Abstract: A fluid mixing device includes inlet ports in fluid communication with respective source containers, an inlet check valve, a mixing container in fluid communication with the inlet check valve, a discharge port in fluid communication with a target container, and a discharge check valve in fluid communication with the mixing container and the discharge port. Responsive to a negative pressure at the mixing container, fluid is drawn from the respective source containers through the inlet ports and through the inlet check valve and into the mixing container, while the discharge check valve precludes drawing of fluid from the target container. Responsive to a positive pressure at the mixing container, fluid is expelled from the mixing container through the discharge check valve and into the target container, while the inlet check valve precludes discharge of fluid from the mixing container to the inlet ports and the source containers.

Abstract: Devices, and methods for generating variable inhalable products (e.g., variable density, phase, and size products) are provided. Methods for treating or preventing a disorder in a subject using variable products generated by the devices are also provided herein. Additionally, inhalers and breathing systems comprising the devices are provided.

Abstract: Compositions, devices, and methods for treating one or more respiratory disorders in a subject (e.g., a mammal) are provided. In an exemplary embodiment, a breathing system is provided and include a pressure-assisted breathing device, and a composition comprising amniotic fluid, an amnion tissue preparation, or a combination thereof. The pressure-assisted breathing device can be a mechanical ventilator. The breathing system can further include a delivery device selected from a nebulizer, a metered dose inhaler, or a dry powder inhaler operably connected to the breathing system to deliver the composition into the breathing system.

Abstract: A peripheral artery balloon is provided that includes a distal end having a first outer diameter, a proximal end having a second outer diameter that is larger than the first outer diameter, and an extended portion that extends from the distal end to the proximal end, the extended portion having an outer diameter that gradually increases from the first outer diameter of the distal end to the second outer diameter of the proximal end. The distal end, proximal end, and extended portion of the peripheral artery balloon are sized to mimic a varying diameter of a natural artery. A hypo-tube for preparing a peripheral artery balloon is also provided, as well as a method of remodeling and/or treating arteries after an atherectomy and/or during an angioplasty using a peripheral artery balloon.

Abstract: A fluid mixing device includes inlet ports in fluid communication with respective source containers, an inlet check valve, a mixing container in fluid communication with the inlet check valve, a discharge port in fluid communication with a target container, and a discharge check valve in fluid communication with the mixing container and the discharge port. Responsive to a negative pressure at the mixing container, fluid is drawn from the respective source containers through the inlet ports and through the inlet check valve and into the mixing container, while the discharge check valve precludes drawing of fluid from the target container. Responsive to a positive pressure at the mixing container, fluid is expelled from the mixing container through the discharge check valve and into the target container, while the inlet check valve precludes discharge of fluid from the mixing container to the inlet ports and the source containers.

Abstract: A device for crossing a lesion in a tissue lumen includes a crossing wire configured to pass through a lumen of a catheter, the crossing wire including a loop at a distal end of the crossing wire. The loop can have a configuration that prevents a width of the loop from exceeding a width of the tissue lumen, and the loop having a pair of lateral opposing portions configured for alignment with a wall of the tissue lumen and a leading portion interconnecting the pair of lateral opposing portions, the leading portion being configured to interrogate the lesion. The loop has a length in an axial direction of the crossing wire extending from the leading portion to proximal ends of the pair of lateral opposing portions, the length being perpendicular to the width, and the length of the loop is at least twice the width of the loop.

Abstract: A reentry apparatus has an outer catheter configured to accommodate a first reentry device and an inner catheter configured to fit within the outer catheter. The inner catheter has a series of expanding anchors extending from the outer surface of the inner catheter and a reentry channel configured to accommodate a second reentry device. A retaining wire extends along the upper surface of the expanding anchors. A reentry channel is located in the configured to accommodate a second reentry device.

Abstract: A peripheral vascular filter according to some aspects of the invention includes a filter body forming a cavity therein, the filter body having a proximal end and a distal end in a length-wise direction of the peripheral vascular filter, the filter body having an opening in the proximal end thereof; a spring system arranged proximal to the filter body and in mechanical connection with the filter body and with a filter wire, the spring system being stretchable along the length-wise direction; a plurality of retractor wires, each retractor wire having a distal end connected to the filter body, and a proximal end connected to spring system. In a deployed configuration, the spring system absorbs forces applied to the filter wire proximal to the filter body to prevent the peripheral vascular filter from becoming dislodged from a position in a peripheral vasculature.

Abstract: A device for crossing a lesion in a tissue lumen includes a crossing wire configured to pass through a lumen of a catheter, the crossing wire including a loop at a distal end of the crossing wire. The loop can have a configuration that prevents a width of the loop from exceeding a width of the tissue lumen, and the loop having a pair of lateral opposing portions configured for alignment with a wall of the tissue lumen and a leading portion interconnecting the pair of lateral opposing portions, the leading portion being configured to interrogate the lesion. The loop has a length in an axial direction of the crossing wire extending from the leading portion to proximal ends of the pair of lateral opposing portions, the length being perpendicular to the width, and the length of the loop is at least twice the width of the loop.

Abstract: A peripheral vascular filter according to some aspects of the invention includes a filter body forming a cavity therein, the filter body having a proximal end and a distal end in a length-wise direction of the peripheral vascular filter, the filter body having an opening in the proximal end thereof; a spring system arranged proximal to the filter body and in mechanical connection with the filter body and with a filter wire, the spring system being stretchable along the length-wise direction; a plurality of retractor wires, each retractor wire having a distal end connected to the filter body, and a proximal end connected to spring system. In a deployed configuration, the spring system absorbs forces applied to the filter wire proximal to the filter body to prevent the peripheral vascular filter from becoming dislodged from a position in a peripheral vasculature.

Abstract: A device and method for delivering a drug from inside a body lumen to tissue surrounding the body lumen. An endoluminal drug delivery device includes a dual-lumen catheter for housing a guidewire and a needle connectable to a drug source. The guidewire exits the catheter through an opening at the distal end, and the needle exits the catheter through an exit port in the outer wall of the catheter. A distal portion of the catheter has a single lumen and includes a taper, allowing the distal tip to act as a dilator. The device optionally includes a catheter lumen splitter and/or a handpiece assembly. A method of delivering fluid to tissue surrounding a body lumen includes inserting a guidewire into the body lumen, tracking the device over the guidewire, deploying the needle through the exit port to the tissue, delivering fluid, and retracting the needle into the catheter.

Abstract: A peripheral vascular filter according to some aspects of the invention includes a filter body forming a cavity therein, the filter body having a proximal end and a distal end in a length-wise direction of the peripheral vascular filter, the filter body having an opening in the proximal end thereof; a spring system arranged proximal to the filter body and in mechanical connection with the filter body and with a filter wire, the spring system being stretchable along the length-wise direction; a plurality of retractor wires, each retractor wire having a distal end connected to the filter body, and a proximal end connected to spring system. In a deployed configuration, the spring system absorbs forces applied to the filter wire proximal to the filter body to prevent the peripheral vascular filter from becoming dislodged from a position in a peripheral vasculature.

Abstract: A reentry apparatus has an outer catheter configured to accommodate a first reentry device and an inner catheter configured to fit within the outer catheter. The inner catheter has a series of expanding anchors extending from the outer surface of the inner catheter and a reentry channel configured to accommodate a second reentry device. A retaining wire extends along the upper surface of the expanding anchors. A reentry channel is located in the configured to accommodate a second reentry device.

Abstract: A device for crossing a lesion in a tissue lumen includes a crossing wire configured to pass through a lumen of a catheter, the crossing wire including a loop at a distal end of the crossing wire, the loop having a configuration that prevents a width of the loop from exceeding a width of the tissue lumen, and the loop having a leading portion configured to interrogate the lesion.

Abstract: A device for crossing a lesion in a tissue lumen includes a crossing wire configured to pass through a lumen of a catheter, the crossing wire including a loop at a distal end of the crossing wire. The loop can have a configuration that prevents a width of the loop from exceeding a width of the tissue lumen, and the loop having a pair of lateral opposing portions configured for alignment with a wall of the tissue lumen and a leading portion interconnecting the pair of lateral opposing portions, the leading portion being configured to interrogate the lesion. The loop has a length in an axial direction of the crossing wire extending from the leading portion to proximal ends of the pair of lateral opposing portions, the length being perpendicular to the width, and the length of the loop is at least twice the width of the loop.

Abstract: A device for crossing a lesion in a tissue lumen includes a crossing wire configured to pass through a lumen of a catheter, the crossing wire including a loop at a distal end of the crossing wire, the loop having a configuration that prevents a width of the loop from exceeding a width of the tissue lumen, and the loop having a leading portion configured to interrogate the lesion.

Abstract: A vascular access device includes a sheath body defining an outer surface and a lumen extending between a first end of the sheath body and a second end of the sheath body. The sheath body has a length of at most 7 cm. Further, the sheath body has a vessel opening defined through the first end in communication with the lumen and an access opening defined through the second end in communication with the lumen. A plurality of perfusion windows extend between and are open to the lumen and the outer surface of the sheath body, each of the plurality of perfusion windows being located within about 3 cm of the first end of the sheath body.

Abstract: A method of managing an access cite and site management device for an interventional cardiology access lumen having a cylindrical hub and a tubular portion extending from the cylindrical hub includes adhering an adhesive pad directly or indirectly to a patient at an intervention cardiology access site. After the adhering, an access lumen is deployed and a portion of the access lumen positioned against a retention pad that is supported by the adhesive pad. The retention pad has a surface configured to the portion of the access lumen.

Abstract: A device and method for delivering a drug from inside a body lumen to tissue surrounding the body lumen. An endoluminal drug delivery device includes a dual-lumen catheter for housing a guidewire and a needle connectable to a drug source. The guidewire exits the catheter through an opening at the distal end, and the needle exits the catheter through an exit port in the outer wall of the catheter. A distal portion of the catheter has a single lumen and includes a taper, allowing the distal tip to act as a dilator. The device optionally includes a catheter lumen splitter and/or a handpiece assembly. A method of delivering fluid to tissue surrounding a body lumen includes inserting a guidewire into the body lumen, tracking the device over the guidewire, deploying the needle through the exit port to the tissue, delivering fluid, and retracting the needle into the catheter.

Abstract: A device and method for delivering a drug from inside a body lumen to tissue surrounding the body lumen. An endoluminal drug delivery device includes a dual-lumen catheter for housing a guidewire and a needle connectable to a drug source. The guidewire exits the catheter through an opening at the distal end, and the needle exits the catheter through an exit port in the outer wall of the catheter. A distal portion of the catheter has a single lumen and includes a taper, allowing the distal tip to act as a dilator. The device optionally includes a catheter lumen splitter and/or a handpiece assembly. A method of delivering fluid to tissue surrounding a body lumen includes inserting a guidewire into the body lumen, tracking the device over the guidewire, deploying the needle through the exit port to the tissue, delivering fluid, and retracting the needle into the catheter.