Abstract: Embodiments include a medical device having a balloon portion with a first end, a second end, and a variable balloon mass to inflate the balloon portion non-uniformly from the first end to the second end. In one embodiment, the balloon portion inflates in a controlled manner to rupture a vulnerable plaque near the second end.

Abstract: Interstitial tissue structure is treated with a flowable liquid agent by: providing a delivery cannula having a proximal end and a distal end and an external surface with at least one expandable member located on the external surface of at least one catheter or needle. The delivery cannula is inserted into live tissue, creating a hole in the tissue surrounding the delivery cannula. Contact is made against an inner surface of the hole with contact pressure from the at least one expandable member, said contact pressure establishing a first level of stress in tissue surrounding the hole in the tissue. The expandable member is expanded to increase the contact pressure and provide a second level of stress in the tissue surrounding the hole in the tissue to a second level of stress that is greater than the first level of stress.

Abstract: A pressure relief apparatus for a balloon dilation catheter having a shaft with a dilation balloon attached to the distal end of the shaft and an inflation/deflation lumen for inflating and deflating the balloon includes a pressure relief port formed through the wall of the inflation/deflation lumen with a pressure relief member secured across the pressure relief port to form a fluid tight seal such that the fluid tight seal formed by the pressure relief member fails at a predetermined pressure to release pressure from the inflation/deflation lumen through the pressure relief port.

Abstract: An apparatus including a cannula having a dimension suitable for insertion into a blood vessel and an expandable body coupled thereto, the expandable body comprising a first expandable member and a second expandable member to isolate a length of the vessel upon expansion within the blood vessel. The expandable body having an intermediate expandable member along a working length between the first expandable member and the second expandable. A method including introducing a cannula and an expandable body coupled thereto into a blood vessel at a point coextensive with a treatment site and expanding a first expandable member and a second expandable member of the expandable body to isolate a length of the vessel adjacent the treatment site. The method further including delivering a treatment agent to a vessel region between the first expandable member and the second expandable member while inflating and deflating an intermediate expandable member.

Abstract: A catheter assembly comprises a first catheter including a wall with an inner surface at least partially defining a lumen. A second catheter is connected to the wall of the first catheter and is disposed outward of the inner surface of the wall. The second catheter is at least partially covered by a sheath portion of the first catheter.

Abstract: Medical device system comprising a catheter including an elongate tubular member having an inner wall surface defining a lumen extending longitudinally through at least a portion of the tubular member. The medical device also includes an inner stop extending inwardly from the inner wall surface of the tubular member at a distal end section of the catheter and a pusher device insertable into the lumen. The pusher device has a contact surface to abut the inner stop of the tubular member.

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: A noncircular inner lumen guiding catheter with assisted variable support has an inner wall defining a noncircular cross-sectional shaped lumen for use in delivery of multiple microcatheters or other devices for treatment of neurovascular defects, such as for treatment of aneurysms. The noncircular inner lumen guiding catheter with assisted variable support includes torque transmittal guidance walls that are flexible linearly but not circumferentially, and that are neither collapsible nor kinkable. The noncircular shaped cross-section of the inner lumen may extend along the entire length of the catheter or a portion thereof, including distal or proximal.

Abstract: To perform a prostatectomy, a directionally illuminating balloon catheter enters a bladder. The catheter has a multi-lumen shaft. The balloon defines an interior fluidically connected to a balloon inflation lumen and is inflated therethrough. The balloon comprises a light source, a light-radiating surface adjacent the shaft-balloon junction, and a substantially opaque surface disposed at a portion of the balloon other than the light-radiating surface such that the integrated light source illuminates a proximal half of the environment outside the balloon. The balloon is inflated while in the bladder. Light from the light source is directed out through the light-radiating surface to illuminate at least a portion of a procedure area at the bladder-prostate junction. With the light illuminating the portion of the procedure area, at least a portion of a prostatectomy is performed at the portion of the procedure area.

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: An expandable cage is expanded within a narrowed region of a blood vessel. The expandable cage has openings therein so that plaque protrudes through the openings when the cage is expanded. A material removing element passes within the cage to remove the plaque extending into the openings. The openings are preferably formed by integrally formed elements which provide a smooth internal surface. The material removing element passes along the smooth internal surface when removing the plaque. A collection bag is coupled to the material removing element to capture the material which has been removed.

Abstract: A catheter having improved ability to cross body passage obstructions and that more easily allows backloading of a guidewire into the lumen of the catheter is comprised of a tip, a shaft, and a lumen. The distal end of the catheter tip is oriented at an angle other than 90° to the lengthwise axis of the catheter tip. A guidewire may be easily backloaded into the elongated catheter lumen at the location of the angled catheter tip.

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: Balloon catheter comprises an elongated shaft having a proximal end and a distal end, the elongated shaft including a biaxially oriented nonporous thermoplastic polymer tubular member having a Shore durometer hardness of less than about 75D with an inflation lumen defined therein. The balloon catheter also comprises a balloon sealing secured proximate the distal end of the shaft and having an interior in fluid communication with the inflation lumen.

Abstract: A system for moving particles suspended in a first fluid, and for infusing them into the stream of a second fluid, includes a catheter with a multi-lumen distal separator. The separator is formed with a plurality of parallel lumens, wherein each lumen has a predetermined diameter. Importantly, the diameter of each lumen is dimensioned to sequentially receive particles therethrough, to prevent the particles from flocculating before they enter the stream of the second fluid. A recollection chamber in fluid communication with the separator allows for reconsolidation of the fluid after leaving the separator and for minimizing the damage caused to the vessel when the fluid exits the catheter. An inflatable balloon, affixed to the outside of the catheter, can be provided to regulate flow of the second fluid and thereby facilitate entry of the particles into the stream of the second fluid and increase retention of particles in targeted tissue.

Abstract: A balloon resection method is disclosed generally comprising inserting a catheter with at least one balloon having an outer wall with a resecting, non-slip surface for resecting unwanted biological material, such as tissues or tumors, and supplying fluid thereto in pulsed fashion to repeatedly deflate and inflate the balloon. In certain embodiments, a pump controls the pulsed supply of fluid based on an established frequency or change in volume. In some embodiments, the a keyed connector is used to identify the balloon type, and in some cases, intra-lumen diameters and densities are calculated. In some embodiments, the balloon portion of the catheter includes multiple balloon segments, which in some cases, are inflatable separately from one another.

Abstract: A system for perfusing a localized site within a body includes a catheter assembly having a venous access line that is adapted to deliver perfusate to the localized site, a venous or arterial drainage line adapted to drain perfusate from the localized site, and an occlusion device adapted to prevent some or substantially all physiological blood flow between the localized site and the systemic circulation of the body during and in the course of perfusing and draining perfusate to and from the localized site. The system may include a blood circuit associated with the catheter assembly to facilitate blood conditioning for use as the perfusate, in the course of a controlled perfusion and/or drainage of untreated, treated, or inactivated treated blood to and from the localized site.

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 steerable catheter comprises a flexible tube, inside of which different conducts are arranged: one or more conducts for drug administration, vacuum conducts associated with different radiofrequency electrodes, conducts for the conductive wires that conducts the radiofrequency energy to the distal end of the catheter, conducts for the fiber optic cable/s that conducts the laser energy to the distal end of the catheter, a guiding wire for the catherization, and another components; the steerable catheter being connected from the proximal end to a energy unit and other pressure and/or dosing devices; and the steerable catheter optionally including an inflatable balloon to help occluding the vessel; and it also incorporates one or two electrode/s or conductive layer/s in the distal end of the catheter; the objective of the steerable catheter being the obtaining of better results in the embolization and/or chemoembolization treatments.

Abstract: Embolectomy catheters, rapid exchange microcatheters, systems and methods for removing clots or other obstructive matter (e.g., thrombus, thromboemboli, embolic fragments of atherosclerotic plaque, foreign objects, etc.) from blood vessels. This invention is particularly useable for percutaneous removal of thromboemboli or other obstructive matter from small blood vessels of the brain, during an evolving stroke or period of cerebral ischemia. In some embodiments, the embolectomy catheters of this invention are advanceable with or over a guidewire which has been pre-inserted through or around the clot. Also, in some embodiments, the embolectomy catheters include clot removal devices which are deployable from the catheter after the catheter has been advanced at least partially through the clot. The clot removal device may include a deployable wire nest that is designed to prevent a blood clot from passing therethrough.

Abstract: Sinusitis and other disorders of the ear, nose and throat are diagnosed and/or treated using minimally invasive approaches with flexible or rigid instruments. Various methods and devices are used for remodeling or changing the shape, size or configuration of a sinus ostium or duct or other anatomical structure in the ear, nose or throat; implanting a device, cells or tissues; removing matter from the ear, nose or throat; delivering diagnostic or therapeutic substances or performing other diagnostic or therapeutic procedures. Introducing devices (e.g., guide catheters, tubes, guidewires, elongate probes, other elongate members) may be used to facilitate insertion of working devices (e.g. catheters e.g. balloon catheters, guidewires, tissue cutting or remodeling devices, devices for implanting elements like stents, electrosurgical devices, energy emitting devices, devices for delivering diagnostic or therapeutic agents, substance delivery implants, scopes etc.

Abstract: A system for delivering a medical instrument into a bodily cavity is provided, including an outer shaft having an aperture in a side wall thereof, wherein the aperture is provided at a distal portion of the outer shaft, an inner shaft positioned inside the outer shaft and having an inflatable balloon disposed at a distal portion thereof, and a needle member movably disposed in the outer shaft, wherein the needle member extends outwardly from the outer shaft through the aperture when the balloon is inflated.

Abstract: A balloon catheter is configured so that a balloon can be easily inserted into the interior of a human body without using a separate wire.

Abstract: To provide a tool for safely and reliably securing a route for endermically approaching the interior of the body; more specifically, an endoscope-equipped puncture balloon that is designed to allow a balloon that does not immediately burst when punctured by a puncturing needle or the like to be used as a target, and that can be used by installing or inserting an endoscope in a tube holding such balloon. In a thin-walled main body tube 1 equipped with an endoscope-installed section at the rear end, a balloon 2 is disposed on the front surface thereof, and a branch tube 4 communicating with the interior of the balloon 2 in a gas-liquid flow manner is disposed on the main body tube 1, the branch tube 4 having a connector 5 annexed to the rear end thereof; thus it is not until the liquid in the balloon is absorbed without the balloon immediately bursting when punctured by a puncturing needle that a bore can be secured until the balloon is contracted.

Abstract: A balloon catheter having a purge hole according to the present invention is configured with a duplex tube structure of an inner tube and an outer tube both of which having an opening at the distal end thereof. A balloon is provided to stretch over the section between the distal ends of the inner tube and the outer tube. A purge hole is provided on the inner tube covered by the balloon, through which the remaining air inside the balloon lumen and the balloon is discharged to a main lumen formed in the inner tube when the balloon is expanded, and which is closed by the balloon when the balloon is contracted.

Abstract: A balloon catheter device of the present invention includes an elongate catheter shaft comprising multifilar cable tubing having a proximal portion and a distal portion. The proximal portion includes a coating that allows the shaft to provide a patent fluid passage, and a part of the distal portion inside a balloon may be uncoated or otherwise open to the balloon lumen, allowing for passage of fluid through the shaft into the balloon lumen. The distal cable tube end includes a connection structure configured to provide desirable strength, pushability, and trackability.

Abstract: A balloon and method of making a balloon catheter is provided. The balloon for the balloon catheter may be made by slicing through an integral dilation element on a parison (10). The parison may then be stretched to spread the slices to form wider gaps (20). The gaps define separate dilation element segments (14), which may make the balloon more flexible.

Abstract: In one aspect, the present invention provides composite coatings for implantable or insertable medical devices. These composite coatings comprise (a) an inorganic portion and (b) a polymeric portion that comprises a poly(vinyl pyrrolidone) (PVP) block.

Abstract: A medical balloon catheter including a shaft comprised of a cross-wound coil tube and a sleeve surrounding the cross-wound coil tube. The cross-wound coil tube includes a monofilament inner coil disposed within a monofilament outer coil. The inner and outer coils are wound in opposite pitch directions. In at least one embodiment, at least one of the inner and outer coils includes a tapered distal section having a tapered diameter. In at least another embodiment, the inner coil extends distally beyond the distal end of the outer coil, providing increased flexibility in a distal portion of the shaft. An inflation balloon is attached to the distal end of the shaft. The shaft includes an inflation lumen formed through the inner coil and a wire guide lumen formed through the distal portion of the shaft and extending through the chamber of the balloon.

Abstract: Sinusitis, mucocysts, tumors, infections, hearing disorders, choanal atresia, fractures and other disorders of the paranasal sinuses, Eustachian tubes, Lachrymal ducts and other ear, nose, throat and mouth structures are diagnosed and/or treated using minimally invasive approaches and, in many cases, flexible catheters as opposed to instruments having rigid shafts. Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies and endoscopic studies.

Abstract: The present application relates to applicators and methods for administering therapeutic agents to cancerous tissue. The applicators can be used to deliver radiation and additional therapeutic agents to cancerous tissue located in a subject.

Abstract: A feeding tube with an inflatable balloon component, a kit containing the feeding tubing, and a method for intubating a patient to deliver the feeding tube to a desired location for delivering nutrients and/or medication to the patient are described herein.

Abstract: Apparatuses and methods for coating and/or loading a medical device with a therapeutic agent prior to or during the placement of the medical device within the patient's body. In one variation, the medical device is coated and/or loaded with a therapeutic agent while the device is positioned in a delivery apparatus. In another variation, the delivery apparatus comprises a reservoir for retaining a therapeutic agent. The user may release the therapeutic agent from the reservoir prior to or during the placement of the device to coat and/or load the device with the therapeutic agent.

Abstract: One embodiment provides a method implemented by a powered inflation device to prepare a balloon catheter for use during a medical procedure. In this embodiment, the method includes drawing an amount of medical fluid from a fluid reservoir into the inflation device during a first motorized operation of the inflation device, removing an amount of air from the balloon catheter during a second motorized operation of the inflation device, and injecting the amount of medical fluid from the inflation device into the balloon catheter during a third motorized operation of the inflation device to inflate a balloon located at a distal end of the balloon catheter. The powered inflation device may be a stand-alone device in one embodiment. In one embodiment, the powered inflation device is coupled to an angiographic injector system. When it is coupled to an angiographic injector system, the balloon inflation device and the injector system may be controlled by a common control panel, or console, in one embodiment.

Abstract: A balloon catheter device (1700) includes an elongate catheter shaft comprising multifilar cable tubing (1706) having a proximal portion and a distal portion. The proximal portion includes a coating (1708) that allows the shaft to provide a patent fluid passage. The distal cable tube end includes a connection structure (1723) configured to provide desirable strength, pushability, and trackability.

Abstract: A balloon or balloon cover comprising a composite material having a least one expanded fluoropolymer material and an elastomer is provided. The expanded fluoropolymer material can contain serpentine fibrils. In exemplary embodiments, the fluoropolymer is polytetrafluoroethylene. The composite material may be axially, helically, and/or circumferentially wrapped to form a balloon or balloon cover. The balloon or balloon cover exhibits a sharp increase in stiffness at a predetermined diameter. The balloon or balloon cover can be designed to have a stop point in either a radial or axial direction.

Abstract: A catheter assembly employs an outer catheter with a pre-formed distal end and an open lumen. An inner catheter having an open lumen and a pre-formed distal end is movably disposed within the outer catheter. Relative rotation and extension of the inner and outer catheters provides the distal end of the catheter assembly with an adjustable range of two- and three-dimensional shapes. The inner catheter can include sections of varying stiffness, such that extension of the inner catheter within the outer catheter modifies the shape of the outer catheter's pre-formed distal end. One or both of the outer and inner catheters includes an occlusion balloon attached to the distal end thereof. The adjustable shaping of the catheter assembly's distal tip provides an improved system for locating and cannulating cardiac venous structures, particularly the coronary sinus via the right atrium.

Abstract: An improved splittable medical device introducer designed to introduce a medical device such as a lead or catheter, into a patient's vasculature without loss of blood or introduction of air is described. The introducer assembly is designed with a notch provided at the proximal end of the introducer housing. The notch, which may comprise a multitude of cross-sectional geometries, is designed to reduce the force required to separate the housing and the introducer sheath, thereby minimizing the possibility of unintentional dislodgement during separation. The notch also increases the repeatability and consistency of the amount of force required to separate the introducer housing and sheath.

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: A catheter for the local delivery of therapeutic agents and methods of using the same for the treatment or prevention of disease are disclosed. A catheter may include a tubular net and a guidewire attached to the tubular net longitudinally along the abluminal side of the net. The catheter may further include a tubular member that opens onto the abluminal side of the tubular net.

Abstract: A cochlear implant electrode includes an implantable electrode carrier having an outer surface with electrode contacts for electrically stimulating nerve tissue of the inner ear of a patient. A drug lumen is within the electrode carrier and adapted to receive a therapeutic fluid. The drug lumen contains delivery openings to the outer surface of the electrode carrier and a hydrogel matrix disposed between the drug lumen and the one or more delivery openings and adapted to swell in volume when exposed to the therapeutic fluid. The hydrogel matrix is adapted to control diffusion of the therapeutic fluid from the drug lumen through the delivery openings to the outer surface of the electrode carrier.

Abstract: A medical device having enhanced steerability for navigation through a patient's vasculature and for positioning the device for performing a medical procedure, such as pulmonary vein isolation. The device generally includes an elongate body, a balloon defining a proximal neck that is affixed to the distal end of the elongate body such that the neck and elongate body are coterminous, a shaft disposed at least partially within the elongate body and at least partially within the balloon, and a pull wire affixed to a distal portion of the shaft, such that pulling the pull wire will cause deflection of the balloon at a point that is immediately distal of the proximal neck of the balloon. Further, the shape of the balloon when deflected and when in a neutral configuration may be substantially the same.

Abstract: Multi-lumen catheter having a monolithic elongate tubular shaft member having a proximal end, a distal end and a longitudinal length therebetween. The tubular shaft member has an outer cross-sectional dimension that varies along the length of the tubular shaft member. The tubular shaft member has an inner core made of a first material and an outer layer made of a second material. The inner core has a first lumen and a second lumen defined therein, the first lumen having a first lumen cross-section and a length extending at least along a portion of the length of the tubular shaft member. The first lumen cross-section is substantially uniform along the length of the first lumen. The second lumen has a second lumen cross-section and a length extending along the length of tubular shaft member. The second lumen cross-section is substantially uniform along the length of the second lumen.

Abstract: An intravascular catheter for peri-vascular and/or peri-urethral tissue ablation includes multiple needles advanced through supported guide tubes which expand with open ends around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, and/or nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. The system also includes means to limit and/or adjust the depth of penetration of the ablative fluid into and beyond the tissue of the vessel wall. The preferred embodiment of the catheter includes structures which provide radial and lateral support to the guide tubes so that the guide tubes open uniformly and maintain their position against the interior surface of the vessel wall as the sharpened injection needles are advanced to penetrate into the vessel wall.

Abstract: An apparatus may include a medical device including an elongate shaft disposed about a guidewire, and a distal tip including a plurality of rounded protrusions, wherein adjacent protrusions are fixed directly to each other by a discrete, relatively flexible connector. The plurality of protrusions may each decrease in size from a proximalmost protrusion distally to distalmost protrusion.

Abstract: A balloon catheter may include a multi-lumen tube having an inflation lumen and a guide wire lumen. The multi-lumen tube may include a proximal end and a distal end and may terminate at a distal tip. The catheter may include an extension tube extending distally from the distal tip of the multi-lumen tube and a dilatation balloon disposed about the multi-lumen tube and the extension tube. The distal tip of the multi-lumen tube may be under the balloon.

Abstract: A method of fabrication of a medical balloon, and a balloon device useful for various medical balloon procedures, such as gastrointestinal, vascular, reproductive system, urinary system and pulmonary applications. At least two layers of a thermoplastic film are sealed at their peripheral edges and heat sealed at one or more locations inside an area enclosed by the sealed edges at predetermined locations, in one implementation of the balloon device. Such configuration enables the balloon to articulate to a desired shape upon inflation, with the desired shape being selected to accommodate a specific medical application.

Abstract: An assembly of a pulmonary venting catheter and a pacing wire disposed therethrough whereby the pacing wire is extended from the distal end of the catheter tube during pacing mode, eliminating the need for exchanging the venting catheter with a pacing catheter to begin pacing after venting. The pacing wire includes a flexible distal end for a first conductor to conductively engage heart tissue after the pacing wire is extended from the catheter distal end; a second conductor, also exposed outside the catheter distal end, completes the circuit. The pacing wire is lockable in unextended and extended positions at the proximal end portion of the assembly. A method for venting and pacing a patient's heart during cardiac surgery is described, which includes retracting the catheter distal end from the pulmonary artery after venting mode, into the right ventricle during pacing mode, whereafter the pacing wire is extended for pacing.

Abstract: An expansion device includes an inflatable balloon moveable from an unexpanded configuration to an expanded configuration configured to pass through soft tissue between two adjacent teeth of a patient when in the unexpanded configuration. The an expansion device also includes an inflation tube having one end connected to the inflatable balloon and another end serving as an entry port for an inflation fluid. The inflatable balloon has a triangular shape when in the expanded configuration.

Abstract: Treatment methods and devices are provided for percutaneously accessing a patient's thoracic region via a controlled opening in the aorta, so that cardiac procedures, such as a coronary bypass procedure, can be performed in a minimally invasive manner. Advantageously, it may be possible to perform the procedure without placing the patient on cardiopulmonary bypass. The method may include percutaneously delivering at least one catheter into an aorta of a heart, forming a controlled opening in the aorta and pericardium via the at least one catheter to access a thoracic region within the patient's chest, and performing at least one coronary bypass graft procedure through the controlled opening.