Abstract: Methods and devices for fixation of soft tissue to bone are provided. In one embodiment, a suture anchor is provided having an elongate cylindrical body with proximal and distal ends and an inner lumen extending therethrough. The elongate body can be configured so that upon partial insertion into a bone hole, it is securely anchored within the bone hole and a suture extending through the inner lumen is freely slidable. It can also configured so that, upon further insertion into the bone hole, at least a portion of the elongate body compresses to lock the suture within the inner lumen such that the suture is prevented from sliding. In another embodiment, a suture anchor is provided having arms that have an open position for receiving a suture therebetween, and a closed position in which the suture is retained but allowed to slide freely.

Abstract: In accordance with the present invention there is provided a suturing device. The suturing device includes a length of suture that will be delivered to the site of the PFO and placed through the tissue adjacent the opening to close the PFO. As described in greater detail below, the suture is advanced through the tissue surrounding the opening by a pair of needles that penetrate the tissue adjacent to the opening. A knot is then loosely tied with the length of suture and advanced to the site of the PFO. The tails of the suture extending from the knot are then cut and removed. It is also contemplated that a pre-formed or pre-tied knot may be disposed on the device, wherein after deployment of the suture through the tissue adjacent to the PFO and removal of the device a loop of suture having a pre-tied knot will remain, wherein the pre-tied knot may then be tightened to close the PFO. Further still it is contemplated that other means may be utilized to retain the sutures.

Abstract: Methods for passing multiple sutures through tissue are provided herein. In particular, the methods described herein allow multiple sutures to be passed through tissue without removing a suture passing instrument from a patient's body. In one embodiment, a method for passing a suture through tissue is provided that includes loading first and second suture limbs into a suture passing instrument, positioning the instrument within a patient's body, actuating the instrument to pass a portion of the first suture limb through the tissue, pulling the first suture limb through the tissue, pulling the second suture limb to reload the suture passing instrument without removing the instrument from the patient's body, actuating the instrument a second time to pass a portion of the second suture limb through the tissue, and pulling the second suture limb through the tissue.

Abstract: A closure device for closing an opening in tissue is provided. The closure device includes an elongate member through which needles may be deployed. The closure device also includes a foot portion having one or more feet slidably mounted relative thereto. The feet are movable between a deployed position and a delivery position. The feet include cuffs removably mounted therein, with sutures connected between the cuffs. When the feet are in the deployed position and the needles are advanced, the needles securely engage the cuffs and draw the cuffs and suture through the lumen wall so that the opening in the lumen wall can be closed with the sutures.

Abstract: A fastener for attaching a sheet-like implant to tissue or bone may be provided with a first arm having a proximal portion and a distal portion, a second arm having a proximal portion and a distal portion, and a bridge formed at least in part by the proximal portion of the first arm overlapping the proximal portion of the second arm. Each of the first and second arms can include at least a partial loop member having a lumen therethrough slidably receiving the other arm, each arm further including a tissue retention member on a distal portion having a projection extending therefrom for engagement of bone or tissue when inserted therein. The staple can also include a one-way position retention assembly for allowing distal movement of each at least partial loop member relative to the other arm therethrough to tension the fastener and maintain a desired configuration.

Abstract: An absorbable screw fastener and a method of firing with an applicator capable of applying a surgical fastener to tissue in order to form tissue connection to secure objects to tissue, the fastener including a body portion having a helical thread, a head portion disposed at the proximal end of the body portion. The head portion includes a driver receiving configuration on its outer surface. The screw fastener further includes a cannulated center lumen with an opening extending from the head portion through the longitudinal length of the body portion.

Abstract: An orthopaedic staple includes a bridge portion having a pair of ends and a staple leg formed from a shape memory material connected to each of the pair of ends. The staple legs have a constrained position where the staple legs are generally parallel to one another and a relaxed position where the staple legs generally converge toward one another. Each of the staple legs has a protruding portion with a maximum leg thickness and a tip, with each of the staple legs increasing in thickness from the tip to the protruding portion. The bridge portion and each of the protruding portions define grasping portions therebetween that are configured to provide resistance to backout of the orthopaedic staple.

Abstract: The field of the disclosure relates generally to sutures and, more specifically, to enhancing suture repair mechanics using adhesives.

Abstract: An adapter assembly for selectively interconnecting a surgical end effector including at least one axially translatable drive member and a powered actuator device including at least one rotatable drive shaft is provided. The adapter assembly includes an actuation shaft configured to convert rotation of a first drive shaft of the powered actuator device into an axial translation of a first drive member of the surgical end effector. The adapter assembly further includes an elongate tube configured to convert rotation of a second drive shaft of the powered actuator device into an axial translation of a second drive member of the surgical end effector. The actuation shaft is disposed within the elongate tube, and the actuation shaft and the elongate tube translate axially independent of each other.

Abstract: A surgical fastener applying apparatus for applying fasteners to body tissue. The apparatus includes a cartridge receiving half-section defining an elongated channel member, an anvil half-section, and a clamping lever. The cartridge receiving half-section releasably receives a cartridge and a firing assembly. The clamping lever includes a protrusion in a sidewall which is receivable in a bifurcated depression formed in a sidewall of the cartridge receiving half-section to releasably retain the clamping lever in a non-clamped position and in a clamped position. The apparatus includes a disposable firing assembly and SULU.

Abstract: A surgical stapling instrument. Various embodiments include an actuation system for selectively generating a plurality of control motions. A surgical end effector is operably coupled to the actuation system. The actuation system interfaces with an actuation member configured to operably engage rotatable camming members to fire staples within the end effector into forming contact with an anvil portion of the end effector.

Abstract: An implantable medical device for sealing and repairing defects in a body tissue or for creating an anastomosis includes a frame and a covering material. In some embodiments, the frame includes a single continuously wound wire that defines an apposition portion, a defect-occupying portion, and a sealing portion. In some embodiments, the tissue-sealing and anastomosis devices provided herein are well-suited for use in the GI tract including the small bowel and colon. In some embodiments, a two-part frame construct facilitates independent tailoring of apposition forces and radial forces exerted on tissues by the two-part frame.

Abstract: A tool for insertion into a surgical saw includes a holder area for the saw and a head which is movable in oscillation by the surgical saw along a work direction where the head has a plurality of teeth which are arranged behind one another in the work direction. A first and second tooth each contains a first shaving surface for shaving off bone material oriented transversely to the work direction and a second pressing surface for pressing on bone material which pressing surface adjoins the shaving surface. The shaving surface, in relation to the work direction, is more inclined than the pressing surface. The two teeth are oriented with their shaving surface and pressing surface opposite each other so during oscillation the shaving surface of the tooth lying ahead in work direction and the pressing surface of the tooth lying therebehind in work direction are in operation.

Abstract: One aspect of the present invention relates to a tissue resection guide that includes a central body, a first flange and a second flange, the flanges having first and second guide surfaces, respectively, suitable for use in tissue resection. Each guide surface lies on a cutting plane, both planes intersecting interior to the flanges. In the embodiments described, the availability of two cutting planes ensures resections in more than one plane are possible. As a result, bone segments can be removed via a cut on two planes without the need to cut across an entire section of bone on one plane. In some embodiments, an opening exists between the first flange and the second flange to ensure that each resection overlaps. In other aspects of the invention, systems and methods of use for the tissue resection guide are described.

Abstract: The invention relates to a system for positioning a surgical device, said surgical device comprising: a base (1) designed to be held in a user's hand, an end-effector (2) for mounting a surgical tool, respectively a guide (20) for guiding a surgical tool (3), said surgical tool being designed to treat a planned volume of a part (P1) of a patient's body, an actuation unit (4) connected to said base (1) and said end-effector (2) for moving said surgical tool (3), respectively tool guide (20), with respect to the base (1) in order to treat said planned volume, said positioning system comprising: (i) a tracking unit (200) configured to determine in real time the pose of at least one of the tool (3), the end-effector (2) and the base (1) with respect to the part to be treated, (ii) a control unit (300) configured to: (a) compute in real time the working space of the surgical tool for said determined pose, (b) compute in real time the volume that remains to be treated to achieve the treatment of the planned v

Abstract: An adjustable rongeur includes a first handle portion pivotally connected to a second handle portion. A shank is connected to the first handle portion at a proximal end of the shank, wherein the shank has a footplate at a distal end thereof. A crossbar is slidably engaged with the shank, wherein the crossbar is connected to the second handle portion, wherein a cutting opening is formed between a distal end of the crossbar and the footplate of the shank. An opening selection actuator is positioned within at least one of the first and second handle portion, wherein the opening selection actuator engages between the first and second handle portions to control a length of the cutting opening.

Abstract: An orthopaedic reamer connector includes a base shaped to allow for connection of an orthopaedic reamer having a connection surface and being configured to rotatably connect to a rotary actuator; two pairs of holders associated with the connection surface that each have a first holder and a second holder that forms an acute angle relative to said first holder. The first holders are opposed to each other by about 180 degrees and the second holders are opposed to each other by about 180 degrees. A pair of stops are associated with each of the two pairs of holders. Each pair of stops has a first stop associated with the first holder and a second stop associated with the second holder.

Abstract: The present disclosure describes a method and device for treatment of bone lesions. The device may include a combination of a drill device, a drill guide, a guide wire, and a syringe. The drill device includes a cannula through which a substance may be injected, an attachment head, and a drill bit. The attachment head may include a fitting for a powered or manual drill and a luer fitting for attaching a syringe or other device. The drill guide includes a cannula with an inner diameter sized to accommodate the cannula of the drill device. The method may include: placing a drill guide near a bone-lesion site, inserting a guide wire through the drill guide, inserting a drill device into the drill guide, removing the guide wire, drilling the bone, and injecting a cellular component and a retention medium into the bone near the lesion site.

Abstract: The present invention provides a surgical reamer (10), surgical reamer system, and kit including a surgical reamer. The surgical reamer has a domed shell (12) extending from the apex to the rim (13), a rotation axis (1), cutting teeth (14) disposed around the domed shell wherein a first connecting bar (15) having a first longitudinal axis and a first diameter is located on the inside surface of the domed shell, with its first longitudinal axis and a first diameter is located on the inside surface of the domed shell, with its first longitudinal axis being adjacent or closely adjacent to the rim and in which a second connecting bar (16) having a second longitudinal axis and a second diameter is located on the inside surface of the domed shell and spaced apart from the first connecting bar.

Abstract: A guided punch is disclosed. The guided punch generally comprises a strike cap comprising a strike surface, a punch comprising a distal cutting edge, and a guide rod. The strike cap defines a first cavity therein. The punch defines a second cavity therein in communication with the first cavity. The guide rod is located within the first and second cavities and extends a predetermined distance beyond the distal cutting edge of the punch. The strike cap and the punch are moveable relative to the guide rod.

Abstract: Methods and devices are provided for implanting a cross-pin through a bone tunnel, such as in an arthroscopic surgical procedure. In general, the methods and devices allow a cross-pin hole to be formed in a medial side of a knee bone such that it intersects a bone tunnel formed in the knee bone. In one embodiment, a cross-pinning guide device is provided that can be configured to angularly position the cross-pin hole relative to the bone tunnel to allow the cross-pin hole to intersect the bone tunnel without passing through another side, e.g., a lateral side, of the knee bone. The knee bone can be a femur or a tibia such that the cross-pin hole and the bone tunnel can each be entirely formed in the femur or in the tibia.

Abstract: Methods and instruments for reconstructing soft tissues of a skeletal joint such as for example of the foot or hand are presented.

Abstract: An orthopedic device for a shoulder joint includes a patient-specific alignment guide. The alignment guide includes a cap having a three-dimensional engagement surface customized in a pre-operative plan by computer imaging to be complementary and closely mate and conform to a humeral head of a proximal humerus of a patient. The alignment guide includes a tubular element extending from the cap and defining a longitudinal guiding bore for guiding an alignment pin at a patient-specific position and orientation determined in the pre-operative plan, and an orientation feature on the cap. The orientation feature is designed to orient the cap relative to the humeral head when the orientation feature is aligned with a landmark of the proximal humerus.

Abstract: A knee arthroplasty assembly for use in a patient's knee joint including a tibia and a femur is disclosed. The assembly can include a tool, a first accessory, and a second accessory. The tool can include a tibial component configured for placement against the tibia and a femoral component configured for placement against the femur. The femoral component can be moveably coupled to the tibial component to place the patient's knee joint in tension by separating the tibia and the femur. The first accessory can be removeably coupled to the tibial component of the tool. The second accessory can be referenced to the first accessory and can have a reference indicator that references the femur for determining a size of the femur.

Abstract: A fluid supply and suction device is provided and includes a tube, a container including first and second parts, which are sealably attachable to define a container interior, the first part being formed to define first and second apertures and being coupled with the tube such that the tube is fluidly communicative with the container interior and a valve system coupled with the first part and configured to admit via the first aperture fluid into the tube such that the fluid flows through the tube and to suction via the second aperture fluid and fragmented particles through the tube and into the container interior.

Abstract: A wire guide which may be used to cross a lesion through the subintimal layer of an intraluminal passage. The wire guide comprises an inner elongated member with a larger diameter proximal portion, a smaller diameter distal portion, and a tapered portion transitioning between the larger and smaller diameters. An outer shell surrounds the inner elongated member. The wire guide may be used to cross a lesion in an intraluminal passage through the subintimal layer while minimizing the portion of the wire guide which deflects against the proximal end of the lesion. Once the wire guide has crossed the intraluminal passage, it may be straightened so devices may be advanced to the lesion over the wire guide and used to clear the intraluminal passage.

Abstract: Described here are devices and methods that may facilitate treatment of a calcified heart valve with shock waves. A shock wave valvuloplasty device may be advanced through a patient's vasculature and self-align with cusps of a calcified aortic valve. Alignment may be facilitated by a central anchor and/or U-shaped distal bends of positioning wires. An elongated carrier may be slidably disposed over a portion of the positioning wire and carry one or more electrode assemblies that may generate shock waves. An inflatable balloon may sealably enclose the electrode assembles, and shock waves may propagate through the liquid-filled balloon and transfer energy to adjacent calcified valve cusps. The shock wave valvuloplasty device may comprise one or more features to direct shock waves to specific areas of calcified tissue. Some variations also comprise a central anchor configured to be positioned below the valve leaflets.

Abstract: The present disclosure relates to systems and methods for removing obstructions or occlusions from vascular and non-vascular passageways. More particularly, the present disclosure relates to systems and methods for en bloc removal of soft fresh thrombi and large emboli within the circulatory system and reinfusing fluid back into the patient to minimize fluid loss.

Abstract: A medical instrument with a hollow shaft and at the distal end a tool actuated via a spring-loaded pull cable, wherein the tool is rotatable about the longitudinal axis of the shaft and is mounted such that it can be angled with respect to the longitudinal axis of the shaft. Actuation of the pull cable and rotation and angled positioning of the tool take place via separate drives, which are arranged on a handle. An anti-twist means protects the pull cable against torsion.

Abstract: A medical device for removing tissue from a subject is provided with a distal housing, an elongate member, a first rotatable member and first and second tissue shearing edges. The distal housing is configured with at least one tissue engaging opening. The elongate member is coupled to the distal housing and configured to introduce the distal housing to a target tissue site. The first rotatable member is located at least partially within the distal housing. The first and second tissue shearing edges are configured to cooperate to shear tissue therebetween. The first rotatable member is configured to engage tissue from the target tissue site, rotate towards the second tissue shearing edge. A first axis of the first rotatable member is offset from the longitudinal axis of the elongate member, lies in a common plane and forms an angle therewith of between 0 and 90 degrees. Methods are also disclosed.

Abstract: Described herein is a system and method for identifying elastic lamina during interventional procedures, such as atherectomy. Such identification can be used to avoid trauma to the external elastic lamina during the procedure.

Abstract: A tissue access site system and methods for opening and closing a tissue access site are provided. A method for opening and closing an access site in a body lumen includes attaching a plurality of closure elements to a perimeter wall of a body lumen by advancing closure elements from an access and closure device associated with a guide wire positioned through the perimeter wall. A tissue cutting element of the access and closure device is advanced along the guide wire to cause the tissue cutting element to penetrate through the perimeter wall to open an access site in the perimeter wall that includes a plurality of tissue flaps. Each of the tissue flaps has a predetermined geometry and is attached to at least one of the closure elements. The closure elements are used to close the access site.

Abstract: Methods and apparatus are provided for selective surgical removal of tissue, e.g., for enlargement of diseased spinal structures, such as impinged lateral recesses and pathologically narrowed neural foramen. In some embodiments, a surgical tissue removal device includes a flexible elongate body that is adapted to conform with the target anatomy and a guidewire connector at the distal end region of the flexible elongate body configured to removably connect to the end of a guidewire so that the guidewire and flexible elongate body can be pulled distally. The body may have at least one blade edge, and the flexible elongate body may be a thin, flat, ribbon shaped flexible body that comprises a profile having a width that is substantially greater than a height.

Abstract: A treatment device for use in treating a biological tissue, includes: a holding portion, an ultrasonic transducer unit, a probe, an inner sheath, a first sealing member, an outer sheath that covers an outer peripheral surface of the inner sheath, a second sealing member, and an actuator that moves the ultrasonic transducer unit, the probe and the inner sheath integrally to the outer sheath along the longitudinal axis.

Abstract: Devices and methods for treating a target site in a body lumen are provided. A medical device includes a stent-like structure including a plurality of scoring and non-scoring filaments interwoven with one another. Generally, the stent-like structure will have more non-scoring filaments than scoring filaments to provide greater structural support and to focus the scoring forces on only a few select areas. The stent-like structure is expanded within the target site to score the target site and to provide temporary structural support while the target site is infused with a therapeutic agent. Such therapeutic agent infusion occurs with the use of a drug eluting or drug coated balloon disposed within the stent-like structure or by occluding the target site and introducing a drug into the occluded target site to sit for a period of time.

Abstract: A cannula is placed in an enlarged opening through a bladder wall and an abdominal wall by applying pulling tension to a placement guide extending through a small pathway to hold an inflated placement balloon in sealing contact with the bladder wall. The seal confines distension fluid in the bladder to establish sufficient reactive resistance to enlarge the opening through the bladder wall with blunt force dilation from an obturator.

Abstract: A surgical access device that includes a seal assembly. The seal assembly includes an upper housing portion having a first seal and a lower housing portion including a second seal. The upper housing portion is rotatably connectable to the lower housing portion. The surgical access device also includes a rotation prevention mechanism configured to prevent inadvertent relative rotation of, and disconnection of, the upper housing portion and the lower housing portion. The rotation prevention mechanism is further configured to be selectively actuated by a user, such that, when actuated, the upper housing portion is selectively rotatable relative to, and disconnectable from, the lower housing portion.

Abstract: A surgical apparatus for permitting access to tissue includes an elongated introducer and a surgical port. The introducer includes an outer wall segment defining a longitudinal axis, a longitudinal port passage extending therethrough and a longitudinal slot in communication with the port passage. The introducer is dimensioned for at least partial introduction within an opening in tissue. The surgical port includes a port body mounted to the introducer with one of its leading and trailing ends disposed within the port passage and with the intermediate segment extending through the longitudinal slot and the other of the leading and trailing end external of the elongated introducer. The port body is dimensioned to be advanced within the port passage for deployment through the opening in the tissue and is adapted to transition from a compressed state to a released state.

Abstract: Disclosed is an expandable percutaneous sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion to a second, enlarged cross-sectional configuration. The sheath is maintained in the first, low cross-sectional configuration by a tubular restraint. In one application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as percutaneous nephrostomy or urinary bladder access.

Abstract: A needle guard clip assembly has a clip and a spring, the clip having a first wall with a needle passage therethrough, a generally parallel second wall, a strut connecting the two walls, and a heel extending from the first wall. The walls, strut, and heel are an integral piece. The spring is associated with and extends from the first wall.

Abstract: Transradial access devices, systems, and methods. An exemplary device of the present disclosure for providing access to a vessel or other luminal organ and to prevent overperforation of the same comprises a needle having a needle tip and at least one current element positioned thereon or embedded therein at or near the needle tip, a sheath positioned around at least part of the needle, and a protractor in communication with the needle, whereby engagement of the protractor causes the needle tip to protract from the sheath through the aperture, and whereby release of the protractor causes the needle tip to retract through the aperture into the sheath. Activation of the at least one current element can facilitation vasodilation of the vessel or other luminal organ.

Abstract: An intrauterine balloon apparatus to augment uterine birthing forces and assist fetal descent during parturition is provided. The body of the balloon apparatus begins packaged in a compressed state minimizing volume, enabling delivery through the birth canal. The apparatus is advanced to a proximal uterine location and deployed for operation by introducing a pressurized agent through its conduit, causing the body to expand and apply directional forces towards the infant and birth canal. The balloon body is shaped to apply pressures dispersed towards the infant and the bidirectional conduit enables fluid conduction as the infant descends. After the infant has successfully descended and been delivered through the birth canal, pressure within the balloon body is relieved through the conduit thereby collapsing the volume of the balloon body and enabling refraction through the birth canal.

Abstract: A catheter to access and navigate the uterine cavity through the cervical canal for delivering, deploying, and facilitating operation of a peripheral intrauterine medical apparatus during parturition includes an elongated, flexible tubular catheter body with a handle at the proximal end controlling a steering mechanism and deflecting the distal tip. The catheter includes a lumen that extends the length of catheter body to a distal end region of the catheter. The peripheral medical apparatus is located in the distal end region and is configured to deploy from the distal tip of the catheter into the uterine cavity. A soft catheter tip reduces the likelihood of injury during intrauterine navigation and placement, and sensors associated with the catheter body provide signals that allow for the monitoring of infant, umbilical cord, placenta and uterine muscle activity during labor to assist operation of the peripheral medical apparatus.

Abstract: An adjustable spinal rod includes a first section and a second section. The first section has a first base portion and a first coupling portion that extends from the first base portion. The second section has a second base portion and a second coupling portion extending from the second base portion. The second coupling portion is axially aligned and slidably engaged with the first coupling portion. The adjustable spinal rod has a first configuration where the adjustable spinal rod defines a first length and a second configuration where the adjustable spinal rod defines a second length different from the first length.

Abstract: A spinal construct comprises a fastener attachable with sacral and/or pelvic tissue of a body. At least one connector is connected with the fastener and defines a first implant cavity and a second implant cavity. At least one lock is disposable with the implant cavities. Systems and methods are disclosed.

Abstract: A receiving part for receiving a rod for coupling the rod to a bone anchoring element includes a receiving part body including a first end and a second end, and having a substantially U-shaped recess at the first end forming a channel for receiving the rod, and an accommodation space for accommodating a head of the bone anchoring element, the accommodation space having an opening at the second end for introducing the head; and a pressure element arranged at least partially in the accommodation space, the pressure element including a first section having a second recess for receiving the rod, and a second section having a flexible portion to clamp the head, the first section and the second section being fixed relative to each other, wherein said pressure element is insertable from the opening.

Abstract: Various exemplary methods and devices are provided for fixing bone anchors to bone. In general, the methods and devices can allow for a bone anchor to be fixed to a bone at a desired angle to a surface of the bone. In an exemplary embodiment, a bone anchor assembly is provided that includes a bone anchor configured to engage bone, a receiver member for seating a head of the bone anchor, and a compression member for securing the bone anchor at fixed angle with respect to the receiver member when the compression member is seated within the receiver member. Corresponding engagement features of the compression member and the receiver member can be engaged in a secured configuration to inhibit or prevent removal of the compression cap from the receiver member and optionally to substantially prevent longitudinal and/or rotational movement of the compression member with respect to the receiver member.

Abstract: Systems for securely connecting a spinal implant to a bone anchor by using an offset connection assembly. The variable angle connection assembly is able to securely connect the spinal implant to the anchors even when there is a variance in the angle and position of the anchors with respect to the spinal implant. The connection assembly will not inadvertently lock the components of the connection assembly preventing the relative movement of the components.

Abstract: A fixing apparatus for cervical vertebrae in which in which a fixing plate is made to be in proximity with cervical vertebrae and screws are inserted into the cervical vertebrae through screw holes formed in the fixing plate, includes an opening and closing member that opens and closes the screw holes while being moved between a closing position for covering the screw holes and an opening position for opening the screw hole on the fixing plate.

Abstract: Dynamic, rigid, and convertible dynamic-to-rigid devices and methods of using such devices to treat spinal instability conditions of the cervical spine are provided. The devices may include an interspinous, interlaminar stabilization device configured for interlaminar placement between the spinous processes of adjacent cervical vertebrae and optionally secured to the lamina using bone screws or crimped or rigidly fixed to the spinous process. Multiple devices may be used to enable treatment of multiple levels at the same time.