Abstract: Embodiments herein relate to systems and methods for intravascular lesion disruption. In an embodiment, a catheter system for imparting pressure to induce fractures upon a vascular lesion within or adjacent a blood vessel wall is included. The system includes a catheter configured to advance to a vascular lesion, the catheter including an elongate shaft that defines at least a first orifice for fluid flow; a balloon, coupled to the elongate shaft, that surrounds the first orifice where the balloon can expand from a collapsed configuration suitable for advancing the catheter through a patient's vasculature to a first expanded configuration suitable for anchoring the catheter in position relative to a treatment site; and a propulsion system configured to propel a fluid from the first orifice toward the balloon wall to create an inertial impulse in a vessel wall to transfer momentum to the vascular lesion. Other embodiments are also included herein.

Abstract: An implantable apparatus for providing tumor treating fields to a target site is disclosed. The implantable apparatus includes an inflatable body having a longitudinal axis and a plurality of stimulation zones coupled to the inflatable body. The stimulation zones are configured to produce an electric field. Inflation of the body causes elongation of the body along the longitudinal axis.

Abstract: Described are means for the direct and continuous connection of a catheter to the lumen of any tubular anatomical structure, or ductus, without medically significant leakage. A port implanted at the body surface with piping to a periductal collar allows drug or radionuclide delivery that bypasses the upstream lumen. The port allows injection, infusion, aspiration, or attachment of an automatic ambulatory pump. A superparamagnetic nanoparticle carrier-bound drug, for example, can be introduced into the lumen to pass downstream until the particles, with or without the drug still bound, are drawn into the lumen wall by a magnetized jacket surrounding the ductus. Such constitutes a method of drug targeting whereby a segment of a vessel or the territory supplied by a branch of that segment can be circumscribed for exposure to the drug. A jacket with side-entry connector positioned in surrounding relation to a lesion requiring treatment can itself be magnetized.

Abstract: The invention relates to a method and apparatus for endoscopically shaping and standardizing the size of a sleeved stomach for use in gastric reduction surgery. The device and method standardize and streamline gastric reduction surgery, specifically vertical sleeve gastrectomy, providing a guide for creating the stomach reduction and also shaping a stomach which will maintain an appropriate structure post-surgery.

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 methods may include delivering a first fluid out of one or more needles, and delivering a secondary fluid (which may be the same type of fluid as the first fluid, or a different type of fluid) from the device without delivering the secondary fluid through a needle.

Abstract: In various embodiments, a device is provided comprising a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being the same or greater than the first pressure. In various embodiments, a method comprising fabricating a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being at or greater than the first pressure, disposing the balloon on an elongate member having a lumen, placing the lumen in fluid communication with an interior volume of the balloon.

Abstract: An apparatus, assembly and method for controlling release of a drug from a drug-eluting balloon during delivery of a drug-eluting balloon to a situs within a body. More particularly, the present invention relates to a diametrically expandable sleeve having a first non-diametrically unexpanded state in which drug retained on or in a drug-eluting balloon is protected from release by a sleeve and a second diametrically expanded state in which drug retained on or in the drug-eluting balloon is exposed for focal release in the body by diametric expansion of the sleeve, exposing openings in the sleeve during diametric expansion and closing the openings in the sleeve when the sleeve is in its diametrically unexpanded state.

Abstract: A medical device may include a tubular sleeve configured for implantation in a body lumen, the sleeve having a first configuration with a first rigidity and a second configuration with a second rigidity greater than the first rigidity, the sleeve including: a flexible membrane defining an interior lumen; and a channel extending along the membrane.

Abstract: A needle apparatus having a sheath with a protective hypotube insert and a method of making the needle sheath. An example needle apparatus includes a handle, a needle having a proximal end connected to the handle and a sheath. The sheath is configured to receive of the needle. The sheath includes a proximal end connected to the handle, a distal end, a lumen and the protective insert. The lumen passes from the proximal end to the distal end of the sheath. The protective insert is received within the lumen at the distal end of the sheath when force and/or heat are applied.

Abstract: A method of constructing an infusion set, patch pump, or element thereof, comprising the steps of mixing at least two of a solvent, an anesthetic, and a lubricant, applying said mixture as a coating to at least one surface of an infusion set, patch pump, or element thereof, and substantially removing said solvent after coating to provide at least one of an anesthetic layer and a lubricant layer upon said infusion set, patch pump, or element thereof.

Abstract: The present invention relates to a pharmaceutical composition for intravascular delivery of a therapeutic agent, such as paclitaxel, rapamycin, or an analog thereof. The composition includes the therapeutic agent and a biocompatible solvent, such as glycofurol. The composition can aid tissue penetration by the therapeutic agent. A catheter assembly that protects the pharmaceutical composition from the surroundings can be used for its intravascular delivery.

Abstract: Various aspects of the present disclosure are directed toward an embolic filter system. The embolic filter system generally includes a filter and an elongated element. In some examples, the elongate element extends to a position distal to a proximal end of the filter and operates to protect against medical devices entangling with the filter. In some examples, the elongate element is soft and compliant and operates with a hemostatic seal to provide for a hemostatic seal within a lumen of the elongate element while maintaining the lumen as a working lumen through which medical devices can be passed.

Abstract: A method for treating back pain in a patient in need of such treatment is provided. The method includes positioning a balloon catheter in or adjacent to a treatment zone containing a basivertebral nerve. A chemical denervation agent is administered with the balloon catheter such that the chemical denervation agent chemically ablates at least a portion of the basivertebral nerve. Kits, systems and methods are disclosed.

Abstract: A uterine manipulator includes a handle and a central shaft that extends distally from the handle. The central shaft includes a distal end portion supporting a balloon. The central shaft also supports a cervical cup. An occluder shaft is slidably supported on the central shaft. A non-inflatable plug is secured to the occluder shaft and configured to move with the occluder shaft as the occluder shaft slides along the central shaft.

Abstract: Self-righting articles, such as self-righting capsules for administration to a subject, are generally provided. In some embodiments, the self-righting article may be configured such that the article may orient itself relative to a surface (e.g., a surface of a tissue of a subject). The self-righting articles described herein may comprise one or more tissue engaging surfaces configured to engage (e.g., interface with, inject into, anchor) with a surface (e.g., a surface of a tissue of a subject). In some embodiments, the self-righting article may have a particular shape and/or distribution of density (or mass) which, for example, enables the self-righting behavior of the article. In some embodiments, the self-righting article may comprise a tissue interfacing component and/or a pharmaceutical agent (e.g., for delivery of the active pharmaceutical agent to a location internal of the subject).

Abstract: Catheter devices/systems and methods therefrom are described herein for treating acute kidney injury, especially in the reduction of contrast-induced acute kidney injury. The catheter devices, systems and associated methods may prevent contrast dyes from entering into the kidney and/or facilitate blood flow beyond the kidney by utilization of the catheter devices, systems and associated methods.

Abstract: The present disclosure provides for a medical device or a substrate coated with polydopamine which is further linked to ligands such as antibodies and/or antibody fragments. The polydopamine coating and the ligands may be linked through a linker such as an organic polymer.

Abstract: An embolization microcatheter having an elongated microcatheter body configured for passing therein a suspension of particles suspended in a suspension fluid; and a microcatheter head connected to a distal end of said microcatheter body and comprising a proximal head section and a distal head section, wherein the proximal head section includes a proximal wall forming a proximal section lumen, the proximal wall having a plurality of through-holes, wherein the distal head section includes a distal wall forming a distal section lumen, and a suspension delivery opening at a distal end of the distal end section; wherein the distal section is devoid of through-holes, and wherein each of the plurality of through-holes are shaped and/or sized to allow passage therethrough of the suspension fluid while blocking passage of the particles suspended therein.

Abstract: A non-occluding drug-coated balloon catheter device for use in a blood vessel transporting blood comprises a catheter shaft including a guidewire lumen, a fluid lumen and a connector port. A balloon is mounted on the catheter shaft and includes an outer envelope surrounding the guidewire lumen in fluid communication with the fluid lumen; a drug coating applied on the exterior surface of the outer envelope; and at least one bypass lumen forming a passage extending from the proximal end of the outer envelope to the distal end of the outer envelope. When the balloon is positioned in a blood vessel and inflated, the exterior surface of the outer envelope presses the drug coating against the blood vessel and the bypass lumen is open between the distal end of the outer envelope and the proximal end of the outer envelope such that blood transport continues through the bypass lumen.

Abstract: A system for endoscopic surgery within a body lumen of a patient including a flexible catheter having an expandable region at a distal portion and an access opening. The expandable region is expandable from a collapsed insertion configuration to an expanded configuration to provide an expanded chamber on a first side of the catheter. The access opening is positioned on a second side opposite the first side to provide a window to access target tissue. The catheter includes a lumen dimensioned to receive an endoscopic instrument therethrough such that a distal end of the endoscopic instrument is positionable within the expanded chamber and angled laterally within the expanded chamber to access the target tissue through the window.

Abstract: A vascular plug comprises a superstructure expandable from a collapsed percutaneous insertion configuration to an expanded deployment or use configuration. The superstructure incorporates a channel or passageway and a catheter extends through the channel or passageway from a proximal side at least to a distal side of the superstructure. The central channel allows for over-the wire plug delivery and a working aperture for secondary vascular interventions under flow arrest prior to final plug release. The plug includes spring-loaded mechanical elements or clotting-enhancement structure for closing the channel or passageway upon a withdrawal or removal of the catheter from the superstructure.

Abstract: At the present time, physicians often treat patients with atrial fibrillation (AF) using radiofrequency (RF) catheter systems to ablate conducting tissue in the wall of the Left Atrium of the heart around the ostium of the pulmonary veins. These systems are expensive and take time consuming to use. The present invention circular ablation system CAS includes a multiplicity of expandable needles that can be expanded around a central axis and positioned to inject a fluid like ethanol to ablate conductive tissue in a ring around the ostium of a pulmonary vein quickly and without the need for expensive capital equipment. The expansion of the needles is accomplished by self-expanding or balloon expandable structures. The invention includes centering means so that the needles will be situated in a pattern surrounding the outside of the ostium of a vein. Also included are members that limit the distance of penetration of the needles into the wall of the left atrium, or the aortic wall.

Abstract: Apparatus and methods for providing intrabronchial delivery of a treatment fluid to control the effects of a bronchial condition. The apparatus can include a shaft having proximal and distal ends and a fluid injection assembly disposed on the distal end. The fluid injection assembly can be a deployable needle assembly, a rotating needle assembly, a needle-less injection assembly, or a nebulizer assembly.

Abstract: The present invention concerns an organic cavity injection device including an injection cannula for injecting a photo-activatable substance inside an organic cavity; at least one element or a plurality of elements configured to control the removal of a resident substance from the organic cavity and simultaneously prevent removal of the non-activated photo-activatable substance from the organic cavity; and an optical waveguide for providing electromagnetic radiation inside the organic cavity to the photo-activatable substance to photoactive the photo-activatable substance inside the organic cavity.

Abstract: Embodiments of the present disclosure comprise occlusion and drug delivery devices and methods. One aspect of the disclosure comprises a drug delivery device comprising an inner expansion member and an outer drug delivery component. Another aspect of the disclosure comprises bioabsorbable, lumen-occluding implants.

Abstract: A medical device includes a vessel member, a port that couples a compartment interior of the vessel member to a region exterior of the vessel member, and a tubular member that defines a lumen. A distal end of the tubular member is attached to an internal surface of the vessel member within the compartment so that a portion of the internal surface of the vessel member provides a seal at a distal end of the lumen. The tubular member passes through the port, and the proximal end of the tubular member is configured to remain exterior of the compartment. A delivery of a sufficient amount of a filling material into the lumen of the tubular member causes a length of the tubular member to pass through the port and into the vessel compartment.

Abstract: The present disclosure relates generally to the use of medical devices for the treatment of vascular conditions. In particular, the present disclosure provides devices and methods for using electrically-induced pressure waves created within a sheath to disrupt vascular blockages via the sheath and/or a tip at the end of the sheath.

Abstract: The present disclosure relates generally to the use of medical devices for the treatment of vascular conditions. In particular, the present disclosure provides devices and methods for using electrically-induced pressure waves to disrupt vascular blockages. The present disclosure not only provides devices and methods for using electrically-induced pressure waves to disrupt vascular blockages, but the present disclosure also provides devices and method for assisting the guidewire in penetrating an occlusion, devices and method for using a sealable valve in the tip of the balloon catheter to reduce the overall size and diameter of the balloon catheter, thereby allowing the balloon catheter to penetrate smaller size blood vessels and devices. Given the persistence of coronary artery disease (CAD) and peripheral artery disease (PAD), there remains a need for improved therapeutic methods designed not only to reduce vascular blockages in the short term, but also to prevent future complications such as restenosis.

Abstract: A sterile liquid transfer assembly for use with a catheter assembly. The sterile liquid transfer assembly includes a protective element and a carrier element. The protective element includes a pliable, hollow protective valve member having a pivot cutaway portion. A tubular member of the protective element depends from a surface of the hollow protective valve member. The protective valve member is configured to define a stop for limiting the insertion of the tubular member in a canal of a patient.

Abstract: An irrigated ablation catheter includes a shaft having a proximal end, a distal end, and an irrigation lumen therein. The catheter further includes an electrode assembly coupled to the distal end of the shaft. The electrode assembly includes an ablation electrode and a manifold. The manifold is coupled to each of the distal end of the shaft and the proximal end of the electrode. At least a portion of the manifold is constructed of a flexible material to allow the electrode assembly to deflect. The manifold includes a body, an inner cavity within the body configured for fluid communication with the irrigation lumen, and an irrigation port also within the body and configured for fluid communication with the inner cavity. The irrigation port extends from the inner cavity to the outer surface of the body, and is configured to allow for an irrigating fluid to be distributed from the manifold.

Abstract: An irrigated ablation catheter includes a shaft and an electrode assembly affixed to a distal end of the shaft. The distal electrode assembly includes a manifold and an ablation electrode affixed together and extending along a center axis. The electrode has a distal irrigation passageway extending therethrough to an opening at a distal tip of the electrode. The opening of the irrigation passageway is offset in distance from the center axis, and allows a thermal sensor such as a thermocouple to be located in a sensor cavity in the electrode on or near the center axis. One variation involves providing a pair of distal irrigation passageways through the electrode where both of the openings of the passageways are offset from the center axis. The thermal sensor in this variation is located in the sensor cavity substantially on the center axis.

Abstract: A balloon catheter is provided that may be used to dilate hardened regions of a stenosis. The balloon catheter is provided with one or more dilation elements that extend along a surface of a balloon. Each dilation element is monolithically connected to an outer surface of the balloon by a connector. The connector is sufficiently sized and designed to undergo stress-induced plastic deformation incurred during blow molding so that a significant portion of each of the dilation elements does not become absorbed into the wall of the final blow molded balloon, thereby maintaining the structural integrity of each of the dilation elements. The dilation element has a flattened outer surface along at least proximal and distal neck portions of the balloon.

Abstract: A delivery device that allows for the sustained release of an agent, particularly useful for the sustained release of a therapeutic agent to limited access regions, such as the posterior chamber of the eye and inner ear. The delivery device is minimally invasive, refillable and may be easily fixed to the treatment area. The delivery device includes a hollow body with an inlet port at its proximal end for insertion of the agent, a reservoir for holding the agent and a delivery mechanism for the sustained delivery of the agent from the reservoir to the patient.

Abstract: Substance delivering spacer devices may comprise expandable reservoirs that are implantable in paranasal sinuses and other cavities, openings and passageways of the body to maintain patency and to provide sustained local delivery of a therapeutic or diagnostic substance. Delivery apparatus including elongate tubular members as well as shapeable distal portions and atraumatic tips are provided. Also provided are sinus penetrator devices and systems for performing ethmoidotomy procedures or for creating other openings in the walls of paranasal sinuses or other anatomical structures.

Abstract: An occlusive system for the vasculature and an embolic coil used in such an occlusive system is described. Also described is an occlusive plug which can be used for occlusive purposes within the vasculature.

Abstract: An apparatus and method for performing non-invasive treatment of the human face and body by electroporation in lieu of cosmetic surgery is provided. The apparatus comprises a high voltage pulse generator and an applicator having two or more electrodes in close mechanical and electrical contact with the patient's skin for applying the pulses to the patient's skin. The applicator may consist of two pieces with one electrode having a sharp tip and another having a flat surface. High voltage pulses delivered to the electrodes create at the tip of the sharp electrode an electric field high enough to cause death of relatively large subcutaneous fat cells by electroporation. Moving the electrode tip along the skin creates a line of necrotic subcutaneous fat cells, which later are metabolized by the body. Multiple applications of the electrode along predetermined lines on the face or neck create shrinkage of the skin and the subcutaneous fat volume underlying the treated area.

Abstract: Systems and methods for treating a blood clot positioned within a blood vessel are disclosed. In one embodiment, a balloon member is positioned on a distal end region of a catheter and an ultrasound emitting element is positioned within the balloon member and arranged for actively emitting ultrasound. In some exemplary embodiments, the disclosure provides a multi-wall balloon member and a multi-lumen catheter with at least one and/or all cavities of the balloon member arranged for heat transfer with the ultrasound emitting element. The disclosure also provides catheter arrangements with an ultrasound emitting element arranged to heat tissue adjacent to the balloon member. Additionally, in some embodiments, at least one and/or all walls of the balloon member have apertures arranged to release a therapeutic agent such as a thrombolytic drug.

Abstract: The disclosure pertains to an intravascular catheter, comprising an elongate member having a proximal end and a distal end, a balloon having an interior surface, an exterior surface, a lumen defined by the interior surface and a cylindrical wall extending between the interior surface and the exterior surface, the cylindrical wall having a proximal end and a distal end, the balloon having a plurality of weeping windows disposed in the wall and able to pass an electric current between the interior surface and the exterior surface and wherein the balloon wall is otherwise electrically insulative, and an electrode disposed in the balloon. The intravascular system is suited for modulation of renal nerves, for example.

Abstract: Systems and method for using a sleeve for enhanced drug delivery are described. The sleeve may incorporate porous materials and may be coated or treated with various drugs and/or therapeutic agents. The sleeve may be utilized in cooperation with balloon catheters and/or other devices. When acting as a reservoir for holding various drugs and/or therapeutic agents, the drug delivery sleeve provides a means of reducing drug losses as well as a controlled mechanism for drug release. The materials for the sleeve, constructed by various techniques, may be circumferentially distensible, may be elastic, and may have varying degrees of recoil as needed for any particular purpose.

Abstract: Embodiments of the present invention provide a device and a method for treating at least one of hypertension, pulmonary arteries, diabetes, obesity, heart failure, end-stage renal disease, digestive disease, urological disease, cancers, tumors, pain, asthma or chronic obstructive pulmonary disease by delivering an effective amount of a formulation to a tissue, In embodiments of the present invention, the formulation may include at least one of a gas, a vapor, a liquid, a solution, an emulsion, or a suspensions of one or more ingredients. In embodiments of the present invention, amounts of the formulation and/or energy are effective to injure or damage tissue, nerves, and nerve endings in order to relieve disease symptoms.

Abstract: An expandable medical balloon including an inner layer formed of a poly (ether-block-amide) copolymer and an outer layer formed of a polyamide, the expandable medical balloon having a burst strength of greater than 50,000 psi, and to methods of making and using the same.

Abstract: A drug delivery device is provided for directly treating a treatment site. The device allows body fluids to perfuse past the device while it is expanded to increase the amount of treatment time that is possible. The drug is delivered through a hollow helical tube that extends around a support structure. The hollow tube includes a series of lateral holes to allow the drug to directly reach the desired treatment site.

Abstract: Systems, devices, and methods for treating a patient having a sympathetically mediated disease associated at least in part with augmented peripheral chemoreflex or heightened sympathetic activation. The treatments include ablating one or more peripheral chemoreceptors or associated afferent nerves to reduce or remove afferent neural signals from the peripheral chemoreceptor.

Abstract: A delivery system for delivering and deploying a medical implant, such as a prosthetic heart valve, includes an elongated support member, a sheath, and a tip. The sheath is movable relative to the elongated support member between a distal position overlying the medical implant and a proximal position exposing the medical implant for release from the delivery system. The tip is attached to the elongated support member and is positioned at a distal end of the sheath when the sheath is in the distal position. The tip has a compressed condition and an expanded condition, and a maximum diameter in the expanded condition that is larger than the outer diameter of the sheath.

Abstract: An irrigated ablation catheter includes a shaft having a proximal end, a distal end, and an irrigation lumen therein. The catheter further includes an electrode assembly coupled to the distal end of the shaft. The electrode assembly includes an ablation electrode and a manifold. The manifold is coupled to each of the distal end of the shaft and the proximal end of the electrode. At least a portion of the manifold is constructed of a flexible material to allow the electrode assembly to deflect. The manifold includes a body, an inner cavity within the body configured for fluid communication with the irrigation lumen, and an irrigation port also within the body and configured for fluid communication with the inner cavity. The irrigation port extends from the inner cavity to the outer surface of the body, and is configured to allow for an irrigating fluid to be distributed from the manifold.

Abstract: A drug or agent coated balloon having a length which is adjustable in vivo is described herein. The balloon is configured to be coated or coatable with one or more drugs where the coating may be applied prior to advancement into a patient body or prior to balloon expansion within the patient body. The length of the expandable portion of the balloon is adjustable to approximate a length of the tissue region to be treated. Moreover, the drug-coated balloon may be used alone or it may be utilized to deploy luminal prostheses having one or more linked or otherwise coupled segments.

Abstract: The present disclosure is directed toward a semi-compliant to non-compliant, conformable balloon useful in medical applications. Conformable balloons of the present disclosure exhibit a low or insignificant straightening force when in a curved configuration and at inflation pressures greater than 4 atm. Balloons of the present disclosure are constructed of material that can compress along an inner length when the balloon is in a curved configuration. In further embodiments, balloons of the present disclosure can be constructed of material that sufficiently elongates along an outer arc when the balloon is in a curved configuration. As a result, medical balloons, in accordance with the present disclosure, when inflated in a curved configuration, exhibit kink-free configurations and do not cause a significant degree of vessel straightening.

Abstract: Described herein are methods and devices for delivering a drug to the frontal sinus system. An inflatable implant is positioned within the frontal sinus system using an anchoring means secured within the frontal sinus cavity. A drug-containing fluid is released directly into the frontal sinus drainage system.

Abstract: A balloon catheter is provided that may be used to dilate hardened regions of a stenosis. The balloon catheter is provided with one or more dilation elements that extend along a surface of a balloon. Each dilation element is connected to an outer surface of the balloon by a connector. The connector is sufficiently sized and designed to undergo stress-induced plastic deformation incurred during blow molding so that a significant portion of each of the dilation elements does not become absorbed into the wall of the final blow molded balloon, thereby maintaining the structural integrity of each of the dilation elements.

Abstract: Articulating balloon catheters and methods of using articulating balloon catheters are described herein. An embodiment of an articulating balloon catheter comprises an elongate member and a balloon. The balloon is attached to the elongate member and is adapted to move between a deflated configuration and an inflated configuration. The balloon has a proximal portion, a distal portion, and an articulating region disposed between the proximal portion and the distal portion. The articulating region of the balloon is configured to provide articulation between the proximal portion and the distal portion of the balloon.