Abstract: The present invention is directed to a hemostatic patch comprising a porous substrate and at least a pair of co-reactive polymer reagents comprising at least one nucleophilic polyalkylene oxide based component and at least one electrophilic polyalkylene oxide-based on the porous substrate in a molar ratio of about 0.2 to about 0.9:1 of primary nucleophilic groups in excess to available electrophilic groups. The present invention is also directed to processes for the manufacture and use of such hemostatic patches.

Abstract: The invention relates to a biocompatible, flexible, haemostatic sheet comprising: a cohesive fibrous carrier structure comprising a three-dimensional interconnected interstitial space; and distributed within the interstitial space, a plurality of reactive polymer particles comprising (i) a water-soluble electrophilic polymer carrying at least 3 reactive electrophilic groups that are capable of reacting with amine groups in tissue and blood under the formation of a covalent bond and (ii) a nucleophilic cross-linking agent that contains at least two reactive nucleophilic groups that are capable of reacting with the reactive electrophilic groups of the electrophilic polymer under the formation of a covalent bond, said reactive polymer particles having a diameter in the range of 0.5-100 ?m and being present in an amount of at least 3% by weight of the fibrous carrier structure.

Abstract: The present invention is directed to multi-layered wound dressings having a carrier layer, at least two sublayers, wherein each sublayer contains at least one reactive, cross-linkable component and the at least two reactive, cross-linkable components are co-reactive with the other and at least one reactive, cross-linkable has a protective leaving group and a buffering salt agent.

Abstract: The present invention is directed to medical devices having a first porous substrate layer with at least a surface coating thereon of a first co-reactive component and a second substrate layer with at least a surface coating layer of a second co-reactive component that reacts with the first co-reactive component, and a removable barrier layer positioned between the first substrate layer and second substrate layer and in contact with said first substrate layer and said second substrate layer.

Abstract: The present invention is directed to an absorbable hemostatic patch that utilizes a biocompatible fibrous, fabric substrate that is melt-blown and napped or loosened at the surface, with the substrate having a low-profile, high flexibility, strength and porosity that is suitable for coating cross-linkable active molecules and ultimately effective for use as a hemostat in situations of problematic bleeding.

Abstract: The present invention is directed to an absorbable hemostatic nonwoven patch that utilizes a biocompatible substrate comprised of melt-blown microfibers as webbed sheets that are layered and bonded/entangled in descending density and ascending porosity; with the substrate having a high flexibility, strength and porosity that is suitable for coating cross-linkable active molecules and ability for laparoscopic use or trocar deployment, ultimately for functional use as a highly effective hemostat in addressing problematic bleeding during both open and minimally invasive surgical procedures.

Abstract: A hemostatic pad comprising a bioabsorbable scaffolding material; a lyophilized thrombin powder, a lyophilized fibrinogen powder, and a meltable binder powder, with all powders disposed on the bioabsorbable scaffolding material. A meltable binder such as PEG bonds the lyophilized thrombin powder and the lyophilized fibrinogen powder to the bioabsorbable scaffolding material for improved friability, wettability and performance in a use, such as for hemostatic treatment or sealing at a wound site.

Abstract: A hemostatic pad comprising a bioabsorbable scaffolding material; a lyophilized thrombin powder, a lyophilized fibrinogen powder, and a meltable binder powder, with all powders disposed on the bioabsorbable scaffolding material. A meltable binder such as PEG bonds the lyophilized thrombin powder and the lyophilized fibrinogen powder to the bioabsorbable scaffolding material for improved friability, wettability and performance in a use, such as for hemostatic treatment or sealing at a wound site.

Abstract: A hemostatic pad comprising a bioabsorbable scaffolding material; a lyophilized thrombin powder, a lyophilized fibrinogen powder, and a meltable binder powder, with all powders disposed on the bioabsorbable scaffolding material. A meltable binder such as PEG bonds the lyophilized thrombin powder and the lyophilized fibrinogen powder to the bioabsorbable scaffolding material for improved friability, wettability and performance in a use, such as for hemostatic treatment or sealing at a wound site.

Abstract: An engagement head for engaging a porous substrate includes at least two pin sets, each pin set including a plurality of pins arranged in a plurality of parallel pin rows at a predetermined pin angle, wherein pins of immediately neighboring pin rows are arranged such that pin angles for the pins in a pin row are inversely symmetrical to pin angles for the pins in a neighboring pin row. The pins of a pin row move collectively in the same direction when a pin set is extended, which direction is determined by the pin angle of the pin row, whereby neighboring pin rows move in opposite longitudinal directions from one another when the pin set is extended. The pin sets may be extended and retracted in unison by a single actuation source.

Abstract: An engagement head for engaging a porous substrate includes at least two pin sets, each pin set including a plurality of pins arranged in a plurality of parallel pin rows at a predetermined pin angle, wherein pins of immediately neighboring pin rows are arranged such that pin angles for the pins in a pin row are inversely symmetrical to pin angles for the pins in a neighboring pin row. The pins of a pin row move collectively in the same direction when a pin set is extended, which direction is determined by the pin angle of the pin row, whereby neighboring pin rows move in opposite longitudinal directions from one another when the pin set is extended. The pin sets may be extended and retracted in unison by a single actuation source.

Abstract: An engagement head for engaging a porous substrate includes at least two pin sets, each pin set including a plurality of pins arranged in a plurality of parallel pin rows at a predetermined pin angle, wherein pins of immediately neighboring pin rows are arranged such that pin angles for the pins in a pin row are inversely symmetrical to pin angles for the pins in a neighboring pin row. The pins of a pin row move collectively in the same direction when a pin set is extended, which direction is determined by the pin angle of the pin row, whereby neighboring pin rows move in opposite longitudinal directions from one another when the pin set is extended. The pin sets may be extended and retracted in unison by a single actuation source.

Abstract: A hemostatic pad comprising a bioabsorbable scaffolding material; a lyophilized thrombin powder, a lyophilized fibrinogen powder, and a meltable binder powder, with all powders disposed on the bioabsorbable scaffolding material. A meltable binder such as PEG bonds the lyophilized thrombin powder and the lyophilized fibrinogen powder to the bioabsorbable scaffolding material for improved friability, wettability and performance in a use, such as for hemostatic treatment or sealing at a wound site.

Abstract: An engagement head for engaging a porous substrate includes at least two pin sets, each pin set including a plurality of pins arranged in a plurality of parallel pin rows at a predetermined pin angle, wherein pins of immediately neighboring pin rows are arranged such that pin angles for the pins in a pin row are inversely symmetrical to pin angles for the pins in a neighboring pin row. The pins of a pin row move collectively in the same direction when a pin set is extended, which direction is determined by the pin angle of the pin row, whereby neighboring pin rows move in opposite longitudinal directions from one another when the pin set is extended. The pin sets may be extended and retracted in unison by a single actuation source.

Abstract: Processes for coating implantable medical devices that improve the stability of therapeutic agents contained within the coating.

Abstract: A method and system for the non-destructive analysis of medical devices uses a confocal Raman microscope and other non-destructive analytical tools to assess the spatial distribution of components of an object such as the distribution of an active pharmaceutical ingredient (API) within a polymer matrix. In a preferred embodiment, confocal Raman spectroscopy was used to differentiate each component found in the sirolimus-eluting coronary stent. The unique spectral features identified for each component were then used to develop three separate calibration curves to describe the solid phase distribution found on drug-polymer coated stents. The calibration curves were obtained by analyzing confocal Raman spectral depth profiles from a set of 16 unique formulations of drug-polymer coatings sprayed onto stents and planar substrates.

Abstract: A method and system for the non-destructive analysis of medical devices uses a confocal Raman microscope and other non-destructive analytical tools to assess the spatial distribution of components of an object such as the distribution of an active pharmaceutical ingredient (API) within a polymer matrix. In a preferred embodiment, confocal Raman spectroscopy was used to differentiate each component found in the sirolimus-eluting coronary stent. The unique spectral features identified for each component were then used to develop three separate calibration curves to describe the solid phase distribution found on drug-polymer coated stents. The calibration curves were obtained by analyzing confocal Raman spectral depth profiles from a set of 16 unique formulations of drug-polymer coatings sprayed onto stents and planar substrates.

Abstract: Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism's reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism's reaction to the introduction of the medical device to the organism. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned.

Abstract: Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism's reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism's reaction to the introduction of the medical device to the organism. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned.

Abstract: Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism's reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism's reaction to the introduction of the medical device to the organism. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned.