Devices and methods for the treatment of chronic total occlusions are provided. One disclosed embodiment comprises a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method includes providing an intravascular device having a distal portion, inserting the device into the vascular lumen, positioning the distal portion in the vascular wall to at least partially surround the occlusion, and removing at least a portion of the surrounded occlusion from the lumen.

An apparatus for treating a total occlusion in a blood vessel may include a self-orienting device including an elongate shaft and an inflatable orienting element. The shaft includes an inflation lumen having a first noncircular shape and a working lumen having a second noncircular shape. The inflatable orienting element includes first and second inflatable members extending laterally from the shaft. An outer diameter of the shaft is 0.045 inches or less, a cross-sectional area of the first noncircular cross-sectional shape is at least 0.00013 square inches, and a cross-sectional area of the second noncircular cross-sectional shape is at least 0.00056 square inches. The shaft may include a distal tail extending distally from the inflatable orienting element, the distal tail being at least 15 millimeters long. The shaft may include a plurality of first apertures communicating with the working lumen and disposed in the distal tail.

Disclosed is a dual lumen retrograde catheter and hub attachment for dialysis. The catheter includes a venous lumen and an arterial lumen that are attached to a proximal hub having at least one luer extension extending therefrom. The distal end of the catheter is configured to be inserted into the blood vessel and placed into a desired position. The proximal end is tunneled backwards under the skin using a trocar and exited. The proximal end of the catheter can attach to a proximal hub via a pair of cannulas with raised barbs for removably securing proximal ends of the lumens thereon. The lumens are secured in a side-by-side configuration via a compression cap that can be screwed onto the proximal hub to prevent the catheter from detaching from the proximal hub.

A method of coupling a catheter tunneler adapter to a catheter is provided. The method includes providing a catheter having a lumen divider at a proximal end thereof; forming a receiving notch in the lumen divider by removing a center portion thereof such that two divider side portions remain; providing a catheter tunneler adapter having a distal end including a radially inward step which defines a contact surface configured to be received in the proximal end of the catheter; positioning the distal end of the catheter tunneler adapter within the catheter until the radially inward step engages the receiving notch; and securing the catheter tunneler adapter to the catheter.

A method of diverting fluid flow from a first vessel including an occlusion to a second vessel includes deploying a prosthesis at least partially in a fistula and making valves in the second vessel incompetent. Making the valves in the second vessel incompetent includes at least one of using a reverse valvulotome to cut the valves, inflating a balloon, expanding a stent, and lining the second vessel with a stent.

An apparatus for subcutaneous lead guidance includes a flexible guide strap, a navigation catheter and a tunneling tool. The guide strap includes an upper layer having a plurality of retainer formations and a substrate attachable on a patient's skin extending between an incision and a target site. The navigation catheter is coupled to the upper layer via the retainer formations from a first end to a second end of the guide strap. The navigation catheter includes a plurality of position sensors for generating a subcutaneous navigation volume between the incision and the target site when the navigation catheter is coupled to a navigation system. The tunneling tool has a distal portion with a leading end and at least one position sensor on the distal portion for viewing digital representation of the distal portion in relation to the navigation volume on a display coupled to the navigation system.

A system and method for increasing the speed of blood and the wall shear stress in a peripheral artery or peripheral vein to a sufficient level and for a sufficient period of time to result in a persistent increase in the overall diameter and lumen diameter of the donating artery or donating vein is provided. The method includes systems and methods to effect the movement of blood at the desired rate and in the desired direction. The movement of blood is monitored and adjusted, as necessary, to maintain the desired blood speed and wall shear stress in the peripheral artery or vein in order to optimize the rate and extent of persistent diameter increase of the peripheral artery or peripheral vein.

Disclosed are cardiac shunts and method of delivery, and in particular, to a shunt to reduce elevated left atrial pressure (LAP). The methods include forming a puncture hole between the left atrium and the coronary sinus, widening the puncture hole, and placing an expandable shunt within the widened puncture hole. A first catheter having a side-extending needle may be used to form a puncture into the left atrium. A second catheter extends along a guidewire and an expandable shunt with distal and proximal flanges is expelled therefrom into the puncture. The shunt defines a blood flow passage therethrough that permits shunting of blood from the left atrium to the coronary sinus when the LAP is elevated. The shunt is desirable formed of a super-elastic material and manipulated with control rods. The shunt defines a tilted flow tube that facilitates collapse into the catheter.

Insertion tools for medical applications. An illustrative example is an insertion tool for implanting a lead such as a subcutaneous defibrillation lead, which includes a handle at a proximal end, a catheter, and a distal end. A plurality of stylets having dottering tips are provided in the insertion tool. Reciprocating action of the dottering tips and/or stylets is imparted to dissect through subcutaneous tissue and create a tunnel for implantation of the lead.

An occlusion bypassing apparatus for re-entering the true lumen of a vessel after subintimally bypassing an occlusion in a vessel. The apparatus includes an outer shaft component, a needle component, and an inflatable balloon. The outer shaft component has a side port proximal to a distal end thereof and a needle lumen there-through that includes a curved distal portion that terminates at the side port of the outer shaft component. The needle component is configured to be slidably disposed within the needle lumen of the outer shaft component. The inflatable balloon includes a body portion that is disposed distal to the side port of the outer shaft component, and the body portion of the balloon has a flattened profile in an inflated state with first and second chambers that laterally extend from opposing sides of the outer shaft component for stabilizing the apparatus within a subintimal space.