Abstract: The present invention relates to: (1) guidewire support/placement catheters; (2) support/placement catheters with imaging; (3) atherectomy catheters, (4) atherectomy catheters with imaging, (5) occlusion crossing catheters, and (6) occlusion crossing catheters with imaging as well as methods for using them to treat disorders (and particularly peripheral artery disease) and systems including them.

Abstract: A method for closing an opening in tissue using a suturing device includes inserting at least a portion of a suture through a tissue tract and through a tissue wall. Following inserting at least a portion of the suture, the method includes advancing a first end of the suture through a bight of the suture, the bight pre-formed about a periphery of a knot tube of the suturing device. Once the first end is advanced, the method includes tensioning the first end of the suture and a second end of the suture adjacent the bight to form a knot affixing a loop of suture across the puncture.

Abstract: Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot near a distal end of a shaft is inserted through the penetration and actuated so that the foot extends along the lumenal axis. The foot carries suturing attachment cuffs, and needles are advanced from the shaft through the vessel wall outside of the penetration and into engagement with the needle cuffs after the foot has been drawn proximally up against the endothelial surface of the blood vessel. The cross-section of the shaft within the tissue tract can be minimized by laterally deflecting the needles as they leave the shaft, while tapered depressions within the foot can guide the advancing needles into engagement with the cuffs. The cuffs lockingly engage the needles and can be withdrawn proximally along the needle paths and through the tissue tract so as to form a loop of suture across the puncture.

Abstract: Described herein are atherectomy catheters, systems and methods that include longitudinally displaceable drive shafts that drive actuation of one or more cutters at the distal end of the catheter. The catheters described herein may include one or more imaging sensors for imaging before, during or after cutting tissue. In some variations the imaging sensor may be rotated around the perimeter of the catheter independently of the rotation of the cutter. Also describe herein are imaging catheters that may be used without cutters.

Abstract: Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot near a distal end of a shaft is inserted through the penetration and actuated so that the foot extends along the lumenal axis. The foot carries suturing attachment cuffs, and needles are advanced from the shaft through the vessel wall outside of the penetration and into engagement with the needle cuffs after the foot has been drawn proximally up against the endothelial surface of the blood vessel. The cross-section of the shaft within the tissue tract can be minimized by laterally deflecting the needles as they leave the shaft, while tapered depressions within the foot can guide the advancing needles into engagement with the cuffs. The cuffs lockingly engage the needles and can be withdrawn proximally along the needle paths and through the tissue tract so as to form a loop of suture across the puncture.

Abstract: Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot near a distal end of a shaft is inserted through the penetration and actuated so that the foot extends along the lumenal axis. The foot carries suturing attachment cuffs, and needles are advanced from the shaft through the vessel wall outside of the penetration and into engagement with the needle cuffs after the foot has been drawn proximally up against the endothelial surface of the blood vessel. The cross-section of the shaft within the tissue tract can be minimized by laterally deflecting the needles as they leave the shaft, while tapered depressions within the foot can guide the advancing needles into engagement with the cuffs. The cuffs lockingly engage the needles and can be withdrawn proximally along the needle paths and through the tissue tract so as to form a loop of suture across the puncture.

Abstract: Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot near a distal end of a shaft is inserted through the penetration and actuated so that the foot extends along the lumenal axis. The foot carries suturing attachment cuffs, and needles are advanced from the shaft through the vessel wall outside of the penetration and into engagement with the needle cuffs after the foot has been drawn proximally up against the endothelial surface of the blood vessel. The cross-section of the shaft within the tissue tract can be minimized by laterally deflecting the needles as they leave the shaft, while tapered depressions within the foot can guide the advancing needles into engagement with the cuffs. The cuffs lockingly engage the needles and can be withdrawn proximally along the needle paths and through the tissue tract so as to form a loop of suture across the puncture.

Abstract: A guidewire loader apparatus is provided for loading a guidewire into a lumen opening of a guidewire lumen of a medical device. The loader apparatus includes a first member defining a respective medical device receiving portion and a respective guidewire receiving portion in communication therewith via a respective interface portion. The loader apparatus further includes a second member configured for placement in an opposed relationship to the first member. The second member defines a respective medical device receiving portion and a respective guidewire receiving portion in communication therewith at a respective interface portion. The first member and the second member cooperatively associate with one another between a first position and a second position. In the first position, the medical device can be positioned into at least one respective medical device receiving portion.

Abstract: Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot near a distal end of a shaft is inserted through the penetration and actuated so that the foot extends along the lumenal axis. The foot carries suturing attachment cuffs, and needles are advanced from the shaft through the vessel wall outside of the penetration and into engagement with the needle cuffs after the foot has been drawn proximally up against the endothelial surface of the blood vessel. The cross-section of the shaft within the tissue tract can be minimized by laterally deflecting the needles as they leave the shaft, while tapered depressions within the foot can guide the advancing needles into engagement with the cuffs. The cuffs lockingly engage the needles and can be withdrawn proximally along the needle paths and through the tissue tract so as to form a loop of suture across the puncture.

Abstract: Catheter-based Optical Coherence Tomography (OCT) systems utilizing an optical fiber that is positioned off-axis of the central longitudinal axis of the catheter have many advantage over catheter-based OCT systems, particularly those having centrally-positioned optical fibers or fibers that rotate independently of the elongate body of the catheter. An OCT system having an off-axis optical fiber for visualizing the inside of a body lumen may be rotated with the body of the elongate catheter, relative to a handle portion. The handle may include a fiber management pathway for the optical fiber that permits the off-axis optical fiber to rotate with the catheter body relative to the handle. The system may also include optical processing elements adapted to prepare and process the OCT image collected by the off-axis catheter systems described herein.

Abstract: Described herein are atherectomy catheters, systems and methods that include a distal tip region that may be moved laterally so that its long axis is parallel with the long axis of the main catheter body axis. Displacing the distal tip region laterally out of the main catheter body axis exposes an annular blade and opens a passageway for cut tissue to enter a storage region within the catheter. The annular blade may be internally coupled to a drive shaft that rotates the blade, and thus the exposed blade edge may have the same crossing profile (OD) as the rest of the distal end region of the catheter. Also described herein are gear-driven atherectomy devices that may use a cable drive shaft to actuate the annular blade. Both push-to-cut and pull-to-cut variations are described, as are methods for cutting tissue and systems including these atherectomy catheters.

Abstract: Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot near a distal end of a shaft is inserted through the penetration and actuated so that the foot extends along the lumenal axis. The foot carries suturing attachment cuffs, and needles are advanced from the shaft through the vessel wall outside of the penetration and into engagement with the needle cuffs after the foot has been drawn proximally up against the endothelial surface of the blood vessel. The cross-section of the shaft within the tissue tract can be minimized by laterally deflecting the needles as they leave the shaft, while tapered depressions within the foot can guide the advancing needles into engagement with the cuffs. The cuffs lockingly engage the needles and can be withdrawn proximally along the needle paths and through the tissue tract so as to form a loop of suture across the puncture.

Abstract: Described herein are catheters for use with Optical Coherence Tomography (OCT) that include an optical fiber core having a first refractive index and an interface medium having a second refractive index, where the first and second refractive indexes are mismatched such that receiving electronics configured to receive optical radiation reflected from the reference interface and the target operate in a total noise range that is within 5 dB of the shot noise limit. These OCT catheters may include a silicon die mirror having a reflective coating that is embedded in the interface medium. The optical fiber can be fixed at just the distal end of the catheter, and may be managed within a handle that is attached to the proximal end of the catheter body, and is configured to allow rotation of the both catheter body and the optical fiber relative to the handle.

Abstract: Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot near a distal end of a shaft is inserted through the penetration and actuated so that the foot extends along the lumenal axis. The foot carries suturing attachment cuffs, and needles are advanced from the shaft through the vessel wall outside of the penetration and into engagement with the needle cuffs after the foot has been drawn proximally up against the endothelial surface of the blood vessel. The cross-section of the shaft within the tissue tract can be minimized by laterally deflecting the needles as they leave the shaft, while tapered depressions within the foot can guide the advancing needles into engagement with the cuffs. The cuffs lockingly engage the needles and can be withdrawn proximally along the needle paths and through the tissue tract so as to form a loop of suture across the puncture.

Abstract: System having wearable components operable in mobile outdoor conditions and methods of using the same are presented. A system may include at least one speaker, a microphone, a first transceiver coupled to a first antenna, a second transceiver coupled to a second antenna, the first and second transceivers operating under first and second protocols, respectively. A controller and a power source are also provided. In one embodiment, a system may include an audio assembly, a housing assembly, a resilient seal, and a housing receptacle. The housing assembly may be in releasable engagement with the receptacle. A method of controlling a user device in accordance with one embodiment of the invention may include receiving data transmitted according to a second protocol, decoding the data and encoding the decoded data according to a first protocol, different from the second, and then transmitting the encoded data to the user device. The method may also be practiced in the reverse direction.

Abstract: A method for closing an opening in tissue using a suturing device includes inserting at least a portion of a suture through a tissue tract and through a tissue wall. Following inserting at least a portion of the suture, the method includes advancing a first end of the suture through a bight of the suture, the bight pre-formed about a periphery of a knot tube of the suturing device. Once the first end is advanced, the method includes tensioning the first end of the suture and a second end of the suture adjacent the bight to form a knot affixing a loop of suture across the puncture.

Abstract: A device for closing an opening in tissue includes a shaft having a proximal end, a distal end, and at least one pin associated with a distal end the shaft. A flexible guidebody extends from the distal end of the shaft, while a foot associated with the device is movable with respect to the shaft through the pin connected to at least one slot of the foot. Another device for closing an opening in tissue includes a shaft having a proximal end and a distal end. A plurality of feet are disposed proximate the distal end of the shaft, the plurality of feet being movable with respect to the shaft. The device further includes a flexible guidebody extending from the distal end of the shaft.

Abstract: System having wearable components operable in mobile outdoor conditions and methods of using the same are presented. A system may include at least one speaker, a microphone, a first transceiver coupled to a first antenna, a second transceiver coupled to a second antenna, the first and second transceivers operating under first and second protocols, respectively. A controller and a power source are also provided. In one embodiment, a system may include an audio assembly, a housing assembly, a resilient seal, and a housing receptacle. The housing assembly may be in releasable engagement with the receptacle. A method of controlling a user device in accordance with one embodiment of the invention may include receiving data transmitted according to a second protocol, decoding the data and encoding the decoded data according to a first protocol, different from the second, and then transmitting the encoded data to the user device. The method may also be practiced in the reverse direction.

Abstract: A guidewire loader apparatus is provided for loading a guidewire into a lumen opening of a guidewire lumen of a medical device. The loader apparatus includes a first member defining a respective medical device receiving portion and a respective guidewire receiving portion in communication therewith via a respective interface portion. The loader apparatus further includes a second member configured for placement in an opposed relationship to the first member. The second member defines a respective medical device receiving portion and a respective guidewire receiving portion in communication therewith at a respective interface portion. The first member and the second member cooperatively associate with one another between a first position and a second position. In the first position, the medical device can be positioned into at least one respective medical device receiving portion.

Abstract: Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot near a distal end of a shaft is inserted through the penetration and actuated so that the foot extends along the lunenal axis. The foot carries suturing attachment cuffs, and needles are advanced from the shaft through the vessel wall outside of the penetration and into engagement with the needle cuffs after the foot has been drawn proximally up against the endothelial surface of the blood vessel. The cross-section of the shaft within the tissue tract can be minimized by laterally deflecting the needles as they leave the shaft, while tapered depressions within the foot can guide the advancing needles into engagement with the cuffs. The cuffs lockingly engage the needles and can be withdrawn proximally along the needle paths and through the tissue tract so as to form a loop of suture across the puncture.