Abstract: Intravascular delivery systems, devices, and methods are disclosed herein. A representative delivery device can include an inner shaft defining a lumen extending along a length of the delivery device, an outer shaft surrounding the inner shaft along at least a portion of the length of the delivery device, and a tip portion distal to the outer shaft. The inner shaft can include a recess configured to receive a self-expandable implant. The outer shaft can be retractable relative to the inner shaft, and can include a functional member that provides increased tensile strength to the outer shaft, and a coil. The tip portion can extend to a distal terminus of the delivery device and include a cross-sectional dimension that tapers in a distal direction.

Abstract: Described herein are devices and methods for determining or administering a therapy to a patient. Devices and methods described herein are configured in different embodiments to carry out different types of treatments in different healthcare settings. In some embodiments, the devices and methods described herein use advanced analytics to administer a therapy to a patient.

Abstract: Systems and methods for treatment of tricuspid valve disease. The systems and methods can anchor a supplemental valve apparatus in the vena cavae and provide a competent valve positioned in the right atrium or in or through the tricuspid annulus without requiring an anchor in the tricuspid annulus. The supplemental valve apparatus can include a supplemental valve coupled to at least one supplemental valve structure, which can extend into at least one of the inferior vena cava or superior vena cava with the supplemental valve positioned in or adjacent the right atrium. The valve apparatus can be delivered percutaneously by a delivery system, which can include the supplement valve apparatus positioned between an inner and outer shaft that can be retracted to deploy the supplemental valve apparatus in or adjacent the right atrium. Methods of delivery and treating a tricuspid valve by a supplement valve apparatus are also described herein.

Abstract: A stent assembly for implantation into a blood vessel includes an inlet zone having at least one inlet stent structure, wherein the inlet stent structure is self-expanding and has an inlet radial force configured to conform to a non-circular cross-sectional shape of the vessel at least substantially. The stent assembly also includes a patency zone having at least one patency stent structure located distal of the inlet stent structure, wherein the patency stent structure is self-expanding and has a patency radial force greater than the inlet radial force, and wherein the patency stent structure is coupled to the inlet stent structure such that the inlet stent structure is configured to be positioned upstream from a narrowing along the blood vessel and the patency stent structure is configured to be positioned at the narrowing of the blood vessel.

Abstract: Described herein are devices and methods for determining or administering a therapy to a patient. Devices and methods described herein are configured in different embodiments to carry out different types of treatments in different healthcare settings. In some embodiments, the devices and methods described herein use advanced analytics to administer a therapy to a patient.

Abstract: Apparatus for transporting particles through a patient's trachea into the respiratory system include a delivery tube having at least a ventilation lumen and a particle delivery lumen. The delivery tube has a centering device near its distal tip, such as a balloon eccentrically mounted on the tube to position an outlet of the particle delivery lumen near a centerline of the trachea above the carina branching into the right and left bronchus. A proximal end of the delivery tube connects to a source of particles, and a controller may be provided to adjust a rate and/or an amount of the particles delivered to the patient. In a specific example, frozen particles are delivered to control core body temperature. In other instances, the particle may be a medicament or other substance for effecting other therapies or diagnostic procedures.

Abstract: Disclosed are methods and devices for restoring patency across a vascular or non-vascular occlusion. A first catheter having a first side port is configured to advance in a first direction through a vessel from a vascular access site on a first side of the occlusion. A second catheter having a second side port is configured to advance in a second direction through the vessel from a vascular access site on a second side of the occlusion. The catheters may have complementary surface configurations to facilitate alignment of the first and second side ports, so that a wire may be passed through the catheters, out of one of the side ports and into the other side port, to bypass the occlusion.

Abstract: Disclosed are methods and systems for restoring patency across a vascular or non-vascular occlusion. The system may include a retrograde catheter, having a proximal end, a distal end, a first central lumen and a first side port spaced proximally apart from the distal end, the first central lumen extending at least as far as the first side port. An antegrade catheter is also provided, having a proximal end, a distal end, a second central lumen in communication with a second side port spaced proximally apart from the distal end. The catheters may have complementary surface configurations to facilitate alignment of the first and second side ports, so that a wire may be passed out of one of the side ports and into the other side port.

Abstract: Disclosed are methods and devices for bidirectional crossing of a vascular obstruction in a patient. The method includes the steps of advancing a first catheter transvascularly in a first (e.g., retrograde) direction towards a vascular obstruction, the first catheter having a first central lumen in communication with a first side port. A second catheter is advanced transvascularly in a second, opposite (e.g., antegrade) direction towards the obstruction, the second catheter having a second central lumen in communication with a second side port. The first and second side ports are aligned to place the first central lumen in communication with the second central lumen; and a wire is advanced through the first and second side ports such that a first end of the wire is on a first side of the obstruction and a second end of the wire is on a second side of the obstruction.

Abstract: Apparatus and methods for creating tissue necrosis include an energy delivery apparatus that can be positioned adjacent a target treatment site such as a vessel without direct contact with the treatment site tissue. Collimated energy is then directed to the vessel to create necrotic regions in the tissue. Exemplary use in renal vessels creates necrotic regions in adjacent nerves which can alleviate hypertension in a patient.

Abstract: Apparatus for transporting particles through a patient's trachea into the respiratory system include a delivery tube having at least a ventilation lumen and a particle delivery lumen. The delivery tube has a centering device near its distal tip, such as a balloon eccentrically mounted on the tube to position an outlet of the particle delivery lumen near a centerline of the trachea above the carina branching into the right and left bronchus. A proximal end of the delivery tube connects to a source of particles, and a controller may be provided to adjust a rate and/or an amount of the particles delivered to the patient. In a specific example, frozen particles are delivered to control core body temperature. In other instances, the particle may be a medicament or other substance for effecting other therapies or diagnostic procedures.

Abstract: Apparatus and methods for creating tissue necrosis include an energy delivery apparatus that can be positioned adjacent a target treatment site such as a vessel without direct contact with the treatment site tissue. Collimated energy is then directed to the vessel to create necrotic regions in the tissue. Exemplary use in renal vessels creates necrotic regions in adjacent nerves which can alleviate hypertension in a patient.

Abstract: Apparatus and methods for creating tissue necrosis include an energy delivery apparatus that can be positioned adjacent a target treatment site such as a vessel without direct contact with the treatment site tissue. Collimated energy is then directed to the vessel to create necrotic regions in the tissue. Exemplary use in renal vessels creates necrotic regions in adjacent nerves which can alleviate hypertension in a patient.

Abstract: Tissue ablation systems and methods for creating ablation zones in tissue comprises locating a target tissue and positioning an interventional catheter adjacent the target tissue. The interventional catheter has an energy source. Collateral tissue adjacent the target tissue is located. The target tissue is ablated with energy from the energy source so as to form a continuous lesion or region of ablation in the target tissue. The ablating is conducted so as to minimize ablating or otherwise damaging the collateral tissue and to increase the likelihood of procedure success.

Abstract: Apparatus and methods for creating tissue necrosis include an energy delivery apparatus that can be positioned adjacent a target treatment site such as a vessel without direct contact with the treatment site tissue. Collimated energy is then directed to the vessel to create necrotic regions in the tissue. Exemplary use in renal vessels creates necrotic regions in adjacent nerves which can alleviate hypertension in a patient.

Abstract: Apparatuses and methods for the prevention, reduction, or elimination of tissue injury by the application of electromagnetic energy. The apparatuses and methods have application for use in various tissues within diverse regions of the body, including for the prevention, reduction, or elimination of acute kidney injury, kidney failure, and contrast-induced nephropathy.

Abstract: Systems and methods for enhancing diagnostic imaging by the means of increasing tissue perfusion and/or vasodilation, and thus, increasing imaging agent perfusion distribution and/or imaging agent uptake by tissue. The desired effects can be achieved by exposing the area of interest to ultrasound either before or after image acquisition, or in between multiple image acquisitions.

Abstract: Systems and methods apply audible acoustic energy to cause vasodilation and/or to increase tissue perfusion.

Abstract: Systems and methods monitor and enable the use of a medical instrument that is configured to be operated in a prescribed manner. The systems and methods employ a use register sized and configured to be carried by the medical instrument, which comprises a memory field for recording a start date and time at an instance of first operation of the medical instrument. The systems and methods also employ a use monitoring controller, which is adapted and configured to be coupled to the use register. The use monitoring controller includes a start validation function that compares the start date and time to a present real date and time and provides a start validation output based upon the comparison. The use monitoring controller also includes an enablement function that enables operation of the medical instrument only if the start validation output meets prescribed criteria.

Abstract: An applicator for delivering ultrasound energy that comprises an ultrasound transducer adapted and configured to be electrically coupled to an ultrasound generator. A housing carries the ultrasound transducer for use. An element supports the transducer within the housing. The element includes an elastic material having a hardness of about 30 Shore A to about 100 Shore A.