Abstract: A device for regulating blood pressure between a patient's left atrium and right atrium comprises an hourglass-shaped stent comprising a neck region and first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the fossa ovalis of the patient's atrial septum; and a one-way tissue valve coupled to the first flared end region and configured to shunt blood from the left atrium to the right atrium when blood pressure in the left atrium exceeds blood pressure in the right atrium. The inventive device may include a biodegradable material that biodegrades to offset flow changes caused by tissue ingrowth. The inventive device may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits.

Abstract: Various systems and methods are provided for reducing pressure at an outflow of a duct such as the thoracic duct or the lymphatic duct. In one embodiment, an indwelling catheter can be configured to be at least partially implanted within a vein of a patient in the vicinity of an outflow port of a duct of the lymphatic system. The catheter can include first and second restrictors each configured to at least partially occlude the vein within which the catheter is implanted and thus to restrict fluid flow within the vein when the restrictors are activated. The restrictors can each be configured to move between an activated configuration, in which the restrictor occludes the vein, and a relaxed configuration, in which the restrictor does not occlude the vein. The catheter can include a pump, such as an axial motor pump, configured to pump fluid through the catheter.

Abstract: A delivery system that includes a catheter, a balloon, a self-expanding prosthesis, and a sheath. The sheath including an opening in a wall of the sheath that initiates rupturing of the sheath so that the self-expanding prosthesis may move from its compressed state to its expanded state. Additionally, a distal end portion of the balloon that is distal to a distal end of the sheath includes an enlarged diameter portion, the enlarged diameter portion having approximately the same outer diameter as an outer diameter of the sheath when the self-expanding prosthesis is in its compressed state, and the enlarged diameter portion being the maximum outer diameter of the balloon when the self-expanding prosthesis is in its compressed state.

Abstract: Various systems and methods are provided for treating pulmonary edema. In general, a pump can be configured to be implanted within a patient at risk of developing edema. The pump can be configured to pump fluid out of the patient's lungs, e.g., out of the patient's interstitial and alveolar spaces. The pump can be configured to be fully implanted within the patient's body. The pump can be configured to continuously pump fluid, or the pump can be configured to be selectively actuatable in response to a trigger event. In an exemplary embodiment, the pump can include an inflow port coupled to an inflow tube in fluid communication with a lymphatic vessel of the patient, and can include an outflow port coupled to an outflow tube in fluid communication with a vein of the patient.

Abstract: Systems, methods, and devices are provided for the treatment of edema. In one aspect a method for implanting an indwelling catheter within a vein of a patient is provided. The catheter can extend from a position upstream of at least one outflow port of a duct of the lymph system to a terminal position downstream of the at least one outflow port. In use, a first restriction can be created within the vein proximal to a distal region of the catheter. The first restriction can define a localized low pressure zone distal of the restriction and within a portion of the vein housing the catheter. The low pressure zone can be adjacent to the at least one outflow port to enable fluid to pass from the at least one lymph duct outflow port into the vein.

Abstract: A delivery system for a self-expandable prosthesis includes a catheter having a distal portion and a proximal portion, a balloon portion positioned on the distal portion, and a self expanding medical device positioned about the balloon portion. The medical device has a compressed state and an expanded state. A sheath couples the medical device in its compressed state about the balloon portion and has only a single opening in a wall of the sheath. When the balloon is expanded, the sheath is configured to (i) first rupture at the single opening, thereby allowing the medical device to self-expand and engage an inner wall of a vessel, and (ii) controllably continue the rupturing from the single opening to the proximal end of sheath, thereby allowing the medical device to expand to its expanded state and a portion of the medical device to engage an inner wall of the vessel.

Abstract: A device for regulating blood pressure between a patient's left atrium and right atrium comprises an hourglass-shaped stent comprising a neck region and first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the fossa ovalis of the patient's atrial septum; and a one-way tissue valve coupled to the first flared end region and configured to shunt blood from the left atrium to the right atrium when blood pressure in the left atrium exceeds blood pressure in the right atrium. The inventive devices may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits. The inventive devices may be used, for example, to treat subjects having heart failure, pulmonary congestion, or myocardial infarction, among other pathologies.

Abstract: A device for regulating blood pressure between a patient's left atrium and right atrium comprises an hourglass-shaped stent comprising a neck region and first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the fossa ovalis of the patient's atrial septum; and a one-way tissue valve coupled to the first flared end region and configured to shunt blood from the left atrium to the right atrium when blood pressure in the left atrium exceeds blood pressure in the right atrium. The inventive devices may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits. The inventive devices may be used, for example, to treat subjects having heart failure, pulmonary congestion, or myocardial infarction, among other pathologies.

Abstract: A device for regulating blood pressure between a patient's left atrium and right atrium, and apparatus for delivery the device, are provided. The delivery apparatus may include one or more latching legs, a release ring, a pull chord, and a catheter wherein the latching legs are configured to engage the device for delivery. The inventive devices may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits. The inventive devices may be used, for example, to treat subjects having heart failure, pulmonary congestion, or myocardial infarction, among other pathologies.

Abstract: A device for regulating blood pressure between a patient's left atrium and right atrium comprises an hourglass-shaped stent comprising a neck region and first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the fossa ovalis of the patient's atrial septum; and a one-way tissue valve coupled to the first flared end region and configured to shunt blood from the left atrium to the right atrium when blood pressure in the left atrium exceeds blood pressure in the right atrium. The inventive device may include a biodegradable material that biodegrades to offset flow changes caused by tissue ingrowth. The inventive device may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits.

Abstract: A device for regulating blood pressure between a patient's left atrium and right atrium comprises an hourglass-shaped stent comprising a neck region and first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the fossa ovalis of the patient's atrial septum; and a one-way tissue valve coupled to the first flared end region and configured to shunt blood from the left atrium to the right atrium when blood pressure in the left atrium exceeds blood pressure in the right atrium. The inventive devices may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits. The inventive devices may be used, for example, to treat subjects having heart failure, pulmonary congestion, or myocardial infarction, among other pathologies.

Abstract: A delivery system for delivering a stent to a bifurcation in a vessel. The delivery system includes two guidewire lumens for directed the stent through the anatomy to the bifurcation. A main branch guidewire lumen has entry and exit ports that are positioned in order to limit how far the delivery system will be allowed into a side branch vessel. The orientation of the main branch guidewire lumen causes the delivery system to bind on the main branch guidewire as the system is positioned in the side branch. The location of the main branch guidewire lumen openings will physically limit the distance into the side branch that the stent will be placed.

Abstract: A delivery system for a self-expandable prosthesis includes a catheter having a distal end and a proximal end, a balloon positioned on the distal end of the catheter, a self-expandable prosthesis positioned on the balloon, and a sheath at least partially surrounding the self-expandable prosthesis. Upon inflation of the balloon, the sheath opens in a controllable manner, allowing the self-expandable prosthesis to be released. The sheath is either removed from the vessel or allowed to remain in the vessel.