Abstract: Methods, devices and systems for in situ formation of an implant within a post-surgical cavity. A balloon is provided within the cavity and a gelling initiator such as a cross-linking agent is introduced into the balloon. A polymer susceptible to solidifying in the presence of the gelling initiator is then introduced into the balloon. The introduced polymer is allowed solidify through contact with the introduced gelling initiator to form the implant while the balloon isolates the solidifying implant from the cavity. The balloon is then ruptured and extracted from the cavity such that the formed implant remains within and directly contacts an interior surface of the cavity.

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

Abstract: A balloon catheter system enables only a target site to be efficiently ablated, ensuring a balloon to be able to be brought into close contact with the target site in conformity to a shape of the target site. The balloon includes a contact portion that contacts the target site and a noncontact portion that does not contact the target site. A membrane thickness of the contact portion is thinner than that of the noncontact portion The target site that is in contact with the thin contact portion is selectively ablated, while the thick noncontact portion is less likely to exhibit a temperature increase. Hence, only the target portion is efficiently ablated.

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

Abstract: Medical devices for delivering a bioactive agent and methods of use thereof are provided. The medical devices include micro-needles integrated within a balloon of a catheter. The balloon can include dimples, cavities or a variable thickness membrane in which the micro-needles are integrated.

Abstract: The invention provides a system and method for localized application of therapeutic substances within a biological lumen and to the wall of the lumen. In various embodiments, a biodegradable tubular prosthesis comprising a plurality of pores is deployed within a biological lumen. Subsequent to, or in conjunction with, the deployment of the prosthesis, a drug-eluting balloon comprising at least one therapeutic agent is expanded within the lumen of the tubular prosthesis, thereby releasing the agent(s) from the balloon and delivering them to the prosthesis pores. The at least one therapeutic agent is then allowed to diffuse through the pores to the lumen wall.

Abstract: An apparatus is provided that is operable in different modes to perform various functions for treating a body lumen. The apparatus includes a shaft including a proximal end, a distal end, a lumen extending therebetween, and a balloon on the distal end having an interior communicating with the lumen. The apparatus includes a valve on the distal end that selectively opens or closes an outlet communicating with the lumen. With the valve open, fluid introduced into the lumen exits the outlet into a body lumen. With the valve closed, fluid introduced into the lumen expands the balloon. The apparatus also includes an actuator for axially compressing the balloon, and a helical member extends between ends of the balloon interior that expands the balloon from a contracted condition to an expanded helical shape when the actuator is activated.

Abstract: The present invention provides a pharmaceutical composition comprising a pharmaceutically acceptable excipient and a compound of the formula: wherein R1, R2, R3, R5, R6 and R8 are each independently a member selected from the group consisting of H, C1-6 alkyl and OH; R4, R7 and R9 are each independently selected from the group consisting of C1-6 alkoxy and OH; R10 is a member selected from the group consisting of H, —OH, —OP(O)Me2, —O—(CH2)n—OH and —O—(CH2)m—O—(CH2)o—CH3, wherein subscripts n and m are each independently from 2 to 8 and subscript o is from 1 to 6; each of L1 and L4 are independently selected from the group consisting of: each of L2 and L3 are independently selected from the group consisting of: and salts, hydrates, isomers, metabolites and prodrugs thereof.

Abstract: A catheter is described herein, having a catheter shaft including a proximal end and a distal end, a tip attached to the distal end, including first and second legs spaced apart to form a slot therebetween, the slot in fluid communication with a lumen of the catheter shaft, and a bladder inflatable element positioned over an outer surface of at least one of the first and second legs.

Abstract: Devices that are adapted to insert a sinus dilator into a stenotic opening of a paranasal sinus in a subject patient using minimally invasive insertion procedures are provided. The devices and methods can be used to treat sinusitis and other nasal and/or sinus disorders.

Abstract: Medical devices for delivering a bioactive agent(s) and methods of use thereof are provided.

Abstract: Embodiments of the invention are related to devices and methods for modulating renal function, amongst other things. In an embodiment, the invention includes an implantable occlusive device including a wall member defining an enclosed volume, the wall member can include a semi-permeable membrane. The device can also include a solution comprising a solvent and a solute disposed within the enclosed volume of the wall member. The semi-permeable membrane can be permeable to the solvent and impermeable to the solute. The enclosed volume can be configured to expand and contract in response to changes in the osmolality of a bodily fluid. The device can include a positioning member configured to maintain the position of the implantable occlusive device relative to a lengthwise axis of a lymphatic vessel.

Abstract: Embodiments of the present invention include a self-powered infuser with a medicament containing vessel coupled to the infuser capable of exerting sufficient pressure to cause a medicament to flow from the containing vessel, through intravenous tubing, and into a patient's circulatory system. The infuser and vessel may be contained within a sealable kit which may have a separate container for perishable medications such that the medications may be inspected and changed without exposing the remainder of the kit's contents. The infuser may be recyclable or disposable.

Abstract: A device and method for administering a bioactive agent to internal tissue in a body, by introducing a balloon in a deflated condition into the body, inflating the balloon, introducing the bioactive agent into the balloon at the time of, after, or before the inflation of the balloon, and delivering the bioactive agent from the balloon to the tissue.

Abstract: A catheter used for treatment of complex vasculature, such as a bifurcated aneurysm, is provided with an inflatable balloon at a distal portion thereof. The shape, location and material of the inflatable balloon are selected such that when inflated, the balloon conforms to the shape of the complex vasculature, or at least a portion thereof, without appreciably deforming the vessel walls. In this manner, the balloon can be used to control flow in the vasculature, for example occluding a selected branch of the vasculature during introduction of material in order concentrate the material and minimize its disbursement by blood flow.

Abstract: A medical implant device includes a shaft, an expandable member coupled to the distal end portion of the shaft, a sleeve and a detachment mechanism. The expandable member is configured to move between a collapsed configuration and an expanded configuration, and can be used to deliver a medicament, a therapeutic substance and/or a structural member into the body. The sleeve is coupled to the distal end portion of the shaft, and is configured to move relative to the shaft between a first position and a second position. The sleeve is configured to be disposed about the expandable member when in the first position and disposed apart from the expandable member when in the second position. The detachment mechanism is coupled to the distal end portion of the shaft, and is configured to detach the expandable member from the shaft when the sleeve is in the second position.

Abstract: A catheter for delivering an agent to an area of treatment is presented. The catheter includes a catheter body, a balloon assembly coupled to the catheter body, a first lumen, and a second lumen. The balloon assembly has spaced-apart balloons that define an area between the balloons. The first lumen extends along the catheter body to pass an inflation material to the balloons to control an inflation level of the balloons. The second lumen extends along the catheter body and having an outlet in the area between the balloons. There may be a third lumen for bypassing a biological fluid such as blood while the catheter is being used. The method of using this catheter is also presented. The method entails simultaneously inflating the balloons to isolate a treatment area and adding an agent to the treatment area through one of the lumens.

Abstract: A system and method for localized delivery of a therapeutic or diagnostic agent within a vessel is provided. The system and method provide for adjustability of the length of the treatment area and for reducing of pressure within the treatment area. A catheter system includes an inner elongated element, an outer elongated element positioned coaxially with respect to the inner elongated element, and a blood-release element at a distal end of the inner elongated element. A proximal occlusion element is positioned at the distal end of the outer elongated element, proximal to an outlet port. A distal occlusion element is positioned at a distal end of the inner elongated element. The distal end of the inner elongated element is distal to and movable with respect to the outer elongated element distal end.

Abstract: A balloon catheter for dilation of stenotic tissue within a tubular member of the body such as a blood vessel provides fluid flow such as blood flow through the balloon while it is being inflated and after it has been inflated. For valvuloplasty applications or for predilitation prior to a TAVI procedure the balloon is placed across the stenotic aortic valve leaflets and inflated to push the leaflets aside to create a greater blood flow area or allow improved subsequent passage of the large TAVI catheter across the stenotic aortic valve leaflets. As the balloon is inflated in diameter, it is required to reduce in length; this length reduction causes a braided inner tubing to also reduce in length. The braided inner tube is thereby required it to increase in diameter during the balloon inflation and create a suitably large blood flow path through the inner tubing.

Abstract: The present application includes devices, systems and methods for therapeutic agent delivery. A device in accord with the invention may include a first infusion lumen having a proximal end, a distal end, a longitudinal axis and a therapeutic agent. This device may also include an inflatable balloon in fluid communication with the first infusion lumen, the inflatable balloon having an exit outlet wherein the device is configured to exert pressure at a target site with an external surface of the balloon, the exerted pressure greater than a target pressure prior to the therapeutic agent exiting the inflatable balloon. A method in accord with the invention may include positioning a delivery device near an intended treatment site, injecting therapeutic agent through an infusion lumen into an inflatable balloon, and determining a target pressure at a target site by monitoring the blood pressure of a patient.

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

Abstract: Methods for more uniformly delivering drugs or other treatment agents locally to the vasculature of a mammal are disclosed. These methods use one or more strategies to facilitate rapid mixing with the blood flowing past a device or otherwise improve the uniformity of drug delivery. Some of these strategies employ medical devices with diffusion members.

Abstract: Procedures for the stabilization of vulnerable plaque can comprise identification of the vulnerable plaque and the delivery of a stabilization composition to the location of the vulnerable plaque. For example, the stabilization composition can be delivered to an isolated portion of the vessel with the vulnerable plaque and/or alternatively or additionally using a profusion balloon that delivers the stabilization composition at the vessel wall near the vulnerable plaque. Suitable stabilization compositions can comprise a collagen crosslinking agent, an elastin stabilization agent, VEGF or a combination thereof. Vascular endothelial growth factor (VEGF) can be used to encourage endothelialization of the vessel wall near the vulnerable plaque.

Abstract: Embolic protection and plaque removal apparatus and methods are provided wherein an aspiration device aspirates, filters and reperfuses blood using a closed fluid circuit having a bi-directional working lumen. The plaque removal device includes a plurality of self-expanding cutting elements that form a cage that self-centers within the blood vessel to reduce the risk of trauma to the vessel lining.

Abstract: Devices for delivering drugs or other treatment agents locally to the vasculature of a mammal are disclosed. These devices have several related structures and are designed to deliver the drugs to facilitate rapid mixing with the blood flowing past the devices.

Abstract: An integrated guiding device has a tube and a corewire within the tube and a torque coupler. The torque coupler can couple the rotational motion of the tube with the rotational motion of the corewire. The wire can be moved longitudinally at least some amount relative to the tube. The device can further comprise a functional medical structure, such as an embolism protection structure. The device can be used in medical procedures, such as less invasive procedures within the cardiovascular system. Improved fiber based embolism protection devices comprise fiber bundles that are twisted prior to delivery.

Abstract: Devices and methods for balloon delivery of rapamycin and other hydrophobic compounds to the wall of blood vessels. Balloon catheters, such as those used for balloon angioplasty, are modified with the addition of a reservoir of dry micelles, disposed at a suitable location within the balloon or catheter. The reservoir may be installed within the angioplasty balloon, within a lumen in communication with the angioplasty balloon, either as a loose or packed powder or as a film coating. The micelle preparation is reconstituted and the micelles are mobilized when the aqueous solution used to inflate the balloons is injected into the catheter. The micelles are infused into tissue surrounding the balloon when pressurized fluid within the balloon leaks through the wall of the balloon.

Abstract: There are disclosed apparatus and methods for treating tissue by delivering at least one therapeutic agent into the tissue. In one embodiment, the apparatus comprises a catheter (30, 40) and a balloon member (150) disposed on a distal region of the catheter. A plurality of pockets (164) are disposed on the balloon member (150), and a plurality of needles (180) are associated with each of the plurality of pockets. The plurality of needles (180) are configured to engage tissue when the balloon (150) is in the inflated state, and further are configured to disperse a therapeutic agent from an associated pocket (164) into the tissue when the balloon (150) is in the inflated state. A first needle (180a) of the plurality of needles may comprise a length that is different than a second needle (180b), permitting the delivery of first and second therapeutic agents to different depths within the tissue.

Abstract: A catheter assembly for intracranial treatment of a patient is disclosed. The assembly comprises outer and inner catheters. The outer catheter has an exterior surface, an inflatable balloon mounted upon the exterior surface, at least one element distal to the balloon, at least one aperture and a lumen. The inner catheter is sized to be received within the lumen and has a passageway extending between a proximal end and at least one port. The lumen is adapted to guide the inner catheter to the desired tissue region in the brain. Each element is adapted to monitor brain activity within the tissue region, to electronically stimulate the tissue region, or to provide information on a precise position of the element when the element is entirely within the brain. The elements are mounted proximal to the distal end of the outer catheter upon the exterior surface of its distal portion.

Abstract: A method and system for delivering a medicament into tissue, for example via a balloon with small pores. Optionally, the pressure used is high enough to cause jetting, but the pore sizes, pore density, pressure and/or delivery time are such that the jetting do not cause unacceptable tissue damage. Optionally, the pores are smaller than 2 microns, are between 300 and 600 per square centimeter and the pressure is above 8 atmospheres.

Abstract: The present disclosure relates to a sheath system for enabling access through an opening in the body of a patient is provided. The sheath system includes a dilation assembly having a radially expandable tubular sheath defining a lumen having a first cross-sectional area when in a non-expanded condition, and a handle assembly operatively coupled to a proximal end of tubular sheath, the handle assembly defining an aperture formed therein, and a first thread defined on the handle in the aperture thereof. The sheath system further includes an expansion assembly including a tubular member defining a lumen having a second cross-sectional area which is larger than the first cross-sectional area of the tubular sheath of the dilation assembly and having an outer surface defining a second thread, the second thread being arranged for engaging the first thread.

Abstract: An exemplary basket catheter includes an outer tubing housing an inner fluid delivery tubing having at least one fluid delivery port. A plurality of splines are each connected at a proximal end of the splines to the outer tubing and at a distal end of the splines to the inner fluid delivery tubing. The inner fluid delivery tubing is operable to be moved in a first direction to expand the splines; and in a second direction to collapse the splines. A porous membrane is provided over at least a portion of the inner fluid delivery tubing. A seal is provided at a proximal end of the porous membrane between the porous membrane and the outer tubing and between the porous membrane and the inner fluid delivery tubing, the seal configured for irrigating between the plurality of splines of the basket catheter while preventing fluid ingress into the outer tubing.

Abstract: The present invention provides a cardiac vascular occlusion system which includes inner and outer guide catheters and an occluding member disposed on the inner catheter. The occluding member may be deployed from a compressed to an expanded position to limit retrograde blood flow in a body lumen. The occluding member may be used when injecting a contrast agent into the body lumen.

Abstract: A medical device, at least a portion of which is formed from a polymer composition including at least one liquid crystal block copolymer having at least one A block and at least one B block wherein the A block is a liquid crystal polymer block formed of repeating units comprising mesogenic groups and the B block is a non-liquid crystal polymer block.

Abstract: A balloon catheter that comprises an inner shaft, a balloon and a sleeve that defines a lumen. A portion of the inner shaft is positioned within the lumen and the balloon is engaged to the sleeve at least two engagement points.

Abstract: A medical device comprising a compartment capable of receiving and holding a substance in a liquid form is disclosed. The compartment is inflatable from a deflated state to an inflated state, such that when the compartment is in the deflated state, the outer wall of the membrane is substantially impermeable to the substance, and when the compartment is in the inflated state, the substance is allowed to permeate through the outer wall.

Abstract: The present disclosure generally provides a multiple balloon assembly used as part of the distal region of a medical device that is capable of delivering a therapeutic agent into a body vessel having bodily fluid. The multiple balloon assembly comprises an inner balloon and an outer balloon. The outer balloon further comprises a proximal taper region, a middle region, and a distal taper region. The inflation of the inner balloon causes the middle region of the outer balloon to contact the inner wall of the body vessel, thereby, occluding the flow of fluid through the body vessel. The proximal taper region and the distal taper region are configured such that they do not touch the inner wall of the body vessel. One of the distal taper and proximal taper regions has a plurality of apertures configured to allow for the therapeutic agent to be delivered into the body vessel at a predetermined rate.

Abstract: A medical device, at least a portion of which is formed from a polymer composition including at least one liquid crystal block copolymer having at least one A block and at least one B block wherein the A block is formed of mesogenic repeat units and the B block is a soft block.

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 present invention is directed to the treatment of various ailments associated with the prostate gland, including benign prostate hypertrophy (BPH), cancer and chronic inflammatory diseases. The present invention describes, inter alia, devices, methods and therapeutic agents for the treatment of prostatic ailments.

Abstract: The invention relates to a drug-coated balloon catheter and to a method for producing the same. The balloon of the catheter includes (i) a main membrane, and (ii) an asymmetrical polymer membrane which is applied to an outside of the main membrane and into which at least one pharmaceutical active ingredient is introduced.

Abstract: Described herein are medical devices which are configured for implantation or insertion into a subject, preferably a mammalian subject. The medical devices contain one or more multilayer regions, which contain: (a) one or more (typically a plurality of) charged nanoparticle layers and (b) one or more (typically a plurality of) charged polyelectroyte layers. Such multilayers have a number of desirable attributes, including high strength, non-compliance, and flexibility. Also described herein are methods of making such devices.

Abstract: A drug delivery catheter and method are provided for delivering drugs to a targeted region of a lumen include drug-laden microcapsules provided within a porous catheter balloon with an effective pore size that prevents free-flow of the microcapsules through the porous wall of the balloon. The microcapsules are frangible under the influence of increased pressure within the balloon. In an alternative embodiment, the microcapsules may be mechanically ruptured by compression between the outer porous balloon and optional, inner, non-porous balloon. The drug is emitted from the microcapsules through the balloon pores and against the targeted luminal surface.

Abstract: A system for treating a vascular condition including a catheter and a splittable elastomeric drug delivery device. The splittable elastomeric drug delivery device includes a balloon disposed on the catheter. The balloon includes a first elastic layer and a second elastic layer. A therapeutic agent layer is disposed on at least a portion of the first elastic layer, and the second elastic layer is disposed on the first elastic layer and the therapeutic agent layer. The first elastic layer has a first elongation-at-break percentage and the second elastic layer has a second elongation-at-break percentage.

Abstract: A dual-layer dilatation balloon, and a process of making such balloon, which includes an inner layer that includes a plasticizer and a polymer selected from the group consisting of a polyamide, a copolymer thereof, and a combination thereof, and an outer layer that includes an ethylene-propylene rubber. The dual-layer balloon optionally further includes a stent disposed on the balloon. The stent is optionally a drug-eluting stent.

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: A porous balloon or other catheter structure is formed by creating specific size pores for delivering an agent to a body lumen. The pores can be created by passing matter or energy through the surface of the catheter structure, as by a laser or a projectile. In the case of a laser, the catheter structure can be reversed so that the inner surface becomes the outer surface to convert diverging pores into converging pores. In the case of projectiles, a pore size can be achieved by selecting an appropriate size and shaped projectile to obtain the desired characteristic. Alternatively, a material to make the catheter structure can include impurities that can be removed once the catheter structure is set, leaving pores where the material formed around the impurities.

Abstract: An ablation device includes an inflatable member having a cavity, a layer surrounding at least part of the inflatable member, wherein the layer includes one or more ablation elements for providing ablation energy, and a plurality of channels located between the layer and the inflatable member, wherein the layer has a plurality of openings that are in fluid communication with the plurality of channels. An ablation device includes an inflatable member having a cavity, and a layer surrounding at least part of the inflatable member, wherein the layer includes one or more ablation elements for providing ablation energy, wherein the layer has a plurality of openings, and is spaced away from at least a portion of the inflatable member.