Abstract: An expandable introducer sheath for passage of implant delivery catheters, such as catheters for delivery of prosthetic heart valves. The expandable sheath balances the amounts, shapes and positions of various stiff and elastic structures in the sheath to selectively program the expandability and buckling stiffness of the sheath. The expandable sheath can include, for example, an expandable tubular layer that includes alternating stiff and elastic wall portions of a single radial thickness. The combination of stiff and elastic wall portions allow for torque and push strength to advance the expandable sheath while at the same time accommodating temporary expansion. The expandable sheath can also be reinforced with a tubular layer of braided fibers or a stent structure for additional strength. Other embodiments include selective use of slots or gaps at the distal end of a stiff wall portion to enhance expandability and distribute strain.

Abstract: A delivery sheath includes an outer tubular layer and an initially folded inner tubular layer. When an implant passes therethrough, the outer tubular layer expands and the inner tubular layer unfolds into an expanded lumen diameter. The sheath may also include selectively placed longitudinal support rods that mediate friction between the inner and outer tubular layers to facilitate easy expansion, thereby reducing the push force needed to advance the implant through the sheath's lumen.

Abstract: A medical device assembly may include an elongated tubular membrane having a wall defining a lumen extending through the membrane from a proximal end to a distal end, the lumen having a first inner diameter, and a percutaneous medical device having a maximum outer diameter greater than the first inner diameter, wherein the membrane is configured to permit the medical device to pass through the lumen, and wherein the membrane includes a plurality of longitudinally-oriented channels recessed along an inner surface of the wall. A medical device delivery sheath may include a tubular first layer of polymeric material formed into a wavy cross-section having a plurality of lobes and a plurality of valleys, wherein the first layer of material is resiliently expandable in a radial direction from a relaxed configuration to an expanded configuration, and wherein the first layer of material is substantially non-expandable in an axial direction.

Abstract: A recanalization catheter for facilitating re-entry into a lumen of a blood vessel from a subintimal space. The recanalization catheter includes first and second mechanically actuatable wings positioned at a distal region of the elongate shaft of the catheter that are actuatable between a retracted position and an expanded position. In the retracted position the mechanically actuatable wings are positioned in first and second elongate channels defined in the elongate shaft, and in the expanded position the mechanically actuatable wings extend outward from the first and second elongate channels. The actuatable wings extend in an arcuate path away from the elongate shaft in the expanded position to be positionable in a circumferential orientation within a subintimal space formed in a vessel wall to automatically orient a lateral port of the elongate shaft toward the true lumen.

Abstract: An expandable delivery sheath includes an elastic outer tubular layer and an inner tubular layer. The inner tubular layer include a thick wall portion integrally connected to a thin wall portion. The thin wall portion can include longitudinal reinforcing members/rods that facilitate unfolding during the passage of the implant, thus decreasing the push force and increasing the consistency of the push force. The inner tubular layer can have a non-expanded or folded condition wherein the thin wall portion folds onto an outer surface of the thick wall portion under urging of the elastic outer tubular layer. When an implant passes therethrough, the outer tubular layer stretches and the inner tubular layer unfolds into an expanded lumen diameter. Once the implant passes, the outer tubular layer again urges the inner tubular layer into the non-expanded condition with the sheath reassuming its smaller profile.

Abstract: Disclosed herein are expandable introducer sheaths and methods of making and using the same. The sheaths minimize trauma to a patient's vasculature by allowing for temporary expansion of a portion of the sheath to accommodate passage of a delivery system for a cardiovascular device, then return to a non-expanded state after the passage of the device. The sheath includes an elongated annular member having longitudinally extending channels that facilitate the sheath's temporary expansion. The channels are positioned in such a way that, upon expansion, they enable the movement of protruding contact surfaces toward the inner and outer surfaces of the annular member, reducing friction between the surface and the passing device. Some embodiments of the expandable sheath include an elastic outer layer that pushes the protruding contact surfaces back towards their original positions after the passage of the device.

Abstract: Inflatable devices are disclosed including a surface which has a network of polymer chains and is configured to be inflatable into a therapeutically or diagnostically useful shape, and at least one ultrashort laser pulse-formed modification in the surface. The network can, for example, include a network morphology that is substantially unchanged by modification with the ultrashort pulse laser. Ultrashort laser pulses can be laser pulses equal to or less than 1000 picoseconds in duration. Advantageously, the etching process uses a relatively low-heat laser to avoid significant heating of surrounding polymers while modifying the surface (and other structures) of the device. The process is configured so that the polymer chain morphology adjacent the modification is substantially unaffected by the low-heat laser. The resulting inflatable device has customized surface features while still retaining substantially homogenous polymer network morphology.

Abstract: A catheter assembly comprises a catheter having a distal end and a longitudinal axis, a stent disposed about the distal end of the catheter, and a stent protector. The stent protector has a stent covering portion disposed about the stent and a catheter engagement portion that removably engages the stent protector to the catheter assembly. The stent covering portion is disposed about the stent without substantially engaging the stent.

Abstract: A heart valve delivery system includes a low-profile catheter having an outer sheath, the outer sheath having therein a stent and a replacement heart valve. In an unemployed configuration, the stent is located distally to the replacement heart valve. Upon deployment, however, the stent and replacement heart valve are expanded and the replacement heart valve is situated within the stent.

Abstract: A catheter assembly comprises a catheter having a distal end and a longitudinal axis, a stent disposed about the distal end of the catheter, and a stent protector. The stent protector has a stent covering portion disposed about the stent and a catheter engagement portion that removably engages the stent protector to the catheter assembly. The stent covering portion is disposed about the stent without substantially engaging the stent.

Abstract: Disclosed herein are designs for improved inflatable structures for use during minimally invasive cardiovascular procedures. These inflatable structures facilitate the perfusion of blood through an anatomical structure, such as a heart valve, during the cardiovascular procedure. The inflatable structures are formed of a plurality of balloons arranged radially around a central location. The plurality of balloons form a lumen through which blood flows. Each balloon of the plurality is shaped or configured to stabilize the adjacent balloons, limiting their movement relative to each other. For example, some embodiments can feature balloons with a keystone shape that limits movement of the balloons inward toward the lumen. Some implementations can also include a support coil running through the lumen. The support coil holds enables the lumen to be open to perfusion even in the early stages of balloon inflation.

Abstract: The methods and devices disclosed herein promote temporal control of balloon inflation patterns. The devices include a covering for a portion of the balloon that compresses the balloon portion during the inflation process. This enables the distal portion of a balloon to be inflated prior to the proximal portion of a balloon, creating a tapered shape at lower inflation pressures. This is especially useful during transvascular implantation procedures, as it prevents dislodgement of an implant mounted on the balloon. As inflation continues, pressure exerted on the balloon by the covering is overcome such that the proximal region of the balloon inflates, forming a shape with generally straighter sides than the tapered shape, thereby expanding the cardiovascular device.

Abstract: A subintimal recanalization catheter system for recanalizing a blood vessel. The system includes a support catheter and a balloon catheter configured to extend through the support catheter. The support catheter includes a tubular portion and an extension segment extending distal of the distal opening of the tubular portion. The balloon catheter, having a balloon secured to a distal portion thereof, is positionable through the tubular portion of the support catheter to position the balloon alongside the extension segment. The system is configured to be advanced into a subintimal space between a first tissue layer and a second tissue layer of a blood vessel wall where the balloon may be inflated against the extension segment to cause a distal portion of the catheter shaft of the balloon catheter to deflect toward the vessel lumen within the subintimal space to facilitate reentry into the vessel lumen.

Abstract: A recanalization catheter for facilitating re-entry into a lumen of a blood vessel from a subintimal space. The recanalization catheter includes first and second mechanically actuatable wings positioned at a distal region of the elongate shaft of the catheter that are actuatable between a retracted position and an expanded position. In the retracted position the mechanically actuatable wings are positioned in first and second elongate channels defined in the elongate shaft, and in the expanded position the mechanically actuatable wings extend outward from the first and second elongate channels. The actuatable wings extend in an arcuate path away from the elongate shaft in the expanded position to be positionable in a circumferential orientation within a subintimal space formed in a vessel wall to automatically orient a lateral port of the elongate shaft toward the true lumen.

Abstract: Various embodiments concern a guide catheter for delivery of an implantable lead within the coronary vein. Such a guide catheter can comprise a tubular body having a main lumen and at least one preformed bend. The tubular body can comprise a liner defining an inner surface, braiding circumferentially surrounding the liner, a jacket covering the braiding and defining an exterior surface of the tubular body, and a plurality of inflation tubes embedded within the jacket. The guide catheter can include a balloon mounted on the tubular body, each of the plurality of inflation tubes in communication with the balloon. The guide catheter can further include a hub providing access to the main lumen, the hub comprising a first port for introduction of contrast media into the main lumen and a second port in communication with the plurality of inflation tubes.

Abstract: An expandable introducer sheath for passage of implant delivery catheters, such as catheters for delivery of prosthetic heart valves. The expandable sheath balances the amounts, shapes and positions of various stiff and elastic structures in the sheath to selectively program the expandability and buckling stiffness of the sheath. The expandable sheath can include, for example, an expandable tubular layer that includes alternating stiff and elastic wall portions of a single radial thickness. The combination of stiff and elastic wall portions allow for torque and push strength to advance the expandable sheath while at the same time accommodating temporary expansion. The expandable sheath can also be reinforced with a tubular layer of braided fibers or a stent structure for additional strength. Other embodiments include selective use of slots or gaps at the distal end of a stiff wall portion to enhance expandability and distribute strain.

Abstract: A delivery sheath includes an elastic outer tubular layer and an inner tubular layer having a thick wall portion integrally connected to a thin wall portion. The inner tubular layer can have a compressed or folded condition wherein the thin wall portion folds onto an outer surface of the thick wall portion under urging of the elastic outer tubular layer. When an implant passes therethrough, the outer tubular layer stretches and the inner tubular layer unfolds into an expanded lumen diameter. Once the implant passes, the outer tubular layer again urges the inner tubular layer into the compressed condition with the sheath reassuming its smaller profile. The sheath may also include selectively placed longitudinal rods that mediate friction between the inner and outer tubular layers to facilitate easy expansion and collapse, thereby reducing the push force needed to advance the implant through the sheath's lumen.

Abstract: A recanalization catheter assembly for recanalization of an occluded blood vessel is disclosed. The recanalization catheter assembly includes an elongate shaft having a tubular portion, a guide member, and a rotary ablation tool. The tubular portion includes a distal opening, from where the rotary ablation tool extends distally. The guide member extends distal of the distal opening and includes a guidewire lumen to receive a guidewire therethrough. The guide member is configured to advance over the guidewire in a subintimal space between a first tissue layer and a second tissue layer of a wall of the blood vessel, while the rotary ablation tool is advanced in a true lumen of the blood vessel.

Abstract: A recanalization catheter for facilitating re-entry into a lumen of a blood vessel from a subintimal space. The recanalization catheter includes first and second mechanically actuatable wings positioned at a distal region of the elongate shaft of the catheter that are actuatable between a retracted position and an expanded position. In the retracted position the mechanically actuatable wings are positioned in first and second elongate channels defined in the elongate shaft, and in the expanded position the mechanically actuatable wings extend outward from the first and second elongate channels. The actuatable wings extend in an arcuate path away from the elongate shaft in the expanded position to be positionable in a circumferential orientation within a subintimal space formed in a vessel wall to automatically orient a lateral port of the elongate shaft toward the true lumen.

Abstract: Embodiments of the disclosure describe an example guide extension catheter. The guide extension catheter may include a proximal shaft having a proximal end, a distal end, the distal end having an attachment region. The guide extension catheter may further include a distal sheath having a proximal end, a distal end and a lumen extending therebetween. The distal sheath may include an outer layer, inner layer and an intermediate reinforcing member disposed between the inner layer and the outer layer. Moreover, the distal sheath is attached to the attachment region adjacent to the reinforcing member.