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: The present invention is directed to methods and devices for accessing a cerebral vessel. The system includes a support catheter having a balloon, which can be advanced into small and tortuous vessels. By advancing the support catheter nearer to the obstruction then can be achieved with conventional guide catheters, the support catheter reduces the likelihood vessel compression and collapse when manipulating a working catheter. The balloon may be used to temporarily stop blood flow.

Abstract: A catheter assembly and method of use comprises advancing a catheter having a rotatably mounted balloon relative to the primary guide wire to a vessel bifurcation along first and second guide wires.

Abstract: Therapeutic device intended for the selective cytoreductive treatment of an obstruction in a natural lumen or passage of the human or animal body, said lumen being obstructed by the effect of a local cell proliferation, said device comprising a tubular element, in particular of cylindrical shape, intended to be placed in said natural lumen and sufficiently flexible to conform to said natural lumen, but sufficiently rigid to maintain an artificial channel in said lumen. The tubular element supports lengthwise a medicinal sleeve which is intended to come into line with, and into contact with, the obstruction once the natural lumen has been intubated, and is designed to deliver locally, at least in its outer surface portion, at least one therapeutic agent which is cytoreductive, in particular cytotoxic, through contact with the cells under whose effect said lumen is obstructed.

Abstract: The present invention provides a medical device having an elongate body with both a proximal end and a distal end, wherein the elongate body defines an intake lumen and an exhaust lumen. The medical device also has a first pliable element defining a cooling chamber disposed at a point along the elongate body, with the cooling chamber being in fluid communication with the intake lumen and the exhaust lumen. A second pliable element is provided which at least partially encloses the first pliable element, thereby defining a junction between the first and second pliable element. Moreover, a check valve is included which is in fluid communication with the junction between the first pliable element and second pliable element, the valve further being in fluid communication with the exhaust lumen. In addition, the medical device may include sensors or other monitoring means in fluid communication with the junction and the cooling chamber.

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: A targeted drug delivery device is provided. The device comprises an elongated member with proximal and distal ends, a plurality of infusion ports associated with the distal end of the elongated member, and a selector mechanism for selectively placing an introducer port into fluid communication with at least one infusion port. A method for treating tissue is also provided. The method comprises introducing a medical device into the tissue, selecting a region of the tissue to treat, positioning the medical device in proximity to the region, and introducing a medicament through the device to treat only that region.

Abstract: A method for accessing the left atrial appendage with a balloon-tipped transseptal sheath is disclosed. A transseptal sheath is delivered to the left atrium through the intraatrial septum from the right atrium. The balloon tip may be inflated to prevent the transseptal sheath from falling proximally into the right atrium. The inflated balloon tip permits safe probing and exploration of the left atrial appendage and facilitates safe maintenance of the position of the transseptal sheath within the left atrial appendage while delivering an implantable device to the left atrial appendage.

Abstract: A catheter is configured to prevent kinking of a catheter during handling or mounting of a pressure device. The catheter has a proximal end of its catheter shaft that is provided with a bending section having a flexibility greater than that of the section of the catheter shaft joining the proximal end.

Abstract: Balloon catheters and methods for manufacturing catheter shafts are disclosed. In one example, a balloon catheter may include an outer tubular member disposed about an inner tubular member. In some cases, a fluid (e.g. cryogenic fluid) can be provided between the inner tubular member and the outer tubular member and may cool the inner tubular member. To help provide a relatively uniform temperature distribution around a circumference of the inner tubular member, two or more spacers, protrusions, or gap-maintaining members can be positioned between the outer tubular member and the inner tubular member to maintain a gap therebetween. In some cases, the spacers, protrusions, or gap-maintaining members may be attached to an inner surface of the outer tubular member or, in other cases, to an outer surface of the inner tubular member. In other embodiments, a step-down in an outer diameter of the outer tubular member is disclosed.

Abstract: The present invention provides medical devices comprising nanocomposite materials. By utilizing nanocomposites in the production thereof, the inventive medical devices can be produced with various advantageous properties. Methods of producing the inventive medical devices are also provided. Inasmuch as the inventive devices are expected to provide certain advantages in their use, there is also provided a method of medical care including methods of treatment or diagnosis, wherein the inventive devices are brought into therapeutic contact with a body to be treated or diagnosed thereby.

Abstract: A system for providing access across a site of obstruction is provided. The system may include a sleeve, having a distal portion that can move from an inverted position to an everted position. A balloon situated within the sleeve can be extended so as to evert sleeve. A pathway can extend across a juncture between the distal portion and the remaining portion of the sleeve so as to provide access across the site of obstruction. A method for providing access across the site of obstruction is also provided.

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 is provided that includes an elongated body extending from a proximal end to a distal end. The body defines at least one lumen. A tip has a proximal end that is disposed in abutting relation with the distal end of the body such that the body is fixed with the tip. The tip defines a lateral opening that is defined by a wall including an external radius disposed in transition with an outer surface of the tip and an internal radius disposed in transition with an inner surface of the tip. The external radius has a non-perpendicular profile with the outer surface of the tip.

Abstract: In one embodiment, balloons are intended for use in valvuloplasty of stenosed aortic valves, with a potential use for valvuloplasty of other heart valves as well. Their common special feature is that the entire or part of their external surface is covered by a drug that is eluted at the valve tissues during the balloon brief contact with them at the time of dilatation. The drug acts against the process of restenosis, which almost uniformly occurs after some time. The shape of the balloon can be the classical cylindrical or an hour-glass shape that facilitates targeted delivery of the drug at the valve tissues. Additional balloon shapes are described for usage after valvuloplasty is carried out in order to achieve targeted drug delivery in the upper or both surfaces of the leaflets, and for prolonged contact with the valve tissues without interruption of blood circulation. An advantage of the balloons is that the local delivery of the drug will significantly reduce the likelihood of restenosis.

Abstract: Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools.

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

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

Abstract: In a medical guide wire 1, a helical spring body 3 is made of austenitic stainless steel wire treated with a solid-solution procedure, and tightly drawn with a whole cross sectional reduction ratio as 90%-99.5%. A metallic wire element of the helical spring body 3 is heat treated at low temperature within a range in which a tensile rupture strength of the helical spring body 3 rapidly increases by partly or totally making use of a conductive heat generated when a core wire 2 and the helical spring body 3 are in part bonded by means of a welding member 4. This makes it possible to improve a mechanical strength property, especially a fatigue-resistant property against a repetitive bending action of the helical spring body 3.

Abstract: The present invention is directed to methods and devices for removing an obstruction. The system includes a support catheter which can be advanced into small and tortuous vessels. By advancing the support catheter nearer to the obstruction then can be achieved with conventional guide catheters, the support catheter reduces the likelihood vessel compression and collapse when pulling on the retrieval element.

Abstract: Dilation catheters including a mechanism used in, for example, removing gas or air from the catheters are disclosed. A dilation catheter may include an elongated tubular member having a distal end and a proximal end, a proximal handle proximate the proximal end of the tubular member, and an inflatable balloon proximate the distal end of the tubular member with inflatable balloon being in fluid communication with a fluid port to supply inflation liquid to the inflatable balloon. The inflatable balloon may include an opening for permitting gas to exit the inflatable balloon. In the proximate location of the opening, an expandable material or a barrier material that permits gas to exit through the opening, while retaining inflation liquid in the inflatable balloon.

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: Medical devices including a substrate that are expandable from a compressed state to an expanded state; a coating on the substrate, the coating having a drug agent incorporated therein; and a sheath over the coating. The sheath is expandable from a compressed state to an expanded state and has at least one perforation therein. The medical devices are configured such that when the substrate is in a compressed state, the sheath is also in a compressed state and the perforation is substantially closed. When the substrate is in an expanded state, the sheath is also in an expanded state and the perforation is substantially open. The invention also includes a method of using the medical devices for the controlled, localized delivery of a drug agent to a target location within a mammalian body.

Abstract: A balloon catheter may comprise a primary inflation balloon and a secondary inflation balloon located to one side of the primary inflation balloon. The secondary balloon comprises a first portion and a second portion, the first portion located closer to the primary balloon. The second portion has a greater size than the first portion, and a portion of the second portion extends outwardly beyond the first portion and overhangs the first portion. In some embodiments, a cross-sectional shape of the secondary balloon in an inflated state comprises a mushroom shape.

Abstract: A retention device for use in a human or mammalian body includes superelastic wires that expand when they are released from a confined state. The retention device may have the outer form of a Foley catheter. One or more superelastic wires within the balloon of a Foley catheter help to insure retention within the body, such as within a urinary bladder.

Abstract: Kit for providing an artificial stomach entrance, comprising a trocar with a trocar sleeve for penetrating the abdominal wall into the stomach and a PEG tube with a distal extension insertable into the stomach in the form of a balloon made of a flexible material if need be with slight stretchability, which has at least one opening and a proximally connecting tubular area, wherein a feeding channel extends from a proximal feeding opening of the tubular area through the tubular area up to the at least one opening and the balloon is connected with a fill channel, which extends along the tubular area up to the proximal end and has a fill opening with a seal.

Abstract: Methods of manufacturing a medical article that include radial deformation of a polymer tube are disclosed. A medical article, such as an implantable medical device or an inflatable member, may be fabricated from a deformed tube.

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 coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

Abstract: An introducer assembly (20) for the deployment of an implantable medical device (12) such as a stent, stent graft or other medical device, includes a dilator tip (22) which is able to be compressed radially so as to be withdrawn into the introducer assembly (20) so as to position the implantable medical device (12) at the distal most end of the introducer assembly once the dilator tip has been withdrawn. This enables the implantable medical device (12) to be positioned much closer to both parts of a patient's anatomy, for instance much closer to an aortic valve (92). In the preferred embodiment the dilator tip (22) includes an inflatable and deflatable balloon element (28) which is able to be withdrawn into the assembly while the implantable medical device (12) remains in its constrained position in the introducer assembly (20).

Abstract: The invention relates to a catheter device for treating a blockage of a vessel, with the catheter device featuring a treatment catheter for treating the vessel blockage which is embodied as an integrated unit with front-mounted stent.

Abstract: A catheter tip for an infusion catheter has a hollow tubular shaped base member with a pair of annular shaped inflation balloons positioned in parallel on the base member. A plurality of microfibers are mounted on the cylindrical surface section between the balloons. The microfibers are in fluid communication with the lumen of the catheter tip. In operation, the catheter tip is advanced into the vasculature of a patient and to a site in a small vein that is near the target tissue for infusion. The balloons are then inflated to anchor the catheter tip, and fluid medicament is infused through the microfibers. In an alternate embodiment, the microfibers can be replaced with at least one orifice.

Abstract: The present invention provides a cannula guide tube; and a kit with the cannula guide tube, a flexible transparent cannula or a transparent catheter with an inflatable balloon at the catheter end, and an exploratory device. The kit is for irrigation, suction and washing out purulent or liquid discharges from bacteria infected sinuses. First, the exploratory device is used to find the entrance orifice to a sinus; second, the cannula guide tube is positioned in the sinus orifice entrance; and third, the flexible transparent cannula or the transparent catheter is inserted through the cannula guide tube into the sinus. The flexible transparent cannula or transparent catheter is used to suction the purulent or liquid discharge and to irrigate and wash out the sinus.

Abstract: An apparatus for applying a substance to internal mammalian tissue is provided. The apparatus includes a member having a flexible, absorbent, porous portion connected to a non-porous portion. The apparatus may be used to treat atrial fibrillation or other non-atrial fibrillation issues with internal mammalian tissue.

Abstract: A medical catheter assembly including either a reinforced balloon bolster or the combination of a balloon bolster and a wire-basket bolster. According to one embodiment, the medical catheter assembly is a low-profile replacement PEG device comprising a feeding tube, an external bolster, an end cap and an internal bolster. The internal bolster comprises a first expandable structure and a second expandable structure. In one embodiment, the first expandable structure is a balloon and the second expandable structure comprises reinforcing members. In another embodiment, the first expandable structure is a balloon and the second expandable structure is a wire basket bolster. The feeding tube has a feeding lumen and an inflation lumen, extending parallel longitudinally. The external bolster is fixed to the external end of the feeding tube and has a feeding lumen aligned with that of the tube and an inflation lumen aligned with that of the tube.

Abstract: An endovascular stapler (100) for securing an endograft to a vessel is disclosed. The stapler has a staple housing (104), an actuating mechanism (148) and an expansion mechanism (126). The staple housing (104) has a plurality of staple cartridges (128) adapted for storing at least one staple (180) therein. The staple cartridges (128) have an exit area (130) for discharging at least one of the staples (180) therethrough. The actuating assembly (148) is adapted for actuating the plurality of staple cartridges (128) to discharge the at least one staple through the exit area. The expansion mechanism (126) is in operative association with staple cartridges (128). The expansion mechanism (126) is operative for pushing the exit area (130) against the endograft when discharging the at least one staple therethrough.

Abstract: An occlusive guidewire system having an ergonomic handheld control mechanism and torqueable kink-resistant guidewire having a distally located inflatable balloon. The present invention provides convenient structure and overall mechanism for operation of a torqueable kink-resistant guidewire, including evacuation and inflation control of an occlusive balloon, and sealing and severing of a crimpable inflation tube which is in communication with an occlusive balloon. The torqueable kink-resistant guidewire includes a centrally located shaft which imparts robustness to the torqueable kink-resistant guidewire. An inflation lumen aligns within the torqueable kink-resistant guidewire for inflation of the balloon.

Abstract: A system for treatment of a vessel bifurcation and its method of use comprises a catheter having a catheter shaft, a portion of which is characterized as an axle about which a rotatable assembly is disposed and rotatable thereabout. The system employs a series of lumens, openings and/or ports to provide a balloon mounted on the rotatable assembly with fluid communication to the catheter shaft.

Abstract: A medical device comprising a supporting structure capable of containing or supporting a pharmaceutically acceptable carrier or excipient, which carrier or excipient may contain one or more therapeutic agents or substances, with the carrier preferably including a coating on the surface thereof, and the coating containing the therapeutic substances, such as, for example, drugs. Supporting structures for the medical devices that are suitable for use in this invention include, but are not limited to, coronary stents, peripheral stents, catheters, arterio-venous grafts, by-pass grafts, and drug delivery balloons used in the vasculature.

Abstract: An apparatus including an expandable body; at least one delivery cannula coupled to an exterior portion of the expandable body; a needle having a protuberance thereon disposed in a lumen of the at least one delivery cannula; a stop disposed in the lumen of the at least one delivery cannula at a position distal to the protuberance on the needle. A method including positioning a catheter assembly including at least one needle delivery device disposed in an at least one delivery cannula, the at least one delivery cannula having an exit end; modifying the shape of the catheter assembly to modify the orientation of the exit end of the at least one delivery cannula at a region of interest; and advancing the at least one needle delivery device beyond the exit end of the at least one delivery cannula according to a controlled orientation.

Abstract: The invention generally relates to internal (e.g., implantable, insertable, etc.) drug delivery devices which contain the following: (a) one or more sources of one or more therapeutic agents; (b) one or more first electrodes, (c) one or more second electrodes and (d) one or more power sources for applying voltages across the first and second electrodes. The power sources may be adapted, for example, to promote electrically assisted therapeutic agent delivery within a subject, including electroporation and/or iontophoresis. In one aspect of the invention, the first and second electrodes are adapted to have tissue of a subject positioned between them upon deployment of the medical device within the subject, such that an electric field may be generated, which is directed into the tissue. Furthermore, the therapeutic agent sources are adapted to introduce the therapeutic agents into the electric field.

Abstract: 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: A balloon trocar includes a cannula assembly including a cannula and an outer sleeve fitting over the cannula. The distal end of the outer sleeve is proximal to the distal end of the cannula. A balloon is coupled to a distal portion of the sleeve and a distal portion of the cannula. The outer surface of the cannula includes a plurality of longitudinal channels for transmitting gas or fluid to the balloon. A bolster having a gel pad at its distal portion is slidably mounted to the cannula assembly and may be locked in a desired position. In use, the trocar is inserted into an incision through a body wall and into a body cavity. The balloon is inflated and the cannula assembly pulled proximally against the incision while the bolster is slid distally to the body wall and locked in place to seal the incision with the compressed balloon.

Abstract: The invention describes a closure device for the provision of freshly created gastric feeding fistulas, the basis of the design of the device being an introverted balloon that allows a sealing and hemostatic axial traction movement on the fistula that is to be sealed, the concentric balloon ends which run transmurally through the stomach and abdominal wall being arranged in a special seal-promoting and hemostatic manner.

Abstract: A configurable percutaneous endoscopic gastrostomy tube includes a shaft having a distal end and a proximal end. The shaft defines a lumen therethrough for passage of a feeding solution or medicine. An expandable retainer is located on the shaft, the retainer having a deployed position and an insertion position. The tube includes a releasable lock for maintaining the expandable retainer in its deployed position, the releasable lock located on the shaft proximal to the expandable retainer. A flexible sheath surrounds the expandable retainer, the sheath being generally loose around the retainer when the retainer is in an insertion position and the sheath being generally snug against an exterior surface of the retainer when the retainer is in a deployed position.

Abstract: A stoma dilation device that includes a tubular support defining a continuous pathway through the device; an inflatable dilation balloon located on the tubular support, the inflatable dilation balloon including a dilation region forming a first portion of the device and a retention region forming a second portion of the device; and a balloon inflation lumen. The retention region of the balloon is configured to have a diameter upon full, unrestrained inflation that is greater than the diameter of the dilation region.

Abstract: Apparatus and methods are provided for delivering fluid into a body lumen during a medical procedure. A distal end of an apparatus may be introduced into a body lumen, and a valve on the distal end may be opened to deliver fluid through a first lumen into the body lumen, e.g., contrast and/or other diagnostic or therapeutic agents. The valve may be closed, and a procedure may be performed within the body lumen, e.g., using a treatment element carried on the distal end. For example, the treatment element may include a balloon that may be inflated when fluid is delivered through the first lumen with the valve closed. Optionally, a prosthesis, energy source, drug platform, and the like may be carried by the balloon for treating the body lumen. In various embodiments, the valve may be located proximal or distal to the treatment element.

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: A system comprising: a hollow tube having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end; at least a portion of the tube comprising a porous membrane; and a gas-rich perfluorocarbon solution incorporated in the porous membrane; wherein the porous membrane has a porosity in the range of 0.001-200 microns, in order that: (i) the gas-rich perfluorocarbon solution is effectively incorporated into the porous membrane; and (ii) when the porous membrane is positioned in blood, the gas-rich perfluorocarbon solution elutes out of the porous membrane, in aggregations small enough to prevent the creation of embolisms in the blood, with the elution of the gas-rich perfluorocarbon solution into the blood varying between minutes and several hours, depending on the temperature and the hemodynamics of the blood.

Abstract: Devices and methods for the treatment of chronic total occlusions are provided. One disclosed embodiment comprises a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method includes providing an intravascular device having a distal portion, inserting the device into the vascular lumen, positioning the distal portion in the vascular wall to at least partially surround the occlusion, and removing at least a portion of the surrounded occlusion from the lumen.