Abstract: A balloon catheter includes an elongated catheter shaft, a hub disposed at a proximal portion of the catheter shaft, an inflatable balloon disposed at a distal portion of the catheter shaft, and a refold tool slidingly disposed over the elongated catheter shaft and positioned between the hub and the inflatable balloon. The balloon is configured to transform between an inflated configuration and a deflated configuration, the balloon having a deflated profile when in the deflated configuration. The refold tool defines a lumen there-through that is flared at a distal end thereof, and the lumen of the tubular component of the refold tool is sized to refold the balloon to a refolded profile that is smaller than the deflated profile when the balloon in the deflated configuration passes through the refold tool.

Abstract: A catheter having an elongated shaft and a balloon on a distal shaft section, the elongated shaft comprising an outer tubular member, and an inner tubular member which has a bonded portion along which an outer surface of the inner tubular member is bonded to an inner surface of the outer tubular member. The inner tubular member has a proximal portion proximal to the bonded portion, and a distal portion distal to the bonded portion with higher axial compression stiffness and column strength than the proximal portion thereof. The catheter has improved trackability, axial collapse resistance, pushability, and crossability, for improved ability to position the balloon at a desired location in a patient's body lumen.

Abstract: The present invention relates to an adjustable length dilatation balloon catheter that includes a balloon catheter, a sheath that is slidably disposed around the balloon catheter, and an inverting tethering system that permits the selective adjustment of the exposed balloon length.

Abstract: Removable cardiac implants, applicators for inserting, repositioning and/or removing them, and methods of using them are described. In particular, removable or repositionable ventricular partitioning devices are described. Systems including removable implants and applicators for inserting and/or removing them are also described.

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: A system for breaking obstructions in body lumens includes a catheter including an elongated carrier, a balloon about the carrier in sealed relation thereto, the balloon being arranged to receive a fluid therein that inflates the balloon, and an arc generator including at least one electrode within the balloon that forms a mechanical shock wave within the balloon. The system further includes a power source that provides electrical energy to the arc generator.

Abstract: A method and apparatus for suture-less placement of an occluding patch in which release of the device can be accelerated. In one embodiment, an inactive form of an adhesive is applied on the area of the patch that will come into contact with cardiac tissue; this allows for the introduction and necessary manipulation of the catheter system until activation of the adhesive occurs. In accordance with one aspect of the invention, the adhesive properties of certain polymeric materials are relied upon rather than their ability to cure or harden into a specific shape. In another embodiment, the patch is immediately released utilizing a detaching mechanism on the balloon or the balloon catheter which supports the patch; the patch along with the inflated balloon remain on the cardiac structure occluding the opening.

Abstract: A balloon catheter is provided with three lumens. The first lumen may be used as a guide wire lumen. The second lumen may be used as an inflation lumen. The third lumen may be used to provide various treatments to a vessel. Methods of using the balloon catheter to treat a patient are also provided.

Abstract: A balloon catheter for use with a guidewire includes an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end. An inflatable balloon is connected to the distal end of the shaft, the balloon including a working surface. A radiopaque identifier is provided for identifying the working surface. A receiver adjacent the proximal end of the shaft is adapted for allowing the shaft to move relative to the receiver in at least the longitudinal direction.

Abstract: Devices and methods for treatment of a patient's vasculature with some embodiments configured for delivery with a microcatheter for treatment of the cerebral vasculature of a patient. Some embodiments may include a permeable shell configured to occlude blood flow therethrough.

Abstract: A multiple balloon catheter designed to quickly and easily obtain hemostasis during open and minimal access surgery in the event of venous injury.

Abstract: A vascular method is disclosed comprising introducing a first flexible wire into a blood vessel, wherein the blood vessel has a first vessel end and a second vessel end and wherein the first flexible wire has a first end and a second end, sliding an angiotip along the first flexible wire in a direction away from the first end of the wire and toward the second end of the wire, frictionally engaging the first flexible wire with the angiotip, and pulling the first flexible wire through the blood vessel in the direction of the second vessel end, wherein the pulling of the first flexible wire pulls the angiotip through the blood vessel in the direction of the second vessel end.

Abstract: A vascular occlusion device for occluding a body cavity includes an elongate member for injecting embolization material into the body cavity and a deflecting device. The deflecting device is disposed around a distal end of the elongate member and is expandable to contact an interior wall of the body cavity in the expanded state. The deflecting device is configured to be deflected by the embolization material to change a shape of the deflecting device in the expanded state. The deflecting device provides a visual and tactile indication of completion of embolization based on the shape of the deflecting device in the expanded state.

Abstract: Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leaden. Methods of making and using the devices are also disclosed.

Abstract: An angioplasty catheter comprises a catheter body having a balloon or other radially expandable shell at its distal end. An external structure is carried over the shell and scores a stenosed region in a blood vessel when the balloon is inflated therein. The catheter has an attachment structure disposed between the catheter body and the balloon to accommodate foreshortening and rotation of the external structure as the balloon is expanded. The external structure may be part of a helical cage structure which floats over the balloon. Stabilizing struts are provided between at least some of the helical struts.

Abstract: An embolic coil deployment system for placing a coil at a preselected site within a vessel of the human body is provided. The deployment system includes a heating element at the distal end of a detachment member and a heat-responsive coupling attached to a delivery member for holding the coil during positioning of the coil. The heating element is heated to reduce the strength of and sever the heat-responsive coupling for releasing the coil at a desired position within the body vessel.

Abstract: A cutting balloon assembly and a method for fabrication of the assembly is described. The cutting balloon assembly comprises a delivery catheter, an expandable balloon mounted on the catheter distal end, and a scoring mesh disposed around the expandable balloon. The scoring mesh comprises interlacing filaments that extend from a mesh proximal end towards a mesh distal end, form distal filament loops at said mesh distal end, and then return to the mesh proximal end. At least a part of the interlacing filaments forms one or more permanent links with neighboring filaments between the mesh proximal end and the mesh distal end.

Abstract: A balloon catheter can evenly transmit a pushing force applied to a reinforcing member to an outer shaft and an inner shaft by fixing the distal end of the reinforcing member to an adhesion part of the outer shaft and the inner shaft. In a balloon catheter, the distal end of a reinforcing member is fixed by an adhesion part of an outer shaft and an inner shaft. Thus, a pushing force of an operator is evenly transmitted to the outer shaft and the inner shaft from the distal end of the reinforcing member through the adhesion part, reducing a relative displacement of the outer shaft and the inner shaft. Moreover, the adhesion part can reduce the detachment of the distal end of the reinforcing member from the outer shaft or the inner shaft.

Abstract: A system for providing access across a site of obstruction is provided. The system may include a sleeve, having a distal portion that can move from an inverted position to an everted position. A balloon situated within the sleeve can be extended so as to evert sleeve. A pathway can extend across a juncture between the distal portion and the remaining portion of the sleeve so as to provide access across the site of obstruction. A method for providing access across the site of obstruction is also provided.

Abstract: A dilatation balloon is fabricated according to a process that forms cavities and indentations in the balloon and/or catheter sections. A length of tubing is axially elongated and radially expanded in a form to provide the requisite biaxial orientation and strength. Then, an excimer laser or another type of laser or mechanical material removal tool is used to remove the polymeric material, virtually without thermal effects. Cavities in the sleeve sections of the balloon are defined and if desired, indentations in the cone sections are defined. Material removal, particularly near the balloon sleeves enables a thinner, more flexible bonding area between the catheter shaft and the balloon. Further, the indentations along the cone sections enables tighter wrapping of the balloon for a reduced delivery profile. Rigidity near the sleeves is reduced for better maneuverability of the catheter in tortuous passageways.

Abstract: Certain aspects of the present invention provide devices for occluding vascular vessels. In some preferred forms, these devices are able to move from a first condition to a less compact, second condition in a vascular vessel so as to fully or partially prevent fluid from passing through the vessel. One such device includes a frame and a flexible sheet material. The device also includes an occluding material that is located in an interior region of the frame. The flexible sheet material and frame are associated with one another such that when the device is in the second condition in the vascular vessel, the sheet material is positioned in the vessel lumen so as to block fluid flow through the lumen.

Abstract: A medical lumen-expansion balloon may include a generally cylindrical central body between first and second body end portions, a low-profile unexpanded first state and a radially-expanded second state, wherein the first body end portion is constrained by fiber material such that it will not expand longitudinally and circumferentially beyond a predetermined size, and the central body is constrained by fiber material so as to be circumferentially substantially noncompliant, but is longitudinally compliant, such that it will elongate with increased volume but will not substantially radially expand.

Abstract: A transluminal balloon for a medical device may include a longitudinal structural portion including at least a first structural layer, the first structural layer including a polyether block amide co-polymer including a polyether, and a polyamide other than nylon 12. A transluminal balloon may include a longitudinal structural portion including an inner structural layer including a first polyether block amide co-polymer, an intermediate structural layer including a polyamide or copolyamide, and an outer structural layer a second polyether block amide co-polymer different from the first polyether block amide co-polymer. The inner and outer structural layers have hoop ratios greater than the intermediate structural layer, and the inner structural layer has a hoop ratio that is greater than or less than the outer structural layer.

Abstract: A tipless balloon catheter includes an elongate tubular body defining an inflation lumen and having proximal and distal ends. A balloon has a proximal neck mounted on the distal end of the elongate tubular body and a distal neck including a distal tip having a distal opening therethrough. The distal opening is in fluid communication with the inflation lumen and an interior of the balloon. A stiffening member extends between the distal end of the elongate tubular body and the distal neck of the balloon. The tipless balloon catheter has a wire guide path defined by the elongate tubular body, the interior of the balloon, and the distal opening.

Abstract: A valvuloplasty catheter has a dog-bone shaped balloon with semi-compliant smaller diameter waist and non-compliant larger diameter bulbous end regions. The balloon centers across the valve with the waist adjacent to the annulus. One bulbous region serves to hyperextend the valve leaflets and the other assists in stabilizing the balloon position to reduce migration. The semi-compliant waist increases in diameter as fluid enters the balloon until it comes into contact with the valve annulus. The pressure within the balloon per unit of volume delivery has a greater slope after contact with the annulus than before resulting in a change in slope for the pressure versus volume curve. The diameter of the balloon and annulus are determined at this inflection point when the balloon contacts the annulus.

Abstract: A balloon catheter includes an outer conduit having an outer surface, and an inner conduit having an outer surface. The inner conduit is suitable for passage over a guide wire, and the inner conduit is movably disposed within the lumen of the outer conduit. There is also a balloon having a proximal margin and a distal margin, such that the proximal margin of the balloon is attached to the outer surface of the distal tip of the outer conduit and the distal margin of the balloon is attached to the outer surface of the portion of the inner conduit that extends beyond the distal tip of the outer conduit. And there is a fluid port for introducing an expansion fluid into the annular space formed between the inner surface of the outer conduit and the outer surface of the inner conduit and into the lumen of the balloon, and for the removal of the expansion fluid.

Abstract: An improved balloon catheter structure includes a beveled distal tip, a reinforced distal portion, and an elastic or split sleeve over at least a portion of the balloon. The balloon may have a short length and a marker at its midline. The catheters are particularly useful for crossing through stent walls at vessel bifurcations.

Abstract: An acupressure appliance to apply pressure to body parts. The acupressure appliance includes a pair of curved rod-like pressure units and a connector connecting the pair of curved rod-like pressure units in a lateral direction. Each pressure unit includes a convex-curved segment of a chevron shape curved continuously in an axial direction, and the pair of curved rod-like pressure units are spaced apart from each other in the lateral direction.

Abstract: A balloon delivery catheter apparatus including a catheter tubing defining a lumen therethrough, a balloon disposed near a distal end of the catheter tubing and moving between deflated and inflated states, and a core wire having a proximal end attached to the catheter tubing inside the lumen and extending distally away and substantially co-axially with the catheter tubing through the balloon to a distal free end. Proximal and distal balloon control bands are concentrically arranged around respective proximal and distal end portions of the balloon. A coil disposed around the core wire has a proximal end attached to at least one of the distal end portion of the balloon and the distal balloon control band.

Abstract: The present invention relates to covered endoprosthetic devices. Covered endoprosthetic devices comprise an endoprosthesis and a sheath. The sheath comprises a central portion and outer portions, wherein the central portion preferentially restricts or causes a restriction of blood flow. Blood flow can be reduced by the central portion of the sheath by varying the permeability of the sheath or by having projections on the sheath that slow blood flow. Permeability may be provided by perforations or holes in the material of the sheath or by varying the polymer structure that makes up the sheath itself. The outer portions of the sheath do not substantially reduce blood flow. Methods of using sheath-covered endoprosthetic devices of the invention to treat aneurysms, especially aneurysms in proximity to small perforator vessels or arteries, are also encompassed.

Abstract: Dilators, such as rapid exchange dilators, configured for percutaneous access are disclosed. The dilator may be configured to be disposable within, or couplable with, a catheter. In some embodiments, the dilator, or the coupled dilator and the catheter, may be configured such that a sheath is not required for percutaneous access. In other embodiments, the dilator may comprise a plug such that a guide wire may be directed from a distal end of the dilator through a port, such as a rapid exchange port, in a sidewall of the dilator. The plug may also be configured to permit passage of fluid through a lumen of the dilator while inhibiting passage of the guide wire through a length of the dilator.

Abstract: An array of a plurality of shape memory material microposts have a proximal end configured to be secured to a substrate with a tissue penetrating distal end.

Abstract: An aortic occluder catheter with expandable balloons for increasing cerebral blood blow has one or more balloons on a catheter shaft. To assist the balloon in bearing up against arterial blood flow while positioned retrograde in the aorta, the balloon is bonded to the catheter shaft using heat shrink tubing and a thermal bonding machine and then further ironed using a second piece of heat shrink tubing and a second heating process.

Abstract: A catheter for subintimally bypassing an occlusion in a vessel includes a catheter shaft including a guidewire lumen disposed therethrough and having a shaft longitudinal axis, at least two balloons coupled to an exterior of the catheter shaft such that longitudinal axes of the balloons are in a common plane with the shaft longitudinal axis when uninflated and with no external forces on the catheter. The balloons are configured such that when the catheter is disposed in the subintima of a vessel and the balloons are inflated, a tip of the catheter shaft is oriented towards a true lumen of the vessel distal of the occlusion.

Abstract: An aortic occluder catheter with expandable balloons for increasing cerebral blood blow has one or more balloons on a catheter shaft. To assist the balloon in bearing up against arterial blood flow while positioned retrograde in the aorta, the balloon is bonded to the catheter shaft in tension.

Abstract: A catheter for use with a subintimal reentry guidewire includes a proximal portion having a proximal guidewire lumen and a proximal inflation lumen, a distal portion having a distal guidewire lumen and a distal inflation lumen, and an intermediate portion disposed between the proximal portion and the distal portion and having an intermediate inflation lumen in fluid communication with the proximal and distal inflation lumens. The intermediate portion is devoid of a guidewire lumen. A blocking mechanism disposed in the distal portion of the catheter is transformable from a non-blocking configuration in which a guidewire is free to translate through the distal guidewire lumen and a blocking configuration in which a guidewire disposed in the distal guidewire lumen is prevented from translating through the distal guidewire lumen.

Abstract: A system for breaking obstructions in body lumens includes a catheter including an elongated carrier, a balloon about the carrier in sealed relation thereto, the balloon being arranged to receive a fluid therein that inflates the balloon, and an arc generator including at least one electrode within the balloon that forms a mechanical shock wave within the balloon. The system further includes a power source that provides electrical energy to the arc generator.

Abstract: A system for breaking obstructions in body lumens includes a catheter including an elongated carrier, a balloon about the carrier in sealed relation thereto, the balloon being arranged to receive a fluid therein that inflates the balloon, and an arc generator including at least one electrode within the balloon that forms a mechanical shock wave within the balloon. The system further includes a power source that provides electrical energy to the arc generator.

Abstract: Everting filter devices and methods for using the devices, including using the devices as intra-vascular filters to filter thrombus, emboli, and plaque fragments from blood vessels. The filter devices include a filter body nominally tubular in shape and having a large proximal opening. The filter body can extend from a proximal first end region distally over the non-everted exterior surface of the filter, further extending distally to a distal-most region, then converging inwardly and extending proximally toward the filter second end region, forming a distal everted cavity. The degree of eversion of the filter can be controlled by varying the distance between the filter first end region near the proximal opening and the closed second end region. Bringing the filter first and second end regions closer together can bring filter material previously on the non-everted filter exterior to occupy the distal-most region.

Abstract: A measuring balloon has an inner bulbous balloon formed from a non-compliant or semi-compliant material and has a central smaller diameter inner waist and two larger diameter bulbs on each side of the inner waist. A compliant outer waist bladder is located on the outside of the inner bulbous balloon adjacent to the inner waist and is inflated via a separate inflation lumen. The inner balloon is inflated at a higher pressure to dilate stenotic aortic valve leaflets, and provide alignment and positioning of the measuring balloon across the aortic annulus. The bladder waist is inflated to a lower pressure to make contact with the aortic valve annulus. Marker bands positioned on the outside of the measuring balloon provide determination of annulus diameter and ovality.

Abstract: A balloon catheter includes a catheter tube and an inflatable balloon. The ends of the balloon are attached to the catheter tube. The outside surface of the balloon in an uninflated state is provided with a relief structure which in an inflated state of the balloon is substantially disappeared. A method for producing such a relief structure is by winding a wire helically around the outer surface of the balloon.

Abstract: The present invention provides insertable medical devices having elastic surfaces associated with bioactive agent-containing microparticulates and a coating material. Upon expansion of the elastic surfaces the microparticulates can be released to a subject.

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: Balloon catheters and methods of making and using the same. A balloon catheter may include a catheter shaft and a balloon coupled thereto. A traction member may be coupled to the balloon catheter adjacent the balloon and may extend along a portion or all of the length of the balloon. The traction member can improve traction between the balloon and a target site.

Abstract: Catheterization systems and methods for treatment of a condition within a blood vessel are provided that include the use of a catheter, a balloon immediately adjacent to the distal end of the catheter, an inflation device for expanding the balloon, and an occlusion-penetrating device for gaining access through an occlusion. The occlusion penetrating device may include an indeflator configured to injected fluid at a high pressure, an RF wire, a hollow needle wire, a dissection tool, a laser wire, or even a very small balloon to exploit existing microchannels in the occlusion.

Abstract: The external surface of a balloon for IABP balloon catheter is designed to have a rough surface occupying an area of 10 to 80% both inclusive of the whole of the external surface, and a smooth surface occupying an area of 90 to 20% both inclusive thereof. The supplied balloon for IABP balloon catheter is certainly unwrapped by a predetermined balloon pressure from a driving machine, with no need to conduct any preloading process, and further which is not unwrapped before and during the insertion of the catheter even in the state that a wrapping sheath is removed.

Abstract: One disclosed embodiment comprises a method for treating lesions in the carotid artery of a mammalian body. The method comprises transcervical access and blocking of blood flow through the common carotid artery (with or without blocking of blood flow through the external carotid artery), shunting blood from the internal carotid artery and treating the lesion in the carotid artery.

Abstract: In a balloon tube (10) which is processed after it is mounted on a mold, a bag part (14) has a plurality of parts having a different drawability in a radial direction centered around an axial direction X, disposed along the axial direction X. The highest drawability part (11), which has the highest drawability, is disposed to separate from both ends of the bag part (14) in the axial direction X thereof. The balloon tube (10) is preferable to stably fabricate a balloon having a uniform film thickness.

Abstract: A delivery device for deploying and resheathing an expandable prosthesis and method of use thereof are described. The delivery device includes a fixed outer sheath and a pusher member that is configured for retracting in a proximal direction and resheathing the prosthesis. The device includes two plates engaging the pusher member, with a first plate configured engage the pusher member to prevent proximal movement and the other plate configured to engage the pusher member for distal movement.

Abstract: The present invention is directed to balloon folding configurations and methods for catheter devices having dual lumens in radial proximity to the balloon, such as, but not limited to, self-aligning stent delivery systems for treatment of bifurcated lesions. The configuration designs alters the conventional catheter profile by packing balloon materials in otherwise vacant areas located on both sides of the side branch shaft and/or the parent shaft, such that the device takes on more of a round profile instead of the classical elongated egg-shaped profile.