Abstract: A stent implant includes a first stent segment having a non-circular axial cross-sectional shape in a relaxed configuration thereof, second and third stent segments on opposite sides of the first stent segment, the second and third stent segments having a circular relaxed axial cross-sectional shape, a fluid-tight covering disposed on at least one of an outer diameter or an inner diameter of the first, second, and third stent segments, and a blood flow egress channel in fluid communication with a space on the outer diameter of the first stent segment, the blood flow egress channel configured to permit blood flow to pass axially out of the space through the blood flow egress channel.

Abstract: Using a driver, a tissue anchor is advanced to a tissue of a subject. The tissue anchor includes an anchoring portion, an anchor head fixedly coupled to the anchoring portion, and a driver interface. The anchoring portion is screwed distally into the tissue by, while the driver is engaged with the driver interface, applying torque, via the driver, to the driver interface such that the anchor head and the anchoring portion rotate together about a longitudinal axis of the tissue anchor. Continued screwing of the anchoring portion distally into the tissue is performed by continuing to apply the torque at least until the driver interface becomes rotatable relative to the anchor head. Subsequently, the driver is disengaged from the driver interface and removed from the subject, while leaving the tissue anchor anchored to the tissue. Other embodiments are also described.

Abstract: An intravascular compliance-enhancing spring implant device includes a fully-cylindrical tubular frame defining a longitudinal axis and a non-circular cross-sectional shape having a major axis diameter and a minor axis diameter that is less than the major axis diameter, first and second longitudinal tissue-contact rails associated with first and second major-axis ends, respectively, of the tubular frame and adapted to press against an inner diameter of a target blood vessel, and first and second lateral connecting strut arrays associated with minor-axis sides of the tubular frame, the first and second lateral connecting strut arrays spanning between the first and second tissue-contact rails on diametrically opposite sides of a lumen of the tubular frame and adapted to be compressed along a major-axis dimension of the tubular frame in a manner as to reduce a distance between the first and second tissue-contact rails, storing spring energy in the lateral connecting strut arrays.

Abstract: Methods of reshaping blood vessels for improving compliance and increasing blood flow are disclosed. One preferred method includes deploying a tubular stent frame within a blood vessel. The stent frame preferably has a non-circular cross-section with a major-axis and a minor-axis. At least one tissue anchor is provided along a wall portion on the minor-axis. The tissue anchor is embedded into a wall of the blood vessel and the wall of the blood vessel is drawn into contact with the minor-axis wall portion. Preferably, tissue anchors are provided along opposing minor-axes of the stent frame for reshaping the blood vessel into a substantially oval cross-section. When exposed to high blood pressure, the stent frame expands to a more circular shape for allowing more blood to pass therethrough. Under low pressure, the stent frame returns to a non-circular cross-section to aid with the pumping of blood.

Abstract: A catheter device includes a flexible tube and an extracorporeal unit. The tube has a distal opening that is configured to be transluminally advanced into a subject, and a proximal end. The extracorporeal unit is coupled to the proximal end, and includes (i) a body, and (ii) a series of cartridges, distributed along a proximal-distal axis of the body, with a distalmost cartridge being closest to the proximal end of the tube. A series of anchors includes a leading anchor and other anchors, each anchor being (i) housed by a corresponding cartridge, with the leading anchor housed by the distalmost cartridge, and (ii) coupled to a tether such that the tether extends along the body, parallel with the proximal-distal axis. Other embodiments are also described.

Abstract: A method involves percutaneously delivering an implant into a first blood vessel. The implant may have a flexible and/or elastic structure. The method also involves extending at least a distal portion of the implant out of the first blood vessel while retaining at least a proximal portion of the implant within the first blood vessel and injecting the implant with a fluid. The fluid is freely moveable between the proximal portion and the distal portion. The proximal portion may be shape-set to form a bulb.

Abstract: Provided is a device for use in medical procedures comprising an elongated body with one or more anchor devices associated with a distal end of the elongated body, whereby the distal end of the elongated body can operably be connected to soft tissue of a subject as part of a medical procedure. The elongated body, in some embodiments, is used as a guide to a medical device, such as a pericardial transection device used for forming cuts in pericardial tissue of a heart, whereby the elongated body provides for guidance and stability when the pericardial transection device is in use. Also provided are various soft tissue anchors, medical kits, and procedures for anchoring an elongated body in soft tissue via use of an anchor device, as well as use of an anchored elongated body in medical procedures such as transection procedures associated with the pericardium.

Abstract: A tissue anchor comprises an anchoring portion, and a crown coupled thereto. The crown includes an anchor head fixedly coupled to the anchoring portion, a driver interface, and a socket. The socket may be fixedly coupled to the driver interface and shaped to receive the anchor head. In a first state the anchor head is seated snugly within the socket, such that torque applied to the driver interface is transferred to the anchoring portion, thereby facilitating screwing of the anchoring portion into the tissue. Screwing of the anchoring portion into the tissue can pull the anchor head distally out of the socket, thereby transitioning the anchor into a second state in which torque applied to the driver interface rotates the socket relative to the anchor head and the anchoring portion. Other embodiments are also described.

Abstract: An implant device includes a unitary stent frame including a first axial end segment having a circular cross-sectional shape, a second axial end segment having a circular cross-sectional shape, and a medial segment disposed between the first axial end segment and the second axial end segment, the medial segment having an oval cross-sectional shape. A fluid-tight covering can be disposed on minor-axis sidewall portions of the medial segment of the stent frame.

Abstract: An implant for adding compliance to a blood vessel includes a first elongate rail shaped to contact an inner wall of a blood vessel and a second elongate rail shaped to contact an opposing inner wall of the blood vessel. Connectors extend between the first and second rails for providing a separation therebetween and maintaining the rails at locations on opposing sides of the lumen after implantation. The connectors push the rails outwardly for biasing the blood vessel toward a substantially oval shape. The connectors are preferably flexible for allowing the blood vessel to change shape during use for adding compliance to the blood vessel. The elongate rails are preferably curved or hemi-spherical for conforming to the shape of the inner wall of the blood vessel.

Abstract: An annuloplasty structure includes a wire, a plurality of anchors, and a plurality of flexible connectors. Each anchor includes (i) a tissue-engaging element, configured to be driven into tissue of a subject; (ii) a neck; and (iii) a head, coupled to the tissue-engaging element via the neck. Each connector is made of a fabric that is shaped to define (i) a hole through which the neck of a respective anchor extends and within which the neck of the respective anchor is rotatable. The head of the respective anchor is disposed on a first side of the hole, and the tissue-engaging element of the respective anchor is disposed on a second, opposite, side of the hole. The wire is threaded through the eyelet of each connector in a manner that slidably couples the connector, and thereby the respective anchor, to the wire. Other embodiments are also described.

Abstract: Systems and devices for accessing an inner space between two layers of tissues are provided. A system can include a helical coil within a catheter delivery system. The helical coil can be delivered to the treatment site at which point it can be turned to penetrate and traverse tissue to reach an inner space. The system can further comprise a gas supply system for providing gas to help displace one or both tissue layers to create more access space within the inner space. A tool, prosthetic, or other device can be transferred via the catheter system into the inner space to perform a procedure therein.

Abstract: Disclosed are various devices and methods for providing tissue access support. One exemplary device embodiment includes an elongated body having distal and proximal ends and extending along a longitudinal axis and defining a first lumen therein. A sealing member is coupled adjacent to the distal end of the elongated body and structured to seal to a first surface of a pericardial tissue. A support tube is provided having distal and proximal ends and extending along a longitudinal axis and defining a second lumen therein, wherein the support tube is slidably arranged in the lumen of the elongated body between first and second sliding positions. A securement member is coupled to the support tube and structured to engage at least a second opposing surface of the pericardial tissue. A guidewire is positioned in the second lumen of the support tube and includes a puncturing tip shaped to penetrate pericardial tissue.

Abstract: A medical device includes a flexible catheter including a distal end, at least one lumen, and a longitudinal axis, an incision device coupled to the distal end of the catheter, and a distal tip coupled to and projecting from the incision assembly. The incision device comprises a wire that includes one or more electrodes for creating an incision through a pericardium. The wire has a first end fixed to an external surface of the distal tip and a second end extending through the distal opening of the distal tip. The wire is structured such that in a deployed configuration, (i) the portion of the wire extending from the first end of the wire to the distal opening of the body of the distal tip forms a shape comprising a protrusion extending relative to a longitudinal axis of the transcatheter and (ii) the electrode is positioned proximal to the protrusion.

Abstract: Exemplary transection devices for making incisions through the pericardial membrane or parietal layer of the pericardium are described. These examples share the characteristic that they are deployed intravascularly through the RAA, IVC, SVC, or via a subxiphoid approach. One example is a pericardial tissue transection device comprising an elongated body with a proximal end and a distal end and extending along a longitudinal length. An incision assembly is coupled to the distal end of the elongated body. The incision assembly comprises an incision member having first and second ends each coupled to the incision assembly and aligned with the longitudinal length of the elongate body. At least a portion of the incision member is structured to reversibly extend laterally from the elongated body.

Abstract: Disclosed is a medical device comprising an incision assembly coupled to a catheter and an incision opening defined along the incision assembly. A retractable cutting apparatus is disposed within the incision opening and comprises a first incision member comprising at least one first cutting surface and defining a first member proximal end rotatably fixed proximate to a distal end of the incision opening and the at least one cutting surface is located on a bottom edge of the first incision member. A second incision member comprises at least one second cutting surface and defines a second member distal end attached to the first incision member at a connection point between a first member distal end and the first member proximal end of the first incision member, and wherein the at least one second cutting surface is located on a bottom edge of the second incision member.

Abstract: A stent comprises a network of elastically deformable struts having a biased cross-sectional shape and forming a first end portion having a first central diameter in a major dimension and a second central diameter in a minor dimension, wherein the first central diameter is greater than the second central diameter, a second end portion having the first central diameter in the major dimension and the second central diameter in the minor dimension, and a middle portion situated between the first end portion and the second end portion, the middle portion having a third central diameter in the major dimension and the second central diameter in the minor dimension, the third central diameter being less than the first central diameter.

Abstract: A tissue anchor includes a tissue-engaging element, a head, and a protrusion. The tissue-engaging element has a sharpened distal tip, and is configured to be driven into tissue of a subject. The head is coupled to a proximal end of the tissue-engaging element, and includes a driver interface that is configured to be reversibly engaged by an anchor driver. The protrusion protrudes away from the head such that driving the tissue-engaging element into the tissue presses the protrusion against the tissue, and is configured to move with respect to the head automatically in response to being pressed against the tissue. Other embodiments are also described.

Abstract: A catheter device includes a tube that has a distal opening that is configured to be transluminally advanced into the subject; and an extracorporeal unit that is coupled to a proximal end of the tube. A series of cartridges is arranged along the extracorporeal unit, each of the cartridges having an initial position in which the cartridge holds a respective anchor. Each of the cartridges is, moveable from the initial position to a deployment position while remaining coupled to the extracorporeal unit. A driver is configured to, for each of the anchors, sequentially, while the respective cartridge is in the deployment position, move the anchor out of the respective cartridge and through the tube toward the distal opening. Other embodiments are also described.

Abstract: Apparatus comprising a tissue anchor for use with an anchor driver. The anchor comprises a head, and a tissue-engaging element coupled to a proximal end of the head. The tissue-engaging element defines a central longitudinal axis of the anchor, and has a sharpened distal tip, configured to be driven into tissue of a subject. The head comprises a driver interface, configured to be reversibly engaged by the anchor driver, and an eyelet, disposed laterally from the central longitudinal axis, defining an aperture on an aperture plane, the aperture having a length along a long axis of the aperture and a width along a short axis of the aperture, the long axis and the short axis disposed on the aperture plane. The eyelet is mounted such that the aperture plane is slanted at a fixed angle with respect to the central longitudinal axis. Other applications are also described.