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, e.g., to deliver a pacing lead within a patient's heart. 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. An elongate member extends from the distal end of the tubular member. An expandable sheath extends along at least a portion of the elongate 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 stylet or other shaped element is insertable into the elongate member for changing a shape of at least a distal tip of the elongate member, e.g., for accessing side branches extending from a body lumen, e.g., within a patient's coronary venous system.

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: Apparatus and methods are provided for providing access to a body lumen, e.g., to deliver a pacing lead within a patient's heart. 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. An elongate member extends from the distal end of the tubular member. An expandable sheath extends along at least a portion of the elongate 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 stylet or other shaped element is insertable into the elongate member for changing a shape of at least a distal tip of the elongate member, e.g., for accessing side branches extending from a body lumen, e.g., within a patient's coronary venous system.

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: 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: A tissue-separating catheter assembly comprises a rotatable shaft, having a distal shaft portion, and a tissue separator device extending along the shaft. The tissue separator device has a distal separator part at the distal shaft portion movable between a retracted state, towards the distal shaft portion, and an outwardly extending, operational state, away from the distal shaft portion. A localization device is movable to a radially expanded state. An expandable tubular element is movable so that its outer end is generally axially aligned with the localization device so to capture a separated tissue section therebetween to aid removal of the separated tissue section from the patient.

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 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: 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: 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: A tissue separator assembly has an elongate tubular member and a tissue separator device located at a distal end of the elongate tubular member. An elongate coupler extends through the lumen of the elongate tubular member and has a distal coupler end. A tissue localization assembly has an elongate member and a localization device located at the distal end of the elongate member. The localization device may be movable from a first, radially-contracted state to a second, radially-expandable state. The distal coupler end of the elongate coupler and the proximal end of the elongate tubular member of the localization assembly are joinable to one another to permit docking of the tissue localization assembly to the tissue separator assembly. Methods of use of this device are also described.

Abstract: A tissue localizing and separating assembly comprises a shaft, having a distal shaft portion, and a tissue separator device extending along the shaft. The tissue separator device has a distal separator part at the distal shaft portion movable between a retracted state, towards the distal shaft portion, and an outwardly extending, operational state, away from the distal shaft portion. A tissue localization assembly has a radially-expandable end. An elongate coupler may be used to dock the tissue localization assembly to the tissue separator device.

Abstract: A tissue-separating catheter assembly comprises a rotatable shaft, having a distal shaft portion, and a tissue separator device extending along the shaft. The tissue separator device has a distal separator part at the distal shaft portion movable between a retracted state, towards the distal shaft portion, and an outwardly extending, operational state, away from the distal shaft portion. A localization device is movable to a radially expanded state. An expandable tubular element is movable so that its outer end is generally axially aligned with the localization device so to capture a separated tissue section therebetween to aid removal of the separated tissue section from the patient.