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 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 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 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 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 valve that includes an expandable valve body defining a lumen and a longitudinally moveable obstructer retained within the lumen of the valve body between the proximal and distal ends of the valve when the valve is in an expanded configuration. The valve, in the collapsed configuration, is delivered to a native valve site by a catheter where the valve body is expanded to anchor the valve at the valve annulus and the collapsed obstructer is subsequently expanded so that the valve is in the expanded configuration.

Abstract: A recanalization catheter for facilitating re-entry into a lumen of a blood vessel from a subintimal space. The catheter includes an inflatable balloon mounted on a distal end region of the catheter shaft of the catheter. The catheter shaft includes a guidewire lumen having a distal opening and a lateral opening in a distal region of the catheter shaft proximal of the distal opening, and an inflation lumen in fluid communication with the balloon. The balloon is configured to be inflated in the subintimal space to a first inflation state at inflation pressures below a threshold inflation pressure to orient the lateral opening toward the lumen of the blood vessel, and inflated to a second inflation state at inflation pressures above the threshold inflation pressure. The catheter includes means for retaining the balloon in the first inflation state at pressures below the threshold inflation pressure.

Abstract: The invention relates generally to an implantable medical device for delivering a therapeutic agent to the body tissue of a patient, and a method for making such a medical device. In particular, the invention pertains to an implantable medical device, such as an intravascular stent, having a coating comprising a first coating composition comprising a therapeutic agent and, optionally, a polymer; and a second coating composition comprising a metallic material.

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: Embodiments of the disclosure describe a balloon catheter. The balloon catheter may include a catheter shaft including a proximal shaft, a midshaft attached to the proximal shaft, and a distal shaft attached to the midshaft. A balloon may be coupled to the distal shaft. An inflation lumen may be defined in the catheter shaft that extends from the proximal shaft, through the midshaft, and into the distal shaft. The inflation lumen may be in fluid communication with the balloon. A core wire may be extending through a portion of the inflation lumen. A push member may be coupled to the core wire, the push member being configured to engage an inner wall surface of the catheter shaft.

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: A medical device for permanent implantation in a circulatory system of a patient may include an implant configured for percutaneous or minimally-invasive insertion into the patient, at least one connector fixedly attached to the implant and configured to releasably attach to a delivery device, the at least one connector being exposed to blood flow within the circulatory system following implantation, and an anti-thrombus feature configured to transition from an undeployed state to a deployed state.

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.

Abstract: Tissue ablation devices and methods for using tissue ablation devices are disclosed. A tissue ablation device may include an elongate guide member having a distal section defined by a sidewall defining a lumen and having a plurality of openings. The distal section may have a helical shape in a released configuration. The tissue ablation device also may include an electrode having a distal end slideable within the distal section of the guide member. The electrode catheter may have an ablation element disposed thereon.

Abstract: A catheter is disclosed, which is capable of delivering embolization beads for treating uterine fibroids. The elongate catheter shaft includes a radially expandable portion at its distal end, which can expand radially locally when an embolization bead passes through it. In some cases, the catheter shaft includes a non-expandable portion, with an inner diameter comparable to the bead diameter, between the handle and the radially expandable portion. In some cases, the radially expandable portion is made from a tubular braid, stretched longitudinally over a mandrel, and encased in a lubricious soft polymer while still stretched. In other cases, the radially expandable portion is made from a slotted nitinol tube, encased in a lubricious soft polymer below the nitinol transition temperature. The polymer is thick enough to prevent the encased element from returning to its unstretched diameter or a larger size above the transition temperature.

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 valve that includes an expandable valve body defining a lumen and a longitudinally moveable obstructer retained within the lumen of the valve body between the proximal and distal ends of the valve when the valve is in an expanded configuration. The valve, in the collapsed configuration, is delivered to a native valve site by a catheter where the valve body is expanded to anchor the valve at the valve annulus and the collapsed obstructer is subsequently expanded so that the valve is in the expanded configuration.

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 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.