Abstract: The present invention is directed to a catheter balloon of a balloon catheter comprising a coating consisting of or containing at least one fatty acid, oil or fat and sirolimus as well as to the use of these systems and compositions. Optionally a stent is crimped on such a coated catheter balloon. Further, methods for coating the inventive catheter balloons are described.

Abstract: The disclosure provides macrolide particulates including a macrolide therapeutic agent such as rapamycin at high concentration in the particulate. In one method the particulates are made by adding a composition containing an polyoxyethylene sorbitan n-acyl ester, poly(ethyleneimine), or alkylated quaternary ammonium salt to a composition including macrolide dissolved in an alcohol such as ethanol. In another method the particulates are made by adding a non-solvent composition to a composition including macrolide and an alkyl-substituted chromanol dissolved in an alcohol such as ethanol. The formed macrolide particulates have one or more desirable properties including sizes in the range of 0.1 ?m to 10 ?m, spherical or near spherical shapes, low polydispersity, and/or stability. The macrolide particulates can be used for therapeutic compositions, or in association with an implantable or insertable medical device, such as associated with a polymeric coating on a device.

Abstract: Disclosed herein is a delivery composition for administering a hydrophobic active agent. In one embodiment, a delivery composition for local administration of a hydrophobic active agent to a tissue or organ of a patient is disclosed. In one embodiment, the delivery composition includes a cationic delivery agent, a therapeutically effective amount of a hydrophobic active agent and a pharmaceutically acceptable aqueous carrier. In one embodiment, the cationic delivery agent includes polyethyleneimine (PEI). In an embodiment, the invention includes a drug delivery device including a substrate; and coated therapeutic agent particles disposed on the substrate, the coated therapeutic agent particles comprising a particulate hydrophobic therapeutic agent; and a vinyl amine polymer. Methods of making the delivery composition, as well as kits and methods of use are also included herein.

Abstract: The present invention is related to a medical device carrying at least on a portion of its surface at least one drug or drug preparation and at least one lipophilic lubricant at a ratio of 0.1-500% by weight of the at least one lubricant in relation to 100% by weight of the drug, wherein the at least one drug is selected of paclitaxel, arsenic trioxide, and lipophilic derivatives of corticoids and selected Limus drugs, and the at least one lipophilic lubricant is a C6-C30-monocarboxylic acid salt.

Abstract: In a method for producing a bioactive surface on an endoprosthesis or on the balloon of a balloon catheter, the surface of the endoprosthesis or the surface of the balloon is softened. The surface of the endoprosthesis or of the balloon is moistened with a solution of an active ingredient and the solvent is separated from the active ingredient. The solvent can be a water-miscible solvent.

Abstract: A balloon with a bioactive surface is prepared by softening the surface of the balloon. The surface of the balloon is moistened with a solution of an active ingredient and the solvent is separated from the active ingredient. The solvent can be a water-miscible solvent.

Abstract: The present invention relates to a balloon (1) for treating stenosis and the method for obtaining this balloon. The method comprises the steps of: bringing the balloon in the deployed configuration; placing a plurality of stylets (17) that are arranged in the axial direction along the outer wall (10) of the balloon; pushing the stylets towards the balloon core (11) in the radial direction such as to form a plurality of laps (12); laying the laps about the core in the tangential direction such as to lay each lap on an adjacent stylet; removing the stylets such as to form a plurality of cavities (13) comprised between each lap and the balloon core; filling the cavities with the drug.

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

Abstract: The present invention is directed to catheter balloons and balloon catheters with such catheter balloons coated with at least one layer containing at least one antiproliferative, immunosuppressive, anti-angiogenic, anti-inflammatory, anti-restenotic and/or anti-thrombotic agent and a top coat consisting of a polyvinyl alcohol—polyethylene glycol graft copolymer as well as the use of these balloon catheters for the prevention of restenosis.

Abstract: Lead extraction is the removal of one or more leads from inside the heart utilizing a lead removal catheter having a tubular sheath that is placed in the blood vessel, either subclavian or femoral. The sheath of the lead removal catheter may accidentally tear or perforate the blood vesselas it is advanced over the lead toward the heart. Such an occurrence must be dealt with quickly to prevent harm to the patient or subject. An expandable member, such as a balloon, attached to the exterior of the sheath of a lead removal catheter can be deployed temporarily adjacent the perforation in the vessel wall. Inflation of the balloon not only stops (or substantially stops) the bleeding, but, upon inflation, the balloon may include one or more channels that allow blood to continue to flow through the channel(s) until the blood vessel perforation can be repaired.

Abstract: Embodiments are generally directed to the delivery of drugs through the use of an expandable polymeric component that is configured to swell when exposed to a recipient's bodily fluid. More specifically, in one embodiment an apparatus for implantation into a recipient comprises an expandable polymeric component and a drug delivery element that releasably carries a drug. The drug delivery element at least partially surrounds the expandable polymeric component.

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: An ischemic stroke device includes a telescoping support member, a first or proximal expandable member connected to the telescoping support member, and a second or distal expandable member connected to the first expandable member. A proximal portion of the first expandable member is attached to a distal end of an outer shaft of the telescoping support member, and a distal end of the first expandable member is attached to a distal portion of an inner core wire of the telescoping support member. The proximal end of the second expandable member is permanently joined to the distal end of the inner core wire. The first expandable member everts to cover the second expandable member that is used to capture an obstruction or clot, prior to pulling the obstruction or clot into a catheter for removal from a patient's vasculature.

Abstract: Adjustable balloon catheter including an inner tubular member having a proximal end portion, a distal end portion, an inflation lumen and a fluid lumen defined therein. An expandable member is coupled to the distal end portion and has an inner chamber defined therein in fluid communication with the inflation lumen, the expandable member transitionable between a deflated and inflated configuration. The expandable member further has an exterior surface, the exterior surface having at least one pore structure defined therein in fluid communication with the fluid lumen. An outer tubular member is movable relative to the inner tubular member, the outer tubular member, the outer tubular member being moveable between an extended position and a retracted position, the outer tubular member being selectively positioned between the extended position and the retracted position to define an exposed length of the working length of the expandable member.

Abstract: A therapeutic formulation is described for a drug delivery balloon comprising a therapeutic formulation which includes a therapeutic agent and an adhesion additive. The adhesion additive promotes adhesion of the therapeutic formulation a vessel wall of a subject. A system and a method of manufacturing a system including an expandable member having a working length with the therapeutic formulation disposed along at least a portion of the working length is also provided.

Abstract: The invention relates to an angioplasty catheter having a balloon and a constraining element carrying at least on a portion of its surface a taxane or taxane preparation and at least one lipophilic antioxidant at a ratio of 3-100% by weight of the at least one antioxidant in relation to 100% by weight of the taxane, wherein a preferred lipophilic antioxidant is propyl gallate. Scoring or cutting balloons as medical devices are excluded.

Abstract: A device for the transfer of radiopaque material within the body comprises a valvuloplasty or other balloon coated with the radiopaque material. The balloon is inflated in the aortic valve for marking the site of an aortic annulus to enable accurate placement of prosthetic valves under fluoroscopic imaging.

Abstract: A biocompatible carrier for delivery of a therapeutic substance or an active agent is disclosed. The carrier contains a bioadhesive material allowing for increased residence time of the active agent at the treatment site.

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: 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: 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 drug-delivering medical device for delivering a drug to a target site in a body lumen is disclosed. The drug-delivering medical device includes a balloon catheter and an inflatable balloon positioned on the balloon catheter. The inflatable balloon has a hydrophilic surface. One or more portions of the hydrophilic surface are coated with two or more nano-carriers. A nano-carrier of the two or more nano-carriers includes a drug surrounded by an encapsulating medium. As the drug is surrounded by the encapsulating medium, the surface of the nano-carrier is devoid of the drug. When the inflatable balloon is inflated upon coming in proximity to a target site in the body lumen, about 30% to 80% of the two or more nano-carriers are released from the hydrophilic surface within 15-90 seconds.

Abstract: Bioactive hydroforming luminal liner compositions are formed of an absorbable crystalline amphiphilic polyether-ester-urethane dissolved in a liquid derivative of a polyether glycol that undergoes transformation into a tissue-adhering, resilient interior cover or liner for the controlled release of its bioactive payload at clinically compromised conduits in humans as in the case of bacteria- and yeast-infected vaginal canals, esophagi, and arteries following angioplasty.

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: A drug eluting balloon device is disclosed, comprising a balloon and a sheath disposed around the balloon, the sheath comprising a plurality of drug delivery areas. When the sheath is in a first position, the drug delivery areas are in the form of pockets adapted to contain a therapeutic agent. When the sheath is expanded, the pockets invert into protrusions in order to deliver the therapeutic agent. In an alternative embodiment, the pockets are adapted to be pushed outwardly upon inflation of the balloon. The device may further comprise a fluid or shape memory material to force the pockets outwardly.

Abstract: This disclosure relates to medical devices and related methods. In some embodiments, the methods include applying a material to the balloon and then removing the material from one or more regions of the balloon.

Abstract: Catheter balloon assemblies (10) for delivering a therapeutic agent to a body vessel are provided, as well as related methods of manufacturing and methods of treatment. The catheter balloon assemblies may include a concentrically disposed dual balloon assembly at the distal portion of the catheter having an inner balloon (44), a porous outer balloon (42) concentrically arrayed around the inner balloon and a catheter shaft (30) adapted to deliver a therapeutic agent to the body vessel through the apertures in the outer balloon. Radial outward expansion of the inner balloon may urge the outer balloon into contact with the wall of a body vessel, where the therapeutic agent may be delivered from the catheter shaft through apertures in the outer balloon directly to the wall of the body vessel.

Abstract: Device, system, method of coating an expandable member is provided. The method comprises providing an expandable member with a plurality of folds defined therein, the expandable member having a folded configuration and a fully expanded configuration at a rated nominal pressure. The expandable member is inflated to an initial pressure of from 10% to about 300% of nominal pressure. A therapeutic agent is disposed on at least a portion of the expandable member. The expandable member is partially deflated to an intermediate pressure by withdrawing an amount of inflation medium from the expandable member, and by applying an external force to the expandable member.

Abstract: A method and device for local delivery of water-soluble or water-insoluble therapeutic agents to the tissue 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 a non-durable coating which is complexed with iodine and has a substantially water-insoluble therapeutic agent dispersed therein. The medical disposable device is inserted into a body lumen, and expanded to contact the non-durable coating against the body lumen and deliver the substantially water-insoluble therapeutic agent to the body lumen tissue.

Abstract: Systems, devices, and methods are provided for drug-eluting angioplasty balloons. An underlying balloon core member is protected by a core-screen from mechanical and flow shear forces during delivery. Inflation of the balloon opens the screen and pores in the screen permitting drug transfer and absorption. Upon deflation, the screen can be compressed and withdrawn with the balloon.

Abstract: An internal compression tourniquet catheter system and method for wound track navigation for controlling hemorrhage from wounds. The preferred embodiments include an inflatable member constructed of thin, flexible and puncture resistant material such that when deflated can be wrapped around the catheter shaft, which passes within and has a lumen to inflate it. The inflatable member is of large potential volume enabling full inflation with near zero internal pressure when unconstrained externally. When positioned within a wound track and inflated, the gas or liquid injected into the balloon lumen creates pressure because its expansion is constrained by the tissues of the wound, and that pressure is transmitted directly to the surrounding tissue of the wound track.

Abstract: The disclosed subject matter describes systems and methods of delivering a therapeutic agent, such as a sclerosing agent, to the walls of a blood vessel to perform sclerotherapy. In an exemplary embodiment a catheter includes a balloon having an inner and outer surface defining a wall, and an interior volume with an unexpanded and expanded configuration and a plurality of fibers extending from the outer surface of the balloon wall. In another exemplary embodiment, a balloon catheter comprises a catheter having a balloon with an unexpanded and an expanded configuration, and a retractable sheath disposed on the exterior surface of the balloon, wherein the sheath has an inner surface and an outer surface, and further wherein a plurality of fibers outwardly extend from the outer surface of the sheath.

Abstract: Medical devices for delivering a bioactive agent and methods of use thereof are provided. The device includes a balloon having micro-needles for delivery of the bioactive agent.

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: Catheter balloons (10) for delivering a bioactive (260) to a body vessel in a greater amount and/or more quickly are provided, as well as related methods of treatment. The catheter balloon may include a dual balloon assembly at the distal portion (300) of the catheter having an inner balloon (44), an outer balloon (42) with apertures (43) concentrically arrayed around the inner balloon, and a catheter shaft (30) adapted to deliver a carrier (270) through the apertures of the outer balloon. The bioactive is disposed on a portion of at least one of the inner and outer balloon surfaces. Radial outward expansion of the inner balloon urges the outer balloon into contact with the wall of the body vessel. The carrier is introducible within the catheter shaft to pass through the annular lumen (242) between the balloons and through the apertures of the outer balloon. The carrier interacts with the bioactive in order to release a therapeutically effective amount of drug to the wall of the body vessel.

Abstract: A tamponade catheter is disclosed for controlling bleeding from a penetrating or perforating wound in a patient comprising a catheter having an inner catheter lumen with a non-elastic inflatable balloon secured to the catheter in fluid communication with an inner catheter lumen of the catheter. A removable outer sheath overlays the inflatable balloon for inserting the inflatable balloon within the wound of the patient. A bendable flexible stiffening stylet is receivable within the inner catheter lumen of the catheter to aid in navigating the catheter into the wound of the patient. The removable outer sheath and the stylet are removable for inflating the inflatable balloon by an introduction of a fluid through the inner catheter lumen of the catheter for enabling the inflated non-elastic inflatable balloon to create pressure within the wound of the patient to control bleeding therefrom.

Abstract: A balloon carries a drug in drug-carrying regions, wherein the drug-carrying regions protect the drug during delivery through a patient's vasculature. Once at a target site, the balloon expands, causing the drug-carrying regions to expose the drug to the target site. One drug eluting balloon device includes a longitudinal sheath that defines an interior space having a balloon disposed therein. When the balloon expands, at least one push element at least partially inverts at least one pocket formed on an outer surface of the sheath. This inversion causes a drug contained within the at least one pocket to be released to the target site. In another embodiment, a plurality of bands is provided, each band made of material having a different resistance to elongation. Upon expansion, the bands invert to expose a drug provided on a surface of the bands.

Abstract: In one aspect, the present invention provides therapeutic-agent-releasing medical devices which comprise at least one region of piezoelectric material. Therapeutic agent release is initiated or increased when the piezoelectric material is subjected to mechanical stress, which leads to the development of a voltage across the piezoelectric material. This voltage is used to initiate or increase therapeutic agent release.

Abstract: Method of coating an expandable member is provided. The method comprises providing an expandable member with a plurality of folds defined therein, the expandable member having a folded configuration and a fully expanded configuration at a rated nominal pressure. The expandable member is inflated to an initial pressure of from 10% to about 300% of nominal pressure. A therapeutic agent is disposed on at least a portion of the expandable member. The expandable member is partially deflated to an intermediate pressure by withdrawing an amount of inflation medium from the expandable member, and by applying an external force to the expandable member.

Abstract: The present invention relates to a catheter balloon with a coating containing rapamycin and shellac and to a method for coating catheter balloons preferably textured catheter balloons with the pharmacological agent rapamycin, shellac and optionally further components. Moreover, the present invention relates also to the use of catheter balloons coated in such a way for the release of the pharmaceutically active agent rapamycin for prophylaxis and treatment of restenosis, preferably restenosis caused by angioplasty. The coated catheter balloons can be used alone or in combination with a coated or uncoated stent, which is crimped on the catheter balloon before or after the coating with shellac and rapamycin.

Abstract: An implantable biodegradable device having two or more layers composed of one or more biodegradable materials is disclosed. The two or more layers are coated with one or more drugs. The implantable biodegradable device further having one or more inert layers is composed of a biodegradable material. The one or more inert layers of the implantable biodegradable device are degraded in response to introduction of one or more external triggers when the implantable biodegradable medical device is placed within a living organism. Further, a layer of the two or more layers having a position above an inert layer is degraded prior to degradation of the inert layer. Subsequently, a layer of the two or more layers having a position below the inert layer is degraded subsequent to degradation of the inert layer.

Abstract: Systems and methods for delivery of therapeutic and/or diagnostic compositions to an interventional site having diseased or newly treated tissue are provided. Integrated interventional catheter systems incorporating surfaces coated with a diagnostic or therapeutic composition, or ports for infusing a diagnostic or therapeutic composition prior to, during or following an interventional procedure are provided.

Abstract: This disclosure relates to medical devices and related methods. In some embodiments, the methods include applying a material to the balloon and then removing the material from one or more regions of the balloon.

Abstract: The present invention relates to balloon catheters for treating a luminal system of a patient. Specifically, the invention relates to catheters having a flexible membrane positioned at a distal portion of the catheter, the flexible membrane retained in a substantially unexposed conformation prior to deployment. Preferably the flexible membrane is capable of delivering a therapeutic agent to a localized environment when deployed to an exposed conformation.

Abstract: Photodynamic bone stabilization and drug delivery systems are disclosed herein. In an embodiment, a photodynamic bone stabilization and drug delivery system of the present disclosure includes an insertion catheter having an inner void for passing at least one light-sensitive liquid, and an inner lumen; an expandable portion releasably engaging a distal end of the insertion catheter, wherein the expandable portion comprises an inner expandable portion in communication with the inner lumen of the insertion catheter and sufficiently designed to maintain a light-sensitive liquid therein; and an outer expandable portion, surrounding the inner expandable portion, sufficiently designed to house and release at least one additive from the outer expandable portion in an outward direction from the inner expandable portion; and a light-conducting fiber sized to pass through the inner lumen of the insertion catheter and into the inner expandable portion for delivering light energy to the light-sensitive liquid.

Abstract: A catheter assembly includes an elongated main body defining two or more longitudinal lumens including distally positioned openings. One or more side-ports are defined in the main body communicating with at least one of the two or more longitudinal lumens. The catheter assembly also includes an inflatable balloon disposed around a portion of the main body. The inflatable balloon includes a distal end disposed substantially adjacent to a proximal side of one or more side-ports. The inflatable balloon in the inflated state is adapted to extend at partially over the one or more side-ports.

Abstract: A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a loading tool. The loading tool may include a tubular member that is configured to be disposed about a balloon catheter. The tubular member may include a distal portion and a proximal portion. The tubular member may be configured to shift between a first configuration and a shortened configuration.

Abstract: The present invention relates to a catheter assembly that can deliver a therapeutic composition. The catheter assembly can include an outer balloon with openings for releasing the therapeutic composition. When the catheter assembly is in its contracted state, the openings are closed, and the assembly retains the therapeutic composition. When the catheter assembly is in its dilated state, the openings are open, and the therapeutic composition is released. The present invention also includes methods of making and using such a catheter assembly.

Abstract: The invention is directed to delivery medical devices that enable consistent “on-demand” delivery of therapeutic agents to a vessel. The medical device of the current invention comprises retractable sheath comprising neckable elements. The design and methods disclosed herein ensures that therapeutic agent delivery occurs essentially only upon necking of the outer sheath, minimizing coating and/or therapeutic agent loss to the bloodstream and providing controlled delivery to the treatment site.