Abstract: Novel compositions for treating wounds and promoting the healing thereof are described, including composition containing novel combinations of a carrier and recombinant platelet derived growth factor having fewer isoforms and enhanced biostability. Methods of treating wounds with novel therapeutic composition using doing procedures leading to effective results with a minimal number of treatment applications are also described.

Abstract: An implantable prosthesis and a method of attaching the prosthesis to a tissue structure disclosed. The prosthesis includes a body having a first side arranged to face the tissue structure having a defect and second side opposite the first side. One or more adhesive-filled pods are disposed on the first side of the body and selectively openable to supply an adhesive in between the tissue structure and the first side of the prosthesis body after the prosthesis body is positioned relative to the defect. The pods may be pierced, punctured, broken, and/or ruptured to supply the adhesive. A deployment device having a piercer may be used to puncture the pods.

Abstract: A deployment device for positioning a soft tissue repair prosthesis includes a self-expanding support body releasably attachable to the prosthesis. The support body may be removably insertable into a pocket of the prosthesis. A handle coupled to the support body facilitates positioning the patch and/or removal of the support body from the pocket. The support body may substantially occupy the pocket in an expanded configuration. The handle may be arranged to direct a pulling force to the outer peripheral edge of the support body and/or cause a portion thereof to be pulled downward and below the body during withdrawal of the deployment device from the prosthesis. The support body may include support segments pivotally coupled together and foldable to collapse the support body for insertion into and removal from the pocket. One or more resilient support members may be provided for collapsing and expanding the support body and the prosthesis.

Abstract: A tissue adhesive for contacting a tissue site, the tissue adhesive comprising: a mixture of natural polymers; and an activating agent enhancing the adhesive properties of the mixture of natural polymers. And a tissue adhesive for contacting a tissue site, the tissue adhesive comprising: a mixture of natural polymers; and an aqueous solution of a water soluble starch or a water soluble starch derivative which forms a gel with the addition of the mixture of natural polymers.

Abstract: The invention relates to a prosthetic porous knit based on a monofilament of a biocompatible polymer material, the pattern followed for the knitting of said monofilament on a warp knitting machine having two guide bars B1, B2 being the following, according to the ISO 11676 standard:—Bar B1: 1.2/4.5/4.3/4.5/4.3/1.0/1.2/1.0//—Bar B2: 1.3/1.0/1.2/1.0/1.2/4.5/4.3/4.5// The invention further relates to a method for producing such a knit and to a hernia prosthesis comprising such a knit.

Abstract: The invention is a device, system, and method for repairing heart valve function, which may include bisecting native valve leaflets for improved deployment of a prosthetic heart valve in the native valve annulus. The invention may include a catheter having a cutting element shaft with a cutting element configured to puncture a valve leaflet and/or make a controlled cut through the leaflet. The device may have an extendable foot configured to be positioned on an opposite side of the valve leaflet from the cutting element shaft. The device may include magnets to guide the cutting element and/or cutting element shaft in proper alignment with the extendable foot and to hold the elements in place during leaflet bisection.

Abstract: The present disclosure comprises micropatterned fabric, meshes, textiles, and implantable devices which may include having one substrate including a mesh, a second substrate having a microstructured surface, and a fibrous layer disposed therebetween. The fibrous layer comprises a plurality of randomly oriented fibers. The devices having the microstructured surface may include a plurality of first level microfeatures and a plurality of second level microfeatures wherein the plurality of second level microfeatures are disposed hierarchically the first level microfeatures. Also disclosed are methods for making such micropatterned fabric, meshes, textiles, and implantable devices.

Abstract: A device includes a capsule along with first and second clip arms, proximal ends of which are received within the channel so that the first and second clip arms are movable relative to one another between an open configuration and a closed configuration. A deployment mechanism includes a tension member connected to a proximal end of the first and second arms, a yoke releasably coupled to the tension member and longitudinally movable relative to the capsule to move the first and second arms between the open and closed configurations. The tension member and yoke are configured to separate from one another in response to a predetermined proximal force relative to the tension member. A locking mechanism is coupled to the deployment mechanism and is configured to engage the capsule to lock the one-piece clipping element in the closed configuration, when the yoke is separated from the tension member.

Abstract: The present invention relates to a surgical anti-adhesion barrier film comprising an oxidized collagen and a polyphosphate compound and to a surgical implant comprising a prosthetic fabric and such a film.

Abstract: A closure device includes a first ring structure having a first distal portion and a first medial portion and a second ring structure having a second distal portion and a second medial portion. The first and second distal portions are movable between an open position, where the first and second distal portions form an angle relative to one another for receiving target tissue therebetween, and a closed position, where the first and second distal portions are drawn toward one another for gripping the target tissue. The device also includes an anvil about which the first and second medial portions are formed. Either one of proximal motion of the anvil relative to the first and second rings or proximal motion of the medial portions relative to the anvil causes the first and second distal portions to move into either one of the open position or the closed position.

Abstract: Surgical stapling devices have a surgical buttress attached to an anvil jaw member, a cartridge jaw member, or both. In use, the surgical buttress reinforces a staple line formed upon application of staples from the surgical stapling device and minimizes leaks which may exude from the staple line and/or tissue being stapled by the surgical stapling device.

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

Abstract: The present disclosure describes kits for surgical repair of soft tissue defects, including hernias. The kits include any combination of components selected from an implantable sheet, a central tie, a delivery tool, a rolling device, and an insertion member. Packaging for the kits and/or components and methods of using the kits and/or components are also provided.

Abstract: The invention relates to a prosthesis (1) comprising a textile (2) of elongate shape defining a longitudinal axis A, and a reinforcing element comprising at least one semi-rigid elongate structure (8) connected to said textile, said structure being substantially parallel to said longitudinal axis A and having a distal end provided with at least one fastening element (4) distinct from said textile and capable of cooperating with a part of a tool (10) that is able to pass through said trocar, in order to temporarily couple said prosthesis to said tool.

Abstract: An end effector for use by a surgeon to staple an anatomical structure of a patient during a minimally invasive procedure can include an anvil, a cartridge, and a knife. The anvil includes a proximal end, a distal end, and a face that is positionable on a first side of the anatomical structure. The cartridge is configured to house a plurality of staples and includes a proximal end, a distal end, and a face that is positionable on a second side of the anatomical structure. The knife has a cutting edge, the knife being operably configured to move from a first position at about a distal end of the end effector to a second position at about a proximal end of the end effector. The distal end of the anvil is movably coupled to the distal end of the cartridge.

Abstract: Exemplary embodiments provide an approach to predicting meal and/or exercise events for an insulin delivery system that otherwise does not otherwise identify such events. The insulin delivery system may use a model of glucose insulin interactions that projects estimated future glucose values based on a history of glucose values and insulin deliveries for a user. The predictions of meal events and/or exercise events may be based on residuals between actual glucose values and predicted glucose values. The exemplary embodiments may calculate a rate of change of the residuals over a period of time and compare the rate of change to thresholds to determine whether there likely has been a meal event or an exercise event. The insulin delivery system may then take measures to account for the meal event or the exercise event by the user.

Abstract: A surgical staple cartridge is disclosed comprising a plurality of staples removably stored within the surgical staple cartridge. The staples comprise staple legs which extend from a staple base portion. The staple legs comprise staple tips configured to pierce tissue and contact a corresponding forming pocket of an anvil of surgical stapling instrument. The staples further comprise zones having different hardnesses.

Abstract: Intradiscal implants, systems, and methods thereof. The intradiscal system may include an expandable implant and one or more intradiscal implants. The intradiscal implants may be supplemental to or integrated with the expandable implant. The intradiscal implant may include one or more flexible anchors with a straight configuration and a curved configuration. The anchor may be bendable, for example, using a shape-memory material.

Abstract: The invention comprises a method for fixating bones in the foot by aligning the bones in their desired position, inserting a screw in the aligned bones, inserting at least one transverse element near the head or tip of the screw, and tightening the screw to compress the bones. The screw comprises a shaft having first and second ends with spirally wound screw threads beginning near the first end and extending along the shaft. Advantageously, the screw is cannulated and screw threads are formed on an interior surface of the cannulation. Illustratively, the transverse elements may be staples, open-ended washers, or open-ended nuts. Reduction instruments and drill guides used in the invention are also disclosed.

Abstract: The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.

Abstract: A clipping device includes a clip including a capsule and a pair of clip arms, proximal ends of which are slidably received within the channel to move the clip arms between an open configuration and a closed configuration. Each of the pair of clip arms includes an elongated opening extending through the proximal ends thereof. A connector includes a central portion received between the proximal ends of the clip arms and a pin extending from the central portion receivable within the opening of each of the clip arms, the connector movable from an unlocked configuration, in which the pin is received within a distal portion of the elongated opening, to a locked configuration, in which the pin is received within a proximal portion of the elongated opening, when a predetermined force is applied thereto.

Abstract: An apparatus for deployment of a hemostatic clip includes a handle assembly, a shaft connected to a distal portion thereof and a clip assembly releasably coupled to a distal portion of the shaft. The clip assembly includes clip arms and a capsule cooperating with the clip arms to provide a first user feedback indicating a decision configuration of the clip assembly. In addition, the apparatus includes a control wire including a ball connector, the control wire extending from the handle assembly and coupled to the clip assembly by the ball connector to maintain the clip assembly coupled to the shaft, wherein the ball connector is detachable from the clip assembly to provide a second user feedback indicating separation of the clip assembly.

Abstract: A clip delivery device includes a clip, a first tube configured to store the clip when the clip is closed; a second tube coupled to a proximal end of the first tube; a hook configured to hook a proximal end portion of the clip; a wire coupled to the hook, the wire is configured to pull the hook in a longitudinal direction thereof; an elongated portion coupled to a proximal end of the second tube, the elongated portion having the wire inserted therethrough; and an operating portion coupled to a proximal end of the elongated portion, the operating portion being configured to operate the wire, wherein the hook includes at least one structural mechanism that is configured to suppress rattling that occurs when the proximal end portion of the clip is pulled into the second tube.

Abstract: Left atrial occlusion devices and methods of implantation. The left atrial occlusion devices can have a plurality of flexible elongate members forming a distally open cage configuration when expanded. The distal ends of the elongate members can optionally be atraumatic. Also disclosed is a method of occluding a left atrial appendage that includes expanding an expandable member against the left atrial appendage to seal off the left atrial appendage from blood flow from the left atrium, and determining if blood is flowing from within the left atrial appendage to a location outside the left atrial appendage.

Abstract: Reinforced surgical constructs and methods of tissue repairs. A surgical construct can offer both repair and shuttling capabilities to allow for a single pass to load multiple sutures at once. A surgical construct includes one or more repair sutures provided with one or more junctions (one or more releasable stitches), to allow the repair sutures to be joined and subsequently released. At least one of the one or more junctions (releasable stitches) can be formed by weaving back and forth another flexible strand (releasing suture) through the one or more repair sutures. When the flexible strand is pulled, it pulls out the one or more junctions (releasable stitches) from the repair sutures, freeing the repair sutures. The surgical construct may be part of a knotless or knotted construct.

Abstract: A bone staple device includes a base; and two legs extending parallel from the base, the two legs each having a tapered end opposite the base; and a cutout region extending through a thickness of the base, the cutout region forming a petal protruding away from the leg; the bone staple device serving as a suture anchor to affix directly to soft tissue.

Abstract: This invention can be embodied in a method and device for therapeutically-occluding a cerebral aneurysm. A method embodiment includes radially-constraining a tubular mesh to form proximal and distal convex portions of the mesh, collapsing the proximal portion into a concave (e.g. bowl) shape, and expanding the distal portion of the mesh within an aneurysm sac by filling it with embolic members and/or material. The expanded distal portion of the mesh holds the concave proximal portion securely against the aneurysm neck and conforms to the wall contours of even an irregularly-shaped aneurysm sac.

Abstract: A tongue elevator device having a handle portion, an elongated neck portion and a manipulator end portion. The handle preferably has an oblong main body having a relatively thin flat portion and a relatively thick transversely-extending end portion for secure and comfortable gripping between the fingers and thumb of the user. The elongated neck portion extends distally from the flat portion of the handle portion, and may be provided with measuring indicia to visually illustrate distances from the manipulator end portion of the device. The manipulator end portion has a concave distal edge, which may be formed angularly or arcuately, and a central recess or slot is provided in the concave distal edge to receive the frenulum tissue. A concave thumb recess may be disposed on the handle portion.

Abstract: A minimally invasively implanted anchor support for securing a medical device to a heart wall including an anchoring member and an expandable distal anchor retraint which is implanted through the anchoring member, through the heart wall, and expands on the opposing heart wall side to anchor a medical device. A single-stage anchor system includes the distal flange and a two-stage anchor system includes the distal flange and a proximal flange which cooperates with the distal flange to secure a medical device to the heart wall and methods of a single-stage anchor system and a two-stage anchor system.

Abstract: An incontinence clamping device has been presented herein. The incontinence clamping device comprises an upper clamp arm having a stopper and a bottom clamp arm having a locking component with a plurality of interlocking gaps. The incontinence clamping device further comprises a top and a bottom stabilizer having a plurality of zig-zag portion including at least one or more elevated and one or more non-elevated portions. The incontinence clamping device further comprises an upper silicone fitting that is used for accommodating the top stabilizer and a bottom silicone fitting that is used for accommodating the bottom stabilizer. The incontinence clamping device in its closed state allows for delivery of different pressures to urethra and corpus spongiosum as a function of various sizes of penises in a flaccid state.

Abstract: A surgical device controls fluid flow through a vessel by releasable constriction of the vessel using a compressible “C”-shape operating member with first and second elongate flexible members respectively configured to form a first loop and a second loop, the first and second loops intersecting to define an eye surrounding the vessel, wherein the operating member has first and second arms separated by a gap, the first arm being attachable to the first elongate flexible member, the second arm being attachable to the second elongate flexible member, so as to apply tension to the first and second elongate flexible members, the eye being located in the gap, whereby compression of the operating member relaxes tension in the elongate flexible members permitting opening of the eye and fluid flow within the vessel.

Abstract: A surgical bone sheath staple device, anchor, and/or scaffold enables low impact installation of distal end members in bones to secure soft tissue and the like via a deployment system. The bone sheath staples, anchors, and scaffolds secure soft tissue to bone to ensure tailored fixation of soft tissue to bone. The bone staples, anchors, and scaffolds integrate sheath and suture tightening members to secure soft tissue to bone and tailor compression of soft tissue to bone to encourage healing. The bone staples, anchors, and scaffolds integrate sheaths and suture to define attachment mechanisms and other features that secure the staples, anchors, and/or scaffolds to bone.

Abstract: A clip device includes a restraining tube having an insertion passage with a first arm part and a second arm part facing each other and disposed within the insertion passage and configured to protrude from the restraining tube. The clip device further includes an operation wire configured to move the first arm part. A first stopper is engaged to the first arm part and a second stopper is engaged to the second arm part. The first stopper is disposed in a region closer to a distal end of the restraining tube than the second stopper. The first stopper is configured to, in response to the operation wire moving from the distal end of the restraining tube to a proximal end of the restraining tube, move relative to the second stopper, contact the second stopper, and move in contact with the second stopper.

Abstract: Methods for delivering a sheet-like implant to a target site including a means of deploying and orienting the sheet-like implant within the body.

Abstract: In one aspect, compositions and wound dressings are described herein. In some embodiments, a composition or wound dressing described herein comprises a mesh formed from a plurality of biodegradable polymer fibers; a first active agent dispersed in the biodegradable polymer fibers; a plurality of biodegradable polymer particles disposed in the mesh; and a second active agent dispersed in the biodegradable polymer particles. The particles can be disposed within the interiors of the fibers of the mesh or between the fibers of the mesh. In another aspect, a composition or wound dressing described herein comprises a first perforated mesh formed from a first plurality of biodegradable polymer fibers; and a second perforated mesh formed from a second plurality of biodegradable polymer fibers, wherein the second perforated mesh is disposed on the first perforated mesh in a stacked configuration and the first and second perforated meshes have different degrees of perforation.

Abstract: A medical device, comprising a fastening assembly, wherein the fastening assembly includes an adapter defining an opening therethrough, a fastener releasably coupled to the adapter, wherein the fastener includes at least two jaws pivotable relative to one another, the fastener having a first configuration wherein the jaws are open and a second configuration wherein the jaws are closed, and at least one cable coupled to the fastener and the adapter, the at least one cable being configured to apply tension to the fastener to transition between the first configuration and the second configuration while the fastener is coupled to the adapter, and to control release of the fastener from the adapter.

Abstract: A trocar site closure clip includes a generally triangular central body, a pair of arms extending from the body, and an elongated support extending from the body between the arms. In use, the clip is advanced into a patient through a trocar, the trocar removed, then the clip partially retracted to engage and pierce the patients tissue. The biodegradable clip remains in the patients tissue, at least partially blocking the trocar site, and degrades over time as the patient heals.

Abstract: A crosslink mechanism features a locking clip with interlocking teeth. When being deployed, the surgeon will compress the spring loaded clips, freeing rotation on both sides of the mechanism. Once clipped onto the sequential reducers, the surgeon releases the clips allowing the spring to lock the teeth and therefore lock rotational freedom out of the mechanism.

Abstract: An indwelling clip includes a clip main body having a pair of arm plate portions that can be opened in a substantially V shape with an elastic force and claw portions formed on respective tip portions of the arm plate portions. The indwelling clip also includes a fastening ring attached to the arm plate portions so as to be movable along a longitudinal direction of the pair of arm plate portions and be able to close the pair of arm plate portions by moving in a direction of the claw portions. An outer surface of the claw portion is provided with a fluorescent body containing a fluorescent pigment emitting red or near infrared light by being irradiated with excitation light.

Abstract: Embodiments of the present disclosure relate to a circulatory support device with an integrated cannula. In an exemplary embodiment, an apparatus for attachment to a cardiac pump, comprises an adaptor. The adaptor comprises an annular cross section configured to receive the cardiac pump. The annular cross section is secured to the cardiac pump. The adaptor also comprises a plurality of channels arranged around the adapter and a cannula comprising a proximal portion, a distal portion, and an intermediate portion comprising a braided mesh extending between the distal portion and the proximal portion. The proximal portion has a proximal end comprising a plurality of elements arranged through the channels and the distal portion comprises a plurality of wires and a tip element. The plurality of wires extend in a distal direction from the braided mesh to the tip element and are secured to the tip element. And, a coating covers at least a portion of the braided mesh.

Abstract: The present disclosure relates to a clip apparatus for an endoscope, the clip apparatus having a simple driving part and enabling accurate and easy clip ligation and separation. The present disclosure provides a clip apparatus for an endoscope, the clip apparatus comprising: a handle part having a moving hole formed therein; a handle slider installed so as to be slidable in the handle part through the moving hole; an inner sheath rotatably connected to the inside of the handle part and extending to the outside of the handle part; a wire connected to the handle slider and disposed inside the inner sheath; an outer sheath disposed so as to cover the inner sheath; an outer handle coupled to the outer sheath so as to move the outer sheath along the length direction of the inner sheath; and a clip coupling part connected to one end of the wire and enabling the coupling of a clip.

Abstract: A surgical staple cartridge is disclosed comprising a plurality of staples removably stored within the surgical staple cartridge. The staples comprise staple legs which extend from a staple base portion. The staple legs comprise staple tips configured to pierce tissue and contact a corresponding forming pocket of an anvil of surgical stapling instrument. The staples further comprise zones having different hardnesses.

Abstract: An implantable medical device (IMD) including a housing defining a propellant chamber, a drug reservoir located within the propellant chamber of the housing configured to receive a therapeutic fluid, a propellant gas within the propellant chamber; and a volume measurement system that includes a temperature sensor configured to measure a temperature of the propellant gas within in the propellant chamber and a pressure sensor configured to measure a pressure of the propellant gas within the propellant chamber. The volume measurement system is configured to measure the pressure and the temperature of the propellant gas to provide current volume information of the therapeutic fluid in the drug reservoir.

Abstract: A tissue thickness compensator may generally comprise a compressible core comprising a plurality of movable particles, and a wrap surrounding the compressible core. The plurality of movable particles may comprise at least one medicament. A tissue thickness compensator may generally comprise a compressible core comprising a plurality of crushable particles, and a wrap surrounding the compressible core. The plurality of crushable particles may comprise at least one medicament. The compressible core may comprise a material selected from a group consisting of a biocompatible material. The wrap may comprise a material selected from a group consisting of a biocompatible material. Articles of manufacture comprising the tissue thickness compensator and methods of making and using the tissue thickness compensator are also described.

Abstract: An anvil buttress loading system includes an anvil assembly, an anvil buttress loading tool, and an anvil buttress. The anvil buttress is retainable on each of the anvil buttress loading tool and the anvil buttress, and is transferrable from the anvil buttress loading tool to the anvil assembly.

Abstract: A medical device that may include an elongate member having a proximal end and a distal end, and a lumen disposed through the elongate member is disclosed. The medical device may also include an opening disposed at the distal end of the elongate member in communication with the lumen, and a pushing element disposed with the lumen. The medical device may also include at least one fiducial disposed within the lumen and distal to the pushing element, and a separating mechanism disposed at the distal end of the elongate member. The separating mechanism may be configured to apply a separating force to deploy the at least one fiducial.

Abstract: Suturing apparatuses can be configured to suture biological tissue, such as an anatomical valve. The suturing apparatuses can include a suturing device having an elongate shaft having a proximal end and a distal end, one or more tissue grasping arms, and a handle with actuators. The suturing device can further include at least two needles. One of the tissue grasping arms can have at least two suture mounts each loaded with a suture portion. The suture portions on the suture mounts can form a single suture strand. Methods for suturing bodily tissue may be performed with the suturing apparatuses. The tissue grasping arms can grasp tissue therebetween and at least two needles can be deployed toward the suture mounts, engage the suture portions, and be retracted through the tissue. A knot can be tied on the ends of the suture strand retrieved by the needles.

Abstract: A system for restoring muscle function to the lumbar spine to treat low back pain is provided. The system may include electrodes coupled to an implantable pulse generator (IPG), a handheld activator configured to transfer a stimulation command to the IPG, and an external programmer configured to transfer programming data to the IPG. The stimulation command directs the programmable controller to stimulate the tissue in accordance with the programming data. The system may include a software-based programming system run on a computer such that the treating physician may program and adjust stimulation parameters.

Abstract: An ultrasonic surgical instrument that can be used in a robotic surgical system includes an end effector having an ultrasonic blade and a clamp arm pivotally secured relative to the ultrasonic blade. A shaft assembly extends proximally from the end effector and includes a tube, an acoustic waveguide received within the tube, and a sheath positioned between the acoustic waveguide and the tube to damp acoustic vibrations from the acoustic waveguide toward the tube. At least one sensor is positioned on at least one of the end effector or the sheath to measure a force applied at the end effector or the sheath as a measured force, respectively, and thereby provide real-time feedback of a non-clamping force applied against one of the ultrasonic blade or the clamp arm.

Abstract: A surgical clamp is disclosed. The surgical clamp comprises a two-piece body comprising atop jaw housing that inter-fits with a bottom jaw housing; the top jaw housing comprising a top jaw; the bottom jaw housing comprising a bottom jaw; the inter-fitting top jaw housing and bottom jaw housing disposed for movement relative to one another; a bias to the top jaw housing and bottom jaw housing apart; and a lever moveable between a lock position and an open position and the lever disposed to prevent opening movement of the top jaw housing relative to the bottom jaw housing and to allow graduated relative closing movement of the top jaw housing relative to the bottom jaw housing in the lock position and to allow opening and closing movement of the top jaw housing relative to the bottom jaw housing in the open position.