Abstract: Devices and methods are described for treatment of cardiac arrhythmias, particularly atrial fibrillation. A three-dimensional computer model of the patient's heart produced from imaging data is used to fabricate a personalized or patient-specific customized ablation catheter. The personalized ablation catheter is shaped to fit the unique anatomy of the patient's left atrium and has ablation elements that correspond with each of the patient's pulmonary vein ostia. Ostial fitment elements engage the ostia to align the ablation elements and a base ring attached by spring members urges the ablation elements into apposition with the inner wall of the left atrium. A neuroprotective mesh is attached across the ring to capture and remove potential emboli. Ablation energy, such as radiofrequency energy, is applied through the ablation elements. Electrodes located on the personalized ablation catheter are used to verify electrical isolation of the pulmonary veins at the completion of the procedure.

Abstract: Apparatuses (devices, systems) and methods for shielding (protecting) surroundings around periphery of regions of interest located inside objects (e.g., patients) from radiation emitted by X-ray systems towards the objects. Apparatus includes: at least one radiation shield assembly including a support base connectable to an X-ray system radiation source or detector, and a plurality of radiation shield segments sequentially positioned relative to the support base, thereby forming a contiguous radiopaque screen configured for spanning around the region of interest periphery with a radiopaque screen edge opposing the object. Radiation shield segments are individually, actively controllable to extend or contract to selected lengths with respective free ends in directions away from or towards the support base(s), for locally changing contour of the radiopaque screen edge.

Abstract: Devices, methods, and systems for treating an ulcer or skin defect are disclosed. First and second base panels of a closure device are adhered to first and second sides of the ulcer or skin defect, respectively. Lateral ties couple the first and second base panels together and provide a predetermined separation distance or lateral gap between the inner edges of the panel. The predetermined separation distance or lateral gap is sufficient to treat the most common sized ulcers or skin defects, for example, accommodating an ulcer or skin defect with a minor axis of at most 50 mm. The lateral ties have their ends fixed to one panel and their opposite ends adjustably and reversibly attached to the other panel so that the separation distance can be reduced or adjusted to provide a lateral compressive force to the ulcer or skin defect, thereby promoting healing.

Abstract: A method for treating a patient using a catheter insertion device. The catheter insertion device includes a housing, a needle, a catheter, a guidewire, and a thumbwheel. The needle extends through the catheter such that a distal end of the needle extends distal of a distal end of the catheter. The guidewire is coupled to the thumbwheel such that rotation of the thumbwheel advances a distal end of the guidewire through a lumen of the needle. The method includes holding the catheter insertion device, inserting the distal end of the needle and catheter into a blood vessel, rotating the thumbwheel to advance the distal end of the guidewire out of the lumen of the needle into the blood vessel, moving the catheter over the guidewire in the blood vessel, and removing the needle and the guidewire from the catheter.

Abstract: The present invention relates to rigid structures and composite materials thereof for providing radiation attenuation/shielding. Some embodiments pertain to a radiation shielding apparatus including: a plurality of positionable radiation-shielding stacks of tiles. The stacks are subsequently and adjacently arranged in a contiguous configuration. A tile positioning mechanism allows movement of tiles within a stack between a stacked (retracted) position and an extended position. In the extended position, the tiles of each of the plurality of radiation shielding stacks at least partially overlap tiles of subsequent and adjacent tile stack at corresponding opposing side-margins thereof.

Abstract: A wound or incision closure apparatus comprises a first and second panel. Each of the panels comprises a bottom adhesive layer, a medial substrate layer, and an upper load distribution layer which connect the two panels. A sensory or therapeutic element is disposed adjacent, within, or between two or more of the layers. The sensory or therapeutic element can provide sensing and/or therapy for the incision and/or monitor the incision so that the therapy can be customized and updated.

Abstract: An apparatus for closing a surgical incision comprises left and right base panels, a plurality of closure components, and a plurality of left and right axial supports coupled to the respective base panels. The closure components couple the left and right base panels to each other laterally and have left and right ends coupled to the respective base panels. The closure components are positioned laterally across the left and right panels, the left axial supports are disposed between pairs of left closure component ends, the right axial supports are disposed between pairs of right closure component ends, and the left and right axial supports are offset from one another such that a serpentine arrangement of consecutive closure components and axial supports is formed. The apparatus can be made of antimicrobial materials or materials impregnated with antimicrobial agents. A flexible adhesive cover can be provided over the apparatus when in use.

Abstract: Devices, methods, and systems for treating an ulcer or skin defect are disclosed. First and second base panels of a closure device are adhered to first and second sides of the ulcer or skin defect, respectively. Lateral ties couple the first and second base panels together and provide a predetermined separation distance or lateral gap between the inner edges of the panel. The predetermined separation distance or lateral gap is sufficient to treat the most common sized ulcers or skin defects, for example, accommodating an ulcer or skin defect with a minor axis of at most 50 mm. The lateral ties have their ends fixed to one panel and their opposite ends adjustably and reversibly attached to the other panel so that the separation distance can be reduced or adjusted to provide a lateral compressive force to the ulcer or skin defect, thereby promoting healing.

Abstract: Devices and methods are described for treatment of cardiac arrhythmias, particularly atrial fibrillation. A three-dimensional computer model of the patient's heart produced from imaging data is used to fabricate a personalized or patient-specific customized ablation catheter. The personalized ablation catheter is shaped to fit the unique anatomy of the patient's left atrium and has ablation elements that correspond with each of the patient's pulmonary vein ostia. Ostial fitment elements engage the ostia to align the ablation elements and a base ring attached by spring members urges the ablation elements into apposition with the inner wall of the left atrium. A neuroprotective mesh is attached across the ring to capture and remove potential emboli. Ablation energy, such as radiofrequency energy, is applied through the ablation elements. Electrodes located on the personalized ablation catheter are used to verify electrical isolation of the pulmonary veins at the completion of the procedure.

Abstract: A wound or incision closure apparatus comprises a first and second panel. Each of the panels comprises a bottom adhesive layer, a medial substrate layer, and an upper load distribution layer which connect the two panels. A sensory or therapeutic element is disposed adjacent, within, or between two or more of the layers. The sensory or therapeutic element can provide sensing and/or therapy for the incision and/or monitor the incision so that the therapy can be customized and updated.

Abstract: Intravascular access is achieved by introducing a catheter having a guide element recess placed to receive the contoured distal end of a guide element. The guide element may be advanced along an outer surface of an access needle to form a loop beyond the distal end of the needle. The deployed guide element may form a partial or complete loop once beyond the distal end of the needle. After the catheter has been properly positioned, the access needle and guide element may be removed by automatic withdrawal leaving the catheter in place within a blood vessel and available for use.

Abstract: A catheter system including an inner tube movable within an outer tube and a funnel-shaped sleeve attached to the inner tube and configured for transitioning between a collapsed state when sequestered within the outer tube and an expanded state when advanced out of the outer tube.

Abstract: An embolic filter positioning system includes a vascular delivery sheath, a filter catheter, a self-expanding embolic filter attached to a distal end of the filter catheter, and an elongate dilator having a tapered dilator tip. The elongate dilator is slidably received in a central lumen of the filter catheter, and the filter catheter is slidably received in the open lumen of the vascular delivery sheath. The tapered dilator tip is positioned distally of the distal end of the vascular delivery sheath, and the self-expanding embolic filter is radially constrained in a proximal portion of the open lumen of the vascular delivery sheath. The tapered dilator tip has an expanded configuration where it covers the open distal end of the vascular delivery sheath and facilitates entry though an arteriotomy and a contracted configuration where it can be retracted through the central lumen of the filter catheter.

Abstract: An embolic protection device comprises a tubular filter body attached to a sheath. The tubular filter body has an open upstream end and a generally closed downstream end for capturing emboli. A self-opening passage through the emboli capture end of the tubular filter body allows multiple catheters to be advanced from the sheath or otherwise into the filter body simultaneously or sequentially. The sheath is attached to a peripheral support structure near the emboli capture end of the filter body to facilitate deployment and retrieval of the filter body through a restraining delivery catheter.

Abstract: The present invention relates to a collision detection and prevention system for medical X-ray equipment, in particular a supplementary system that augments an existing safety system, which is useful when the X-ray equipment includes an auxiliary apparatus, such as a radiation shield, which may interfere with the existing collision detection and prevention system.

Abstract: Various devices and methods useful for providing vasocompression to a patient who is undergoing chemotherapy treatment.

Abstract: An embolic protection device comprises a tubular filter body attached to a sheath. The tubular filter body has an open upstream end and a generally closed downstream end for capturing emboli. A self-opening passage through the emboli capture end of the tubular filter body allows multiple catheters to be advanced from the sheath or otherwise into the filter body simultaneously or sequentially. The sheath is attached to a peripheral support structure near the emboli capture end of the filter body to facilitate deployment and retrieval of the filter body through a restraining delivery catheter.

Abstract: Apparatuses (devices, systems) and methods for shielding (protecting) surroundings around periphery of regions of interest located inside objects (e.g., patients) from radiation emitted by X-ray systems towards the objects. Apparatus includes: at least one radiation shield assembly including a support base connectable to an X-ray system radiation source or detector, and a plurality of radiation shield segments sequentially positioned relative to the support base, thereby forming a contiguous radiopaque screen configured for spanning around the region of interest periphery with a radiopaque screen edge opposing the object. Radiation shield segments are individually, actively controllable to extend or contract to selected lengths with respective free ends in directions away from or towards the support base(s), for locally changing contour of the radiopaque screen edge.

Abstract: The present invention relates to rigid structures and composite materials thereof for providing radiation attenuation/shielding. Some embodiments pertain to a radiation shielding apparatus including: a plurality of positionable radiation-shielding stacks of tiles. The stacks are subsequently and adjacently arranged in a contiguous configuration. A tile positioning mechanism allows movement of tiles within a stack between a stacked (retracted) position and an extended position. In the extended position, the tiles of each of the plurality of radiation shielding stacks at least partially overlap tiles of subsequent and adjacent tile stack at corresponding opposing side-margins thereof.

Abstract: An embolic protection device comprises a tubular filter body attached to a sheath. The tubular filter body has an open upstream end and a generally closed downstream end for capturing emboli. A self-opening passage through the emboli capture end of the tubular filter body allows multiple catheters to be advanced from the sheath or otherwise into the filter body simultaneously or sequentially. The sheath is attached to a peripheral support structure near the emboli capture end of the filter body to facilitate deployment and retrieval of the filter body through a restraining delivery catheter.