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: 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, 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 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: 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 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: 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: 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.