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: A surgical site retractor is configured to retract tissue, such as in an intercostal procedure. The retractor may be formed from non-radiopaque material for improved monitoring via x-ray imaging. The retractor may have a rigid retractor and a soft tissue retractor, where the rigid retractor has a plurality of legs and the soft tissue retractor extends between the legs to prevent soft tissue from extending between said legs. The retractor may have a bendable arm with an implement holder, such as distal cuff or clip adapted to resiliently hold an implement such as a tube of an elongated port-access device. A method involves partly installing the surgical site retractor, expanding the surgical site retractor, deploying the surgical implement from outside the body through the incision and into the patient, resiliently capturing the implement with the holder of the arm, and bending the arm to hold the implement in a desired position.

Abstract: Disclosed herein are suture clip delivery devices that can be loaded with several flat, disk-shaped suture clips and can deploy the suture clips one after another onto respective sutures without reloading the device with additional suture clips. An exemplary device includes a handle portion with an actuation mechanism that is coupled to a shaft portion that holds and deploys the suture clips. The shaft portion includes a mandrel on which the suture clips are mounted and a retainer that restricts the suture clips from moving proximally when the actuation mechanism pulls the mandrel proximally, which causes a distal-most suture clip to slide off the mandrel and be deployed onto one or more suture. The mandrel and remaining suture clips can them move distally to prepare to deploy the next suture clip.

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. Some embodiments include an elongated coil with a hole passing between the elongated coil and an adjacent coil. Further embodiments disclose cannulae that include a wire helically wound to form coils, and an insert having a porous section with at least one hole.

Abstract: A surgical site retractor is configured to retract tissue, such as in an intercostal procedure. The retractor may be formed from non-radiopaque material for improved monitoring via X-ray imaging. The retractor may have a rigid retractor and a soft tissue retractor, where the rigid retractor has a plurality of legs and the soft tissue retractor extends between the legs to prevent soft tissue from extending between said legs. The retractor may have a bendable arm with an implement holder, such as distal cuff or clip adapted to resiliently hold an implement such as a tube of an elongated port-access device. A method involves partly installing the surgical site retractor, expanding the surgical site retractor, deploying the surgical implement from outside the body through the incision and into the patient, resiliently capturing the implement with the holder of the arm, and bending the arm to hold the implement in a desired position.

Abstract: Disclosed herein are suture clip delivery devices that can be loaded with several flat, disk-shaped suture clips and can deploy the suture clips one after another onto respective sutures without reloading the device with additional suture clips. An exemplary device includes a handle portion with an actuation mechanism that is coupled to a shaft portion that holds and deploys the suture clips. The shaft portion includes a mandrel on which the suture clips are mounted and a retainer that restricts the suture clips from moving proximally when the actuation mechanism pulls the mandrel proximally, which causes a distal-most suture clip to slide off the mandrel and be deployed onto one or more suture. The mandrel and remaining suture clips can them move distally to prepare to deploy the next suture clip.

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: 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: In one embodiment, a multi-layer suture fastener that includes a generally disc-shaped body defining a plurality of axially spaced-apart layers. Each layer can include an inner axial surface and an outer axial surface. A suture opening can extend from the inner axial surface to the outer axial surface of each layer. The suture openings can have an open configuration and a closed configuration. One or more lines of suture can be passed through the suture openings when in the open configuration. The suture openings can be placed in the closed configuration. In the closed configuration, the one or more lines of suture can be restricted by radial surfaces of the suture opening from sliding through the suture openings in at least one longitudinal direction of the one or more lines of suture.

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: A device for deploying a suture clip onto a suture can include a proximal handle portion that includes an actuation mechanism. The device can also include an outer shaft defining an inner lumen. A crimping assembly can be at least partially disposed within a distal end of the outer shaft. The crimping assembly can include a plurality of crimping members configured to receive and radially compress a suture clip. The actuating mechanism can be configured to move the plurality of crimping members radially inwardly from a first position, where the crimping members are configured to receive a suture clip, to a second position where the plurality of crimping members are configured to radially compress the suture clip, causing the suture clip to plastically deform and become secured around one or more sutures.

Abstract: A surgical site retractor is configured to retract tissue, such as in an intercostal procedure. The retractor may be formed from non-radiopaque material for improved monitoring via X-ray imaging. The retractor may have a rigid retractor and a soft tissue retractor, where the rigid retractor has a plurality of legs and the soft tissue retractor extends between the legs to prevent soft tissue from extending between said legs. The retractor may have a bendable arm with an implement holder, such as distal cuff or clip adapted to resiliently hold an implement such as a tube of an elongated port-access device. A method involves partly installing the surgical site retractor, expanding the surgical site retractor, deploying the surgical implement from outside the body through the incision and into the patient, resiliently capturing the implement with the holder of the arm, and bending the arm to hold the implement in a desired position.

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: A surgical site retractor is configured to retract tissue, such as in an intercostal procedure. The retractor may be formed from non-radiopaque material for improved monitoring via x-ray imaging. The retractor may have a rigid retractor and a soft tissue retractor, where the rigid retractor has a plurality of legs and the soft tissue retractor extends between the legs to prevent soft tissue from extending between said legs. The retractor may have a bendable arm with an implement holder, such as distal cuff or clip adapted to resiliently hold an implement such as a tube of an elongated port-access device. A method involves partly installing the surgical site retractor, expanding the surgical site retractor, deploying the surgical implement from outside the body through the incision and into the patient, resiliently capturing the implement with the holder of the arm, and bending the arm to hold the implement in a desired position.

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: 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: A device for suturing an incision in an artery has a handle, a supply of suture stored on spindle housed in the handle, a tube extending from the handle having a lumen through which suture extends, and a curved needle at a distal end of the handle, the curved needle having an opening through which a free end of the suture extends. A method for suturing an incision in an artery includes creating sequential openings in first and second flaps of the incision, with loops of suture extending through openings in one flap, with a free end of suture extending through the second flap being pulled through the loops and secured to another free end of suture extending through the first flap, to close the incision.

Abstract: The present disclosure concerns embodiments of multi-lumen cannulae that can be used in various different medical procedures. The multi-lumen cannulae can comprise an elongated body comprising multiple different ports that connect to the various different sidewall lumens contained within the elongated body. The multi-lumen cannulae can also comprise a central lumen that extends through the entire elongated body and can be fluidly connected to the various different sidewall lumens. The multi-lumen cannulae can further comprise two balloons on the exterior of the elongated body, which can be used to isolate the right atrium of a patient's heart.

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: Disclosed herein are exemplary embodiments of suture securement devices that replace the need to tie knots in sutures. Some embodiments comprise an annular outer body and one or more suture engagement tabs extending inwardly from the outer body. The devices can comprise a superelastic and/or shape-memory material and have a generally in-plane initial configuration. The suture engagement portions are deformable out-of-plane to an active configuration with the outer body compressed and the tabs interlocked with each other. The device can be heat-set in the deformed configuration. The interlocked tabs exert a pinching force on sutures passing between them that restricts the sutures from sliding through the opening in one longitudinal direction.