Abstract: Novel, lubricious coatings for medical devices are disclosed. The coatings provide improved lubricity and durability and are readily applied in coating processes a low temperatures that do not deform the device. The present invention is also directed to a novel platinum catalyst for use in such coatings. The catalyst provides for rapid curing, while inhibiting cross-linking at ambient temperatures, thereby improving the production pot life of the coatings.

Abstract: A method of making an implantable prosthesis includes applying a gelling enhancer layer over an inner surface of a wall of a silicone shell having anterior and posterior walls surrounding an interior volume. The method includes filling the interior volume of the shell with a silicone gel and curing the silicone gel. The cured silicone gel that is located within a zone that is in the vicinity of the gelling enhancer layer has a higher level of cohesiveness than the cured silicone gel that is located outside the zone. The zone of the silicone gel having the higher level of cohesiveness has a thickness of 2-10 mm. The silicone gel located outside the zone has a first concentration level of a gelling enhancer and the silicone gel located within the zone has a second concentration level of the gelling enhancer that is 5%-300% greater than the first concentration level.

Abstract: A novel two-step process for batch coating surgical needles with cross-linked silicone coatings is disclosed. The surgical needles are cured using a two-step process. The coatings on the needles are partially cured in the first step and mechanically separated. The coatings on the needles are then fully cured in the second step.

Abstract: Systems and methods for coating surgical needles are provided.

Abstract: Novel, lubricious coatings for medical devices are disclosed. The coatings provide improved lubricity and durability, and are readily applied in coating processes. The present invention is also directed to a novel platinum catalyst for use in such coatings. The catalyst provides for rapid curing, while inhibiting cross-linking at ambient temperatures, thereby improving the production pot life of the coatings.

Abstract: A blackened surgical needle made by the method of treating blackened surgical needles, comprising the steps of: a. determining that a blackening process may have produced loose black oxide particles on the blackened surgical needle; b. placing at least one blackened surgical needle having loose black oxide particles on its surface into a bath, wherein the bath comprises: i. an effective amount of citric acid to remove loose black oxide particles from the at least one blackened surgical needle; and ii. a source of ultrasound; and c. applying the ultrasound in the bath for a time sufficient to remove loose black oxide particles from the surface of the at least one needle and wherein the contents of the bath are maintained at a pH below 3.25.

Abstract: Novel compositions and systems for closure of wounds are disclosed. The compositions provide devices of improved flexibility and elasticity and are readily applied to wound sites or over wound closure devices. The present invention is also directed to a novel platinum catalyst for use in such compositions. The catalyst provides for rapid curing on topical surfaces such as skin and bonds to such surfaces in about 2-5 minutes.

Abstract: Novel methods for producing porous silicone compositions are disclosed. Methods of this invention provide improved processes for preparing porous silicone rubbers having low specific gravity and mainly closed cells which are suitable for highly permeable gas penetration while adequately sealing liquid material. Examples of these sealing materials include but are not limited to encapsulants for bioindicators and syringe sealing components wherein the permeability is sufficient to permit sterilization while preventing passage or leaking of liquids to be sterilized through the described silicone materials.

Abstract: Novel compositions and systems for closure of wounds are disclosed. The compositions provide devices of improved flexibility and elasticity and are readily applied to wound sites or over wound closure devices. The present invention is also directed to a novel platinum catalyst for use in such compositions. The catalyst provides for rapid curing on topical surfaces such as skin and bonds to such surfaces in about 2-5 minutes.

Abstract: The present disclosure provides a coating apparatus and method for applying a coating of a therapeutic agent, comprising an openable and sealable device compartment, a therapeutic agent positioned in communication with the device compartment, a thermal source for vaporizing the therapeutic agent, and a vacuum source in fluid communication with the device compartment.

Abstract: A system for dispensing a curable composition includes a dual barrel syringe including a first syringe barrel with a first plunger, and a second syringe barrel with a second plunger. A static mixer is connected with distal ends of the first and second syringe barrels. The first and second plungers are moveable toward the distal ends of the first and second syringe barrels for expelling first and second components of a curable composition from the distal ends of the barrels into the static mixer for mixing the components to form the curable composition. A flexible spreader connected with a distal end of the static mixer has a flat dispensing opening, and a plurality of channels extending to the flat dispensing opening to dispense the curable composition. A hot gas blower generates a hot gas stream flowing distally over the distal end of the flexible spreader for curing the curable composition.

Abstract: Novel, lubricious coatings for medical devices are disclosed. The coatings provide improved lubricity and durability and are readily applied in coating processes a low temperatures that do not deform the device. The present invention is also directed to a novel platinum catalyst for use in such coatings. The catalyst provides for rapid curing, while inhibiting cross-linking at ambient temperatures, thereby improving the production pot life of the coatings.

Abstract: The present disclosure provides a coating applicator operable to apply a coating of a therapeutic agent upon an object comprising an openable and sealable device compartment, a therapeutic agent positioned in communication with the device compartment, an atomizer operable to atomize the therapeutic agent, and a source of vacuum in communication with the device compartment. The coating applicator may further comprise a drier, and the drier may comprise an arrangement to operate the source of vacuum for a time sufficient to promote drying of applied therapeutic agent. Deposition of the atomized therapeutic agent may be promoted by contacting the atomized therapeutic agent while the object is in a chilled condition and by contacting the object with atomized therapeutic agent while the atomized therapeutic agent is in a heated condition. Related methods are also disclosed.

Abstract: A method of reducing surgical site infection (SSI), using a coated medical device having a tissue penetrating surface and an abradable coating on the medical device comprising at least one antimicrobial agent in the coating.

Abstract: Provided are rapidly cross-linkable silicone compositions, systems, kits, and methods for filling implanted medical devices in situ, the implanted medical devices, including for example, body implants and tissue expanders, the compositions including a platinum divinyl disiloxane complex; a low viscosity vinyl terminated polydimethylsiloxane; a low viscosity hydride terminated polydimethylsiloxane; and a silicone cross-linker, where the rapidly cross-linkable silicone composition has a viscosity of ?150 cPs for ?1 min. post-preparation and ?300 cPs?5 min. post-preparation, at ambient temperature.

Abstract: Provided are rapidly cross-linkable silicone foam compositions, kits, and methods for filling implanted medical devices in situ or in vivo, the implanted medical devices, including for example, body implants and tissue expanders, the compositions including a platinum divinyl disiloxane complex; a low viscosity vinyl terminated polydimethylsiloxane; a low viscosity hydride terminated polydimethylsiloxane; a silicone cross-linker; and a gas and/or gas-filled microcapsules, where the rapidly cross-linkable silicone foam composition has a viscosity of ?150 cPs for ?1 min. post-preparation and ?300 cPs?5 min. post-preparation, at ambient temperature.

Abstract: Novel compositions and systems for closure of wounds are disclosed. The compositions provide devices of improved flexibility and elasticity and are readily applied to wound sites or over wound closure devices. The present invention is also directed to a novel platinum catalyst for use in such compositions. The catalyst provides for rapid curing on topical surfaces such as skin and bonds to such surfaces in about 2-5 minutes.

Abstract: Novel, lubricious coatings for medical devices are disclosed. The coatings provide improved lubricity and durability and are readily applied in coating processes a low temperatures that do not deform the device. The present invention is also directed to a novel platinum catalyst for use in such coatings. The catalyst provides for rapid curing, while inhibiting cross-linking at ambient temperatures, thereby improving the production pot life of the coatings.

Abstract: A novel method of blackening surgical needles is disclosed. Surgical needles having outer surfaces are first placed into a first pretreatment bath having a novel composition. The needles are then placed into a second blackening bath having a novel composition for a sufficient period of time to effectively blacken the surfaces of the needles. The novel methods for blackening the surfaces of a stainless steel alloy surgical needle provide a chromium (VI)-free alternative to current needle manufacturing processes. Another unique feature of this novel method is its short processing time. The blackening processes of the present invention can be utilized for in-line treatment processes which can be easily incorporated into high speed needle manufacturing processes, such as strip mounted processes. In addition, the processes of the present invention are readily adaptable to batch processes. Also disclosed are novel systems for blackening surgical needles and novel blackening baths for surgical needles.

Abstract: A gas sterilizable syringe includes an enclosure having walls that define a fluid chamber. A flowable material is disposed within the fluid chamber of the enclosure. A plunger is assembled with the enclosure and is moveable toward a distal end of the enclosure for dispensing the flowable material. One or more apertures are formed in at least one of the walls of the enclosure. A gas permeable barrier covers at least one of the apertures formed in at least one of the walls of the enclosure for enabling sterilization gases to pass through the at least one aperture covered by the gas permeable barrier while preventing the flowable material from passing through the at least one of aperture. The gas permeable barrier is permeable to the sterilization gases and impermeable to the flowable material disposed within the fluid chamber of the enclosure.