Abstract: Apparatus and methods are provided for substantially continuously forming thin-walled sleeves that may be incorporated into tubular devices sized for introduction into a patient. In one embodiment, a pair of sheets including coated surfaces oriented towards one another are directed through a cutting apparatus to cut the sheets into multiple pairs of strips. The pairs of strips are bonded together to create a plurality of sleeves having lumens defined by the coated surfaces. In another embodiment, a sheet having a coated surface is fed through a cutting tool to separate the sheet into a plurality of strips, and the strips are formed into sleeves, e.g., by feeding the strips through a die or mandrel using a substantially continuous process. Optionally, the sleeves may be subsequently cut into individual tubular devices and/or further processed, e.g., by providing one or more layers around the sleeves to create catheters, sheaths, or other apparatus.

Abstract: Apparatus and methods are provided for making coated liners and/or tubular devices including such coated liners. A sleeve may be provided that includes an outer first surface and an inner second surface extending between first and second ends thereof, and a hydrophilic or other coating may be applied to the first. The coated sleeve may be cut between the first and second ends to create opposing edges extending between the first and second ends, and the cut sleeve may be reversed such that the coated first surface defines an inner surface and the opposing edges are disposed adjacent one another, thereby providing a coated liner. Optionally, a tubular structure, e.g., one or more reinforcing layers and/or or outer layers may be attached around the coated liner, thereby providing a tubular device including an inner surface with a desired coating.

Abstract: A medical device includes a proximal end, a distal end sized for introduction into a body lumen, and a lumen extending between the proximal and distal ends. The tubular device includes an inner liner including a coating on an inner surface thereof, a reinforcing layer surrounding at least a portion of the liner; and an outer layer surrounding the reinforcing layer and inner liner. The liner and outer layer may include multiple sections having different properties than one another, adjacent sections attached together by seams, which may be offset from one another. Apparatus and methods for making tubular devices with coated liners are also provided.

Abstract: Apparatus and methods are provided for delivering a lead over a rail into a target body lumen, cavity, or other vessel, e.g., a coronary vein or a right ventricle within a patient's heart. For example, a distal end of an elongate guidewire or other rail may be introduced into the coronary venous system via the coronary sinus, advanced through the coronary venous system to a location beyond a target vessel, and secured at the location beyond the target vessel. A catheter or other elongate tubular member is advanced over the rail and manipulated to position an outlet of the tubular member adjacent to or otherwise aligned relative to the target vessel. A distal end of a lead is delivered through the tubular member and out the outlet into the target vessel. The catheter and rail are then removed, leaving the lead within the target vessel.

Abstract: Material transport catheters and methods for their use rely on rotation of an impeller within a catheter body and a clearing element for preventing buildup of materials at the opening of the catheter body. The impeller preferably comprises an inner tube or shaft having a helical rotor formed over an outer surface thereof. The clearing element may comprise a free end of a structure near the distal end of the catheter body for disrupting clot, wherein the free end of the structure extends into the distal opening of the catheter body to break up materials as the impeller is rotated. Alternatively, the clearing element may comprise a cutting member disposed at the distal opening of the catheter body.

Abstract: A system for delivering an agent to tissue surrounding a target vessel includes an elongate delivery device and a source coupled to a proximal tubular portion of the device. A first lumen extends through the tubular portion and an expandable sheath of the device, wherein the expandable sheath has a proximal end that surrounds and overlies a distal end of the tubular portion. The device further includes a stiffening member, attached to the sheath, and a balloon attached to the stiffening member, at a location spaced apart from the sheath. A second lumen extends, within the tubular portion and the stiffening member, to the balloon. A volume of fluid may be delivered, from the source, through the first lumen and into a section of the target vessel that is downstream from the expandable sheath and upstream of the balloon, in order to expand the sheath, fill the section and apply a pressure sufficient to cause extravasation of the section.

Abstract: An apparatus for providing access to a body lumen includes a tubular proximal portion and an expandable distal portion, which extends distally from a distal end of the proximal portion. The expandable distal portion includes an expandable sheath and a stiffening member. The proximal portion has a first lumen extending from a proximal end to a distal end thereof, and the expandable sheath defines a second lumen that is in fluid communication with the first lumen and extends distally from the proximal portion to a distal terminal opening of the second lumen. The stiffening member is attached directly to the expandable sheath so as to extend alongside the second lumen, and the distal terminal opening of the second lumen is defined by a portion of a perimeter of a distal terminal end of the expandable sheath that becomes spaced apart from the stiffening member when the sheath is expanded.

Abstract: Apparatus and methods are provided for providing access to a body lumen. The apparatus includes a tubular member including a proximal end, a distal end sized for insertion into a body lumen, and a lumen extending between the proximal and distal ends. A pushable stiffening member extends from the distal end of the tubular member, the elongate member terminating in a distal tip. An expandable sheath extends along at least a portion of the stiffening member, the sheath being expandable from a contracted condition to minimize a profile of the sheath to allow insertion along with the stiffening member into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen communicating with the tubular member lumen. In one embodiment, the sheath includes an outer lumen and an inner lumen floating within the outer lumen, and the stiffening member is carried in the inner lumen.

Abstract: A sheath for delivering a lead or other device into a body lumen is adapted to be removed from around the delivered lead or device via a longitudinally extending feature. This feature of the sheath may be a ripcord, a seam or interlocking features the releasably engage one another.

Abstract: A system and/or apparatus for delivering a medical device into a body includes an elongate tubular member and a valve fitted within a proximal end thereof. The valve preferably includes a tubular body and a flap, wherein the tubular body is engaged within the proximal end of the tubular member and has an open end approximately aligned with a proximal termination of the proximal end of the tubular member. The flap of the valve preferably extends over a hole formed in an end wall of the tubular body opposite a side of the end wall that faces a passage of the tubular body, which passage extends between the open end and the end wall. The hole communicates with the passage and with the lumen of the tubular member, and the flap is movable away from the hole when the device is introduced through the passage and the hole.

Abstract: Material transport catheters and methods for their use rely on rotation of an impeller within a catheter body and a clearing element for preventing buildup of materials at the opening of the catheter body. The impeller preferably comprises an inner tube or shaft having a helical rotor formed over an outer surface thereof. The clearing element may comprise a free end of a structure near the distal end of the catheter body for disrupting clot, wherein the free end of the structure extends into the distal opening of the catheter body to break up materials as the impeller is rotated. Alternatively, the clearing element may comprise a cutting member disposed at the distal opening of the catheter body.

Abstract: Splittable tubular devices and methods for making them are provided. In one embodiment, a tubular device includes a proximal end, a distal end sized for introduction into a body lumen, and a lumen extending between the proximal and distal ends. The tubular device includes an outer tubular layer defining a circumference; and a reinforcing layer bonded to the outer tubular layer, the reinforcing layer including a circumferential interruption. To make a tubular device, an elongate tubular reinforcing structure may be folded into itself to define first and second longitudinal edges, and rolled until the longitudinal edges are disposed adjacent one another. The reinforcing structure may be attached to a tubular structure such that the longitudinal edges define a circumferential interruption extending along a length of the tubular structure.

Abstract: Valves for medical devices and methods for making them are provided. In one embodiment, a valve is injection molded as a single piece that includes a tubular body and a flap. The tubular body includes an open first end, a closed second end, and a passage extending between the first and second ends defining a central longitudinal axis. The second end includes an end wall including a hole therein communicating with the passage. The flap is formed in the end wall over the hole and is movable away from the second end when an elongate device is introduced through the passage and the hole. Apparatus are also provided for delivering a medical device into a patient's body that includes an elongate tubular member including proximal and distal ends, a lumen extending between the proximal and distal ends; and a valve attached to the proximal end.

Abstract: Apparatus and methods are provided for substantially continuously forming thin-walled sleeves that may be incorporated into tubular devices sized for introduction into a patient. In one embodiment, a pair of sheets including coated surfaces oriented towards one another are directed through a cutting apparatus to cut the sheets into multiple pairs of strips. The pairs of strips are bonded together to create a plurality of sleeves having lumens defined by the coated surfaces. In another embodiment, a sheet having a coated surface is fed through a cutting tool to separate the sheet into a plurality of strips, and the strips are formed into sleeves, e.g., by feeding the strips through a die or mandrel using a substantially continuous process. Optionally, the sleeves may be subsequently cut into individual tubular devices and/or further processed, e.g., by providing one or more layers around the sleeves to create catheters, sheaths, or other apparatus.

Abstract: Apparatus and methods are provided for creating tubular devices, e.g., as components for catheters, sheaths, and or other devices sized for introduction into a patient. In one embodiment, a method is provided for making a tubular device using a sheet of material including a coated first surface. The sheet is rolled around a mandrel until longitudinal edges of the sheet are disposed near or adjacent one another, e.g., without attaching the longitudinal edges together. A tubular braid is positioned over the sheet-wrapped mandrel, one or more tubular segments are positioned over the tubular braid, and heat shrink tubing is positioned over the tubular segments. The resulting assembly is heated to cause the tubular segments to at least partially reflow and/or otherwise laminate the tubular segments to the tubular braid and sheet. The heat shrink tubing and mandrel are then removed to create the tubular device.

Abstract: A system for delivering an agent to tissue surrounding a target vessel includes an elongate delivery device and a source coupled to a proximal tubular portion of the device. A first lumen extends through the tubular portion and an expandable sheath of the device, wherein the expandable sheath has a proximal end that surrounds and overlies a distal end of the tubular portion. The device further includes a stiffening member, attached to the sheath, and a balloon attached to the stiffening member, at a location spaced apart from the sheath. A second lumen extends, within the tubular portion and the stiffening member, to the balloon. A volume of fluid may be delivered, from the source, through the first lumen and into a section of the target vessel that is downstream from the expandable sheath and upstream of the balloon, in order to expand the sheath, fill the section and apply a pressure sufficient to cause extravasation of the section.

Abstract: Apparatus, systems, and methods are provided for delivering stem cells or other agents to cardiac tissue surrounding a cardiac vessel or to tissue adjacent other body lumens. The apparatus includes an expandable member and a source of one or more agents communicating with a lumen extending between proximal and distal ends of the apparatus. The distal end of the apparatus is advanced through one or more body lumens until the distal end is disposed within or adjacent the target body lumen. The target body lumen is sealed, e.g., by expanding the expandable member, thereby isolating the target body lumen. One or more agents are delivered into the target body lumen with sufficient pressure to extravasate the one or more agents into tissue surrounding the target body lumen.

Abstract: Coated devices for introduction into bodies and methods for making and using them are provided, such as delivery sheaths, guidewire lumen cores, and elongate leads. In one embodiment, a tubular device includes a proximal end, a distal end sized for introduction into a body lumen, and a lumen extending between the proximal and distal ends. The tubular device includes a relatively thin inner polyurethane liner including a coating on an inner surface thereof, e.g., providing a lubricious and/or hydrophilic lumen, and an outer layer surrounding the liner. In another embodiment, a lead is provided that includes a proximal end, a distal end, and at least one electrode on the distal end. A polyurethane cover surrounds at least a portion of an outer surface of the lead that include a coating, e.g., including a lubricious and/or hydrophilic material. Optionally, the cover may be removable from around the lead body.

Abstract: A method for making a tubular device includes coating a first surface of a thin sheet, rolling the sheet such that side edges of the sheet are disposed adjacent one another with the coating disposed inwardly, creating a longitudinal seam along the side edges to create a sleeve, and attaching a tubular structure around the sleeve. In another embodiment, the method includes coating a first surface of a thin sheet, wrapping the sheet partially around a mandrel with the coating disposed inwardly, positioning a slotted tube around the sheet and mandrel, attaching the tube to the thin, and trimming any excess material of the sheet. In another embodiment, the method includes coating an outer surface of a thin sleeve, inverting the sleeve, and attaching a tubular structure around the inverted sleeve, thereby providing a tubular device including a lubricious, hydrophilic, and/or otherwise coated inner surface.

Abstract: Apparatus and methods are provided for substantially continuously forming thin-walled sleeves that may be incorporated into tubular devices sized for introduction into a patient. In one embodiment, a pair of sheets including coated surfaces oriented towards one another are directed through a cutting apparatus to cut the sheets into multiple pairs of strips. The pairs of strips are bonded together to create a plurality of sleeves having lumens defined by the coated surfaces. In another embodiment, a sheet having a coated surface is fed through a cutting tool to separate the sheet into a plurality of strips, and the strips are formed into sleeves, e.g., by feeding the strips through a die or mandrel using a substantially continuous process. Optionally, the sleeves may be subsequently cut into individual tubular devices and/or further processed, e.g., by providing one or more layers around the sleeves to create catheters, sheaths, or other apparatus.