An asymmetric device for regulating blood volume distribution across a patient's atrial septum having a first expandable end region and a second expandable end region. The first expandable end region is transitionable from a contracted delivery state to an expanded deployed state in which the first expandable end region extends into the patient's left atrium and an inlet end of the first expandable end region is in a first plane. The second expandable end region is transitionable from a contracted delivery state to an expanded deployed state in which the second expandable end region extends into the patient's right atrium and an outlet end of the second expandable end region is in a second plane, such that the first plane intersects the second plane. The device further includes a neck region joining the first expandable end region to the second expandable end region, wherein the neck region is sized and shaped for placement in the patient's atrial septum.

Medical devices, systems, and methods reduce the distance between two points in tissue, often for treatment of congestive heart failure and often in a minimally invasive manner. An anchor is inserted along an insertion path through a first wall of the heart. An arm of the anchor is deployed and rotationally positioned according to a desired alignment. Application of tension to the anchor may draw the first and second walls of the heart into contact along a desired contour so as to effect a desired change in the geometry of the heart. Additional anchors may be inserted and aligned with the first anchor to close off a portion of a ventricle such that the ventricle is geometrically remodeled and disease progression is reversed, halted, and/or slowed.

An expandable tissue anchor (20, 120, 190, 220, 320, 420) includes an elongate tissue-coupling portion (30, 130, 192, 230, 330, 430) supported by an anchor shaft (32) at a first end (34) of the tissue-coupling portion (30, 130, 192, 230, 330, 430). The tissue-coupling portion (30, 130, 192, 230, 330, 430) is configured to be delivered in an unexpanded generally elongate configuration through a cardiac tissue wall from a first side of the wall to a second side of the wall, and to expand, on the second side of the cardiac tissue wall, to an expanded open shape configuration, such that the expanded tissue-coupling portion (30, 130, 192, 230, 330, 430) can be drawn tightly against the second side of the cardiac tissue wall when a tensile force is applied to the tissue-coupling portion (30, 130, 192, 230, 330, 430). The anchor (20, 120, 190, 220, 320, 420) also includes an elongate tip portion (38, 138, 238, 338, 438) supported at a second end (40, 240, 340, 440) of the tissue-coupling portion (30, 130, 192, 230, 330, 430) and configured to be delivered through the cardiac tissue wall ahead of the tissue-coupling portion (30, 130, 192, 230, 330, 430), the tip portion (38, 138, 238, 338, 438) including material having a stiffness less than a stiffness of the tissue-coupling portion (30, 130, 192, 230, 330, 430).

According to one embodiment, a tissue penetrating device includes an elongate shaft having a proximal end, a distal end, and a lumen extending there between. A first needle is disposed within the lumen of the elongate shaft and is extendable therefrom between a first configuration and a second configuration. In the first configuration, the first needle is disposed within the elongate shaft's lumen and is substantially aligned with an axis of the lumen. In the second configuration, the first needle extends distally of the elongate shaft's distal end and bends away from the lumen's axis. A second needle is disposed within a lumen of the first needle and is extendable therefrom when the first needle is positioned in the first configuration and when the first needle is positioned in the second configuration. The second needle may be extended from the first needle to penetrate tissue of a patient.

A device for regulating blood pressure in a heart chamber is provided. The device includes a shunt positionable within a septum of the heart. The shunt is designed for enabling blood flow between a loft heart chamber and a right heart chamber, wherein the flow rate capacity of the device is mostly a function of pressure in the left heart chamber.

A minimally invasively implanted anchor support for securing a medical device to a heart wall including an anchoring member and an expandable distal anchor retraint which is implanted through the anchoring member, through the heart wall, and expands on the opposing heart wall side to anchor a medical device. A single-stage anchor system includes the distal flange and a two-stage anchor system includes the distal flange and a proximal flange which cooperates with the distal flange to secure a medical device to the heart wall and methods of a single-stage anchor system and a two-stage anchor system.

A method for treating a valve of a heart of a subject is provided. The method includes inserting a needle into the heart, and, using the needle, injecting a soft-tissue-filling material into an annulus of the valve. Other embodiments are also described.

A shunt for regulating blood pressure between a patient's left atrium and right atrium comprises an anchor comprising a neck region, first and second end regions, and a conduit affixed with the anchor that formed of a biocompatible material that is resistant to transmural and translation tissue ingrowth and that reduces a risk of paradoxical embolism.

Methods and systems for closing an opening or defect in tissue, closing a lumen or tubular structure, cinching or remodeling a cavity or repairing a valve preferably utilizing a purse string or elastic device. The preferred devices and methods are directed toward catheter-based percutaneous, transvascular techniques used to facilitate placement of the devices within lumens, such as blood vessels, or on or within the heart to perform structural defect repair, such as valvular or ventricular remodeling. In some methods, the catheter is positioned within the right ventricle, wherein the myocardial wall or left ventricle may be accessed through the septal wall to position a device configured to permit reshaping of the ventricle. The device may include a line or a plurality of anchors interconnected by a line. In one arrangement, the line is a coiled member.

A heart implant alignment and delivery device includes an elongate body having an opening that is disposed near a distal end of the elongate body. The opening is configured so that a heart implant is positionable within the opening with the heart implant exposed to a surrounding environment and so that the heart implant is substantially aligned with the distal end of the elongate body. The device also includes an implant reposition member, such as a cable, that is releasably coupleable with the heart implant and that is operationally coupled with the elongate body so that a first operation of the implant reposition member causes the heart implant to be retractably deployed from the opening of the elongate body. The first operation of the implant reposition member may be effected via a handle mechanism that is attached to a proximal end of the elongate body.