Abstract: A semi-compliant fiber-reinforced medical balloon having a folded wall thickness of from about 0.0010 to about 0.0060 inches and a rated burst pressure of at least 15 atmospheres and exhibiting compliance in the radial direction of from 0.5% expansion per atmosphere to about 1.0% expansion per atmosphere when pressurized from a fully inflated diameter to the rated burst pressure of the balloon includes a base balloon formed from a semi-elastic polymer material having an elongation to break of from about 10% to about 20%, a fiber layer is disposed over the base balloon with fibers having an elongation to break of from about 10% to about 20% and an outer layer formed from a semi-elastic polymer material having an elongation to break of from about 10% to about 20% disposed over the fiber layer.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the performance of procedures in the left atrium. The access route is through the inferior vena cava to the right atrium, where a trans-septal puncture, followed by advancement of the catheter is completed. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the right atrium and through the atrial septum into the left atrium. The distal end of the sheath is subsequently expanded using a radial dilatation device.

Abstract: A tool for engaging and withdrawing a wire guide from a patient includes a deformable distal segment having a self-expanding bias such that the distal segment assumes a tortuous configuration, and a control line attached to the distal segment and configured to extend through an intraluminal sheath, such that pulling the control line deforms the distal segment in opposition to the self-expanding bias to tighten about a wire guide. The tool may be withdrawn from the patient while tightened about the wire guide, such that the wire guide simultaneously extends out of the patient at each of a first and a second percutaneous entry point.

Abstract: Provided is a coated implantable medical device, comprising: a substrate; and a coating disposed on the substrate, wherein the coating comprises at least one polymer and at least one pharmaceutical agent in a therapeutically desirable morphology and/or at least one active biological agent and optionally, one or more pharmaceutical carrying agents; wherein substantially all of pharmaceutical agent and/or active biological agent remains within the coating and on the substrate until the implantable device is deployed at an intervention site inside the body of a subject and wherein upon deployment of the medical device in the body of the subject a portion of the pharmaceutical agent and/or active biological agent is delivered at the intervention site along with at least a portion of the polymer and/or a at least a portion of the pharmaceutical carrying agents.

Abstract: Embodiments of aortic occlusion devices are described herein that include radially expandable and collapsible proximal and distal end portions, such as annular self-expanding stents or frames, that are configured to radially expand within an aorta to secure the device within the aorta. The devices can also include a catheter extending axially between the distal end portion and the proximal end portion and a porous covering, or filter, positioned around the catheter and between the proximal end portion and the distal end portion and configured to filter emboli from blood flowing into upper-body arteries. The device can further include a one-way valve positioned at or adjacent to the distal end portion of the device and configured to restrict retrograde blood flow through the device toward the heart.

Abstract: Devices, systems and methods wherein a dilator, such as a balloon or other expandable member, is positionable within the frontal sinus ostium and adjacent frontal recess and useable to dilate the frontal sinus ostium and substantially all of the frontal sinus recess without requiring repositioning and repeated re-expansion of the dilator. One balloon catheter device of the invention comprises a catheter body that is less than about 50 cm in length (and in some embodiments less than 25 cm in length and a semi-compliant or non-compliant balloon on the catheter body. The balloon may have a working length of about 12 mm to about 30 mm and a width at its widest point when fully inflated of about 2 mm to about 7 mm. Such balloon may be constructed to withstand inflation pressures of about 12 atmospheres. In some embodiments, the dilator is advanced through or over a guide (e.g., guidewire or guide catheter) that has a preformed shape.

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

Abstract: An apparatus including a cannula having a dimension suitable for insertion into a blood vessel and an expandable body coupled thereto, the expandable body comprising a first expandable member and a second expandable member to isolate a length of the vessel upon expansion within the blood vessel. The expandable body having an intermediate expandable member along a working length between the first expandable member and the second expandable. A method including introducing a cannula and an expandable body coupled thereto into a blood vessel at a point coextensive with a treatment site and expanding a first expandable member and a second expandable member of the expandable body to isolate a length of the vessel adjacent the treatment site. The method further including delivering a treatment agent to a vessel region between the first expandable member and the second expandable member while inflating and deflating an intermediate expandable member.

Abstract: A system for examining a colon includes a catheter, such as a rectal catheter, having a proximal end, a distal end, and a central lumen extending from the proximal end to the distal end of the catheter, and a flexible tube coupled with the catheter. The system includes a first balloon located adjacent a distal end of the flexible tube, and a second balloon extending around the catheter and being located between the distal and proximal ends of the catheter, whereby the distance between the first and second balloons is adjustable by sliding the flexible tube through the central lumen of the catheter. The first and second balloons are inflatable for isolating a section of a colon, and a gas or contrast agent may be introduced into the isolated colon section for conducting the examination.

Abstract: A method and system for increasing the flow resistance of collateral pathways in the lung by employing aspiration to establish an artificial convective flow current between compartments in the lung in order to entrain and deliver a clogging agent preferentially to the collateral pathways. The method may sometimes be performed after lung has been assessed for the presence of collateral pathways.

Abstract: Disclosed are pharmaceutical compositions and methods for digesting atherosclerotic plaques in a patient in need thereof. The compositions include and the methods utilize a mixture of collagenases for digesting plaques and optionally may include or utilize additional agents such as cyclodextrins, chelating agents, and tissue plasminogen activator.

Abstract: This invention is directed to a method of treating a vascular disease involving administration to a patient by means of an angioplasty balloon a composition comprising a permeability-enhancing substance and a therapeutic agent.

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. 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: A medical device includes a substrate having at least a portion thereof functionalized with at least one reactive member and a chemotactic agent functionalized with at least one complementary reactive member. The at least one reactive member and the at least one complementary reactive member are covalently bonded, adhering the chemotactic agent to the substrate.

Abstract: Angioplasty and other dilatation devices are provided with scoring elements which incorporate a drug to be delivered to a body lumen, typically a blood vessel. The non-cutting scoring elements have drugs and other active substances coated over a portion thereof or incorporated within internal structure of the element so that the drug is released into the luminal wall closely associated diseased regions of the body lumen as the non-cutting scoring structure is radially expanded into the wall.

Abstract: A fixed wire dilatation catheter for treating the vasculature of a patient. The dilatation catheter includes an elongated member that has a distal end portion which can be elongated to puncture through blockages within the blood vessels. The dilatation catheter also includes an expandable device located along the elongated member at a location proximal the distal end portion of the elongated member.

Abstract: Methods and devices for providing improved ultrasound visibility of medical devices intended for intravascular use are described. The inclusion of gas/solid boundary regions within a medical devices improves the resolution of the device under ultrasound visualization. Gas/solid boundary regions may be provided through the use of embedded gas-filled microlumens, microwells, or enclosed pockets within the medical device.

Abstract: Disrupting tissue and devices and systems for disrupting tissue. The disclosure describes ways to deliver moieties to a target tissue, where the target tissue in general is not at the point of introduction, in such a way that minimal damage is produced in the tissue at the point of introduction. In some embodiments this is accomplished by jetting fluid at high velocity into the target tissue. The disclosure further describes novel agents deliverable in such systems for use in remodeling tissues. Some of these agents comprise a liquid while others do not. Additionally, although not specifically described in detail much of the disclosure may additionally be used in the delivery of therapeutic drugs.

Abstract: A medical device including an outer balloon, an inner balloon, and at least one delivery unit is disclosed. The outer balloon defines a first internal cavity that remains in fluid communication with a first inflation lumen. The inner balloon is disposed within the first internal cavity, and defines a second internal cavity that is in fluid communication with a second inflation lumen. Each delivery unit includes at least one needle configured to pierce a tissue and at least one reservoir containing a material. Further, inflation of the outer balloon or the inner balloon is structured and arranged to deliver the material into the tissue through the needle lumen.

Abstract: Disclosed are methods, devices, and systems for treating a body lumen with a sclerothepeutic agent. The method includes the steps of positioning a porous balloon assembly at a site in the lumen to be treated, inflating the assembly to establish a close approximation to the lumen wall, forcing the sclerotherapeutic agent to exit the pores and come in contact with the lumen wall, and to deflate and retrieve the balloon assembly. The methods, devices and systems disclosed herein are especially useful for the treatment of incompetent veins and their contributory branches.

Abstract: Methods and systems for fetal intervention to address malformations or other conditions are presented. In one instance, a method is provided that includes introducing a guide catheter into the fetus' venous system and using controlled magnets to position the guide catheter at a desired location. The method also involves positioning the treatment catheter at a treatment location using the guide catheter and delivering a treatment using the treatment catheter at the treatment location. In one particular application, a hypoplastic left heart is treated by using a balloon catheter as the treatment catheter and inflating a balloon on the balloon catheter at the aortic valve. Other methods and systems are disclosed.

Abstract: Embolectomy catheters, rapid exchange microcatheters, systems and methods for removing clots or other obstructive matter (e.g., thrombus, thromboemboli, embolic fragments of atherosclerotic plaque, foreign objects, etc.) from blood vessels. This invention is particularly useable for percutaneous removal of thromboemboli or other obstructive matter from small blood vessels of the brain, during an evolving stroke or period of cerebral ischemia. In some embodiments, the embolectomy catheters of this invention are advanceable with or over a guidewire which has been pre-inserted through or around the clot. Also, in some embodiments, the embolectomy catheters include clot removal devices which are deployable from the catheter after the catheter has been advanced at least partially through the clot. The clot removal device may include a deployable wire nest that is designed to prevent a blood clot from passing therethrough.

Abstract: Methods and devices described for improved catheters including those having a deflectable section to allow for expansion while maintaining flow through a vessel.

Abstract: Methods, devices, kits and compositions to treat a myocardial infarction. In one embodiment, the method includes the prevention of remodeling of the infarct zone of the ventricle. In other embodiments, the method includes the introduction of structurally reinforcing agents. In other embodiments, agents are introduced into a ventricle to increase compliance of the ventricle. In an alternative embodiment, the prevention of remodeling includes the prevention of thinning of the ventricular infarct zone. In another embodiment, the prevention of remodeling and thinning of the infarct zone involves the cross-linking of collagen and prevention of collagen slipping. In other embodiments, the structurally reinforcing agent may be accompanied by other therapeutic agents. These agents may include but are not limited to pro-fibroblastic and angiogenic agents.

Abstract: Systems and methods are provided for performing a medical procedure within a patient's body that involves a thoracic duct including an ostium communicating with the patient's venous system. An apparatus is provided that includes a catheter including proximal and distal ends and a lumen extending therebetween. An expandable sealing member is carried beyond the distal end that is expandable from a delivery condition to a deployed condition in which the sealing member defines a concave contact surface shaped for engaging a vessel wall surrounding the outlet of the thoracic duct. The sealing member includes an aspiration port in the contact surface communicating with the catheter lumen for removing fluid from the thoracic duct.

Abstract: A needleless injector including a body including a fluid chamber; an outer shaft extending from an outer shaft proximal end to an outer shaft distal end, wherein the outer shaft includes an outer shaft lumen to accommodate an injection shaft; an injection shaft located within the outer shaft lumen and moveable lengthwise and/or rotationally within the outer shaft lumen, wherein the injection shaft includes an injection shaft proximal end, an injection shaft distal end, an injection shaft terminus, and an injection lumen. The injector further includes an injection orifice at the distal end of the injection shaft and in fluid communication with the fluid chamber through the injection lumen; a pressure source in communication with the fluid chamber; and an optical device that allows viewing a location at a distal end of the device.

Abstract: An introducer sheath. The introducer sheath includes a tubular body. The tubular body extends from a distal end toward a proximal end. The tubular body includes a lumen. The lumen is defined at least partially by a wall. The tubular body includes a secondary channel. The secondary channel is disposed within the wall. The secondary channel is configured to receive a guidewire.

Abstract: The gradient coated stent 150 of the present invention provides a coated stent having a continuous coating 130 disposed on the stent elements. The continuous coating 130 includes a first coating component and a second coating component. The concentration of the first coating component varies continuously over at least part of the thickness of the continuous coating 130. The concentration of the second coating component can also vary over at least part of the thickness of the continuous coating 130. In one embodiment, the concentration of the first coating component decreases in the direction from the stent element towards the outer edge of the continuous coating 130 and the concentration of the second coating component increases in the direction from the stent element towards the outer edge of the continuous coating 130.

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: Intravenous access is achieved by introducing a catheter over an access needle which is initially present in the catheter. A tapered dilating element is positioned over the needle and provides a transition between the needle and a larger catheter lumen. The access needle is hollow and has a port which allows blood to flash back through a lumen of the catheter so that flashback can be observed on a catheter hub or the catheter itself.

Abstract: A method and device for local delivery of water-soluble or water-insoluble therapeutic agents to the surface of a normal or diseased body lumen is disclosed. An expandable structure of a medical disposable device, such as a balloon of a balloon catheter, is coated with an amphiphilic polymer coating comprising a therapeutic agent and an amphiphilic polymer or co-polymer. The medical disposable device is inserted into a body lumen, and expanded to contact the amphiphilic polymer coating against the body lumen. The total solubility of the polymer or co-polymer in vivo prevents any embolic hazard associated with the amphiphilic polymer coating.

Abstract: There is provided a catheter for providing a delivery substance to a bifurcated vessel, and isolating a treatment zone within the bifurcation. The catheter includes a proximal shaft and a first and second distal shaft positioned within the proximal shaft. The proximal shaft has a proximal occlusion element at a distal end thereof, the first distal shaft has a first distal occlusion element at a distal end thereof, and the second distal shaft has a second distal occlusion element at a distal end thereof. When the proximal occlusion element, and the first and second distal occlusion elements are deployed, a treatment zone is defined, and a delivery substance may be introduced into the treatment zone via the proximal shaft.

Abstract: A system for treating a blood clot includes a microcatheter extending through an optional aspiration catheter, and a guidewire subassembly extending through and beyond the microcatheter, the guidewire assembly having a guidewire, an element coupled to and extending around a portion of the guidewire, and a balloon coupled to and extending around the element. The balloon includes or is coupled to a proximal seal in contact with the inner surface of the microcatheter and has at least one radially arranged pore. Infusate flows through the microcatheter into the element and between the element and the guidewire, and out and into the balloon to pressurize the balloon. The infusate escapes the balloon through the pores.

Abstract: A system for moving particles suspended in a first fluid, and for infusing them into the stream of a second fluid, includes a catheter with a multi-lumen distal separator. The separator is formed with a plurality of parallel lumens, wherein each lumen has a predetermined diameter. Importantly, the diameter of each lumen is dimensioned to sequentially receive particles therethrough, to prevent the particles from flocculating before they enter the stream of the second fluid. A recollection chamber in fluid communication with the separator allows for reconsolidation of the fluid after leaving the separator and for minimizing the damage caused to the vessel when the fluid exits the catheter. An inflatable balloon, affixed to the outside of the catheter, can be provided to regulate flow of the second fluid and thereby facilitate entry of the particles into the stream of the second fluid and increase retention of particles in targeted tissue.

Abstract: A method for infusing a liquid into a patient's vasculature in accordance with an infusion protocol is disclosed. For this method, an infusion catheter having a multi-lumen infusion unit that is mounted adjacent the catheter's distal end is positioned in an artery within a predetermined distance from an intended target tissue surface. An inflation balloon is then deployed to at least partially occlude the artery and a force is exerted on the liquid to establish a flow rate for the liquid in the catheter. Specifically, the force is exerted to infuse the liquid from the catheter through the infusion unit and into the vasculature with a homogeneous distribution of the liquid to cover the intended surface of the target tissue. The flow rate can be established in accordance with an infusion protocol that is characterized by time and liquid volume parameters based on viscosity and pressure values in the liquid.

Abstract: The invention generally relates to carbon nanotube based drug delivery methods, devices, and compositions. More particularly, the invention relates to controlled drug delivery using anchored carbon nanotube arrays.

Abstract: A cannula assembly for directing blood from the heart of a patient and a minimally invasive method of implanting the same. The cannula assembly includes a flexible cannula body having a proximal end and a distal end with a receiving portion, and a transseptal tip having a distal end and a proximal end with an engaging portion. First and second anchors are coupled to the transseptal tip and configured to be deployed from a contracted state to an expanded state. The engaging portion of the transseptal tip is operable to removably engage the receiving portion of the flexible cannula body in vivo.

Abstract: A catheter and methods for luminal therapy are provided wherein a catheter has an outer balloon with a multiplicity of apertures for infusing one or more therapeutic agents into a vessel wall, an intermediate balloon having a multiplicity of apertures offset from the apertures of outer balloon to serve as a baffle that reduces jetting and promotes uniform distribution of therapeutic agent exiting through the outer balloon, and an impermeable inner balloon disposed within the intermediate balloon that enables the intermediate and outer balloons to be forced into engagement with the vessel wall to dilate the vessel and disrupt plaque lining the vessel wall and to also facilitate the uniform delivery of the therapeutic agent.

Abstract: Catheter devices for diagnosing and treating discogenic pain are provided. The catheter devices comprise a tubular body configured for insertion into an intervertebral disc and a pressure measuring device disposed along the length of the tubular body, the pressure measuring device configured to measure the pressure within the intervertebral disc. The catheter devices are capable of measuring the pressure within an intervertebral disc of a subject while the subject is moving.

Abstract: Sinusitis and other disorders of the ear, nose and throat are diagnosed and/or treated using minimally invasive approaches with flexible or rigid instruments. Various methods and devices are used for remodeling or changing the shape, size or configuration of a sinus ostium or duct or other anatomical structure in the ear, nose or throat; implanting a device, cells or tissues; removing matter from the ear, nose or throat; delivering diagnostic or therapeutic substances or performing other diagnostic or therapeutic procedures. Introducing devices (e.g., guide catheters, tubes, guidewires, elongate probes, other elongate members) may be used to facilitate insertion of working devices (e.g. catheters e.g. balloon catheters, guidewires, tissue cutting or remodeling devices, devices for implanting elements like stents, electrosurgical devices, energy emitting devices, devices for delivering diagnostic or therapeutic agents, substance delivery implants, scopes etc.

Abstract: A vena cava filter catheter includes a catheter having a lumen disposed therethrough and at least one strand of biocompatible wire. The at least one strand has a first state in which the at least one strand has an elongate geometry suitable for traversing the lumen of the catheter and a second state in which the at least one strand assumes a pre-set geometry in which the at least one strand assumes a tortuous configuration adapted to occupy a space approximating a luminal diameter of an inferior vena cava.

Abstract: Sinusitis and other disorders of the ear, nose and throat are diagnosed and/or treated using minimally invasive approaches with flexible or rigid instruments. Various methods and devices are used for remodeling or changing the shape, size or configuration of a sinus ostium or duct or other anatomical structure in the ear, nose or throat; implanting a device, cells or tissues; removing matter from the ear, nose or throat; delivering diagnostic or therapeutic substances or performing other diagnostic or therapeutic procedures. Introducing devices (e.g., guide catheters, tubes, guidewires, elongate probes, other elongate members) may be used to facilitate insertion of working devices (e.g. catheters e.g. balloon catheters, guidewires, tissue cutting or remodeling devices, devices for implanting elements like stents, electrosurgical devices, energy emitting devices, devices for delivering diagnostic or therapeutic agents, substance delivery implants, scopes etc.

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: Sinusitis, mucocysts, tumors, infections, hearing disorders, choanal atresia, fractures and other disorders of the paranasal sinuses, Eustachian tubes, Lachrymal ducts and other ear, nose, throat and mouth structures are diagnosed and/or treated using minimally invasive approaches and, in many cases, flexible catheters as opposed to instruments having rigid shafts. Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies and endoscopic studies.

Abstract: An anchoring mechanism and method for anchoring a device within a biological conduit include an expandable element configured for retaining the device at a desired angle relative to a central axis of the biological conduit. A steering mechanism is preferably provided for orienting the device prior to operation of the anchoring mechanism. The anchoring mechanism and method are employed in drug delivery devices, brachytherapy devices or for anchoring a catheter or sheath to provide a working channel for reliable guidance of a wide range of tools to a target location within the body.

Abstract: A medical balloon catheter including a shaft comprised of a cross-wound coil tube and a sleeve surrounding the cross-wound coil tube. The cross-wound coil tube includes a monofilament inner coil disposed within a monofilament outer coil. The inner and outer coils are wound in opposite pitch directions. In at least one embodiment, at least one of the inner and outer coils includes a tapered distal section having a tapered diameter. In at least another embodiment, the inner coil extends distally beyond the distal end of the outer coil, providing increased flexibility in a distal portion of the shaft. An inflation balloon is attached to the distal end of the shaft. The shaft includes an inflation lumen formed through the inner coil and a wire guide lumen formed through the distal portion of the shaft and extending through the chamber of the balloon.

Abstract: An integrated therapeutic and imaging device that uses at least two balloons to provide a guarded zone that can be evacuated and replaced with a fluid that is sufficiently clear to permit optical coherence tomography (or even high resolution ultrasound) imaging that would otherwise be of poor quality or impossible. Methods of making and operating the imaging device to obtain clear, high quality images, as well as treating a patient's tissue with the device within a living body in association with obtaining an image of the patient's tissue, are included.

Abstract: A method for localized delivery of a therapeutic or diagnostic agent within a vessel is provided. The method provides for adjustability of the length of the treatment area and for reducing of pressure within the treatment area. A catheter system includes an inner elongated element, an outer elongated element positioned coaxially with respect to the inner elongated element, and a blood-release element at a distal end of the inner elongated element. A proximal occlusion element is positioned at the distal end of the outer elongated element, proximal to an outlet port. A distal occlusion element is positioned at a distal end of the inner elongated element. The distal end of the inner elongated element is distal to and movable with respect to the outer elongated element distal end.

Abstract: A catheter assembly includes a catheter having an elongate tubular body defining a lumen extending from an open proximal end to an open distal end. A cuff deployment device is concentrically supported on the elongate tubular body and is movable along a longitudinal axis of the elongate tubular body. The cuff deployment device includes a deployment mechanism having an actuated position and a non-actuated position. A cuff has a hollow cylindrical body defining an internal catheter engagement surface. The catheter assembly has a first configuration in which the deployment mechanism is in the non-actuated position and the cuff is supported by and movable with the cuff deployment device, and a second configuration in which the deployment mechanism is in the actuated position and the cuff is concentrically mounted at a fixed axial location of the elongate tubular body and is free of contact with the cuff deployment device.

Abstract: A tissue ablation device comprising a balloon catheter, or other expandable element, wherein said expandable element is comprised of a semipermeable membrane. The balloon membrane is expanded by an osmotically active solution to contact a vascular endothelium, or other desired tissue, whereupon the resultant osmotic gradient affects a water flux from the vascular endothelium, or other desired tissue, across the semipermeable membrane and towards the osmotically active solution.