Abstract: An adjustable implant is disclosed herein. The adjustable implant may comprise a shell including membrane and a base and having a first diameter in a plane parallel to the base. A band may be disposed within the shell. The band may have a first end and a second end connected to a spool. The band may be in a round (e.g., elliptical) configuration having a second diameter in the plane that is less than the first diameter. By wrapping the band onto the spool, the diameter of the band may be decreased and the height of the implant may be increased. By unwrapping the band from the spool, the diameter of the band may be increased and the height of the implant may be decreased.

Abstract: Surgical constructs and methods are provided for securing soft tissue to bone. One exemplary embodiment of a construct is formed from a suture filament and includes two terminal ends of filament and an intermediate portion disposed along at least a portion of a length extending between the terminal ends. The construct can have a first terminal end that is the first terminal end of the filament, and a second terminal end that includes a loop. The loop can be formed by disposing the second terminal end of the filament within a volume of a portion of the intermediate portion of the filament. In some disclosed methods, both terminal ends of the filament can be passed through tissue when performing soft tissue repairs. Various other embodiments of constructs and methods are provided, including constructs having two or more filaments associated with an anchor and methods of using such constructs.

Abstract: A wound closure device includes a filamentary element having a proximal end and a distal end, and a plurality of barbs extending outwardly from the filamentary element. Each barb has a base connected with the filamentary element, a tip spaced from the base, and an outer edge that extends between the base and the tip. The outer edge includes a first section having a concave surface that extends between the base and a transition point of the barb and a second section having a convex surface that extends between the transition point of the barb and the tip of the barb. The outer edge transforms from the concave surface of the first section to the convex curve of the second section at the transition point of the barb. The tip of the barb has a convexly curved surface facing the distal end of the filamentary element.

Abstract: The invention concerns a handle for a video endoscope including a housing and an interface portion rotatably supported relative to the housing where the interface portion includes a first connector element at its distal end section that is connectable to a second connector element of an associated elongate shaft of the video endoscope. Thereby a detachable, rotatable electrical and/or mechanical connection between the handle and the associated shaft is achieved. The coupling includes an electrical connection assembly arranged at an exterior of the interface portion forming an electrical connection to a stationary electric component of the handle. The handle includes a mechanical rotation stop for a rotation of the interface portion relative to the housing such that a rotation range is limited and damage to the electrical connection assembly is prevented.

Abstract: Systems, devices, and methods are provided for securing soft tissue to bone. One exemplary embodiment of a device includes an anchor, a repair filament, and a connecting filament that is coupled to the repair filament, is in contact with the anchor's distal end, and is effective to connect the repair filament to the anchor such that the repair filament slides with respect to the anchor. The anchor can be rigid, and can include an axial bore extending therethrough. At least one of the repair filament and the connecting filament can extend through at least a portion of the axial bore, and the bore can be sized such that a portion of the filament extending therethrough barely fits to help maintain the connection between the anchor, repair filament, and connecting filament. Embodiments of the systems and devices disclosed can be used in a number of methods for repairing soft tissue.

Abstract: Meniscal repair devices, systems, and methods are provided.

Abstract: Methods and devices for transvascular prosthetic chordae tendineae implantation are disclosed. A catheter is advanced into the left atrium. From an atrium side, a leaflet anchor having a leaflet suture is secured to the mitral valve leaflet. A ventricular anchor is anchored to the wall of the ventricle to secure the ventricular wall to a ventricle suture. The leaflet suture and the ventricle suture may be tensioned and connected by a suture lock to form an artificial chordae. The suture lock has a body with a suture path extending therethrough. A wall in the housing is movable to reduce the cross section of the suture path. A drive mechanism advances the movable wall to clamp sutures extending through the suture path, in response to rotation of a coupling on the housing.

Abstract: A suture anchor for fixation within an anatomical structure includes an actuation member in contact with an anchor body at a first location thereof. The anchor body is elongate along a direction of elongation and defines a central axis. In a neutral configuration, the anchor body is flat and defines a thickness along a transverse direction and a width along a lateral direction, the width being greater than the thickness. The anchor body has first and second tails that are braided together along a portion of the actuation member from the first location to a second location of the anchor body. The actuation member is configured to apply a force to the braided anchor body so as to actuate the anchor body in a manner increasing its maximum thickness along a second direction that is angularly offset from the direction of elongation.

Abstract: This disclosure enables various threading devices (e.g., suturing devices) that can sequentially send a plurality of carriers (e.g., needle caps, sleeves) to an object (e.g., animate, inanimate, human tissue, organ tissue, heart tissue) or sequentially receive a plurality of carriers (e.g., needle caps, sleeves) from an object (e.g., animate, inanimate, human tissue, organ tissue, heart tissue). For example, some threading devices can sequentially send some carriers in a relatively rapid succession or some threading devices can sequentially receive some carriers in a relatively rapid succession.

Abstract: A suture and button construct, having an oblong button defining at least a first aperture and a second aperture; a suture length, including a braid defining a lumen and having a middle section and two end sections, each extending through a button aperture and both terminating in an end. Both ends have a needle attached. Also, two shuttles are engaged to the suture length, each having a free end and a loop end, terminating in a loop. Each shuttle enters the lumen in the middle section and extend through an aperture, while in the lumen and exit on the opposite button side from the middle section, so that both shuttle loops are available outside the lumen, to pull a suture end through the lumen and a button aperture.

Abstract: A composition and methods of making or use thereof include a plurality of fibers forming a shape for augmenting fixation of a bone screw, or the plurality of fibers form a shape having a peg portion and a sheet portion to augment tendon to bone repair. The physical presence of the plurality of fibers provides initial fixation, while the use of an osteoinductive material provides long term enhancement of bone formation around the site of the bone screw or the tendon to bone repair.

Abstract: A surgical stapling apparatus includes a staple cartridge assembly, an anvil assembly operatively associated with the staple cartridge assembly, and a surgical buttress. The staple cartridge assembly includes a tissue facing surface having staple retaining slots defined therein, each staple retaining slot housing a staple therein, and an annular knife disposed radially inwardly of the tissue facing surface. The anvil assembly includes an anvil member including a tissue facing surface having staple forming recesses defined therein, and an anvil shaft extending from the anvil member. The surgical buttress is releasably disposed on the tissue facing surface of the staple cartridge assembly or the anvil assembly. The surgical buttress has an annular configuration defining a central aperture therethrough, and includes body segments extending radially outwardly about the central aperture in spaced radial relation relative to each other, and a ring segment interconnecting the body segments.

Abstract: Bone attachment shim device composed of a biomaterial compatible with bone and provides an enhanced surface area on the outer surface of the device for engaging the bone, an enhanced surface area within the device for engaging the bone screw, and is composed of a partial shaft design which is greater than 180 but less than 270 degrees around when viewed in cross section. The device preferably has a biased tip for facilitating placement into bone tissue.

Abstract: An exemplary method includes fixating a first suture anchor in a first bone. The first suture anchor has a resilient member and a flexible strand attached to the resilient member. The flexible strand is passed to a second suture anchor, and tensioned. The second suture anchor is fixated in a second bone to secure the flexible strand to the second bone.

Abstract: Anchor delivery systems include markings on the surfaces of the delivery device which are visually exposed to the user through openings or fenestrations in the anchor, providing visual feedback to the user on the progress of the anchor's insertion. A suture-locking plug is deformable within the anchor tip, thereby enhancing suture entrapment within the tip of the anchor. A compliant component of the handle places the handle components in tension, thereby absorbing built-in axial looseness in the handle. The handle further includes a spin cavity which allows for free spin of the inserter shaft to finalize insertion of the anchor into bone when the anchor has not been fully seated flush with or below the cortical bone surface.

Abstract: The present disclosure relates to an ostomy method and an implantation method. The ostomy method includes steps of making an incision in the chest to expose the heart, puncturing the left ventricle with a puncture needle, thrusting the puncture needle into the ventricular septum and then into the right ventricle to form a puncture site on the ventricular septum, and dilating the puncture site of the ventricular septum with a dilator to form an opening. The method of the present disclosure can reduce the death rate.

Abstract: The system and method for laparoscopic repair of abdominal wall hernia using umbrella mesh includes an umbrella mesh having a substantially circular mesh attached to an umbrella-like frame having a plurality of radially spaced spokes resiliently mounted at a hub, the spokes being hollow and housing helical tacks. The umbrella mesh is folded and mounted on an umbrella load cartridge. The cartridge may be loaded on the distal end of a pistol-grip laparoscopic instrument having a rotary control for orienting the mesh over the weakened area, a mesh release handle for gradually opening and releasing the mesh, and a firing handle for firing helical tacks from the spokes for fastening the mesh to the supporting abdominal wall.

Abstract: Surgical devices and methods of soft tissue repair using pre-looped tensionable and non-pre-looped tensionable knotless fixation devices. A flexible material (for example, suture or suture tape) may be attached to the fixation device. A flexible material may be threaded through an eyelet of a tip provided as part of a swivel anchor assembly to provide added stability to the fixation devices.

Abstract: The invention is a staple comprising a bridge member having a top surface and an opposing bottom surface defining a thickness between and two lateral edges defining a width therebetween and either the thickness or the width includes a center flared area, such as a “diamond-like” shape meaning that it has a v-shape on opposing lateral edges flanked by opposing fillets to form an inserter mount area and the staple has a pair of legs spaced apart along the axis and each joined at a rounded flared shoulder to the bridge member. In a four-legged version the bridge has a waist.

Abstract: Suture passer systems for tissue suspension and tissue compression are described. The system can include a shaft and a needle, wherein the needle is freely rotatable with respect to the shaft. The suture may include an overmolded segment. Methods of placing one or more implants, sutures, fastener, bone anchors and other devices are also described. The methods include moving tissue, including the superior pharyngeal constrictor muscle, palatopharyngeal arch, and palatoglossal arch. The methods include hyoid bone suspension.

Abstract: Surgical devices and methods of tissue repair using tensionable knotless fixation devices. A flexible material (for example, suture or suture tape) may be attached to the fixation device. A flexible material may be threaded through an eyelet of a tip provided as part of a swivel anchor assembly to provide added stability to the fixation devices.

Abstract: The present disclosure provides a heart valve repair method, comprising: advancing a distal end of a suture implanting apparatus from an outside of a body through a transapical approach into a left ventricle or a right ventricle of a heart; holding each leaflet of a heart valve with the distal end of the suture implanting apparatus; implanting at least one suture into the leaflet; withdrawing the suture implanting apparatus from the body; advancing a distal end of a suture locking apparatus from the outside of a body through a transapical approach into the corresponding left ventricle or the corresponding right ventricle; using the suture locking apparatus to lock the plurality of sutures; and withdrawing the suture locking apparatus from the body. The heart valve repair method has a simple surgical procedure, a low degree of patient trauma, and a high success rate of surgery.

Abstract: The invention relates in some aspects to a device for use in anchoring an implant, including anchors, sutures, implants, clips, tools, lassos, and methods of anchoring among other methods. Anchors as disclosed herein could be utilized to secure a coaptation assistance device, an annuloplasty ring, an artificial valve, cardiac patch, sensor, pacemaker, or other implants. The implant could be a mitral valve ring or artificial mitral valve in some embodiments.

Abstract: A knotless suture anchor assembly for engaging a bone tunnel and holding suture therein to knotlessly secure said suture to soft tissue including an elongated generally cylindrical hollow outer member having an axial lumen, an outer surface with projections for engaging the wall of the bone tunnel, a distal end and a proximal end; and an elongated, generally cylindrical inner member having an axis, a proximal end and a distal end, the distal end having a transverse passage for receiving suture therethrough, the transverse passage having a proximal and distal end and adapted to receive a plurality of sutures in said eyelet, the inner member adapted to move coaxially relative to the outer member between a distal, suture-unlocked position and a proximal, suture-locked position.

Abstract: Arcuate fixation members with varying configurations and/or features are provided, along with additional components for use therewith in provided intervertebral implants. The arcuate fixation members may be of different lengths, cross sectional geometries, and/or cross sectional areas. Applications of intervertebral implants utilizing arcuate fixation members are particularly suitable when a linear line-of-approach for delivering fixation members is undesirable.

Abstract: A method for securing suture to bone comprises drilling a hole in a desired portion of bone at a desired procedural site, passing a strand of suture through a portion of soft tissue to be approximated to the portion of bone, and extending the free suture ends proximally from the soft tissue. The suture is loaded into an anchor implant. Using an inserter, on a distal end of which is attached the anchor implant, the anchor implant is manipulated into the bone hole. The suture is then tensioned to a desired level by pulling on the free suture ends, after the anchor implant is positioned in the bone hole. The free suture ends are wrapped about a suture cleat on an inserter handle once the desired tension level is achieved. A proximal anchor component is moved distally to engage with a distal anchor component to lock the anchor in place within the bone hole, and to lock the suture in place within the anchor. Then, the inserter is removed from the procedural site.

Abstract: A suture securing device having a plurality of zones includes a first zone, a second zone and a third zone. The device includes a lower layer extending across each of the first zone, the second zone and the third zone, an upper layer disposed in the first zone and the second zone, and an insert having at least one eyelet disposed in the first zone, the insert being sandwiched between the upper layer and the lower layer.

Abstract: A fibrous tissue repair device includes first and second tubular anchors having corresponding longitudinal passages. The tissue repair device includes corresponding first and second inserters. Each inserter has a shaft with a distal portion received in the longitudinal passage of the corresponding tubular anchor. A flexible strand couples the first and second anchors.

Abstract: Methods for whip-stitching soft tissue with a needle and a looped suture avoid placing the tissue graft through the suture loop, which also eliminates the need for passing a tissue clamp through the suture loop. The methods described herein can also include combinations of the techniques described.

Abstract: Devices, systems, and methods for improving airflow within an airway. One example embodiment includes a method for treating a subject. The method includes (1) placing an expandable object into one or more airways of the bronchial tree of the subject, (2) expanding the expandable object within at least one of the one or more airways such that at least a portion of a wall of the one or more airways is expanded, and (3) placing a stent in the airway such that a portion of the stent is adjacent to the portion of the wall of the one or more expanded airways.

Abstract: This invention relates to devices that join a pair of edges. Previously, suture assemblies used holes perpendicular to a vertical plane. Embodiments of the present invention use a first pad tunnel (130) between a first pad lower plane opening (126) and a first pad upper plane opening (122). A first pad tunnel major axis (132) passes through a first pad upper plane opening center (124) and a first pad lower plane opening center (128). For reference a first pad orthogonal axis (134) passes through the first pad upper plane opening center (124) orthogonal to the first pad upper plane (118) and the first pad lower plane (120). A first pad angle (?1) is measured clockwise from the first pad orthogonal axis (134) to the first pad tunnel major axis (132). The first pad angle is at least five degrees but no more than 175 degrees.

Abstract: Implantable medical devices for connecting tissue layers or occluding body conduits and tissue structures include apposition portions, a central region, and a covering material. The methods of using the devices include endoscopic deployment, and the devices may include self-expanding frameworks that facilitate a secure connection between the tissue structures. In some embodiments, one or more tethers are used to longitudinally contract the device in situ.

Abstract: In an aspect, a device includes a body structure including a core and a sleeve disposed around at least a portion of the core, the core defining a channel through the core extending from a first end of the core to a second end of the core, the sleeve including a flange adjacent the second end of the core; and a deployable portion coupled to the body structure adjacent the first end of the core, the deployable portion having a wired structure transitionable between a retained configuration and a deployed configuration, wherein a top portion of the wired structure extends beyond the first end of the core in a longitudinal direction when the wired structure is in the retained configuration, and wherein first end of the core extends beyond the top portion of the wired structure when the wired structure is in the deployed configuration.

Abstract: Systems, devices and methods for repairing a native heart valve. In one embodiment, a repair device for repairing a native mitral valve having an anterior leaflet and a posterior leaflet between a left atrium and a left ventricle comprises a support having a contracted configuration and an extended configuration, and an appendage, such as a flap or apron extending from the support. In the contracted configuration, the support is sized to be inserted under the posterior leaflet between a wall of the left ventricle and chordae tendineae. In the extended configuration, the support is configured to project anteriorly with respect to a posterior wall of the left ventricle by a distance sufficient to position at least a portion of the posterior leaflet toward the anterior leaflet, and the appendage is configured to extend beyond an edge of the posterior leaflet toward the anterior leaflet.

Abstract: Methods and devices are provided for anchoring suture to bone. In one exemplary embodiment, a cannulated suture anchor is provided and it includes a suture-engaging member formed therein and configured to receive a suture therearound such that trailing ends of the suture can extend through the suture anchor. The suture anchor can also include at least a proximal portion having dual threads to facilitate engagement with bone. The present invention also provides exemplary sutures and drivers that can be used with the various methods and devices disclosed herein, or with other methods and devices known in the art.

Abstract: In an example of a method for making a pulsatile delivery device, one type of charges are generated on a polymeric layer, and charges opposite the one type of charges are generated on a delivery layer including a film forming material and a predetermined substance dispersed throughout the film forming material. The charged polymeric and delivery layers are placed into contact to form a bi-layer structure. A stack with at least two bi-layer structures is formed so that the polymeric layers and the delivery layers are alternating throughout the stack. The stack is sealed so that one of the polymeric layers remains exposed.

Abstract: A suture anchor system including an anchor, a plug and an inserter. The anchor inserter includes a tubular outer shaft having a cannulation dimensioned to receive an inner shaft. The distal end of the outer shaft cannulation is threaded for engagement with the plug. The anchor includes a longitudinal cannulation formed within the anchor body, including a smooth-sided portion and a threaded portion. An eyelet, dimensioned to receive a suture therein, extends transverse to the longitudinal axis of the anchor and intersects the distal portion of the cannulation. The plug is a generally elongated, tubular threaded rod comprising a cannulation adapted to receive a distal end of the inner inserter shaft.

Abstract: An anchor construct having an anchor having a length of suture material passing therethrough, the suture material having a loop strand terminating at a first end and a post strand terminating at a second end, a splice loop formed by first end, a sliding construct formed by the first end and the second end, wherein the sliding construct is configured to adjust the relative position of the splice loop and the anchor. The anchor construct can be deployed by passing the first end through a first body and through the splice, creating a locking loop of a first size around the first body, implanting the anchor into a bone hole, pulling the post strand to decrease the perimeter of the positioning loop to a second size smaller than the first size, and pulling the loop strand to decrease the perimeter of the locking loop to a smaller second size.

Abstract: Medical devices for applying a cinch to a suture and methods for making and using such devices are disclosed. An example medical device may include an elongated shaft including a proximal region and a distal region. The distal region may define a lumen having a lumen dimeter, and a distally facing end surface. The medical device may also include an outer cinch member defining a bore and having an outer surface defining a shoulder. An elongated inner shaft may extend through and be longitudinally movable within the lumen and the bore and including a distal end section. An inner cinch member may be engaged with the distal end section of the elongated inner shaft.

Abstract: Devices and methods for reinforcing tissue grafts are described herein. In one embodiment, an implant is described that includes a proximal end portion having a through-hole formed therein, a distal end portion, and a reinforcing insert disposed in the through-hole. The insert includes a proximal face, a distal face opposed to the proximal face, a first upper surface extending between the proximal and distal faces and having a generally convex shape that abuts against at least a portion of a sidewall of the through-hole, and a second lower surface extending between the proximal and distal faces and having a generally concave shape. The second lower surface and portions of the sidewall of the through-hole not abutted by the first upper surface form a reinforced through-hole of the implant.

Abstract: A device having an implantable body associated with at least two filaments or sutures and configured for use in soft tissue reconstructions is provided. One exemplary embodiment includes an implantable body, an adjustable filament loop for holding ligament grafts that is coupled to the body, and a shuttle suture removably coupled to the implantable body and configured for shuttling the body through at least a portion of a bone tunnel. The loop can be defined by a self-locking knot, and one or more loop-adjusting limbs can extend from the knot, with a portion of the limb(s) also extending into a hollow portion of the shuttle suture. In some embodiments having two adjustable limbs, an intermediate portion of each limb can be the portions disposed in respective hollow portions of the shuttle suture. Other configurations of devices and systems, as well as methods for performing ACL repairs, are also provided.

Abstract: A tissue repair construct having first and second implants coupled via a flexible element is provided. The flexible element forms an adjustable loop closed with a sliding knot, and has first and second free ends extending from the knot formed by wrapping the second end around the first end. The second implant can have a changeable configuration. The construct can be placed within a surgical site in a patient's body such that the first implant is passed into a bone adjacent to soft tissue and the second implant is disposed on an opposed side of the soft tissue. The first free end of the flexible element is configured to be tensioned to decrease a size of the loop and thereby change the configuration of the second implant and to thereby cause at least the second implant to move towards the first implant.

Abstract: An anchoring system is a combination of a nanofiber scaffold material and an arthroscopically deployable suture anchor. The anchor is deployed into a bone tunnel using common techniques. The nanofiber material extends out of the proximal end of the implant, once deployed. The implant also includes pre-loaded sutures or has the ability to accept and lock sutures to the implant. For an implant pre-loaded with suture, the implant is placed into the bone, the material is deployed above the anchor onto the surface of the bone, suture is passed through the soft tissue, and knots are tied to secure the tissue against the bone, sandwiching the material between the bone and tissue, to provide a pathway for cells from the bone marrow to the soft tissue-bone interface, promote the healing response, provide a biomimetic structure that cells readily adhere to, and create a larger healing footprint.

Abstract: The present invention relates to bone-implants for treating a lesion on a bone, comprising: a bone anchor, a container in communication with the bone anchor and an osteoconductive bone-filler material inside the container, and methods thereof.

Abstract: An endoluminal pursestring device is provided and includes a handle assembly, a shaft, an elongated fork, a plurality of surgical fasteners disposed with the shaft, and a suture engaged with the surgical fasteners. The suture is secured to a head of each of the surgical fasteners, and extends proximally through the handle assembly. In use, a distal end of the endoluminal pursestring device is positioned adjacent tissue surrounding a lumen, and the handle assembly is rotated to cause the distal-most surgical fastener to be rotated into the tissue. The following surgical fasteners are also rotated into other portions of the tissue surrounding a lumen. The suture connecting each of the surgical fasteners is then pulled such that the surgical fasteners are pulled together, thereby closing the lumen.

Abstract: Devices, systems, and methods to improve both the reliability of soft tissue repair procedures and the speed at which the procedures are completed are provided. The devices and systems include one or more tissue augmentation constructs, which include constructs that are configured to increase a footprint across which suture applied force to tissue when the suture is tied down onto the tissue. The tissue augmentation constructs can be quickly and easily associated with the repair suture, and can be useful in many different tissue repair procedures that are disclosed in the application. In one exemplary embodiment, one or more constructs are disposed on a suture threader, which can be used to associate the construct(s) with a repair suture(s) being used to repair the soft tissue. Tissue augmentation constructs can include various blocks and patches, among other formations. Exemplary methods for manufacturing the tissue augmentation constructs are also provided.

Abstract: A surgical instrument includes a handle assembly having a gear drive mechanism. The gear drive mechanism includes a variable radius gear to provide a desired mechanical advantage to a user during actuation of a movable handle of the surgical instrument.

Abstract: A suture anchor for knotless fixation of tissue. A swivel suture anchor has an anchor tip for receiving a suture strand, for surgical tissue repair without requiring suture knots. Tension on the repair constructs is adjustable. The swivel anchor is secured in a hole in bone by advancing a fixation device, such as a cannulated interference screw, over the body of the anchor.

Abstract: A stimulation system for delivery of a stimulation signal to a hypoglossal nerve of a patient to treat obstructive sleep apnea. The stimulation system includes an implantable receiver coil configured to be implanted under a mandible of the patient; a nerve electrode coupled to the implantable receiver coil, the nerve electrode configured to deliver the stimulation signal to the hypoglossal nerve of the patient; an external pulse generator configured to generate the stimulation signal; and an external transmitter coil configured to wirelessly transmit the stimulation signal from the external pulse generator to the implantable receiver coil, the external transmitter coil being carried by an adhesive patch configured to be placed on the skin adjacent the implantable receiver coil under the mandible of the patient.

Abstract: A locking suture construct having suture material with a first end and a second end, each attached to a first body in a slidable manner, a constricting member formed in the second end of the suture material, and a bight in the suture material between the first end and the second end. The bight can be pulled through the constricting member around a second body to create a locking loop. The first end and the second end are passed through the locking loop. Pulling the first end increases a perimeter of the locking loop and moves the constricting member toward the second body. When the constricting member reaches the second body, pulling the first end reduces the perimeter of the locking loop and moves/rotates the constricting member around the second body toward the first body to hold the first body in relative position to the second body.