Abstract: A fastening system and a deployment system for controlling translation and rotation of a deployment device are presented. A fastening system may comprise one or more components configured for arresting or restricting translation of a delivery catheter of a medical device, including a mitral valve fixation device such as the MitraClip®. A deployment system may comprise one or more components configured for locking rotation of a crimping cam to a slider to control deployment of a mitral valve fixation device.

Abstract: A tunable fixation device for fixation of heart valve leaflets includes a central assembly, an arm moveably coupled to the central assembly, and a gripping element moveable relative to the arm to capture a native leaflet therebetween. The arm has a body portion and a wire frame coupled to the body portion. The wire frame has a first and second wire segment, and an interconnection portion interconnecting the first and second wire segments. The interconnection portion is slidingly engaged with the body portion. The first wire segment is configured to deform upon force applied to the second wire segment by sliding movement of the interconnection portion relative to the body portion, and the second wire segment is configured to deform upon force applied to the first wire segment by sliding movement of the interconnection portion relative to the body portion.

Abstract: Medical device delivery system including a catheter, handle, lock line handle, and lock line. The catheter includes a proximal end portion and a distal end portion. The handle is coupled to the proximal end portion of the catheter. The lock line handle is releasably coupled to the handle and actuatable between a lock position and an unlock position. The lock line includes a first end portion fixedly coupled to the lock line handle, a second end portion releasably coupled to the lock line handle, and an intermediate portion configured to be releasably coupled to the medical implant disposed proximate the distal end portion of the catheter. Actuating the lock line handle from the lock position toward the unlock position increases tension on the lock line, and actuating the lock line handle from the unlock position toward the lock position decreases tension on the lock line.

Abstract: A transcatheter valve prosthesis including a tubular stent includes an interior skirt or skirt portion is coupled to and covers an inner circumferential surface of the stent, and an exterior skirt or skirt portion is coupled to and covers an outer circumferential surface of the stent. A prosthetic valve component is disposed within and secured to the interior skirt or skirt portion. The interior and exterior skirts or skirt portions may overlap to form a double layer of skirt material on the stent, or may be portions of a skirt that do not overlap such that only a single layer of skirt material covers the stent. When the stent is in at least the compressed configuration, at least one endmost crown may be positioned radially inwards with respect to the remaining endmost crowns formed at the inflow end of the stent in order to accommodate the exterior skirt.

Abstract: A transcatheter valve prosthesis including a tubular stent includes an interior skirt or skirt portion is coupled to and covers an inner circumferential surface of the stent, and an exterior skirt or skirt portion is coupled to and covers an outer circumferential surface of the stent. A prosthetic valve component is disposed within and secured to the interior skirt or skirt portion. The interior and exterior skirts or skirt portions may overlap to form a double layer of skirt material on the stent, or may be portions of a skirt that do not overlap such that only a single layer of skirt material covers the stent. When the stent is in at least the compressed configuration, at least one endmost crown may be positioned radially inwards with respect to the remaining endmost crowns formed at the inflow end of the stent in order to accommodate the exterior skirt.

Abstract: Medical device delivery system including a catheter, handle, lock line handle, and lock line. The catheter includes a proximal end portion and a distal end portion. The handle is coupled to the proximal end portion of the catheter. The lock line handle is releasably coupled to the handle and actuatable between a lock position and an unlock position. The lock line includes a first end portion fixedly coupled to the lock line handle, a second end portion releasably coupled to the lock line handle, and an intermediate portion configured to be releasably coupled to the medical implant disposed proximate the distal end portion of the catheter. Actuating the lock line handle from the lock position toward the unlock position increases tension on the lock line, and actuating the lock line handle from the unlock position toward the lock position decreases tension on the lock line.

Abstract: A method of preventing paravalvular leakage includes concurrent delivery of a heart valve prosthesis and an annular sealing component. During delivery, the sealing component is moved from a first position to a second position of the heart valve prosthesis which is longitudinally spaced apart from the first position of the heart valve prosthesis. The sealing component is secured around the heart valve prosthesis at the second position by a contoured outer surface of the heart valve prosthesis. The sealing component may be a flexible ring or may be a cylindrical flexible sleeve having a plurality of ribs longitudinally extending over the cylindrical sleeve. The ribs operate to deploy the sealing component such that at least a portion of the cylindrical sleeve buckles outwardly away from the outer surface of the heart valve prosthesis.

Abstract: Medical device delivery system including a catheter, handle, lock line handle, and lock line. The catheter includes a proximal end portion and a distal end portion. The handle is coupled to the proximal end portion of the catheter. The lock line handle is releasably coupled to the handle and actuatable between a lock position and an unlock position. The lock line includes a first end portion fixedly coupled to the lock line handle, a second end portion releasably coupled to the lock line handle, and an intermediate portion configured to be releasably coupled to the medical implant disposed proximate the distal end portion of the catheter. Actuating the lock line handle from the lock position toward the unlock position increases tension on the lock line, and actuating the lock line handle from the unlock position toward the lock position decreases tension on the lock line.

Abstract: A transcatheter valve prosthesis including a tubular stent includes an interior skirt or skirt portion is coupled to and covers an inner circumferential surface of the stent, and an exterior skirt or skirt portion is coupled to and covers an outer circumferential surface of the stent. A prosthetic valve component is disposed within and secured to the interior skirt or skirt portion. The interior and exterior skirts or skirt portions may overlap to form a double layer of skirt material on the stent, or may be portions of a skirt that do not overlap such that only a single layer of skirt material covers the stent. When the stent is in at least the compressed configuration, at least one endmost crown may be positioned radially inwards with respect to the remaining endmost crowns formed at the inflow end of the stent in order to accommodate the exterior skirt.

Abstract: A transcatheter valve prosthesis including a tubular stent includes an interior skirt or skirt portion is coupled to and covers an inner circumferential surface of the stent, and an exterior skirt or skirt portion is coupled to and covers an outer circumferential surface of the stent. A prosthetic valve component is disposed within and secured to the interior skirt or skirt portion. The interior and exterior skirts or skirt portions may overlap to form a double layer of skirt material on the stent, or may be portions of a skirt that do not overlap such that only a single layer of skirt material covers the stent. When the stent is in at least the compressed configuration, at least one endmost crown may be positioned radially inwards with respect to the remaining endmost crowns formed at the inflow end of the stent in order to accommodate the exterior skirt.

Abstract: A transcatheter valve prosthesis including a tubular stent includes an interior skirt or skirt portion is coupled to and covers an inner circumferential surface of the stent, and an exterior skirt or skirt portion is coupled to and covers an outer circumferential surface of the stent. A prosthetic valve component is disposed within and secured to the interior skirt or skirt portion. The interior and exterior skirts or skirt portions may overlap to form a double layer of skirt material on the stent, or may be portions of a skirt that do not overlap such that only a single layer of skirt material covers the stent. When the stent is in at least the compressed configuration, at least one endmost crown may be positioned radially inwards with respect to the remaining endmost crowns formed at the inflow end of the stent in order to accommodate the exterior skirt.

Abstract: A piping component comprising a pipe member comprising a body section, a proximal section having a proximal opening, and a distal section having a distal opening, wherein the proximal and distal openings are in communication with one another to permit fluid to flow through the body section. The piping component further comprises a barrel valve adapted to be positioned at least partially within the body section comprising a barrel member and a rotation member connected to the barrel member. A bore is formed In the barrel member, When the barrel member is in a first orientation, the bore is aligned to permit fluid flow through the body section. When the barrel member is in a second orientation, the bore is aligned to prevent fluid flow through the body section.

Abstract: Devices and methods for delivering a sealing element post-implantation of valve prosthesis that functions to occlude or fill gaps present between the valve prosthesis and the native valve tissue, thereby reducing, minimizing, or eliminating leaks there through. In a first method, an injectable material is placed within a native valve sinus to form a sealing element that presses native valve leaflets against an outer surface of a heart valve prosthesis. In a second method, an injectable sealing material or a preformed annular sealing component is positioned between the outer surface or perimeter of a heart valve prosthesis and native heart valve tissue. In a third method, a preformed sealing element or component is placed within a heart valve prosthesis to press the prosthesis against native valve tissue.

Abstract: A valve prosthesis includes one or more anti-paravalvular leakage components coupled to a stent. The anti-paravalvular leakage component may encircle the stent and include a radially expandable control ring coupled to an unattached edge of a flexible skirt which extends the unattached skirt edge outwardly away from the stent and against the native heart valve to form an open-ended annular pocket around the stent. The anti-paravalvular leakage component may encircle the perimeter of the stent and include a flexible skirt having opposing edges coupled to the stent to form one or more enclosed compartments around the stent. Each compartment includes a one-way valve which allows for blood flow into the compartment but prevents blood flow out of the compartment. The anti-paravalvular leakage component may be at least one flap that is coupled to an inner surface of the stent and formed of a flexible material moveable by blood flow.

Abstract: A method of preventing paravalvular leakage includes concurrent delivery of a heart valve prosthesis and an annular sealing component. During delivery, the sealing component is moved from a first position to a second position of the heart valve prosthesis which is longitudinally spaced apart from the first position of the heart valve prosthesis. The sealing component is secured around the heart valve prosthesis at the second position by a contoured outer surface of the heart valve prosthesis. The sealing component may be a flexible ring or may be a cylindrical flexible sleeve having a plurality of ribs longitudinally extending over the cylindrical sleeve. The ribs operate to deploy the sealing component such that at least a portion of the cylindrical sleeve buckles outwardly away from the outer surface of the heart valve prosthesis.

Abstract: A valve prosthesis includes one or more anti-paravalvular leakage components coupled to a stent. The anti-paravalvular leakage component may encircle the stent and include a radially expandable control ring coupled to an unattached edge of a flexible skirt which extends the unattached skirt edge outwardly away from the stent and against the native heart valve to form an open-ended annular pocket around the stent. The anti-paravalvular leakage component may encircle the perimeter of the stent and include a flexible skirt having opposing edges coupled to the stent to form one or more enclosed compartments around the stent. Each compartment includes a one-way valve which allows for blood flow into the compartment but prevents blood flow out of the compartment. The anti-paravalvular leakage component may be at least one flap that is coupled to an inner surface of the stent and formed of a flexible material moveable by blood flow.

Abstract: Devices and methods for delivering a sealing element post-implantation of valve prosthesis that functions to occlude or fill gaps present between the valve prosthesis and the native valve tissue, thereby reducing, minimizing, or eliminating leaks there through. In a first method, an injectable material is placed within a native valve sinus to form a sealing element that presses native valve leaflets against an outer surface of a heart valve prosthesis. In a second method, an injectable sealing material or a preformed annular sealing component is positioned between the outer surface or perimeter of a heart valve prosthesis and native heart valve tissue. In a third method, a preformed sealing element or component is placed within a heart valve prosthesis to press the prosthesis against native valve tissue.

Abstract: The present invention is a data processing system and method for analyzing billing indices regarding billed telecommunications items. The system includes a data input mechanism for receiving the telecommunications bills; a database of pre-determined billing indices; a processor configured to compare the billed indices from the telecommunications bill against of the pre-determined indices, identify billing discrepancies, and generate deprovision requests and billing disputes based upon the billing discrepancies; and data output mechanisms for transmitting the deprovision requests and the billing disputes. The system and method also determines and corrects errors in the database of pre-determined billing indices, and identifies and accrues installed telecommunication components that are not included as the billed telecommunication items.