Abstract: Disclosed herein is a catheter for plaque stabilisation by cryotherapy, the catheter comprising: a first tube with a first end for receiving a flow of a coolant and a second end for supplying the flow of the coolant to a cooling element; a second tube, with a first end and a second end, wherein the second end of the second tube is configured to receive a flow of the coolant from the cooling element such that the second tube provides a flow path of the coolant from the second end of the second tube to the first end of the second tube; an inflatable flexible heat transfer element on the outer surface of the catheter; and a conduit for supplying an inflation fluid for inflating the flexible heat transfer element, wherein, when the flexible heat transfer element is inflated by the inflation fluid, the cooling element is configured to be within the balloon and in thermal conductivity with the inflation fluid; wherein the cooling element comprises an elongate tubular wall defining an elongate cooling chamber therei

Abstract: Methods and apparatus are provided for renal neuromodulation using a pulsed electric field to effectuate electroporation or electrofusion. It is expected that renal neuromodulation (e.g., denervation) may, among other things, reduce expansion of an acute myocardial infarction, reduce or prevent the onset of morphological changes that are affiliated with congestive heart failure, and/or be efficacious in the treatment of end stage renal disease. Embodiments of the present invention are configured for percutaneous intravascular delivery of pulsed electric fields to achieve such neuromodulation.

Abstract: Medical devices and methods for delivering fluid. The medical devices include one or more needles for delivering fluid. The methods may optionally include expanding an expandable member such as an inflatable member to expand an expandable scaffold outward toward a lumen wall. The devices may include one or both of one or more spine securing members or one or more needle alignment members.

Abstract: A medical balloon device includes an outer member extending along an axis. An inflatable member has a proximal end extending from a first end of the outer member and a distal end. An inner member is positioned within the outer member and the inflatable member such that a first end of the inner member is coupled to the distal end of the inflatable member. A support member is movably disposed within the inner member and includes a first end configured to removably engage the first end of the inner member. Translation of the support member along the axis causes the inflatable member to move between a first position in which the inflatable member has a first length and a first profile and a second position in which the inflatable member has a second reduced length and a second reduced profile. Methods of use are disclosed.

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: Disclosed is a system and method for the placement of elongate medical members within a patients body using coaptive ultrasound. In a particularly preferred embodiment, a flexible tube includes a first balloon at a distal end of the tube, and a second balloon at the distal end of the tube and positioned within the first balloon. The first and second balloons are inflatable to form one or more echogenic windows between them, which echogenic window may be detected from within a patient's body by an ultrasound probe that is external to the patient's body. Detection of such echogenic window is used to identify an acceptable location on the patient's body at which to insert a guidewire configured to receive an elongate medical member without damage to surrounding patient tissues or organs.

Abstract: A device for emptying stool from the rectum of a patient by means of a shaft body which is introduced into the bowel via the anus and is able to buckle or fold axially and radially, and which is provided with a dumbbell- or hourglass-shaped balloon body for assuring the transanal positioning of the device. The invention is further characterized by the special design of and choice of material for the shaft body and the balloon envelope and by the specific positioning of the balloon body on the shaft body, wherein the axial deflection of the free forward end of the shaft body is limited or an uncontrolled deflection of the shaft is prevented, and the probability of perforation of the bowel wall under the effect of force acting on the shaft body from an axial direction is therefore decisively reduced by the intestinal tube described according to the invention.

Abstract: Balloon catheter devoid of guidewire or guidewire lumen and having a proximal shaft with only a single continuous lumen. A coil assembly is mounted at its proximal end to the distal end of the proximal shaft defining an interface therebetween. Disposed about a distal section of the proximal shaft and a proximal section of the coil assembly is a sleeve. A balloon, having a vent hole, forms a proximal leg seal about an outer surface of a distal end of the sleeve and an opposite distal leg seal. The sleeve covers the interface and extends axially in a distal direction terminating underneath the proximal leg seal of the balloon. A distal section of the coil assembly at least partially coincides with the distal leg seal of the balloon. A wire member secured at a plurality of connection points along the coil assembly extends axially within the balloon.

Abstract: A catheter for centrally crossing an occluded blood vessel includes a catheter body having a distal end, a proximal end, and a central passage. A rotatable drive shaft extending through the central passage and has a distal end, a proximal end, and a central lumen. A cutting tip is mounted on the distal end of the rotatable drive shaft and configured to cut through occlusive material when rotated. A plurality of spiral or other flat springs is disposed circumferentially about a distal portion of the catheter body to maintain centering of the catheter and form a passage as the catheter is advanced through a chronic total occlusion.

Abstract: A system for removing an obstruction from a blood vessel. The system can include a catheter with a proximal section with a proximal section lumen diameter, a distal section with a distal section lumen diameter less than the proximal section lumen diameter, an intermediate section extended between proximal and distal sections. The system can include a clot retrieval device with a clot engaging element. The system can include a shaft being advanceable through the lumen of the catheter the obstruction of the blood vessel, the shaft can include a shaft proximal section; a shaft distal section attached to the clot engaging element and configured to cross the obstruction, a diameter of the shaft proximal section being greater than a diameter of the shaft distal section thereby inhibiting the shaft proximal section from distally advancing through the catheter distal section.

Abstract: A guidewire includes a guidewire shaft and an inflatable element arranged at a distal end of the guidewire shaft. At least a portion of the guidewire shaft is formed of metal, and the guidewire shaft includes a lumen that fluidly communicates with an interior of the inflatable element. The inflatable element is operable to transition between a deflated state in which the inflatable element is configured to pass through an isthmus of a Eustachian tube (ET), and an inflated state in which the inflatable element is configured to dilate the ET.

Abstract: A system and method are provided for treating an aneurysm or other vessel disease or defect. The present disclosure includes an expandable device for placement in a vessel, where the mechanically expandable device includes a membrane. Also disclosed is a delivery device constructed and arranged to position the expandable device such that the exterior surface of the expandable device engages with the inner surface of the vessel and maintains a fluid pathway through said vessel.

Abstract: An apparatus for performing a medical procedure includes a balloon with a variable profile. The balloon includes at least one inflatable chamber occupied by a fluid, such as air, and solids, such as generally spherical balls. When the chamber is inflated, the solids are spaced apart as a result of their ability to move or flow, but when the chamber is evacuated, the solids become compacted and prevent it from fully collapsing. The balloon may have a plurality of inflatable chambers with solids in different arrangements to achieve different objectives during the medical procedure, such as for example stent deployment. For example, one chamber may be expanded while the other is restrained to alter the balloon geometry, such as for providing focused force or permitting perfusion.

Abstract: A medical probe includes a hollow guidewire, a balloon, and a magnetic position sensor. The hollow guidewire is configured for insertion into a channel of an organ of a patient. The balloon is fixed to a distal end of the hollow guidewire, is configured to be inserted into the channel using the hollow guidewire, and is further configured to be inflated by pumping of fluid through the hollow guidewire. The magnetic position sensor is fitted at the distal end of the hollow guidewire.

Abstract: The present invention relates to devices for treating or managing fecal or bowel incontinence and methods employing them. In an embodiment, such a device can form a seal with at least a portion of the bowel to prevent unwanted discharge of fecal matter from the rectum.

Abstract: A catheter a first sheath having a proximal end and a distal end, and a length extending between the proximal end and the distal end. The first sheath being devoid of any bonds between the proximal end and the distal end, and a flexural modulus of the first sheath varying along the length. A method of making a catheter having more than one flexural modulus.

Abstract: A catheter device is disclosed for transvascular delivery of a medical device to a cardiac valve region of a patient. The catheter device comprises an elongate sheath (2) with releasable locking members for controllably locking the elongate sheath in a shape at least partly along its length from a relaxed state to a locked state when positioned in relation to a cardiac valve. Furthermore, alignment members (5) are provided to provide for a desired positioning in relation to the cardiac valve. Embolic protection (8) is further provided.

Abstract: An inflatable structure for use in biological lumens and methods of making and using the same are disclosed. The structure can have an inflatable balloon formed into a plurality of cells encircled by a shell. A strap can extend between the cells. The shell can have proximal and distal tapered necks, longitudinally-oriented flutes, and apertures at the proximal and distal ends of the shell. The shell can include a reinforcement having tapered sections over the necks and strips extending between the tapered sections. A semi-compliant or compliant balloon can be placed around the outside of the inflatable structure.

Abstract: Catheter systems of the invention are directed to the removal of occlusions, such as thrombi and plaque, within blood vessels. In certain aspects, catheter systems of the invention include an elongate body defining a first lumen and comprising a distal portion, an inner member configured for insertion into the first lumen, the inner member comprising an energy source configured to deliver therapeutic energy to a treatment site; and a dissolution element coupled to the distal portion of the elongate body. The dissolution element may include a heating element, steam, and a balloon.

Abstract: A balloon dilation assembly for use in balloon valvuloplasty is disclosed, which includes at least three outer balloons arranged around a central balloon and fixed to the central balloon, wherein each balloon has a supply tube for inflation and flow channels are provided between each adjacent pair of outer balloons, whereby at least one of the outer balloons is shorter in length than the remaining outer balloons and the central balloon.

Abstract: Embodiments of the present invention provide a method for treatment of nonvascular body lumen strictures such as benign prostatic hyperplasia (BPH), urethral strictures, ureteral strictures, prostate cancer, esophageal strictures, sinus strictures, biliary tract strictures, asthma and chronic obstructive pulmonary disease (COPD). The method involves delivering, preferably via drug coated balloon catheters, of anti-inflammatory and anti-proliferative drugs (rapamycin or paclitaxel and their analogues) and one or more additives.

Abstract: A balloon catheter system and method for clearing blockage in the sinus ostium. The balloon catheter system and method employs a first balloon which dilates the sinus ostium while a second balloon removes an obstruction by resection. The system and method can then remove and/or drain any biological matter in the sinus. In some embodiments, the system employs an imaging device for viewing the anatomy and delivers irrigating and/or therapeutic agents to the sinus and/or sinus ostium.

Abstract: An apparatus for performing an endovascular procedure using ultrasonic energy includes a catheter with a proximal end portion and a distal end portion. The distal end portion includes a first window, which may expose a wave guide for delivering the ultrasonic energy for performing the endovascular procedure. A cover may be provided for selectively covering the window. By selectively controlling the position of the sheath, the transmission of ultrasonic energy may be regulated accordingly for providing a desired treatment regimen.

Abstract: A device and method for treating a patient with total or near total occlusion is provided. The device can be positioned in a blood vessel at a treatment site. An occlusion at the treatment site is enlarged by a catheter. The catheter can be advanced over a guidewire into the occlusion. One or more of [a] compression or torsion applied to the guidewire or [b] compression or torsion applied to the catheter body expands or creates a path through the occlusion. The expansions or creation of the access path can be by cutting or abrading the occlusion or by a shoe-horn effect.

Abstract: An ablation device includes a handle assembly including a distal end and a probe extending distally from the distal end of the handle assembly. The probe includes a heat-transfer portion and at least one fluid-flow path in fluid communication with the heat-transfer portion. The handle assembly includes at least one fluid reservoir in fluid communication with the at least one fluid-flow path and at least one apparatus configured to cause fluid flow between the at least one fluid reservoir and the heat-transfer portion. The probe is configured to apply thermal energy released by an exothermic chemical reaction that occurs when fluid from the at least one fluid reservoir is caused to flow to the heat-transfer portion.

Abstract: A medical-device position adjusting method includes inserting a guide wire farther forward than a lesion area of the body lumen from the port member; inserting an anchor device into the body lumen and fixing the guide wire to an inner wall surface of the body lumen by the anchor portion at a position farther forward than the lesion area; inserting the medical device from the port member along the guide wire to a position of the lesion area; and fixing the guide wire and the port member with the proximal-end fixing member, causing the guide wire to move in an insertion/pulling-out direction through the operation unit so as to change a path of the guide wire in the body lumen, and adjusting a position of the medical device in the lesion area.

Abstract: A spacer and implant assembly are disclosed, the spacer including an outer balloon that is folded so as to be dilatable, and an inner balloon that is folded so as to be dilatable, and that is removably inserted into the outer balloon. The inner balloon dilates in response to introduction of a dilating fluid having a lower viscosity than a viscosity of a filling material inserted into the outer balloon, and the outer balloon dilates in response to the dilation of the inner balloon.

Abstract: A balloon catheter is described, having a reinforced, co-axial, duel lumen design. At least one of the lumens is formed of a multilayer, tubular element in which one of the layers functions, in part, to provide radial reinforcement to the tubular element.

Abstract: A delivery system for stabilizing a catheter shaft across an aortic arch can include one or more stabilizing members configured to fix or stabilize the position of the catheter relative to the aortic arch of a patient.

Abstract: A microwave delivery device, including a coaxial feedline having an inner conductor, an inner dielectric insulator coaxially disposed about the inner conductor, and an outer conductor coaxially disposed about the inner dielectric, and a radiating portion operably coupled to a distal end.

Abstract: A system for removing obstructions from a blood vessel comprises a clot retrieval device and a catheter. The clot retrieval device comprises a clot engaging element attached to the distal end of an elongate shaft. The elongate shaft has a shaft proximal section, a shaft distal section and a shaft intermediate section between the shaft distal and proximal sections. The catheter has a catheter proximal section, a catheter distal section, and a catheter intermediate section between the proximal and distal sections. The maximum diameter of a shaft proximal section is greater than an inner distal lumen of the catheter distal section.

Abstract: A compression stent for applying a localized high stress against a blood vessel wall to cause vessel wall compression and blockage of sympathetic and nerve signal transmission within the wall of a blood vessel. The compression stent can also sever nerves located in the vessel wall. Blockage of sympathetic nerve signal transmission reduces hypertension and improves other clinical problems that are associated with sympathetic nerve signals.

Abstract: The invention provides a guidewire with a centering mechanism. The mechanism lifts the guidewire from a vessel wall and biases it towards the center of the vessel. Since the guidewire can be selectively lifted away from the vessel wall, scraping the catheter against the wall can be avoided, the tip can be guided into the correct branch of a bifurcation, and an imaging device can be used to its full potential. In certain aspects, the invention provides a guidewire with an elongated shaft with a proximal portion and a distal portion comprising a distal tip. One or more centering mechanism can be provided on a guidewire.

Abstract: The present disclosure provides a processing method for a polymer material to create a medical device with improved mechanical properties. This method allows better tailoring of the material's mechanical properties, hence a device to withstand greater structural loads in vivo. The method comprises providing an extruded polymer tube having an initial diameter and an initial length along a longitudinal direction, and longitudinally, bi-directionally straining the extruded polymer tube in a mold from the initial length to an expanded or extended length. The mold comprises a plurality of stationary heating elements. After longitudinally straining the tube, it is radially expanding in the mold from the initial diameter to an expanded diameter.

Abstract: A method of dilating a first Eustachian tube (ET) and a second ET of a patient using a dilation catheter includes directing the dilation catheter into the mouth of the patient and advancing the dilation catheter into a first ET on one side of the patient's head while a proximal portion of the dilation catheter is disposed in the mouth of the patient. The method further includes expanding the expandable member to thereby dilate the first ET. The method may further include repositioning the dilation catheter relative to a second ET on another side of the patient's head and advancing the dilation catheter into the second ET while a proximal portion of the dilation catheter is disposed in the mouth of the patient. The method may further include expanding the expandable member to thereby dilate the second ET.

Abstract: Coronary sinus cannulation apparatus and methods relating to tissue visualization catheters that can locate and/or cannulate a morphological feature within a body lumen, such as the coronary sinus, are described. Such devices can also perform a variety of therapeutic tissue treatments under direct in vivo visualization thereafter. Moreover, such apparatus and methods may also be utilized with guidewires to facilitate delivery into the coronary sinus to eliminate repositioning of the device and/or repeating an entire sequence of operations, consequently improving procedure effectiveness and reducing procedure time.

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 catheter having a tubular body and a rotatable shaft disposed within a lumen of the tubular body. A cutting element is coupled to the rotatable shaft, the cutting element having a cutting edge, the cutting element and rotatable shaft being longitudinally moveable within the tubular body between a stored position in which the cutting element is positioned distal of a side opening and a cutting position in which the cutting element is contained within the lumen of the tubular body and longitudinally aligned with the side opening. The cutting element is configured to extend through the side opening and to cut material from the wall of a vessel at a treatment site as the catheter is pulled proximally through the treatment site. The catheter may optionally have a rotating distal tip with an abrasive surface. The catheter includes a collection chamber positioned proximally of the cutting window.

Abstract: An implant is disclosed. The implant includes a reinforcement component attached to a sheet component. The sheet component is formed as a porous and fibrous material. The implant is adapted to be implanted on an area of a penis having Peyronie's plaques excised. The implant will elongate during erection of the penis and contract when the penis returns to a flaccid state. The reinforcement component includes a longitudinal rod and a transverse connector, with the longitudinal rod providing column strength to the implant and the sheet component providing support for penile tissue.

Abstract: A device and method for performing probing and intubation of the nasolacrimal system includes a tubular probe through which a tracer fluid is injected and collected in the nasal cavity to verify that the tip of the probe has passed through an obstruction and reached the nasal cavity. A sleeve fitted over the probe has distal segment that is inflated in order to retain the sleeve in the nasolacrimal system once the tubular probe has been withdrawn. Removal of blood and other obstructions encountered during the probing or intubation process is accomplished by connecting the proximal end of the probe to a suction device.

Abstract: A device and method for deploying an endoluminal sleeve is disclosed. The endoluminal sleeve has a proximal end that is rolled with a thread. The distal end is disposed about a balloon and can be expanded to contact the lumen wall. An adhesive holds the sleeve in place and the endoluminal sleeve is unrolled. The balloon is deflated and moved to a second location. The balloon is then inflated again expanding the endoluminal sleeve proximate the second location.

Abstract: Devices and methods for balloon delivery of rapamycin and other hydrophobic compounds to the wall of blood vessels. Balloon catheters, such as those used for balloon angioplasty, are modified with the addition of a reservoir of dry micelles, disposed at a suitable location within the balloon or catheter. The reservoir may be installed within the angioplasty balloon, within a lumen in communication with the angioplasty balloon, either as a loose or packed powder or as a film coating. The micelle preparation is reconstituted and the micelles are mobilized when the aqueous solution used to inflate the balloons is injected into the catheter. The micelles are infused into tissue surrounding the balloon when pressurized fluid within the balloon leaks through the wall of the balloon.

Abstract: A catheter hub includes a distal assembly including a distal hub member adapted to be fixedly attached to an outer catheter and a proximal assembly including a proximal hub member adapted to be fixedly attached to an inner catheter disposed through the outer catheter. An elongate member connects the proximal and distal assemblies such that the proximal and distal assemblies can translate longitudinally relative to one another.

Abstract: Methods and devices for maintaining vascular access and/or minimizing bleeding during percutaneous interventions. The method can include advancing an access wire through a previously placed access catheter in a contralateral femoral artery to position an inflatable balloon on the access wire in a vascular access sheath located in an ipsilateral femoral artery, without using any additional guidewires to advance the access wire. After withdrawing the vascular access sheath at least partway out of the ipsilateral femoral artery to expose the vascular injury, the balloon can be inflated to occlude the ipsilateral femoral artery or an ipsilateral iliofemoral artery at or near the vascular injury.

Abstract: New devices, systems, and methods are disclosed for preventing, treating, and/or at least minimizing ischemia and/or reperfusion injury by restoring and/or modulating blood flow, particularly in the cerebral vasculature where blood vessels are narrow and tortuous. These devices, systems, and methods make it possible for a clinician to adequately and systematically restore blood flow to ischemic tissue while simultaneously modulating the blood flow to minimize reperfusion injury. New thrombectomy devices and systems, which, for example, expand with greater radial force, further enable improved binding with clots and restoration of blood flow.

Abstract: A method of treating Peyronie's disease through implantation of a supporting structure in a penis suffering from a Peyronie's plaques affected area includes providing an incision in the penis and accessing the Peyronie's plaques affected area. The method includes excising plaque out of the Peyronie's plaque affected area and exposing exposed tissue of the penis, and placing an implant on the exposed tissue of the penis. The implant has a sheet component attached to a reinforcing component. The method includes positioning the implant allowing for tissue ingrowth into the sheet component and providing column strength to the exposed tissue of the penis with the reinforcing component of the implant, and securing the implant subcutaneously to the penis prior to closing the incision.

Abstract: A device and method to avert anal fecal leakage is disclosed that possess at least two means for the prevention of anal leakage or hemostatic application. The device is inserted internally and is used inside of the rectal cavity for absorption along with a sealing member placed externally against the anus which is designed as a secondary means for the prevention of leakage. An embodiment of the device includes a third sealing means to prevent leakage into the anal canal. The device is constructed to be flexible with a minimum of intrusiveness for the user during use. The device is constructed for one person insertion and removal unless patient or user is incapacitated. Due to its design, the device is capable for use over a wide range of human and certain animal applications.

Abstract: The biodegradable kyphoplasty balloon system includes a biodegradable balloon catheter and a delivery system. The biodegradable balloon catheter includes an elastomeric tube and a biodegradable balloon. The elastomeric tube has opposed open and closed ends with a resealable slit being formed in a central portion thereof. The elastomeric tube is formed from an elastomer such that the resealable slit acts as a one-way inflation valve. The biodegradable balloon is mounted on the elastomeric tube such that the biodegradable balloon is sealed thereto about the resealable slit for selective inflation thereof. The delivery system includes a hollow push tube and an inflation tube. The hollow push tube has opposed first and second open ends. The inflation tube has opposed open and closed ends, with an aperture being formed through the inflation tube adjacent the closed end thereof. The hollow push tube slidably receives the inflation tube.

Abstract: Pharmaceutically acceptable hydrogel polymers of natural, recombinant or synthetic origin, or hybrids thereof, are introduced in a dry, less hydrated, or substantially deswollen state and rehydrate in a physiological environment to undergo a volumetric expansion and to affect sealing, plugging, or augmentation of tissue, defects in tissue, or of organs. The hydrogel polymers may deliver therapeutic entities by controlled release at the site. Methods to form useful devices from such polymers, and to implant the devices are provided.

Abstract: Methods for cardiac ventricular restoration include delivering an implantable expandable device into the ventricle via a catheter. The expandable device is anchored either to the wall of the left ventricle or to the inter-ventricular septum and then expanded. When expanded, the device assumes a size and shape which fills the lower portion of the ventricular cavity restoring the normal volume and ellipsoid shape of the remaining portion of the cavity and favorably altering myocardial oxygen demand and wall stress.