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.

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.

Abstract: The present invention relates to a nano-enhanced device for substance transfer between the device and a tissue. The device comprises a substrate with substantially aligned carbon nanotubes anchored within the substrate, and with at least one end of the carbon nanotubes protruding from the substrate. The protruding nanotube ends may be coated with a drug for delivery of the drug into body tissue. The present invention may be incorporated into an angioplasty catheter balloon or into a patch that is worn on the skin. The carbon nanotubes can be grouped in clusters to effectively form nano-needles which can transfer fluid to or from the subdermal tissue. The nano-needles can be used in conjunction with a sensor to ascertain body fluid information such as pH, glucose level, etc.

Abstract: A drug delivery catheter and method for delivering microcapsules or microspheres containing a drug, pharmacological or other bioactive agent includes a balloon catheter having a coating on the balloon of a soluble biocompatible polymer containing a plurality of microcapsules or microspheres containing a drug or other agent. The balloon is porous to allow it to be inflated with a solvent fluid that passes through the porous wall of the balloon and dissolves the polymer, releasing the microspheres.

Abstract: The invention provides systems and methods for tissue expansion. A tissue expander may have an implant portion which may be used to expand the tissue. A delivery/drainage system may be also be provided, which may be in fluid communication with a pocket surrounding the tissue expander. Various port configurations may be provided that may provide access to the implant portion and/or the delivery/drainage system. The tissue expander may advantageously help prevent or treat infection, or check the state of the pocket surrounding the tissue expander.

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: The present invention relates to balloon catheters with or without crimped stent, whose surface is coated with at least one antirestenotic agent and at least one transport promoting molecular dispersant, as well as a method for the preparation of these medical devices.

Abstract: A system and method of treating urinary incontinence including a catheter and injection guide operatively disposed together. At least one needle is operatively disposed within at least one lumen and at least one channel extending through the catheter and injection guide respectively. The injection guide is transformable from a pre-injection configuration for placement in the bladder to an injection configuration for injection of a pharmaceutical such as botulinum toxin into the bladder tissue. Upon introduction of the pharmaceutical to the bladder tissue, symptoms of incontinence are alleviated.

Abstract: The present disclosure relates to balloon catheter medical devices. Some balloon catheter medical devices may include a balloon surface having paclitaxel embedded in a low-molecular weight matrix substance adhered thereto and dried. The dried paclitaxel may be immediately releasable after coming into contact with tissue. Other balloon catheter medical devices may include a balloon surface having a lipophilic proliferation inhibitor, an inflammation inhibitor, or an antioxidant adhered thereto.

Abstract: Various embodiments provide a device comprising a balloon disposed at least partially along a template, the template including an aperture, wherein the template has a substantially cylindrical portion that resists deformation in a radial direction, wherein the balloon expands radially during inflation, wherein a portion of the balloon at least partially protrudes about the aperture. Other embodiments are directed toward balloons having textured surfaces.

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 guidewire catheter having at least one guidewire lumen extending therethrough and a slidable concentric tube disposed over the guidewire catheter. At least one bellow is coupled to the concentric tube and configured for conversion between an unexpanded and expanded configuration wherein movement of the concentric tube in a first direction causes the at least one bellow to expand and movement of the concentric tube in a second direction causes the at least one bellow to contract. Additionally, the concentric tube contains at least one port for delivery of a therapeutic agent, e.g. a sclerosing agent. The at least one bellow expands and contracts via mechanical forces.

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

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: 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: The present invention relates to methods and compositions for delivering a nucleic acid to be expressed in the myocardium of a patient. More specifically, the present invention relates to techniques and polynucleotide constructs for treating heart disease by in vivo delivery of angiogenic transgenes.

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 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 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, an antioxidant, 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 some embodiments, the additive is a liquid. In other embodiments, the additive is at least one of a surfactant and a chemical compound, and the chemical compound has one or more hydroxyl, amino, carbonyl, carboxyl, acid, amide or ester groups.

Abstract: A timed-release drug delivery assembly includes an expandable structure and drug microparticles. The expandable structure is defined by host material that causes expansion of the expandable structure. The expandable structure has a non-expanded state prior to exposure to a gastric environment during which a size of the expandable structure enables entry of the expandable structure into a stomach of a patient, and an expanded state after exposure to the gastric environment during which the size and shape of the expandable structure prevents exit of the expandable structure from the stomach. The drug microparticles are held at least in part by the host material to enable release of the drug microparticles into the gastric environment over a predefined period of time. The expandable structure may include, in the expanded state, a substantially hollow framework to avoid blocking a pyloric valve of the stomach.

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: A catheter-based/intravascular fluid injection system with application to renal denervation includes a multiplicity of needles which expand open around a central axis to engage the wall of a blood vessel, or the wall of the left atrium, allowing the injection of a cytotoxic and/or neurotoxic solution for ablating conducting tissue, or nerve fibers around the ostium of the pulmonary vein, or circumferentially in or just beyond the outer layer of the renal artery. The expandable delivery system includes expandable components that facilitate positioning of a multiplicity of injection needles against the inside wall of a blood vessel from where they can be advanced. The system also includes means to limit and/or adjust the depth of penetration of the ablative fluid into the tissue of the wall of the targeted blood vessel.

Abstract: The present invention is related to a medical device carrying at least on a portion of its 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 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 nordihydroguaiarectic acid, resveratrol and propyl gallate, and wherein scoring or cutting balloons as medical devices are excluded.

Abstract: The present invention is related to a medical device carrying at least on a portion of its surface a Limus drug or Limus drug preparation and butylated hydroxytoluene at a ratio of 3-100% by weight of butylated hydroxytoluene in relation to 100% by weight of the Limus drug.

Abstract: A method for delivering a therapeutic substance to a treatment site within a body lumen includes advancing a balloon catheter to the treatment site. A balloon of the balloon catheter is inflated and while the balloon is inflated, a primer that coats the treatment site and attracts the therapeutic substance thereto is delivered through a first fluid delivery lumen of the balloon catheter. The balloon of the balloon catheter is deflated for a predetermined period of time. The balloon of the balloon catheter is reinflated and while the balloon is reinflated, the therapeutic substance is delivered through a second fluid delivery lumen of the balloon catheter. The primer improves adherence of the therapeutic substance to the treatment site.

Abstract: A non-polymeric or biological coating applied to a radially expandable interventional medical device in a collapsed, wrapped, or folded configuration, the coating applied within at least one fold. Properties of the coating material applied to the medical device are adjusted or varied to result in a desired combination of coverage of the surface of the medical device, drug loading, and coating thickness. The coating is sterile, and is capable of being carried by a sterile medical device to a targeted tissue location within the body following radial expansion. The therapeutic coating transfers off the medical device due in part to a biological attraction with the tissue and in part to a physical transference from the medical device to the targeted tissue location in contact with the medical device.

Abstract: A method of occluding includes imbibing a porous elongate element comprised of ePTFE with a calcium-containing solution. The method also includes delivering, via a delivery catheter, the calcium-imbibed porous elongate element to a target occlusion site. The method further includes administering, after the calcium-imbibed porous elongate element has been completely delivered to the target occlusion site and resides entirely within a volume defined by the target occlusion site, an alginate-containing solution to the target occlusion site.

Abstract: Medical devices using an expandable body to deliver a therapeutic agent. In one particular embodiment, the medical device comprises a tubular catheter and an inner expandable body (e.g., a scaffolding) contained within the catheter. The inner expandable body is connected to a core wire for advancing or retracting the inner body. The inner body may be advanced to exit out of the catheter or retracted to withdraw the inner body back into the catheter. This particular embodiment further comprises a sheath on the outside of the interior of the catheter. The sheath carries a plurality of capsules that contain a therapeutic agent. The therapeutic agent is delivered by pushing the core wire to advance the inner body, which expands against the sheath, causing the capsules on the sheath to be compressed against body tissue such that the therapeutic agent is released.

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 present disclosure provides a textured dilatation balloon that includes a balloon body having a proximal end, a distal end, and at least one indentation in the balloon body in an un-inflated state, wherein the balloon body comprises a continuous polymer tube with an external surface having at least one therapeutic agent disposed within the at least one indentation.

Abstract: An endoprosthesis (e.g., a sleeve) can be used to deliver therapeutic agents to vascular dissections or perforations. The sleeve can have a tissue adhesive and a drug-eluting biodegradable substrate layer.

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: 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: Methods and devices are disclosed that, in various embodiments and permutations and combinations of inventions, diagnose and treat Multiple Sclerosis, Deep Vein Thrombosis, and/or Pulmonary Embolism or symptoms associated with these maladies. In one series of embodiments, the invention consists of methods and devices for identifying patients whose Multiple Sclerosis, Deep Vein Thrombosis, and/or Pulmonary Embolism or associated symptoms are caused or exacerbated, at least in part, by blockages of one or more of the patient's veins. In some instances, stenoses or other flow limiting structures or lesions in the patient's affected veins are identified. Further, in some instances the nature of such lesions and whether there is a significant disruption of blood pressure, or both, is ascertained. In some embodiments, methods and devices for applying one or more therapies to the blockages in the patient's veins are provided.

Abstract: The present invention is related to dilatable medical products having short-term contact with the organism, as e.g. balloon catheters coated with at least one layer of at least one antiproliferative, immunosuppressive, anti-angiogenic, anti-inflammatory, fungicidal and/or anti-thrombotic agent and a transport mediator or a mixture of transport mediators, methods for coating of these coated dilatable medical products and the use of compositions for this coating.

Abstract: A wound drainage and hemostasis promoting medical device (1) are disclosed. A balloon (15) is temporary inflated and arranged outside a sheath (10), in contact with tissue surrounding a wound cavity for hemostasis promotion. The drainage device comprises a fluid communication channel for wound exudate from wound. The balloon is deflated and retracted into said sheath for removal from said wound cavity. Thus the medical device is percutaneously retractable from said confined wound.

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: Methods and intravascular treatment devices for treating atherosclerosis are provided.

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: 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: 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: 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: Introducer sheath for use in inserting a balloon catheter into a patient's vasculature includes a tubular member having an inner diameter, an outer diameter, a proximal end, a distal end, and a length therebetween, the inner diameter being sized to receive a catheter shaft having an attached expandable member in a deflated condition. The inner diameter can be varied from a first inner diameter at the proximal end and a second inner diameter at the distal end, the first inner diameter being greater than the second inner diameter. A method of inserting a balloon catheter into the vasculature of a patient is also disclosed. Additionally, a balloon catheter kit including a catheter and an introducer sheath is disclosed.

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 non-polymeric or biological coating applied to a radially expandable interventional medical device in a collapsed, wrapped, or folded configuration, the coating applied within at least one fold. Properties of the coating material applied to the medical device are adjusted or varied to result in a desired combination of coverage of the surface of the medical device, drug loading, and coating thickness. The coating is sterile, and is capable of being carried by a sterile medical device to a targeted tissue location within the body following radial expansion. The therapeutic coating transfers off the medical device due in part to a biological attraction with the tissue and in part to a physical transference from the medical device to the targeted tissue location in contact with the medical device.

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: A method for delivering at least one drug at a target site in a blood vessel for treating at least one of an acute myocardial infarction, a thrombus containing lesion and a saphenous-vein graft lesion is disclosed. The method includes delivering nano-carriers at the target site. The nano-carriers include one or more drugs encapsulated with a first biological agent. The nano-carriers further include a second biological agent in contact with one or more of the first biological agent and the one or more drugs. The first biological agent and the second biological agent have a first dissolution rate and a second dissolution rate respectively. The first dissolution rate is different from the second dissolution rate. The one or more drugs are released at the target site from the nano-carriers at a first release rate and a second release rate in response to dissolution of the first biological agent and the second biological agent, respectively.

Abstract: Medical balloons having one or more folds, on which are disposed protective surfaces e.g., protective lines or strips, and at least one therapeutic agent between the lines. The protective surfaces prevent, inhibit, or reduce the contact between therapeutic agent on one area, e.g., a surface area, and an opposing area or therapeutic agent on the opposing area when the balloon is folded. The protective surfaces also prevent, inhibit, or reduce loss of therapeutic agent from the balloon surface as a result of, for example, contact with a medical device during expansion or removal of a protective sheath. Also a medical device delivery system comprising a medical device surrounded by a retractable sheath, wherein protective surfaces are disposed on the sheath.

Abstract: The invention discloses an insertable medical device for delivering one or more pro-healing agents to a site of deployment of a stent in a blood vessel. The surface of the insertable medical device is coated with nano-carriers that include the one or more pro-healing agents encapsulated with one or more biological agents. The nano-carriers are released when the insertable medical device is expanded at the site. The nano-carriers thus released penetrate tissues at the site resulting in dissolution of the one or more biological agents. Thereafter, the one or more pro-healing agents are released from the nano-carriers at the site. Thus, an in-tissue release of the one or more pro-healing agents at the site is achieved thereby improving endothealisation, extracellular matrix formation and healing at the site post deployment of the stent in the blood vessel.

Abstract: A drug delivery device for delivering therapeutic agents and a method of making such a device is disclosed. The device includes an inflatable 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 desirable delivery of a substance from the micropores of the coating and into the tissue of a patient's lumen.

Abstract: Methods for the treatment of asthma are provided, which comprise: (a) providing an implantable or insertable medical device that comprises an asthma treatment agent; and (b) inserting or implanting the medical device within the lungs (e.g., the trachea or the bronchial tree) of a patient, whereupon the therapeutic agent is delivered to the patient in an amount effective to reduce or eliminate the symptoms of asthma. Also disclosed herein are medical devices and kits for carrying out such methods.