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: 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: 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: 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: 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 therebetween. A pushable stiffening member extends from the distal end of the tubular member. An expandable sheath extends along at least a portion of the stiffening member, the sheath being expandable from a contracted condition to facilitate insertion into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen communicating with the tubular member lumen. A distal portion of the sheath is steerable, e.g., using a pull wire disposed within a lumen of the sheath or within the stiffening member. In addition or alternatively, the stiffening member may be biased to a predetermined shape to facilitate introduction.

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: 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: 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 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: Apparatus and methods are provided for accessing body lumens and/or for delivering instruments into body lumens, e.g., vessels within a patient's vasculature. A flexible sheath is provided that is expandable from a contracted condition to an enlarged condition wherein the sheath at least partially defines a lumen therein. The sheath is lubricious and has a relatively thin wall, thereby providing a collapsible/expandable guide for delivering fluids and/or instruments through tortuous anatomy and/or into relatively narrow passages. The sheath is advanced from an entry site to a body lumen in the contracted condition. Once the sheath reaches a target body lumen, the sheath is expanded to the enlarged condition, thereby defining a lumen within the sheath, and fluids and/or instruments are introduced into the body lumen via the sheath lumen. Upon completing the procedure, the sheath is removed from the body lumen.

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: 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 provide distal protection while accessing blood vessels within a patient's vasculature. A flexible sheath and distal protection element, e.g., a balloon or filter, are carried by a stiffening member. The sheath is lubricious and has a relatively thin wall, thereby providing a collapsible/expandable guide for delivering fluids and/or instruments. The sheath is advanced into a blood vessel in a contracted condition, expanded to an enlarged condition to define a lumen, and the distal protection element is deployed within the vessel beyond the sheath. Fluids and/or instruments are introduced into the vessel via the sheath lumen, the distal protection element retaining the fluids and/or capturing emboli released by the instruments. Upon completing the procedure, the sheath, distal protection element, and stiffening member are removed from the vessel.

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.