Abstract: An implant and method for repairing and/or replacing functionality of a native mitral valve are in various embodiments configured to reduce or eliminate mitral regurgitation and residual mitral valve leakage. A coiled anchor can be used to implant a prosthetic valve in a native mitral valve of a heart. The coiled anchor can include a first turn, a second turn, and a third turn. The coiled anchor is configured to be implanted at the native mitral valve with the second turn and the third turn positioned in a left ventricle of the heart and around the valve leaflets of the native mitral valve. The first turn is positioned in a left atrium of the heart such that the first turn is spaced apart from the native mitral valve. The coiled anchor is configured for positioning such that the first turn is the sole turn of the coiled anchor positioned in the left atrium.

Abstract: The present disclosure provides medical devices, systems and methods and in particular to devices and methods useful for anchoring graft materials to bodily structures.

Abstract: Devices, systems and methods to position a prosthetic heart valve such that the prosthetic valve does not compress conduction tissue and thereby produce heart block. Guide devices promote positioning the prosthetic valve within a native aortic valve to avoid the conduction tissue and, optionally, to center the prosthetic valve within the native heart valve. Prosthetic valves include one or more cut-outs, openings or recesses configured to align with the conduction tissue so that the conduction tissue is not contacted in a way that would lead to higher incidents of complete heart block.

Abstract: A method of operating a counterpulsation device (CPD) in a human or animal subject is disclosed, the method including: receiving a heart beat signal indicative of the heart beat of the subject; providing counterpulsation therapy by controlling the pressure supplied to a CPD drive line in pneumatic communication with the CPD to cause the CPD to alternately fill with blood and eject blood with a timing that is determined at least in part based on the heart beat signal; while providing counterpulsation therapy, receiving a CPD drive line pressure signal indicative of the pressure in the CPD drive line; and adjusting the pressure supplied to the drive line based at least in part on the drive line pressure signal.

Abstract: A coiled anchor is positioned at a mitral valve by extending and deflecting a catheter such that a distal end portion of the catheter has a curved shape that is disposed in a left atrium and a distal end of the catheter is positioned near a commissure of the mitral valve. A ventricular portion of the coiled anchor is advanced from the catheter under the mitral valve at the commissure and into a left ventricle. An atrial portion of the coiled anchor is deployed in the left atrium by retracting the catheter off the atrial portion of the coiled anchor while maintaining the position of the ventricular portion of the coiled anchor in the left ventricle.

Abstract: A method includes coupling, at least temporarily, a support member adjacent to a target tissue. The support member is configured to support the target tissue and to define a path along which a cutting device can move. The method includes moving the cutting device along the path defined by the support member to cut and/or dilate the target tissue. In some embodiments, the method optionally includes disposing a cannula of a device within the cut defined in target tissue. The cannula is coupled to the target tissue such that a lumen defined by the cannula is in fluid communication with a volume defined at least in part by the target tissue.

Abstract: An implant and method for repairing and/or replacing functionality of a native mitral valve are in various embodiments configured to reduce or eliminate mitral regurgitation and residual mitral valve leakage. A coiled anchor with a central turn that reduces in size upon implantation is used to approximate the amount of reduction in the size and the reshaping of the native mitral annulus to reduce valve leakage. A clip can be further applied to the native valve leaflets to reduce the size of the native mitral annulus and leakage therethrough. A prosthetic heart valve can be implanted in the coiled anchor to replace and further improve functionality of the valve. In some cases, the prosthetic valve can be implanted in a clipped valve, where the clip is detached from one of the native valve leaflets to provide space for the prosthetic valve to expand.

Abstract: Methods, devices and systems for anchoring and/or sealing a heart valve prosthesis and, in particular, a mitral valve prosthesis (202). Inflatable elements (204, 206) are used to seal and anchor the mitral valve prosthesis (202) and/or other elements associated with repairing a native mitral valve.

Abstract: A system including an anchor for docking a prosthetic valve at a native valve of a heart can have a first end, a second end, and a central axis extending between the first and second ends, and defines an inner space coaxial with the central axis. The valve prosthesis can include a protective layer or annular ring that surrounds a bottom edge of the second frame end. The protective layer or annular ring can include two layers, and the two layers can be different materials.

Abstract: A method of operating a counterpulsation device (CPD) in a human or animal subject is disclosed, the method including: receiving a heart beat signal indicative of the heart beat of the subject; providing counterpulsation therapy by controlling the pressure supplied to a CPD drive line in pneumatic communication with the CPD to cause the CPD to alternately fill with blood and eject blood with a timing that is determined at least in part based on the heart beat signal; while providing counterpulsation therapy, receiving a CPD drive line pressure signal indicative of the pressure in the CPD drive line; and adjusting the pressure supplied to the drive line based at least in part on the drive line pressure signal.

Abstract: The present disclosure provides medical devices, systems and methods and in particular to devices and methods useful for anchoring graft materials to bodily structures.

Abstract: Systems, devices and methods for securing tissue including the annulus of a mitral valve. The systems, devices and methods may employ catheter based techniques and devices to plicate tissue and perform an annuloplasty.

Abstract: Various systems, devices and methods associated with the placement of a dock or anchor for a prosthetic valve. The anchor can take the form of an anchor having multiple coils. The distal end portion of the anchor can be spaced radially outwardly from the next adjacent coil to help direct the anchor around native leaflets of a native valve. Various methods include different procedures for delivering the anchor and prosthetic valve.

Abstract: Various systems, devices and methods associated with the placement of a dock or anchor (72) for a prosthetic valve (120). The anchor (72) may take the form of a helical anchor having multiple coils (104, 108) and/or a stent-like structure. Various methods include different levels of minimal invasive procedures for delivering the prosthetic valve anchor (72) and prosthetic valve (120), as well as tissue anchors for plication or other purposes to the native valve position in the heart (14).

Abstract: An apparatus includes a tubular member defining a lumen and a channel, and a support member. The tubular member has a connection portion configured to be coupled to an organ wall. An outer edge of the connection portion is configured to contact a first portion of an inner surface of the wall when the connection portion is in an expanded configuration such that an interior volume of the organ is in fluid communication with the lumen. The support member is movably disposed within the channel and is configured to minimize movement of the wall relative to the tubular member. An end portion of the support member is disposed within the channel when the support member is in a first configuration. The end portion of the support member configured to contact a second portion of the inner surface of the wall when the support member is in a second configuration.

Abstract: Methods for replacing a native heart valve. An anchor comprises coils adapted to support a heart valve prosthesis. The anchor is positioned at a native heart valve. An expansible heart valve prosthesis is delivered into the anchor and expanded inside the coils. This moves at least one coil from a first diameter to a second, larger diameter while securing the anchor and the heart valve prosthesis relative to each other. The heart valve prosthesis comprises a seal on the expansible heart valve prosthesis. Additional apparatus and methods are disclosed.

Abstract: Systems and methods comprising an anchor adapted to be positioned at a native heart valve annulus. The anchor comprises multiple coils adapted to support a heart valve prosthesis. A flexible outer tube adapted to hold the multiple coils of the anchor can combine with the anchor to form an assembly. A delivery tool adapted to deliver the assembly into position at a native heart valve can be provided and used. The outer tube is adapted to be removed from the multiple coils of the anchor after the coil portions of the anchor are positioned above and/or below the heart valve annulus. Additional apparatus and methods are disclosed.

Abstract: Systems and methods for replacing a native heart valve. An anchor comprises multiple coils adapted to support a heart valve prosthesis. At least one of the coils is normally at a first diameter, and is expandable to a second, larger diameter upon application of radial outward force from within the anchor. An expansible heart valve prosthesis is provided and is configured to be delivered into the anchor and expanded inside the multiple coils. This moves at least one coil from the first diameter to the second diameter while securing the anchor and the heart valve prosthesis relative to each other. The system further includes a seal on the anchor that can prevent at least some blood leakage after implantation of the heart valve prosthesis in the helical anchor. Additional apparatus and methods are disclosed.

Abstract: Various systems, devices and methods associated with the placement of a dock or anchor (72) for a prosthetic mitral valve (120). The anchor (72) may take the form of a helical anchor having multiple coils (104, 108) and/or a stent-like structure. Various methods include different levels of minimal invasive procedures for delivering the prosthetic valve anchor (72) and prosthetic valve (120), as well as tissue anchors for plication or other purposes to the mitral valve position in the heart (14).

Abstract: Systems and methods for replacing a heart valve. An expansible helical anchor is formed as multiple coils to support a valve prosthesis. At least one of the coils is expandable to a second, larger diameter upon application force from within the anchor. A gap is defined between adjacent coils sufficient to prevent engagement by at least one of the adjacent coils with the native heart valve. An expansible heart valve prosthesis is provided and is configured to be delivered into the anchor and expanded inside the coils into engagement. This moves the coil from the first diameter to the second diameter while securing the anchor and prosthesis together. The system further includes a seal on the expansible heart valve prosthesis configured to engage the helical anchor and prevent blood leakage past the heart valve prosthesis after implantation of the heart valve prosthesis in the helical anchor.