Abstract: Embodiments of a method and apparatus to prevent reperfusion injury. In one embodiment, blood flow proximal to a lesion is occluded. An infusion catheter is advanced to a region distal to the lesion and an anti-reperfusion injury drug is delivered. The lesion may then be treated with a dilating device to reintroduce blood flow to the region distal to the lesion.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade to release the drug into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade to release the drug into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: Coaxial balloon catheters are described herein. The balloon catheter can include outer and inner tubes in a coaxial relationship, with a balloon attached to an end thereof. A support sleeve can be disposed around the inner tubular member proximate the proximal end of the balloon. The support sleeve can have a channel formed therein to communicate with an inflation lumen and a balloon interior. The channel may be formed by separation of two longitudinal edges extending through the support sleeve. The support sleeve can include an outward extending portion that is sized to engage the distal end of the outer tube in order to limit relative movement between the inner and outer tubes. The support sleeve can be configured to orient the inner tube eccentrically or concentrically relative to the outer tube. The support sleeve can have an elongate body that can be extended in proximal or distal direction.

Abstract: Embodiments of the invention provide apparatus, methods and systems for delivering treatments and for medications to the site of an aneurysm (SOA). One embodiment of a method comprises delivering a neural growth stimulating factor (NGSF) to the site of the aneurysm to grow new nerve cells and/or stimulate the regeneration of damaged nerve cells. The NGSF may be delivered in a carrier such as a gel which can be selected to allow for long term delivery of the NGSF to the SOA. In many embodiments, the NGSF may be delivered to the SOA using a micro-catheter based system which includes a microcatheter that can be advanced in the cerebral vasculature. The microcatheter may also be used to delivery occlusive element to the SOA such as occlusive coils or balloon which promote clotting and reduce bleeding at the SOA and together with the carrier allow for long term release of NGSF.

Abstract: A naso/orogastric device having backflow blocking means and comprises a naso/orogastric tube sized and shaped for being disposed within the esophagus so that at least a distal end thereof being placed in the stomach lumen of a patient, at least one elastic esophageal body, positioned along the naso/orogastric tube, having a pressure dependent volume, at least one esophageal sensor that detects fluid around at least one segment of the naso/orogastric tube, and a pressure regulator that regulates a pressure within the elastic esophageal body according to the detection.

Abstract: Medical devices with surfaces on which viable biologic cells are magnetically attracted and retained are disclosed along with methods of magnetic coating. The medical devices can be located in a carrier liquid containing high concentrations of magnetic cells before or after implantation. The carrier liquid with magnetic cells may be contact with the medical device in vitro or in vivo. In either case, the carrier liquid may have a concentration of magnetic cells that is high enough to facilitate coating of the medical device within an acceptable period of time, e.g., several hours or less. Magnetization of medical devices before, during, and/or after implantation and apparatus for performing the same are disclosed. Degaussing of magnetic medical devices is also disclosed.

Abstract: An intravascular aspirating assembly comprising an elongate guidewire having a proximally facing filter disposed on a distal portion thereof, a single operator exchange aspiration catheter disposed on the guidewire, the aspiration catheter having a proximal end, a distal end and an aspiration lumen extending therebetween, an extension catheter slidably disposed in the aspiration lumen and having a length greater than that of the aspiration catheter.

Abstract: A method for making a tool to remove a discrete object from the body of a human or animal patient includes a single length of Nitinol tubing and a sheath. The tubing includes a tool head section at a distal end of the tubing and a shaft section extending from a proximal end of the tubing to the tool head section. The tool head section includes a slitted section and a non-slitted section. The non-slitted section is disposed at a distal most end of the tubing. The slitted section includes a plurality of longitudinal slits forming a plurality of strands.

Abstract: An inflatable toroidal-shaped balloon for medical use is provided with a central opening traversing the balloon in an inflated state. The balloon is useful to achieve larger outer diameters than conventional balloons.

Abstract: Bioactive, hydroforming luminal liner compositions are formed of high molecular weight crystalline, absorbable copolyesters dissolved in a liquid derivative of a polyether glycol that undergoes transformation into a tissue-adhering, resilient interior cover or liner for the controlled release of its bioactive payload at clinically compromised conduits in humans as in the case of bacteria- and yeast-infected vaginal canals, esophagi, and arteries following angioplasty.

Abstract: Apparatus and methods are disclosed for medical treatment comprising bone, tissue or duct dilatation using inflatable dilatation elements together with apparatus and techniques for tensioning, stretching, folding, and/or wrapping the dilatation elements externally as well as in situ to facilitate insertion, positioning and withdrawal procedures.

Abstract: A prostate immobilizer has a shaft with a fluid passageway extending therethrough, a balloon affixed over an end of the shaft such that the fluid passageway communicates with an interior of the balloon, a lumen extending within the shaft so as to have an end opening adjacent an end of the balloon, and a device for locking a position of the shaft. The device has a positioning member having a stem portion extending from a head portion, and a locking member having a locked position and an unlocked position. The locking member cooperates with the stem portion of the positioning member so as to fix a position on the shaft. A channel is formed in the head portion so as to receive the shaft therein.

Abstract: Apparatus and methods are disclosed for medical treatment comprising bone, tissue or duct dilatation using inflatable dilatation elements together with apparatus and techniques for tensioning, stretching, folding, and/or wrapping the dilatation elements externally as well as in situ to facilitate insertion, positioning and withdrawal procedures.

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: A balloon catheter assembly includes a first tubular member with a proximal portion and a distal portion and a lumen extending between the proximal portion and the distal portion. A balloon has a proximal waist length, a distal waist length and an expandable region therebetween disposed about the distal portion. A tie layer is disposed between the proximal waist length or distal waist length and the first tubular member. The tie layer comprises a polyester polymer and a polyamide polymer.

Abstract: A balloon catheter (10) having a shaft (16), a balloon (14), and an external delivery tube (12) is disclosed. Methods of using the balloon catheter having an external delivery tube are also disclosed. In one example, the balloon catheter is an agent delivery catheter including a catheter body extending between catheter proximal and distal portions. An inflatable balloon assembly (100) is coupled with the catheter body. An agent delivery assembly (102) is coupled with the catheter body and the inflatable balloon assembly. The agent delivery assembly includes a delivery lumen (32) extending through the catheter body, and an agent delivery tube extending along an exterior balloon surface (64). The agent delivery tube includes at least one delivery orifice (70) directed outside of the exterior balloon surface. The agent delivery assembly is isolated from fluid communication with the inflatable balloon assembly.

Abstract: The present invention relates to the regional delivery of therapeutic agents for the treatment of vascular diseases wherein regional delivery refers to delivery of a therapeutically effective amount of the therapeutic agent to an area of the vessel that includes not only afflicted tissue but non-afflicted tissue at the periphery of the afflicted tissue as well.

Abstract: A balloon catheter having a soft distal tip member having a non-tacky inner (liner) layer material and a soft flexible outer layer material, with both materials being readily thermally bondable to the catheter balloon.

Abstract: A balloon catheter having a multilayer catheter shaft is formed to have an inner layer and an outer layer, where the inner layer and outer layer are selected from materials that enhance the pushability of the catheter while preserving the flexibility. Using a combination of a high Shore D duromater value material and a lower Shore D duromater value material, various combinations of multilayer catheter shafts are disclosed utilizing different glass transition temperatures and block copolyamides to obtain the desired characteristics.

Abstract: The present invention relates to a balloon catheter system for draining and/or supplying fluid from/into hollow organs, body cavities or cysts, comprising a conduit catheter with an open distal end, a hollow needle guided in a separate guide conduit and a balloon surrounding the catheter stem at the distal end of the conduit catheter. The conduit catheter with the hollow needle can be inserted from outside into the hollow organ via a guide catheter, into the body cavity or cyst, the balloon can be filled with filling medium via the hollow needle through an opening formed in the guided duct and provided in the lumen of the balloon, and it can be fixed in the hollow organ, body cavity or cyst. The hollow needle can be removed from the guide duct after filling the balloon. The balloon and the conduit catheter remain in the hollow organ, body cavity or cyst.

Abstract: Systems and methods for treating a tissue region employ an expandable structure projecting beyond the distal end of a catheter tube. A distal tail projects beyond the far end of the basket assembly. The distal tail includes a guidewire lumen that accommodates passage of a guidewire without threading the guidewire through the catheter tube.

Abstract: Apparatus and methods for locating morphological features within a body cavity using a catheter including proximal and distal ends, a transparent balloon carried on the distal end, and an optical imaging assembly carried on the distal end for imaging through the balloon. The balloon includes a channel extending therethrough to a lumen extending through the catheter. A guidewire or other localization member is received in the lumen that is extendable through the channel. During use, the catheter is inserted into a right atrium of a heart, and the balloon is expanded and placed against the wall of the heart to locate the coronary sinus. Sufficient force is applied to clear blood between the surface and the wall and clear the field of view of the imaging assembly. The catheter is manipulated to locate the coronary sinus, whereupon the localization member is advanced into the coronary sinus.

Abstract: Catheter and methods for designing, making, and using catheters are disclosed. An example catheter is a balloon catheter. The balloon catheter may include a proximal shaft. The proximal shaft may be a bare metal hypotube having a skew value of ?1.0 to ?2.5. A midshaft may be attached to the proximal shaft. A distal shaft may be attached to the midshaft. A balloon may be coupled to the distal shaft. An inflation lumen may be defined that extends from the proximal shaft, through the midshaft, and into the distal shaft. The inflation lumen may be in fluid communication with the balloon.

Abstract: An anchored working channel includes an elongated shaft with a proximal end and a distal end, and at least one inflatable balloon positioned at the distal end of the elongated shaft and having an outer wall having an outer surface for contacting surrounding tissue, wherein the elongated shaft has a first lumen through which fluid is supplied to inflate the at least one inflatable balloon such that the balloon anchors the shaft to surrounding tissue, wherein the elongated shaft has a second lumen that accommodates at least one medical instrument and/or device inserted therein, and wherein the outer surface of the at least one inflatable balloon comprises a textured surface for preventing slippage of the outer surface on surrounding tissue.

Abstract: An cardioplegic fluid delivery catheter includes an expandable member for occluding the ascending aorta of a patient. A length of the catheter allows the distal end to be within the ascending aorta while the proximal end extends from a peripheral artery. The delivery catheter has a multi-lumen construction with a primary lumen extending configured to allow a cardioplegic fluid to be delivered to the aorta. Secondary lumens provide for balloon inflation and aortic root pressure monitoring. The delivery catheter includes a shaft having a pre-determined curve profile at a distal end of the delivery catheter. The pre-determined curve profile generally corresponds to the curve of the bottom surface of the aortic arch. The shaft may be eccentric to the expandable member such that retraction of the shaft causes a distal tip to be parallel within the ascending aorta.

Abstract: Apparatus and methods are described for effective removal of emboli or harmful fluids during therapeutic and diagnostic vascular procedures, such as angiography, balloon angioplasty, stent deployment, laser angioplasty, atherectomy, and intravascular ultrasonography. A catheter with an occluder mounted at its distal end creates an occlusion proximal to the lesion and provides a pathway for introducing a treatment catheter. Prior to, during or subsequent to the procedure, suction is activated to establish retrograde flow to remove emboli from the site. Additionally, a thin catheter with a distal fluid ejection nozzle may be introduced distal to the treatment site to rinse emboli from the treatment site. The suction flow and/or ejected fluid flow may be varied in a pulsatile manner to simulate regular blood flow and/or perturb settled emboli into being captured that may otherwise not be collected. The method establishes a protective environment before any devices enter the treatment site.

Abstract: A clot removal system includes first and second barriers that each have an expanded configuration forming an occlusion within a vessel and a collapsed configuration. At least one deployment device distally deploys the first barrier relative to a clot, and proximally deploys the second barrier relative to the clot. The at least one deployment device also delivers a thrombolytic agent into an isolated segment defined at least in part by the first and second barriers in the expanded configurations, and positions an impeller within the isolated segment. The impeller includes a substantially cylindrical hub having at least two impeller blades attached to rotate with the cylindrical hub. Each of the at least two impeller blades has a proximal end attached to the cylindrical hub and a distal end attached to the cylindrical hub.

Abstract: An implantable port system which in at least one embodiment includes a base having an upper surface configured to be positioned under and in contact with a first tissue surface in a body, and a port housing having a lower surface configured to be positioned over a second tissue surface above the first tissue surface. The base and the port housing may be separate from one another and do not contact each other at the time of positioning the base. The base and port may be connected together upon positioning the port in contact with the second tissue surface. A method of implanting a port system may include installing at least a portion of a base of the system beneath a tissue layer in a body, and attaching a port housing to the base at a location above the tissue layer, wherein the port housing is not in contact with the base during the installation of a least a part of the base system beneath the tissue layer.

Abstract: Sinusitis, enlarged nasal turbinates, tumors, infections, hearing disorders, allergic conditions, facial fractures and other disorders of the ear, nose and throat 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, endoscopic studies and transillumination studies. Access and occluder devices may be used to establish fluid tight seals in the anterior or posterior nasal cavities/nasopharynx and to facilitate insertion of working devices (e.g., scopes, guidewires, catheters, tissue cutting or remodeling devices, electrosurgical devices, energy emitting devices, devices for injecting diagnostic or therapeutic agents, devices for implanting devices such as stents, substance eluting devices, substance delivery implants, etc.

Abstract: Renal function may be modulated by an implantable device having one or more leads or catheters disposed near the kidney via the lymphatic system. In one embodiment, lymphatic drainage from the kidney is modulated to increase or decrease tubular reabsorption of salt and water. The renal function modulation therapy may be delivered in an open-loop or closed-loop fashion, with the latter dependent upon a physiological variable such as blood pressure or cardiac output.

Abstract: A catheter assembly and method of using the catheter assembly is provided herein. The catheter assembly has a catheter shaft having an elongated body extending about a longitudinal axis, a proximal portion and a distal portion, an outer surface, and at least one lumen extending therethrough the elongated body at least one means for sealing at least a portion of the lumen of the bronchial vessel. At least a portion of the catheter assembly is configured for insertion into at least a portion of a bronchial vessel of a target lung region. The means for sealing is moveable between a collapsed state and an expanded state. At least a portion of the vessel can be sealed by inflating the means for sealing. The catheter assembly can then be used to infuse a dialysate solution into the target lung region.

Abstract: An object of the present invention is to provide a tissue cell culture system whereby a call tissue can be efficiently and quickly proliferated in vivo and the onset bacterial infection in an injured part can be avoided in the course of a treatment. More specifically, a closed cell culture system (1) characterized in that a defection (2) of a tissue on the body surface or inside the body is tightly sealed to form a closed environment free from the invasion of bacteria, etc. and then a solution appropriate for cell culture is circulated in the tissue defection thus sealed to thereby regenerate the defective tissue; and a method of administering a drug which comprises dissolving a remedy in the perfusion with the use of the above system and thus promoting the treatment of the defection.

Abstract: Multi-luminal endoscopic systems for sterilely delivering deployable devices or obtaining bodily tissues. The system comprise an outer catheter comprising a wall that encloses an outer lumen; an inner catheter movably disposed within the outer lumen and having an inner lumen; a balloon-tipped catheter movably disposed within the inner lumen and having a distal end and a proximal end, wherein the distal end of the balloon-tipped catheter comprises a balloon tip that can be expanded to contact the wall of the outer catheter to provide a seal to prevent bodily fluids from entering the outer lumen; and a push catheter having a lumen and is located within the outer lumen. The delivery systems can comprise concentric catheters. Systems used for tissue collecting can comprise catheters with different common center.

Abstract: The present invention relates to an appliance for cannulation of a blood vessel with a cannula which, after introduction into the vessel, is in fluidic communication with the vessel. At least one means is also provided to permit a controlled division of the blood into a first subsidiary stream which leaves the vessel through the cannula, and a second subsidiary stream which continues to flow through the vessel.

Abstract: A balloon catheter comprising a catheter (3) and a balloon (7) located at a distal end (5) of the catheter (3). A plurality of measuring electrodes (12) formed on a primary substrate (17) extend around the catheter (3) within the balloon (7). The primary substrate (17) is formed by a portion of a flexible resilient membrane (25) which also forms a secondary substrate (19). The measuring electrodes (12) are formed on the primary substrate (17) by first electrically conductive tracks (27) and second electrically conductive tracks (28) which are electrically connected to the first electrically conductive tracks (27) are simultaneously formed on the secondary substrate (19). The membrane (25) is coiled to form a roll, and the primary substrate (17) is also coiled around the rolled secondary substrate (19).

Abstract: The invention is directed to a nasal delivery device comprising one or more microneedles, and to methods of nasally administering a composition with a nasal delivery device comprising one or more microneedles. In certain embodiments, the nasal delivery device comprises a substrate for administration of a composition to the nasal and/or sinus mucosa, wherein the substrate is non-absorbent and comprises one or more microneedles. In some embodiments, the nasal delivery device comprises a reservoir comprising one or more therapeutic agents, wherein the reservoir is in fluid communication with one or more microneedles.

Abstract: A catheterization device that may be designed by use of an adaptive genetic algorithm computational fluid dynamics approach, as well as other Global Optimization methods that may include simulated annealing, multistart and interval methods, continuous branch and bound methods, evolutionary algorithms, and tabu search and scatter search methods, as well as other available Global Optimization methods that is able to maximize/optimize the dwell time of an infused agent in the vicinity of a vascular lesion. The device may have an internal by-pass channel that allows the blood upstream of the lesion to continue its pulsatile flow through the vessel in the part of it occluded by the lesion, while simultaneously allowing the disbursement and maximal dwell time of an antithrombolytic or other diagnostic or therapeutic agent needed to treat the lesion.

Abstract: A device for filtering emboli from blood flowing through a lumen defined by the walls of a vessel in a patient's body. The device has a filter element being expandable from a collapsed configuration to an expanded configuration. The filter element includes a material having pores, and the material having pores includes cylindrical wires having at least three different diameters arranged in a pattern of graduated diameters.

Abstract: The present disclosure describes a cecostomy tube having a head with an opening and a valve. There is a flexible catheter with a lumen having proximal and distal ends, the proximal end of the catheter in fluid communication with the opening in the head, a portion of the catheter extending away from the head to define the distal end. The catheter also has walls defining inside and outside surfaces from the opening defined in the head to the distal end of the catheter. There is a retainer provided on the distal end of the catheter. The retainer can change shape from a first profile or configuration to a second profile where the second profile is larger than the first profile and the second profile is adapted to retain the cecostomy tube in place in a body. The device may be placed in a single, initial surgical operation.

Abstract: A catheter is adapted to exchange heat with a body fluid, such as blood, flowing in a body conduit, such as a blood vessel. The catheter includes a shaft with a heat exchange region disposed at its distal end. This region may include hollow fibers which are adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. The hollow fibers enhance the surface area of contact, as well as the mixing of both the heat exchange fluid and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body or alternatively positioned to systemically cool the entire body system.

Abstract: The invention provides a system and a method for removal of contrast from blood. In one aspect, the invention provides a catheter for removal of contrast from the veins that drain the cerebral circulation. In a second aspect, the invention provides a method for removing contrast from blood by contacting the blood with a sorbent.

Abstract: An introduction assembly and method for the insertion of medical instruments through a thoracic passage into a selected one of either the left or right atrium of the heart. Catheters or other instruments dedicated to performing required cardiac maneuvers are passed through an introductory sheath having a distal end disposed within the targeted atrium. Upon completion of the required cardiac maneuvers the instruments are removed from the atrium and a closure assembly is passed through the introductory sheath into a closing relation to an entry site, formed in the pericardium and corresponding atrium wall, to facilitate healing thereof. The introductory assembly and method facilitates the concurrent, operative disposition of a plurality of catheters or other instruments into the interior of the selected atrium through different thoracic passages and entry sites thereby allowing synergistic interaction between the multiple catheters in the performance of the required cardiac maneuvers.

Abstract: Apparatus and methods are disclosed for medical treatment comprising bone, tissue or duct dilatation using inflatable dilatation elements together with apparatus and techniques for tensioning, stretching, folding, and/or wrapping the dilatation elements externally as well as in situ to facilitate insertion, positioning and withdrawal procedures.

Abstract: An apparatus for sealing a puncture includes a cartridge, a pusher member, a sealant, and a tamping device on a proximal end of the cartridge. During use, the cartridge, sealant, and pusher member are advanced over a positioning member and into the puncture by advancing a cartridge hub carrying the tamping device. When further distal advancement of the cartridge is limited, the cartridge hub is further advanced, activating the tamping device, and causing the pusher member to advance relative to the sealant to compress the sealant within the puncture.

Abstract: A multi-needle injection system having a collapsible and expandable frame portion is provided. The system can be adapted for delivery trans-urethrally into the bladder, and expanded to touch or penetrate a wall portion of the bladder. A plurality of positioned needles can inject at multiple points into the bladder wall simultaneously to introduce a therapeutic or treatment substance.

Abstract: Balloon catheter comprises an elongated shaft having a proximal end, a distal end, an inflation lumen extending therein, and a biaxially oriented nonporous thermoplastic polymer tubular member having a Shore durometer hardness of less than about 75D and having the inflation lumen 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 catheter having an elongated shaft which has a multilayered distal tip with a first layer formed of a polyimide first material and a second layer formed of a polymeric second material. In one embodiment the multilayered distal tip is a separate member, distal to the distal end of a proximal portion of the shaft. In another embodiment, the shaft has an outer tubular member, and a multilayered inner tubular member with a distal end which forms the multilayered distal tip of the shaft. In a presently preferred embodiment, the polyimide material is a thermoset polyimide. In one embodiment, the polymeric second material is a polyamide material.

Abstract: Devices, systems, and methods for removing contrast from luminal organs. In at least one embodiment of a device for removing contrast from luminal organs of the present disclosure, the device comprises an elongated body having at least one lumen extending therethrough and an aperture defined along the elongated body, said aperture configured to facilitate withdrawal of contrast from a mammalian luminal organ, a first detector for detecting a contrast present within the mammalian luminal organ, the detector positioned at or near a distal end of the elongated body, an inflatable balloon coupled to the elongated body proximal to the detector, and a second detector for detecting balloon inflation, the second detector positioned along the elongated body within the balloon.

Abstract: Devices, systems and methods for stenting, spacing, draining, ventilating and/or delivering drugs and other therapeutic or diagnostic substances to desired locations within the bodies of human or non-human animal subjects, including methods and systems for treating paranasal sinusitis and ethmoid disease.