Abstract: A controlled volume inflation-deflation device to inflate a balloon to occlude a blood vessel by dialing a knob that locks at rotational positions to locate a plunger at equally spaced locations within a syringe of the inflation-deflation device. The inflation-deflation device includes a releasable latch to lock the proximal and distal housings together to hold the plunger forward for occlusion, and to separate and hold the proximal and distal housings to retract the plunger for perfusion. When the inflation-deflation device is returned to the latched position, the balloon is re-inflated to its previous occlusive diameter. Also, an extension tube made of a lower modulus outer material co-extruded over and miscible with a higher modulus inner material may be used to produce a suitably low compliance extension tube for the inflation-deflation device.

Abstract: The invention is directed to devices and methods for passing optical radiation into and out of a body lumen. In particular, the invention is directed to a rotatable ferrule for use in an optical guidewire and methods for using a rotatable ferrule. The rotatable ferrule may be either rotatably captured by and free to rotate within a guidewire, or may rotate upon release from a releasable, mechanically stable friction-fit engagement with a guidewire. The invention is further directed to sterile interfaces for readily connecting and disconnecting an optical guidewire with and from other optical instrumentation while maintaining the sterility of the guidewire, and methods for using a sterile interface device. The invention is also directed to interface devices that provide either direct or indirect optical and mechanical connection between an optical guidewire and peripheral instrumentation.

Abstract: Devices and methods for passing optical radiation into and out of a body lumen may include a rotatable ferrule for use in an optical guidewire and methods for using a rotatable ferrule. The rotatable ferrule may be either rotatably captured by and free to rotate within a guidewire, or may rotate upon release from a releasable, mechanically stable friction-fit engagement with a guidewire. Sterile interfaces for readily connecting and disconnecting an optical guidewire with and from other optical instrumentation while maintaining the sterility of the guidewire, and methods for using a sterile interface device are disclosed. Interface devices can be used to provide either direct or indirect optical and mechanical connection between an optical guidewire and peripheral instrumentation.

Abstract: Radiopaque cobalt-based alloys having a smooth electropolished surface with rounded edges and methods for electropolishing such alloys. A cobalt-based alloy includes cobalt, chromium, and one or more radiopaque elements. In one embodiment, examples of radiopaque elements include so-called platinum group metals (i.e., platinum, palladium, ruthenium, rhodium, osmium, or iridium). Group 10 elements (i.e., platinum or palladium) are particularly preferred. Because of the presence of the platinum group metal(s), such alloys are generally difficult to electropolish. Electrolyte formulations and methods for electropolishing such alloys are also disclosed.

Abstract: Intravascular cardiac restraining implants designed for treatment of heart disease and heart failure and methods for their use. The disclosed implants can be used to reshape or reinforce a diseased, weakened or distended portion of a patient's heart to counteract heart disease and heart damage. An intravascular cardiac restraining implant may include a first tissue anchor configured for implantation in a first region of a coronary vein, a second tissue anchor configured for implantation in a second region of the coronary vein, and at least one elongate member coupled to the first tissue anchor and the second tissue anchor. In one embodiment, the at least one elongate member may be a spring or a similar device configured for biasing the first and second tissue anchors toward one another, thus reshaping or reinforcing a diseased, weakened or distended portion of a patient's heart.

Abstract: Methods for making devices include providing a tubular member to be formed into a device, placing a removable sacrificial block material in the lumen of the tubular member and laser cutting the tubular member. A tubular member made from nickel-titanium alloy can be tightly adhered to a sacrificial sleeve utilizing the phase changes associated with nickel-titanium. A mandrel which includes an enlarged diameter section causes the workpiece to expand slightly within its elastic deformation range to dislodge islands from the workpiece. Such a mandrel could be formed from a tubular member which has a central lumen that can be used to deliver a pressurized medium to “blast” islands from the workpiece.

Abstract: A catheter for delivering an agent to an injection site in a wall of a patient's body lumen, with an elongated shaft having a needle-through lumen slidably containing a needle therein, and an expandable member on the distal shaft section which has a collapsed configuration and a radially expanded configuration. In the radially expanded configuration, the expandable member supports the shaft in a position spaced away from the body lumen wall, and the needle slidably exits the needle-through lumen in the extended configuration through the port spaced away from the body lumen wall as a portion of the expandable member maintains the position of the port section of the shaft in the body lumen. The expandable member typically has an open-walled, helical, or lobed configuration providing a perfusion path along the expandable member.

Abstract: An agent delivery catheter that includes an anti-whipping feature, improved assembly of distal parts and/or accuracy/repeatability of needle delivery to a target tissue. Additional features include fitting a catheter with a pneumatic delivery device for delivery of a therapeutic agent without using a needle.

Abstract: The present invention relates to balloon catheters for treating a luminal system of a patient. Specifically, the invention relates to catheters having a flexible membrane positioned at a distal portion of the catheter, the flexible membrane retained in a substantially unexposed conformation prior to deployment. Preferably the flexible membrane is capable of delivering a therapeutic agent to a localized environment when deployed to an exposed conformation.

Abstract: Systems and methods for electropolishing devices are disclosed. The electropolishing system includes electropolishing fixtures configured to reposition the devices during the electropolishing process.

Abstract: An electropolishing system that includes electropolishing fixtures. The electropolishing fixtures include pendulum assemblies configured to establish electrical contact between a device being electropolished and an anode and to reposition the device during the electropolishing process.

Abstract: Systems, devices and methods for eluting an agent at a treatment site are disclosed. The devices include an expandable frame and at least one membrane. The membrane may carry an agent to elute at the treatment site. The membrane may allow blood flow at the treatment site during agent delivery.

Abstract: Catheter or guidewire mounted automatic vessel occlusion and fluid dispersion devices that expand to occlude or partially occlude a vessel when a fluid is flowing in the catheter or guidewire, and that automatically collapse when fluid flow is stopped. Each occlusion device has an elastic skeleton covered with a flexible cover coupled thereto and may have a hole(s) or openings in its distal or proximal end thereof to allow controlled flow through the desired end of the occlusion device. The fluid may be a flush fluid for enabling or improving the performance of imaging devices and image enhancing fluids, of treatment fluids for localized treatment of a vessel or tissues in communication with the vessel and/or of the transmission of energy to the vessel wall and adjacent tissues. Various embodiments are disclosed.

Abstract: The present invention relates to balloon catheters for treating a luminal system of a patient. Specifically, the invention relates to catheters having a flexible membrane positioned at a distal portion of the catheter, the flexible membrane retained in a substantially unexposed conformation prior to deployment. Preferably the flexible membrane is capable of delivering a therapeutic agent to a localized environment when deployed to an exposed conformation.

Abstract: A substantially anhydrous electropolishing electrolyte solution that includes at least one sulfate salt. The substantially anhydrous electropolishing electrolyte solutions described herein do not use water as a solvent; instead, such electropolishing electrolyte solutions use anhydrous alcohols and/or glycols as a solvent. For example, an electropolishing electrolyte solution, as described herein, may include an alcohol, at least one mineral acid, and at least one sulfate salt. The at least one sulfate salt can act as a source of sulfate ions to replenish sulfate ions consumed in the electropolishing process. Anhydrous sulfate salts can also act as water scavengers by reacting with water to form sulfate salt hydrates. Methods of electropolishing metal articles using such electropolishing electrolyte solutions are disclosed herein as well.

Abstract: The present invention relates to balloon catheters for treating a luminal system of a patient. Specifically, the invention relates to catheters having a flexible membrane positioned at a distal portion of the catheter, the flexible membrane retained in a substantially unexposed conformation prior to deployment. Preferably the flexible membrane is capable of delivering a therapeutic agent to a localized environment when deployed to an exposed conformation.

Abstract: Substantially anhydrous electropolishing electrolyte solutions. The substantially anhydrous electropolishing electrolyte solutions described herein do not use water as a solvent; instead, such electropolishing electrolyte solutions use anhydrous alcohols and/or glycols as a solvent. For example, an electropolishing electrolyte solution, as described herein, may include an alcohol, at least one mineral acid, and phosphorous pentoxide (“P2O5”). Methods of electropolishing metal articles using such electropolishing electrolyte solutions are disclosed herein as well.

Abstract: An apparatus including a tether, and an aptation device coupled to the tether at a position corresponding to a location to contact cusps of an atrioventricular valve during systole, wherein the tether and aptation device are suitable for percutaneous delivery to a patient. An apparatus including a support annulus comprising a length corresponding to a circumference of one of an interior portion of an atrium and an atrioventricular valve annulus; and an aptation device coupled to the support annulus corresponding to a location to contact cusps of an atrioventricular valve during at least one of systole when the support annulus is seated in one of an atrium and an atrioventricular valve annulus, wherein the support annulus and aptation device are suitable for percutaneous delivery to a patient. Also, a method of introducing an aptation device to contact cusps or leaflets of an atrioventricular valve.

Abstract: A catheter for delivering an agent to an injection site in a wall of a patient's body lumen, with an elongated shaft having a needle-through lumen slidably containing a needle therein, and an expandable member on the distal shaft section which has a collapsed configuration and a radially expanded configuration. In the radially expanded configuration, the expandable member supports the shaft in a position spaced away from the body lumen wall, and the needle slidably exits the needle-through lumen in the extended configuration through the port spaced away from the body lumen wall as a portion of the expandable member maintains the position of the port section of the shaft in the body lumen. The expandable member typically has an open-walled, helical, or lobed configuration providing a perfusion path along the expandable member.

Abstract: Systems, devices and methods for eluting an agent at a treatment site are disclosed. The devices include an expandable frame and at least one membrane. The membrane may carry an agent to elute at the treatment site. The membrane may allow blood flow at the treatment site during agent delivery.