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: 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: An implant comprises a leaflet-augmentation patch, a patch anchor, and a cord. The patch comprises a flexible sheet, and a frame that supports the flexible sheet. The frame defines a spring configured to tension the cord. The cord couples the patch anchor to the patch in a manner in which anchoring the patch anchor to a first leaflet of a heart valve of a subject positions the patch to coapt with a second leaflet of the valve during ventricular systole. Other embodiments are also described.

Abstract: An anchor is anchorable to tissue of a ventricle downstream of a heart valve of a subject. Each wing of a pair of wings defines a lateral surface and a medial surface, such that the medial surface of one wing of the pair faces the medial surface of the other wing of the pair. The wings are coupled to the anchor such that, when the anchor is anchored to the tissue, the anchor supports the wings at the valve, with the lateral surface of each wing facing a respective leaflet of the valve. During systole, the lateral surface of each wing is in contact with the respective leaflet, and the medial surfaces of the wings move into contact with each other, obstructing retrograde blood flow. During diastole, the medial surfaces move out of contact with each other, facilitating antegrade blood flow. Other implementations are also described.

Abstract: An implant comprises a helical member. A guide assembly is used to guide the implantation of the helical member along a tissue of a heart. The guide assembly has a distal part that is transluminally advanceable to the heart, and comprises a guide frame that is intracardially expandable toward an expanded state, a guide rail, and multiple fasteners, configured to hold the guide rail in a guide arrangement around at least part of the guide frame. A driver of the system is configured to, while the guide rail is in the guide arrangement, anchor the helical member along an intracardial surface of tissue adjacent the guide frame, guided by the guide rail. Other implementations are also described.

Abstract: A catheter device includes a tube, and an extracorporeal unit coupled to a proximal end of the tube. An implant includes a series of anchors and a tether. The series of anchors includes a first anchor and other anchors, arranged along the extracorporeal unit. Each of the anchors includes a tissue-engaging element, and a head that defines an eyelet. The tether extends, along the extracorporeal unit, through the eyelet of each of the other anchors to the first anchor such that (i) the first anchor is advanceable, with a distal end of the tether, distally into and through the tube toward the tissue, and (ii) subsequently, the other anchors are slidable, sequentially, over and along the tether, distally into and through the tube toward the first anchor. Other applications are also described.

Abstract: Apparatus is provided, including an implant including a tissue-adjusting member including a longitudinal member, and a tissue anchor coupled to the tissue-adjusting member and configured to be anchored into the tissue of the patient. A tissue-coupling element is coupled to the longitudinal member. A delivery tool is reversibly couplable to the implant and is configured to deliver the implant to the tissue of the patient. The delivery tool includes an elongate shaft, a tissue-coupling-element holder coupled to a portion of the elongate shaft, the tissue-coupling-element holder being configured to hold the tissue-coupling element during delivery of the implant to the tissue of the patient, and an actuating element configured to rotate the tissue anchor so as to facilitate anchoring of the tissue anchor into the tissue of the patient while not rotating the tissue-coupling-element holder with respect to the shaft.

Abstract: An implant comprises a wall that surrounds a lumen. A delivery tool comprises a catheter, a control assembly, and an ultrasound tool. The catheter is transluminally advanceable into a subject, and has a distal opening. The implant can be delivered via the catheter. The control assembly can advance at least a portion of the wall out of the distal opening, and can steer the catheter to place the portion against a site of a tissue of the subject, the site disposed distally from the portion and opposite the distal opening. The ultrasound tool can (i) position an ultrasound transceiver within the lumen and facing the portion, and (ii) facilitate imaging of the site by transmitting ultrasound energy through the portion. An anchor driver can anchor the implant to the tissue by driving an anchor through the portion and into the site. 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: System for use with tissue of a heart comprises a tissue anchor comprising an engaging head that has a coupling eyelet that defines an eyelet plane, and a helical tissue-coupling element, reversibly anchorable to the tissue, and having a central helix axis that lies on the eyelet plane. The system also comprises an anchor driver, having a distal portion that has a casing that defines a slot, the slot defining a slot plane, and dimensioned to receive at least part of the eyelet therein in a manner in which the eyelet plane is coplanar with the slot plane. The anchor driver also comprises a detent, configured to reversibly inhibit movement of the eyelet with respect to the slot. The anchor driver is configured to anchor the tissue anchor to the tissue by rotating the tissue anchor by applying a rotational force to the eyelet. Other embodiments are also provided.

Abstract: A radiopaque frame is transluminally advanced to an atrium of a heart of a subject. The frame is expanded within a valve adjacent the atrium such that part of the frame remains disposed in the atrium. While the frame remains expanded within the valve, progressive portions of an annuloplasty structure are progressively positioned and anchored around the annulus using multiple anchors by, for each of the anchors sequentially (i) while fluoroscopically imaging the frame and a distal end of a delivery tool, and facilitated by mechanical guidance from the frame, positioning the distal end of the delivery tool between the frame and a wall of the atrium; and (ii) driving the anchor into the annulus laterally from the frame. Subsequently, the frame is contracted and withdrawn from the subject while leaving the annuloplasty structure anchored around the annulus. Other embodiments are also described.

Abstract: An example anchor-manipulation tool includes (i) at a distal portion of the tool, an anchor-engaging element and an actuator, (ii) at an extracorporeal proximal portion of the tool, a controller, and (iii) a flexible longitudinal member extending between the proximal portion and the distal portion. The distal portion of the tool can be transluminally advanced to an anchor that is intracorporeally implanted in a subject. Subsequently, the anchor-engaging element can be engaged with an eyelet defined by a head of the anchor. Subsequently, the controller can be used to transition the tool into an articulatably-coupled state in which: (i) the eyelet at least in part inhibits movement of the anchor-engaging element away from the anchor, and (ii) the distal portion of the anchor-manipulation tool is deflectable with respect to the anchor. Subsequently, the anchor can be de-anchored by using the anchor-manipulation tool to apply a de-anchoring force to the eyelet.

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: Methods are described for use with a valve of a heart of a subject, the valve having an annulus, a first leaflet and an opposing leaflet, the heart having an atrium upstream of the valve, and a ventricle downstream of the valve. A tissue anchor, and an implant that includes a flexible frame, are transluminally advanced to the atrium. The implant is deployed within the atrium. Via anchoring of the tissue anchor to the annulus of the valve, the implant is secured within the heart by a first part of the frame being secured to the annulus, such that the frame extends over the first leaflet toward the opposing leaflet with a first side of the frame facing the first leaflet. Part of the frame can be disposed between the first leaflet and the opposing leaflet. 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 method is described for use with a heart of a subject, the heart having a valve and an atrium upstream of the valve. The method includes transluminally advancing multiple tissue anchors to the atrium; and securing an elongate contraction member at least partly around an annulus of the valve by anchoring the tissue anchors to the annulus, such that the tissue anchors are distributed along the elongate contraction member. The method further includes subsequently contracting the annulus by applying tension the elongate contraction member, such that a radiopaque indicator that is disposed within the heart and that is coupled to the contraction member undergoes a conformational change in response to the tension. The conformational change of the radiopaque indicator within the heart is observed, and the tension is adjusted responsively to the observed conformational change. Other embodiments are also described.