Abstract: Described herein are reusable surgical needles having a resiliently collapsible rear loop that captures a suture as it is passed through an object and resiliently expands upon exiting the object to release the suture. Also described are suture spool assemblies that comprise a rigid housing and a rotatable spool of suture material suspended within the housing so that a plurality of sutures can be dispensed from the assembly in succession during a surgery. Also described are annular pledgets having diametrical dimensions similar to an outer ring of a cardiac implant such that a single annular pledget can be used with a plurality of sutures that secure the cardiac implant to native tissue around the perimeter of the cardiac implant. Related methods of suturing cardiac implants are also disclosed.

Abstract: A multiple-fire securing device includes a hollow outer shaft, a reloader, a reloader movement assembly, a rail, and securing structures each defining an inner securing orifice. The reloader longitudinally moves within the outer shaft and has a distal end shaped to temporarily contact one of the securing structures. The rail is disposed within the reloader and has an installing location. The securing structures are disposed on the rail. The reloader movement assembly moves the reloader longitudinally in a distal direction to deliver a first securing structure to the installing location from a first proximal position and moves the reloader proximally away from the installing location without the first securing structure to a position in which the distal end of the reloader temporarily contacts a second one of the securing structures. The second and successive securing structures are moved one at a time to the installing location.

Abstract: Disclosed are devices and methods for delivering several sutures accurately and simultaneously around the perimeter of an annular prosthetic device (prosthetic heart valve, annuloplasty ring, etc.) to secure the prosthetic device within a native heart valve region. Devices can comprise a proximal handle portion including an actuator and a distal suturing portion including several curved and straight needles arrayed around the shaft axis. The straight needles and the curved needles are configured to simultaneously guide a plurality of sutures through the native tissue and through the annular prosthetic device. The actuator can cause the straight needles to move axially relative to the curved needles and can also cause the curved needles to rotate, such that the motions are coordinated to simultaneously place all the sutures.

Abstract: Some disclosed suture securement devices comprise a flat, thin, generally planar body that has one or more suture engagement slots extending into the body from a perimeter inlet for receiving sutures laterally into the device. The slots can be resiliently widened to receive a suture and then released to clamp onto the suture. Some embodiments include two or more such suture engagement slots that independently receive and secure different sutures. Some embodiments include one or more locking tabs that have a closed position that retains the slots against widening and blocks the inlet to the slot. In some embodiment two or more slots are position next to each other on the same side of the device, while in other embodiments slots are positioned on opposite sides of the device. Other types of suture securement devices are also disclosed.

Abstract: Disclosed herein are annular prosthetic devices, such as annuloplasty rings, that include suture clips integrated into or mounted within an annular frame. The clips can quickly secure to sutures to obviate the need to tied knots in the sutures during implantation. Embodiments comprise an annular frame having an open central region and a plurality of suture clips spaced angularly apart around the frame. Each of the suture clips can comprise two opposing tabs that extend toward each other such that the suture clip forms a gripping region between ends of the tabs and the gripping region is configured to grip a suture inserted through the suture clip between the two tabs. The annular frame and the plurality of suture clips can be formed from a single piece of flat material with the suture clip tabs being formed by laser cutting the piece of flat material, or the suture clips can be movable along a track formed in the annular frame.

Abstract: Described herein are reusable surgical needles having a resiliently collapsible rear loop that captures a suture as it is passed through an object and resiliently expands upon exiting the object to release the suture. Also described are suture spool assemblies that include a rigid housing and a rotatable spool of suture material suspended within the housing so that a plurality of sutures can be dispensed from the assembly in succession during a surgery. Also described are annular pledgets having diametrical dimensions similar to an outer ring of a cardiac implant such that a single annular pledget can be used with a plurality of sutures that secure the cardiac implant to native tissue around the perimeter of the cardiac implant. Related methods of suturing cardiac implants are also disclosed.

Abstract: Described herein are systems and methods for securing sutures that obviate the need for tying knots. Instead of tying two ends of a suture or two sutures together with a knot, two or more suture portions can be fused or cauterized together using heat. A device can be applied to adjacent suture portions that heats the suture portions and causes the suture portions to fuse together, effectively securing the suture portions together without a knot.

Abstract: A knotless suture fastener installation system for securing medical devices such as cardiac implants. The knotless suture fasteners may be spring-biased so as to grip onto sutures passed therethrough. The system includes a fastener deployment tool with a proximal handle and a distal shaft to which a fastener cartridge attaches. A plurality of disposable cartridges are sequentially attached to the end of the deployment tool and used to secure the medical implant one fastener at a time. The deployment tool may also cut the sutures being fastened.

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: Disclosed suture clips comprise a generally disk-shaped body having an annular outer body, first and second tabs extending radially inwardly from opposing sides of the annular outer body, first and second slots passing through a thickness of the suture clip and separating the annular outer body from lateral sides of the first and second tabs, and the first and second slots comprise stepped portions configured to align the suture clip on a rail of a clip deployment device. The stepped slots create bracketing surfaces that interface with the rail on which the clips are mounted, such that the bracketing surfaces prevent or limit the freedom of the clips from tilting or shifting relative to the rail. The disclosed clips can also comprise rounded edges on engagement surfaces of the tabs to minimize particulate formation.

Abstract: Disclosed are devices and methods for delivering several sutures accurately and simultaneously around the perimeter of an annular prosthetic device (prosthetic heart valve, annuloplasty ring, etc.) to secure the prosthetic device within a native heart valve region. Devices can comprise a proximal handle portion including an actuator and a distal suturing portion including several curved and straight needles arrayed around the shaft axis. The straight needles and the curved needles are configured to simultaneously guide a plurality of sutures through the native tissue and through the annular prosthetic device. The actuator can cause the straight needles to move axially relative to the curved needles and can also cause the curved needles to rotate, such that the motions are coordinated to simultaneously place all the sutures.

Abstract: Some disclosed suture securement devices comprise a flat, thin, generally planar body that has one or more suture engagement slots extending into the body from a perimeter inlet for receiving sutures laterally into the device. The slots can be resiliently widened to receive a suture and then released to clamp onto the suture. Some embodiments include two or more such suture engagement slots that independently receive and secure different sutures. Some embodiments include one or more locking tabs that have a closed position that retains the slots against widening and blocks the inlet to the slot. In some embodiment two or more slots are position next to each other on the same side of the device, while in other embodiments slots are positioned on opposite sides of the device. Other types of suture securement devices are also disclosed.

Abstract: Disclosed herein are annular prosthetic devices, such as annuloplasty rings, that include suture clips integrated into or mounted within an annular frame. The clips can quickly secure to sutures to obviate the need to tied knots in the sutures during implantation. Embodiments comprise an annular frame having an open central region and a plurality of suture clips spaced angularly apart around the frame. Each of the suture clips can comprise two opposing tabs that extend toward each other such that the suture clip forms a gripping region between ends of the tabs and the gripping region is configured to grip a suture inserted through the suture clip between the two tabs. The annular frame and the plurality of suture clips can be formed from a single piece of flat material with the suture clip tabs being formed by laser cutting the piece of flat material, or the suture clips can be movable along a track formed in the annular frame.

Abstract: Described herein are systems and methods for securing sutures that obviate the need for tying knots. A device can be applied to adjacent suture portions that heats the suture portions and causes the suture portions to fuse together, effectively securing the suture portions together without a knot. The device can include a handle, an outer shaft coupled to the handle, an inner shaft movable proximally and distally within the outer shaft; a suture holder at the distal end portion of the outer shaft, and an electrical heating element positioned within the outer shaft. Actuation of the device causes the inner shaft and the heating element to move distally relative to the outer shaft and the suture holder, such that the heating element moves into the proximity of the suture holder to fuse together sutures held by the suture holder.

Abstract: A knotless suture fastener installation system for securing medical devices such as cardiac implants. The knotless suture fasteners may be spring-biased so as to grip onto sutures passed therethrough. The system includes a fastener deployment tool with a proximal handle and a distal shaft to which a fastener cartridge attaches. A plurality of disposable cartridges are sequentially attached to the end of the deployment tool and used to secure the medical implant one fastener at a time. The deployment tool may also cut the sutures being fastened.

Abstract: Suture clip deployment devices for applying suture clips to sutures are described. Some embodiments can include a generally tubular main body and a vacuum port located at the distal end, a hollow inner body longitudinally slidable within the main body and extending from the main body at its distal end, and a suture recess located in the generally tubular main body. At least one suture clip configured to frictionally fit on an outer surface of the inner body is deployed during use. Clip deployment can occur after a vacuum source is applied to the device so as to draw the suture into the device. The suture lines can be retrieved through the suture recess, and the device can be actuated so as to deliver the suture clip off the delivery device and onto the suture, locking the suture in place.

Abstract: A cardiac implant system including a cardiac implant such as an annuloplasty ring, a prosthetic heart valve, or a valved conduit pre-assembled at the time of manufacture with devices for securing the implant to a heart valve annulus using knotless suture fasteners. The knotless suture fasteners may be embedded within a pliant sealing edge of the cardiac implant, or they may be positioned adjacent to the sealing edge. The knotless suture fasteners are spring-biased so as to grip onto annulus anchoring sutures pass to therethrough upon removal of a restraining device, such as a hypotube inserted within the suture fasteners. Guide tubes are assembled in line with the suture fasteners to permit introduction of suture snares that pass through the suture fasteners and through the sealing edge to facilitate capture of the pre-installed annulus anchoring sutures.

Abstract: Disclosed herein are embodiments of spring cannulae, including one or more holes in the sidewall of the cannula. Some disclosed cannulae include a wire, helically wound to form coils, and at least one hole in the cannula that interrupts one or more of the coils. Some embodiments further include a fused region of the coils through which the hole passes. Some embodiments include a ring attached to ends of the interrupted coils, where the hole is surrounded by the ring. Some embodiments include a sheath that is attached to a radial surface of the interrupted coils, where the hole passes radially though the sheath.

Abstract: Suture clip deployment devices for applying suture clips to sutures are described. Some embodiments can include a generally tubular main body and a vacuum port located at the distal end, a hollow inner body longitudinally slidable within the main body and extending from the main body at its distal end, and a suture recess located in the generally tubular main body. At least one suture clip configured to frictionally fit on an outer surface of the inner body is deployed during use. Clip deployment can occur after a vacuum source is applied to the device so as to draw the suture into the device. The suture lines can be retrieved through the suture recess, and the device can be actuated so as to deliver the suture clip off the delivery device and onto the suture, locking the suture in place.

Abstract: A prosthetic valve assembly and method of implanting same is disclosed. The prosthetic valve assembly includes a prosthetic valve formed by support frame and valve leaflets, with one or more tethers each having a first end secured to the support frame and the second end attached to, or configured for attachment to, to papillary muscles or other ventricular tissue. The tether is configured and positioned so as to avoid contact or other interference with movement of the valve leaflets, while at the same time providing a tethering action between the support frame and the ventricular tissue. The valve leaflets may be flexible (e.g., so-called tissue or synthetic leaflets) or mechanical.