Abstract: Systems and methods for reversing remodeling of the heart caused by mitral regurgitation are disclosed. An exemplary method may comprise installing a valve implant to at least partially restrict mitral regurgitation, and anchoring the valve implant using one or more anchors that are each attached to the wall of the heart. The anchors may include a pre-tensioned elastic material coated with a slow-absorbable or dissolvable coating configured to release the tension of the pre-tensioned elastic material at an appropriate time to promote reshaping of the heart.

Abstract: A heart valve implant is disclosed herein. The heart valve implant comprises an inflatable valve body, a shaft, an anchor assembly and an inflation (injection) port. Also disclosed herein, are methods of trans-apically and trans-septally delivering a heart valve implant within a heart such that the valve body can be inflated in situ to partially or completely restrict blood flow through a heart valve in a closed position. The inflation (injection) port permits inflation of the valve body with an adjustable amount of an inflation fluid to attain a desired degree of inflation of the valve body when disposed within the heart valve.

Abstract: A trans-apical implant includes a spacer defining spacer cavity configured to be expanded from a retracted position, a shaft extending from the spacer, the shaft defining an inflation lumen fluidly coupled to the spacer cavity and configured to be fluidly coupled to an expansion medium source, and a spacer valve assembly disposed within at least one of the spacer or shaft, the spacer valve assembly configured to allow selectively allow an expansion medium to flow into the spacer cavity to be selectively expand the spacer from a retracted position to an expanded position.

Abstract: An implant delivery system may comprise a catheter including at least one lumen, a guide wire configured to be received in the lumen, and an implant. The guide wire may comprise a clamping mechanism disposed about a distal end of the guide wire. The clamping mechanism may include a first and at least a second jaw wherein at least one of the jaws is configured to pivot between a closed position wherein the jaws define at least one internal cavity between the jaws configured to receive at least a portion of the implant and an open position configured to release the implant. The implant may be configured to be received in the lumen and may comprise a driver configured to be releasably received in the cavity of the clamping mechanism.

Abstract: A heart valve implant is disclosed herein. The heart valve implant comprises an inflatable valve body, a shaft, an anchor assembly and an inflation (injection) port. Also disclosed herein, are methods of trans-apically and trans-septally delivering a heart valve implant within a heart such that the valve body can be inflated in situ to partially or completely restrict blood flow through a heart valve in a closed position. The inflation (injection) port permits inflation of the valve body with an adjustable amount of an inflation fluid to attain a desired degree of inflation of the valve body when disposed within the heart valve.

Abstract: A trans-femoral implant includes an anchor assembly and a balloon assembly configured to be separately delivered to an implant site within a heart. Once delivered, the anchor assembly and balloon assembly may be coupled to form an implant within the heart. The balloon anchor may include a fluid inflatable balloon that may be selectively filled via a balloon filling valve. The balloon assembly may further include a latching mechanism that may couple with a distal end of the anchor assembly, such that the length of the implant may be adjusted within the heart.

Abstract: A method and system according to one embodiment may include a plurality of apparatus configured to percutaneously deliver a heart valve implant. The method and system may include an implant comprising an anchor configured to engage cardiac tissue, a shaft coupled to the anchor, and a valve body coupled to the shaft. The method and system may further include at least partially collapsing the heart valve implant and percutaneously inserting the heart valve implant into a heart. The percutaneously inserted implant may be secured within the heart and may then be expanded.

Abstract: A trans-apical implant includes a spacer defining spacer cavity configured to be expanded from a retracted position, a shaft extending from the spacer, the shaft defining an inflation lumen fluidly coupled to the spacer cavity and configured to be fluidly coupled to an expansion medium source, and a spacer valve assembly disposed within at least one of the spacer or shaft, the spacer valve assembly configured to allow selectively allow an expansion medium to flow into the spacer cavity to be selectively expand the spacer from a retracted position to an expanded position.

Abstract: A heart valve implant may include a shaft and an anchor configured to be coupled to an end of the shaft. A spacer may be coupled to a portion of the shaft and comprise a plurality of individual segments including a first and at least a second individual segment. The first segment may be coupled to the shaft. The second segment may be coupled to at least a portion of an exterior surface of the first segment and may have at least one cross-section dimension which is greater than an internal cross-sectional dimension of a delivery lumen. Additional segments may be coupled to an inner, adjacent segment. The segments may include a collapsible body portion to facilitate percutaneously delivery through a lumen. The segments may define an outer surface of the spacer configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through the heart valve in a closed position.

Abstract: A heart valve implant according to one embodiment may include a shaft and an anchor disposed on one end of the shaft, the anchor configured to engage tissue. The heart valve implant may further include an expandable member disposed over at least part of the shaft, the expandable member comprising a resiliently deformable internal layer and a resiliently deformable external layer disposed over the internal layer, the expandable member defining a chamber and being configured to receive an inflation medium in the chamber to expand the expandable member, the expandable member further configured to deform upon contact with at least a portion of at least one leaflet of a heart valve to at least partially conform to the shape of the leaflet.

Abstract: A method according to one embodiment may include providing a heart valve implant including an anchor capable of engaging coronary tissue, a shaft coupled to said anchor, and a valve body coupled to said shaft. The method may further include at least partially collapsing the heart valve implant and percutaneously inserting the heart valve implant into a heart. The percutaneously inserted implant may be secured within the heart and may then be expanded. Of course, many alternatives, variations, and modifications are possible without departing from this embodiment.

Abstract: An implant delivery system may comprise a catheter including at least one lumen, a guide wire configured to be received in the lumen, and an implant. The guide wire may comprise a clamping mechanism disposed about a distal end of the guide wire. The clamping mechanism may include a first and at least a second jaw wherein at least one of the jaws is configured to pivot between a closed position wherein the jaws define at least one internal cavity between the jaws configured to receive at least a portion of the implant and an open position configured to release the implant. The implant may be configured to be received in the lumen and may comprise a driver configured to be releasably received in the cavity of the clamping mechanism.

Abstract: A trans-femoral implant includes an anchor assembly and a balloon assembly configured to be separately delivered to an implant site within a heart. Once delivered, the anchor assembly and balloon assembly may be coupled to form an implant within the heart. The balloon anchor may include a fluid inflatable balloon that may be selectively filled via a balloon filling valve. The balloon assembly may further include a latching mechanism that may couple with a distal end of the anchor assembly, such that the length of the implant may be adjusted within the heart.

Abstract: A catheter according to one embodiment may be configured to extend through a transseptal puncture site, a left atrium, and into a left ventricle. The catheter may comprise a shaft defining at least one lumen configured to receive at least one of an implant and/or a dilator, a first steerable actuator coupled to the shaft at a position on the shaft substantially corresponding to the annulus of the mitral valve when the distal end of the shaft is disposed within the left ventricle, and a handle assembly coupled to a proximal end of the shaft. The handle assembly may comprise a first actuator coupled to the first steerable actuator. The first actuator may be configured to apply a force to the first steerable actuator to deflect the shaft about a region proximate to the first steerable actuator.

Abstract: A trans-apical implant includes a spacer defining spacer cavity configured to be expanded from a retracted position, a shaft extending from the spacer, the shaft defining an inflation lumen fluidly coupled to the spacer cavity and configured to be fluidly coupled to an expansion medium source, and a spacer valve assembly disposed within at least one of the spacer or shaft, the spacer valve assembly configured to allow selectively allow an expansion medium to flow into the spacer cavity to be selectively expand the spacer from a retracted position to an expanded position.

Abstract: A heart valve implant may include a shaft and an anchor configured to be coupled to an end of the shaft. A spacer may be coupled to a portion of the shaft and comprise a plurality of individual segments including a first and at least a second individual segment. The first segment may be coupled to the shaft. The second segment may be coupled to at least a portion of an exterior surface of the first segment and may have at least one cross-section dimension which is greater than an internal cross-sectional dimension of a delivery lumen. Additional segments may be coupled to an inner, adjacent segment. The segments may include a collapsible body portion to facilitate percutaneously delivery through a lumen. The segments may define an outer surface of the spacer configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through the heart valve in a closed position.

Abstract: A heart valve implant may include a shaft extending generally along a longitudinal axis of the heart valve implant. A spacer may be coupled to the shaft between a first and a second end region of the shaft. The spacer may be configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through the heart valve in a closed position and at least one anchor may be configured to be coupled to the first end region of the shaft. At least one safety stop may extend generally radially outwardly from the longitudinal axis of the heart valve implant beyond at least a portion of an outer perimeter of the spacer. The safety stop may include a cross-section which is greater than a cross-section of the heart valve in at least one dimension. The safety stop may also be configured to at least partially restrict a movement of the heart valve implant with respect to the heart valve in at least one direction.

Abstract: A regurgitation implant may comprise a conduit or straw which may be coupled to a shaft. The shaft may be coupled to at least one anchor portion configured to couple the regurgitation implant to native coronary tissue. At least a portion of the conduit may be configured to be disposed proximate a mitral valve such that the regurgitation implant may interact and/or cooperate with at least a portion of the native mitral valve to induce a controlled amount of regurgitation through the conduit and therefore through the mitral valve. The regurgitation through the conduit and the mitral valve may cause the heart to dilute in a manner that is generally consistent with advanced disease of the heart. The amount of regurgitation may therefore be adjusted depending on the desired condition of the heart.

Abstract: A catheter according to one embodiment may be configured to extend through a transseptal puncture site, a left atrium, and into a left ventricle. The catheter may comprise a shaft defining at least one lumen configured to receive at least one of an implant and/or a dilator, a first steerable actuator coupled to the shaft at a position on the shaft substantially corresponding to the annulus of the mitral valve when the distal end of the shaft is disposed within the left ventricle, and a handle assembly coupled to a proximal end of the shaft. The handle assembly may comprise a first actuator coupled to the first steerable actuator. The first actuator may be configured to apply a force to the first steerable actuator to deflect the shaft about a region proximate to the first steerable actuator.

Abstract: A heart valve implant according to one embodiment may include a shaft and an anchor disposed on one end of the shaft, the anchor configured to engage tissue. The heart valve implant may further include an expandable member disposed over at least part of the shaft, the expandable member comprising a resiliently deformable internal layer and a resiliently deformable external layer disposed over the internal layer, the expandable member defining a chamber and being configured to receive an inflation medium in the chamber to expand the expandable member, the expandable member further configured to deform upon contact with at least a portion of at least one leaflet of a heart valve to at least partially conform to the shape of the leaflet.