member is coupled to the distal end portion and has an inner chamber defined therein in fluid communication with the inflation lumen, the expandable member transitionable between a deflated and inflated configuration. The expandable member further has an exterior surface, the exterior surface having at least one pore structure defined therein in fluid communication with the fluid lumen. An outer tubular member is movable relative to the inner tubular member, the outer tubular member, the outer tubular member being moveable between an extended position and a retracted position, the outer tubular member being selectively positioned between the extended position and the retracted position to define an exposed length of the working length of the expandable member.

Abstract: A system for retrieving an implantable medical device includes a delivery sheath that houses an inflatable balloon catheter and a retrieval device. The retrieval device includes a first support rod and a second support rod and a helix extending between distal ends of the first support rod and the second support rod. The inflatable balloon catheter is translatable into a position between the implantable medical device and a wall of a patient blood vessel. The balloon is inflated to force the device away from the wall. The helical member of the retrieval device is expanded radially be translating the second support rod distally. The helical member is moved over the balloon catheter and the medical device, where rotation of the first support rod will cause the helical member to radially compress to trap the balloon catheter and medical device therein for subsequent retrieval from the body.

Abstract: Catheter having a hypotube with a skive defined by a first angled cut, an axial cut, and a second angled cut. A midshaft member includes a guidewire lumen and an inflation lumen in fluid communication with an inflation lumen of the hypotube, the inflation lumen of the midshaft member configured to receive at least a portion of the hypotube. A distal tubular shaft member extends distally from the midshaft member. The distal tubular shaft member has a guidewire lumen and an inflation lumen defined therein, the guidewire lumen of the distal tubular shaft member in fluid communication with the guidewire lumen of the midshaft member. The inflation lumen of the distal tubular shaft member is in fluid communication with the inflation lumen of the midshaft member and a balloon is coupled to the distal tubular shaft member and in fluid communication with the inflation lumen.

Abstract: A vessel location device includes a catheter, an expandable member, and an inflation member. The catheter includes a distal end portion, a proximal end portion and a blood flashback lumen, wherein the blood flashback lumen has a distal opening positioned at the distal end portion and a proximal opening at the proximal end portion. The expandable member is positioned at the distal end portion at a location distal of the distal opening of the blood flashback lumen. The inflation member is configured to deliver a flow of inflation fluid to the expandable member to selectively expand the expandable member within a vessel to temporarily seal a vessel puncture.

Abstract: Embolectomy catheters, rapid exchange microcatheters, systems and methods for removing clots or other obstructive matter (e.g., thrombus, thromboemboli, embolic fragments of atherosclerotic plaque, foreign objects, etc.) from blood vessels. This invention is particularly useable for percutaneous removal of thromboemboli or other obstructive matter from small blood vessels of the brain, during an evolving stroke or period of cerebral ischemia. In some embodiments, the embolectomy catheters of this invention are advanceable with or over a guidewire which has been pre-inserted through or around the clot. Also, in some embodiments, the embolectomy catheters include clot removal devices which are deployable from the catheter after the catheter has been advanced at least partially through the clot. The clot removal device may include a deployable wire nest that is designed to prevent a blood clot from passing therethrough.

Abstract: A device for the transfer of radiopaque material within the body comprises a valvuloplasty or other balloon coated with the radiopaque material. The balloon is inflated in the aortic valve for marking the site of an aortic annulus to enable accurate placement of prosthetic valves under fluoroscopic imaging.

Abstract: This disclosure contains methods, devices, and systems for object removal from a body, including removal of a stent from a body. Some methods of the present disclosure include inflating a balloon on a catheter, engaging a stent with a socket defined by a surface of the balloon, the surface inwardly sloped toward a lumen of the catheter, and retracting a portion of the stent through the socket and into the lumen. The present disclosure also includes methods for making a catheter, including forming a balloon, inverting a portion of the balloon, and attaching the balloon to a catheter such that a surface of the balloon defines a socket that is inwardly sloped toward a lumen of the catheter.

Abstract: A device for repositioning an implant within a lumen of a subject including (a) a catheter having forward and rearward ends and a collapsible and expansible stop element mounted adjacent the forward end of the catheter, the stop element being adapted to engage a wall of the lumen when expanded and to provide one or more passages extending from a rear side of the stop element to a forward side of the stop element when the stop element is expanded and engaged with the wall of the lumen and (b) one or more snares, each snare having engagement features, the stop element and the snares being constructed and arranged so that the snares can be positioned extending through the one or more passages with their engagement features forward of the stop element.

Abstract: A device for occluding a septal defect is provided. In general, the occluding device has a contracted state that allows the occluding device to be received within a delivery device for deployment to the site of the defect and an expanded state that is achieved when the occluding device is deployed from the delivery device. The occluding device has a proximal portion, which may be substantially circular, a distal portion, which may be substantially ovaloid, and a connecting portion extending between the two. The distal portion may define first and second outer parts at opposite ends of the major axis, which may be bent or curved. The configuration of the proximal and distal portions allow the occluding device to securely engage the septal wall and be kept in position at the septal defect without causing substantial interference with the functioning of adjacent heart structures.

Abstract: A balloon catheter assembly including a catheter, a sleeve, and a balloon. The catheter has a body, an exterior surface, a lumen, a port providing fluid communication between the lumen and the exterior surface, and a coupling mechanism to couple the lumen to an inflation source. The sleeve has an interior surface facing the exterior surface, the sleeve being coaxial with the catheter and configured to move longitudinally about the catheter. The balloon is disposed about the catheter and has a middle segment covering the port, a distal segment coupled to the sleeve, and a proximal segment coupled to the catheter. The middle segment has a middle longitudinal stiffness, the distal segment has a distal longitudinal stiffness, and the proximal segment has a proximal longitudinal stiffness. The middle longitudinal stiffness is greater than the proximal longitudinal stiffness and the middle longitudinal stiffness is greater than the distal longitudinal stiffness.

Abstract: A non-compliant fiber-reinforced medical balloon comprises a first fiber layer and a second fiber layer embedded in a continuous matrix of thermally-weldable polymer material defining a barrel wall, cone walls and neck walls. The fibers of the first fiber layer run substantially parallel to one another and substantially parallel to the longitudinal axis. The fibers of the first fiber layer have a pattern of different lengths and are divisible into a first group and a second group based on length.

Abstract: A medical device, the medical device formed at least in part from a melt blend of at least one polymer comprising hydrolysable groups and a carbodiimide.

Abstract: A system for deploying and selectively inflating a balloon at a desired location, without the aid of fluoroscopy is described.

Abstract: The method for making a reinforced balloon for a balloon catheter involves blending a polymer with a nano composite to form a composite matrix, extruding a parison from the composite matrix, blow molding the parison into a balloon and orienting the nano composite generally axially with respect to the balloon. The balloon formed has a high strength for resisting bursting. The nano composite may be carbon nanotubes, nano-ceramic fibers or a nano clay.

Abstract: A delivery system for implanting a medical device into the body of a patient or subject and a method of use thereof. The delivery system includes a delivery catheter having a catheter lumen and an inner member extending therethrough. The inner member includes a distal tip portion, a proximal portion, and an intermediate portion, the intermediate portion being disposed adjacent to the distal end of the delivery catheter. A first sealing member, positioned near a distal end of the proximal portion, forms a fluid seal between the inner member and an inside surface of the delivery catheter. A second sealing member, positioned near a proximal end of the distal tip portion, forms a fluid seal between the inner member and an inside surface of the delivery catheter. The intermediate portion extends between the first seal and the second seal. In one embodiment, a medical device and a hydrating fluid are present in a device-containing region between the intermediate portion and the delivery catheter.

Abstract: A pressure relief apparatus for a balloon dilation catheter having a shaft with a dilation balloon attached to the distal end of the shaft and an inflation/deflation lumen for inflating and deflating the balloon includes a pressure relief port formed through the wall of the inflation/deflation lumen with a pressure relief member secured across the pressure relief port to form a fluid tight seal such that the fluid tight seal formed by the pressure relief member fails at a predetermined pressure to release pressure from the inflation/deflation lumen through the pressure relief port.

Abstract: The delivery of biological compounds to ischemic and/or infarcted tissue are described herein where such a system may include a deployment catheter and an attached imaging hood deployable into an expanded configuration. In use, the imaging hood is placed against or adjacent to a region of tissue to be imaged in a body lumen that is normally filled with an opaque bodily fluid such as blood. A translucent or transparent fluid, such as saline, can be pumped into the imaging hood until the fluid displaces any blood, thereby leaving a clear region of tissue to be imaged via an imaging element in the deployment catheter. Additionally, any number of therapeutic tools can also be passed through the deployment catheter and into the imaging hood for performing any number of procedures on the tissue for identifying, locating, and/or accessing ischemic and/or infarcted tissue.

Abstract: The present invention provides apparatus and methods for a conduit, such as an implantable conduit for a vessel. The conduit may comprise a main member and a side-branch member. The conduit may be implanted with the side-branch member initially disposed within the main member. When positioned, the side-branch member may then be extended from within the main member and into a vessel side-branch. The materials for the conduit may include circumferentially distensible and/or low recoil materials. The materials for the conduit may be constructed by various techniques and may include materials with enhanced flexibility and kink resistance.

Abstract: Catheter devices and methods useable for directing a guidewire from a subintimal position within the wall of an artery into the true lumen of that artery or other applications wherein it is desired to direct a guidewire or other elongate device from one location to another location within a subject's body.

Abstract: Devices, systems and methods for atrial appendage occlusion. A device is described with respect to non-surgically occluding the left atrial appendage with minimal invasiveness. Additionally, a system and method are described for using the device to perform the left atrial appendage occlusion procedure.

Abstract: A device for reducing pressure within a lumen includes a reservoir structured for holding a fluid therein, an injection port in fluid communication with the reservoir, a compliant body structured to expand and contract upon changes in pressure, and a conduit extending between and fluidly coupling the reservoir and the compliant body. The fluid may be a compressible or a noncompressible fluid.

Abstract: An introducer sheath. The introducer sheath includes a tubular body. The tubular body extends from a distal end toward a proximal end. The tubular body includes a lumen. The lumen is defined at least partially by a wall. The tubular body includes a secondary channel. The secondary channel is disposed within the wall. The secondary channel is configured to receive a guidewire.

Abstract: An endovascular graft, which is configured to conform to the morphology of a vessel to be treated, includes a tubular ePTFE structure; an inflatable ePTFE structure disposed over at least a portion of the ePTFE tubular structure; and an injection port in fluid communication with the inflatable ePTFE structure for inflation of the inflatable ePTFE structure with an inflation medium. The inflatable ePTFE structure may be longitudinally disposed over the tubular ePTFE structure. The ePTFE structure may be a bifurcated structure having first and second bifurcated tubular structures, where the inflatable ePTFE structure is disposed over at least a portion of the first and second bifurcated tubular structures.

Abstract: In one embodiment of the invention, a stent may be provided comprising a first undulating band having alternating peaks and troughs, a second undulating band having alternating peaks and troughs, a first substantially longitudinal connector extending between the first and second undulating bands and a second very short connector extending between the first and second undulating bands, the first connector substantially longer than the second very short connector.

Abstract: The present invention relates to a drug eluting stent for delivering therapeutic agents to a body lumen. The stent includes an expandable substrate configured for implantation in a vessel of a human body and a therapeutic agent composition coated over the stent. The balloon catheter shaft has a resilient unit that helps to transmit a force to the distal end, thereby helping to cross lesions.

Abstract: An occlusion device may comprise a first tube having a first balloon positioned at a distal end, and a second tube having a second balloon positioned at a distal end. The first balloon may be sized and configured to occlude a vascular lumen upstream of a vascular puncture, and the second balloon may be sized and configured to simultaneously occlude the vascular lumen downstream of the vascular puncture. A method of occluding a vascular puncture may comprise positioning a distal end of an occlusion device comprising a first balloon and a second balloon through the vascular puncture and into a vascular lumen. The first balloon may be positioned downstream of the vascular puncture, and the second balloon may be positioning upstream of the vascular puncture.

Abstract: A stoma dilator having a base dilator and a plurality of dilators coaxially disposed over the base dilator. The base dilator has a hub and an opening therethrough. Each of the plurality of dilators has a tapered distal end, a proximal end, and a tubular body, and are held in separated, telescoping position by a dilator positioner such that part of each distal end is exposed from beneath another dilator and is graspable for movement such that a smaller dilator does not become inaccessible inside of a larger dilator. The stoma dilator includes a hollow sheath positioned over an outermost dilator to hold open a tissue opening created by the plurality of dilators. The base dilator and the plurality of dilators may be removed while the sheath remains in a tissue opening. Another device may be inserted through the sheath, and the sheath may be peeled away therefrom.

Abstract: The present disclosure concerns embodiments of an expandable and collapsible embolic deflector that can be collapsed to a very small profile for insertion through a patient's vasculature and then expanded once inside the body. The embolic deflector comprises a flexible, inflatable frame that supports a blood-permeable membrane that prevents emboli above a predetermined size from entering vasculature that is blocked by the membrane. The frame comprises an inflatable body made of a soft polymeric material, such as urethane, Pebax, or nylon, similar to a balloon of a balloon catheter. In particular embodiments, the frame does not include any metal components. In certain embodiments, the frame can include one or more radiopaque markers, which can be made of a metal or metal alloy. In either case, the risk of potential trauma to the patient can be reduced since the amount of hard metal components is significantly reduced or completely eliminated.

Abstract: A process for forming a catheter balloon includes subjecting a tubular parison in a mold to molding fluid pressure. The resulting catheter balloon includes a balloon portion having two ends and tubular leg portions extending from either end. The ends of the balloon portion are tapered to the tubular leg portions. While in the mold, the tubular leg portions are drawn axially sufficiently to form permanent creases in the tapered ends. This drawing may be sufficient to cause the material of the tapered ends to exceed the yield strength, particularly with the balloon material in a malleable state. Anomalies on tapered parts of the mold may include ribs or spiral ribs to assist in the creasing process.

Abstract: A percutaneous thrombus extraction device for removing a thrombus from within a blood vessel includes a flexible outer sheath defining a first passage between a proximal end and a distal end. An inner sheath is movably positionable within the first passage. The inner sheath defines a second passage between a proximal end and a distal end. The inner sheath is moveable in a radial direction between a collapsed configuration and an expanded configuration along a length of the inner sheath defined between the proximal end and the distal end. A catheter is movably positionable within the second passage, and has an expandable body at a distal end portion of the catheter. The expandable body is movable between a collapsed configuration and an expanded configuration.

Abstract: A percutaneous transluminal angioplasty device includes an embolic filter mounted to the catheter shaft at a location distal to the angioplasty balloon. Thus the filter can be down-stream from the blockage and can be properly positioned to capture embolic particles that may be set loose into the blood stream as the angioplasty procedure can be performed. The embolic filter can be normally un-deployed against the catheter shaft to facilitate introduction and withdrawal of the device to and from the operative site. Once the angioplasty balloon can be properly positioned, however, means operatively associated with the embolic filter can be actuated to erect the filter to position a filter mesh across the lumen of the vessel.

Abstract: The three dimensional, low friction vasoocclusive coil has a portion that is three dimensionally box or cubed shaped. The three dimensional box or cubed shaped portion will form a basket for filling the anatomical cavity at the site in the vasculature to be treated. The vasoocclusive device is formed from at least one strand of a flexible material formed to have a first inoperable, substantially linear configuration for insertion into and through a catheter or cannula to a desired portion of the vasculature to be treated, and a second operable, three dimensional configuration for occluding the desired portion of the vasculature to be treated. The vasoocclusive coil may optionally include a portion that is substantially J-shaped or helically shaped, for filling and reinforcing the three dimensional portion.

Abstract: A vascular plug for implantation into a patient's vessel includes an inflatable balloon and a flow accelerator. The flow accelerator includes a conical portion and a tubular coupling element which couples the conical portion to an aperture to the interior of the inflatable balloon. The flow accelerator will concentrate and therefore accelerate fluid flow into the inflatable balloon. Flow accelerator will increase the pressure of fluid thereby to cause the inflatable balloon to inflate even within a pressurised blood vessel. The plug may include a sleeve which provides a chamber between the flow accelerator and the balloon, into which blood may pass from the inflatable balloon or the flow accelerator to create additional blood statis and as a result thrombosis and a second occlusive barrier.

Abstract: Devices, systems and methods are provided for performing intra-lumenal medical procedures in a desired area of the body. Thrombectomy systems and methods of performing medical procedures to re-establish the intravascular flow of blood are provided for the treatment of ischemic disease states.

Abstract: Catheter balloon assemblies (10) for delivering a therapeutic agent to a body vessel are provided, as well as related methods of manufacturing and methods of treatment. The catheter balloon assemblies may include a concentrically disposed dual balloon assembly at the distal portion of the catheter having an inner balloon (44), a porous outer balloon (42) concentrically arrayed around the inner balloon and a catheter shaft (30) adapted to deliver a therapeutic agent to the body vessel through the apertures in the outer balloon. Radial outward expansion of the inner balloon may urge the outer balloon into contact with the wall of a body vessel, where the therapeutic agent may be delivered from the catheter shaft through apertures in the outer balloon directly to the wall of the body vessel.

Abstract: This invention is related to the use of polyurethane-based polymer as a drug delivery device to deliver biologically active compounds at a constant rate for an extended period of time and methods of manufactures thereof. The device is very biocompatible and biostable, and is useful as an implant in patients (humans and animals) for the delivery of appropriate bioactive substances to tissues or organs.

Abstract: Devices, systems, and methods for inverting and closing the left atrial appendage. In at least one embodiment of a method for closing a left atrial appendage of the present disclosure, the method comprises the steps of inverting a distal portion of a left atrial appendage, and constraining the inverted distal portion of the left atrial appendage using a device configured to fit within an interior of the left atrial appendage.

Abstract: The present embodiments provide apparatus suitable for treating a medical condition at a target site. In one embodiment, the apparatus comprises a plurality of strands, each having proximal and distal regions, wherein the plurality of strands are twisted in a generally helical manner to form a tubular shape. The proximal and distal regions of each of the plurality of strands comprise a contracted configuration adapted for delivery to the target site. Further, the distal region of at least one of the plurality of strands comprises an expanded, radially deployed configuration adapted to facilitate treatment of the medical condition. The distal region of at least one of the plurality of strands may be deployed in a self-expanding or balloon-expandable manner.

Abstract: A blood flow cessation device includes a catheter, an expandable member, and a rapid exchange port. The catheter includes a distal end portion and a proximal end portion. The expandable member is positioned at the distal end portion and is selectively expandable to stop blood flow through a vessel. The rapid exchange port is formed in the catheter at a location proximal of the expandable member. The rapid exchange port is configured receive a guidewire that passes through the distal end portion of the catheter to be positioned within the vessel.

Abstract: The present invention relates to compositions and methods for improving outcomes in vascular interventional procedures. In particular, the present invention relates to compositions and methods for improving outcomes in vascular interventional procedures using an anti-no-reflow guide wire that attenuates the “no-reflow” phenomenon that is associated with negative outcomes.

Abstract: A method of deploying a stent in a bifurcation includes introducing two guidewires through the main vessel and using the two guidewires for guiding a dual lumen catheter carrying a stent first to an initial position proximal to the stent deployment position, retracting one wire, and projecting it from the catheter and through a side of the stent a branch guidewire into the second branch vessel, and then moving the catheter to the predetermined deployment position while guided by the main guidewire in the first branch vessel, and the branch guidewire in the second branch vessel. The stent is then expanded, and the catheter is removed with the stent remaining in its deployed position An alternative embodiment includes introducing one wire, advancing the system over the one wire and subsequently introducing the second wire.

Abstract: A method for fabrication of a cutting balloon assembly is described. The method includes providing a predetermined number of filaments having predetermined properties, diameter and length and fabricating a scoring mesh on a weaving jig having a plurality of pins disposed circumferentially about the jig's surface. The fabrication of the scoring mesh includes placing the filaments between the pins and interlacing the filaments to form a scoring mesh by interweaving and intertwining at least a part of filament to form one or more permanent links with neighboring filaments. The fabrication of the scoring mesh also includes forming distal and proximal filament loops that protrude from the mesh distal and proximal ends, respectfully. The scoring mesh is mounted on an expandable balloon mounted on a distal end of a delivery catheter.

Abstract: A filter device is provided having a biodegradable features. The filter device comprises an elongate stent portion and a conical filter portion attached thereto that is preferably balloon expandable. The conical filter portion includes a plurality of struts extending between a holding ring and the stent portion to define the conical shape of the filter portion. The struts can be biodegradable so that they degrade over time. The struts and/or holding ring can be configured so that at least one of the struts remains attached to the holding ring after a predetermined period of time. The struts are biased toward the wall of the body vessel in which the filter device is installed, so that after the predetermined period of time, the struts, and the strut attached to the holding ring, will expand toward the body vessel wall for bioabsorption.

Abstract: The invention provides an intravascular catheter with an expandable member such as a balloon with an imaging device on a surface of the expandable member. The imaging device can use an optical fiber on a surface of the expandable member to image a treatment site. Since an image can be captured directly from the surface of the expandable member, an operator can examine the treatment site while positioning the expandable member. With the treatment site in view, the operator can deliver the treatment (e.g., inflate the balloon or deploy the stent) with confidence that it will be located properly.

Abstract: A stent deployment device is provided with a tapered balloon wrap to protect the edge of a crimped stent during stent deployment. The balloon is wrapped unevenly so that the distal end is looser and has a wider circumference than the proximal end of the balloon. With a stent crimped upon such a balloon, the distal balloon end billows out and covers the distal edge of the stent. This shielding billow prevents the stent edge from becoming damaged or causing harm if the stent is distally impacted while traversing body vessels on the way to the deployment site.

Abstract: Assemblies, kits, and methods for occluding a vascular vessel, such as a varicose vein, are disclosed. An assembly can include a removable inner member, a removable outer member, and an elongated expandable member positioned in a compressed form between portions of the inner and outer members. To facilitate their removal, one or both of the inner and outer members can include a handle coupled to a proximal end. The elongated expandable member can include a gelatin material or a collagen material that is configured, when wetted, to expand from a compressed first diametrical size to a second larger diametrical size within a time period of 5 minutes or less. At the second larger diametrical size, the gelatin or collagen material can occlude a vascular vessel for a period of at least 20 days without degrading.

Abstract: An internal compression tourniquet catheter system and method for wound track navigation for controlling hemorrhage from wounds. The preferred embodiments include an inflatable member constructed of thin, flexible and puncture resistant material such that when deflated can be wrapped around the catheter shaft, which passes within and has a lumen to inflate it. The inflatable member is of large potential volume enabling full inflation with near zero internal pressure when unconstrained externally. When positioned within a wound track and inflated, the gas or liquid injected into the balloon lumen creates pressure because its expansion is constrained by the tissues of the wound, and that pressure is transmitted directly to the surrounding tissue of the wound track.

Abstract: A device for introduction into a body vessel includes a main elongated element, a balloon positioned at the main elongated element distal end, a distal connecting element positioned at the distal end of the balloon to receive a guidewire during use, and a longitudinally movable sheath positioned external to the main elongated element, a position of the sheath distal end with respect to the balloon defining an exposed portion of the balloon that expands when fluid is delivered to the balloon through the inflation lumen.

Abstract: The disclosed subject matter describes systems and methods of electrospinning a fiber for a variety of applications. An exemplary embodiment includes a medical device application for delivering a therapeutic agent, such as a sclerosing agent, to the walls of a blood vessel to perform sclerotherapy. A method of fabricating a medical balloon comprises charging a polymer material with an electric voltage, dispensing the charged polymeric material through a nozzle, collecting the charged polymeric material on a grounded mandrel, wherein the mandrel includes a tubular body having a plurality of openings extending through the tubular body, and forming an electrospun medical balloon defined by a body having a varied thickness.