Abstract: The present invention provides insertable medical devices having elastic surfaces associated with bioactive agent-containing microparticulates and a coating material. Upon expansion of the elastic surfaces the microparticulates can be released to a subject.

Abstract: Provided herein are methods for treating an individual having (suffering from) an acute myocardial infarction and drug eluting stents useful for treating such individuals. These methods include treating an individual by introducing, such as by surgically inserting, at a site of an acute coronary artery occlusion upstream of the site of acute myocardial infarction, a drug eluting stent (DES) that is capable of eluting from 25 pg to 950 pg of IGF-1 directly into the coronary circulation. The treatment is specifically directed to stimulation of repair or survival of damaged cardiac muscle or left ventricular remodeling.

Abstract: Method of coating an expandable member, e.g. balloon, is provided, the method comprising providing an expandable member having an outer surface. The method includes a plasma treatment with a supply of gas performed on at least a portion of the outer surface of the expandable member. A therapeutic agent is applied on at least the plasma treated portion of the outer surface of the expandable member after the plasma treatment is performed. The plasma treatment can reduce the adhesion of therapeutic agent to the surface of the expandable member. A medical device made by the disclosed method is also provided.

Abstract: For selective treatment of diseased tissue sections or organ parts, the surface of medical devices entering into contact with areas thereof under pressure is coated with lipophilic substantially water-insoluble medicaments binding to various tissue components with good adherence thereto, said medicaments having an effect thereupon a short time after entering into contact therewith without exerting a harmful influence upon adjacent healthy tissue.

Abstract: A system comprises an inflatable bone tamp including a plurality of linearly aligned expandable bodies. The system further comprises an elongated tubular shaft extending through the plurality of linearly aligned expandable bodies. The elongated tubular shaft includes a shaft wall and an interior partition structure. The system further comprises a plurality of channels extending through the shaft, each of the channels formed by a segment of the shaft wall and the interior partition structure and each of the channels in communication with the respective one of the plurality of expandable bodies via openings in the shaft. Each of the expandable bodies is independently inflatable.

Abstract: A process for making a folded composition-eluting balloon catheter includes coating one or both surfaces of a one or more foldable wings with a hydrophilic coating, applying a composition as a coating on the coated surface and providing the composition within a fold of the one or more foldable wings, and folding the one or more foldable wings to seal the composition by the one or more foldable wings to prevent/reduce its release until after inflation of the balloon. Another process for making a folded composition-eluting balloon catheter includes coating one or both surfaces of the one or more foldable wings with a hydrophilic coating-composition mixture and providing the composition by the one or more foldable wings, and folding the one or more foldable wings to seal the composition between the fold of the one or more foldable wings to prevent/reduce its release until after an inflation of the balloon.

Abstract: A cutting balloon catheter and method of making and using the same. The cutting balloon catheter may include a catheter shaft having a balloon coupled thereto. One or more cutting members or blades may be coupled to the balloon. The cutting members may configured to be more flexible.

Abstract: Apparatuses and methods for coating and/or loading a medical device with a therapeutic agent prior to or during the placement of the medical device within the patient's body. In one variation, the medical device is coated and/or loaded with a therapeutic agent while the device is positioned in a delivery apparatus. In another variation, the delivery apparatus comprises a reservoir for retaining a therapeutic agent. The user may release the therapeutic agent from the reservoir prior to or during the placement of the device to coat and/or load the device with the therapeutic agent.

Abstract: Materials and methods for reducing or preventing bleeding and associated side effects during and after percutaneous medical procedures.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a guide extension catheter. The guide extension catheter may include an elongate tubular member having a proximal region, a distal region, and a slot formed in the tubular member between the proximal region and the distal region. The proximal region of the tubular member may be configured to shift between a first configuration and a collapsed configuration. The guide extension catheter may also include an elongate shaft for shifting the proximal region between the first configuration and the collapsed configuration.

Abstract: A blood clot filter includes a number of locator members and anchor members, each of the members tipped with a retainer encompassed within bio-resorbable cover material. Upon delivery into a blood vessel, the locator and anchor members position the filter near the vessel centerline. After a period of time, the bio-resorbable cover material resorbs, allowing the retainer on the members to penetrate and attach to the vessel wall. A method of implanting the filter includes delivering the filter into a blood vessel and allowing the bio-resorbable cover material to resorb so retainers on the members can engage the vessel walls.

Abstract: An assist device (10) for sclerosing treatment of varicose veins, aimed at being partially inserted into a blood vessel (20), including a tubular element (11), which has at least three ways (13, 14, 15), at least two of which (13, 14) are connected each one to at least one related inflatable balloon element (12, 12?, 16) by at least one through hole (30, 31), and at least one remaining way (15) of said three ways (13, 14, 15) has likewise at least one hole (32) for the passage of a sclerosing substance (17), aimed at reaching a wall (18) of said blood vessel (20), in which at least one (16) of said at least two balloon elements (12, 12?, 16) has an elongated shape extending toward at least another balloon element (12, 12?) and a variable volume comprised in the range of 30% to 99% of the space inside said blood vessel, independently from the initial dimensions of the vessel (20), interposed between the external surfaces of the outermost of said at least two balloon elements (12, 12?, 16).

Abstract: A medical treatment device enables an injection needle to accurately puncture brain tissue at a prescribed position and a drug solution to be injected into brain tissue, while avoiding damage to the brain tissue as the injection needle is handled. The use of the medical treatment device involves inflating a first balloon located on the outside of a catheter, directing a distal portion of a puncture needle, which is located inside the catheter, to outside the catheter through an opening in the catheter, after which the first balloon is deflated and a second balloon is inflated, and moving the catheter towards the brain tissue located on the opening side so that the injection needle projecting from the opening punctures the brain region.

Abstract: An apparatus for delivery through a vessel including an extensor segment and first and second anchor segments positioned on either side of the extensor segment, wherein each segment has associated with it an individually-addressable electro-active polymer.

Abstract: This present invention concerns a new combination of balloon catheters and formulations containing active substances that adhere to the surface of the balloon membrane. Furthermore the present invention concerns coating processes for the manufacture of these balloon catheters as well as their use in the treatment and prophylaxis of vascular diseases.

Abstract: Methods and apparatus for delivering a substance to a target tissue are provided which may include any number of features. One feature is storing a substance or drug in a reservoir or reservoirs over an expandable member. The expandable member can be a balloon catheter, for example. The reservoir(s) can be disposed in a Transforming Reservoirs Matrix layer disposed over the expandable member. Another feature is a mechanical activator or a plurality of mechanical activators positioned near the reservoir(s).

Abstract: The invention relates to a coated medical device for rapid delivery of a therapeutic agent to a tissue in seconds to minutes. The medical device has a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent, at least one of an oil, a fatty acid, and a lipid, and an additive. In certain embodiments, the additive has a hydrophilic part and a drug affinity part, wherein the drug affinity part is at least one of a hydrophobic part, a part that has an affinity to the therapeutic agent by hydrogen bonding, a part that has an affinity to the therapeutic agent by charge, and a part that has an affinity to the therapeutic agent by van der Waals interactions. In embodiments, the additive is at least one of a surfactant and a chemical compound. In further embodiments, the chemical compound is water-soluble.

Abstract: The instant invention provides for a pivoting ring that can be used as a seal for an inflatable member. The pivoting ring seal offers a mechanical action which acts to tighten with increasing inflation and/or expansion of an inflatable member. As the inflatable member increases in pressure and/or size, one side of the ring is lifted and pivots around a fulcrum in the middle of the ring seal causing the opposite side of the ring seal to decrease in diameter. The pivot ring causes the opposite part of the seal to tighten about an inner member allowing for a higher-pressure seal. In addition to a higher pressure seal, the working length of the inflatable member can be adjusted by moving the ring along the length of the inflatable member.

Abstract: Medical device are provided for delivering a therapeutic agent to a tissue. The medical device has a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent and an additive. In certain embodiments, the additive has a hydrophilic part and a drug affinity part, wherein the drug affinity part is at least one of a hydrophobic part, a part that has an affinity to the therapeutic agent by hydrogen bonding, and a part that has an affinity to the therapeutic agent by van der Waals interactions. In embodiments, the additive is water-soluble. In further embodiments, the additive is at least one of a surfactant and a chemical compound, and the chemical compound has a molecular weight of from 80 to 750 or has more than four hydroxyl groups.

Abstract: A balloon catheter adapted for use with a guidewire includes an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end. An inflatable balloon is supported along the distal end of the shaft, the balloon when inflated including first and second spaced ends and a working surface between the ends. An insert located within the interior compartment of the balloon includes at least a radiopaque portion separate from the shaft. Related methods are also disclosed.

Abstract: A balloon catheter includes an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end. An inflatable balloon is supported along the distal end of the shaft, the balloon when inflated including first and second spaced conical end sections and a working surface between the conical sections. The balloon further includes at least one radiopaque marking identifying the transition from the conical end section to the working surface. Related aspects are also disclosed.

Abstract: The present invention is related to scoring or cutting balloon catheters carrying at least on a portion of their surface at least one oxidation-insensitive drug or oxidation-insensitive polymer-free drug preparation and at least one lipophilic antioxidant at a ratio of 3-100% by weight of the at least one lipophilic antioxidant in relation to 100% by weight of the drug, wherein the at least one oxidation-insensitive drug is selected of taxanes, thalidomide, statins, corticoids and lipophilic derivatives of corticoids, and the at least one lipophilic antioxidant is selected of nordihydroguaiaretic acid, resveratrol and propyl gallate.

Abstract: Apparatus and methods for treatment of an internal cavity are provided. The internal cavity is coated with a treatment solution. The treatment solution can include a solidifiable matrix with or without a drug or combination of drugs incorporated therein, or a drug solution without a solidifiable matrix. The treatment solution is coated onto at least a portion of the internal cavity, and acts as a slow-release drug delivery system.

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

Abstract: A balloon catheter for use in connection with a guidewire comprises an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end, an inflatable balloon supported, along the distal end of the shaft, the balloon when inflated including first and second spaced ends and a working surface between the ends, and at least one wire including at least a radiopaque portion for identifying the location of working surface of the balloon.

Abstract: Medical devices are provided for delivering a therapeutic agent to a tissue. The medical device has a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent and an additive. The additive has a hydrophilic part and a hydrophobic part and the therapeutic agent is not enclosed in micelles or encapsulated in particles or controlled release carriers.

Abstract: Balloon catheters, methods for preparing balloon catheters, and uses of balloon catheters are disclosed. The balloon catheter includes an elongate member, an expandable balloon, and a coating layer overlying an exterior surface of the expandable balloon. The coating layer includes a total drug load of a hydrophobic therapeutic agent and a combination of additives including a first additive and a second additive. The hydrophobic therapeutic agent is paclitaxel, rapamycin, or paclitaxel and rapamycin. The first additive is a surfactant. The second additive is a chemical compound having one or more hydroxyl, amino, carbonyl, carboxyl, acid, amide, or ester groups.

Abstract: A balloon catheter includes an elongated, tubular shaft having a proximal end and a distal end, and a balloon positioned along the distal end of the shaft. A portion of a wall of the balloon partially comprises a coextruded radiopaque material. Related aspects and methods are also disclosed.

Abstract: The present invention relates generally to the maintenance of blow flood using drug eluting stents and/or other coated medical devices to increased length of time of blood flow. Further, the present invention relates to drug-releasing coated devices for reducing smooth muscle cell proliferation and platelet activity to further limit restenosis utilizing resveratrol and quercetin, polyphenols that are linked to the cardioprotection of red wine consumption. The present invention also provides products and methods for treating or preventing atherosclerosis, stenosis, restenosis, smooth muscle cell proliferation, platelet cell activation and other clotting mechanisms, occlusive disease, or other abnormal lumenal cellular proliferation condition in a location within the body of a patient.

Abstract: The present invention relates generally to the maintenance of blow flood using drug eluting stents and/or other coated medical devices to increased length of time of blood flow. Further, the present invention relates to drug-releasing coated devices for reducing smooth muscle cell proliferation and platelet activity to further limit restenosis utilizing resveratrol and quercetin, polyphenols that are linked to the cardioprotection of red wine consumption. The present invention also provides products and methods for treating or preventing atherosclerosis, stenosis, restenosis, smooth muscle cell proliferation, platelet cell activation and other clotting mechanisms, occlusive disease, or other abnormal lumenal cellular proliferation condition in a location within the body of a patient.

Abstract: A drug-delivering insertable medical device for treating a medical condition associated with a body lumen is disclosed. The drug-delivering insertable medical device includes an outer surface coated with two or more nano-carriers having two or more average diameters. A nano-carrier of the two or more nano-carriers has an average diameter suitable for penetrating one or more layers of two or more layers of the body lumen. The nano-carrier includes a drug surrounded by an encapsulating medium. The encapsulating medium includes one or more of a biological agent, a blood excipient, and a phospholipid.

Abstract: A method of preparing a cutting balloon comprises the steps of providing a balloon body having an exterior surface, an unexpanded state and an expanded state; and engaging at least one blade to the exterior surface when the balloon body is in the unexpanded state.

Abstract: The present invention provides systems and methods for the targeted delivery of a therapeutic agent using expandable devices that are temporarily or permanently placed within the body. Such therapeutic agents may be delivered as a coating on the outer surface of the expandable device. Once positioned at a desired location within the body, the device is expanded such that its drug-coated outer surface establishes direct contact with a target tissue. The expanded device remains in contact with the target tissue for a pre-determined amount of time prior to being withdrawn from the body. Delivery of the therapeutic agent using the expandable device may be followed, or preceded, by delivery of a second expandable device to the same location within the body.

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

Abstract: A pleural drainage system having an inflatable membrane and a method of using the system are disclosed. The pleural drainage system includes a pleural drainage catheter system. The pleural drainage catheter system includes an inflatable membrane and a drainage catheter integrally coupled to the inflation membrane, the drainage catheter defining a drainage lumen through which fluid is drawn from the pleural cavity, and an inflation lumen coupled for flow of inflation fluid to and from an interior of the inflatable membrane. The pleural drainage system further includes a suction system coupled to the drainage catheter and a fluid collector coupled to receive fluid from the drainage catheter. The pleural drainage system further includes an inflation system connected to deliver inflation fluid to the interior of the inflatable membrane. The pleural drainage system may be used to monitor an associated airleak in the pleural cavity of a patient.

Abstract: A coating composition for drug eluting medical devices, which is capable of forming a drug coating layer that is not susceptible to peeling during delivery to a target tissue is provided. This coating composition contains: a water-insoluble drug; at least one selected from the group consisting of hyaluronic acid, alkanoyl hyaluronic acids obtained by substituting at least part of hydrogen atoms in the hydroxyl groups of hyaluronic acid with an alkanoyl group, and salts of hyaluronic acid and the alkanoyl hyaluronic acids; and at least one selected from the group consisting of amino-acid esters and salts thereof. A drug coating layer, a medical device and a method of treatment are also provided.

Abstract: A reinforced composite balloon may comprise a body layer and a reinforcing layer. The reinforcing layer may comprise a single-layer structural network having a plurality of apertures. The reinforcing layer may be molded from a reinforcing tube having a plurality of apertures or aperture precursor holes.

Abstract: A coating composition for drug-eluting medical devices, which enables a medical device to be delivered to a target tissue for the purpose of treating an affected blood vessel part such as restenosis, without easy separation of a drug from the medical device during the delivery process is provided. The coating composition for drug-eluting medical devices contains a water-insoluble drug and at least one selected from the group consisting of ester compounds of amino acids, which have a hydropathy index of the amino acid of zero or less than zero, and salts thereof. A drug coating layer, a drug-eluting medical device and a method of treatment are also provided.

Abstract: A catheter assembly includes an expandable and collapsible structure having an outer surface. The expandable and collapsible structure is adapted to expand between a contracted state and a dilated state. A guard is bonded to the outer surface of the expandable and collapsible structure. The guard and the expandable and collapsible structure cooperatively define a plurality of reservoirs. A coating disposed in the reservoirs. The coating includes a bioactive agent. The coating protrudes from the reservoirs when the expandable and collapsible structure is expanded to the dilated state.

Abstract: Exemplary embodiments of devices and methods for treating a lung including, for example, treatments for chronic obstructive pulmonary disease are disclosed. A device may include a plurality of media and a deployment member. The media may be configured for deployment into one or more airways of a lung. The deployment member may be configured for insertion into or proximate the one or more airways of the lung. Also, the deployment member may be configured to deploy the plurality of media substantially simultaneously. Further, the plurality of media may be configured to be retained within the one or more airways of the lung.

Abstract: Apparatus and methods for treatment of an internal cavity are provided. The internal cavity is coated with a treatment solution. The treatment solution can include a solidifiable matrix with or without a drug or combination of drugs incorporated therein, or a drug solution without a solidifiable matrix. The treatment solution is coated onto at least a portion of the internal cavity, and acts as a slow-release drug delivery system.

Abstract: A medical device is configured to position a bag member filled with a therapeutic substance in a prescribed region of the brain. The use of this medical device involves, with a sheath inserted in the brain region, filling a therapeutic substance into a bag member through an infusion tube, followed by retracting the sheath relative to the infusion tube until the bag member protrudes forward beyond the distal end of the sheath. After this, the bag member is put indwelling in the brain region by moving an operating member relative to the infusion tube to detach the bag member from the distal end of the infusion tube.

Abstract: The invention provides therapeutic particulates including a macrolide, such as rapamycin, in solid state crystalline form, having a size of 20 ?m or less, or 10 ?m or less. The particulates are formed in one method by preparing a composition with a macrolide and first (e.g., xylene) and second (e.g., an alcohol, acetone, or acetonitrile) solvents. In the composition a maximum solubility for the macrolide that is greater than a maximum solubility of the macrolide dissolved in either the first or second solvent individually. The first and second solvents are then evaporated from the composition to provide the macrolide particulates. In another method, the particulates can be formed by a method including sonication and stirring/evaporation steps, and the particulates can be obtained from a supersaturated solution, formed during the process.

Abstract: The present invention relates compositions for delivering therapeutic agents from a medical device including an expandable and collapsible structure and methods employing them. A lipid coating including one or more fatty acids increases the amount of therapeutic agent released from the device at the delivery site. The therapeutic agent can be in a matrix including a hydrophilic polymer or an amphiphilic polymer. Release and adhesion coatings can also facilitate delivery of therapeutic agent.

Abstract: A balloon catheter, in particular a balloon catheter for angioplasty, the balloon having an inner or outer surface modified by means of a photoactivation reaction.

Abstract: The invention relates to a balloon catheter with a catheter body (1) and with a balloon (2), wherein the balloon (2) is arranged along part of the length of the balloon catheter and can be expanded by delivery of a pressure medium through a delivery line (3). The balloon catheter is characterized in that the outside of the balloon (2) has a multiplicity of punctiform or groove-shaped depressions (4). These improve the application of forces to a vascular wall or stent surrounding the balloon (2). Moreover, in the case of balloons (2) coated with a medicament, the adherence of the medicament is strengthened.

Abstract: A medical device that releases a pharmaceutical agent to a target site is disclosed. The medical device includes a balloon, and a coating on at least a portion of the balloon. Each particle of the particles of the pharmaceutical agent is at least partially encapsulated in a polymer layer. The method includes the steps of providing a device including a balloon, and a coating on at least a portion of the balloon, the coating including particles of a pharmaceutical agent, and each particle of the pharmaceutical agent is at least partially encapsulated in a polymer layer; positioning the device to allow the balloon to reach the target site; and inflating the balloon of the device.

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

Abstract: A drug coating layer which is a drug coating layer having a morphological form including a plurality of elongated bodies having long axes that each crystal of a water-insoluble drug independently has on a substrate surface, in which the long axes of the elongated bodies are nearly linear in shape, and the long axes of the elongated bodies form an angle in a predetermined range with respect to a substrate plane with which the long axis of the elongated body intersects. The drug coating layer can provide low toxicity and a high intravascular stenosis inhibitory effect.

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.