Abstract: Implants and methods for treating diseased heart valves. The implants may include a support member configured for placement near the diseased valve and an anchoring system coupled to the support member. The support member may be used to treat regurgitation and/or support a valve replacement therein. The support member may have an annular shape with an opening configured to generally align with an opening of the diseased valve. In some examples, the support member includes a coaptation structure configured to seal with the native leaflets. The anchoring system may include one or more tethers anchored to tissue of a ventricle, such as a ventricle wall and/or a papillary muscle. In some examples, sufficient tension is applied on the tethers to stabilize or reduce ventricle dilation.

Abstract: A device for treating a diseased native valve in a patient includes a frame structure and a valve segment coupled to the frame structure. The frame structure has an unexpanded configuration and an expanded configuration. The valve segment has a plurality of leaflets, a seal, and a seal support. An inflow edge of the plurality of leaflets is unsupported by the frame structure. The seal is attached to the inflow edge of the plurality of leaflets and positioned radially between the frame structure and the plurality of leaflets. The seal support is attached to or within the seal and provides axial rigidity to the seal.

Abstract: A blood flow control device having a catheter adapted to be advanced into a blood vessel to a blood flow control site within the blood vessel; an expandable anchor supported by the catheter, the expandable anchor being adapted to expand to engage a wall of the blood vessel, the expandable anchor having a blood impermeable wall defining an adjustable blood flow path extending through the expandable anchor from a proximal opening to a distal opening, the catheter being disposed outside of the adjustable blood flow path; a flow control element supported by the catheter, the flow control element being adapted to change a dimension of the adjustable blood flow path to change a rate of blood flow through the blood flow path; and a blood flow control actuator disposed at a proximal section of the catheter and adapted to actuate the flow control element.

Abstract: Methods and apparatuses for pumping blood within a blood vessel are described. The methods and apparatuses can be used for renal decongestion by pumping blood through the kidney(s), thereby increasing a pressure gradient across the kidney(s). The apparatuses can include one or more inflatable elements that can be repeatedly inflated and deflated to cause a pumping action within the blood vessel. In some embodiments, the one or more inflatable elements are positioned within one or more stents.

Abstract: A delivery system for an interventional device includes an elongate catheter body, a catheter shaft extending within the elongate catheter body and configured to releasably attach to the interventional device, and at least one flexible element attached to a distal portion of the catheter shaft. The at least one flexible element has an expanded configuration in which the at least one flexible element extends beyond an outer circumference of the elongate catheter body and a collapsed configuration in which the at least one flexible element collapses within an inner circumference of the elongate catheter body. The at least one flexible element is configured to act as a tactile stop when pulled proximally against the elongate catheter body and/or to fold over the interventional device to act as a retraction aid.

Abstract: Methods and apparatuses for pumping blood within a blood vessel are described. The methods and apparatuses can be used for renal decongestion by pumping blood through the kidney(s), thereby increasing a pressure gradient across the kidney(s). The apparatuses can include one or more inflatable elements that can be repeatedly inflated and deflated to cause a pumping action within the blood vessel. In some embodiments, the one or more inflatable elements are positioned within one or more stents.

Abstract: A blood flow control device having a catheter adapted to be advanced into a blood vessel to a blood flow control site within the blood vessel; an expandable anchor supported by the catheter, the expandable anchor being adapted to expand to engage a wall of the blood vessel, the expandable anchor having a blood impermeable wall defining an adjustable blood flow path extending through the expandable anchor from a proximal opening to a distal opening, the catheter being disposed outside of the adjustable blood flow path; a flow control element supported by the catheter, the flow control element being adapted to change a dimension of the adjustable blood flow path to change a rate of blood flow through the blood flow path; and a blood flow control actuator disposed at a proximal section of the catheter and adapted to actuate the flow control element.

Abstract: A blood flow control device having a catheter adapted to be advanced into a blood vessel to a blood flow control site within the blood vessel; an expandable anchor supported by the catheter, the expandable anchor being adapted to expand to engage a wall of the blood vessel, the expandable anchor having a blood impermeable wall defining an adjustable blood flow path extending through the expandable anchor from a proximal opening to a distal opening, the catheter being disposed outside of the adjustable blood flow path; a flow control element supported by the catheter, the flow control element being adapted to change a dimension of the adjustable blood flow path to change a rate of blood flow through the blood flow path; and a blood flow control actuator disposed at a proximal section of the catheter and adapted to actuate the flow control element.

Abstract: Methods and apparatuses for pumping blood within a blood vessel are described. The methods and apparatuses are can be used for renal decongestion by pumping blood through the kidney(s), thereby increasing a pressure gradient across the kidney(s). The apparatuses can include one or more inflatable elements that can be repeatedly inflated and deflated to cause a pumping action within the blood vessel. In some embodiments, the one or more inflatable elements are positioned within one or more stents.

Abstract: A delivery system for an interventional device includes an elongate catheter body, a catheter shaft extending within the elongate catheter body and configured to releasably attach to the interventional device, and at least one flexible element attached to a distal portion of the catheter shaft. The at least one flexible element has an expanded configuration in which the at least one flexible element extends beyond an outer circumference of the elongate catheter body and a collapsed configuration in which the at least one flexible element collapses within an inner circumference of the elongate catheter body. The at least one flexible element is configured to act as a tactile stop when pulled proximally against the elongate catheter body and/or to fold over the interventional device to act as a retraction aid.

Abstract: A delivery system including a restraining member maintains a collapsed implant in its collapsed state for delivery through a small passageway to a desired site in a mammalian body. Once the implant is positioned at the desired site, the restraining member is released so that the stent may expand or be expanded to its expanded state. In a preferred embodiment, the restraining member comprises a sheet of material that surrounds at least a portion of the collapsed stent. Portions of the restraining member are releasably coupled to one another with a low profile thread-like member or suture.

Abstract: A stent-graft including a stent member having an inner surface and an outer surface, a generally tubular graft member and a coupling member that couples the stent member to the graft member. The coupling member, which is the preferred embodiment is in the form of a ribbon, covers only a portion of the inner or outer surface of the stent member and secures the stent member and graft member to one another. Alternatively, the coupling member can be described as interconnecting less than entirely the inner or outer surface of the graft member to the stent member. With this construction, regions of the stent member do not interfere with the coupling member. Shear stresses between the stent member and the coupling member and the risk of tearing the graft or coupling member or delamination therebetween may be reduced as compared to a fully enveloped stent member. This construction also provides improved flexibility and kink resistance.

Abstract: The invention relates to an endoluminal prosthesis adapted for placement at a bifurcation site within the body. The stent or stent-graft may be constructed to have segments of differing structural properties. A section of the stent-graft may be constructed to have a single-lumen tubular stent member covering a multilumen graft member. The stent-graft may comprise at least two modular components adapted for in situ assembly. An extended cylindrical interference fit may be used to seal the modular components.

Abstract: The invention consists of an endoluminal prosthesis adapted for placement at a bifurcation site within the body. The stent or stent-graft may be constructed to have segments of differing structural properties. A section of the stent-graft may be constructed to have a single-lumen tubular stent member covering a multilumen graft member. The stent-graft may comprise at least two modular components adapted for in situ assembly. An extended cylindrical interference fit may be used to seal the modular components.

Abstract: Devices, systems, methods and kits are provided for endoscopically accessing a body cavity and providing a directed pathway toward a target tissue within the cavity. The directed pathway is provided by a multi-catheter guiding system which is positioned in a desired configuration, generally directed toward the target tissue. Interventional devices may then be passed through the guiding system to the target tissue. Depending on the location of the target tissue and the desired angle of approach, the guiding system may be required to maintain one or more curves in one or more planes to properly direct the interventional devices. The multi-catheter guiding system of the present invention comprises an outer guiding catheter and a coaxially positioned inner guiding catheter, each of which independently form curvatures so that together the curves properly direct the interventional device.

Abstract: Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.

Abstract: Disclosed are methods, systems, and devices for the endovascular repair of cardiac valves, particularly the atrioventricular valves which inhibit back flow of blood from a heart ventricle during contraction. The procedures described herein can be performed with interventional tools, guides and supporting catheters and other equipment introduced to the heart chambers from the patient's arterial or venous vasculature remote from the heart. The interventional tools and other equipment may be introduced percutaneously or may be introduced via a surgical cut down, and then advanced from the remote access site through the vasculature until they reach the heart.

Abstract: The present invention provides apparatuses, systems, methods and kits for fastening sutures or similar devices used in medical surgical procedures. In particular, the present invention is suitable for use with percutaneous or minimally invasive procedures in which sutures are placed with catheter-based devices wherein the tying of knots is particularly challenging. Suture fasteners of the present invention provide for fastening the sutures together in a fixed position at any location along the suture strands. In addition, the fasteners are adjustable to allow repositioning of the fastener after placement to a new desired location along the suture strands. Similarly, such fasteners may be used to hold a single suture strand for various applications.

Abstract: A stent-graft including a stent member having an inner surface and an outer surface, a generally tubular graft member and a coupling member that couples the stent member to the graft member. The coupling member, which is the preferred embodiment is in the form of a ribbon, covers only a portion of the inner or outer surface of the stent member and secures the stent member and graft member to one another. Alternatively, the coupling member can be described as interconnecting less than entirely the inner or outer surface of the graft member to the stent member. With this construction, regions of the stent member do not interfere with the coupling member. Shear stresses between the stent member and the coupling member and the risk of tearing the graft or coupling member or delamination therebetween may be reduced as compared to a fully enveloped stent member. This construction also provides improved flexibility and kink resistance.

Abstract: The invention consists of an endoluminal prosthesis adapted for placement at a bifurcation site within the body. The stent or stent-graft may be constructed to have segments of differing structural properties. A section of the stent-graft may be constructed to have a single-lumen tubular stent member covering a multilumen graft member. The stent-graft may comprise at least two modular components adapted for in situ assembly. An extended cylindrical interference fit may be used to seal the modular components.