Abstract: A tubular system is configured to transluminally deliver an implant comprising a tissue anchor having a coupling head and a distal helical tissue-engaging element, into a heart of a subject. The tissue anchor is slidable through a channel of the system, the channel being slidable within a catheter. An anchor driver is configured, while coupled to the coupling head of the tissue anchor, to drive the tissue anchor through the system and out the system's distal end, to anchor the tissue-engaging element to tissue of the heart. While a first electrode is in contact with the subject and a second electrode is inside the heart of the subject, a control unit receives an electrophysiological signal from the electrodes, and based on the electrophysiological signal, indicates a position of the second electrode inside the heart. Other embodiments are also described.

Abstract: A stand comprises a track. A first handle is mountable on the stand such that the stand supports the first handle. A first catheter defines a first lumen, and is coupled to the first handle. A second handle is mountable on the stand proximally from the first catheter in a manner in which the stand also supports the second handle. A second catheter defines a second lumen, and is coupled to the second handle. The second catheter is extendable through the first lumen. A third handle is slidably mountable on the track proximally from the second handle, such that the third handle is axially slidable along the track. A third catheter defines a third lumen, and is coupled to the third handle. A distal end of the third catheter is advanceable out of the second lumen. Other embodiments are also described.

Abstract: A leaflet support for use with a native valve of a heart of a subject includes a frame that defines an array of adjoining cells, as well as an aperture between an upstream side and a downstream side of the frame. When placed against an annulus of the heart, the frame facilitates blood flow, via the cells, between the upstream side and the downstream side. The leaflet support further includes a barrier that is impermeable to blood flow, and that is coupled to the frame in a manner that obstructs blood flow through the aperture. The leaflet support further includes ventricular legs, that each extend radially outward and upstream, toward the frame. Other embodiments are also described.

Abstract: Apparatus is provided, including: (A) a valve body (204) including a first frame (206) shaped to define a lumen therethrough, and a valve member (205) disposed within the lumen, (B) an upstream support (210), configured to be placed against an upstream surface of a native heart valve, and (C) a flexible sheet (214) that couples the upstream support to the valve body. The valve body has a compressed state in which the first frame has a first diameter, and an expanded state in which the first frame has a second diameter that is greater than the first diameter. The support includes a second frame (212) that has a compressed state, and an expanded state in which the second frame is annular, has an inner perimeter that defines an opening through the second frame, and has an outer perimeter. Other embodiments are also described.

Abstract: A catheter, advanced toward an anatomical site, has a proximal end and a steerable distal end. An anchor is advanced through the catheter. An anchor driver drives the anchor out of the catheter's distal end, anchoring the anchor at the site. A first constraining member engages tissue, and inhibits, after the anchor has been driven out of the catheter and before the anchoring, movement of at least the anchor driver's distal end, on a first axis between the anchor driver's distal end and a site at which the first constraining member engages the tissue. A second constraining member inhibits, after the anchor has been driven out of the catheter and before the anchoring, movement of at least the anchor driver's distal end, on a second axis. Other embodiments are also described.

Abstract: A prosthetic heart valve implant is provided including a frame shaped so as to define upstream and downstream openings at upstream and downstream ends of the frame, respectively, when the implant is in an expanded state for implantation at a heart native valve. A sheet is coupled to the frame. When the implant is in the expanded state, the frame is shaped so as to define the following longitudinal portions arranged along a central longitudinal axis of the prosthetic heart valve implant: a substantially cylindrical mid portion having a diameter greater than respective diameters of the upstream and the downstream ends of the frame; an upstream portion, extending upstream and radially inward from the mid portion; and a downstream portion, extending downstream and radially inward from the mid portion. Other embodiments are also described.

Abstract: A first catheter has a first lumen therealong, a first-catheter proximal portion, and a steerable first-catheter distal portion that is transluminally advanceable to the heart. A second catheter has second lumen therealong, a second-catheter proximal portion, and a steerable second-catheter distal portion. The second catheter extends through the first lumen, such that the second-catheter proximal portion extends proximally out from the first-catheter proximal portion, the second-catheter distal portion extends distally out from the first-catheter distal portion, and within at least the first-catheter proximal portion, the first lumen and the second lumen are coaxial on a longitudinal axis. A first handle is coupled to the first-catheter proximal portion, and extends obliquely away from the first-catheter proximal portion at a nonzero angle with respect to the longitudinal axis. A second handle is coupled to the second-catheter proximal portion, and is disposed proximally from the first handle.

Abstract: A leaflet support for use with a native valve of a heart of a subject includes a frame that defines an array of adjoining cells, as well as an aperture between an upstream side and a downstream side of the frame. When placed against an annulus of the heart, the frame facilitates blood flow, via the cells, between the upstream side and the downstream side. The leaflet support further includes a barrier that is impermeable to blood flow, and that is coupled to the frame in a manner that obstructs blood flow through the aperture. The leaflet support further includes ventricular legs, that each extend radially outward and upstream, toward the frame. Other embodiments are also described.

Abstract: An implant includes an expandable frame having a continuous lumen and has (a) an upstream row of upstream cells and (b) at least two downstream rows of downstream cells. An upstream portion of each cell is shaped by ascending and descending struts that form a respective peak that points in an upstream direction. A valve member is disposed within the lumen and facilitates unidirectional flow of blood from an upstream end of the frame to a downstream end of the frame. A covering has (i) a first portion entirely covering an outer surface of a downstream row of downstream cells, and (ii) a second portion partially covering an outer surface of an upstream row of downstream cells. Outer surfaces of the peaks of the upstream row of downstream cells are disposed upstream of an upstream end of the covering at the outer surface. Other embodiments are also described.

Abstract: A first part of an annuloplasty structure is anchored to an annulus of a valve of a heart by using a driver to screw a tissue-coupling element of a first anchor into a first site of the annulus, such that the tissue-coupling element enters cardiac tissue in a direction parallel to a central longitudinal axis of the driver through the distal end of the anchor driver. The same is subsequently done for second and third parts of the annuloplasty structure using second and third anchors at second and third sites of the annulus, mutatis mutandis. Between anchors, the driver is retracted out of the heart. Subsequently, the valve is treated by reducing a distance between the first site and the second site, and a distance between the second site and the third site, by tightening a flexible and elongate contracting member of the annuloplasty structure.

Abstract: Anchor deployment systems and tools are provided. An anchor deployment tool can include a flexible tube including a distal anchor manipulation portion. The tool can also include a deployment element, which is positionable within the flexible tube, and is configured to, while the distal anchor manipulation portion is proximate an implantable device, (i) engage the anchors in the flexible tube, (ii) advance each of the anchors in a distal direction to the distal anchor manipulation portion, and (iii) anchor the implantable device to tissue of a subject by deploying each of the tissue anchors through the implantable device and into the tissue.

Abstract: A tube and a set of anchors, are transluminally advanced toward a heart of a subject. Tabs are distributed axially along an anchor storage area of the tube, each of the tabs protruding medially from a circumferential wall of the tube. The anchors are disposed in the anchor storage area, a first anchor engaged and restrained by a first tab at a first axial location of the tube, and a second anchor engaged and restrained by a second tab at a second axial location of the tube proximal from the first axial location. The first anchor is engaged by the driver at the first axial location, advanced to a distal end of the tube, and anchored to tissue of the heart. Subsequently, the second anchor is engaged by the driver at the second axial location, advanced to the distal end of the tube, and anchored to the tissue.

Abstract: Apparatus includes a delivery tool and a prosthetic valve, the prosthetic valve includes a first frame, and a second frame coupled to the first frame. The delivery tool includes a first catheter, a second catheter, and a rod. A steerable portion of the second catheter extends out of the first catheter, and a steerable distal portion of the rod extends out of the second catheter. An extracorporeal rod-controller is operably coupled to the rod such that operating the extracorporeal rod-controller steers the steerable distal portion of the rod. In a delivery state of the apparatus, the prosthetic valve is compressed onto the rod, distal to the distal end of the second catheter, and the apparatus is transfemorally and transseptally advanceable into a left atrium of a heart of a subject. Other embodiments are also described.

Abstract: A system and method are provided for preventing a sharp stick hazard from a needle tip of an automatic injector device. In some embodiments, a skin contact surface of the device is attached to an injection site, for example by an adhesive. Optionally a locking mechanism holds a needle extended into an injection site. A body of the device is optionally movably attached to the skin contact surface. Pulling the body away from the injection site optionally moves the body with respect to the skin contact surface. Movement of the body with respect to the skin contact surface optionally moves interlinked parts of the locking mechanism, releasing the locking mechanism.

Abstract: Systems and apparatuses for use with a guidewire are provided. The systems/apparatuses can include a first housing, shaped to define a first channel through which the guidewire is slidable and a second housing, shaped to define a second channel through which the guidewire is slidable in at least a first direction toward the first housing. The systems/apparatuses can also include a guidewire-engaging element, disposed within the second housing, and configured to inhibit the guidewire from sliding through the second channel in a second direction away from the first housing. A tubular member having a lumen through which the guidewire is slidable and being slidably coupled to the first housing can also be included. Other embodiments are also described.

Abstract: A rod (508) is transfemorally advanceable to the heart. An implant (460) comprises (i) a first frame (462), compressed around a first longitudinal site of a distal portion of the rod, (ii) a second frame (464), compressed around a third longitudinal site of the distal portion, (iii) a valve member (50), disposed within the second frame, and (iv) a flexible sheet (466), coupling the first frame to the second frame, and disposed around a second longitudinal site of the distal portion, the second longitudinal site being between the first longitudinal site and the third longitudinal site. An extracorporeal controller (569) is coupled to a proximal portion of the rod, and is operably coupled to the distal portion of the rod. Operating the controller bends the distal portion of the rod causing articulation between the frames. Other embodiments are also described.

Abstract: A delivery tool including a shaft and a proximal capsule and a distal capsule is dimensioned for percutaneous delivery to the heart. An open end of the proximal capsule faces the open end of the distal capsule. The capsules are coupled to the shaft in a manner that allows axial movement of the capsule with respect to the shaft. A prosthetic heart valve includes a tubular portion that defines a lumen and prosthetic leaflets disposed within the lumen. The prosthetic heart valve is restrainable in a compressed state by the delivery tool, such that a downstream end of the tubular portion is disposed within the distal capsule. The distal capsule is shaped so as to define an opening for visualizing ensheathing of at least a portion of the downstream end of the tubular portion within the distal capsule. Other embodiments are also described.

Abstract: A leaflet support for use with a native valve of a heart of a subject includes a frame that defines an array of adjoining cells, as well as an aperture between an upstream side and a downstream side of the frame. When placed against an annulus of the heart, the frame facilitates blood flow, via the cells, between the upstream side and the downstream side. The leaflet support further includes a barrier that is impermeable to blood flow, and that is coupled to the frame in a manner that obstructs blood flow through the aperture. The leaflet support further includes ventricular legs, that each extend radially outward and upstream, toward the frame. Other embodiments are also described.

Abstract: A method for treating a native heart valve of a patient includes anchoring a plurality of anchors of an implant into tissue around an annulus of the valve. At the annulus, a force-distribution element is incorporated into the implant such that the force-distribution element extends along a longitudinal portion of the elongate contracting member. The method can also include circumferentially tightening the annulus by pulling the plurality of anchors closer together, such as by actuating a contracting mechanism of a contracting system, such that (i) the contracting mechanism, coupled to an elongate contracting member of the implant, applies a longitudinal tensioning force to the elongate contracting member, and (ii) the force-distributing element distributes the longitudinal tensioning force over at least two of the anchors. Other embodiments are also described.

Abstract: Apparatus is provided, including: (A) a valve body (204) including a first frame (206) shaped to define a lumen therethrough, and a valve member (205) disposed within the lumen, (B) an upstream support (210), configured to be placed against an upstream surface of a native heart valve, and (C) a flexible sheet (214) that couples the upstream support to the valve body. The valve body has a compressed state in which the first frame has a first diameter, and an expanded state in which the first frame has a second diameter that is greater than the first diameter. The support includes a second frame (212) that has a compressed state, and an expanded state in which the second frame is annular, has an inner perimeter that defines an opening through the second frame, and has an outer perimeter. Other embodiments are also described.