Abstract: The present disclosure provides a method including positioning a first guidewire within a primary guidewire lumen of a multi-lumen tapered tip. A second guidewire is positioned within a secondary guidewire lumen and a shared guidewire lumen of the multi-lumen tapered tip, the second guidewire preventing the first guidewire from entering the shared guidewire lumen. A delivery system including the multi-lumen tapered tip is advanced over the second guidewire. By advancing the delivery system over a single guidewire, any possibility of entanglement of multiple guidewires during advancement of the delivery system is eliminated. The method further includes a guidewire exchange including releasing the second guidewire from the shared guidewire lumen, advancing the first guidewire through and out of the shared guidewire lumen, and advancing the delivery system over the first guidewire to a deployment location.

Abstract: A stent graft delivery system. The system includes a stent graft cover having a central longitudinal axis. The stent graft cover houses a first guidewire lumen extending along a first guidewire lumen axis and configured to track along a first guidewire. The first guidewire lumen axis is offset the central longitudinal axis. The stent graft delivery system further includes a tapered tip extending distally from the stent graft cover and defining an offset through-channel extending within the tapered tip along a tapered tip offset axis and configured to track along the first guidewire. The first guidewire lumen axis and the tapered tip offset axis extend along a common axis.

Abstract: A stent graft delivery system and method of assembling the same is disclosed. The stent graft delivery system includes a stent graft cover configured to maintain a stent graft in a constricted configuration, and is configured to slide relative to the stent graft to enable the stent graft to expand radially outwardly. The stent graft cover extends along a first central axis. A tapered tip defining an opening therethrough is configured to track along a guidewire. The opening extends along a second central axis that is offset from the first central axis. This provides a delivery system with an opening in a leading edge that is not center relative to the outer stent graft cover.

Abstract: A delivery system for delivering an endovascular graft within a blood vessel. The delivery system includes a tip assembly including a tip and a sleeve having a proximal end. The delivery system includes a tip capture mechanism. The tip assembly is configured to move axially relative to the tip capture mechanism and between a delivery position and a release position. The tip capture mechanism includes a landing zone. The delivery system includes a travel limiter configured to align the proximal end with the landing zone when the tip assembly is in the release position to facilitate removal of the delivery system from the blood vessel.

Abstract: A delivery catheter includes a tip, a spindle and a lock mechanism. The tip includes a tapered portion and a tip sleeve. The tip sleeve extends proximally and has a lumen. The spindle includes a plurality of spindle pins. The lock mechanism locks the tip sleeve to the spindle to prevent relative longitudinal movement between the spindle and the tip sleeve. The delivery catheter includes a delivery configuration with the tip sleeve covering the spindle pins and a release configuration with a proximal end of the tip sleeve distal of the spindle pins. The lock mechanism locks the prosthesis delivery system in the release configuration. Each spindle pin of the plurality of spindle pins includes a smooth, curved profile.

Abstract: A stent graft delivery system and method of assembling the same is disclosed. The stent graft delivery system includes a stent graft cover configured to maintain a stent graft in a constricted configuration, and is configured to slide relative to the stent graft to enable the stent graft to expand radially outwardly. The stent graft cover extends along a first central axis. A tapered tip defining an opening therethrough is configured to track along a guidewire. The opening extends along a second central axis that is offset from the first central axis. This provides a delivery system with an opening in a leading edge that is not center relative to the outer stent graft cover.

Abstract: A delivery catheter includes a tip, a spindle and a lock mechanism. The tip includes a tapered portion and a tip sleeve. The tip sleeve extends proximally and has a lumen. The spindle includes a plurality of spindle pins. The lock mechanism locks the tip sleeve to the spindle to prevent relative longitudinal movement between the spindle and the tip sleeve. The delivery catheter includes a delivery configuration with the tip sleeve covering the spindle pins and a release configuration with a proximal end of the tip sleeve distal of the spindle pins. The lock mechanism locks the prosthesis delivery system in the release configuration. Each spindle pin of the plurality of spindle pins includes a smooth, curved profile.

Abstract: A delivery catheter includes a tip, a spindle and a lock mechanism. The tip includes a tapered portion and a tip sleeve. The tip sleeve extends proximally and has a lumen. The spindle includes a plurality of spindle pins. The lock mechanism locks the tip sleeve to the spindle to prevent relative longitudinal movement between the spindle and the tip sleeve. The delivery catheter includes a delivery configuration with the tip sleeve covering the spindle pins and a release configuration with a proximal end of the tip sleeve distal of the spindle pins. The lock mechanism locks the prosthesis delivery system in the release configuration. Each spindle pin of the plurality of spindle pins includes a smooth, curved profile.

Abstract: A delivery system for use with a prosthetic heart valve having a stent frame to which a valve structure is attached includes a shaft assembly including a distal end, an intermediate portion, and a first coupling structure disposed near the distal end and configured to be coupled to a distal end of the prosthetic heart valve via a first tether. A sheath assembly defines a lumen sized to slidably receive the shaft assembly. The delivery system is configured to transition from a loaded state in which the sheath assembly encompasses the prosthetic heart valve to a deployed state in which the sheath assembly is withdrawn from the prosthetic heart valve. The first coupling structure is configured to be manipulated in a first direction to provide a controlled expansion or contraction of the distal end of the prosthetic heart valve.

Abstract: A delivery system for percutaneously delivering and deploying a stented prosthetic heart valve. The delivery device includes a delivery sheath slidably disposed over an inner shaft, and a capture assembly. The capture assembly includes a spindle and a biasing member. The spindle is attached to the inner shaft and defines slot. The biasing member is disposed within the slot and self-transitions from a deflected condition to a normal condition. In a delivery state, the delivery sheath retains the prosthesis over the inner shaft and coupled to the spindle via the capture slot, including a portion of the prosthetic valve being engaged within the slot and the biasing member forced to the deflected condition. In a deployment state, the delivery sheath is proximally withdrawn and the biasing member self-transitions toward the normal condition to eject the prosthetic valve from the capture slot.

Abstract: A delivery system for use with a prosthetic heart valve having a stent frame to which a valve structure is attached includes a shaft assembly including a distal end, an intermediate portion, and a first coupling structure disposed near the distal end and configured to be coupled to a distal end of the prosthetic heart valve via a first tether. A sheath assembly defines a lumen sized to slidably receive the shaft assembly. The delivery system is configured to transition from a loaded state in which the sheath assembly encompasses the prosthetic heart valve to a deployed state in which the sheath assembly is withdrawn from the prosthetic heart valve. The first coupling structure is configured to be manipulated in a first direction to provide a controlled expansion or contraction of the distal end of the prosthetic heart valve.

Abstract: A delivery system for use with a prosthetic heart valve having a stent frame to which a valve structure is attached includes a shaft assembly including a distal end, an intermediate portion, and a first coupling structure disposed near the distal end and configured to be coupled to a distal end of the prosthetic heart valve via a first tether. A sheath assembly defines a lumen sized to slidably receive the shaft assembly. The delivery system is configured to transition from a loaded state in which the sheath assembly encompasses the prosthetic heart valve to a deployed state in which the sheath assembly is withdrawn from the prosthetic heart valve. The first coupling structure is configured to be manipulated in a first direction to provide a controlled expansion or contraction of the distal end of the prosthetic heart valve.

Abstract: A delivery system for use with a prosthetic heart valve having a stent frame to which a valve structure is attached includes a shaft assembly including a distal end, an intermediate portion, and a first coupling structure disposed near the distal end and configured to be coupled to a distal end of the prosthetic heart valve via a first tether. A sheath assembly defines a lumen sized to slidably receive the shaft assembly. The delivery system is configured to transition from a loaded state in which the sheath assembly encompasses the prosthetic heart valve to a deployed state in which the sheath assembly is withdrawn from the prosthetic heart valve. The first coupling structure is configured to be manipulated in a first direction to provide a controlled expansion or contraction of the distal end of the prosthetic heart valve.

Abstract: A delivery system for percutaneously delivering and deploying a stented prosthetic heart valve. The delivery device includes a delivery sheath slidably disposed over an inner shaft, and a capture assembly. The capture assembly includes a spindle and a biasing member. The spindle is attached to the inner shaft and defines slot. The biasing member is disposed within the slot and self-transitions from a deflected condition to a normal condition. In a delivery state, the delivery sheath retains the prosthesis over the inner shaft and coupled to the spindle via the capture slot, including a portion of the prosthetic valve being engaged within the slot and the biasing member forced to the deflected condition. In a deployment state, the delivery sheath is proximally withdrawn and the biasing member self-transitions toward the normal condition to eject the prosthetic valve from the capture slot.

Abstract: A catheter to be used without a guidewire which includes a support wire shaft formed of metal, a balloon mounted on a distal portion of the catheter, and an inflation shaft for inflating the balloon, wherein a core wire may be interchangeably inserted into the support wire shaft when the catheter is within a human body to change the stiffness and improve control thereof. In one embodiment, the portion of the support wire shaft that extends just proximal of, through and distal of the balloon is formed entirely of a metal wound coil. The flexibility characteristics of this support wire shaft can be controlled by varying the pitch of the wound coil and the thickness of the wire or ribbon it is made from. An overjacket is also provided on the metal wound coil portion to hold pressure within the inflation lumen and provide a suitable material for bonding a distal end of the balloon to the support wire shaft.

Abstract: A stent delivery system comprises an inner member and an expandable balloon mounted in a collapsed state on the inner member, the expandable balloon having a first and a second end. A compressible stent having a first diameter is mounted in a compressed state around the expandable balloon between the first and second ends of the balloon. At least a first retainer pillow is formed in the expandable balloon at its first end and has an outer diameter which is at least substantially equal to the diameter of the compressed stent. A first pillow support member is mounted on the inner member and supports the first retainer pillow to maintain the pillow's outer diameter.

Abstract: A mold for forming medical balloons and the balloons formed therefrom are disclosed. The mold has a generally cylindrical inner molding surface for forming a working length of the balloon, and generally cylindrical outer molding surfaces at either end of the mold for forming shafts of the balloon. Joining these outer and inner molding surfaces are taper molding regions composed of two generally conical molding surfaces oriented at two different angles from a longitudinal axis of the mold. A balloon resulting from a manufacturing process using a mold according to the present invention reflects the geometry of the mold and has a unique concave taper profile and a well-defined working length.