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 medical device of the current invention comprises an expandable member, a hydrophilic coating comprising at least one therapeutic agent about the expandable member or structural layer and a retractable outer sheath with a selectively permeable microstructure. The design and methods disclosed herein ensures that therapeutic agent delivery occurs essentially only during retraction of the outer sheath, minimizing coating and/or therapeutic agent loss to the bloodstream and providing controlled delivery to the treatment site.

Abstract: A plaque-modifying balloon and method for use in an endovascular procedure includes an elongated balloon that defines a longitudinal axis and is inflatable from a first deflated configuration to a second radially expanded configuration. One or more plaque-modifying elements are mounted on the outside of the inflatable balloon. Optionally, a compressible sheath made of a relatively low durometer, flexible material is mounted on the balloon to cover the elements during transit of the plaque-modifying balloon to and from the treatment site.

Abstract: The present invention relates to compositions which are suitable for selective filling or selective coating of folds of a folded balloon, and especially relates to compositions of a contrast agent and an active agent in a solvent for filling of folds of a folded catheter balloon as well as to methods for selective filling or selective coating of folds of a folded catheter balloon and to filled or coated folded catheter balloons which can be obtained according to one of these methods.

Abstract: A treatment device includes: a balloon; a biologically active agent part applied on an outer surface of the balloon; a protective sleeve encircling the balloon and being displaceable proximally; and an interposed member having a self-expanding function arranged between the balloon and the protective sleeve. When the protective sleeve is moved proximally in order for the balloon to be exposed to the inside of a blood vessel, the presence of the interposed member prevents the biologically active agent part from being scraped and peeled off by THE inner surface of the protective sleeve.

Abstract: Systems, devices and methods for eluting an agent at a treatment site are disclosed. The devices include an expandable frame and at least one membrane. The membrane may carry an agent to elute at the treatment site. The membrane may allow blood flow at the treatment site during agent delivery.

Abstract: A drug delivery balloon is provided comprising a balloon having a surface, and a coating disposed on at least a portion of the balloon surface, the coating including an cytostatic therapeutic agent, an excipient, and a plasticizer. In accordance with the present subject matter, at least 30% of the coating transfers from the balloon surface within two minutes after inflation of the balloon. Alternatively, at least 30% of the coating transfers from the balloon surface within one minute after inflation. The coating results in an effective pharmacokinetic profile of an cytostatic therapeutic agent in a vasculature or target tissue.

Abstract: Catheters with laminar flow bioactive agent delivery properties and methods of using for treating or preventing vascular disease are disclosed.

Abstract: A drug delivery balloon is provided, the a balloon having an outer surface, and a tunable coating disposed on at least a length of the balloon surface. The tunable coating includes a first therapeutic agent and a first excipient, and a second therapeutic agent and a second excipient. The first and second therapeutic agents have different dissolution rates during balloon inflation and therefore provide a coating that is tunable.

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: 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: 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: The invention relates to an active-substance-containing coating for the balloon of a balloon catheter, to a balloon of a balloon catheter with the coating, and to a balloon catheter with such a balloon. The invention further relates to the use of the coating for a balloon of a balloon catheter, and to a method for coating an active-substance-coated balloon and for producing an agent for modifying the release of an active substance applied to a surface of the balloon of a balloon catheter. A coating for a balloon of a balloon catheter is proposed which comprises at least one lipophilic active substance and an agent for modifying the release of active substance to a vessel that surrounds the balloon, wherein the agent for modifying the release of active substance is a polysaccharide having a molecular mass of 10,000 Da to 100,000,000 Da.

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

Abstract: 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: Various embodiments of a pelvic treatment system and method are provided. The present invention can include one or more drug eluting darts or barbs that are lodged into the wall and will elute the drug over a desired time period (weeks, months for example) to treat OAB, BPH, tissue weaknesses, or other disorders or diseases.

Abstract: A method for coating catheter balloons with a defined amount of a pharmacologically active agent, uses a coating device having a volume measuring device for releasing a measurable amount of a coating solution by means of a dispensing device specifically onto the surface of the catheter balloon.

Abstract: A medical device includes an implantable structure and a coating layer including a water-insoluble therapeutic agent and one or more additives selected from xylitol, iodine or Ethylenediaminetetraacetic acid (EDTA), and physiologically-acceptable salts thereof. The one or more additives can be present in an amount effective to increase the rate of release of the water-insoluble therapeutic agent from the coating layer. The implantable medical device structure can be an expandable structure such as a balloon or stent. Also described are methods of making and using such implantable medical devices and coating layers.

Abstract: A medical device includes an implantable structure and a coating layer including a water-insoluble therapeutic agent and one or more additives selected from heparin, heparan sulfate, dextran and dextran sulfate, and physiologically-acceptable salts thereof. The one or more additives can be present in an amount effective to increase the rate of release of the water-insoluble therapeutic agent from the coating layer. The implantable medical device structure can be an expandable structure such as a balloon or stent. Also described are methods of making and using such implantable medical devices and coating layers.

Abstract: System for treating vascular disease comprising a balloon having an outer surface for temporary contact with a vessel wall when in an expanded state, a coating disposed on at least a portion of the outer surface, the coating including an initial amount of a cytostatic agent selected from the group consisting of Zotarolimus (ABT578), everolimus, pimecrolimus, and a combination thereof, the coating being capable of maintaining a therapeutically effective amount of the cytostatic agent on the outer surface for delivery to a vessel wall, and further wherein between about 4.9% to about 23% of the initial amount of the cytostatic agent on the outer surface remains disposed on the outer surface after delivery of the therapeutically effective amount of the cytostatic agent to the vessel wall, and optionally, a stent disposed on the balloon.

Abstract: The invention provides methods for treating an obstructed biological conduit that include administering to the conduit an agent that can degrade extracellular matrix of obstructing tissue. Particular methods include delivery of an enzyme or a mixture of several enzymes to the area or region of obstruction wherein the enzyme(s) have the capability to degrade extracellular matrix components within the obstruction thereby restoring the normal flow of transported fluid through the conduit. The invention also includes prophylactically dilating a section of conduit to minimize the risk of obstruction formation.

Abstract: The invention relates generally to devices and methods for local delivery of therapeutic agents to the wall of a bodily lumen with minimal shearing damage to the therapeutic agents, more specifically to the wall of a blood vessel following atherectomy. A preferred delivery mechanism comprises a balloon, or double balloon, though any distal catheter design may be used to reduce shear stress and to conserve and/or isolate the therapeutic substance.

Abstract: The invention provides systems for treating an obstructed biological conduit that include administering to the conduit an agent that can degrade extracellular matrix of obstructing tissue. Particular methods include delivery of an enzyme or a mixture of several enzymes to the area or region of obstruction wherein the enzyme(s) have the capability to degrade extracellular matrix components within the obstruction thereby restoring the normal flow of transported fluid through the conduit. The invention also includes prophylactically dilating a section of conduit to minimize the risk of obstruction formation.

Abstract: The invention provides a balloon catheter formed with a plurality of depressions. The balloon is coated with a matrix incorporating a therapeutic substance, which fills the depressions. When the balloon is expanded within a body lumen, the therapeutic substance may diffuse into the lumen wall, or all or a portion of the coating transfers to the lumen wall. A lattice frame may surround the balloon, applied prior to coating if the coating is to transfer, operative to maintain a more linear balloon profile during inflation, promoting more even transfer pressure. A contrast dye is incorporated into the transferred coating, enabling ready location and inspection of the treated lumen area.

Abstract: Systems, devices and methods for eluting an agent at a treatment site are disclosed. The devices include an expandable frame and at least one membrane. The membrane may carry an agent to elute at the treatment site. The membrane may allow blood flow at the treatment site during agent delivery.

Abstract: A balloon catheter includes a first outer tubular member, a second inner tubular member, an inflatable balloon, and a drug coating applied to at least a portion of the inflatable balloon. The inflatable balloon has opposing distal and proximal end portions. The inflatable balloon resides on the first and second tubular members in a twisted turn orientation of a pre-determined angle relative to the proximal end portion of the inflatable balloon attached to the first outer tubular member, such that the second inner tubular member achieves a constant torque of the balloon to twist and fold itself when retracted back into a portion of the first outer tubular member. Folds caused by the twisted turn orientation are configured and adapted to protect the drug coating while the inflatable balloon is deflated, thereby reducing premature drug elution and increasing the reliability and consistency of drug delivery.

Abstract: Embodiments of the present invention provide a method for treatment of respiratory disorders such as asthma, chronic obstructive pulmonary disease, and chronic sinusitis, including cystic fibrosis, interstitial fibrosis, chronic bronchitis, emphysema, bronchopulmonary dysplasia and neoplasia. The method involves administration, preferably oral, nasal or pulmonary administration, of anti-inflammatory and anti-proliferative drugs (rapamycin or paclitaxel and their analogues) and an additive.

Abstract: Medical devices may be utilized for local and regional therapeutic agent delivery. These therapeutic agents or compounds may reduce a biological organism's reaction to the introduction of the medical device to the organism. In addition, these therapeutic drugs, agents and/or compounds may be utilized to promote healing, including the prevention of thrombosis. The drugs, agents, and/or compounds may also be utilized to treat specific disorders, including restenosis, vulnerable plaque, and atherosclerosis in type 2 diabetic patients.

Abstract: The invention is directed to eluting medical devices that enable consistent “on-demand” delivery of therapeutic agents to a vessel. The medical device of the current invention comprises an expandable member, a hydrophilic coating comprising at least one therapeutic agent about the expandable member or structural layer and an outer sheath with a variably permeable microstructure. The design and methods disclosed herein ensures that therapeutic agent delivery occurs essentially only during expansion of the expandable member, minimizing coating and/or therapeutic agent loss to the bloodstream and providing controlled delivery to the treatment site.

Abstract: Embodiments of the present invention provide a method for treatment of respiratory disorders such as asthma, chronic obstructive pulmonary disease, and chronic sinusitis, including cystic fibrosis, interstitial fibrosis, chronic bronchitis, emphysema, bronchopulmonary dysplasia and neoplasia. The method involves administration, preferably oral, nasal or pulmonary administration, of anti-inflammatory and anti-proliferative drugs (rapamycin or paclitaxel and their analogues).

Abstract: Embodiments described herein concern medical products, which come into contact with the organism, such as short-term implants and long-term implants, coated with at least one layer, containing a molecular-disperse distributed or dissolved active substance in at least one carrier and optionally one or more adjuvants, wherein the at least one layer forms a stably spreadable solution, methods for making this coating of stably spreadable solution and use of the medical products coated with the stably spreadable solution.

Abstract: In embodiments, medical devices, such as balloon catheters, can deliver a biologically active material to body tissue of a patient. The medical device includes a sponge delivery layer which can deliver multiple doses of one or more therapeutic agents to the body tissue. The medical device can further include a drug reservoir, which can supply the delivery layer with one or more therapeutic agents.

Abstract: The invention generally relates to internal (e.g., implantable, insertable, etc.) drug delivery devices which contain the following: (a) one or more sources of one or more therapeutic agents; (b) one or more first electrodes, (c) one or more second electrodes and (d) one or more power sources for applying voltages across the first and second electrodes. The power sources may be adapted, for example, to promote electrically assisted therapeutic agent delivery within a subject, including electroporation and/or iontophoresis. In one aspect of the invention, the first and second electrodes are adapted to have tissue of a subject positioned between them upon deployment of the medical device within the subject, such that an electric field may be generated, which is directed into the tissue. Furthermore, the therapeutic agent sources are adapted to introduce the therapeutic agents into the electric field.

Abstract: In accordance with one aspect, medical devices are provided which comprise an electroactive polymer material and therapeutic-agent containing particles. The device is configured such that the particles are delivered from the device upon actuation of the electroactive polymer material.

Abstract: The invention provides methods for treating an obstructed biological conduit that include administering to the conduit an agent that can degrade extracellular matrix of obstructing tissue. Particular methods include delivery of an enzyme or a mixture of several enzymes to the area or region of obstruction wherein the enzyme(s) have the capability to degrade extracellular matrix components within the obstruction thereby restoring the normal flow of transported fluid through the conduit. The invention also includes prophylactically dilating a section of conduit to minimize the risk of obstruction formation. The invention further includes methods for prolonging patency of hemodialysis access.

Abstract: A method including positioning a catheter at a location in a blood vessel; imaging a thickness of a portion of a wall of the blood vessel at the location; identifying a treatment site; advancing a needle a distance into the wall of the blood vessel to the treatment site; and introducing a treatment agent through the needle to the treatment site. A composition including an inflammation-inducing agent and a carrier in the form of microspheres having a particle size suitable for transvascular delivery. A composition including a therapeutic angiogenesis promoter in a carrier and an opsonin-inhibitor coupled to the carrier. An apparatus for delivery of a therapeutic angiogenesis promoter.

Abstract: A constraining structure for use with a balloon catheter includes multiple longitudinal struts and multiple expandable radial rings. The constraining structure can expand radially but may not expand substantially in the longitudinal direction. The constraining structure can have multiple compartments configured to expand independently of one another. Inflating the balloon catheter within the constraining structure can allow for dilation of the blood vessel in a predetermined topography.

Abstract: The present invention provides an intraluminal stent delivery catheter device having improved stent retention. Particularly, the present invention is directed to a catheter having an expandable member and a fibrous matrix positioned over the expandable member and a stent mounted on the outer surface of the fibrous matrix. The fibrous matrix provides mechanical interface for improved stent retention, delivery and deployment.

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: 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: Embodiments of the invention include lubricious medical device coatings. In an embodiment the invention includes a coating for a medical device including a first layer comprising polyvinylpyrrolidone derivatized with a photoreactive group; and a first cross-linking agent comprising at least two photoreactive groups; a second layer disposed on the first layer comprising polyvinylpyrrolidone derivatized with a photoreactive group; a second cross-linking agent comprising at least two photoreactive groups; and a polymer comprising polyacrylamide, the polymer derivatized with at least one photoreactive group. Other embodiments are included herein.

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: Medical device includes a tubular member having a proximal end and distal end defining a longitudinal axis therebetween, an expandable member proximate the distal end of the tubular member having at least one axial fold in a deflated condition, a tissue engaging member comprising at least one straight wire extending along at least part of the longitudinal axis of the expandable member, and a therapeutic agent disposed on at least the expandable member or the tissue engaging member. The at least one straight wire of the tissue engaging member is located inside the at least one fold of the expanded member when in the deflated condition. The tissue engaging member is configured for deployment at a select location upon inflation of the expandable member. A method of delivering a therapeutic agent is also provided.

Abstract: Embodiments of the invention include devices and coatings for devices including coated hydrophobic active agent particles. 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 cationic agent in contact with the particulate hydrophobic therapeutic agent. Other embodiments are also included herein.

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: The invention discloses novel 42-0-(heteroalkoxyalkyl) rapamycin compounds of formula (1) and process for preparation thereof. These compounds are useful in the treatment of hyperproliferative vascular diseases such as restenosis and atherosclerosis Wherein, R denotes 3, 4 and 5 membered 3-hydroxy heteroalkoxyalkyl compounds selected from Tetrahydrofuran-3-ol, Oxetan-3-ol, Tetrahydropyran-3-ol, Tetrahydro-4- methyl furan-3-ol, Tetrahydro-2,5,5-trimethyl furan-3-ol, Tetrahydro-2,5-diethyl-2-methyl furan-3-ol, Tetrahydro-6-methoxy-2-methyl 2H-Pyran-3-ol and Tetrahydro-2,2-dimethyl-6-phenyl 2H-Pyran-3-ol.

Abstract: An embodiment of the present invention relates to a balloon catheter, which has a drug-releasing coating and/or cavity filling on at least parts of the outwardly facing surface of the dilatable balloon, characterized in that the coating comprises a drug and a gelatin mixture, the gelatin components of the gelatin mixture comprising 10-90 wt. % high-bloom gelatin having a gel strength of ?250 bloom and 90-10 wt. % medium-bloom gelatin having a gel strength of ?50 to <250 bloom, the specifications in wt. % relating to the total weight of the gelatin components of the gelatin mixture.

Abstract: A drug delivery balloon is provided, the a balloon having an outer surface, and a tunable coating disposed on at least a length of the balloon surface. The tunable coating includes a first therapeutic agent and a first excipient, and a second therapeutic agent and a second excipient. The first and second therapeutic agents have different dissolution rates during balloon inflation and therefore provide a coating that is tunable.

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: Methods and systems are disclosed for selective drug or fluid delivery in a lumen through a coating or fluid delivery channels. One system includes an elongate catheter having a proximal end and a distal end with an axis therebetween, the catheter having a radially expandable balloon near the distal end and an energy delivery portion proximate the balloon for transmission of energy, a thermally changeable coating having a releasable drug coupled to the balloon, the thermally changeable coating being oriented to be urged against the body tissue when the expandable balloon expands and an energy source operatively coupled to the energy delivery portion configured to energize the energy delivery portion to heat and liquefy the thermally changeable coating to release the drug to the body tissue.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade to release the drug into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.