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.

Catheter assemblies include a stabilization mechanism disposed at a distal end of the catheter assembly for stabilizing the catheter assembly within a subintimal space. The stabilization mechanism includes a self-expanding support structure that is slidably positionable within an inflatable balloon. The catheter assemblies include an outer shaft which has the balloon at a distal end thereof and an inner shaft which has the support structure mounted on a distal end thereof. The inner shaft is slidably disposed within a lumen of the outer shaft and has a first configuration in which the support structure is held in a compressed state within the outer shaft and a second configuration in which the support structure is permitted to return to an expanded state within the inflatable balloon. In the expanded state, the stabilization mechanism has a flattened laterally-extending profile.

A subintimal entry catheter can be used for crossing an occlusion in a blood vessel of a patient. The catheter can include a distal end portion and a lumen extending longitudinally within the catheter and radially to an opening in a first radial side at the distal end portion of the catheter. The catheter can be used to cross at least a portion of an occlusion through a subintimal space. A wire can be provided through the lumen and to the opening to reenter the true lumen of the blood vessel.

A catheter system and corresponding methods are provided for accessing a blood vessel true lumen from a sub-intimal plane of the vessel. The catheter includes components that are symmetric about the longitudinal axis and allow for reentry without the need to ensure a correct orientation of the cannula.

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 performing a medical procedure, includes providing a catheter including a first lumen in fluid communication with a first distal opening and a second lumen in fluid communication with a second distal opening, advancing a distal end of a first intra-catheter stiffener element through the first lumen and out of the first distal opening, coupling the first intra-catheter stiffener element to the catheter, advancing a distal end of a second intra-catheter stiffener element through the second lumen and out of the second distal opening, coupling the second intra-catheter stiffener element to the catheter, and advancing the catheter into a patient.

A tunneler device is provided which includes a handle, a shaft extending distally from the handle, a connecting device including a body supported on a distal end of the shaft configured to be received within a lumen of a catheter, and a resilient separation prevention device supported on the connecting device. The resilient separation prevention device is inwardly deflectable towards the connecting device upon insertion of the connection device into the lumen of the catheter and biased towards a non-deflected position in engagement with an inner surface of the catheter to prevent retraction of the connecting device from the catheter.

A reentry apparatus has an outer catheter configured to accommodate a first reentry device and an inner catheter configured to fit within the outer catheter. The inner catheter has a series of expanding anchors extending from the outer surface of the inner catheter and a reentry channel configured to accommodate a second reentry device. A retaining wire extends along the upper surface of the expanding anchors. A reentry channel is located in the configured to accommodate a second reentry device.

A medical device assembly includes a tunneler having a proximal end and a distal end and a carrier element fixed to the distal end of the tunneler. In various embodiments the carrier element is configured to be slidably disposed within a lead connection lumen. In various embodiments the carrier element includes a plurality of recesses configured to engage a lead extension set screw. In various embodiments the carrier element can freely rotate relative to the rest of the tunneler.

A subcutaneous tunneling device includes a shaft having a bend, a catheter connector extending from a distal end of the shaft distal of the bend, and a sleeve. The catheter connector can include a body having a gripping portion, and a barbed extension distal of the body configured for insertion into a lumen of a catheter. The sleeve is slidably mounted on the shaft, and has a retracted position exposing the catheter connector to permit a distal end of a catheter to be coupled thereto, and an extended position covering the catheter connector and the distal end of the catheter.