Abstract: Devices, systems and methods for passing a suture. In general, described herein are suturing devices, such as suture passers, as well as methods of suturing tissue. These suture passing devices may include dual deployment suture passers in which a first distal jaw member is moveable at an angle with respect to the longitudinal axis of the elongate body of the device and the second distal jaw member is retractable proximally to the distal end region of the elongate body and/or the first jaw member. Also described herein are suture passers in which the tissue penetrator passing the suture travels in an approximately sigmoidal pathway, with the distal end of the tissue penetrator extending distally from one jaw of the device.

Abstract: The present invention provides an intracardiac device suitable for minimally-invasive delivery, wherein said device comprises a device body and one more stabilizing elements attached to said device body. The stabilizing elements may be selected from the group consisting of: stabilizing wings having at least one portion with a thickness greater than that of the device body, wings comprising one or more auxiliary support arms, wings having a metal wire coil wound around them, wings having a leaf spring attached thereto, polymer-coated stabilizing wings, and mechanical stabilization elements comprising a rotatable jaw-like structure.

Abstract: The needle holder includes a primary hollow shaft, a secondary hollow shaft attached to the primary hollow shaft in a generally “T” configuration, a pair of extendible jaws rotatably positioned at a distal end of the primary shaft, a trigger mechanism mounted on the primary shaft for selectively extending the jaws, a first rotation member in the primary shaft, a second rotation member in the secondary shaft, a driven gear attached to the first rotation member, and a drive gear attached to the second rotation member and configured to selectively engage the first gear. The jaws are selectively extendible and rotatable.

Abstract: The present disclosure relates to an anchor assembly. The anchor assembly includes an anchor defining a cavity and an opening to the cavity and an insertion member configured for arrangement within the anchor cavity. The insertion member may include a body having a proximal end portion and a flat distal end portion. A method of tissue repair and other anchor assemblies are also disclosed.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repairing the native valve of a patient during a non-open-heart procedure. The system includes a surgical delivery instrument, a valve repair device, and a gripper control mechanism. The surgical delivery instrument has at least one lumen. The valve repair device is configured to be delivered through the lumen of the surgical delivery instrument and to be attached to a native valve of a patient. The valve repair device has a pair of paddles, and first and second gripping members. The paddles are movable between an open position and a closed position. The paddles and the first and second gripping members are configured to attach to the native valve of the patient. The gripper control mechanisms each include a suture and a wire having a loop at a distal end. The suture extends from the surgical delivery instrument and through the loop of the wire. The suture is removably attached to the gripping member.

Abstract: A port closure device includes a pair of jaws that may move repeatably between open and closed positions and repeatably pass a needle therebetween. The jaws are generally perpendicular to a longitudinal axis of the device in the closed position and generally parallel to the longitudinal axis in the open position. The device further includes a jaw control rod for controlling movement of the jaws and a needle control rod for controlling the passing of the needle between the two jaws.

Abstract: Systems and method are described for counterbalancing the force required to deform a flexure joint. The system includes an elastically deformable flexure joint, a control joint, and an energy balance system. The control joint is mechanically linked to the flexure joint such that movement of the control joint causes a corresponding deformation of the flexure joint. The energy balance system provides a spring force to aid movement of the control joint and to overcome an elastic force required to deform the flexure joint.

Abstract: A vascular closure device includes an anchor, a suture carrying portion, and a plurality of needles. The anchor is positionable through a vessel puncture in a vessel wall and operable between expanded and contracted positions. The suture carrying portion is positioned distal of the anchor and configured to carry at least one suture. The plurality of needles are operable between an advanced position extending through the vessel wall adjacent to the vessel puncture to connect to the at least one suture, and a retracted position in which the plurality of needles position the at least one suture through the vessel wall. At least one of the plurality of needles extends through an aperture in the anchor when in the advanced position.

Abstract: Described herein are tissue closure devices and methods for ligating a target tissue, such as the left atrial appendage. The tissue closure device may have an elongate body, a snare at least partially housed within the elongate body, a suture at least partially housed within the elongate body, and a tightening element coupled to the suture. The suture may have a suture loop, and the tightening element may be configured to decrease the size of the suture loop when the area of a tissue within the suture loop decreases.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a surgical delivery instrument, a valve repair device, and a paddle control mechanism. The surgical delivery instrument has at least one lumen. The valve repair device is configured to be delivered through the lumen of the surgical delivery instrument and to attach to a native valve of a patient. The valve repair device includes a first paddle, a second paddle, and a pair of gripping members. The first and second paddles are movable between an open position and a closed position. The paddles and the gripping members are configured to attach to the native valve of the patient. The paddle control mechanism is configured to move the first and second paddles independently of each other.

Abstract: Embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support member is positioned to at least partially surround the native leaflets of a valve. A locking member is used to couple both ends of the support member, forming a support band. An expandable prosthetic heart valve is delivered into the native heart valve and expanded while the expandable prosthetic valve is at least partially within the support band, thereby causing one or more of the native leaflets of the native heart valve to be frictionally secured between the support band and the expanded prosthetic heart valve.

Abstract: A torque-transmitting, variably-flexible device, comprising a hollow body having a proximal end, a distal end and a given length, a torque-transmitting element that extends substantially entirely over the given length of the hollow body, a steering element that steers the distal end of the hollow body, the steering element being comprised of steering tendons disposed within the hollow body, and stiffening tendons disposed within the hollow body to selectively maintain the hollow body in a relatively stiff condition, wherein the stiffening tendons are unassociated with the steering element of the device.

Abstract: A surgical training device is provided. The training device includes a practice model comprising a base with a plurality of eyelets connected to the outer surface of the base. The plurality of eyelets defines at least one predetermined pathway for practicing the passing of at least one needle and suture through the eyelets of the predetermined pathway. Various eyelets are described including angled, flexible, deflectable, interchangeable, retractable, rotatable and ones having apertures of various shapes and sizes. The predetermined pathway is marked with markings on the outer surface of base or with color-coded eyelets. Suture pathways define anatomical pathways as well as differing skill levels. The model provides a platform for practicing hand-to-hand transfer and depth perception among other skills required in laparoscopic procedures.

Abstract: A recanalization catheter for facilitating re-entry into a lumen of a blood vessel from a subintimal space. The recanalization catheter includes first and second mechanically actuatable wings positioned at a distal region of the elongate shaft of the catheter that are actuatable between a retracted position and an expanded position. In the retracted position the mechanically actuatable wings are positioned in first and second elongate channels defined in the elongate shaft, and in the expanded position the mechanically actuatable wings extend outward from the first and second elongate channels. The actuatable wings extend in an arcuate path away from the elongate shaft in the expanded position to be positionable in a circumferential orientation within a subintimal space formed in a vessel wall to automatically orient a lateral port of the elongate shaft toward the true lumen.

Abstract: Implant delivery systems are disclosed. In general overview, an exemplary system includes any number of the following: a delivery device, a sling assembly, guide members, and connectors that interconnect the above. Embodiments of all the above components and their combinations are disclosed. Methods of using the above system in suprapubic, prepubic, transvaginal, trans-obturator and other approaches are also disclosed.

Abstract: An arthroscopic surgical device for tunneling through hard tissue including an arcuate tunneling needle driver and a bone engagement element, the arcuate needle driver and the bone engagement element being joined together to provide a joined needle driver and bone engagement element having at least two different operative orientations including an arthroscopic operative orientation wherein the joined arcuate needle driver and bone engagement element has a trans-incision insertion cross-sectional footprint and a tunneling operative orientation suitable for tunneling, wherein the joined arcuate needle driver and bone engagement element has a tunneling cross-sectional footprint which is substantially greater than the insertion cross-sectional footprint.

Abstract: Devices, systems and methods for compressing, cutting, incising, reconfiguring, remodeling, attaching, repositioning, supporting, dislocating or altering the composition of tissues or anatomical structures to alter their positional or force relationship to other tissues or anatomical structures. In some applications, the invention may be used to used to improve patency or fluid flow through a body lumen or cavity (e.g., to limit constriction of the urethra by an enlarged prostate gland).

Abstract: Apparatus and methods for forming pilot holes in bone and deploying a staple therein for fixing a sheet-like implant to the bone. A pilot hole forming trocar assembly including a trocar and a position retention sleeve can be included. The trocar can be releasably coupled to the position retention sleeve and slide in keyed arrangement within the sleeve when uncoupled. The trocar can include a distal portion having a retractable blade and a pair of pilot hole forming spikes extending distally from the trocar shaft. Once the pilot holes are formed, the position retention sleeve maintains the position relative to the pilot holes while the trocar is removed and a staple delivery device can be inserted in the lumen of the position retention sleeve to deploy a staple in the pilot holes.

Abstract: A device for gathering tissue of a heart valve leaflet may include an outer tube extending in an elongation direction and having an open distal end, a capture tool movable in the outer tube between a contained position and a use position, and a tissue securing component disposed at a distal end of the outer tube and adapted to be applied to captured tissue of the heart valve leaflet to hold the captured tissue in a gathered configuration. The outer tube may have an inner surface and a lumen extending therethrough. The capture tool may be operable to capture tissue of the heart valve leaflet and to draw the captured tissue into the outer tube in the gathered configuration. The tissue securing component may be a suture having a looped portion. At least part of the looped portion may extend through a lumen of at least one support tube.

Abstract: End effectors with redundant closing mechanisms, and related tools and methods are disclosed. The disclosed end effectors may be particularly beneficial when used for minimally invasive surgery. An example surgical tool comprises an elongate shaft having a proximal end and a distal end, a tool body disposed at the distal end of the shaft, a jaw movable relative to the tool body between a clamped configuration and an open configuration, a first actuation mechanism coupled with the jaw and operable to vary the position of the jaw relative to the tool body between the clamped configuration and the open configuration, and a second actuation mechanism coupled with the jaw. The second actuation mechanism has a first configuration where the jaw is held in the clamped configuration and a second configuration where the position of the jaw relative to the tool body is unconstrained by the second actuation mechanism.

Abstract: A personal electronic device (PED)-endoscope image and diagnosis capture system is provided. The system includes a PED adapter having a magnification lens connection side and a PED connection side. A magnification lens is connectable with the lens connection side of the PED adapter. An eyepiece lens coupler is also provided and connects the magnification lens to the endoscope eyepiece. A PED is connected to the PED adapter and includes a processor, a memory and an image capture system with a PED lens. The PED adapter aligns the magnification lens with the PED lens. The processor is configured to activate the image capture system using a remote or voice-activated trigger signal and store captured images in the PED memory. Patient data and examination data can be associated with the images, and the images and data can be transferred from the PED to an electronic medical records system.

Abstract: The present embodiments provide apparatus and methods for treating tissue by applying a force to the tissue. In one embodiment, the apparatus comprises a deployable segment having proximal and distal regions, a main body extending therebetween, and a loop member formed at the distal region of the deployable segment. A cannula having a bore is dimensioned to circumferentially surround at least a portion of the main body at a location proximal to the loop member, and a spring member is disposed between the cannula and the loop member. The proximal end of the spring member is affixed to the cannula, and the distal end of the spring member is movable to apply a compressive force to adjust the size of the opening of the loop member and compress tissue disposed within the opening of the loop member. In an alternative embodiment, the cannula is omitted, and a diameter of the loop member is configured to be reduced and increased any number of times before final deployment of the deployable segment.

Abstract: An intramedullary implant has opposite ends inserted into bores in abutting phalanges for correcting hammer toe and for similar arthrodesis procedures. A rear end of the implant may be threaded and is received in a bore in the proximal phalanx. A front end has an asymmetric pointed shape with longitudinally and/or angularly spaced rear-facing gripping flukes. The pointed front end is received in the middle phalanx. The asymmetric pointed shape is self-aligning, enabling entry to begin without first longitudinally aligning the bones. The rear end when screwed into place can be rotated to select the orientation of the asymmetric pointed shape. The pointed front end is inserted and pushed to bring the phalanges into abutment where the implant holds them against retraction or rotational displacement.

Abstract: An electrosurgical instrument includes a housing, a shaft extending from the housing, and an end effector assembly attached at a distal end of the shaft. A handle assembly is coupled to the housing and includes a movable handle for manipulating the end effector assembly. An outer sleeve is disposed about the shaft and selectively translatable relative thereto. An energizable member is operably coupled to the outer sleeve. A deployment mechanism is provided including a lever rotatably coupled to the housing and positioned proximally of the movable handle and at least one link member coupled between the lever and the outer sleeve. The link member(s) couple to the outer sleeve distally of the movable handle. Rotation of the lever translates the outer sleeve distally to move the outer sleeve over the end effector assembly and simultaneously deploy the energizable member distally past the end effector assembly.

Abstract: A vein harvesting device. The vein harvesting device includes a retractor and a drive shaft. The retractor includes an elongated portion defining a longitudinal axis, and supports a first engagement structure including a plurality of first tines. The drive shaft includes an elongated portion, and is movable along the longitudinal axis with respect to the retractor such that the elongated portion of the drive shaft contacts the first engagement structure causing the plurality of first tines to move about the longitudinal axis from a first position to a second position.

Abstract: An adjustable annuloplasty ring assembly (10) comprises a support ring (30), an adjustable ring (32) nested at least partly within the support ring, and at least one deployable pressing element (34) for deforming the adjustable ring using the support ring (30) as support. Plural pressing elements (34) may be used at different positions around rings. Each pressing element (34) may have a variable extents of deployment, to vary the extent of deformation of the adjustable ring at the position of the pressing element. Each pressing element may comprise a deflectable blade (40), and the state of the blade may be retained by a ratchet (50). The pressing elements may be operated in a predetermined controlled sequence.

Abstract: A device for delivering an implant (e.g., an embolic micro-coil) to a vascular disorder of a patient includes a delivery pusher, a moveable element, and first and second elongate members. The delivery pusher defines a lumen between its proximal and distal ends. The moveable element (e.g., a floating tube or a floating coil) defines a passageway therethrough and is disposed within the lumen of the delivery pusher. The first and second elongate members (e.g., core wires) are also disposed within the lumen of the delivery pusher. A portion of each elongate member passes through the passageway of the moveable element. Movement of the first elongate member in a first direction (e.g., retraction of the first elongate member from a locked to an unlocked configuration) causes a time-delayed or lost motion movement of the second elongate member in the same (i.e., first) direction, which releases the implant from the delivery pusher.

Abstract: The invention in certain aspects relates to a surgical fastener for fastening tissue segments having tissue surfaces. The fastener includes a first fastener member having a base and a piercing element connected to the base for piercing the tissue segments to be fastened, a second fastener member having an opening for receiving and retaining the piercing element of the first fastener member such that the tissue segments to be fastened are retained between the first and second fastening members, and means for promoting adhesion between the tissue surfaces. The invention also relates to related methods and devices for promoting adhesion of tissue segments and preventing fastener migration, especially in an endoscopic procedure for the treatment of GERD.

Abstract: A surgical instrument including a power assist device, and its method of use for deploying surgical fasteners, is disclosed. The surgical instrument may include a handle, an elongated shaft extending from the handle, and a surgical fastener deployment system including a driveshaft. The driveshaft is actuatable between at least a first proximal position and a second distal position. A striker is movable relative to the driveshaft and an impact surface is associated with the driveshaft. The impact surface is constructed and arranged to be struck by the striker member to displace the driveshaft to the second distal position and deploy the surgical fastener.

Abstract: An apparatus for gathering of tissue of a heart valve leaflet comprises an elongated member and a grasping assembly movable in the elongated member between a retracted position and an extended position. The grasping assembly includes an actuating arm having a proximal end and a distal end. The grasping assembly is attached to the distal end of the activating arm. The grasping assembly is operable to gather and clamp the tissue of the heart valve leaflet such that clamped tissue has a gathered configuration.

Abstract: A fistula treatment system comprises a guide such as a guide coil 1101 which is adapted to extend partially around a tissue tract and an implant element 1102. The implant element 1102 is activated to draw tissue surrounding the tract inwardly.

Abstract: A fastener is provided for attaching body tissue to body tissue or another material to body tissue. The fastener includes a head portion, a body portion, and an anchoring element. The anchoring element is on the distal end of the fastener, and has one or more barbs or similar anchoring devices that are configured to prevent removal of the fastener once it is attached to the body tissue. The head is located on the proximal end of the fastener, and anchors the body tissue or other material when the fastener is attached to the body tissue. The disclosure also provides a driver apparatus for inserting the fasteners. The applicator device includes an indexer for sequentially indexing one or more fasteners, and a driver for applying an insertion force to a fastener that is sufficient to insert the fastener and attach it to body tissue. The disclosure also provides a method of using the fastener and applicator device.

Abstract: A shaft for a rigid endoscopic instrument includes an elongate outer shaft and an elongate transmission element that can be arranged movably inside the outer shaft, wherein the outer shaft includes a proximal portion and a distal portion, which can be connected releasably to each other. The invention also relates to a rigid endoscopic instrument having such a shaft.

Abstract: A system and method for repairing a human heart uses a catheter with an extendable tip and multiple tissue fasteners. The catheter is advanced into a human heart with the extendable tip adjacent a first tissue portion. The extendable tip is extended to form a tissue-receiving opening, the first tissue portion is positioned within the tissue-receiving opening, and the extendable tip is withdrawn to mechanically hold the first tissue portion. A first tissue fastener is secured to the first tissue portion, which is then released from the tissue-receiving opening. A second tissue fastener may subsequently be passed through a second tissue portion.

Abstract: Apparatus and methods for Achilles tendon repair are described where an elongate tendon repair assembly may be introduced into a single incision to access the damaged tissue. The assembly may define a channel for receiving a portion of the tendon and which may provide support to the tissue during repair. One or more retractable needles each carrying a length of suture may be deployed within the channel for piercing through the tendon and a cinching member may secure each of the suture lengths for tensioning the suture against the damaged tendon. Once the suture lengths have been deployed, the needles may be retracted and the device removed from the incision.

Abstract: A surgical suturing system comprises a shaft having a proximal end, a distal end, a longitudinal axis between the proximal and distal ends, and receiver on the distal end with a rotary drive. A cartridge is selectively attachable to and detachable from the receiver. The cartridge has a surgical needle, a length of suture connected to the needle, a needle driver operative to engage and move the needle relative the cartridge, a transmission operatively connected to the needle driver, and a torsional interface rotationally coupling the rotary drive to the transmission.

Abstract: A absorbable surgical screw fastener is provided which includes a head and a tapered shaft extending distally of the head. Buttress threads are provided about the tapered shaft to secure the fastener in tissue. The fastener includes slots formed in the head and buttress threads. A gap is provided between the buttress threads in the head to secure a prosthetic. There is also provided a surgical instrument having novel lockout structure to prevent inadvertent actuation.

Abstract: Embodiments of the invention may be directed to apparatuses for securing and sealing apertures in tissue and related methods of use.

Abstract: The present disclosure relates to a suture anchor. The suture anchor includes a body having a proximal end and a distal end, the body including threads along at least a partial length of the body and at least one through hole, the threads including a profile such that the threads located near the distal end of the body include a first shape and the threads located near the proximal end of the body include a second shape different from the first shape. Delivery devices and anchor dilators are also disclosed.

Abstract: A clip for closing a puncture in a body lumen comprises a clip having a resiliently expandable circumference and a plurality of barbed prongs extending at least approximately in the same direction from one edge of the clip. A device for deploying such a clip is described. A method for deploying such a clip is also described.

Abstract: An anvil assembly suitable for trans-oral delivery includes an anvil head configured to receive a suture that secures the anvil head in a delivery position and is separable from the anvil head following delivery of the anvil assembly. An anvil delivery assembly includes the anvil assembly, a delivery assembly secured to the anvil assembly, and a suture selectively secured to the anvil assembly for securing the anvil assembly in a delivery position and retrieving the anvil assembly.

Abstract: An insertion device includes an elongate member and a stylet. The elongate member has a proximal end portion, a distal end portion, and defines a lumen therethrough. The stylet has a distal end portion, a proximal end portion, and is slidably coupled to the elongate member. The stylet is configured to move from a first position to a second position with respect to the elongate member. The distal end portion of the stylet is configured to removably couple a mesh carrier thereto. A portion of the distal end portion of the stylet is disposed outside of the lumen of the elongate member when the stylet is in its first position and is disposed within the lumen when the stylet is in its second position.

Abstract: Described are implants and tools for use in treating pelvic conditions such as incontinence, including urinary incontinence in a male or female, for example an incontinence sling and delivery system that can include a sling implant and delivery tool system, wherein the implant can include a mesh sling and one or more anchors provided at or extending from a portion of the sling to facilitate tissue fixation; the delivery tool system can include at least a tunneler having a lumen, and an insertion tool; and wherein useful methods can involve inserting the tunneler through an incision and into a pelvic region of a patient, connecting the insertion tool to the sling, and inserting the sling into the tunneler to place the sling to provide tissue support.

Abstract: Disclosed is an ambulatory system for monitoring one or more physiological parameters in a body lumen, such as the esophagus. The system includes an implantable probe having a sensor for the physiological parameter and a transmitter for transmitting data to an external receiver. The probe may be used for monitoring any of various physiological parameters, including pH, temperature, and pressure, within the esophagus or other body lumens. Methods and deployment catheters are also disclosed.

Abstract: A spinal implant can be fastened on a bony element of a patient via a flexible tie. In some embodiments, the spinal implant has two jaws, each having a recess and an opening. The recess is configured to receive a portion of a rod. A portion of the flexible tie is passed through the opening and between a wall of the recess and a surface of the rod to form a loop that can be placed around the bony element. The two jaws are hinged at one end and engaged at the opposite end via a locking member. The locking member can be adjusted to simultaneously hold the jaws together in a fixed position relative to the rod and lock the flexible tie, which has been properly tensioned, in translation relative to the spinal implant.

Abstract: According to an example embodiment, an implant assembly may include a first handle, a first elongated member defining a first lumen, and a tissue support member extending through the first lumen of the first elongated member, the tissue support member including a first end and a second end, the first end being attached to the first handle.

Abstract: Methods and apparatuses for lifting, suspending and stiffening a patient's tissue are disclosed. In an embodiment, a method of lifting and stiffening a patient's tissue includes inserting at least one suture into the patient's tissue in a first direction, pulling the suture in a second direction so as to lift and suspend the tissue in a lifted position and stiffen the tissue in the lifted position, and cutting the suture so that the tissue remains in the lifted position. Preferably, the patient's tissue is the patient's soft palate.

Abstract: A method for securing a suture to bone can include loading the suture in a distal opening of an inserter of an assembly. The suture can be coupled to soft tissue. The assembly can include the inserter, an anchor carried by the inserter, a distal tip and a driver each coupled to the inserter. A hole can be formed in the bone with the distal tip, and the distal opening and a portion of the suture can be positioned in the hole. The driver can be actuated to allow movement relative to the inserter and can be advanced in a first direction to drive the anchor about the inserter into the hole to secure the distal tip, anchor and suture to the bone with an absence of a knot. The driver can be moved in a second direction to remove the inserter from the distal tip, anchor and suture.

Abstract: A system and associated method for manipulating tissues and anatomical or other structures in medical applications for the purpose of treating diseases or disorders or other purposes. In one aspect, the system includes a delivery device configured to deploy and implant anchor devices for creating continuous defects or indentations in lobes of a prostate.

Abstract: A surgical clip applier includes an actuation mechanism, a body portion, a jaw blade, and a clip cartridge, the jaw blade and clip cartridge removeably disposed within the body portion. The jaw blade including first and second opposed jaws operably connected to the actuation mechanism to effectuate closure of a surgical clip, the first and second opposed jaws connected to each other at a proximal end by a shank section. The clip cartridge disposed within the body portion adjacent to the jaw blade and configured to store at least one surgical clip therein. The clip cartridge having a first nub which abuts a first end of the shank section of the jaw blade, and a second nub which abuts a second end of the shank section of the jaw blade, such that longitudinal and vertical movement of the jaw blade is arrested.