Abstract: The apparatus includes a catheter having a combined infusion/aspiration lumen, a three lumen proximal portion and a two lumen distal portion. An infusion/aspiration valve located at the distal end of the catheter facilitates performing infusion and aspiration through the same lumen, which in turn reduces the number of lumens, and enables the combined infusion/aspiration lumen to be made larger without the need to increase the diameter of the catheter. Differing material properties in the proximal and distal portions of the catheter enable the proximal portion to be made stiffer for pushability, while the distal portion is more flexible to navigate tortuous vasculature and enable a greater amplitude agitator to be received within the catheter.

Abstract: A coaxial dual lumen pigtail catheter utilizes coaxial construction incorporating a thin wall guiding catheter technology for the outer lumen and using a strong braided diagnostic technology for the central lumen to accommodate high-pressure injections. The catheter includes a manifold body to provide for connection to each of the dual lumens. The distal end of the coaxial dual lumen pigtail catheter tapers to a more flexible portion that is perforated by spiral side holes to provide for more undistorted pressure readings in the left ventricle. The coaxial dual lumen pigtail catheter also utilizes proximal straight sideholes at the end of the dual lumen portion and a taper between the dual lumen portion and the single lumen portion.

Abstract: The present invention provides bariatric therapy systems. One system includes a gastrointestinal implant device and a delivery mechanism therefor. The device can include a sleeve for placement into a small intestine and to minimize absorption of nutrients by its walls. An anchoring mechanism coupled to a proximal end of the sleeve and designed to be secured within the stomach can be provided. A passageway extending through the anchoring mechanism and the sleeve can also be provided, along which food can be directed from the stomach to the small intestine. The delivery mechanism can include a housing for accommodating the device, and a deploying balloon situated within the housing and which can be actuated to direct the sleeve of the device from within the housing to the site of implantation. Methods for providing bariatric therapy are also provided by the present invention.

Abstract: A medical device for collecting cells includes an inflatable balloon and a perforated sleeve surrounding the balloon. The sleeve includes a plurality of openings therein for collecting cells when inserted into a body cavity. The balloon and sleeve can be housed in a sheath in a compressed delivery condition for being delivered to a target site for cell collection. The balloon and sleeve can then be inflated to expand into contact with the target site. The openings in the sleeve create a mildly abrasive surface for enhancing cell collection while limiting patient trauma. The balloon and sleeve can be reciprocated back and forth to collect cells from the surface of the body cavity. The balloon and sleeve having the collected cells can then be deflated and retracted from the body cavity.

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

Abstract: Methods and systems for regulating aortic regurgitation during aortic valve replacement or repair procedures utilize a temporary aortic valve (TAV) catheter and a controller. The temporary aortic valve catheter has an expandable occlusion device which can partially occlude the aortic lumen during ventricular diastole with a lesser occlusion during ventricular systole. Exemplary balloon structures include multiple, independently inflatable balloons which are inflated in synchrony with the cardiac cycle by the controller. By controlling aortic regurgitation, the repair or replacement protocols can be conducted with less interference from blood flow.

Abstract: A vascular occluder includes first and second baffle members which are formed of an expansion device such as a stent across which extends an impermeable membrane. The baffle members are held at a given separation by spacer elements. The separation creates a chamber between the baffle members in which the blood is able to stagnate, thereby creating a second occlusion barrier. One of the baffle members may have an aperture within its membrane for receiving a delivery catheter for delivery of thrombogenic agent into the chamber. The occluder has a given length, thereby making it suitable for implantation in difficult vessel sections and is also able to avoid problems of recanalization of the vessel which can occur with prior art occluders.

Abstract: Described herein are flexible implantable devices or stents that can, for example, navigate tortuous vessels of the neurovasculature. The devices can also conform to the shape of tortuous vessels of the vasculature. In some embodiments, the devices can direct blood flow within a vessel away from an aneurysm or limit blood flow to the aneurysm. Methods and structures are provided for adjusting, along a length of the device, the porosity of the device while maintaining a cross-sectional dimension. In some embodiments, a distal stent cover covers the distal end of the device and reduces friction between the stent and an inner surface of a delivery device, such as a catheter.

Abstract: Described are needleless injection systems and methods that involve features including one or more of a tissue tensioner and a fitting that includes or attaches to a shaft, exemplary embodiments including: an elastic sleeve sized to fit under tension about the distal end of a flexible scope, such as an endoscope; a non-metal, polymeric tube-like device being optionally attached to the elastic sleeve for delivering a therapeutic fluid to a treatment site within a patient wherein the elastic sleeve may include an integral balloon (tissue tensioner) feature that can be used to position the injection orifice of the tube-like device proximate a treatment area.

Abstract: The present invention relates to a catheter (1?, 1?) for intraluminal treatment which comprises a main tubular body (2) extending along a longitudinal axis (X) between a proximal end portion (2?) and a distal end portion (2?), which delimits at least one central lumen (4). The main tubular body identifies at least one balloon (8). The catheter further comprises at least one inner tubular body (6), at least partially housed in the central lumen, which delimits at least one inner lumen (16) for housing at least one guide wire, the portion of distal extremity of the balloon being joined to the inner tubular body. Furthermore, the central axis (Y) of the inner lumen is arched or undulated to form an accumulation of material for the expansion of the balloon. The present invention further refers to a method of manufacturing the catheter of the invention and to a machine for the production of a tool used during the aforesaid method.

Abstract: A device arranged to sustain and/or provide at least partial patency of a small blood vessel exhibiting an occlusion, the device constituted of a tubular body expandable from a first small diameter state for manipulation to, and through, the occlusion of the small blood vessel and a second large diameter state, the inner dimensions of the second large diameter state being no more than 50% of the diameter of the small blood vessel at the occlusion location, the device presenting a conduit for blood flow through the occlusion when in the large diameter state. In one embodiment the small blood vessel is an intracranial blood vessel.

Abstract: A catheter comprising a first lumen for receiving a guidewire and having an exit opening at a distal tip of the catheter. A second lumen, adjacent the first lumen and separated from the first lumen by a common wall, the second lumen configured for receiving contrast fluid, wherein perforations are formed in the common wall; a guidewire in the first lumen the guidewire being configured to be capable of advancement distally to extend out of the exit opening, the guidewire having two conditions: a first condition in which the guidewire is advanced distally to block the perforations whereby fluid may not flow from the second lumen to the first lumen; a second condition in which the guidewire is withdrawn proximally to unblock the perforations whereby fluid may flow from the second lumen into the first lumen and thence out of the exit opening.

Abstract: The invention relates to a device for the implantation of occlusion helixes (3) that can be separated by electrolysis in blood vessels and body cavities, especially aneurysms (12), said device comprising an insertion aid (4), at least one occlusion helix (3) that is distally arranged in relation to the insertion aid (4) and at least one electrolytically corrodible severance element (2), with at least one stabilization helix (5) being arranged between severance element (2) and occlusion helix (3) and said stabilization helix (5) being connected with the occlusion helix (3) by an electrically isolating adhesion layer (7) such that the occlusion helix (3) becomes isolated from the voltage when an electrical voltage is applied to the severance element (2).

Abstract: A device arranged to sustain and/or provide at least partial patency of a small blood vessel exhibiting an occlusion, the device constituted of a tubular body expandable from a first small diameter state for manipulation to, and through, the occlusion of the small blood vessel and a second large diameter state, the inner dimensions of the second large diameter state being no more than 50% of the diameter of the small blood vessel at the occlusion location, the device presenting a conduit for blood flow through the occlusion when in the large diameter state. In one embodiment the small blood vessel is an intracranial blood vessel.

Abstract: A catheter has a series of hollow loops arranged along a tube for carrying working fluid from a heat exchange system to exchange heat with a patient in whom the catheter is advanced. The loops when inflated are transverse to the catheter axis and parallel to each other, and circumscribe a hollow passageway through which blood can flow. Blood also flows around the outer perimeters of the loops.

Abstract: A medical system is provided, including a catheter body having a proximal portion and a distal portion; a shaft slidably disposed within a portion of the catheter body, the shaft defining a distal tip; a fluid injection tube coupled to the distal portion of the catheter body and the distal tip of the shaft, the fluid injection tube being transitionable from a first geometric configuration to a second geometric configuration; a membrane coupled to the shaft and enclosing at least a portion of the fluid injection tube therein; and a coolant source in fluid communication with the fluid injection tube. The first geometric configuration may be substantially linear, the second geometric configuration may be substantially helical, and the membrane may be tensioned across at least a portion of the fluid injection tube in the second geometric configuration.

Abstract: Systems, devices, apparatus and methods that may be used for en bloc circumferential esophageal mucosal resection or ablation that can extend over only a selected portion or all of the length of the esophagus.

Abstract: Balloon catheter includes an elongate tubular shaft having an outer tubular member having proximal and distal portions, and an inner tubular member having a distal length extending distally from the distal portion of the outer tubular member. The elongate tubular shaft has an inflation lumen and a guidewire lumen defined therein. The guidewire lumen extends along at least the distal length of inner tubular member. The balloon catheter also includes a distal end section coupled to a distal end of the inner tubular member and having a proximal end and a distal end. The balloon catheter also includes a balloon having a proximal portion sealingly coupled to the distal portion of the outer tubular member, a distal portion sealingly coupled to the distal end section, and a working length therebetween. The balloon defines an inner chamber. The proximal end of the distal end section is disposed within the inner chamber.

Abstract: A medical balloon includes a generally cylindrical barrel wall having proximal and distal ends disposed between tapered cone walls and neck walls with a fiber layer comprised of circumferentially wrapped ribbon-shaped fiber embedded in a continuous matrix of polymer material defining the tapered cone walls and barrel wall, wherein the distance between the fiber wraps defines a fiber pitch or density that varies over the working length of the barrel wall in non-linear increments, for example in step-wise increments over the length of the barrel wall.

Abstract: A balloon for catheter of the type that has a film body that is inflatable and deflatable using a fluid supplied from a catheter, the film body including a hard layer containing a polyamide and a flexible layer formed on the hard layer and containing a polyamide elastomer having a Shore D hardness that is not larger than 62, and the content of the amide units of the polyamide elastomer in the flexible layer is not less than 60 wt %.

Abstract: An angioplasty balloon having an elastic constraining structure that partially expands with the balloon so that, at maximum balloon inflation, the constraining structure forms a pattern of channels or “pillows” on the balloon.

Abstract: A surgical system including an expandable device is provided, including an inflatable body and a compliant sleeve. The compliant sleeve includes a distal end, a proximal end, and a cavity extending from the proximal end to the oppositely disposed distal end configured to receive a portion of the inflatable body. The cavity is defined by an inner wall and an outer wall of the compliant sleeve. The distal end of the compliant sleeve forms a closed portion of the cavity and the proximal end includes an opening.

Abstract: The invention relates to an implantable medical device. This implantable medical device (10) to be implanted at an implantation site comprises a proximal end (P), a central portion (C) and a distal end (D), characterized in that it comprises, at its proximal end (P), at least one means (20) for positioning the implantable device (10) at a precise point of a branching (E) of a blood vessel (V), such as a coronary artery. The invention provides precise, exact and almost perfect positioning of the implantable medical device 10 such as a stent 11 at the branching E of the blood vessel V to be treated, in order to treat the ostial lesions or stenoses that have been very difficult to treat until now.

Abstract: A subintimal recanalization catheter system for recanalizing a blood vessel. The system includes a support catheter and a balloon catheter configured to extend through the support catheter. The support catheter includes a tubular portion and an extension segment extending distal of the distal opening of the tubular portion. The balloon catheter, having a balloon secured to a distal portion thereof, is positionable through the tubular portion of the support catheter to position the balloon alongside the extension segment. The system is configured to be advanced into a subintimal space between a first tissue layer and a second tissue layer of a blood vessel wall where the balloon may be inflated against the extension segment to cause a distal portion of the catheter shaft of the balloon catheter to deflect toward the vessel lumen within the subintimal space to facilitate reentry into the vessel lumen.

Abstract: The present invention relates to a balloon catheter (10) as well as an applicator (50), particularly for invasive radiotherapy. The balloon catheter (10) provides a catheter shaft (11) for introducing a probe (40), a first, outer balloon (20) and a second, inner balloon (30), disposed inside the outer balloon (20), the inner space (31) of the second, inner balloon (30) connecting to a channel (32) for connection to a media inlet (41) and intermediate space (21) between the first, outer balloon (20) and the second, inner balloon (30) connecting to a channel (22) for connection to a media storage unit (42). In order that the balloon catheter can be securely controlled with respect to its shape and position in a patient in a simple but clear manner prior to irradiation, it is provided according to the invention that outer balloon (20) is formed of a flexible, non-extendible material and that inner balloon (30) is formed of a flexible, extendible material.

Abstract: A catheter assembly may be provided with a catheter body and an inflatable balloon. The catheter body has a proximal end, a distal end and a balloon inflation lumen. The inflatable balloon is attachable to the distal end of the catheter body. The balloon has an inner surface that at least partially defines an interior volume. The balloon is configured such that the interior volume can be in fluid communication with the inflation lumen of the catheter body to inflate the balloon. The balloon also has a proximal surface and a distal surface. The balloon is provided with a channel that extends through the balloon. The channel is configured to provide fluid communication between the proximal surface of the balloon and the distal surface of the balloon. Other catheter assemblies and methods of use are also disclosed.

Abstract: A system and associated method for manipulating tissues and anatomical or other structures in medical applications for the purpose of treating sexual dysfunction. In one aspect, the system includes a delivery device configured to deploy and implant anchor devices for such purposes.

Abstract: A balloon catheter includes an elongate support member defining first and second openings therein, open proximal and distal ends, and an axial lumen; and a balloon disposed on the elongate support member, the balloon defining a balloon interior through which the support member extends, where the balloon interior has a proximal end region, a middle region, and a distal end region, with the first opening located in the middle region, and the second opening located in the distal end region, such that the support member lumen is in communication with the balloon interior through each of the first and second openings, and such that a pressurized liquid introduced through the open proximal end of the support member will enter the balloon interior through the first opening, and subsequently exit the balloon interior through the second opening, back into the lumen, and out the open distal end of the support member.

Abstract: An ocular implant adapted to reside at least partially in a portion of Schlemm's canal of an eye. The implant includes a spine extending along a longitudinal axis of the implant, a plurality of curved supports extending from the spine, each support comprising a first end extending from a first location on a first side of the spine and a second end extending from a second location on a second side of the spine, the second location being proximal to the first location, so that each support forms a portion of a helix, the spine and supports defining a volume having a maximum width perpendicular to the longitudinal axis between 0.005 inches and 0.04 inches, the ocular implant being configured to bend preferentially in a preferential bending plane.

Abstract: A delivery system for delivery of an implantable stented device to a body lumen, the device having a plurality of structures at its proximal end, wherein the delivery system comprises a first body portion removably attached to a second body portion and wherein the second body portion includes a plurality of attachment components at its distal end for attachment to the plurality of structures at the proximal end of the device.

Abstract: Multilayer balloon for a catheter comprises a first layer made of a first polymer material having a first Shore durometer hardness, a second layer made of a second polymer material having a second Shore durometer hardness greater than the first Shore durometer hardness, wherein the second layer is an inner layer relative to the first layer, and a third layer made of a third polymer material having a third Shore durometer hardness less the first Shore durometer hardness, wherein the third layer is an inner layer relative to the second layer. Method of making a multilayer balloon for a catheter and a balloon catheter are also provided.

Abstract: Various methods for optimizing coating of medical devices, such as balloon catheters are disclosed. One method configures catheter balloon folds based on balloon diameter and volume. Other methods include using a specifically-sized protective sheath, using a vacuum, using pressure, pulling the balloon through a coating solution, using at least one spacer or a wick between at least one fold for metering a therapeutic coating into the folds of the balloon, placing an intermediate layer between the balloon and the therapeutic coating, placing a soluble film having a therapeutic agent around the catheter balloon or inside the folds, and any combination thereof. Balloon catheters and catheter balloons having a specific folding configuration, a specifically-sized protective sheath, an intermediate layer, or a soluble film are also disclosed.

Abstract: An assembly including an obstruction device including a proximal obstruction balloon and a distal obstruction balloon mounted on a shaft, the balloons being inflatable via an inflation lumen, and a delivery system that includes an insertion tool and an injection site assembly assembled with one of the balloons, the insertion tool including a connector which is connectable to the injection site assembly and which permits passing tools and injection fluid therethrough.

Abstract: A fistula catheter in which an intracorporeal fixing part comprises an inner balloon and an outer balloon is disclosed, whereby it is possible to prevent removal from the fistula by means of the inner balloon, even if the outer balloon deflates.

Abstract: A catheter system comprises a catheter having an elongate catheter shaft such that a portion of the catheter shaft proximal a stent retaining region defines at least one bend that is bent around the longitudinal axis of a vessel. The catheter also has a side branch guidewire housing, defining a side branch guidewire lumen, and a side branch guidewire that extends through the side branch guidewire lumen.

Abstract: Sizing an internal body structure in a patient includes guiding a sizing mechanism via a wire guide to a target location within the internal body structure, inflating a balloon of the sizing mechanism at the target location, and injecting a contrast fluid into the internal body structure. The inflated balloon blocks a flow of the injected contrast fluid to indicate that a size of the inflated balloon is accordant with a size of the body structure. Related apparatus is also disclosed.

Abstract: An intravascular snare device for use in capturing debris found in blood vessels. The snare device is fabricated from a tube and includes longitudinally and circumferentially extending members. The snare device specifically embodies structure that provides enhanced radial opening and angular resistance to collapse.

Abstract: The present disclosure relates to drug eluting devices, and their uses. The drug eluting devices can allow for perfusion during deployment. The coatings the may contain bioactive materials which elute once deployed in a patient and can have anti-proliferative, anti-inflammation, or anti-thrombotic effects. Sol gel technology can be used to coat the devices.

Abstract: An occlusion device delivery system can deliver an expandable coiled implant using a catheter. A distal portion of the catheter has proximal and distal apertures extending through a wall of the catheter. The expandable coiled implant is wound about the distal portion and has a proximal section that extends within the proximal aperture and a distal section that can extend radially within the distal aperture. Further, the system has an elongate member that extends through the lumen and engages and radially restrains the at least one of the proximal and distal sections within its respective aperture while engaged with the member.

Abstract: A balloon catheter having a pre-mounted recovery sheath for recovering an expanded device, such as an embolic protection device, in a patient's body lumen, and a method of using a balloon catheter system of the invention to recover the expanded device.

Abstract: A fluid delivery catheter that uses micro-needles for fluid delivery though a vessel wall. The catheter may provide fluid delivery therapy for various procedures, such as, for example, delivery of tumescent fluid or renal denervation. The catheter includes an elongate member with deployable and retractable needles disposed about a distal end of the elongate member. The needles may be disposed radially about the distal end and/or along a length of the distal end.

Abstract: A prosthetic valve is provided for implantation in a stenosed aortic valve. The prosthetic valve includes a radially collapsible frame configured for advancement through a patient's vasculature using a catheterization technique. A collapsible valvular structure is sewn to the frame for permitting blood to flow in only one direction. An internal cover extends along an internal surface of the frame. The internal cover forms a tubular sleeve positioned between a lower extremity of the frame and the valvular structure. The internal cover prevents the passage of blood through spaces between bars of the frame. An upper end of the internal cover is sutured to the valvular structure. The internal cover is preferably made of pericardium.

Abstract: An occlusion device delivery system and methods are provided in which an expandable coiled implant can be delivered using the delivery system. The system can comprise a catheter having a lumen extending between distal and proximal portions. The distal portion can have proximal and distal apertures extending through a wall of the catheter. The expandable coiled implant, which can be wound about the distal portion, can have a proximal section that extends within the proximal aperture and a distal section that can extend radially within the distal aperture. Further, the system can comprise an elongate member that extends through the lumen and engages and radially restrains the at least one of the proximal and distal sections within its respective aperture while engaged with the member.

Abstract: An integrated crossing balloon catheter. The catheter includes a hub assembly secured to the proximal end of the catheter shaft, an inflatable balloon secured to the distal end of the catheter shaft, and a stiffening tube positioned over the inflatable balloon and a distal end portion of the catheter shaft. The stiffening tube is configured to be advanced through a vasculature with the catheter shaft as a unit. The stiffening tube is translatable along the catheter shaft from a first position in which the inflatable balloon is within the stiffening tube to a second position in which the inflatable balloon is exposed from the stiffening tube.

Abstract: A stent delivery catheter including a catheter tubing defining a lumen therethrough, a balloon disposed near a distal end of the catheter tubing and moving between deflated and inflated states, and proximal and distal balloon control bands concentrically arranged around respective proximal and distal end portions of the balloon. The proximal balloon control band has a proximal end located proximally of a proximal end of the balloon and a distal end located adjacent a proximal end of a received unexpanded stent. The distal balloon control band has a proximal end located adjacent a distal end of the received unexpanded stent and a distal end located distally of a distal end of the balloon. The balloon control bands each have a diametric cross-section larger than the balloon in an uninflated state and the unexpanded stent received over the balloon to impede axial movement of the unexpanded stent off of the balloon.

Abstract: A balloon disposed near a distal end of the catheter tubing and moving between deflated and inflated states, and proximal and distal stent retention bands concentrically arranged around respective proximal and distal end portions of the balloon. The proximal stent retention band has a distal end located within 2 mm of the proximal end of a stent coaxially received by the balloon and the distal stent retention band has a largest diameter within 2 mm of the distal end of the stent received by the balloon.

Abstract: A system for treatment of a vessel bifurcation and its method of use comprises a catheter having a catheter shaft, a portion of which is characterized as an axle about which a rotatable assembly is disposed and rotatable thereabout. The system employs a series of lumens, openings and/or ports to provide a balloon mounted on the rotatable assembly with fluid communication to the catheter shaft.

Abstract: A stent arrangement which has at least a first ring (3) and zig zag struts (5) extending axially from the periphery of the ring. There can be first and second rings (3, 4) axially spaced apart and defining substantially parallel planes and a plurality of zig zag portions (5) between the first and second ring portions around the periphery thereof. The stent can be formed from a single wire or laser cut from a cannula and can be covered or uncovered.

Abstract: A balloon catheter system enabling balloon stretching and deflating, and balloon stretch-releasing and inflating operations to be performed at a time with a single operation. The system includes a catheter shaft including outer and inner tubes slidable to each other and a deflatable/inflatable balloon arranged between the distal ends thereof. A solution transport path is formed between the outer and inner tubes. Anterior and posterior tanks are arranged in a handle. The tanks and the inner tube passing through the central portion thereof are slidable to each other. Stopcocks are mounted in sliding portions between the inner tube and these tanks. These tanks are connected to the inside of the balloon via the solution transport path. A piston is provided inside the posterior tank. Thus, the inner pressures of these tanks change by reciprocating the inner tube fixed to the piston, thus simplifying balloon deflating and inflating operations.

Abstract: A medical device for blood flow restoration and/or for use as an implantable member in a human vessel includes a self-expanding member, a guidewire, and a connection mechanism. The self-expanding member includes a plurality of cells and filaments having specific ranges of thicknesses, widths, and heights. The self-expanding member can take on a volume-reduced coiled form with overlapped edges, and can generate optimal radial forces against a vessel wall and/or thrombus when deployed and expanded.