Abstract: Described herein are shock wave devices and methods for the treatment of calcified heart valves. One variation of a shock wave device may comprise an elongated flexible tube carried by a sheath. The tube may have a fluid input end, which may be located near a proximal end of the sheath. The tube may include a loop portion. The loop portion may be configured to be at least partially accommodated within a cusp of the heart valve. The tube may be fillable with a conductive fluid. In some variations, the shock wave device may include an array of electrode pairs associated with a plurality of wires positioned within the loop portion of a tube. The electrode pairs may be electrically connectable to a voltage source and configured to generate shock waves in the conductive fluid in response to voltage pulses.

Abstract: Described herein are shock wave devices and methods for the treatment of calcified heart valves. One variation of a shock wave device may comprise an elongated flexible tube carried by a sheath. The tube may have a fluid input end, which may be located near a proximal end of the sheath. The tube may include a loop portion. The loop portion may be configured to be at least partially accommodated within a cusp of the heart valve. The tube may be fillable with a conductive fluid. In some variations, the shock wave device may include an array of electrode pairs associated with a plurality of wires positioned within the loop portion of a tube. The electrode pairs may be electrically connectable to a voltage source and configured to generate shock waves in the conductive fluid in response to voltage pulses.

Abstract: Described herein are shock wave devices and methods for the treatment of calcified heart valves. One variation of a shock wave device may comprise an elongated flexible tube carried by a sheath. The tube may have a fluid input end, which may be located near a proximal end of the sheath. The tube may include a loop portion. The loop portion may be configured to be at least partially accommodated within a cusp of the heart valve. The tube may be fillable with a conductive fluid. In some variations, the shock wave device may include an array of electrode pairs associated with a plurality of wires positioned within the loop portion of a tube. The electrode pairs may be electrically connectable to a voltage source and configured to generate shock waves in the conductive fluid in response to voltage pulses.

Abstract: Described herein are shock wave devices and methods for the treatment of calcified heart valves. One variation of a shock wave device may comprise an elongated flexible tube carried by a sheath. The tube may have a fluid input end, which may be located near a proximal end of the sheath. The tube may include a loop portion. The loop portion may be configured to be at least partially accommodated within a cusp of the heart valve. The tube may be fillable with a conductive fluid. In some variations, the shock wave device may include an array of electrode pairs associated with a plurality of wires positioned within the loop portion of a tube. The electrode pairs may be electrically connectable to a voltage source and configured to generate shock waves in the conductive fluid in response to voltage pulses.

Abstract: Described herein are shock wave devices and methods for the treatment of calcified heart valves. One variation of a shock wave device may comprise an elongated flexible tube carried by a sheath. The tube may have a fluid input end, which may be located near a proximal end of the sheath. The tube may include a loop portion. The loop portion may be configured to be at least partially accommodated within a cusp of the heart valve. The tube may be fillable with a conductive fluid. In some variations, the shock wave device may include an array of electrode pairs associated with a plurality of wires positioned within the loop portion of a tube. The electrode pairs may be electrically connectable to a voltage source and configured to generate shock waves in the conductive fluid in response to voltage pulses.

Abstract: Described here are devices and methods that may facilitate treatment of a calcified heart valve with shock waves. A shock wave valvuloplasty device may be advanced through a patient's vasculature and self-align with cusps of a calcified aortic valve. Alignment may be facilitated by a central anchor and/or U-shaped distal bends of positioning wires. An elongated carrier may be slidably disposed over a portion of the positioning wire and carry one or more electrode assemblies that may generate shock waves. An inflatable balloon may sealably enclose the electrode assembles, and shock waves may propagate through the liquid-filled balloon and transfer energy to adjacent calcified valve cusps. The shock wave valvuloplasty device may comprise one or more features to direct shock waves to specific areas of calcified tissue. Some variations also comprise a central anchor configured to be positioned below the valve leaflets.

Abstract: A delivery system for an implantable vascular prosthesis is provided for a vascular prosthesis including at least first and second helical sections having alternating directions of rotation that are coupled to one another at apices. The delivery system includes an elongate body, a plurality of retainers and an outer sheath. The plurality of retainers are configured to temporarily retain a plurality of inner wound apices of the vascular prosthesis. The outer sheath is configured to retain the vascular prosthesis in a contracted state on the elongate body.

Abstract: A delivery system for an implantable vascular prosthesis is provided for a vascular prosthesis including at least first and second helical sections having alternating directions of rotation that are coupled to one another at apices. The delivery system includes an elongate body, a plurality of retainers and an outer sheath. The plurality of retainers are configured to temporarily retain a plurality of inner wound apices of the vascular prosthesis. The outer sheath is configured to retain the vascular prosthesis in a contracted state on the elongate body.

Abstract: Methods and apparatus are provided for removing emboli during an angioplasty, stenting or surgical procedure comprising a catheter having a funnel-shaped occlusion balloon of uniform thickness disposed on a distal end of the catheter. The occlusion balloon is fused to the distal end so that it provides a substantially seamless flow transition into a working lumen of the catheter. Additionally, a distal edge of the occlusion balloon is configured to be in close proximity with an inner wall of a vessel to facilitate blood flow into the catheter and efficiently remove emboli.

Abstract: An apparatus for delivering a stent into a blood vessel includes a sheath having a rounded bullet-shaped distal portion including a plurality of flexible leaflets integrally molded thereto. The stent is disposed in its contracted condition within a lumen of the sheath proximate the distal portion. A bumper is slidably disposed within the lumen that includes a helical compression coil, a bumper element attached to the helical coil including a blunt distal edge for abutting the stent, and an extension element extending distally from the bumper element through the stent and between the leaflets to facilitate introducing the apparatus over a guidewire. The sheath is formed by inserting a bullet into a blunt-ended tube, and inserting the tube into a bullet-shaped bore in a heated die until the tube material is softened and deforms into a rounded bullet shape. Slits are then cut into the distal portion to create the leaflets.

Abstract: Methods and apparatus are provided for removing emboli during an angioplasty, stenting or surgical procedure comprising a catheter having a funnel-shaped occlusion balloon of uniform thickness disposed on a distal end of the catheter. The occlusion balloon is fused to the distal end so that it provides a substantially seamless flow transition into a working lumen of the catheter. Additionally, a distal edge of the occlusion balloon is configured to be in close proximity with an inner wall of a vessel to facilitate blood flow into the catheter and efficiently remove emboli.

Abstract: An apparatus for delivering a stent into a blood vessel includes a sheath having a rounded bullet-shaped distal portion including a plurality of flexible leaflets integrally molded thereto. The stent is disposed in its contracted condition within a lumen of the sheath proximate the distal portion. A bumper is slidably disposed within the lumen that includes a helical compression coil, a bumper element attached to the helical coil including a blunt distal edge for abutting the stent, and an extension element extending distally from the bumper element through the stent and between the leaflets to facilitate introducing the apparatus over a guidewire. The sheath is formed by inserting a bullet into a blunt-ended tube, and inserting the tube into a bullet-shaped bore in a heated die until the tube material is softened and deforms into a rounded bullet shape. Slits are then cut into the distal portion to create the leaflets.

Abstract: Methods and apparatus are provided for removing emboli during an angioplasty, stenting or surgical procedure comprising a catheter having a funnel-shaped occlusion balloon of uniform thickness disposed on a distal end of the catheter. The occlusion balloon is fused to the distal end so that it provides a substantially seamless flow transition into a working lumen of the catheter. Additionally, a distal edge of the occlusion balloon is configured to be in close proximity with an inner wall of a vessel to facilitate blood flow into the catheter and efficiently remove emboli.

Abstract: A delivery apparatus includes a tubular sheath including proximal, intermediate, and distal portions defining a lumen. A wall of the distal portion is transparent, allowing observation of the lumen within the distal portion. The distal portion terminates in a rounded distal tip including a plurality of leaflets. A self-expanding stent is disposed within the intermediate portion, and a bumper member is slidably disposed within the lumen proximate the stent. Before use, the sheath is retracted to bump the stent forward into the distal portion until the stent is observed within the distal portion. After the apparatus has been pre-loaded, the distal portion is advanced into a blood vessel, e.g., across a stenosis, and the sheath is retracted, causing the leaflets to open and allow the stent to be deployed, whereupon the stent automatically expands to dilate the stenosis.