Abstract: Disclosed are puncture sealing systems and methods of locating a puncture site within a vessel. The systems can include puncture locating dilators and access sheaths that are configured to locate the puncture site within a vessel so that the position of the puncture site relative to a distal end of the access sheath is known during a puncture sealing procedure.

Abstract: An apparatus is provided that is operable in different modes to perform various functions for treating a body lumen. The apparatus includes a shaft including proximal and distal ends, a lumen extending there between, and a balloon on the distal end. The apparatus includes a valve on the distal end that selectively opens or closes an outlet communicating with the lumen. With the valve open, fluid introduced into the lumen exits the outlet into a body lumen. With the valve closed, fluid introduced into the lumen expands the balloon. The valve may be biased to be closed, e.g., by a spring element disposed within the balloon. Optionally, the apparatus also includes an actuator for expanding a helical member within the balloon interior, e.g., either before or after expanding the balloon, such that the helical member and balloon may adopt an expanded helical shape for removing material within a body lumen.

Abstract: Disclosed are puncture sealing systems and methods of locating a puncture site within a vessel. The systems can include puncture locating dilators and access sheaths that are configured to locate the puncture site within a vessel so that the position of the puncture site relative to a distal end of the access sheath is known during a puncture sealing procedure.

Abstract: A deployment instrument for deploying a closure device for sealing a percutaneous puncture in a wall of a body passageway, the deployment instrument including a carrier assembly, wherein the carrier assembly is configured to hold the closure device in a pre-deployment state, and a tensioner assembly, wherein the filament is fixedly attached to the tensioner assembly, wherein the deployment instrument is configured to increase the tension in the filament upon linear movement of the deployment instrument away from the wall of the body passageway when the closure device is anchored to the wall via the anchor such that the tension is gradually increased as the deployment instrument is moved between a first linear distance and a second linear distance greater than the first linear distance from the wall of the body passageway.

Abstract: A closure device system for sealing a percutaneous puncture in a vessel wall can comprise a toggle configured to engage an interior surface of the vessel wall, a plug configured to engage an exterior sur-face of the vessel wall, and a suture that extends through the plug and through the toggle along at least a first direction so as to couple the toggle to the plug. The system can further comprise a tube that extends through the plug and through the toggle along the first direction such that a distal end of the tube is disposed distally to the toggle. The tube can define a guidewire lumen that extends therethrough along the first direction. And the guidewire lumen can be configured to receive a guidewire that protrudes from the vessel wall such that the plug, toggle, and tube are slidable along the guidewire toward the vessel wall.

Abstract: Disclosed are puncture sealing systems and methods of locating a puncture site within a vessel. The systems can include elongated dilators and access sheaths that are configured to locate the puncture site within a vessel so that the position of the puncture site relative to a distal end of the access sheath is known during a puncture sealing procedure.

Abstract: Apparatus and methods are provided for removing obstructive material within a body lumen. The apparatus includes a macerator device deployable from a sheath that includes an expandable cage carried by a shaft and within a constraint tube. The shaft is movable relative to the constraint tube for deploying and expanding the cage within a body lumen such that an open end of the cage is oriented towards obstructive material. The cage is advanced to capture the material or the material is directed into the cage using an expandable member expanded beyond the material and retracted to direct the material into the cage. The cage is withdrawn into the constraint tube to compress the cage radially inwardly. Materials extending through apertures in the cage are sheared off by a sharpened edge of the constraint tube. The smaller, sheared off particles are then aspirated from the body lumen through the sheath.

Abstract: A method for removing material within a body lumen of a patient is disclosed. The method include introducing a distal end of a tubular member into a body lumen. The tubular member has a guide member extending distally from the distal end. Next, the tubular member is positioned such that the distal end is disposed adjacent material to be removed and a distal tip of the guide member is disposed beyond the material. One or more lumen clearing elements are then deployed from the distal tip of the guide member. Each lumen clearing element includes an expandable structure that expands from a contracted condition within the guide member to an expanded condition when deployed from the distal tip. Then, the deployed one or more lumen clearing elements are retracted along a track of the guide member to engage the material disposed adjacent the distal end of the tubular member and draw the material into a lumen of the tubular member.

Abstract: A vascular closure device includes a deployment assembly, a sealing unit carried by the deployment assembly, and a tamper carried by the deployment assembly and that is disposed along a suture with respect to the sealing unit. The vascular closure device includes a locking assembly coupled to the tamper so as to selectively inhibit advancement of the tamper along the suture in the distal direction toward the sealing unit. The locking assembly is adapted to transition from A) a locked configuration where the tamper is inhibited from sliding along the suture, into B) an unlocked configuration where the tamper is slidable along the suture in the distal direction and into contact with the sealing unit.

Abstract: A vascular closure device configured to seal a puncture site in the vessel wall in a more efficient manner is disclosed. The vascular closure device includes a guide member that extends through a portion of the sealing device and that is removable from the portion the sealing device.

Abstract: A closure device system for sealing a percutaneous puncture in a vessel wall can comprise a toggle configured to engage an interior surface of the vessel wall, a plug configured to engage an exterior surface of the vessel wall, and a suture that extends through the plug and through the toggle along at least a first direction so as to couple the toggle to the plug. The system can further comprise a tube that extends through the plug and through the toggle along the first direction such that a distal end of the tube is disposed distally to the toggle. The tube can define a guidewire lumen that extends therethrough along the first direction. And the guidewire lumen can be configured to receive a guidewire that protrudes from the vessel wall such that the plug, toggle, and tube are slidable along the guidewire toward the vessel wall.

Abstract: Apparatus and methods are provided for delivering fluid into a body lumen during a medical procedure. A distal end of an apparatus may be introduced into a body lumen, and a valve on the distal end may be opened to deliver fluid through a first lumen into the body lumen, e.g., contrast and/or other diagnostic or therapeutic agents. The valve may be closed, and a procedure may be performed within the body lumen, e.g., using a treatment element carried on the distal end. For example, the treatment element may include a balloon that may be inflated when fluid is delivered through the first lumen with the valve closed. Optionally, a prosthesis, energy source, drug platform, and the like may be carried by the balloon for treating the body lumen. In various embodiments, the valve may be located proximal or distal to the treatment element.

Abstract: An endovascular navigation system and method are disclosed. The endovascular navigation system includes an elongate flexible member, a processor, and a display. The elongate flexible member includes an endovascular electrogram lead disposed at its distal end for sensing an endovascular electrogram signal of the venous vasculature of the patient, and a first wireless interface configured to wirelessly transmit the endovascular electrogram signal to the processor. The processor includes a second wireless interface configured to wirelessly receive the endovascular electrogram signal from the elongate flexible member. The processor is configured to determine that the position of the distal end of the elongate flexible member is within a predetermined structure within the venous vasculature of the patient. The display is configured to display a visual indication that the distal end of the elongate flexible member is within the predetermined structure.

Abstract: A method of navigating and positioning an endovascular device in a vasculature is disclosed. Initially, a system including an endovascular device and at least one transducer is inserted into the lumen of a patient. An acoustic signal is then transmitted within the lumen. A reflected signal is pre-processed to extract one or more acoustic features. The one or more acoustic features are processed using a computer readable set of rules to produce an output related to guidance of the instrument within a blood vessel or a position of the instrument within the blood vessel.

Abstract: In an aspect, embodiments of the invention relate to the effective and accurate placement of intravascular devices such as central venous catheters, in particular such as peripherally inserted central catheters or PICC. One aspect of the present invention relates to vascular access. It describes devices and methods for imaging guided vascular access and more effective sterile packaging and handling of such devices. A second aspect of the present invention relates to the guidance, positioning and placement confirmation of intravascular devices without the help of X-ray imaging. A third aspect of the present invention relates to devices and methods for the skin securement of intravascular devices and post-placement verification of location of such devices. A forth aspect of the present invention relates to improvement of the workflow required for the placement of intravascular devices.

Abstract: The endovascular navigation system includes an elongate flexible member configured to access the venous vasculature of a patient, a sensor disposed at a distal end of the elongate flexible member and configured to sense a physiological characteristic of the venous vasculature, a processor and an output device. The processor is configured to receive and process the physiological characteristic of the venous vasculature, and to determine that the position of the distal end of the elongate flexible member is within a predetermined structure within the venous vasculature. The output device is configured to display a visual indication that the distal end of the elongate flexible member is within the predetermined structure within the venous vasculature, where the visual indication is different from the physiological characteristic of the venous vasculature of the patient.

Abstract: An endovascular navigation system and method are disclosed. The endovascular navigation system includes an elongate flexible member, a endovascular electrogram lead disposed at a distal end of the elongate flexible member and configured to sense an endovascular electrogram signal, a processor and an output device. The processor is configured to receive the endovascular electrogram signal, to determine a peak amplitude of a P-wave in the endovascular electrogram signal, and to determine that the position of the distal end of the elongate flexible member is within a predetermined structure within the venous vasculature of the patient. The output device is configured to display a visual indication that the distal end of the elongate flexible member is within the predetermined structure within the venous vasculature of the patient, where the visual indication is different from the endovascular electrogram signal of the venous vasculature of the patient.

Abstract: An endovascular navigation system and method are disclosed. The endovascular navigation system includes an elongate flexible member, a endovascular electrogram lead disposed at a distal end of the elongate flexible member and configured to sense an endovascular electrogram signal, a processor and an output device. The processor is configured to receive the endovascular electrogram signal, to determine a peak amplitude of a P-wave in the endovascular electrogram signal, and to determine that the position of the distal end of the elongate flexible member is within a predetermined structure within the venous vasculature of the patient. The output device is configured to display a visual indication that the distal end of the elongate flexible member is within the predetermined structure within the venous vasculature of the patient, where the visual indication is different from the endovascular electrogram signal of the venous vasculature of the patient.

Abstract: A photoactivatable fouling-resistant copolymer composed of a photoactivatable monomer and a hydrophilic monomer is disclosed. The photoactivatable monomer includes an aryl ketone derivative having one or more polar groups or alkyl groups.

Abstract: A method for preparing and resulting articles of manufacture comprising a substrate having a surface, a bulk beneath the surface, and a grafted polymer layer on the substrate surface, the substrate surface and the grafted polymer layer, in combination, constituting a modified surface having a fibrinogen adsorption of less than about 125 ng/cm2 in a fibrinogen binding assay in which the modified surface is incubated for 60 minutes at 37° C. in 70 ?g/mL fibrinogen derived from human plasma containing 1.4 ?g/mL I-125 radiolabeled fibrinogen.