Abstract: Disclosed are methods for producing an interlaced device or composition which includes at least a first and a second interlaced element. Each interlaced element includes a mated first and second part, the first part having two termini and the second part having two termini, and a defined central void through which the other interlaced element passes. The method includes the processing and mating of a first and a second substrate layer, each including a top surface, a bottom surface and a mating zone. The first substrate layer includes a portion corresponding to a first part of a first interlaced element and a first part of a second interlaced element. The second substrate layer includes a portion corresponding to a second part of a first interlaced element and a second part of a second interlaced element. Also disclosed are interlaced devices or compositions.

Abstract: Provided is a wound closure assisting and maintaining apparatus that can be attached to a wide open wound of a patient and can stretch skin around the wound gradually to achieve the wound closure and maintain the wound closure during most critical postoperative period. The apparatus includes: a loop suture being threaded through skin; a tightening member for gathering both ends of the threaded loop suture at one point and for exerting a pressure of wound tightening force evenly on skin; a pulling member for pulling the loop suture in order to tighten the threaded loop suture; a housing member for housing the pulling member and making the loop suture tightened by transformation of a pulling force to a wound tightening force when pulling member pulls the loop suture out of skin; and a locking member for fixing a position of the pulling member to maintain the tightened status.

Abstract: The present invention provides devices for closing septal defects, such as a patent foramen ovale (PFO). The closure devices include a proximal anchor member, a distal anchor member, and at least one flexible center joint connecting the two anchor members. According to some embodiments, the proximal and/or distal anchor members may include a generally cylindrical member split along the central portion of its length to form an elongate oval. The proximal and/or distal anchor members may further include a tissue scaffold. At least some of the closure devices according to the present invention are repositionable and retrievable.

Abstract: The present invention provides a device and method for safely applying cyanoacrylate or other adhesives to skin lacerations.

Abstract: In a closure device for an opening in a layer of tissue comprising a plurality of wings which provide and/or hold bearing areas on tissue surrounding the opening, the wings are held by means of respective joints for swivelling movement on a base part.

Abstract: A method, system and apparatus for augmenting the surgical repair of soft tissue injuries, in which a first end of a bridge member attaches to a first portion of healthy tissue, and a second end of the bridge member attaches to a second portion of healthy tissue. The bridge member (or bridge members) used to augment the soft tissue repair may be interconnected or function independently. Flexibility and elasticity of the bridge member are determined by the situation and may be altered to improve healing. The device may be used in arthroscopic procedures, and may be manufactured in a variety of lengths, or may be manufactured one length and be cut to the desired length, or otherwise altered to provide an optimal length of the bridge member.

Abstract: A tissue opening occluder comprising first and second occluder portions, each occluder portion including a frame structure and an attachment structure to attach one portion to the other portion. The frames may be utilized to constrain the tissue between the two portions enough to restrict the significant passage of blood therethrough. The frame portions may be covered by a fabric suspended from a perimeter thereof. The occluder portions are conjoined at least one point on each portion.

Abstract: Devices and methods are disclosed for achieving hemostasis in solid visceral wounds. Such devices and methods are especially useful in the emergency, trauma surgery or military setting. In such cases, the patient may have received trauma to the abdominal viscera. The devices utilize flexible, variable depth transfixing bolts that penetrate the viscera. These bolts are pulled tight to bring the tissue into apposition and hold said tissue in apposition while the wound heals. These bolts overcome the limitations of sutures that are currently used for the same purposes. The bolts come in a variety of lengths and diameters. Since the bolts are flexible, the curvature may be adjusted by the surgeon. The devices are flexible, bendable, and conformable in their wet or dry state. They can be used either straight or through a broad range of curvatures to suit the needs of various pathologies.

Abstract: Anastomotic components may be attached to hollow bodies or vessels by magnetic or mechanical force to create an anastomosis, form a port in a vessel, or repair a diseased vessel lumen. Anastomoses are created by coupling a first connection to an end of a vessel and then attracting it to a second connector secured to the side wall of another vessel. The connection between the first and second connectors may be solidly magnetic, solely mechanical, or a combination thereof. Also disclosed are methods and devices for treating diseased vessel lumens, for example abdominal aortic aneurysm. A plurality of docking members is attached to the vessel at solicited positions, and then one or more grafts is secured to the docking members in any suitable manner.

Abstract: A stent for occluding the human ductus arteriosus comprises a length of wire of shape memory effect or superelastic material which is expandable from a relatively straightened state for introduction into the patient to an occluding state wherein the wire defines an occluding anchor part and a spiral anchor part and a straight linking part connecting the two wherein the wire has a series of turns extending over the cross-sectional area of the occluding anchor part.

Abstract: The present invention provides an occluder with a plurality of flexible rings that comprise a self centering mechanism to keep the occluder properly centered in a defect. The self centering mechanism is located between the left and right sides of the occluder. Because the occluder remains properly centered, the chance that portions of the aperture will be exposed is reduced and the effectiveness of the occluder is increased.

Abstract: A tissue approximation device and processes for using the device, particularly in the mid-face region, are provided. The device is an implantable, biodegradable construct that has attachment points emanating from at least one supportive backing. The device also has a connecting member or leash which extends between the backing and an anchor which is attached to bone or soft tissue. Attachment to soft tissue is accomplished by a second backing having attachment points emanating from the backing and attachment to bone is accomplished by a post. The connecting member allows for repeated adjustments in length between the anchor and the backing in vivo or ex vivo until the desired amount of tissue approximation is achieved. The device improves the mechanical phase of wound healing and evenly distributes tension over the contact area between the device and tissue.

Abstract: A percutaneously insertable system for sealing punctures in blood vessels includes an element that is percutaneously insertable into and deplorable within a blood vessel, a thread-like member attached to the element that passes through the wall of the blood vessel and arresting element movable on the thread and into engagement with the other surface of the blood vessel thereby to seal the opening.

Abstract: A tissue approximation device and processes for using the device are provided. The device is an implantable, biodegradable construct (except for hernia repairs) that has attachment points emanating from a supportive backing. The device improves the mechanical phase of wound healing and evenly distributes tension over the contact area between the device and tissue. Processes for using the device include wound closure, vascular anastomoses, soft tissue attachment and soft tissue to bone attachment.

Abstract: Surgical instruments and methods are provided. In one aspect, a method of securing a fixation device within an opening in a tissue is provided, including delivering a material in a flowable state to said opening, and changing the state of the material so that the material forms an interference fit that secures the fixation device in the opening.

Abstract: A generally U-shaped surgical staple comprises a base 10 and a pair of generally “L”-shaped legs 12 extending substantially perpendicularly from opposite ends of the base respectively. The legs 12 in use of the staple are bent through approximately 90° relative to the base. To effect a greater compression of the stapled tissue the legs include a penetrative portion 16 adjacent the tip and a compressive structure 30 which, due to its increased height relative to that of the penetrative portion, spreads the compressive forces of the staple further along the length of the incision being closed. The compressive portion also provides a depth stop to avoid the tip penetrating too deeply into the tissue in which it is deployed.

Abstract: To secure a first body tissue with a second body tissue, a first anchor is moved along a first path through the first body tissue into the second body tissue. A second anchor is moved along a second path through the first body tissue into the second body tissue. A suture extending between the anchors may be tightened by moving the second anchor along a path which extends transverse to the path of the first anchor. The suture which extends between the anchors may have free ends which are connected with a suture retainer. The free ends of the suture may be interconnected either before or after the anchors are moved along the first and second paths. Alternatively, the suture may be a continuous loop which extends between the two anchors. A guide assembly may be provided to guide movement of the anchors along the two paths. The paths along which the anchors move may intersect so that the anchors may be interconnected at the intersection between the two paths.

Abstract: An epidermal lifting mechanism (10) comprising at least one strip of flexible material (50), first and second end portions (60), a middle portion (70), adhesive material (40), a plurality of resilient spring structures (20, 22, 24) extending through the at least one strip of flexible material, and a flap mechanism (80) integral with the middle portion.

Abstract: The present invention provides a device and method for safely applying cyanoacrylate or other adhesives to skin lacerations.

Abstract: A method for joining and holding closed a wound in bodily tissue, fastening junctions of wounds, tying off wounds, joining a foreign element to tissue, and altering the position of tissue using a barbed suture including sharp pointed ends. Each end of the suture includes barbs on that permit movement in an opposing direction to the barbs on the other end of the suture. This two-way barbed suture is used by the method of the present invention in applications including abdominal surgeries such as a Nissen fundoplication, laparoscopic uses such as stabilizing a bowel structure and performing a closure of a cystostomy, liver to bowel anastomosis, closure of an orifice of a Zenker's Diverticulum, endoscopic uses such as closure of ulcerative lesions or and post-procedural tissue defects, bladder wound closure, valve replacement surgery, device attachment, cosmetic surgery, and blood vessel wound closure.

Abstract: A dressing and an epidermal lifting mechanism for use with an application to a predetermined epidermal surface and methods of using same. The epidermal lifting mechanism comprises a strip of material having a first end portion of a predetermined shape, a second end portion of a predetermined shape, and middle portion coupling the first end portion to the second end portion. The first end portion and the second end portion each include a side including an adhesive layer. An overlaying, non-adhesive barrier layer may be located between a portion of the adhesive layer and an end portion.

Abstract: The present invention provides an internal fracture fixation assembly for fixation of a fracture in a bone. The assembly includes an implantable first suture retaining member having a body configured and dimensioned to be positionable proximate an outer surface of the bone on a first side of the fracture. First and second parallel channels extend through the first suture retaining member. The assembly also includes a suture. A first portion of the suture extends through the first channel of the first suture retaining member, while a second portion of the suture extends through the second channel. At least one of the portions of the suture is positioned in the bone. Furthermore, the assembly includes an implantable second suture retaining member having a body configured and dimensioned to be positionable proximate the outer surface of the bone on a second side of the fracture. A first channel extends through the second suture retaining member.

Abstract: A delivery device applies a biocompatible and biodegradable barrier material to a tissue region, e.g., to seal a vascular puncture site. The material comprises two liquid components, which are pre-packaged in individual dispensers. Upon mixing, the liquid components cross-link to create a barrier matrix. A holder attaches to the delivery device. The holder mutually supports the first and second dispensers while the protein solution and polymer solution are conveyed from the dispensers into a fluid delivery channel. The protein and polymer solutions mix as a result of flow through the channel.

Abstract: An epidermal lifting mechanism comprising at least one strip of flexible material, first and second end portions, a middle portion, adhesive material, a plurality of resilient spring structures extending through the at least one strip of flexible material, and a flap mechanism integral with the middle portion.

Abstract: A sternal closure device including impermanently joined sliding and receiving attachment structures which are adapted for intercostal positioning between at least two corresponding rib pairs and substantially surrounding a patient's sternum with each structure having a cross member, a plurality of integrated legs and foot members, a plurality of sternum engagement surfaces, and an end portion. The receiving structure further incorporates a resiliently tensioned catch member with angularly disposed teeth like structures positioned to receive and position a plurality of receiving structure projection members when inserted therein. The catch member further serves as a stabilizing structure with stabilization facilitated via an easily removed single screw like structure markedly facilitates quick release.

Abstract: An occlusion device having laminated polyvinyl alcohol sheets for occluding a defect. The laminated polyvinyl alcohol sheets provide an increased tear strength to the sheets that allows the device to be fully retrievable through the same catheter used to deploy it. The laminated sheets are created by obtaining thin sheets of polyvinyl alcohol foam, arranging the sheets on one another, and applying heat and pressure to laminate the sheets together.

Abstract: Consistent with the present invention, tissue adhesive compositions and an associated laser exposure system are provided for bonding or sealing biological tissues. The compositions are comprised of chemically derivatized soluble collagen which is formulated to concentrations ranging from 300 mg/ml (30%) to 800 mg/ml (80%) collagen protein. In particular, Type I collagen, for example, is first prepared by extraction from bovine or porcine hide and purified. The collagen preparations are then chemically derivatized with sulfhydryl reagents to improve cohesive strength and with secondary derivatizing agents, such as carboxyl groups, to improve the adhesive strength of the solder to the tissue. The compositions are then formed into viscous solutions, gels or solid films, which when exposed to energy generated from an infrared laser, for example, undergo thermally induced phase transitions.

Abstract: Methods and devices for forming an anastomosis between hollow bodies utilizes magnetic force to couple anastomotic securing components and create a fluid-tight connection between the lumens of the hollow bodies. End-to-side, side-to-side and end-to-end anastomoses can be created without using suture or any other type of mechanical fasteners, although any such attachment means may be used in conjunction with the magnetic attachment. The securing components have magnetic, ferromagnetic or electromagnetic properties and may include one or more materials, for example, magnetic and nonmagnetic materials arranged in a laminated structure. The system of anastomotic securing components may be used in many different applications including the treatment of cardiovascular disease, peripheral vascular disease, forming AV shunts for dialysis patients, etc., and may be sized and configured for forming an anastomosis to a specific hollow body, for example, a coronary artery or the aorta.

Abstract: A tissue approximation device and processes for using the device are provided. The device is an implantable, biodegradable construct (except for hernia repairs) that has attachment points emanating from a supportive backing. The device improves the mechanical phase of wound healing and evenly distributes tension over the contact area between the device and tissue. Processes for using the device include wound closure, vascular anastomoses, soft tissue attachment and soft tissue to bone attachment.

Abstract: The present invention generally relates to surgical clips. A surgical clip comprises a first piece comprising a first base and a first projection extending from the first base, a second piece comprising a second base, a second projection extending from the second base wherein the second projection further comprises a top surface, at least one side surface and a bottom surface, the surfaces defining a reservoir therein, and the first and the second piece are detachably connectable. In a preferred embodiment, the reservoir is self-releasing to deliver therapeutic materials when the first piece and second piece are connected.

Abstract: A tool (101) is provided for inserting and mating two plug members (2, 3) of a sealing device (1) for closing a wound in the wall of a vessel by placing the distal plug member (2) of the sealing device inside the vessel and the proximal plug member (3) on the outside of the vessel. The distal plug member is provided with an elongated retracting means (6) extending from the distal plug member. The tool comprises a gear mechanism (32) coupled to the retracting means for converting a movement of the tool in a proximal direction away from the wound (22), when the distal plug member is anchored in the vessel (20), to a pushing movement for moving the proximal plug member in a direction towards the distal plug member in response to a stretching force in the retracting means.

Abstract: A device and system for delivery of a flowable biocompatible material to a tissue tract in a controlled manner generally includes a reservoir adapted to be in fluid connection with a cannula, a discharging mechanism adapted to discharge the contents of the reservoir and a cannula retractor to withdraw the cannula. The cannula retractor is operably interconnected with the discharging mechanism so that a measured quantity of the reservoir contents is smoothly discharged to substantially fill at least a portion of the tissue tract.

Abstract: A tissue staple that includes a pair of legs arranged generally parallel to one another connected by a pair of tabs. The tabs define an arc that extends distally from the proximal ends of the legs, and further define a slot between the tabs. The distal end of the leg may include a forked portion that defines two or more tissue piercing prongs. The location of the fork also may define a tissue stop. The legs may also include an indent that bends inwardly toward an indent formed on the other leg.

Abstract: A tissue barrier (10), for example of titanium alloy, for insertion into an incision in sclera of the eye for the treatment of conditions such as presbyopia, comprises an elongate body which is inert and/or non-reactive in tissue. The barrier can include lateral flanges (14) or not. In a preferred embodiment the barrier has an inverted T-shaped cross-section.

Abstract: A tissue approximation device and method, particularly in the mid-face region, are provided. The device is an implantable, biodegradable construct that has attachment points emanating from a supportive backing. The device also has an extension member or leash which extends from the backing which is configured to receive a tissue or bone attachment device at one of a plurality of selectable locations along the elongated member, for example via engagement holes extending in a line away from the backing. Once tissue is engaged with the attachment points, the extension member is pulled until the tissue is approximated in the desired position. Then the appropriate extension member hole(s) are selected to attach the extension member to supportive tissue or bone (for example temporal fascia) for permanent tissue approximation.

Abstract: An occlusion device for occluding an abnormal opening includes a body configured to receive expansion medium so as to expand to a deployed position, in which the periphery of the body sealingly presses against the wall of the abnormal opening.

Abstract: Disclosed is a bandage for closing a wound or incision, and methods for the use of same. The bandage comprises a first flat flexible component having adhesive on a lower surface and one or more first elongated connectors extending in an offset manner from one edge thereof in a first direction. The bandage further comprises a second flat flexible component having adhesive on a lower surface and one or more second elongated connectors extending in an offset manner from one edge thereof in a second direction generally opposite to the first direction. Pulling elements are joined to the first and second elongated connectors. Means are provided for attaching the first elongated connectors to the second flat flexible component and the second elongated connectors to the first flat flexible component.

Abstract: The present invention relates generally to the field of hemostasis, including methods, compositions, and devices that can be employed to achieve hemostasis at an increased rate. More specifically the present invention relates to hemostatic compositions that achieve a hemostatic effect at a distance from the site of application of the composition, and a method for administering such a composition to effectively reduce localized vascular complications associated with treating a breach or puncture in a vein or artery and reduce the time to achieve hemostasis.

Abstract: The present invention provides a light-activated adhesive composite suitable for medical and surgical applications. The composite includes a scaffold and a light-activated adhesive, such as a laser tissue solder. The scaffold includes a biological, biocompatible, or biodegradable material, such as PLGA or SIS.

Abstract: Disclosed is a bandage for closing a wound or incision, and methods for the use of same. The bandage comprises a first flat flexible component having adhesive on a lower surface and one or more first elongated connectors extending in an offset manner from one edge thereof in a first direction. The bandage further comprises a second flat flexible component having adhesive on a lower surface and one or more second elongated connectors extending in an offset manner from one edge thereof in a second direction generally opposite to the first direction. Pulling elements are joined to the first and second elongated connectors. Means are provided for attaching the first elongated connectors to the second flat flexible component and the second elongated connectors to the first flat flexible component.

Abstract: A tissue or organ regeneration material which can easily be placed in a necrotic area or defective space of a tissue or organ in a living body, while suppressing an excessive growth of fibroblasts, to thereby effectively regenerate an intended tissue or organ, and a method of regenerating a tissue or organ by using the above material. The tissue or organ regeneration material wherein fibroblasts shows substantially no growing property in a gel based on the hydrogel-forming polymer is constituted by using a hydrogel-forming polymer, an aqueous solution of which shows a thermo-reversible sol-gel transition such that it assumes a sol state at a lower temperature and assumes a gel state at a higher temperature.

Abstract: A percutaneously insertable system for sealing punctures in blood vessels includes an element that is percutaneously insertable into and deplorable within a blood vessel, a thread-like member attached to the element that passes through the wall of the blood vessel and arresting element moveable on the thread and into engagement with the other surface of the blood vessel thereby to seal the opening.

Abstract: A fibrin mixture and dispenser assembly is provided for mixing a first protein component with sterile water to form a first protein solution and for dispensing the first protein solution. The first protein solution forms a biological adhesive when intermixed with a second protein solution. The second protein solution is preferably mixed and dispensed by a similar fibrin mixture and dispenser assembly. The two fibrin mixture and dispenser assemblies can be housed within a single housing. The assembly includes a piercer and a first tubular extension having grooves for providing fluid communication between a reservoir and a mixing chamber or a vial. The reservoir is also in fluid communication with a dispensing needle through a second tubular extension. The reservoir is configured to contain water which is introduced to the mixing chamber. The mixing chamber is configured to contain the first protein component.

Abstract: Clip apparatus for closing a vessel aperture resulting from insertion of a surgical implement comprising an elongated strand comprising a central portion and extremity portions extending from said central portion. The tips of said extremity portions remote from said central portion are shaped to retain tissue encountered thereby. The extremity portions have memory characteristics seeking to cause said extremity portions to curl with respect to said central portions to retain tissue engaged thereby when said strand is in an unconstrained disposition.

Abstract: An endoluminal and intracorporeal negative pressure, wound care treatment, and prophylaxic system 10 and method includes a pressure distributor 40 for placement substantially within an internal organ or tissue abscess 34. A fluidic communication means 22 is provided between the pressure distributor 40 and a negative pressure source 20. A collection canister 24 is provided between the negative pressure source 20 and the pressure distributor 40 for collecting any effluents 36 that may be drawn from the abscess 34 during application of negative pressure. An introducing conduit 44 is provided for introducing the pressure distributor 40 into the abscess 34. A positioning conduit 46 is provided to properly position the pressure distributor 40 within the abscess 34. Negative pressure is applied to the pressure distributor 40 in order to provide negative pressure therapy within the abscess 34.

Abstract: A method and device for sealing a blood vessel puncture by means of a self-anchoring, barbed tissue connector.

Abstract: A frame (1) and a method for suturing a wound (22). The frame (1) is placed on each side of the wound (22) and reaches across it. The frame (1) has a first and second foundation part (2, 3) for placing on the skin (20) on each side and along the wound/wound edges respectively. A joining device extends (10) between the first and second foundation parts (2, 3). The first and second foundation parts (2, 3) are arranged with an adhesive (4, 5) for securing to the skin (20), and the joining device (10) is a flexible, jointed device of mainly constant length.

Abstract: Apparatus and methods for closing a septal defect including a flap of tissue partially detached from a septum of a heart. A needle is advanced through a patient's vasculature within a delivery apparatus until the needle is disposed within a first chamber adjacent the septum. The needle is directed through the flap of tissue until the needle is disposed within a second chamber opposite the septum. A filament attached to an intermediate region of the needle is pulled, thereby causing the needle to pivot about the intermediate region such that the ends of the needle straddle the septal opening. A locking element is secured to the filament to secure the flap of tissue against the septum, and the filament is cut. Alternatively, the filament is biased to coil to engage the flap of tissue and secure the needle against the septum to close the opening.

Abstract: An especially useful fibrin glue composition comprises a biocompatible, bioabsorbable hyaluronic acid derivative material, upon which are applied or chemically bonded fibrinogen and thrombin, along with other optional constituents, such as additional coagulation factors, anti-fibrinolytics, stabilizers and biologically active substances. The fibrinogen, thrombin and other components can take the form of a dry preparation, an aqueous or nonaqueous preparation, or as a combination thereof. Such a fibrin glue composition can be placed directly on a wound site and is fully reabsorbed into the body.

Abstract: A medical closure screen device for a separation of first and second tissue portions is provided, which includes a mesh screen comprising tubular vertical risers, vertical strands with barbed filaments, and horizontal spacers connecting the risers and strands in a grid-like configuration. An optional perimeter member partly surrounds the screen and can comprise a perimeter tube fluidically coupled with the vertical risers to form a tubing assembly. Various input/output devices can optionally be connected to the perimeter tube ends for irrigating and/or draining the separation according to methodologies of the present invention. Separation closure, irrigation and drainage methodologies are disclosed utilizing various combinations of closure screens, tubing, sutures, fluid transfer elements and gradient force sources. The use of mechanical forces associated with barbed strands for repositionably securing separated tissues together is disclosed.