Abstract: A low profile catheter valve comprises a movable sealer portion positioned within the inflation lumen of a catheter. The sealer portion forms a fluid tight seal with the inflation lumen by firmly contacting the entire circumference of a section of the inflation lumen. The sealer portion may be positioned proximally of a side-access inflation port on the catheter, to establish an unrestricted fluid pathway between the inflation port and an inflatable balloon on the distal end of the catheter. As desired, the clinician may move the sealer portion to a position distal of the inflation port, thereby preventing any fluid from being introduced into or withdrawn from the balloon via the inflation port.

Abstract: A cathode for a miniature X-ray device includes an insulating shell, a cathode and an anode. The cathode includes a focusing cup formed into an end. The focusing cup can include a thin metal layer that conforms to an inner surface of the cathode. An emitting material having a low work function, such as diamond, is deposited directly onto the internal surface of the focusing cup. The anode has a flat receiving surface for collecting electrons emitted from the anode. An interior coating is applied as a circumferential belt on the interior surface of the insulating shell. The interior coating, formed of a negative secondary emission yield material, extends lengthwise in the region of the cathode to an anode gap, covering the region of the insulating shell most likely to be subject to stray electrons emitted from the cathode.

Abstract: A mold for forming medical balloons and the balloons formed therefrom are disclosed. The mold has a generally cylindrical inner molding surface for forming a working length of the balloon, and generally cylindrical outer molding surfaces at either end of the mold for forming shafts of the balloon. Joining these outer and inner molding surfaces are taper molding regions composed of two generally conical molding surfaces oriented at two different angles from a longitudinal axis of the mold. A balloon resulting from a manufacturing process using a mold according to the present invention reflects the geometry of the mold and has a unique concave taper profile and a well-defined working length.

Abstract: A filter for filtering micro-emboli from a patient's blood during an angioplasty procedure is disclosed which comprises a plurality of curved wires connected to a rod between a first connector fixed with respect to the rod and a second connector slidingly mounted on the rod. Two layers of filter material are connected to opposite sides of the wires, and each layer includes perforations which are offset from the perforations in the other layer. When the rod and the wires are disposed within a catheter, the inner wall of the catheter compresses the wires toward the rod and when the rod is extended from the catheter, the wires resume their curved shape and pull the sliding connector along the rod toward the fixed connector.

Abstract: An over-the-wire catheter provides substantially shadow-free delivery of radiation to a body lumen by having a treatment region wherein a guidewire tube and a radiation source tube form a parallel double helix configuration. When a radiation source is inserted into the radiation source tube and a guidewire is present in the guidewire tube, no portion of the treatment site will be obscured from all radiation emitted by the radiation source because, within the treatment region, the guidewire and the radiation source are not in a conventional, axially parallel configuration. Optionally, a balloon may be mounted about or adjacent the treatment region of the catheter, the balloon providing centering and/or dilatation functions.

Abstract: A process for forming a heat weld between a catheter shaft and a surrounding balloon comprises selecting an elongate catheter shaft formed of thermoplastic polymeric material that is opaque to red and near-infrared light, and selecting a balloon formed of thermoplastic polymeric material that is transparent or translucent to red and near-infrared light. While a neck of the balloon is fitted in close contact around a distal portion of the catheter shaft, a laser beam of red and near-infrared light is applied through the balloon neck to impinge on the underlying opaque distal shaft, which is heated thereby. Heat from the shaft is conducted into the surrounding balloon neck so that adjacent annular portions of both components melt and mix. The molten materials are allowed to cool, forming a secure weld joint between the neck and the shaft. The process yields strong, flexible bonds between balloons and catheter shafts that may be selected from a wide variety of materials.

Abstract: A medical device for stenting within a patient's vascular system is a low profile fixed-wire balloon catheter. The balloon is not attached directly to the wire-like structure of the catheter, providing a degree of independent rotation therebetween.

Abstract: A catheter to be used without a guidewire which includes a support wire shaft formed of metal, a balloon mounted on a distal portion of the catheter, and an inflation shaft for inflating the balloon, wherein a core wire may be interchangeably inserted into the support wire shaft when the catheter is within a human body to change the stiffness and improve control thereof.

Abstract: A catheter to be used without a guidewire which includes a support wire shaft formed of metal, a balloon mounted on a distal portion of the catheter, and an inflation shaft for inflating the balloon, wherein a core wire may be interchangeably inserted into the support wire shaft when the catheter is within a human body to change the stiffness and improve control thereof. In one embodiment, the portion of the support wire shaft that extends just proximal of, through and distal of the balloon is formed entirely of a metal wound coil. The flexibility characteristics of this support wire shaft can be controlled by varying the pitch of the wound coil and the thickness of the wire or ribbon it is made from. An overjacket is also provided on the metal wound coil portion to hold pressure within the inflation lumen and provide a suitable material for bonding a distal end of the balloon to the support wire shaft.

Abstract: A guidewire apparatus for use during percutaneous catheter interventions such as angioplasty or stent deployment. A protection element comprising a filter or an occluder is mounted near the distal end of a steerable guidewire, which guides a therapeutic catheter. The guidewire apparatus comprises a hollow shaft movably disposed about a core wire. The shaft and core wire control relative displacement of the ends of the protection element, causing transformation of the protection element between a deployed configuration and a collapsed configuration. The protection element is freely rotatable about the guidewire apparatus. A tracking member disposed adjacent the distal end of the guidewire apparatus can be used to guide the device along another guidewire. Thrust bearings may be employed to facilitate unlimited rotation of the steerable guidewire within the protection element, especially while the protection element is retained in the collapsed configuration.

Abstract: Extremely hydrophobic nitric oxide (NO) releasing polymers are disclosed. The extremely hydrophobic NO-releasing polymers provided are extensively cross-linked polyamine-derivatized divinylbenzene diazeniumdiolates. These polymers can be loaded with extremely high NO levels and designed to release NO in manners than mimic natural biological systems. The NO-releasing extremely hydrophobic polymers provided can maintain a sustained NO release for periods exceeding nine months. Also provided are related medical devices made using these NO-releasing extremely hydrophobic polymers.

Abstract: A catheter shaft for a balloon catheter includes a centrally-located guidewire lumen. A body portion of the catheter shaft includes arc-shaped nodes that define a guidewire track within the guidewire lumen. Each node provides a single contact point for a guidewire within the guidewire lumen, thereby limiting frictional contact due to “rolling” friction, rather than “sliding” friction, between the catheter shaft and an inserted guidewire. The nodes include a crown region that includes the contact point. The crown region may be formed of a material having a lower coefficient of friction than the remaining portion of the catheter shaft. At least one node has an inflation lumen extending therethrough. The inflation lumen is in fluid communication with an interior of an inflatable balloon.

Abstract: The invention is an intraluminal therapy catheter having a least two treatment members disposed near the distal end of the catheter, the members being independently inflatable to perform angioplasty and/or fluid-sourced brachytherapy. A first treatment member is helically mounted about the shaft of the catheter, and forms a helical perfusion channel when inflated into contact with the vessel being treated. In a first embodiment of the invention, the second treatment member is also helically mounted about the catheter shaft and capable of forming a helical perfusion channel when inflated into contact with the vessel. The first and second treatment members are intertwined to form a double helix configuration wherein each member is capable of being inflated to generally fill the helical perfusion channel created by simultaneous inflation of the other member.

Abstract: A bifurcated endoluminal prosthesis is provided that includes a valve or gate in one of the bifurcated branches. The valve or gate prevents flow of blood through the branch when it is closed and permits the flow of blood when it is open. In one variation, the valve comprises a spring member attached to a graft material substantially impermeable to the flow of blood. The spring member holds the graft material over the opening that forms a lumen in the bifurcated portion. The spring member may be flipped from a closed position in which it is initially deployed, to an open position whereby the graft material forms an opening continuous with lumen in the bifurcated portion permitting the flow of blood therethrough. The invention may be used in bifurcated or branched tubular grafts for endoluminal placement within a body lumen, including blood vessels, and for the treatment of abdominal and other aneurysms.

Abstract: A device for sensing aneurysmal pressure in a body cavity includes a housing including at least one chamber formed therein. A first fluid is positioned in a first portion of the chamber. A second fluid is positioned in a second portion of the chamber. A compressible fluid is positioned in the second portion of the chamber. A divider is positioned between the first and second fluids. A pressure membrane is in communication with the first portion of the chamber. The aneurysmal pressure is transmitted through the membrane and the first fluid to position the divider within the chamber. A method for determining aneurysmal pressure in a body cavity includes deploying a sensing device including radiopaque substance adjacent an aneurysm. The radiopaque substance is moved within the device in response to the aneurysmal pressure. The sensing device is imaged and pressure and/or relative pressure is read directly.

Abstract: Disclosed herein is an improved core wire for use in a medical catheter. In one aspect, a tapering core wire is incorporated into the distal end of a catheter. The catheter has a tubular body. Both ends of an inflatable balloon are mounted to the tubular body. The core wire extends from the distal end of the tubular body. In one embodiment, substantially all of the taper of the core wire occurs in the extending portion of the core wire over a length of at least 15 mm but no more than 60 mm. In another aspect, a core wire with a shapeable tip and method of manufacturing the same are provided. A core wire previously made superelastic is subject to additional processing to remove its superelasticity thereby allowing the material to be shapeable to aid in advancing the core wire through a blood vessel or other body cavities. In another aspect of the present invention, a method is provided for securing the core wire to the distal end of an elongated catheter tubular body.

Abstract: An endovascular support device for treatment of chronic restenosis or other vascular narrowing is disclosed together with a method of manufacture and a method for delivering a plurality of such devices to an affected area of a vessel. In a preferred embodiment, the endovascular support device comprises a unitary wire-like structure configured to form a plurality of upper and lower peaks which may be compressed for delivery to an affected area of a coronary or peripheral vessel in a human, and then expanded to maintain a passageway through the vessel.

Abstract: A tubular prosthesis is implanted at a target location within a body lumen by transluminally placing and embedding an expansible prosthesis body within a sealing layer. The sealing layer occludes at least a circumferential band within an interface region between the prosthesis body and the inner wall of the body lumen, thus providing for blockage of body lumen flow past the prosthesis. The sealing layer may be introduced prior to or simultaneously with the prosthesis body. A tubular prosthesis may be implanted in blood vessels, particularly to protect aneurysms.

Abstract: A method for reducing distal embolization during insertion of devices to treat plaque, thrombi and other intravascular occlusions. Using a guide catheter, a guidewire is delivered to a site proximal to the lesion. An aspiration catheter is then introduced over the guidewire, and the two are moved together in a distal to proximal direction across the occlusion. The aspiration catheter is then moved in a proximal to distal direction while continuously aspirating, which prevents embolization of any particles which may be created during the crossing of the guidewire.

Abstract: An expandable stent and stent graft having a small initial diameter, flexibility along its longitudinal axis prior to expansion and a large expanded and rigid Local stain on the stent material is minimized, as and after the balloon is expanded. More particularly, the stent has rotation joints having minimal strain during stent expansion. The stent is substantially the same length before and after expansion and being flexible longitudinally when constrained, it is easy to locate. A method of manufacturing stents is described comprising rotation of a tube beneath a moving film, with light passing through the film onto the tube, at selected locations. A laser scanning system for stent manufacture is also disclosed.