Abstract: Balloon catheters, coil assemblies, and methods for making the same. An example balloon catheter may include a coil assembly. The coil assembly may include a coil, a coating disposed on the coil, and a sheath disposed over the coil and the coating. A guidewire lumen may be defined by the coil assembly. An outer tube disposed over at least a portion of the coil assembly. A balloon may be coupled to the outer tube. An inflation lumen may be defined between the coil assembly and the outer tube.

Abstract: Systems for treating a vessel bifurcation comprise a bifurcated catheter having a first branch and a second branch. Each branch defining an exchange region that extends from the distal end of the shaft to the guidewire port of the shaft. The catheter has a radial alignment mechanism which provides improved radial alignment characteristics of at least the exchange region of the branches.

Abstract: Dilation catheters including a mechanism used in, for example, removing gas or air from the catheters are disclosed. A dilation catheter may include an elongated tubular member having a distal end and a proximal end, a proximal handle proximate the proximal end of the tubular member, and an inflatable balloon proximate the distal end of the tubular member with inflatable balloon being in fluid communication with a fluid port to supply inflation liquid to the inflatable balloon. The inflatable balloon may include an opening for permitting gas to exit the inflatable balloon. In the proximate location of the opening, an expandable material or a barrier material that permits gas to exit through the opening, while retaining inflation liquid in the inflatable balloon.

Abstract: A method of making a fiber-reinforced medical balloon is described herein. The method entails pressurizing a portion of a balloon, and ejecting a fiber precursor fluid from at least one nozzle adjacent to the portion. One or more fibers are formed from the fiber precursor fluid and deposited on an exterior surface of the portion. Preferably, the fibers are polymer nanofibers, and the method is carried out using an electrospinning process.

Abstract: Device for carrying out a cutting balloon intervention using a cutting balloon catheter with an inflatable balloon arranged in the region of its front end holding an axially positioned blade and with OCT monitoring, the cutting balloon catheter being combined with an OCT catheter to form an integrated unit.

Abstract: The present invention relates to a method of thermal treatment of thermally responsive material wherein areas in or on the material to be thermally treated are defined and thermal energy is inputted on or into the defined areas in order to change/influence the material characteristics. The present invention further relates to medical devices or parts thereof manufactured at least in part from thermally responsive material by a process comprising at least one step of thermal treatment of this thermally responsive material.

Abstract: Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support stent is delivered to a position on the surface of the outflow side of a native heart valve of a patient, the support stent defining a support-stent interior. An expandable prosthetic heart valve is delivered into the native heart valve from the inflow side of the native heart valve and into the support-stent interior. The expandable prosthetic heart valve is expanded while the expandable prosthetic valve is in the support-stent interior and while the support stent is at the position on the surface of the outflow side of the heart valve, thereby causing one or more of the native leaflets of the native heart valve to be frictionally secured between the support stent and the expanded prosthetic heart valve.

Abstract: A dual lumen introducer sheath provides access to at least one renal artery and at least one peripheral blood vessel of a patient. The introducer sheath includes a proximal hub comprising first and second ports, a first lumen, and a second lumen. The first lumen extends from the first port to a first distal aperture and has sufficient length such that when the first port is positioned outside the patient the first distal aperture is positionable in the abdominal aorta at or near origins of the patient's renal arteries. The second lumen extends from the second port to a second distal aperture, has a shorter length than the length of the first lumen, and is configured to allow passage of a catheter device through the second lumen and into or through an iliac artery contralateral to an insertion point of the introducer sheath into the patient.

Abstract: Catheters, balloons, and methods of manufacturing balloons for balloon catheters using lasers are disclosed. A catheter with a shaft sized for use with a 0.014 inch guide wire includes a polymeric balloon having a body portion with an inflated outer diameter of more than 6 millimeters. An inflatable balloon includes an inflated outer diameter to inner waist diameter ratio of 12.5 to 1. An inflatable polymeric balloon that has a body portion with two regions that have different molecular orientations is also provided. A method of processing an elongate polymeric material includes heating a portion of the polymeric material with a laser while longitudinally stretching the portion of the polymeric material. A method of manufacturing a balloon includes heating and longitudinally stretching a first and second portion of an elongate polymeric tube to form first and second end portion. The remaining body portion is radially expanded to form the balloon.

Abstract: The present invention is directed to expandable medical balloons that have strips of lubricous material along their lengths The expandable medical balloons are formed from extruded preform segments. The preform segments are coextrusions of a first material, which forms the tubular primary material of the preform segments, and a second material, which forms the strips of lubricous material.

Abstract: An interventional catheter for angioplasty and the like, including a catheter tube including an outer tubular member, an inner tubular member disposed within the lumen of the outer tubular member, and a balloon attached to the distal end of the outer tubular member and the distal end of the inner tubular member. The outer tubular member includes a first portion having a first stiffness and a second portion having a second stiffness less than the first stiffness. The inner tubular member has an inner surface having a first coefficient of friction and an outer surface having a second coefficient of friction greater than the first coefficient of friction.

Abstract: Composite fiber reinforced balloons for medical devices prepared by applying a web of fibers to the exterior of a preformed underlying balloon and encasing the web with a matrix material to form a composite balloon. The fiber web is applied to at least the cone portion of the underlying balloon form. Either the cone portion of the underlying balloon form, or the web fibers applied to said cone portion, or both, have a friction-enhancing material coated thereon.

Abstract: The invention describes a closure device for the provision of freshly created gastric feeding fistulas, the basis of the design of the device being an introverted balloon that allows a sealing and hemostatic axial traction movement on the fistula that is to be sealed, the concentric balloon ends which run transmurally through the stomach and abdominal wall being arranged in a special seal-promoting and hemostatic manner.

Abstract: A catheter assembly and related methods directed to a main balloon and a side balloon, wherein the side balloon is coupled in fluid communication with the main balloon at a location distal of the side balloon. In one example, a side inflation member couples the side balloon in fluid communication to the main balloon at a distal end portion of the main balloon. A side catheter branch of the catheter assembly, which defines a side guidewire lumen, can be operatively mounted to the side balloon at a side balloon connection point to help maintain alignment of the side catheter branch relative to the side balloon.

Abstract: Described are devices useful to deliver fluid to tissue of the bladder, bladder neck, prostate, urethra, ureter, kidney, and related methods, the devices including one or a combination of features such as a steerable shaft, an optical mechanism, multiple fluid delivery orifices that may be moveable or extendable laterally, longitudinally, or distally; the methods allowing for delivery of one or multiple types of fluid to tissue such as the bladder (including the bladder neck), urethra, prostate, kidney, ureter, etc.

Abstract: A catheter having an elongate shaft including a plurality of apertures disposed along at least a length of the shaft to facilitate bending. The catheter includes an inflatable balloon, wherein a subset of the plurality of apertures provides fluid communication from an inflation lumen to the inflatable balloon.

Abstract: A system for treating uterine disorders includes a balloon catheter having a cannula with a proximal end and a distal end, and an inflatable balloon secured over the distal end of the cannula. The device includes a heating assembly coupled with the distal end of the cannula and disposed inside the inflatable balloon, and an impeller disposed inside the heating assembly. In one embodiment, the heating assembly includes an elongated heating tube having a heating film covering an outer wall thereof, at least one fluid inlet extending though the outer wall and a fluid outlet located at a distal end of the elongated heating tube. The impeller is rotatable for drawing fluid through the at least one fluid inlet and into the elongated heating tube for heating the fluid, and discharging the heated fluid from the fluid outlet for circulating the fluid throughout the inflatable balloon.

Abstract: A medical device such as a catheter, stent or balloon, or a component thereof is formed by depositing an inorganic-organic hybrid composite material on an eliminatable shape form and removing the shape form, leaving the medical device or component thereof formed of the inorganic-organic hybrid composite material. Multiple layers of the inorganic-organic hybrid composite material can be used in the formation. A particular structure is an expandable balloon member for a catheter assembly.

Abstract: A catheter device including an elongate tubular shaft having a consistent material composition for a substantial proportion of its length. The device includes a proximal shaft portion having a first flexibility and a distal shaft portion having a second flexibility, wherein the second flexibility is greater than the first flexibility and wherein at least the distal shaft portion comprises at least one score in a surface thereof. The device includes a wholly external wire guide structure secured to the tubular shaft by a figure-eight polymer sleeve.

Abstract: An self-expanding frame is mounted on the distal end of a shaft. The frame is sized and configured so that it can be inserted into the cavity of an aneurysm. Suction is applied to the interior of the aneurysm through the shaft or through another catheter, and the wall of the aneurysm is collapsed onto the exterior surface of the frame. The frame is then collapsed upon further suction being applied to the interior of the aneurysm, which collapses the aneurysm wall with it. The frame folds down on itself, carrying with it the aneurysm wall. The frame is detachable from the shaft and can be left in the collapsed aneurysm.

Abstract: A catheter configured to carry one or more stents and having an inflatable balloon for expanding a stent surrounding the balloon. The catheter is characterized in having a positioner for moving the one or more stents relative to the balloon from a first position in which the stent does not surround the balloon to a second position in which the stent surrounds the balloon. Also disclosed is a method for deploying a stent at a desired location in the vascular system.

Abstract: Inflatable medical devices and methods for making and using the same are disclosed. The inflatable medical devices can be medical balloons. The balloons can be configured to have a through-lumen or no through-lumen and a wide variety of geometries. The device can have a high-strength, non-compliant, fiber-reinforced, multi-layered wall. The inflatable medical device can be used for angioplasty, kyphoplasty, percutaneous aortic valve replacement, or other procedures described herein.

Abstract: Treatment methods and devices are provided for percutaneously accessing a patient's thoracic region via a controlled opening in the aorta, so that cardiac procedures, such as a coronary bypass procedure, can be performed in a minimally invasive manner. Advantageously, it may be possible to perform the procedure without placing the patient on cardiopulmonary bypass. The method may include percutaneously delivering at least one catheter into an aorta of a heart, forming a controlled opening in the aorta and pericardium via the at least one catheter to access a thoracic region within the patient's chest, and performing at least one coronary bypass graft procedure through the controlled opening.

Abstract: Methods and devices for augmenting bone, such as in performing vertebroplasty are disclosed. A bone cement injection needle is provided, having a laterally deflectable distal end. The distal end may be provided with one or two or more cavity creation elements, such as inflatable balloons. A cavity creation element may include one or more filament layers. Systems are also disclosed, including the steerable injection needle, introducer and stylet. The system may additionally include a cement delivery gun, one-time use disposable cement cartridges and a cement mixing chamber. Methods are also disclosed.

Abstract: A guide catheter system includes a guide catheter having a proximal end, a distal end, an outer wall and a first, second and third electrode wherein the first, second and third electrodes are spaced longitudinally apart from each other on the outer wall of the catheter, and an electrical impulse generator connected to the guide catheter wherein the electrical impulse generator includes a circuit for selecting an adjacent pair of electrodes to use as a bipolar electrode system to send an electrical impulse and a method of use thereof to treat vasospasm.

Abstract: A medical device including a coating disposed on at least a portion of a surface of the medical device, the coating including at least one polymer material having reversible wettability.

Abstract: A system including an overtube configured to radially expand facilitates insertion of instruments in a patient. The system is directed to an overtube comprising an elongated body having a distal end and a proximal end, the overtube configured to radially expand from an insertion configuration to an expanded configuration, and including at least one articulation section having at least one degree of freedom and including a main channel expandable in the radial direction, and at least one additional channel. The at least one articulation section can radially expand. The system may include a radially expandable overtube having an optical channel configured to receive an optical device. The main channel and/or the at least one additional channel may be sized to receive one or more medical instruments.

Abstract: A system, method and workflow is described that may be used for the treatment of a patient having a cardiac syndrome characterized by an unwanted aperture in a structure of the heart. Images of the patient are obtained with a C-arm X-ray device, and the images are used to determine the size and location of the aperture. A catheter is used to insert an occluder into the patient and emplace the occluder in the aperture so as to close the aperture. The occluder may be guided using one of fluoroscopic images from the C-arm X-ray device, acoustic or magnetic sensors. Diagnosis of the syndrome and the minimally interventional treatment may be performed by the same treatment suite.

Abstract: A catheter arrangement is described that is arranged to permit a guide wire or other structure to be fed laterally from the region of an expandable working element. The catheter includes an elongate flexible tubular member and an inflatable structure carried by a distal portion of the flexible tubular member. The flexible tubular member has a guide wire lumen and at least one fluid supply lumen that is in fluid communication with the inflatable structure. The inflatable structure includes at least one, and preferably two, inflatable members (which may take the form of balloons). In the case of two inflatable members, the first and second inflatable members are radially spaced about the guide wire lumen such that at least one gap is formed between the inflatable members. With this arrangement, the distal end of a guide wire may be advanced through the guide lumen and out of a side opening such that the guide wire passes laterally between the first and second inflatable members.

Abstract: Methods and devices with two individual tubes for treating abdominal aortic aneurysm that bypass the aneurysm and are placed from the upper aorta to the iliac arteries. A separate upper cuff may also be provided, to secure the tubes above the aneurysm.

Abstract: A reduced pressure treatment system includes a filament delivery conduit having a distal end positioned at a subcutaneous tissue site of a patient and a proximal end positioned extracorporeal to the patient. A continuous filament is positioned in the filament delivery conduit such that one end of the continuous filament extends from the proximal end of the filament delivery conduit and another end of the continuous filament extends from the distal end of the filament delivery conduit. The continuous filament forms a filament mass adjacent the tissue site. A reduced pressure delivery conduit is adapted to fluidly communicate with a reduced pressure source and the filaments mass to deliver a reduced pressure to the tissue site through the filament mass.

Abstract: Apparatus and methods for retracting a balloon back into a delivery sheath following a medical procedure using the balloon. A handle on the device includes a balloon folding mechanism coupled to a proximal end of a guide wire shaft so that actuating the balloon folding mechanism causes rotation of the guide wire shaft within a catheter body. A distal end of the balloon is attached to a distal end of the guide wire shaft, which extends beyond the distal end of the catheter body, and a proximal end of the balloon is attached to the distal end of the catheter body so that actuating the folding mechanism causes the balloon to wrap around the guide wire shaft. The folding mechanism may also be configured for elongating the balloon. Rotating, or rotating and elongating, the deflated balloon results in a balloon with a smaller profile that may easily be retracted into a delivery sheath.

Abstract: A balloon dilation catheter comprising: a tubular member having a proximal end and a distal end and an inflatable balloon disposed at the distal end of the tubular member. The tubular member comprises a first lumen disposed in communication with an interior of the inflatable balloon and a second lumen for receiving a guidewire substantially along the entire length of the tubular member. The second lumen has a first opening at the proximal end of the tubular member and a second opening at the distal end of the tubular member. A first slit is disposed longitudinally from the first opening along substantially the entire length of the tubular member to permit separation of the guidewire with respect to the second lumen. The subject balloon dilation catheter provides improved rapid exchange advantages of either the catheter or the guidewire used in a catheterization technique.

Abstract: An energy delivery probe is provided that may include any of a number of features. One feature of the energy delivery probe is that it can apply energy to tissue, such as a duct, to shrink, damage, or occlude the duct. In some embodiments, the energy can be applied with a vapor media. In some embodiments, the duct can be a ductus deferens or an ejaculatory duct of the male reproductive system. Another feature of the energy delivery probe is that it can utilize an inflatable member to form a seal to contain the vapor media. Methods associated with use of the energy delivery probe are also covered.

Abstract: The present disclosure generally relates to a tool, a kit including said tool, and a method of use of the tool or the kit for making a subcutaneous pocket in a layer of fat for the introduction of a subcutaneous medical device, and more specifically, a tool, kit, and method of use thereof using a calibrated inflatable volume with a guide to open a subcutaneous pocket at the appropriate location in a body by inflating the volume to the appropriate size. The tool is calibrated to rest against a layer of muscle using a guide wire and inflate in a specific shape to a specific volume to gently displace fatty tissue that may obstruct the implantation of a subcutaneous device between the skin and the ultimate resting place. The tools allows for creating localized lateral retraction in an area of interest without placing strain on the skin or the muscle. A kit using the tool further includes surgical equipment needed for the surgery.

Abstract: A balloon catheter and stent delivery system for medical treatment of a patient includes a balloon having a pattern of ridges in an initial deflated state. The ridges may cooperate with structural elements of a stent crimped onto the balloon, to increase and enhance longitudinal retention of the stent while the catheter system is advanced or withdrawn. Upon inflation, the balloon recovers to an inflated shape having a cylindrical working portion. The balloon catheter thus provides for uniform expansion of the stent when the balloon is inflated. The present invention also tends to protect the leading or distal end of the stent during advancement, and tends to protect the leading or distal end of the stent during advancement, and tends to protect the proximal end of the stent during any withdrawal of the catheter system.

Abstract: A two-part implantable heart valve and procedure are disclosed that allow expansion and positioning of a first part of the implantable heart valve having a temporary or transient valvular structure. A second part of the implantable heart valve is deployed within the first part and attaches thereto. The valvular structure of the second part then acts to function as the heart valve replacement. A tool or system is provided for determining an adequate percutaneous heart valve size for a given stenotic valve. A balloon can be inflated inside the stenotic valve to a desired pressure. When this pressure is reached an angiographic image is taken and the balloon diameter is measured at a waist area created by contact between the balloon and the stenotic valve. The diameter represents the minimum percutaneous heart valve diameter to be implanted.

Abstract: The present invention comprises systems, methods and devices for the delivery of compositions for occluding or of means for opening conduits. The implantable occlusive material may be delivered pre-formed or in situ cured and, may be a resorbable material that supports tissue ingrowth that eventually replaces the material leaving little or no original material in place. The delivery system is positioned to allow for placement of the occlusive material into the body conduit. Use of delivery systems, methods and devices for re-opening an occluded body conduit are also included.

Abstract: A multi-lumen guiding catheter for PTCA is disclosed. The guiding catheter comprises of a tubular body having a first and at least one second continuous lumen there-through from a proximal end to a distal end thereof The first lumen is having a cross-section and a length, the cross-section of the lumen is being large enough to permit passage there-through of a balloon of the balloon dilatation catheter The at least one second continuous lumen is positioned either in a concentric or eccentric manner in respect to the first lumen, and is adapted provide continuous intra-coronary infusion of a flowing matter A method of continuous intra-coronary infusion of flowing matter thorough a guiding catheter for PTCA is also presented. It comprises of steps of obtaining the aforesaid guiding catheter, and then, administrating a flowing matter thorough this second lumen from its proximal end.

Abstract: A translumenal access system includes a translumenal access catheter, a trocar, and one or more guidewires. The trocar may be introduced through adjacent tissue layers, typically from an endoscope, and the translumenal access catheter introduced through the resulting penetration over the trocar. A balloon on the catheter may be used to dilate the penetration, and an enlarged distal portion of the balloon may be used to draw the tissue layers into apposition. The first stent may be exchanged for the trocar and a second stent may be introduced through a side port on the access catheter. The stents may be then used to introduced catheters or other interventional tools, optionally for delivering one or more stents to the enlarged tissue penetration.

Abstract: Embodiments of the present invention provide systems and methods for deploying and/or retrieving a balloon configured to at least partially occlude a vessel, such as the coronary sinus. More particularly, embodiments of the present invention provide a stylet and a balloon catheter configured such that the stylet can be inserted into a lumen in the catheter and used to exert a force against an interior portion of the balloon in order to stretch the balloon and reduce the diameter of the balloon. In one embodiment, the stylet and the balloon both have specialty-configured tips that work together to prevent tearing of the balloon when the stylet is exerting a force against the interior of the balloon's tip.

Abstract: Systems and methods for treating a vessel include devices having a main elongated element with a balloon at its distal end, an auxiliary elongated element wherein a distal end of the auxiliary elongated element is proximal to the balloon, and a core wire having a internal core wire portion and an external core wire portion, wherein the external core wire portion is external to the balloon. In some embodiments, a distal connecting element is attached to the distal end of the balloon. In some embodiments, the distal connecting element is positioned at a rotational distance from the auxiliary elongated element. In some embodiments, the balloon is a fixed wire balloon. Inflation of the balloon causes guidewires positioned within the device and external core wires to be pushed up against the lesion, providing a focused force for cracking the lesion.

Abstract: The present invention provides a mechanism by which the physical properties of diseased blood vessel walls can be manipulated to achieve an effective vessel lumen diameter for a prolonged period of time. The methods and devices of the present invention selectively isolate and treat the medial or adventitial layers of these diseased blood vessels. The invention is based on the delivery of proteolytic enzymes and crosslinking agents via specialized delivery devices to a select layer of the diseased blood vessel wall. By isolating and treating these layers of the artery, collagen degrading and collagen crosslinking agents can be delivered so as to affect the diameter of the blood vessels and control blood flow therein.

Abstract: A device for retrieval of a foreign body, such as an undeployed stent from a vessel of a patient, has a central shaft for receiving a guidewire therein. A balloon support extends from the central shaft and has a free end carrying an inflatable balloon. The inflatable balloon is arranged to expand inwardly towards the central shaft on inflation, so as in use to bear against the outer circumference of the stent and hold the stent against the central shaft. The combined stent and device can then be withdrawn from the vessel.

Abstract: An method and apparatus are disclosed including an expandable body having a diameter suitable for insertion into a blood vessel and capable of being modified from a first diameter to a second larger diameter in response to an inflation pressure. The expandable body includes an outer wall having a plurality of delivery outlets extending from a working length of the outer wall. The delivery outlets coincide with regions of a lesion exposed between a framework implanted within the vessel when the expandable body is in an expanded state. A treatment agent is delivered from the delivery outlets to regions of the lesion exposed between the implantable framework.

Abstract: Various devices for ablating tissue in a lateral direction and methods of operation thereof. One embodiment of such a device includes: (1) an elongated body configured to carry ablative energy from an ablative energy source associated with a proximal end to a distal end and (2) a distal tip located at the distal end, the distal tip configured to deliver the ablative energy in a direction substantially lateral to a longitudinal axis of the elongated body.

Abstract: A catheter having a proximal shaft and a distal shaft each having a proximal end section and a distal end section. The distal end of the proximal shaft and the proximal end of the distal shaft are connected to each other, a catheter holding hub is connected to the proximal end of the proximal shaft, and a part of at least the distal shaft is constructed from an inner shaft and an outer shaft coaxially surrounding the inner shaft. The inner shaft is extended out from the outer shaft to the distal side. The lumen of the inner shaft forms a guidewire lumen. The catheter has a means for restricting relative movement of the outer shaft and the inner shaft occurring when pressing force exceeding a predetermined level is applied to the catheter.

Abstract: A toroidal balloon system apparatus and method for use in a vessel includes a catheter defining an inflation lumen and having an inflation port in communication with the inflation lumen; and a toroidal balloon attached to the catheter. The toroidal balloon defines a balloon lumen in communication with the inflation port to inflate the balloon and a central lumen which allows fluid flow through the balloon and the vessel when the toroidal balloon is inflated.

Abstract: A catheter enabling an increase in operability when the catheter is inserted from the outside to the inside of a body and capable of remarkably reducing the risk of damage to shafts even in an unforeseen accident without complicating steps and increasing production cost. The catheter comprises at least the distal side shaft formed of a resin tube, the rear end side shaft with a higher rigidity than that of the distal side shaft, and a guide wire lumen. The catheter is characterized in that a core wire is disposed therein to adjust a flexibility so that the rear end portion of the distal side shaft is harder than the distal end portion of the distal side shaft and softer than the rear end side shaft, and the core wire is fixed to the distal side shaft near the rear end side opening part of the guide wire lumen and at a part of the rear end side portion of the distal end shaft.

Abstract: A balloon dilation catheter comprising a tubular member having a proximal end and a distal end. An inflatable balloon is disposed at the distal end of the tubular member. A first lumen is disposed in the tubular member and in is communication with an interior of the inflatable balloon. A second lumen is disposed in the tubular member for receiving a guidewire substantially along a portion of its length. The second lumen has a first opening in the proximal region of the tubular member and a second opening at the distal region of the tubular member. A first slit is disposed longitudinally in the tubular member and extends along at least a portion of the tubular member, the first slit comprising a first pair of longitudinal edges in a side by side relationship.