Abstract: Various devices are described to provide filtering of flow from the aorta to the left carotid artery and the right carotid artery. The filters can be brought into a desired position through one or more peripheral arteries. A single filter device can provide the desired filtering or a plurality of devices can be used. In particular a single filter device can span between the brachiocephalic artery and the left carotid artery. These filter devices can be used effectively to capture emboli generated during procedures on the heart so that emboli do not travel to the patient's brain where the emboli can cause a stroke or other adverse event. In particular, these filters can be used during percutaneous procedures on the heart, such as endovascular heart valve replacement.

Abstract: A spacer for a knee replacement prosthesis. The spacer may have a lower surface with a locking component adapted to interlock with a tibial tray, an upper surface optionally with a tibial post and a pair of smooth-surfaced and slightly concave condyle support platforms disposed on opposite sides of the tibial post, and a substantially hollow body with an internal reservoir that can be filled with antibiotic material. The reservoir may be accessible from a port on the hollow body that leads into the internal reservoir, and which permits refilling of the reservoir. In some embodiments, the reservoir may be refillable from this port without removal of the spacer from the patient; for example, a percutaneous needle may be inserted into the port. The spacer may dispense antibiotic from this reservoir to the surrounding area in order to treat an infection.

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: A medical treatment system and method of treatment is described having an implant that can be positioned and deployed, then undeployed to allow repositioning of the implant. The system includes a self-expanding medical implant that longitudinally foreshortens upon radially expanding from a radially compacted state, a distal interface configured to attach the implant to a distal mount of a delivery device, and a proximal interface configured to attach the implant to a proximal mount of the delivery device. Moving the distal mount longitudinally away from the proximal mount applies a longitudinal tension to the implant causing the implant to expand longitudinally and contract radially, and moving the distal mount toward the proximal mount reduces a longitudinal tension in the implant allowing the implant to expand radially toward a fully expanded state.

Abstract: Apparatus for percutaneous access to a patient's body comprising a first steerable tube (12), shaped to define a first lumen, and a first coupling (152) at a longitudinal site of the first tube; and a second steerable tube (14), shaped to define a second lumen and a second coupling (154), the second coupling being intracorporeally couplable to the first coupling, the apparatus having (A) an unlocked state in which the second tube is rotatable within the first lumen, and (B) a locked state in which the second coupling is coupled to the first coupling, and rotation of the second tube is inhibited. The apparatus is configured such that when the second coupling becomes disposed at the longitudinal site in a given rotational orientation of the second tube, the apparatus moves into the locked state by the second coupling automatically coupling to the first coupling. Other embodiments are also described.

Abstract: Catheters for occluding, visualizing, irrigating, evacuating, and delivering agents to a treatment area are disclosed. The catheters comprise a catheter body comprising five lumens, first and second occlusion balloons coupled to the catheter body, an optional space-occupying balloon coupled to the catheter body and disposed between the first and second occlusion balloons, and an optional visualization means that enables visualization between the first and second occlusion balloons. Methods for using these catheters are also disclosed. A method comprises inflating the first and second occlusion balloons, inflating the space-occupying balloon, allowing fluid to exit via an evacuation lumen, optionally irrigating or aspirating to facilitate fluid exit via said lumen, and delivering an agent to a treatment area via the agent lumen.

Abstract: A device for treating the lumen of a living body includes a shaft insertable into a blood vessel, and a balloon provided on the shaft and shiftable between a deflated state and an expanded state. In the expanded state, the balloon has a recessed portion configured to form a coating chamber which is substantially blocked between an inner surface of the blood vessels and the device for treating the lumen of a living body, a discharge port provided on the recessed portion to discharge a coating substance toward the coating chamber; and a suction port provided on the recessed portion to apply a negative pressure to the coating chamber.

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

Abstract: A drug or agent coated balloon having a length which is adjustable in vivo is described herein. The balloon is configured to be coated or coatable with one or more drugs where the coating may be applied prior to advancement into a patient body or prior to balloon expansion within the patient body. The length of the expandable portion of the balloon is adjustable to approximate a length of the tissue region to be treated. Moreover, the drug-coated balloon may be used alone or it may be utilized to deploy luminal prostheses having one or more linked or otherwise coupled segments.

Abstract: Assemblies, kits, and methods for occluding a vascular vessel, such as a varicose vein, are disclosed. An assembly can include a removable inner member, a removable outer member, and an elongated expandable member positioned in a compressed form between portions of the inner and outer members. To facilitate their removal, one or both of the inner and outer members can include a handle coupled to a proximal end. The elongated expandable member can include a gelatin material or a collagen material that is configured, when wetted, to expand from a compressed first diametrical size to a second larger diametrical size within a time period of 5 minutes or less. At the second larger diametrical size, the gelatin or collagen material can occlude a vascular vessel for a period of at least 20 days without degrading.

Abstract: An example of recovery catheter assembly comprises an actuator element and a mechanically radially expandable and contractible recovery device operably connected to the actuator element. The recovery device has proximal and distal blocking portions and a central portion therebetween. The recovery device is at least partially placeable in a first, radially collapsed configuration and in a second, radially expanded configuration by manipulation of the actuator element. When in the second, radially expanded configuration, the proximal and distal blocking portions have radial dimensions greater than the radial dimension of the central portion thereby at least partially defining a collection chamber at the central portion.

Abstract: Balloon catheter, applicator, particularly for invasive radiotherapy, and method of controlling the balloon catheter with respect to its shape and position in a tissue to be treated prior to an irradiation. The balloon catheter provides a catheter shaft for introducing a probe, an outer balloon and an inner balloon, disposed inside the outer balloon, the inner space of the inner balloon connecting to a channel for connection to a media inlet and intermediate space between the outer balloon and the inner balloon connecting to a channel for connection to a media storage unit. In order that the balloon catheter can be securely controlled with respect to its shape and position in a patient in a simple but clear manner prior to irradiation, the outer balloon is formed of a flexible, non-extendible material and the inner balloon is formed of a flexible, extendible material.

Abstract: A medical device consists of a dual lumen catheter with three intra-connecting balloons comprising a balloon stent. The adjustable tissue approximation using negative pressure exerted between device and mucosa of stomach/esophagus/colon with improved injury site isolation via adjustable balloon stent and added potential of negative pressure application to injury site for active healing process and distal feeding potential.

Abstract: The invention comprises an indwelling medical device which is capable of delivering a therapeutic agent evenly along the length of the indwelling portion, including the outer wall, of the device.

Abstract: A method is described including introducing a delivery device to a point within a renal artery or a renal segmental artery and delivering a treatment agent from the delivery device according to conditions that create a turbulent blood flow and wherein the treatment agent is capable of inhibiting a biological process contributing to nephropathy. In other embodiments, an apparatus and kit are described including a delivery device for insertion to a point within a renal artery or renal segmental artery and delivery of a treatment agent capable of inhibiting a biological process contributing to nephropathy.

Abstract: A transcutaneous multimodal delivery device for drug delivery and the methods of making and using the same are provided.

Abstract: The present invention provides a catheter for the delivery of fluid medication across an anatomical region. In accordance with some embodiments, the catheter includes a tube having a plurality of exit holes in a side wall of the tube and an elongated member positioned within the tube. The exit holes combine to form a flow-restricting orifice of the catheter. Advantageously, fluid within the catheter flows through all of the exit holes, resulting in uniform distribution of fluid within an anatomical region.

Abstract: A method of administering a reduced pressure tissue treatment to a tissue site includes percutaneously inserting a tube through a skin tissue of a patient to place a distal end of the tube adjacent the tissue site, the tube having at least one passageway. A balloon associated with the tube is positioned adjacent the tissue site, and the balloon is inflated to dissect and form a void adjacent the tissue site. A manifold having a plurality of flow channels is delivered through the passageway to the tissue site. The manifold is positioned such that at least one of the flow channels is in contact with the tissue site, and a reduced pressure is applied to the tissue site through the flow channels of the manifold.

Abstract: Agents and devices for affecting nerve function are described. In some variations, a combination of agents, e.g., a cardiac glycoside, an ACE inhibitor, and an NSAID are delivered to affect nerve function. The agent may be delivered locally in a site-specific manner to a targeted nerve or portion of a nerve. For example, the agent may be delivered locally to the renal nerves to impair their function and treat hypertension. One variation of a delivery device includes one or more needle housings supported by a balloon. A delivery needle is slidably disposed within a needle lumen of each needle housing.

Abstract: An embolic frame having looped support struts. The frame configuration provides enhanced longitudinal compliance, improved sealing against a vessel wall, low profile delivery, and a short deployed length. The looped support struts have a high degree of “radial” stiffness with a low degree of “longitudinal” stiffness. In the deployed state, the frame exerts a relatively high stress onto a vessel wall to maintain an effective seal, yet remains compliant in the longitudinal direction. The looped support struts elongate when tensioned and assume a compressed and essentially linear form. While constrained in this linear state by a delivery catheter, the support struts exert minimal stress onto the delivery system. The overall delivery profile and stiffness are therefore reduced. When the delivery catheter constraint is removed during deployment, the struts “snap open” and assume a looped configuration which exert a high degree of force onto the vessel wall.

Abstract: A medical material supply device which can percutaneously supply a material for nerve regeneration that promotes the regeneration of a nerve is insertable into a vessel and includes: a supply section configured to penetrate from an inner wall to an outer wall of the vessel at a predetermined position in the vessel, thereby being able to supply a material for nerve regeneration to the outer wall of the vessel; and an elongated body which is inserted into the vessel, in which the supply section is provided with a linear portion which is provided at the elongated body and is configured to penetrate from the inner wall to the outer wall of the vessel.

Abstract: The present invention is directed in various methods, devices and systems relating to providing a balloon on a sheath in combination with orbital atherectomy in order reduce the number of steps in the procedure. In certain embodiments, the balloon comprises adjunctive low pressure balloon for prevention of vessel trauma during dilatation.

Abstract: An inflatable balloon cuff may be adapted to seal a patient's trachea when associated with an endotracheal tube. These cuffs may include indicia that facilitate attachment of the cuff relative to the tube to reduce manufacturing variability for such characteristics as rotational and length alignment. Such indicia may include protrusions that are formed in the wall of the cuff collars or may include visual indicators, e.g., colorimetric or shape-wise indicators. Cuffs with improved attachment relative to the tube may have increased sealing performance.

Abstract: A device for treating the lumen of a living body includes a shaft insertable into a blood vessel, and a balloon provided on the shaft and shiftable between a deflated state and an expanded state. In the expanded state, the balloon has a recessed portion configured to form a coating chamber which is substantially blocked between an inner surface of the blood vessels and the device for treating the lumen of a living body, a discharge port provided on the recessed portion to discharge a coating substance toward the coating chamber; and a suction port provided on the recessed portion to apply a negative pressure to the coating chamber.

Abstract: A catheter and method for draining a bladder and injecting a two part biologic adhesive is provided. The catheter has a tubular body extending between proximal and distal ends. A balloon is located adjacent the distal end with a first port extending between the proximal end and the balloon providing for inflation an deflation of the balloon. A second port extends substantially between the proximal end and the distal end for drainage. A pair of ports separate from one another and from the first and second ports extend between the proximal end and the balloon. The pair of ports are each arranged in fluid communication with separate openings located between the balloon and the proximal end to provide separate fluid flow paths for the separate components of the two part biologic adhesive between the proximal end and the openings.

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

Abstract: Balloon catheters, and methods of treatment therewith, are provided including an inflatable first balloon at least partially enclosed by an expandable second balloon that has holes. The annular space between the first balloon and the second balloon is configured to promote delivery of the fluid evenly through holes in the second 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 first balloon may have various configurations including being tapered relative to the second balloon. The second 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: A catheter system for localized delivery of a therapeutic or diagnostic agent within a vessel is provided. The system provides for adjustability of the length of the treatment area and for reducing of pressure within the treatment area. The catheter system includes an inner elongated element, an outer elongated element positioned coaxially with respect to the inner elongated element, a blood-release element at a distal end of the inner elongated element and a supply elongated element coaxial to the outer 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: Substance delivering spacer devices may comprise expandable reservoirs that are implantable in paranasal sinuses and other cavities, openings and passageways of the body to maintain patency and to provide sustained local delivery of a therapeutic or diagnostic substance. Delivery apparatus including elongate tubular members as well as shapeable distal portions and atraumatic tips are provided. Also provided are sinus penetrator devices and systems for performing ethmoidotomy procedures or for creating other openings in the walls of paranasal sinuses or other anatomical structures.

Abstract: A kit of parts comprises a system and instructions for use for controlling patient temperature which uses a central venous line catheter having a heat exchange element. The central venous line catheter is provided with one or more lumens for providing access to the central blood supply of the patient, and with additional lumens for communicating heat exchange fluid to the heat exchange element. Heat exchange fluid temperature is controlled through a feed back loop in which patient temperature is sensed and used to control a temperature control unit comprising a heating device and/or a cooling device in heat exchange relationship with the heat exchange fluid. A tubing set transports the heat exchange fluid between the central venous line and the temperature control unit, with a pump serving to circulate the fluid in a closed fluid circuit in the system.

Abstract: A balloon catheter is provided that may be used to dilate hardened regions of a stenosis on a vessel wall. The balloon catheter is provided with cutting elements that extend along a surface of a balloon. At least one bioactive is present, either on the cutting element, within the interior of the balloon, within the material of the balloon or on an outside surface of the balloon. The bioactive is delivered to the vessel wall upon dilation of the balloon.

Abstract: A system for applying a treatment to a defect in one bone of two bones forming a joint that comprises a bladder for delivering a reduced pressure to the defect and for providing a positive pressure as bracing between the two bones of the joint is disclosed. A method for applying such treatment is also disclosed. A bladder for applying such treatment that comprises a reduced-pressure chamber and a bracing chamber is also disclosed.

Abstract: A drug introduction sleeve is disclosed that includes a selectively expandable body portion. The body portion is defined by a first open end and a second open end. A hollow interior is formed within the body portion. The body portion is selectively expandable from a first unexpanded configuration to a second expanded configuration whereby the volume of the hollow interior is increased when the body portion is expanded to the second expanded configuration, sufficient to temporarily retain a drug bolus.

Abstract: Surgery is performed on a patient with a novel device by: excising tissue from tissue mass within a patient to create a cavity within the tissue mass; inserting a novel device of this invention into the cavity; shaping a flexible expandable component of the device to adjust dimensions on the flexible expandable component; providing a liquid into the component through the liquid input port; and controlling pressure or flow rate of the liquid in the component to move the liquid through the multiple openings and into the cavity. The device has a liquid inlet port, an exterior surface having length, width and depth, and multiple openings in the surface distributed throughout the length, width and depth to act as liquid delivery ports; the exterior surface of the liquid delivery device being shapeable by internal pneumatic pressure or hydraulic pressure to better fit inside dimensions of a surgical cavity; the multiple openings deliver the liquid through the multiple openings.

Abstract: Composite CNT microneedle fabrication and finally-constructed delivery device embodiments are described. The microneedles can provide a self-administered, painless alternative to standard hypodermic injection.

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

Abstract: A medical device is disclosed. The medical device may include an elongate member having a proximal end and a distal end an expandable end effector assembly extending distally from the distal end of the elongate member. The end effector assembly may include a plurality of end effector units each having an injector for simultaneously delivering material into tissue.

Abstract: Disclosed are methods, devices, and systems for treating a body lumen with a sclerothepeutic agent. The method includes the steps of positioning a porous balloon assembly at a site in the lumen to be treated, inflating the assembly to establish a close approximation to the lumen wall, forcing the sclerotherapeutic agent to exit the pores and come in contact with the lumen wall, and to deflate and retrieve the balloon assembly. The methods, devices and systems disclosed herein are especially useful for the treatment of incompetent veins and their contributory branches.

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 and a balloon member disposed on a distal region of the catheter. A plurality of pockets are disposed on the balloon member, and a plurality of needles are associated with each of the plurality of pockets. The plurality of needles are configured to engage tissue when the balloon is in the inflated state, and further are configured to disperse a therapeutic agent from an associated pocket into the tissue when the balloon is in the inflated state. A first needle of the plurality of needles may comprise a length that is different than a second needle, permitting the delivery of first and second therapeutic agents to different depths within the tissue.

Abstract: An introducer sheath. The introducer sheath includes a tubular body. The tubular body extends from a distal end toward a proximal end. The tubular body includes a lumen. The lumen is defined at least partially by a wall. The tubular body includes a secondary channel. The secondary channel is disposed within the wall. The secondary channel is configured to receive a guidewire.

Abstract: The invention provides methods for the treatment of vaginal laxity which include delivering a cell-containing composition to the vagina. The composition can include fat tissue to provide a bulking effect to reduce the size of the vaginal opening. The cells can provide healing and revascularization of the vaginal treatment area to sustain the bulking provided by the fat. The invention also provides systems and compositions useful for performing the method, and can include instruments and devices for removal of autologous adipose tissue from a patient (e.g., by liposuction), equipment for the enrichment of cells from adipose tissue, mechanical processing of adipose tissue, and the mixing of cells and processed adipose tissue. Devices for the delivery of the cell compositions to the vagina can also be included in the system.

Abstract: A system for treating a blood clot includes a microcatheter extending through an optional aspiration catheter, and a guidewire subassembly extending through and beyond the microcatheter, the guidewire assembly having a guidewire, an element coupled to and extending around a portion of the guidewire, and a balloon coupled to and extending around the element. The balloon includes or is coupled to a proximal seal in contact with the inner surface of the microcatheter and has at least one radially arranged pore. Infusate flows through the microcatheter into the element and between the element and the guidewire, and out and into the balloon to pressurize the balloon. The infusate escapes the balloon through the pores.

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

Abstract: The invention generally relates to carbon nanotube based drug delivery methods, devices, and compositions. More particularly, the invention relates to controlled drug delivery using anchored carbon nanotube arrays.

Abstract: A catheter and methods for luminal therapy are provided wherein a catheter has an outer balloon with a multiplicity of apertures for infusing one or more therapeutic agents into a vessel wall, an intermediate balloon having a multiplicity of apertures offset from the apertures of outer balloon to serve as a baffle that reduces jetting and promotes uniform distribution of therapeutic agent exiting through the outer balloon, and an impermeable inner balloon disposed within the intermediate balloon that enables the intermediate and outer balloons to be forced into engagement with the vessel wall to dilate the vessel and disrupt plaque lining the vessel wall and to also facilitate the uniform delivery of the therapeutic agent.

Abstract: A tissue ablation device comprising a balloon catheter, or other expandable element, wherein said expandable element is comprised of a semipermeable membrane. The balloon membrane is expanded by an osmotically active solution to contact a vascular endothelium, or other desired tissue, whereupon the resultant osmotic gradient affects a water flux from the vascular endothelium, or other desired tissue, across the semipermeable membrane and towards the osmotically active solution.

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

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

Abstract: The present invention generally relates to a medical device for delivering a therapeutic agent to an internal portion of a patient's body. The medical device includes a shaft and a self-expanding delivery member in operative communication with the shaft. The delivery member is shaped from a porous material that is capable of releasing a therapeutic agent to an internal portion of a patient's body. The medical device further includes a therapeutic agent delivery lumen in fluid communication with the delivery member to fluidly connect the delivery member with a therapeutic agent source. A retention member may also be provided to selectively collapse the delivery member.

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