Abstract: A novel in vitro methodology for predicting the in vivo behavior, such as absorption time or mechanical strength retention, of biodegradable polymeric implants and medical devices. The present invention provides a novel in vitro methodology, hydrolysis profiling, for studying the degradation of absorbable polymers. Accuracy and reproducibility have been established for selected test conditions. Data from this in vitro method are correlated to in vivo absorption data, allowing for the prediction of accurate in vivo behaviors, such as absorption times.

Abstract: A novel single plane tissue repair patch is disclosed. The patch has a base member with an opening therethrough, and a closure member associated with the opening. Mounted to the periphery of the bottom side of the base member is a locating structure. The mesh may be used in open surgical procedures for hernia repairs and other repairs of body wall defects.

Abstract: A bimodal bioabsorbable polymer composition. The composition includes a first amount of a bioabsorbable polymer polymerized so as to have a first molecular weight distribution; a second amount of said bioabsorbable polymer polymerized so as to have a second molecular weight distribution having a weight average molecular weight between about 10,000 to about 50,000 Daltons, the weight average molecular weight ratio of said first molecular weight distribution to said second molecular weight distribution is at least about two to one; wherein a substantially homogeneous blend of said first and second amounts of said bioabsorbable polymer is formed in a ratio of between about 50/50 to about 95/5 weight/weight percent. Also disclosed are a medical device, a method of making a medical device and a method of melt blowing a semi-crystalline polymer blend.

Abstract: A tissue approximation device comprising two elongate arms, an attachment means to secure the elongate arms to each other, adhesive pads on at least a portion of the elongate arms to anchor the tissue approximation device to the skin, and a locking means to lock the elongate arms in place relative to each other.

Abstract: A surgical fastener for securing a prosthetic device to tissue includes a first leg having a proximal end, a distal end, a first insertion tip at the distal end, and a first articulating joint that separates said first leg into a proximal segment and a distal segment that is deflectable relative to the proximal segment, and a second leg including a proximal end, a distal end, a second insertion tip at the distal end, and a second articulating joint that separates said second leg into a proximal segment and a distal segment that is deflectable relative to the proximal segment. A bridge connects the proximal ends of the first and second legs for forming a closed end of the surgical fastener. After implantation in tissue, the insertion tips are deflectable away from vessels and nerves to minimize injury to the vessels and nerves, and to minimize patient discomfort and pain.

Abstract: The present invention provides improved medical devices for use in surgical procedures and methods for manufacturing improved medical devices. In some embodiments, the improved medical devices can include improved surgical needles that are capable of being repeatedly passed through tissue using minimal force. More particularly, the improved surgical needles can be manufactured with two or more different coatings that provide the surgical needles with both durability and lubricity for ease of repeated and successive passes through tissue. Improved methods for manufacturing the surgical needles and for providing and applying coatings to the surgical needles are also provided.

Abstract: A bimodal bioabsorbable polymer composition. The composition includes a first amount of a bioabsorbable polymer polymerized so as to have a first molecular weight distribution; a second amount of said bioabsorbable polymer polymerized so as to have a second molecular weight distribution having a weight average molecular weight between about 10,000 to about 50,000 Daltons, the weight average molecular weight ratio of said first molecular weight distribution to said second molecular weight distribution is at least about two to one; wherein a substantially homogeneous blend of said first and second amounts of said bioabsorbable polymer is formed in a ratio of between about 50/50 to about 95/5 weight/weight percent. Also disclosed are a medical device, a method of making a medical device and a method of melt blowing a semi-crystalline polymer blend.

Abstract: A medical device having a contact surface exposed repeatedly to bodily tissue is disclosed. The contact surface is coated with a silicone polymer and one or more non-silicone hydrophobic polymers. The preferred medical device is a surgical needle, and the preferred coating is a polydimethylsiloxane and polypropylene wax hydrocarbon mixture. The incorporation of the non-silicone hydrophobic polymer increases the durability of the coating on the device without sacrificing lubricity.

Abstract: An antimicrobial composition comprising an ionic complex of an anionic polyester with an antimicrobial metal, wherein the anionic polyester has an ion exchange capacity from about 0.19 meq/g to about 1.0 meq/g.

Abstract: An antimicrobial composition for coating a medical device. The antimicrobial composition includes a polymeric film forming material and an antimicrobial agent comprising a material selected from the group of extract of Houttuynia cordata, sodium houttuyfonate, sodium new houttuyfonate and mixtures thereof. A medical device having an antimicrobial composition that includes a material selected from the group of extract of Houttuynia cordata, sodium houttuyfonate, sodium new houttuyfonate and mixtures thereof and a method for making same are also provided.

Abstract: A method of making a packaged antimicrobial suture comprising the steps of providing a containment compartment that is substantially free of an antimicrobial agent; positioning a suture within the containment compartment, said suture comprising one or more surfaces having an antimicrobial agent disposed thereon, said antimicrobial agent being selected from the group consisting of halogenated hydroxyl ethers, acyloxydiphenyl ethers, and combinations thereof; placing the containment compartment having the suture in an outer package; and subjecting the outer package, the containment compartment and the suture to time, temperature and pressure conditions sufficient to transfer an effective amount of the antimicrobial agent from the suture to the containment compartment, while retaining an effective amount of said antimicrobial agent on the suture, thereby substantially inhibiting bacterial colonization on the suture and the containment compartment.

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: The present invention provides improved medical devices for use in surgical procedures and methods for manufacturing improved medical devices. In some embodiments, the improved medical devices can include improved surgical needles that are capable of being repeatedly passed through tissue using minimal force. More particularly, the improved surgical needles can be manufactured with two or more different coatings that provide the surgical needles with both durability and lubricity for ease of repeated and successive passes through tissue. Improved methods for manufacturing the surgical needles and for providing and applying coatings to the surgical needles are also provided.

Abstract: An implant having an adhesive structure comprising a planar surface having two sides and rectangular cuboid-based protrusions having pyramidal tips extending from at least one of said sides, optionally having a porous basic supporting structure, and methods of making and using such implants.

Abstract: An implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect including a first composite structure including at least one layer of a non-absorbable material, wherein the first composite structure has a central portion sized and shaped to cover at least a portion of the tissue or muscle wall defect, and has an outer periphery. The prosthesis further includes a second structure having a reinforced central region and an outer peripheral edge, a reinforcing element positioned between the first and second structures, and having an outer periphery and a stiffness greater than that of the first and second structures, and at least one pulling element coupled to the reinforced central region of the second structure. The second structure is coupled to the first structure substantially only at their respective peripheries.

Abstract: The present invention provides a wound dressing comprising a tessellated water-soluble molding matrix comprised of a polymer selected from the group consisting of polyvinyl alcohol, gelatin, and mixtures thereof and a 1,1-disubstituted ethylene monomer. The present invention further provides methods of using the wound dressing and kits containing the wound dressing.

Abstract: A chemical vapor sterilization process is enhanced by concentrating a germicide via exploitation of the difference between the vapor pressures of the germicide and its solvent. A diffusion restriction can be placed into the diffusion path to assist this process and the path then opened to provide rapid diffusion of the thus concentrated germicide. The path through the diffusion restriction can be closed to allow the pressure in a sterilization chamber to be lowered prior to receiving the concentrated germicide.

Abstract: A novel method of characterizing laser drilled boreholes is disclosed. The method uses x-ray microscopy for dimensional characterization. The x-ray output may be processed to control manufacturing equipment in automated production systems, including laser drilling systems and swaging apparatus.

Abstract: An applicator/dispenser assembly for dispensing and/or applying an adhesive material comprises: a first body portion and a second body portion, at least one of the first and second body portions being movable relative to the other of the first and second body portions; a cavity in at least one of the first and second body portions; and a piercing or breaking member arranged on one of the first and second body portions. Movement of one of the first and second body portions relative to the other of the first and second body portions moves the piercing or breaking member into the cavity. When a container of adhesive material is at least partially disposed within the cavity, movement of one of the first and second body portions relative to the other moves the piercing or breaking member to rupture the container for dispensing and/or applying the adhesive material.

Abstract: A surgical wound closure device including a substrate having a proximal surface and a distal surface; a drape having a proximal surface and a distal surface, and being disposed proximally to said substrate; and an adhesive layer having a proximal surface and a distal surface; said drape being disposed releasably adherently to said distal surface of said adhesive layer. Also provided is a surgical procedure including the steps of providing a surgical wound closure device positioning the proximal surface of said adhesive layer on a patient; separating said substrate from said drape and adhesive layer to expose said distal surface of said drape; making a surgical incision through said drape; performing a surgical procedure; removing said drape from said adhesive layer to expose said distal surface of said adhesive layer; aligning said substrate and said adhesive layer; and adhering said proximal surface of said substrate to said adhesive layer.