Abstract: A prosthesis can comprise an expandable frame, a plurality of distal anchors and a plurality of proximal anchors. The anchors can extend outwardly from the frame. The frame can be configured to radially expand and contract for deployment within a body cavity. The frame and anchors can have one of many different shapes and configurations. For example, when the frame is in an expanded configuration, the frame can have a larger cross-sectional dimension in a middle portion of the frame and a smaller cross-sectional dimension in a proximal portion and a distal portion of the frame, wherein the middle portion is between the proximal and distal portions. As another example, the anchors can have looped ends, the entire anchor may loop out from the frame.

Abstract: An implant structure, comprises a body portion, a first adjusting mechanism, and a second adjusting mechanism. The body portion is configured to be secured within a heart of a patient. The first adjusting mechanism is coupled to a first portion of the body portion, and comprises a first ring that surrounds the first portion and is moveable with respect to the body portion. The second adjusting mechanism is coupled to a second portion of the body portion, and comprises a second ring that surrounds the second portion and is moveable with respect to the body portion. A first elongate tool is configured to remodel tissue of the heart by actuating the first adjusting mechanism. A second elongate tool is configured to remodel tissue of the heart by actuating the second adjusting mechanism.

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 prosthetic heart includes a support structure, an actuator member, a plurality of leaflets, and a sealing material. The support structure includes a plurality of struts movably coupled together such that the support structure moves incrementally between a radially compressed state and a radially expanded state. The struts include a plurality of commissure struts. The actuator member is coupled to the struts of the support structure and is configured to incrementally move the support structure between the radially compressed state and the radially expanded state and to automatically lock the support structure in a particular state. The leaflets are coupled to the commissure struts of the support structure and configured to allow unidirectional blood flow through the prosthetic heart valve. The sealing material is coupled to the support structure and includes a plurality of commissure extensions that wrap around and are coupled to the commissure struts of the support structure.

Abstract: An anchor is shaped to define a helix. A deployment tool is reversibly coupled to the anchor, and includes a lance. The deployment tool is configured to transluminally advance the anchor to the heart, and to stabilize the anchor at the tissue by driving the lance into the tissue. The deployment tool is also configured to anchor the anchor to the tissue, for example, by driving the tissue-penetrating helix into the tissue while the anchor remains stabilized at the tissue by the lance in the tissue, and to subsequently retract the lance from the tissue while leaving the anchor anchored to the tissue. Other embodiments are also described.

Abstract: A multiple-firing clip device includes a hollow shaft defining a lateral opening communicating with an environment and a distal shaft portion between the lateral opening and a distal end opening. A shuttle longitudinally moves on the shaft and comprises a shuttle body defining a lumen surrounding the shaft, a snare, and a snare-extender slide defining a snare track to form a snare travel path in which the snare is disposed from the body and through the track and a portion of the body. The slide moves along a given extent defining a slide distance and a distal end and movement of the slide to the distal end shortens the snare travel path to extend the snare portion through the lateral opening, through the distal shaft portion, and distally out from a distal side of the body longer than the given extent to secure a suture with the snare.

Abstract: An apparatus is provided for use with a tissue anchor and an anchor driver. The apparatus includes a housing, shaped to define a channel. The channel includes (i) an anchor-storage zone, and (ii) a proximal opening configured to provide access for the anchor driver to the anchor-storage zone. The channel is configured to enable sliding of the tissue anchor therewithin to be stored in the anchor-storage zone. The apparatus also includes a retaining member, shaped to define a cradle for cradling and holding the tissue anchor in the anchor-storage zone. The retaining member includes a pillar pivotable with respect to the cradle, and configured to support the tissue anchor at the cradle. Other embodiments are also described.

Abstract: Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement mitral valve to a native mitral valve location. A delivery component can have a plurality of slots that provide for desired bending of the delivery component, particularly compound bending of the delivery component that can facilitate steering of the delivery component in three dimensions.

Abstract: A guidewire is slidable through a percutaneous medical device. A distal end of the percutaneous medical device is moved in a proximal direction away from an anatomical site of a body of a subject. Simultaneously, a position of a distal end of the guidewire, with respect to the anatomical site, is maintained by moving a housing toward another housing that is coupled to the medical device. 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: 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.

Abstract: An annuloplasty implant comprises a flexible member, helical anchors, and non-compressible portions. The helical anchors are configured to anchor the flexible member at least partway around the valve by being screwed into tissue of the heart of a subject. Each of the non-compressible portions comprises a helical coil having a plurality of turns, and at rest has a helix pitch that contacts each turn of the coil with an adjacent turn of the coil. The flexible member extends through the non-compressible portions. The implant is configured such that applying tension to the flexible member from one end thereof contracts the implant, thereby drawing the anchors closer to each other, the helical coil of each of the non-compressible portions inhibiting contraction of the implant at the non-compressible portion.

Abstract: A method and apparatus for monitoring a subject's autoregulation function state is provided. The method includes: a) continuously sensing a tissue region of the subject with a tissue oximeter, the sensing producing first signals, and determining frequency domain tissue oxygen parameter values; b) continuously measuring a blood pressure level of the subject using a blood pressure sensing device, the measuring producing second signals, and determining frequency domain blood pressure values; c) determining a coherence value indicative of the subject's autoregulation state in each of a plurality of different frequency bands; and d) determining a peak coherence value indicative of the subject's autoregulation state based on the determined coherence value from each of the plurality of different frequency bands.

Abstract: Disclosed is a tubing system for use in a blood sampling-blood pressure monitoring system. The blood sampling-blood pressure monitoring system may include a control valve, a reservoir with a plunger, a sampling site, and a blood pressure transducer for measuring the blood pressure of a patient. The tubing system may comprise: a plurality of flexible tubing sections and a plurality of rigid tubing sections. The plurality of rigid tubing sections and flexible tubing sections may be interlinked with one another between the patient and the blood pressure transducer for the blood pressure measurement of the patient.

Abstract: An implant, disposed within a catheter, comprises a ring, anchors, and adjustment elements. The ring comprises struts arranged in a pattern of alternating peaks and troughs. Each strut has a first end-portion and a second end-portion. Each peak is defined by convergence of adjacent first end-portions disposed at an angle with respect to each other, and each trough is defined by convergence of adjacent second end-portions. Each of the anchors has a longitudinal axis, is coupled to the ring at a respective trough, and is configured to be driven along the longitudinal axis with respect to the trough and into tissue of the heart. Each of the adjustment elements is configured to adjust an angular disposition between a respective pair of the struts. A first adjustment element is coupled to its pair, and a second adjustment element is coupled to its pair distal to the first adjustment element.

Abstract: An anchor of an implant is transluminally advanced to a heart of a subject, the anchor including a distal helical element, and a post extending proximally from the distal helical element. The implant is anchored to tissue of the heart by driving the distal helical element into tissue of the heart, and compressing a fabric tube against the tissue by moving an annular member, coupled to the post, toward the tissue such that the fabric tube becomes sandwiched between the annular member and the tissue. Other embodiments are also described.

Abstract: A prosthesis for placement within a native heart valve preferably includes an expandable frame having locking tabs disposed along a proximal end. A plurality of distal anchors is disposed along a distal end of the frame. Each distal anchor is provided with a cushion cover. An outer fabric member surrounds the frame and may extend outwardly from the frame in an expanded condition for providing an improved seal in the region of a native annulus. A valve body is positioned within an interior of the expandable from for allowing blood flow in only one direction. In preferred embodiments, the cushions are positioned over enlarged head portions of the distal anchors for further reducing trauma on surrounding tissue.

Abstract: Devices, systems and methods are described for implantation of a prosthesis within a lumen or body cavity and delivery systems for delivering the prosthesis to a location for implantation. A delivery system can include a tether connected to a single directional handle knob for release of the prosthesis within the lumen or body cavity and retraction of the tether towards the handle.

Abstract: A mitral valve prosthesis includes an expandable frame having a proximal end, a distal end, and a middle portion. A plurality of tips extends from the proximal end of the frame for attachment to a delivery catheter. A plurality of anchors is disposed along the distal end of the frame and extend toward the proximal end for engaging tissue. An outer circumferential portion extends around the middle portion of the frame and is positioned radially outwardly of the frame. The outer circumferential portion preferably increases in diameter along a distal direction. A distal end of the outer circumferential portion is located distal of free ends of the anchors when the expandable frame is deployed. A valve body is positioned within an interior of the expandable frame and includes leaflets adapted to allow flow in a first direction and prevent flow in a second direction.