Abstract: A rotational atherectomy device for removing a stenotic tissue from a vessel of a patient is disclosed. The device comprises a rotatable, flexible, hollow drive shaft having a fluid impermeable wall defining a fluid impermeable lumen of the drive shaft and, an abrasive element mounted to a distal end portion of the drive shaft proximal to and spaced away from a distal support element formed at a distal end of the drive shaft, the distal support element being inflatable by pressurized fluid which flows in an antegrade direction through said lumen of the drive shaft and is at least partially re-directed into the distal fluid inflatable support element.

Abstract: The invention presents methods and systems for accessing a pericardial space and preventing strokes arising from a left atrial appendage (“LAA”) by achieving a complete occlusion of the LAA using an epicardial approach without creating a puckering of the LAA ostium. A complete occlusion of the LAA is desired because bleeding arising from the LAA often leads to embolic strokes. Due to the peculiar anatomy of the LAA ostium, traditional LAA ligation techniques using sutures can lead to puckering, thus compromising the occlusion of the LAA. The invention achieves a complete occlusion and a more effective hemostatic seal with the use of inflatable balloons having electromagnetic coils internally, as well as hydrogels, sponges, and caliber tubes attached to the respective balloon's exterior, anchoring balloons, a closure device having a suture looped through two semi-rigid hollow tube that can be coated with hydrogel or silicone, and locking mechanisms.

Abstract: Various methods and devices for inserting a guidewire into the body are provided. In one embodiment, a guidewire insertion device is provided and includes and outer sheath having an outer surface and an inner lumen extending therethrough, and a dilator having an inner lumen extending therethrough and having a length greater than a length of the outer sheath. A guidewire can be configured to extend through the inner lumen of the dilator such that the guidewire is removably and replaceably disposable within the dilator and coupled thereto. A locking mechanism can be effective to selectively configure the guidewire between a locked position in which the guidewire is stationary relative to the dilator and an unlocked position in which the guidewire is movable relative to the dilator.

Abstract: Balloon catheters, and methods of treatment therewith, are provided including an inflatable first balloon at least partially enclosed by an expandable second balloon that has holes. The annular space between the first balloon and the second balloon is configured to promote delivery of the fluid evenly through holes in the second balloon to avoid problems of underloading and/or overloading. Preferably, the annular space is in communication with the holes, and the annular space is configured to receive and then to release and distribute the fluid via the holes in a substantially uniform manner such that even amounts of fluid are released in the distal and proximal holes. The first balloon may have various configurations including being tapered relative to the second balloon. The second balloon may also be tapered accordingly. The device may also include raised portions disposed in the annular space and configured to define channels having various configurations.

Abstract: Methods and devices for preventing fluid flow through the relatively short guidewire lumen of a rapid exchange catheter. The guidewire lumen for a rapid exchange catheter is provided with a narrowed or sealed section allowing for passage of a guidewire therethrough while preventing fluid flow while a guidewire is disposed therethrough. The narrowed or sealed section extends for a relatively short length of the guidewire lumen to avoid creating excessive friction between the guidewire and the guidewire lumen. In several embodiments the narrowed or sealed section is placed proximal of the distal end of the guidewire lumen.

Abstract: A catheter capable of rapid inflation and deflation and operation by one individual.

Abstract: A surgical system and method for correction of a bone injury or disorder are provided. The device includes an elongated shaft that extends between a proximal end and a distal end and defining an interior lumen. A valve disposed with the proximal end of the elongated shaft and including a membrane. An inflatable structure is coupled to the distal end of the elongated shaft. A stylet is configured for insertion through the membrane and is removably disposed in the interior lumen of the elongated shaft such that the stylet provides strength to the elongated shaft.

Abstract: A surgical procedure including making an incision in the patient's body, inserting at least two sutures close to the junction of the pericardium on the upper right pulmonary vein and making an incision in the pericardium substantially parallel to the ascending portion of the aorta. An incision is made between the sutures on the upper right pulmonary vein, an inflow cannula is inserted into the vein and through the mitral-valve into the left ventricular chamber and the inflow cannula is secured to the upper right pulmonary vein. The procedure includes inserting a blood pump having an outflow graft into the patient's body and cutting the outflow graft to a desired length, attaching a clamp to the aorta and then attaching the outflow graft to the aorta. The clamp is removed and air is flushed or removed from the outflow graft and the blood pump. The blood pump is then connected to the inflow cannula.

Abstract: A catheter comprising a sheath to be inserted into a living body, wherein the sheath includes a tubular reinforcement layer of at least one layer, which is formed with a spiral slit continuous from the distal side to the proximal side thereof; a termination end of the spiral slit is provided on the proximal side of the slit proximal portion at the site of the proximal side of the spiral slit; and at the same time, there is formed a slit termination portion in which inclination angle of the spiral slit with respect to the circumferential direction of the reinforcement layer is larger than that of the slit proximal portion.

Abstract: A catheter having a distal balloon and a deformable guidewire shaft of the catheter. The deformable guidewire shaft is adjacent to and external to the balloon. Inflation of the balloon bends the deformable guidewire shaft in order to orient or deflect a distal tip of the deformable guidewire shaft in a desired direction to guide and direct a guidewire extending through the deformable guidewire shaft towards a specific endovascular region. For example, it may be desired to orient the distal tip of the guidewire shaft towards a target vessel of a bifurcation or the balloon catheter may be used to bypass a Chronic Total Occlusion (CTO).

Abstract: Systems and methods for magnetic targeting of therapeutic particles are provided. Therapeutic particles comprise one or more magnetic or magnetizable materials and at least one therapeutic agent. Therapeutic particles are specifically targeted using uniform magnetic fields capable of magnetizing magnetizable materials, and can be targeted to particular locations in the body, or can be targeted for capture, containment, and removal. Also provided are bioresorbable nanoparticles prepared without the use of organic solvents, and methods for therapeutically using such bioresorbable nanoparticles.

Abstract: A catheter assembly for intracranial treatment of a patient for facilitating concurrent electrical sensing and fluid flow is provided and includes an outer flexible tube having a proximal end, a principal lumen extending therealong to the proximal end, and at least one radial aperture through the wall communicating with the lumen as well as a secondary lumen adjacent to the tube outer-wall surface and extending therealong. The catheter assembly including a depth electrode within the secondary lumen, extending along the length thereof. The depth electrode having electrical contacts exposed to brain tissue along the flexible tube.

Abstract: Implantable devices and methods for delivering drugs and other substances to locations within the body of a human or animal subject to treat or diagnose sinusitis and a variety of other disorders. The invention includes implantable substance delivery devices that comprise reservoirs and barriers that control the rate at which substances pass out of the reservoirs. The delivery devices may be advanced into the body using guidewires, catheters, ports, introducers and other access apparatus. In some embodiments the delivery devices may be loaded with one or more desired substance before their introduction into the body. In other embodiments the delivery devices are loaded and/or reloaded with a desired substance after the delivery device has been introduced into the body.

Abstract: A medical catheter assembly including either a reinforced balloon bolster or the combination of a balloon bolster and a wire-basket bolster. According to one embodiment, the medical catheter assembly is a low-profile replacement PEG device comprising a feeding tube, an external bolster, an end cap and an internal bolster. The internal bolster comprises a first expandable structure and a second expandable structure. In one embodiment, the first expandable structure is a balloon and the second expandable structure comprises reinforcing members. In another embodiment, the first expandable structure is a balloon and the second expandable structure is a wire basket bolster. The feeding tube has a feeding lumen and an inflation lumen, extending parallel longitudinally. The external bolster is fixed to the external end of the feeding tube and has a feeding lumen aligned with that of the tube and an inflation lumen aligned with that of the tube.

Abstract: An embodiment of the present invention relates to a catheter comprising a dilatable balloon, characterized in that the primary balloon wall is produced from a material that comprises or consists of a polyamide/polyvinylpyrrolidone (PA/PVP) polymer mixture.

Abstract: The present invention provides a medical device having an elongate body with both a proximal end and a distal end, wherein the elongate body defines an intake lumen and an exhaust lumen. The medical device also has a first pliable element defining a cooling chamber disposed at a point along the elongate body, with the cooling chamber being in fluid communication with the intake lumen and the exhaust lumen. A second pliable element is provided which at least partially encloses the first pliable element, thereby defining a junction between the first and second pliable element. A check valve is included which is in fluid communication with the junction between the first pliable element and second pliable element, the valve further being in fluid communication with the exhaust lumen. Additionally, the medical device may include sensors or other monitoring means in fluid communication with the junction and the cooling chamber.

Abstract: A breast cavity spacer device, such as for use with a percutaneous lumpectomy, is provided. The device includes a body having a projection on one end. The body has a bore extending there through. A catheter is disposed at least partially within the bore. A balloon member is fluidly coupled on one end of the catheter, the balloon member having an elliptical shape.

Abstract: An improved embolic filter frame is provided. The filter frame provides enhanced longitudinal compliance, improved sealing, low profile delivery, and short deployed length. The looped support struts have high “radial” stiffness with low “longitudinal” stiffness. When deployed, the frame exerts a relatively high stress onto a vessel wall to maintain an effective seal, yet remains longitudinally compliant. Minor displacements of the support wire or catheter are therefore not translated to the filter. The looped support struts elongate when tensioned and assume a compressed and essentially linear form. When the delivery catheter constraint is removed, the struts “snap open” and assume a looped configuration, exerting a high degree of force onto the vessel wall, creating an enhanced filter to vessel wall seal.

Abstract: Devices, systems, and methods for lead delivery. In at least one exemplary embodiment of a catheter for delivering a lead within a mammalian body of the present disclosure, the catheter comprises an elongated tube comprising a wall extending from a proximal end to a distal end, a lead delivery channel within the elongated tube, the lead delivery channel defining an outlet for delivering a lead, a balloon chamber positioned at or near the distal end of the elongated tube, and at least one balloon positioned within the balloon chamber, the at least one balloon capable of inflation to reversibly anchor the elongated tube within a mammalian body when at least a portion of the elongated tube is positioned therein.

Abstract: An endoluminal stent transit device. The endoluminal stent transit device includes a wire having a distal end and a proximal end, and a guide element attached to the wire at the distal end, which is movable between a first position and a second position. The guide element in the first position is in a contracted configuration while located within a lumen of a catheter and has a first diameter smaller than the catheter, and in the second position is in an expanded configuration while located outside of the lumen of the catheter and has a second diameter larger than the catheter.

Abstract: A system for implanting a catheter in a urethra. The system includes a catheter having a valve disposed at a distal portion of the catheter. The valve may be operable in response to an external magnetic field. The system also includes a tool having a tip member extending into an opening at the distal portion of the catheter to couple the tool to the catheter. the system also includes an element extending from the tool. The catheter has an internal path that provides a conduit for the element to be extended through the valve to engage a proximal portion of the catheter. The tool is adapted use the element to stress the catheter and stiffen the catheter along the length of the catheter. Stiffening the catheter facilitates implantation of the catheter in the urethra by enabling pull forces, push forces, and torque forces to be transmitted from the tool through the catheter to the proximal portion of the catheter without undue stress on the urethra.

Abstract: A low profile stent device consisting of a stent plus an optional covering is placed percutaneously into a blood vessel to provide vascular closure to a nearby large diameter arteriotomy site. A self-expanding stent device is mounted onto a balloon for postdilitation and is held in a small diameter configuration by an outer case. A balloon expandable stent device has hinge and strut features that provide it with crush resistance. The cone and sheath of the deliver catheter serves as a dilator and introducer sheath to assist in delivery. An attachable guidewire reduces profile by eliminating a guidewire lumen. A locator balloon placed through the large diameter arteriotomy introducer sheath assists positioning.

Abstract: An electrical ablation apparatus comprises first and second electrodes. Each electrode comprises a first end configured to couple an energy source and a second end configured to couple to a tissue treatment region. An energy source is coupled to the first and second electrodes. The energy source is configured to deliver a first series of electrical pulses sufficient to induce cell necrosis by irreversible electroporation and a second series of electrical pulses sufficient to induce cell necrosis by thermal heating, through at least one of the first and second electrodes. The first series of electrical pulses is characterized by a first amplitude, a first pulse length, and a first frequency. The second series of electrical pulses is characterized by a second amplitude, a second pulse length, and a second frequency.

Abstract: Methods, devices and systems are described for treating venous insufficiency in which the vein is compressed at least partially along a treatment zone. A system can be provided including an injection device, such as a glue gun, that is operably connected to a delivery catheter that can be advanced across a treatment zone in the vein. The delivery catheter can be used to deliver one, two, or more boluses of media (e.g., cyanoacrylate) to occlude the vein along different spaced-apart sections of the treatment zone. External compression can also be applied to the vein by a compression element, such as a hand or multifunctional ultrasound transducer, to occlude portions of the vein along the treatment zone prior to or during the introduction of the boluses of media.

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: A balloon catheter having a shaft, a balloon, and an external delivery tube, as well as methods of use thereof. In one example, the balloon catheter is an agent delivery catheter including a catheter body extending between catheter proximal and distal portions. An inflatable balloon assembly is coupled with the catheter body. An agent delivery assembly, which is coupled with the catheter body and the inflatable balloon assembly, includes a delivery lumen extending through the catheter body and an agent delivery tube extending along an exterior balloon surface. The agent delivery tube includes at least one delivery orifice directed outside of the exterior balloon surface. The agent delivery assembly is isolated from fluid communication with the inflatable balloon assembly.

Abstract: Methods and systems are provided for a device having a first member and a second member coupled to the first member where the second member is configured to modify a configuration of a human or animal orifice or conduit. In some embodiments, the first member is a shaft and the second member is an inflatable membrane system configured to facilitate inflation or deflation of the inflatable membrane system. In some embodiments, the first member is a U-shaped member with end members configured for insertion to an internal nasal valve. Other embodiments are disclosed.

Abstract: A coupling device for connecting two ends of respective tubular members, allow the opening and the closing of a first tubular member and the simultaneous engagement of the two tubular members, as to prevent pollution, includes: a first case housing a first end of a respective first tubular member, comprising closing means of said first end; a second case, wherein a flexible terminal section of a respective second tubular member is received, comprising means for driving a second end of said second tubular member from a retracted position to a engagement position into said first end and vice versa; and means for reversibly connecting said first and second cases at a respective coupling port thereof, defining a single sealed environment; wherein the engagement and the disengagement of said second end and the automatic mechanical activation and deactivation of said closing means for opening and closing said first end.

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: A balloon dilation catheter includes a substantially rigid inner guide member and a movable shaft coupled to a balloon that is slidably mounted on the substantially rigid inner guide member. To treat a sinus cavity of a subject using the balloon dilation the substantially rigid inner guide member is advanced into a drainage pathway of the sinus (e.g., frontal recess) of the subject via a nasal passageway. The shaft and balloon are advanced in a distal direction over the substantially rigid inner guide member to place the balloon in the drainage pathway. The balloon is inflated to expand or otherwise remodel the drainage pathway.

Abstract: The present invention is directed in various methods, devices and systems relating to providing a balloon on a sheath in combination with orbital atherectomy in order reduce the number of steps in the procedure. In certain embodiments, the balloon comprises adjunctive low pressure balloon for prevention of vessel trauma during dilatation.

Abstract: This invention describes the administration of multiple therapeutic agents with insulin in conjunction with bexarotene, ketamine, monoclonal antibodies Etanercept, IGF-1, and acetylcholine esterase inhibitors physostigmine, for treatment of Alzheimer's disease and other neurodegenerative diseases. Insulin, improves memory; also augments and amplifies the effects of the adjuvant therapeutic agents (paracrine and intracrine effects) and consequently reduces the ? amyloid, its soluble precursors, prevents damage to the neuronal skeletal network (taupathy), and blocks glutamate excitotoxicity, reduces brain inflammation, prevents apoptosis, and increases the acetylcholine levels in the neurons and synapses; by using a combination of insulin, bexarotene, ketamine, Etanercept, IGF-1, and physostigmine therapeutic agents.

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

Abstract: The invention relates to a method for producing a bioactive surface on the balloon (3) of a balloon catheter (1). According to said method, the surface of the balloon (3) is at least partially wetted with a first solution of an active substance (8) and the section of the surface of the balloon (3) wetted with the first solution of an active substance (8) is then wetted with a second, saturated solution of the active substance (28). The invention further relates to a balloon (3) of a balloon catheter (1) the surface of which is at least partially coated with an active substance (11), the coating (11) being homogeneous and brittle in the entire coated region.

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: A catheter has a shaft that defines a delivery lumen, for example, to deliver an elongate medical device therethrough; a proximal section of the catheter includes a seal zone portion, a handle portion and a proximal port portion. A relatively thin wall section of the proximal port portion extends between the seal zone portion and a proximal edge that defines part of a perimeter of a proximal opening of the delivery lumen. The handle portion projects laterally from the seal zone portion, generally opposite the relatively thin wall section. An inflation subassembly of the catheter includes a compliant sleeve member and an inflation lumen extending from the sleeve member, proximally along the shaft, and into a connector port formed in the handle portion. The inflation lumen may be formed by fusing a section of a tube to the shaft and molding the handle portion around another section of the tube.

Abstract: An inflatable balloon cuff may be adapted to seal a patient's trachea when associated with an endotracheal tube. These cuffs may include indicia that facilitate attachment of the cuff relative to the tube to reduce manufacturing variability for such characteristics as rotational and length alignment. Such indicia may include protrusions that are formed in the wall of the cuff collars or may include visual indicators, e.g., colorimetric or shape-wise indicators. Cuffs with improved attachment relative to the tube may have increased sealing performance.

Abstract: This invention relates to a method that comprises the introduction of a catheter via left subclavian vein, advancing into the right atrium and then positioning it in the inferior vena cava, just at the cava-diaphragm junction, where it is anchored at its extreme; and thereafter an external inflation of a balloon positioned in said catheter takes place through a physiological solution to reach a diameter corresponding to half the diameter of the inferior vena cava, resulting in hemi-occlusion in the expiration phase (breath-out) and total occlusion for a short period during the inspiration phase (breath-in), regulating (normalizing) the venous return and decreasing the cardiac volume overload, as a treatment for heart failure. The invention also comprises hydromechanics devices to normalize the venous return in the circulatory system. Said venous return is increased in 90% of patients with heart failure.

Abstract: A non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon. The non-compliant medical balloon is composed of a woven fabric layer composed of at least two woven fabric fibers forming an angle. The angle remains substantially unchanged when the balloon changes from a deflated state to an inflated state.

Abstract: The present invention relates to devices and systems that alter intracranial compliance, cerebral blood flow and/or intracranial pressure pulsatility/waveform by oscillating the contraction and expansion of a compressible composition within the cranial or spinal cavities such that they increase intracranial capacity. The contraction and expansion of the compressible composition in the oscillating compliance devices can be due to an individual's intracranial pressure, the result of the expansion and compression of a reservoir which is mediated by the contractility of the heart or driven by a pump gaited to a biorhythm. The invention also relates to methods for protecting an individual's brain from abnormal arterial pulsations and for altering an individual's cerebral blood flow using the devices and systems of the invention.

Abstract: The present invention relates to the regional delivery of therapeutic agents for the treatment of vascular diseases wherein regional delivery refers to delivery of a therapeutically effective amount of the therapeutic agent to an area of the vessel that includes not only afflicted tissue but non-afflicted tissue at the periphery of the afflicted tissue as well.

Abstract: Methods and percutaneous devices for assessing, and treating patients having sympathetically mediated disease, involving augmented peripheral chemoreflex and heightened sympathetic tone by reducing chemosensor input to the nervous system via percutaneous carotid body ablation.

Abstract: Balloon catheter, guide catheter and method for dilating openings in paranasal sinuses. A non-removable guide member (e.g., guidewire) extends from the distal end of the balloon catheter. The non-removable guide member initially passes through the opening of the paranasal sinus and is followed by the catheter body on which the balloon is mounted. The balloon is then inflated causing dilation of the opening of the paranasal sinus. In some embodiments, the non-removable guide member may be shapeable so that the operator may place the non-removable guide member in a desired shape prior to insertion of the balloon catheter. In some embodiments, the length of the non-removable guide member may be adjustable such that the operator may adjust the length of the non-removable guide member prior to insertion of the balloon catheter.

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: The embodiments herein provide an atraumatic urinary catheter. The atraumatic urinary catheter has a first tubule, a second tubule and a third tubule. The first tubule is provided with a first channel and a second channel. The first channel is wide and extended from a proximal end to a distal end of the first tubule and the first channel is open in both ends. The second tubule comprises a third channel, which is connected to a bladder cavity. The third tubule placed on the first tubule and the second tubule as a cover, to form a catheter's balloon. In order to avoid balloon explosion, the sterile water in the balloon is drained by the self-retaining mechanism of the catheter to prevent an irritation and tissue traumatization.

Abstract: A catheter having an elongated shaft which has a multilayered distal tip with a first layer formed of a polyimide first material and a second layer formed of a polymeric second material. In one embodiment the multilayered distal tip is a separate member, distal to the distal end of a proximal portion of the shaft. In another embodiment, the shaft has an outer tubular member, and a multilayered inner tubular member with a distal end which forms the multilayered distal tip of the shaft. In a presently preferred embodiment, the polyimide material is a thermoset polyimide. In one embodiment, the polymeric second material is a polyamide material.

Abstract: Disclosed is an access catheter, having a distal segment which is moveable from a reduced outside diameter for positioning at a target site, and an enlarged outside diameter to create an enlarged internal working lumen. In one application, the catheter is configured for use as an intracranial aspiration catheter. Methods are also disclosed.

Abstract: An apparatus is presented for use with a biologically-compatible-fluid pressure source.

Abstract: Balloon systems for treating bifurcated lumens include desirable burst and folding characteristics. In some cases, the balloon systems can be formed by varying the wall thickness of a balloon parison.

Abstract: The present invention provides a kit for the delivery a therapeutic agent to an organ blood flow and the removal of the excess of said therapeutic agent from said organ blood flow, said kit comprises: (a) the therapeutic agent, (b) a first retrievable medical device (26), for delivering said therapeutic agent into the organ inflow, (c) a second retrievable medical device for isolating the organ outflow vessel and (d) a separation device (25) comprising at least one filter able to separate the therapeutic agent excess from the organ outflow, having an inlet (38) for the organ outflow having a therapeutic agent excess and an outlet (39) for filtered organ outflow.