Abstract: A method of making a packaged antimicrobial suture. The method includes the steps of providing a containment compartment molded from a polymeric resin comprising a polymeric material and an antimicrobial agent, positioning a suture within the containment compartment, the suture comprising one or more surfaces; covering the containment compartment having the suture in an outer package cover having an inner surface, and subjecting the outer package, the containment compartment and the suture to time, temperature and pressure conditions sufficient to vapor transfer an effective amount of the antimicrobial agent from the containment compartment to the suture, while retaining an effective amount of the antimicrobial agent on the containment compartment, thereby substantially inhibiting bacterial colonization on the suture and the containment compartment. A packaged antimicrobial suture is also provided.

Abstract: Packaging for a surgical needle comprises a cartridge having a surgical needle and a needle driver operative to engage and move the needle relative the cartridge. The packaging has a bobbin, and a length of suture connected to the needle and wound around the bobbin. The packaging may further comprise an outer shell enclosing the cartridge, bobbin, and suture. The outer shell may comprise a sheet of material folded over the cartridge and bobbin. The packaging may further comprise a platform resiliently holding the cartridge. The bobbin may be a rotating spool. The cartridge may comprise a pair of arms defining a generally U-shaped distal end, and the packaging may have a block interposed between the arms. The packaging may further comprise a housing and a top sheet enclosing the enclosing the cartridge, bobbin, and suture.

Abstract: A method of making a packaged antimicrobial suture. The method includes the steps of providing a containment compartment molded from a polymeric resin comprising a polymeric material and an antimicrobial agent, positioning a suture within the containment compartment, the suture comprising one or more surfaces; covering the containment compartment having the suture in an outer package cover having an inner surface, and subjecting the outer package, the containment compartment and the suture to time, temperature and pressure conditions sufficient to vapor transfer an effective amount of the antimicrobial agent from the containment compartment to the suture, while retaining an effective amount of the antimicrobial agent on the containment compartment, thereby substantially inhibiting bacterial colonization on the suture and the containment compartment. A packaged antimicrobial suture is also provided.

Abstract: A package for a medical device having a handle and an elongated shaft. The package includes a holster for holding the medical device, the holster having a tubular member for receiving the elongated shaft and a handle cover located at a proximal end thereof. The handle cover has a holster opening for accessing the handle to draw the medical device from the holster. The package includes a pouch having a sealed area bounded by a top sealed edge, a bottom sealed edge, a pair of side sealed edges extending between the top and bottom sealed edges, and at least one opening tab spaced from the bottom sealed edge. The medical device and the holster are disposed within the sealed area of the pouch with the elongated shaft of the medical device extending along the bottom sealed edge and the holster opening being located adjacent the at least one opening tab.

Abstract: A package for a medical device having a handle and an elongated shaft. The package includes a holster for holding the medical device, the holster having a tubular member for receiving the elongated shaft and a handle cover located at a proximal end thereof. The handle cover has a holster opening for accessing the handle to draw the medical device from the holster. The package includes a pouch having a sealed area bounded by a top sealed edge, a bottom sealed edge, a pair of side sealed edges extending between the top and bottom sealed edges, and at least one opening tab spaced from the bottom sealed edge. The medical device and the holster are disposed within the sealed area of the pouch with the elongated shaft of the medical device extending along the bottom sealed edge and the holster opening being located adjacent the at least one opening tab.

Abstract: A method of making a packaged antimicrobial suture. The method includes the steps of providing a containment compartment molded from a polymeric resin comprising a polymeric material and an antimicrobial agent, positioning a suture within the containment compartment, the suture comprising one or more surfaces; covering the containment compartment having the suture in an outer package cover having an inner surface, and subjecting the outer package, the containment compartment and the suture to time, temperature and pressure conditions sufficient to vapor transfer an effective amount of the antimicrobial agent from the containment compartment to the suture, while retaining an effective amount of the antimicrobial agent on the containment compartment, thereby substantially inhibiting bacterial colonization on the suture and the containment compartment. A packaged antimicrobial suture is also provided.

Abstract: A machine and process for packaging armed sutures into tray packages. The machine has a frame with a rotatable indexing disc member mounted to the top of frame. A plurality of tool nests are rotatably mounted to the top of the indexing disc. Tray packages mounted in the tool nests are rotated to wind sutures into a suture channel in the packages. A stylus having a front nose member and a rear heel member guides suture into the suture channel.

Abstract: A machine and process for packaging armed sutures into tray packages. The machine has a frame with a rotatable indexing disc member mounted to the top of frame. A plurality of tool nests are rotatably mounted to the top of the indexing disc. Tray packages mounted in the tool nests are rotated to wind sutures into a suture channel in the packages. A stylus having a front nose member and a rear heel member guides suture into the suture channel.

Abstract: Automated packaging of surgical needle-suture assemblies includes a framing operation in which adjacent sheets of polymer coated aluminum foils are conveyed through a sequence of steps in an apparatus which produces frames containing plastic packets of needle-suture assemblies. A vision system having video cameras connected to a specially adapted computer enables monitoring the product traveling through the framing operation to detect various defects in the foil and in the product formation. Upon detection of a defect, the computer system can either identify and separate rejected product from good product or shut down the apparatus.

Abstract: A process for applying a biobarrier member to a vent opening in a foil member used for medical device packaging. The process provides for cutting a biobarrier member from a roll of stock and sealing the biobarrier member about the vent opening in the foil member. The seal is tested for integrity and the biobarrier member is tested for porosity.

Abstract: A package for maintaining a needle-suture product in a sterile condition includes a peelable foil container in which a peripheral heat seal defines a cavity for retaining a suture packet. The packet has a plastic tray and a stiff paper lid secured to the tray by hinged paper cleats extending into sockets in the tray. The lid covers most of the area of the tray, leaving an uncovered portion for accessing a needle mounted in the tray. A suture attached to the needle is coiled in a peripheral track in the tray so that an extended length of suture material can be retained in a relatively small space. The container has top and bottom aluminum foils with differentiated polymeric coatings on their interior surfaces, which are thermally fused to form the seal. Unsealed foil flaps are provided at one end of the container to enable peeling apart the foils to open the package.

Abstract: Automated packaging of surgical needle-suture assemblies includes a framing operation in which adjacent sheets of polymer coated aluminum foils are conveyed through a sequence of steps in an apparatus which produces frames containing plastic packets of needle-suture assemblies. The apparatus pulls a web of foil off a large diameter feed roll and maintains web alignment as it travels down line through the apparatus by a system that optically detects transverse movement of the web as it is fed into the apparatus and adjusts the position of the feed roll relative to the centerline of travel using a hi-directional stepper motor. Discontinuities in the polymer coating on the top surface of the web of foil are automatically detected so that remedial steps can be taken to avoid processing defective sections of the web. A vision system having video cameras connected to a specially adapted computer enables monitoring the product travelling through the apparatus to detect various defects in the product formation.

Abstract: A method for making sterile suture packages employs a frame assembly line, a sterilization line and a blanker/cartoner line. A web of foil is advanced in a series of movements through the frame assembly line to assemble a frame containing needle-suture assemblies in a plurality of cavities in the frame, the frame having top and bottom aluminum foils with heat seal coatings on their facing surfaces. The cavities are formed in the bottom foil of each frame by a combination of pressurized air and mechanical plugs which are forced against the bottom foil and an underlying die having recesses for defining the cavities. A blanking operation following sterilization and sealing separates individual packages, each containing one needle-suture assembly, from the frame. The packages are then conveyed by belts through inspection stations and reoriented for loading into shipping cartons.

Abstract: A method for making sterile suture packages employs a frame assembly line, a sterilization line and a blanker/cartoner line. A web of foil is advanced in a series of movements through the frame assembly line to assemble a frame containing needle-suture assemblies in a plurality of cavities in the frame, the frame having top and bottom aluminum foils with heat seal coatings on their facing surfaces. The cavities are formed in the bottom foil of each frame by a combination of pressurized air and mechanical plugs which are forced against the bottom foil and an underlying die having recesses for defining the cavities. A blanking operation following sterilization and sealing separates individual packages, each containing one needle-suture assembly, from the frame. The packages are then conveyed by belts through inspection stations and reoriented for loading into shipping cartons.