Abstract: The present disclosure relates generally to coating medical devices. In particular, the present disclosure provides materials and methods for coating a portion of a balloon catheter with a pharmaceutical agent using electrodeposition techniques. Although angioplasty and stenting can be effective methods for treating vascular occlusions, restenosis remains a pervasiveness problem. Therefore, coating portions of a balloon catheter with a pharmaceutical agent that inhibits restenosis can reduce the likelihood of restenosis.

Abstract: Embodiments of the invention are directed towards a rapid exchange catheter configured for insertion into a subintimal space and crossing an occlusion in a subintimal space. The catheter includes a proximal end, a distal end, a first lumen configured to receive a first wire, the first lumen extending longitudinally through a least a lateral port of the catheter, and a second lumen having at least a portion distal of the lateral port and extending through at least the distal end of the catheter. The catheter also includes an exchange port arranged on a exterior portion of the catheter configured to the receive a second wire and second rapid exchange port in communication with the second lumen. Moreover, other embodiments of the invention are directed towards methods for using the rapid exchange catheter to cross an obstruction in a vessel, e.g., a total or partial occlusion, in a subintimal space.

Abstract: A device suitable for removing material from a living being is provided, featuring at least an aspiration pump, powered by a motor. The aspiration pump and any optional infusate pump preferably feature a helical pumping mechanism, and operate at a high rate of rotation, thereby ensuring adequate pumping performance and flexibility. The helical pumping mechanism may be a helical coiled wire about a central core tube. The helical coil wire, whether together with, or independent of, the core tube, may be rotated to cause a pumping action. Additionally, a narrow crossing profile is maintained, ensuring that the device may reach more tortuous regions of the vasculature. In one embodiment, the system comprises a wire-guided mono-rail catheter with a working head mounted on a flexible portion of the catheter that can laterally displace away from the guide wire to facilitate thrombus removal.

Abstract: A method for detaching an object from a patient includes providing a tool having a sheath, and a separating assembly operably coupled to a distal end of the sheath. The separating assembly includes a separator moveably coupled to a tip via a threadable connection. The separating assembly is placed near patient tissue that is attached to the object, the sheath is rotated to move the separator distal to the tip, and the separator is applied to the patient tissue that is attached to the object, so as to separate the tissue. A separating system includes a sheath, and a separator threadably coupled with a distal end of the sheath. The separator is adapted to switch between a first configuration where a separating mechanism is deployed, and a second configuration where the separating mechanism is undeployed.

Abstract: Systems and methods for separating an object such as a pacing lead from a patient tissue involve a flexible and torqueable shaft having an internal lumen sized to receive the object, and a hard separating mechanism for separating the object from the tissue. Typically the shaft and separating mechanism are advanced along or toward the object, and the separating mechanism is contacted with the tissue. The shaft is rotated to effect separation between the object and the tissue. The systems and methods are well suited for use in cardiac pacing or defibrillator lead explant procedures.

Abstract: The invention generally relates to method and apparatus for crossing an obstruction in a tubular member, and more particularly to a medical device method for crossing of a chronic occlusion in a subintimal or interstitial space of an artery.

Abstract: Methods and systems for separating an object, such as a lead, from formed tissue are provided. Specifically, a tissue slitting device is configured to engage patient formed tissue at a slitting engagement point. While the object is subjected to a first traction force, the tissue slitting device is caused to move further into the engaged tissue and slit the tissue past the point of engagement. The slitting device causes the tissue to separate along an axial direction of the length of the formed tissue and releases at least some of the force containing the object. The methods and systems are well suited for use in cardiac pacing or defibrillator lead explant procedures.

Abstract: A system includes a microprocessor executable verification module in a base unit and a microprocessor readable identifier of an endovascular device in a memory of the endovascular device. The microprocessor executable verification module, based on the identifier, at least one of configures the endovascular device for use and determines whether the endovascular device can be enabled for use.

Abstract: A device for extending a lead according to some embodiments includes a body, a coil element coupled to the body, the body configured to cover the coil element during use, the coil element comprising an inner lumen sized to receive an outer surface of a lead, the coil element is movable between a first configuration in which the coil element slides over the lead, and a second configuration in which at least some coils grip the outer surface of the lead; an actuation mechanism operatively coupled to the coil element, the actuation mechanism configured to move the coil element between the first and second configurations; and a tether coupled to the lead via the body, the coil element, and/or actuation mechanism, the tether configured to extend further proximally than a proximal-most end of the lead and configured to transfer tension force applied to the tether to the lead.

Abstract: The present disclosure is directed, in one embodiment, to a wire centering sheath system in which wires outwardly extend from a sheath to brace against a vessel wall. The wire centering sheath system may be used to center endovascular devices.

Abstract: Methods, devices and systems for separating an implanted object, such as a lead attached to a cardiac conduction device, from formed tissue within a blood vessel are provided. The methods, devices and systems for separating a lead from the tissue relate to dilating the tissue surrounding the lead from underneath the tissue and/or between the lead and the tissue.

Abstract: This disclosure discusses various methods and devices for providing multiple types of indicators to be used with a sheath set. One type of indicator indicates the linear position and alignment of each of the sheaths within the sheath set, and another type of indicator indicates the rotational position and alignment of the sheaths. Both types of indicators may be included on the ends of the sheath set proximal to the user outside the patient's vasculature, thereby informing the user of the sheath set of the linear and rotational position and alignment of the ends of the inner and outer sheaths within the vasculature.

Abstract: Methods and devices for separating an implanted object, such as a pacemaker lead, from tissue surrounding such object in a patient's vasculature system. Specifically, the tissue separating device includes a handle, an elongate sheath and a circular cutting blade that may extend from the distal end of the sheath upon actuating the handle. The circular cutting blade is configured to engage the tissue surrounding an implanted lead and cut such tissue in a coring fashion as the device translates along the length of the lead, thereby allowing the lead, as well as any tissue remaining attached to the lead, to enter the device's elongate shaft. The tissue separating device includes a cam mechanism at the distal portion of the sheath that allows the user of the device to more accurately control the extension and rotation of the cutting blade upon being actuated by the handle.

Abstract: Device and method for puncturing blood vessels while using fluoroscopy. The disclosed device enables improved needle orientation control and avoids direct exposure of the clinician's hand to X-ray during the puncturing procedure.

Abstract: Various embodiments of an eccentric balloon catheter are disclosed. In some embodiments, an eccentric balloon catheter includes an eccentrically positioned guidewire tube, with an interior lumen, that extends at least a portion of the length of the catheter body. Optical fibers may extend the length of the catheter body and may also be eccentrically positioned within the catheter body. An inflatable balloon may be positioned within a window within the catheter body near the distal end of the catheter. When inflated, the balloon and catheter may slide relative to one another. When used within a vessel, an inflated balloon may press against a vessel wall and bias the catheter toward an opposite vessel wall.

Abstract: An endovascular device monitoring system is provided that determines, based on movement of the endovascular device past a selected reference location, at least one of a movement rate of a endovascular device and position of a distal end of a endovascular device in a body of a patient.

Abstract: A method and device for local delivery of a water-insoluble therapeutic agent to the tissue of a normal or diseased body lumen is disclosed. An expandable structure of a medical disposable device, such as a balloon of a balloon catheter, is coated with a non-durable coating which comprises poly(HEMA) complexed with iodine and has a substantially water-insoluble therapeutic agent dispersed therein. The medical disposable device is inserted into a body lumen, and expanded to contact the non-durable coating against the body lumen and deliver the substantially water-insoluble therapeutic agent to the body lumen tissue.

Abstract: Methods and devices for separating an implanted object, such as a pacemaker lead, from tissue surrounding such object in a patient's vasculature system. Specifically, the surgical device includes a handle, an elongate sheath and a circular cutting blade that extends from the distal end of the sheath upon actuating the handle. The circular cutting blade is configured to engage the tissue surrounding an implanted lead and cut such tissue in a coring fashion as the surgical device translates along the length of the lead, thereby allowing the lead, as well as any tissue remaining attached to the lead, to enter the device's elongate shaft. The surgical device has a barrel cam cylinder in the handle assembly that imparts rotation of the blade and a separate cam mechanism in the tip of outer sheath assembly that imparts and controls the extension and retraction of the blade.

Abstract: Technology for wireless transmission of messages to remote receiving devices is disclosed. The technology includes receiving a message for transmission, determining transmission parameters for transmission of the message, and transmitting the message to a remote receiving device according to the determined transmission parameters. The technology may also include encoding the message to effect message latency and may be employed for message transmission via the ionosphere or other atmospheric layer at frequencies in the Medium Frequency (MF), High Frequency (HF), or Very High Frequency (VHF) spectrum. Further, the disclosed technology may be employed for message transmission to effect low latency financial transaction execution, such as high speed high frequency trading.

Abstract: Expandable laser catheters for utilizing laser energy to remove obstructions from body passages are described. In one embodiment, the laser catheter includes a shaftway having a distal end including a flexible portion configured in a series of radial folds. Multiple optical fibers, configured to transmit laser energy, extend along the shaftway and are attached to the flexible portion. An inflatable, ring-shaped balloon is attached to the catheter within the flexible portion. In use, the catheter is inserted into a body passage such as an artery, and advanced until the distal end is adjacent to an obstruction. The balloon is inflated to expand the flexible portion and to bring the optical fibers nearer the inner wall of the body passage. Laser energy is directed by the optical fibers toward targeted regions of the obstruction, As the catheter is advanced and the process repeated, a core is formed from the obstruction and contained within the flexible portion.