Abstract: The medical devices of the invention comprise an expandable portion which is covered with a sponge coating for release of at least one biologically active material. The sponge coating is made of a non-hydrogel polymer having a plurality of voids. The device can further include means for infusing or expelling the biologically active material or drug into the voids. The drug is delivered to the body lumen of a patient by expelling the drug and inflating or expanding the expandable portion of the catheter or device.

Abstract: The balloon catheter according to the present invention is one is provided with a catheter shaft having flexibility with a lumen formed inside; a balloon that is disposed at the distal end side of the catheter shaft and in communication with the lumen; a fluid regulating portion that passes a fluid that is supplied from a fluid supply source to the balloon and, simultaneous with the supply from the fluid supply source being stopped, prevents backflow of the fluid that is supplied to the balloon to the fluid supply source side; and a fluid releasing portion that releases the fluid that is supplied to the balloon to outside of the balloon.

Abstract: The invention described herein consists of an oxygen deliver source for local blood or tissue oxygenation. The invention consists of porous polymer structures being part of a medical device from which a liquid oxygen carrier is locally or systemically released. The substrate membrane impregnated with the oxygen carrier may be a part of a tube, a balloon, a perfusion balloon, a stent and a wire. The substrate membrane is sealed with a removable housing for the oxygen carrier to allow storage of the medical device.

Abstract: A protector for a medical device including a tubular member, the tubular member including a polymer matrix material and a scavenger for moisture, oxygen or a combination thereof dispersed in the polymer matrix material.

Abstract: The present invention provides a systems that delivers therapeutic to the inner lumens, chambers, cavities, and vessels of the body. A therapeutic delivery device for delivery of therapeutic to a target site within the body of a patient is provided. This device may include a catheter, an expandable multi-port housing fluidly coupled to the catheter and a sheath. The multi-port housing in this device may be sized to travel within a lumen of a patient and may be adapted to expand from a first configuration to a second configuration. The multi-port housing may also contain at least two ejection ports coupled to an internal lumen of the multi-port housing.

Abstract: The medical devices of the invention comprise an expandable portion which is covered with a sponge coating for release of at least one biologically active material. The sponge coating is made of a non-hydrogel polymer having a plurality of voids. The device can further include means for infusing or expelling the biologically active material or drug into the voids. The drug is delivered to the body lumen of a patient by expelling the drug and inflating or expanding the expandable portion of the catheter or device.

Abstract: An abdominal cavity balloon for preventing a haemorrhage in a patient's pelvic region, comprising an inflatable balloon, wherein the balloon is provided with a smooth surface and with a strip that is flexurally stiff and formed to follow the balloon's shape for positioning the balloon.

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: 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: The invention relates to a medical device 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 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 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, a contrast agent, and an additive.

Abstract: A gastric space filler device for treating obesity in a patient by reducing the stomach volume features at least one inflatable space filler with drag delivery and stimulation features and includes therapeutic devices and anchoring apparatus enabling tracking, visualization and optimized management of inter-balloon connecting sections, drug reservoirs and pumping systems along with related improvements.

Abstract: A device and method for delivering a bioactive to the uterine wall. In one embodiment, the device comprises a balloon having the bioactive present within the material of the balloon or on an outside surface of the balloon. Another embodiment provides a method comprising inserting the balloon into the uterus, inflating the balloon so that the outside surface of the balloon exerts pressure on uterine wall and delivering the bioactive to the uterine wall.

Abstract: A medical device comprising a plurality of capsules, and a method of administering therapeutic agent to a patient using the same. The capsules further comprise a therapeutic agent and a multilayer polyelectrolyte shell. The medical device is adapted to apply a pressure to the capsules that is greater than or equal to the critical pressure of at least a portion of the capsules, such that therapeutic agent is released from the capsules.

Abstract: Medical device coatings are provided that simultaneously release a therapeutic agent at different rates from different portions of the medical device coating. In a first embodiment, medical device coatings are provided that include particles comprising a therapeutic agent with two or more different particles sizes within a single layer on a surface of the implantable device. In a second embodiment, medical device coatings are provided having a higher concentration of the therapeutic agent in a first region of the coating than in a second region of the coating. In a third embodiment, medical device coatings are provided that are formed by certain coating processes wherein the droplet size of a spray coating solution is changed during the coating process. These coating processes preferably include applying a solution comprising a therapeutic agent and a suitable solvent to a surface of an implantable medical device.

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: The inventors have demonstrated that they can deliver therapeutic compositions to the inner ear of mammals via a variety of routes including the round window membrane, the semicircular canals, via cochleostomy and through the stapes footplate. Using pancaspase inhibitors, the inventors have shown that relatively large volumes of compositions can be injected with little to no hearing loss.

Abstract: Tissue expanding and drug delivery systems with actuating three-dimensional surfaces are described for controlling the delivery and release of therapeutic agents against or upon tissue regions of interest. Such treatments devices and methods may include systems utilizing pores having various pore architectures to control the release of one or more drugs from an outer layer of an expandable delivery instrument, such as a balloon.

Abstract: Methods and devices for facilitating the treatment and repair of nasal sinus afflictions utilizing devices that are positioned within proximity of the nasal sinus and the afflicted location. The methods and devices are particularly beneficial for the treatment of sinusitis, broken noses, sleep apnea, cleft palates and deviated septums. In addition, the devices may enhance and expedite patient recovery and reduce or mitigate bleeding.

Abstract: Embodiments of the present disclosure provide a delivery apparatus for delivering a prosthetic heart valve to a native valve site via the human vasculature. The delivery apparatus is particularly well-suited for advancing a prosthetic valve through the aorta (i.e., in a retrograde approach) for replacing a stenotic aortic valve.

Abstract: The present invention is directed to a medical device, such as a stent, having a coating comprising a release component and an insoluble fibrous component. The release component is capable of being degraded thus leaving a gap between the stent and the insoluble fibrous component. Further, the insoluble fibrous component is capable of being wrapped about the stent, and capable of moving substantially freely about the stent upon degradation of the release component. This capacity enables the insoluble fibrous component to form a reinforced thrombus plug in, for instance, an aneurysm or fistula.

Abstract: Systems and related methods for treating postpartum hemorrhage through insertion of a flexible and expandable cryoballoon into the intrauterine cavity, inflating it to conform to the size and shape of the cavity, pressurizing it to apply pressure on damaged tissue and/or blood vessels that are bleeding, and filling it with a chilled fluid to provide numbing and blood coagulation. The cryoballoon can be coated with a drug or hormone to promote blood coagulation and/or uterine contractions to expedite the cessation of bleeding. In addition, cryoballoon can be coated with a topical anesthetic and/or antiseptic agent to numb and clean the damaged areas. Further, the cryoballoon can be fabricated of a biodegradable, bioerodeable or other biocompatible material so that it can be left in the intrauterine cavity for an extended period of time after insertion.

Abstract: The present invention is directed to an apparatus and method for delivering a drug to a selected site in the vascular system of a patient. More specifically, the apparatus is a balloon catheter comprising an expandable balloon with a pouch around at least a portion of the balloon. When the balloon is not expanded, an agent can be located in the area between the pouch and the balloon. The agent is released through the pouch when the balloon is expanded.

Abstract: The present invention relates to a medical device and a method of delivering a drug to a target circulation or tissue. The medical device has an expandable portion which is fabricated from a porous elastomeric material with a plurality of voids therein. The voids are loaded with drugs in various formulations. Upon inflation of the expandable portion, the overall diameter increases, the wall thickness decreases and, consequently, the voids are stretched to cause the drug to be expelled from the voids and into the bodily lumen or tissue adjacent to the medical device. The voids include any open volume within the expandable portion capable of containing the drug.

Abstract: The present invention provides improved devices, methods, and kits for inhibiting restenosis and hyperplasia after intravascular intervention. In particular, the present invention provides controlled radiosensitizer delivery in combination with ionizing radiation to selected locations within a patient's vasculature to reduce and/or inhibit restenosis and hyperplasia rates with increased efficacy. In one embodiment, the combination radiation and radiosensitizer delivery catheter for inhibiting hyperplasia comprises a catheter body having a proximal end and distal end, an ionizing radiation source coupleable to the catheter body for applying a radiation dose to a body lumen, and a porous material, matrix, membrane, banier, coating, infusion lumen, stent, graft, or reservoir for releasing an radiosensitizer to the body lumen.

Abstract: A catheter for the positioning of a radioactive material for therapeutic radiation treatment of the body is disclosed. The catheter includes a radioactive source positioned at the distal end thereof and is sufficiently flexible and strong to navigate in the body to the desired treatment location. The radioactive source may be provided to the catheter in a number of different ways. In one set of embodiments, the radioactive source is bonded to the inner or outer surface of the catheter body, a catheter attachment or a carrier positionable within the catheter body. In another set of embodiments, one of the catheter body, catheter attachment or carrier positionable within the catheter body includes a cavity within which the radioactive source is placed. In this set of embodiments, the radioactive source may be provided in a variety of different forms, depending upon the particular needs of the treatment method.

Abstract: Medical devices including a substrate that are expandable from a compressed state to an expanded state; a coating on the substrate, the coating having a drug agent incorporated therein; and a sheath over the coating. The sheath is expandable from a compressed state to an expanded state and has at least one perforation therein. The medical devices are configured such that when the substrate is in a compressed state, the sheath is also in a compressed state and the perforation is substantially closed. When the substrate is in an expanded state, the sheath is also in an expanded state and the perforation is substantially open. The invention also includes a method of using the medical devices for the controlled, localized delivery of a drug agent to a target location within a mammalian body.

Abstract: A balloon for use in surgical procedures, such as angioplasty. The balloon is configured as a balloon catheter with an axial series of segmented chambers, each connected to a tubular core that is adapted to a transport a pressurizable fluid source. The chambers are made of an elastically expandable material that inflates in response to the introduction of a pressurized fluid source. Each chamber includes a body lumen inner wall engaging surface and a pair of generally opposed flanges. Flexibly compliant links are disposed between adjacent chambers. These links may be integral with the flanges, or may constitute a separate hinge that couples the chambers at least to the central core. As the balloon is routed through a body lumen, curvature in the lumen is mimicked by the balloon, as it is able to flexibly conform to the shape of the lumen path by preferential bending at the flexibly compliant links.

Abstract: The present invention provides an assembly and method for topically applying a local anesthetic agent into the trachea and/or hypopharynx during intubation with a tracheal tube. The present invention is designed to topically anesthetize the tracheal surfaces that are in contact with the tracheal tube, thereby preventing the patient from experiencing physiological reactions such as coughing, pain or discomfort from the indwelling tracheal tube, as well as post operative or post extubation laryngospasm. Local anesthetic application can be performed by bolus or continuous infusion.

Abstract: A biosensor for monitoring pressure or other physical parameters at an aneurysm site is mountable to a tubular prosthesis that is expandable between contracted and enlarged conditions. A loop, having the biosensor attached thereto, is securable around the prosthesis. An apparatus is used to deliver the loop to an aneurysm site that includes a catheter having a connector on its distal end for detachably securing the loop thereto. The prosthesis is advanced in a contracted state to the aneurysm, and the apparatus, with the loop connected thereto, is advanced to the aneurysm site. The loop and the prosthesis are positioned coaxially with respect to one another, and the prosthesis is expanded towards its enlarged condition, thereby engaging the loop around the prosthesis and engaging the prosthesis with a wall of the blood vessel at the treatment site.

Abstract: The present invention relates to a medical device and a method of delivering a drug to a target circulation or tissue. The medical device has an expandable portion which is fabricated from a porous elastomeric material with a plurality of voids therein. The voids are loaded with drugs in various formulations. Upon inflation of the expandable portion, the overall diameter increases, the wall thickness decreases and, consequently, the voids are stretched to cause the drug to be expelled from the voids and into the bodily lumen or tissue adjacent to the medical device. The voids include any open volume within the expandable portion capable of containing the drug.

Abstract: The present invention relates to a system and device for preventing stenosis and/or restenosis after an invasive procedure in a body vessel or cavity having an inner wall surface, the system comprising inserting a device coated with a growth arresting, lipid-derived, bioactive substance at a desired location along the inner wall surface of the body vessel or cavity.

Abstract: A method and device for perfusing an organ system is provided. The device may be further described as a catheter or cannula with an expandable flow control member positioned of the distal portion of the catheter shaft. The flow control member has a porous portion, and at least one impermeable portion, which prevent fluid from flowing out the ends of the flow control member. The flow control member is further characterized as having an interior chamber that is in fluid communication with a perfusion lumen that extends along the length of the catheter shaft and is in fluid communication with an external perfusion pump. The perfusion lumen is configured for providing flow to the interior of the flow control member, to create radial expansion thereof and to provide adequate flow to the arch vessels through said porous portion to sustain the metabolic demands of the brain.

Abstract: An intravascular catheter such as an angioplasty catheter having a catheter shaft with an expandable tubular element on its distal end which upon inflation to an internal pressure at or above a threshold pressure expands in a manner which is related to the internal pressure. The maximum transverse dimension of the expandable tubular element is generally not greater than the maximum transverse dimension of the catheter shaft. Preferably, the expandable tubular element is formed of a heat shrinkable polymeric material such as a polyolefinic ionomer.

Abstract: The invention relates to a medical device, such as a stent or a balloon catheter that includes an expandable body portion which has an exterior surface that contacts a vessel wall during treatment. The medical device includes a first coating disposed over at least a portion of the exterior surface. The first coating includes a therapeutic substance that is intended for controlled release from the exterior surface. The medical device further includes a second coating overlaying at least a substantial portion of the first coating. The second coating includes a material that is generally impervious to elution of the therapeutic substance therethrough when the body portion is inserted into the vessel lumen. The material of the second coating is relatively inelastic so that the second coating fractures during expansion of the body portion to allow elution of the therapeutic substance through fissures formed in the second coating.

Abstract: Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism's reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism's reaction to the introduction of the medical device to the organism. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned.

Abstract: The invention described herein consists of an oxygen deliver source for local blood or tissue oxygenation. The invention consists of porous polymer structures being part of a medical device from which a liquid oxygen carrier is locally or systemically released. The substrate membrane impregnated with the oxygen carrier may be a part of a tube, a balloon, a perfusion balloon, a stent and a wire. The substrate membrane is sealed with a removable housing for the oxygen carrier to allow storage of the medical device.

Abstract: A therapeutic agent is applied to an internal tissue site of a patient by advancing typically a catheter into the patient to cause a portion of the catheter, typically a catheter balloon, to occupy the internal site. The balloon portion of the catheter carries the therapeutic agent, usually mixed with a controlled release carrier for the agent, typically on an outer surface of the section, to permit release thereof from the catheter balloon at the internal tissue site so that the therapeutic agent is locally applied to the internal tissue site.

Abstract: A mechanical dilatation and medicament delivery device for enlarging a flow passage of a vessel by dilating and delivering a therapeutic agent or medicament to an obstruction in the vessel. The present invention comprises a substantially cylindrically shaped expansion member and includes a means engaged to the expansion member for altering the distance between the proximal end and the distal end of the expansion member thereby transforming the expansion member between a diametrically contracted configuration to diametrically expanded configuration. A therapeutic agent or medicament is coated on either the expansion member, or incorporated into a substrate coated on the expansion member.

Abstract: A mechanical dilatation and medicament delivery device for enlarging a flow passage of a vessel by dilating and delivering a liposome or micelle-encapsulated therapeutic agent or medicament to an obstruction in the vessel. The present invention comprises a substantially cylindrically shaped expansion member and includes a means engaged to the expansion member for altering the distance between the proximal end and the distal end of the expansion member thereby transforming the expansion member between a diametrically contracted configuration to diametrically expanded configuration. A liposome or micelle-encapsulated therapeutic agent or medicament is coated on either the expansion member, or incorporated into a substrate coated on the expansion member.

Abstract: A catheter having a perfusion section encapsulated by a porous membrane. The catheter can include a shaft to accommodate a radiation source. A spiraled balloon can be positioned about the shaft for centering within a body lumen. Additionally, a longitudinal balloon or mechanical expansion can be provided about the shaft for positioning within a body lumen. A radiotherapy system can be included with a radiation source and a catheter having a perfusion section encapsulated by a porous membrane. A method is provided where a catheter with a perfusion section encapsulated by a porous membrane is advanced through a body lumen. The body lumen is treated by the catheter while a body fluid is perfused past the perfusion section.

Abstract: Tissue in the crura is treated by advancing a tissue penetrating element from a catheter tube through a wall of the esophagus. The tissue penetrating element is operated to affect a tightening of the crura, e.g., to treat hiatal hernia.

Abstract: A drug delivery device for delivering therapeutic agents and method of making such a device. The device including an inflatable balloon having a plurality of holes formed in the wall of the balloon. A microporous coating covers a portion of the outer surface of the wall of the balloon. The thickness of the coating and the size of the micropores can permit controlled delivery of a substance from the micropores of the coating and into the tissue of a patient's lumen.

Abstract: The invention features a method for triggering release of a drug from a hydrogel polymer to tissue at a desired location of the body using a catheter. A portion of the catheter is coated on its outer surface with a polymer having the capacity to incorporate a predetermined substantial amount of drug which is immobilized in the polymer until released by a triggering agent or condition that is different from physiological conditions. Upon contact with a triggering agent or condition, the polymer reacts, e.g., swells or contracts, such that the drug is delivered to the desired body tissue. A balloon catheter is shown in which the hydrogel is carried on the exterior surface of the balloon.

Abstract: A balloon catheter having an elongated tubular portion having a proximal end portion and a distal end portion. The balloon is attached to the catheter near the distal end portion. At least one reservoir is attached to the balloon. An expandable copolymer gel fills the reservoir and an electrode is operably attached to the expandable copolymer gel. This permits the balloon to change shape in response to a voltage applied to the electrode.

Abstract: At least a portion of a catheter system (10) is provided with fullerene material (56) for performing or facilitating a medical procedure. In the case of a balloon catheter, the outer surface of the balloon may have a coating of fullerenes (64), which are preferably photosensitive or activated by light. A light source (60) can be used to illuminate or other wise activate the fullerene material. The light source (60) may be formed by one or more optical fibers extending through the shaft of the catheter, and into the balloon. Various arrangements of the catheter system are possible, whereby the light source may selectively emit light outward through the fullerene material, and associated portions of the catheter system, which may be translucent. When activated by light, the fullerene coating may preferably generate, and give off therapeutic oxygen radicals. These oxygen radicals may affect local cell function to prevent or reduce cell proliferation.

Abstract: A medical device, such as a stent or balloon of a balloon catheter which includes a body portion which has an exterior surface which contacts, at least in part, a vessel wall during treatment. The body portion is expandable from a first position, wherein the body portion is sized for insertion into the vessel lumen, to a second position, wherein at least a portion of the exterior surface is in contact with the lumen wall. The medical device includes a first coating disposed over at least a portion of the exterior surface of the body portion with the first coating including a drug or therapeutic substance which is intended for controlled release from the surface. The medical device further includes a second coating overlying at least a substantial portion of the first coating. The second coating includes a material that is generally impervious to elution of the drug or therapeutic substance therethrough when the body portion is in a first position when inserted into the vessel lumen.

Abstract: A novel process for paving or sealing the interior surface of a tissue lumen by entering the interior of the tissue lumen and applying a polymer to the interior surface of the tissue lumen. This is accomplished using a catheter which delivers the polymer to the tissue lumen and causes it to conform to the interior surface of the lumen. The polymer can be delivered to the lumen as a monomer or prepolymer solution, or as an at least partially preformed layer on an expansile member.

Abstract: The present invention regards a therapeutic delivery balloon and includes a system for delivering therapeutic to an irregular interior vessel surface. This system includes a catheter having a proximal end, a distal end, and an internal lumen; a source of fluid in communication with the internal lumen of the catheter; and, a first inflatable balloon having an exterior surface, wherein the balloon is hyper-deformable, is in communication with the internal lumen of the catheter, and has an exterior surface in communication with a therapeutic when the balloon is in expanded state.