Abstract: Apparatus and methods are provided for making one or more tubular components of medical catheters or other tubular bodies using a strip of polymer material including a length, a width, and a first surface including a lubricious or other coating or surface modification. The strip is directed adjacent an elongate mandrel, such as beading, such that the length of the strip extends along the mandrel and the coating is disposed towards the mandrel. The strip is rolled at least partially around the mandrel such that the coating or surface modification is disposed inwardly towards the mandrel, and one or more strip-constrainment members are wrapped around the rolled strip. The directing, rolling, and wrapping steps may be substantially continuous to create one or more strip-mandrel-constrainment member subassemblies.

Abstract: The present invention provides devices, systems, methods and kits for the percutaneous removal of unwanted tissue or obstructive matter from body cavities or lumens, particularly from the vasculature. Blood vessels, including the coronary, peripheral and neurovascular circulation, which are narrowed or blocked by atheromatous material or plaque are often treated with traditional endarterectomy procedures. The present invention allows the benefits of such a procedure with an intraluminal approach, particularly a percutaneous approach. Generally, the present invention provides a set of catheters or tools which are percutaneously introduceable to the site of the blockage or occlusion. The tools dissect or cut through the innermost tissue layer of the lumen to an underlying tissue layer. The innermost tissue layer is then stripped away from the underlying layer with the occlusive material thereattached.

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 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: 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: 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: 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: An apparatus for imaging a body structure within a body cavity includes a catheter including proximal and distal ends, an imaging element on the distal end, and an extension extending distally from the distal end for contacting a surface of a body cavity into which the catheter is introduced. The extension has a length to maintain the optical imaging element away from the surface. Optionally, a transparent member, e.g., an expandable balloon, may be attached to the distal end of the tubular member and the extension to isolate the imaging element from contact with fluid within the body cavity. During use, the catheter is inserted into a chamber of a beating heart, and the extension and/or balloon is placed against the wall of the chamber. Sufficient force is applied to stabilize the imaging element relative to the wall while the heart is beating.

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: 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: 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 a body lumen within a patient's body. Generally, the apparatus includes a tubular member including proximal and distal ends, a steering element extending between the proximal and distal ends, and an actuator for directing the distal end between a relaxed configuration and a complex curved configuration. In the relaxed configuration, the distal end may assume a straight or curved shape. In the complex curved configuration, the distal end may assume a curvilinear shape. In one embodiment, the complex curved configuration may include a first curved portion defining an arc within a plane, and a second portion that extends out of the plane. An embodiment with a left hand rule configuration may be introduced into the right atrium of a heart from a superior approach, and the complex curved configuration may facilitate accessing 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 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: An apparatus for treating tissue includes a flexible catheter including a proximal end, a distal end for introduction into a chamber of a heart, a transparent balloon carried by the distal end, an optical imaging assembly carried by the distal end for imaging tissue structures beyond the distal end through the balloon, and a needle deployable from the tubular member for penetrating the tissue structure to treat tissue. The apparatus may include a source of stems cells or other therapeutic and/or diagnostic agent coupled to the needle, a guide catheter advanceable over the needle for accessing a region beyond the tissue structure penetrated by the needle, and/or an energy probe deployable from the catheter for delivering electrical energy to tissue in the region beyond the tissue structure. The apparatus may be used to deliver stem cells into infracted tissue or for ablating heart tissue, e.g., from a trans-septal approach.

Abstract: Thrombectomy and other treatments are achieved using a catheter having a positioning cage and a macerator within the positioning cage. The catheter is introduced to a target body lumen, typically a blood vessel, and a positioning cage deployed at a treatment site. The macerator is then operated to disrupt thrombus, clot, or other occlusive materials at the treatment site, and the catheter is used to collect and remove the disruptive materials from the body lumen. In particular examples, the macerator may be radially expansible and optionally rotated and/or axially translated within the positioning cage to effect disruption of the occlusive material.

Abstract: An apparatus for accessing a body lumen includes a tubular member including a proximal end, a distal end sized for introduction into a body lumen, and a passage extending along a steerable distal portion of the tubular member. The passage includes a first region extending substantially parallel to a center of modulus of the distal portion and a second region offset from the center of modulus. A steering element is disposed through the passage extending along the distal portion that includes a proximal end disposed adjacent the tubular member proximal end, and a distal end fixed to the tubular member distal end beyond the distal portion. A steering adjustment member is slidable within the passage for selectively directing a portion of the steering element between the first and second regions to vary the steerability of the distal portion.

Abstract: Clot disruption and dissolution are achieved using a catheter having the ability to infuse a thrombolytic agent, agitate the clot and agent, and aspirate broken-up clot from the blood vessel. A flow resistor in the catheter provides for infusion and/or aspiration to be concentrated primarily at a clot treatment area in a blood vessel while also providing optional infusion and/or aspiration distal to the treatment area. In some embodiments, infusion, aspiration and guidewire passage occur through a common lumen. The thrombolytic agent, such as tPA, streptokinase, or urokinase, is directly released into the clot at the point where the agitator is engaging the clot. In this way, the thrombolytic activity of the agent is enhanced and the dissolution of the clot is improved.

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.