Abstract: A surgical suturing device comprises an arced needle track, an arced needle positioned in the needle track, and a length of suture connected to the needle. A reciprocating needle driver is operative to engage and move the needle in the needle track. A rotary input rotates about an axis. A link has a proximal end connected to the rotary input and a distal end connected to the needle driver. Rotation of the rotary input in a first angular direction translates the needle driver in a second angular direction opposite of the first angular direction.

Abstract: A tissue puncture closure device that includes an anchor (208, 508), a sealing pad (210, 510), a compaction member (212, 312, 412, 512), a suture (204, 504), and a suture cutting member (270, 472, 570). The compaction member is configured to compact the sealing pad toward the anchor. The suture is coupled to the sealing pad and anchor, and a portion of the suture extends through at least a portion of the compaction member. The suture cutting member is operable to cut the suture. The suture cutting member is operable within a portion of the compaction member to cut the suture.

Abstract: An intraluminal member can be used to deliver an adhesive to a vein while causing the vein to spasm, thereby controlling adhesive migration and improving procedure efficacy.

Abstract: The present invention relates to a suture which is firmly maintained and fixed to an operation site to stably sustain suturing or lifting effects for a long time. More specifically, the present invention provides a suture having a conic or pyramidal shape with a cut top, wherein a suture supporter comprising a communication hole penetrating the both ends is provided at one end. The suture support can have one or more portions which are cut vertically from a lower end at a lower end portion having a larger diameter between the both ends, or a part of the lower end can be removed so as to form one or more gaps formed from the end at a wall of the end portion.

Abstract: A vascular closure system (10) includes a dual lumen tube (14), an inflatable balloon (16), and a distal sealing assembly (18). The dual lumen tube includes a proximal end portion, a distal end portion, a first lumen, and a second lumen. The first lumen is coupled in fluid communication with an inflation fluid and has a first distal opening at a distal end of the dual lumen tube. The second lumen extends from the proximal end portion to the distal end portion. The inflatable balloon is mounted to the dual lumen tube in fluid communication with the first lumen, and is inflatable within a vessel to temporarily seal closed a tissue puncture. The distal sealing assembly includes a distal sealing member (74) positioned distal of the inflatable balloon, and is detachable from the distal sealing assembly at a location exterior and adjacent to the vessel.

Abstract: An apparatus for closing a surgical incision comprises left and right base panels, a plurality of closure components, and a plurality of left and right axial supports coupled to the respective base panels. The closure components couple the left and right base panels to each other laterally and have left and right ends coupled to the respective base panels. The closure components are positioned laterally across the left and right panels, the left axial supports are disposed between pairs of left closure component ends, the right axial supports are disposed between pairs of right closure component ends, and the left and right axial supports are offset from one another such that a serpentine arrangement of consecutive closure components and axial supports is formed. The apparatus can be made of antimicrobial materials or materials impregnated with antimicrobial agents. A flexible adhesive cover can be provided over the apparatus when in use.

Abstract: A delivery system and method for placing a medical implant, such as for diagnosing, monitoring and/or treating cardiovascular diseases. The delivery system includes a hollow catheter, an anchor coupled to the catheter, and an implant secured within the anchor. The anchor has a base portion with first and second longitudinal ends and a cage therebetween. The anchor further has flexible arms, flexible legs, features for securing the medical implant within the cage of the base portion, and a coupler portion connected to and spaced apart from the second longitudinal end of the base portion. Surfaces of the arms and legs are adapted to clamp the anchor to a wall. The system further includes a pusher wire adapted to cause the anchor to acquire a stowed configuration in which the legs axially extend from the base portion, permitting the anchor to be retrieved after its deployment.

Abstract: Embodiments include coatings for adherence of biomaterials to a tissue. Systems and methods for adapting such coated materials to vascular access closure are further proved.

Abstract: A method of assembling an adjustable continuous filament assembly whereby a single length of filament is spliced to form a nonadjustable portion and a single free segment. The single free segment is introduced into the inner core of the nonadjustable portion at a first position. The single free segment is passed through at least a portion of the inner core of the nonadjustable portion. The single free segment is withdrawn from the nonadjustable portion at a second position, thereby forming an adjustable portion secured to the nonadjustable portion and adjustable by the single free segment.

Abstract: A biodegradable device for providing scaffolding for a trocar defect to promote healing. The device consists of an upper and lower scaffold, offset by a connector. The device is arranged so the distance between the lower surface of the upper scaffolding and upper surface of the lower scaffolding holds the fascia around the trocar defect while promoting tissue growth. The surfaces of the scaffolding in contact with the trocar defect are textured to maximize adherence to tissue.

Abstract: The present disclosure relates to devices and methods for implanting a prosthesis into a heart of a mammal, such as a person. The disclosure includes a prosthesis that acts as a pressure vent between the left and right atria of the heart. The disclosure also includes a mounting tool for mounting the prosthesis onto a loading tool, the loading tool useful for loading the prosthesis onto a device for delivering the prosthesis into the patient's heart. Control devices and methods for using these devices are also disclosed. The intracardiac pressure vents disclosed allow sufficient flow from the left atrium to the right atrium to relieve elevated left atrial pressure and resulting patient symptoms. The devices also limit the amount of flow from the right atrium to the left atrium to minimize the potential for thrombi or other embolic material from entering arterial circulation.

Abstract: Described are devices, methods, and systems useful in the treatment of fistulae, and in certain embodiments those having openings extending into the alimentary canal, such as anorectal fistulae. Illustratively, an anorectal fistula can be treated by placing a volumetric construct within the primary opening of the fistula. In certain embodiments, the volumetric construct can include a rolled remodelable material processed to form a substantially unitary body. Advantageous such remodelable materials can include collagenous extracellular matrix materials, such as small intestine submucosa.

Abstract: The invention relates to a sealing device for repair of cardiac and vascular defects or tissue opening such as a patent foramen ovale (PFO) or shunt in the heart, the vascular system, etc. and particularly provides an occluder device and trans-catheter occluder delivery system. The sealing device would have improved conformity to heart anatomy and be easily deployed, repositioned, and retrieved at the opening site.

Abstract: Apparatus for sealing a vascular wall penetration disposed at the end of the tissue tract comprises a shaft, an occlusion element, a hemostatic implant, and a protective sleeve. The apparatus is deployed through the tissue tract with the occlusion element temporarily occluding the vascular wall penetration and inhibiting backbleeding therethrough. The hemostatic implant, which will typically be a biodegradable polymer such as collagen carrying an anti-proliferative agent or coagulation promoter, will then be deployed from the sealing apparatus and left in place to enhance closure of the vascular wall penetration with minimum scarring. The implant may be radiopaque to allow observation before release.

Abstract: Embodiments are described for closing vascular access ports, such as arteriotomies, which involve placement and deployment of an expandable device configured to prevent blood flow across a subject arteriotomy while also keeping disturbance of intravascular flow to a minimum. Suitable prostheses may comprise one or more frames constructed from lengths of flexible materials, such as shape memory alloys or polymers. Such frames may be coupled to sheetlike or tube-like structures configured to spread loads, minimize thrombosis which may be related to intravascular flow, and maintain hemostasis.

Abstract: A device for the repair of tissue and methods of use and manufacturing thereof are described herein. Applications for the use of the device include, e.g., repair of atrial septal defects (ASD), patent foramen ovale (PFO), left atrial appendage closure and stent graft fixation among other applications throughout the anatomy. The implant portion of the device is available in a variety of sizes and configurations to accommodate the vast complexity of the target anatomy.

Abstract: Methods and devices for diagnosing, monitoring, and/or treating tissue through an opening or port through an airway wall are provided herein.

Abstract: Disclosed is a closure catheter, for closing a tissue opening such as an atrial septal defect, patent foreman ovale, or the left atrial appendage of the heart. The closure catheter carries a plurality of tissue anchors, which may be deployed into tissue surrounding the opening, and used to draw the opening closed. Methods are also disclosed.

Abstract: Apparatus and methods for positioning and securing anchors are disclosed herein. The anchors are adapted to be delivered and implanted into or upon tissue, particularly tissue within the gastrointestinal system of a patient. The anchor is adapted to slide uni-directionally over suture such that a tissue plication may be cinched between anchors. A locking mechanism, either within the anchor itself or positioned proximally of the anchor, may allow for the uni-directional translation of the anchor while enabling the anchor to be locked onto the suture if the anchor is pulled, pushed, or otherwise urged in the opposite direction along the suture. This uni-directional anchor locking mechanism facilitates cinching of the tissue plication between the anchors, and it may be utilized in one or several anchors in cinching a tissue fold.

Abstract: The present disclosure includes vessel closure devices, systems, and methods. A closure device configured to close an opening in a body lumen may include an elongate member having a distal end and a proximal end. An anchor member may be disposed on the elongate member proximate the distal end of the elongate member. A cap member may also be disposed on the elongate member a distance from the distal end of the elongate member. The anchor member and the cap member cooperate to close the opening in the body lumen.

Abstract: Methods and apparatuses for closure of vascular punctures or other openings in bodily tissues. The apparatuses and methods described herein are configured for everting a portion of tissue around a puncture site for wound closure on the external surface of the wound. For example, the tissue eversion apparatus may be configured for drawing up a portion of a vessel surrounding a venous or arterial puncture and orienting the inner surface of the vessel at least partially outward so that a closure element may be placed around the inverted region on the exterior surface of the vessel. In some embodiments, the devices are bioabsorbable.

Abstract: A tissue puncture closure assembly including a wire assembly and first and second devices. The wire assembly includes a first wire member and a second wire member that each include a distal end portion and a proximal end portion. At least portions of the second wire member are arranged side-by-side with the first wire member. The distal end portion of the first wire member is connected to the distal end portion of the second wire member, and a proximal end portion of the first wire member is disconnected from the proximal end portion of the second wire member. The first device is operable to advance over the first wire member. The second device is operable to advance over the second wire member.

Abstract: A tissue puncture closure assembly including a wire assembly and a sealing pad delivery device. The wire assembly includes a proximal end portion, a distal end portion, and a temporary expandable anchor positioned at the distal end portion. The sealing pad delivery device includes a carrier tube, a sealing pad positioned in the carrier tube, and a lateral wire slot. The lateral wire slot is defined in an outer surface of the sealing pad delivery device and extends along at least a portion of a length of the sealing pad delivery device. The lateral wire slot is configured to permit mounting of the sealing pad delivery device to the wire assembly in a lateral direction.

Abstract: One embodiment is directed to a method for providing surgical access across a wall of a tissue structure, comprising: advancing a helical needle into the wall of the tissue structure such that the needle pulls an intercoupled suture member across the wall to form a deployed suture pattern, the deployed suture pattern being characterized in that: the portion of the suture member encapsulated by the wall of the tissue structure is substantially helical in formation and represents a number of helical loops that is greater than about one helical loop, and is less than about three helical loops; portions of the suture member on either side of the wall are in a slack configuration such that tension in the suture member arising from the encapsulated portion pulls in additional length from the slack configuration on either side of the wall to accommodate expansion of the substantially helical encapsulated portion.

Abstract: A method for closing an opening formed in a wall of a body lumen or body tissue can include positioning a splittable carrier tube adjacent to the opening, the carrier tube having a splittable distal end with an outer surface retaining a closure element in a substantially tubular configuration or having an asymmetrically-elongated tubular shape with a trapezoidal longitudinal cross-sectional profile. The method including splitting a distal end of the carrier tube with a splitter and deploying the closure element from the carrier flaps of the carrier tube and over the splitter to allow the closure element to engage at least a portion of the wall of the body lumen or the body tissue and substantially close the opening.

Abstract: Apparatus and methods for sealing a puncture communicating with a blood vessel are provided that include introducing a porous carrier formed from lyophilized hydrogel or other material into the puncture. The plug may include at least one of first and second hydrogel precursors and a pH adjusting agent carried by the porous carrier in an unreactive state prior to exposure to an aqueous physiological environment. Once exposed to bodily fluids, the carrier expands as the lyophilized material hydrates to enhance and facilitate rapid hemostasis of the puncture. When the plug is placed into the puncture, the natural wetting of the plug by bodily fluids (e.g., blood) causes the first and second precursors to react and cross-link into an adhesive or “sticky” hydrogel that aids in retaining the plug in place within the puncture.

Abstract: Surgical accessories are presented in vivo and used by surgical tools in the surgical site to perform additional tasks without the need to remove the tools from the surgical site for tool change or instrument loading. The accessories can be introduced into the surgical site by a dedicated accessory introducer, or can be supported on the body of a surgical tool inserted into the surgical site and be manipulated using another surgical tool in the surgical site. The accessory introducer can be resiliently biased to bias the accessories toward a predetermined position in the surgical site.

Abstract: Adjacent tissue layers can be accessed using a catheter device with a distal tip having a conductive portion including a first cutting feature and one or more projections extending from the first cutting feature towards an outer diameter of the distal tip. Electrical energy can be supplied to the conductive portion of the device to cut tissue. A stent can be delivered to form a fluid communication between the adjacent tissue layers.

Abstract: The invention relates to a sealing device for repair of cardiac and vascular defects or tissue opening such as a patent foramen ovale (PFO) or shunt in the heart, the vascular system, etc. and particularly provides an occluder device and trans-catheter occluder delivery system. The sealing device would have improved conformity to heart anatomy and be easily deployed, repositioned, and retrieved at the opening site.

Abstract: Apparatus for sealing a puncture communicating with a blood vessel includes a bioabsorbable sealing member secured to one end of a filament or other retaining member. The sealing member is delivered through the puncture into the vessel, and refracted against the wall of the vessel to provide temporary hemostasis. The sealing member is rapidly absorbed after exposure within the vessel, e.g., to an aqueous or heated physiological environment (e.g., exposure to blood or body temperature), immediately or shortly after completing a medical procedure via the puncture, e.g., within the time period that the patient is ambulatory. Optionally, extravascular sealing material is delivered into the puncture proximal to the sealing member. The retaining member and/or extravascular material may be bioabsorbable, being absorbed at a slower rate than the sealing member. Alternatively, the filament is removed from the puncture after hemostasis is established.

Abstract: Apparatus and methods for blocking needle tracts are disclosed. In some embodiments, the needle tracts are blocked by using a needle that includes an elongated shaft that defines an outer surface, and a polymer coating applied to the outer surface of the shaft, the coating being adapted to block the tract formed by insertion of the needle into an object.

Abstract: Apparatus and methods for sealing a puncture through tissue includes an introducer sheath sized for introduction into a puncture, cartridge sized for insertion into the introducer carrying a sealant, and a locking element for coupling the introducer sheath to the cartridge. When the cartridge is advanced into the introducer sheath, the locking element couples the introducer sheath to the cartridge such that subsequent retraction of the cartridge causes the introducer sheath to retract, thereby deploying the sealant from the cartridge within the puncture beyond the introducer sheath.

Abstract: The present invention relates to wound closure devices, devices and systems for delivery, kits and methods therefor. The wound closure devices can achieve wound closure in lieu of compression and can be configured to be quickly deployable by an introducer or from outside the body.

Abstract: An occluder for sealing gaps between a medical device and adjacent body tissue includes an expandable body configured to fill the gaps between the medical device and the body tissue. The occluder includes a fastener at one end of the body and adapted to couple to a first end of the medical device, and an expandable disk at the other end of the body and adapted to couple to the medical device at a position spaced from the first end.

Abstract: A tissue closure device including a hub and first and second flanges extending therefrom. The hub extends along a central longitudinal axis between a proximal surface and an opposing distal surface. The first flange is frameless and extends from the hub adjacent the proximal surface thereof. The second flange extends from the hub adjacent the distal surface thereof. The first and second flanges are moveable between: a closed position, in which the first and second flanges extend radially away from the hub and are substantially orthogonal to the central longitudinal axis; and an open position, in which the first and second flanges extend longitudinally away from the hub in opposite directions from each other and are substantially parallel with the central longitudinal axis.

Abstract: Absorbable polyester fibers, braids, and surgical meshes with prolonged strength retention have been developed. These devices are preferably derived from biocompatible copolymers or homopolymers of 4-hydroxybutyrate. These devices provide a wider range of in vivo strength retention properties than are currently available, and could offer additional benefits such as anti-adhesion properties, reduced risks of infection or other post-operative problems resulting from absorption and eventual elimination of the device, and competitive cost. The devices may also be particularly suitable for use in pediatric populations where their absorption should not hinder growth, and provide in all patient populations wound healing with long-term mechanical stability. The devices may additionally be combined with autologous, allogenic and/or xenogenic tissues to provide implants with improved mechanical, biological and handling properties.

Abstract: Occluder devices for occluding an anatomical aperture, such as an atrial septal defect (ASD) or a patent foramen ovale (PFO) comprise two sides connected by a central tube. The occluder devices are formed from a tube, which is cut to produce struts in each side. Upon the application of force, the struts deform into loops. The loops may be of various shapes, sizes, and configurations, and, in at least some embodiments, the loops have rounded peripheries. In some embodiments, at least one of the sides includes a tissue scaffold. The occluder devices include a catch system that maintains its deployed state in vivo. When an occluder device is deployed in vivo, the two sides are disposed on opposite sides of the septal tissue surrounding the aperture and the catch system is deployed so that the occluder device exerts a compressive force on the septal tissue and closes the aperture.

Abstract: Methods and devices are provided for securing suture to tissue. In one exemplary embodiment, the implant can include an intermediate portion, a first radially expandable portion extending from the intermediate portion, and a second radially expandable portion extending from the intermediate portion. The implant can be configured to be inserted through a delivery device in a first configuration and deployed into a hole formed in tissue in a second configuration such that the intermediate portion is positioned within the hole. A suture can be inserted through a passageway of the intermediate portion positioned within the hole, and the suture can be tensioned to secure the tissue to bone.

Abstract: Described are devices, methods, and systems for achieving occlusion of vascular vessels. Further described are certain reduced or low profile procedures and devices for the percutaneous occlusion of the saphenous vein, such as in the treatment of a varicose vein condition caused by venous reflux. Devices and procedures can involve an endoluminal delivery device having an atraumatic distal end, that is advancable through a vascular vessel, and an occlusion device received on the endoluminal delivery device. The endoluminal delivery device can have one or more adaptations for releasably receiving the occlusion device. The occlusion device can include a sponge form material. The occlusion device can include a remodelable material or a synthetic material. The occlusion device can include an anchor.

Abstract: Methods and apparatus are disclosed for sealing a puncture or incision formed percutaneously in tissue separating two internal portions of the body of a living being with an anchor, a sealing plug and a filament connecting the anchor and sealing plug. The methods and apparatus provide for a compaction mechanism that is expandable and tamps the sealing plug into place.

Abstract: An interventional medical device connector and a method for using same. The interventional medical device connector comprises an implant (1) and a pusher (5). One end of the implant (1) is provided with at least one lock ring (9). The top end of the pusher (5) is provided with at least one locking hole (7). The pusher (5) is provided with at least one control wire (4). The control wire (4) slides along the axial direction of the pusher (5), and the top end of the control wire (4) can reach at least one of the locking holes (7). The control wire (4), the lock ring (9) and the locking hole (7) together form a connection means having a lock-pin structure. Use of this means of connection effectively overcomes the defects of existing threaded connections, reduces risks, and provides convenience of use.

Abstract: A bioresorbable anchor for deployment in a live body, in one embodiment the anchor comprises an inner anchor made of a first bioresorbable material and an outer anchor made of a second bioresorbable material, wherein the outer anchor envelops the inner anchor. In another embodiment, the anchor comprises a base anchor made of a first bioresorbable material and a second bioresorbable material overlays at least a portion of the base anchor. The first bioresorbable material has a faster resorption rate than the second bioresorbable material. Further, the second bioresorbable material can provide additional strength to the anchor structure. A tissue puncture closure device comprising a filament extending from a first end of the closure device to a second end of the closure device; an anchor comprising a plurality of bioresorbable materials; a sealing plug slidingly attached to the filament adjacent to the anchor; and a tamping assembly.

Abstract: A surgical access port that includes a cylindrical member having a proximal end and a distal end and defining a longitudinal axis; at least two lumen extending through the cylindrical member along the longitudinal axis; at least one cavity defined in the cylindrical member and positioned radially within the at least two lumen; and a source of inflation fluid coupled to the at least one cavity, the source of inflation configured to permit selectable inflation of the at least one cavity, whereby inflation of the at least one cavity increases the radial distance between the at least two lumen.

Abstract: A surgical fastener configured to close an opening in tissue is provided. The surgical fastener includes a base defining a central axis at least one pair of legs extending from the base. Each of the legs includes a base portion and a tissue engaging portion. When in a first position, each of the tissue engaging portions is arranged to define an insertion direction and when in a second position, each of the tissue engaging portions extends inward towards the central axis. The surgical fastener is at least partially formed from a shape memory material including a combination of Polydioxanone and Poly(L-lactide) or a combination of Trimethylene Carbonate and Poly(L-lactide). The pair of legs are configured to move from the first position to the second position upon activation of the shape memory material.

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

Abstract: A medical implantable occlusion Device (100) is disclosed comprising a braiding of at least one thread, an expanded diameter portion (102), and a tubular member (103) having a distal endpoint closest to the expanded diameter portion having a distal rim (107). The braiding comprises a stem (108) having a first end connected to the expanded diameter portion and a second end connected to the distal region, where the stem in a relaxed state is partly sunk into the tubular member beneath the distal rim (107), wherein the proximal region comprises a connecting member (113), wherein ends of the at least one thread are fixed to the connecting member, the expanded diameter portion comprises returning loops of the at least one thread whereby opposite ends of the at least one thread forming the expanded diameter portion are fixed to the connecting member.

Abstract: A surgical delivery instrument for delivering a vascular hole closure device having first and second flexible members and a first and second engagement members extending from the respective flexible member. The delivery instrument includes a housing having first and second longitudinally extending openings and first and second projecting surfaces, the first projecting surface extending into the first opening for engagement by the first engagement member and the second projecting surface extending into the second opening for engagement by the second engagement member. The first engagement member is held by the first projecting surface until a predetermined force is applied to the first engagement member during placement of the closure device at a target site.

Abstract: The present invention generally relates to the field of transcatheter device closure techniques for closing an opening in a tissue and more particularly, to occlusion devices for closing anatomical defects in tissue. More particularly the present invention refers to occlusion devices for closing septal abnormalities such as atrial septal defects and patent foramen ovale, and to methods of closing an anatomical defect in a tissue.

Abstract: The present invention is directed to a method for sealing a puncture in a wall of a lumen of a body comprising the steps of deploying a deployment member of a sealing device through an elastic membrane adjacent the wall of the lumen and the puncture, wherein the sealing device includes a sealing element; positioning the sealing element adjacent the wall of the lumen; retracting the deployment member relative to the sealing element to stretch the membrane away from the wall of the lumen; retracting the deployment member relative to the sealing element to allow the elastic nature of the membrane to force the sealing element against the puncture; and retracting the device from the puncture.

Abstract: The present invention relates to medical devices for repairing tissue and more specifically to devices which facilitate tissue regeneration and to surgical methods for the implantation and fixation of such devices. In one embodiment, the medical device is an elongate conduit that includes a longitudinal bore extending therethrough to facilitate the transfer of blood from a vascular region of tissue to a tear or damaged area located in an avascular and/or semi-vascular region of tissue. A filament and/or filaments are attached to the conduit and are positioned to secure the conduit and fixate the adjacent tear walls in mutual engagement. In another embodiment, a series of conduits are connected via a filament and/or filaments to facilitate the implantation of multiple conduits.