Abstract: The present invention relates to a spray dried plasma composition having one or more of the following characteristics: when reconstituted, largely amorphous and has no cholesterol crystals; when reconstituted, the number of large particulates is reduced; has low residual moisture; reconstitutes rapidly in under four minutes; highly stable when stored under refrigeration, at room temperature or at elevated temperatures and allows for storage for longer periods of time; when reconstituted, exhibits recovery of the most fragile of proteins, including von Willebrand's factor; when reconstituted with Sterile Water for Injection (SWFI), reconstituted plasma is at a pH that is near normal plasma pH, and does so without treatment or storage in CO2 or other pH adjustment; and when reconstituted, has reduced complement activation (C5A, C3A).

Abstract: The present invention includes a spray drying disposable device for use in a spray drying system. The disposable has a spray drying head and a plasma drying chamber. The head has a spray dry nozzle assembly in fluid communication with the plasma source and the pressurized aerosol gas source. The pressurized gas flows in a vortex pattern that atomizes plasma droplets in the chamber. The head also includes a plenum has uniform air pressure of the drying gas. A baffle plate forms the floor of the plenum having drying gas jets that supply drying gas to the chamber. The atomized plasma droplets evaporate in the presence of the drying gas emitted from the jets to obtain dried plasma particles and humid air. A capture filter captures the dried plasma particles and allows the humid air to pass. The humid air passes through the gas outlet and the exhaust port.

Abstract: An ostomy bag device includes a bag with first and second chambers communicating via a first opening and a pressure sensitive interface. The bag includes a second opening interfacing with a stoma exit and receiving waste in the first chamber, a third opening expelling the waste from the first chamber, and a fourth opening releasing gas from the second chamber. The interface transitions from a first state in which the interface prevents a gas flow through the first opening from the first to second chambers and a second state in which the interface allows the flow. A first pressure differential in the first chamber relative to the second chamber causes the interface to assume the first state preventing the flow and a second pressure differential in the first chamber relative to the second chamber higher than the first differential causes the interface to assume the second state allowing the flow.

Abstract: The present invention relates to a spray dried plasma composition having one or more of the following characteristics: when reconstituted, largely amorphous and has no cholesterol crystals; when reconstituted, the number of large particulates is reduced; has low residual moisture; reconstitutes rapidly in under four minutes; highly stable when stored under refrigeration, at room temperature or at elevated temperatures and allows for storage for longer periods of time; when reconstituted, exhibits recovery of the most fragile of proteins, including von Willebrand's factor; when reconstituted with Sterile Water for Injection (SWFI), reconstituted plasma is at a pH that is near normal plasma pH, and does so without treatment or storage in CO2 or other pH adjustment; and when reconstituted, has reduced complement activation (C5A, C3A).

Abstract: The present invention relates to a spray dried plasma composition having one or more of the following characteristics: when reconstituted, largely amorphous and has no cholesterol crystals; when reconstituted, the number of large particulates is reduced; has low residual moisture; reconstitutes rapidly in under four minutes; highly stable when stored under refrigeration, at room temperature or at elevated temperatures and allows for storage for longer periods of time; when reconstituted, exhibits recovery of the most fragile of proteins, including von Willebrand's factor; when reconstituted with Sterile Water for Injection (SWFI), reconstituted plasma is at a pH that is near normal plasma pH, and does so without treatment or storage in CO2 or other pH adjustment; and when reconstituted, has reduced complement activation (C5A, C3A).

Abstract: The present invention relates to a spray dried plasma composition having one or more of the following characteristics: when reconstituted, largely amorphous and has no cholesterol crystals; when reconstituted, the number of large particulates is reduced; has low residual moisture; reconstitutes rapidly in under four minutes; highly stable when stored under refrigeration, at room temperature or at elevated temperatures and allows for storage for longer periods of time; when reconstituted, exhibits recovery of the most fragile of proteins, including von Willebrand's factor; when reconstituted with Sterile Water for Injection (SWFI), reconstituted plasma is at a pH that is near normal plasma pH, and does so without treatment or storage in CO2 or other pH adjustment; and when reconstituted, has reduced complement activation (C5A, C3A).

Abstract: The present invention relates to a spray dried plasma composition having one or more of the following characteristics: when reconstituted, largely amorphous and has no cholesterol crystals; when reconstituted, the mean size of large particulates is reduced; has low residual moisture; reconstitutes rapidly in under four minutes; highly stable when stored under refrigeration, at room temperature or at elevated temperatures and allows for storage for longer periods of time; when reconstituted, exhibits recovery of the most fragile of proteins, including von Willebrand's factor; when reconstituted with Sterile Water for Injection (SWFI), reconstituted plasma is at a pH that is near normal plasma pH, and does so without treatment or storage in CO2 or other pH adjustment.

Abstract: The spray dried plasma by the nature of its characteristics and the process by which it is made allows for a dried plasma with reduced pathogens. It has at least three aspects of pathogen reduction that results in a plasma product with reduced or no pathogens. The first aspect relates to a spray drying disposable and machine that eliminates or minimizes the introduction of pathogens into the spray drying process and is referred to as the anti-contamination process. The second aspect of pathogen reduction relates to the spray drying process and parameters that reduces pathogens that may be present in the donor plasma, and/or inhibit pathogen growth and/or pathogen proliferation introduced by the donor plasma. The third aspect results in reduced pathogens occurring during storage of the dried plasma wherein the manufacturing and storage conditions are such that pathogens are reduced, and/or pathogen growth and/or pathogen proliferation are inhibited.

Abstract: A method of treating plasma with a pretreatment solution that has a physiologically compatible spray dry stable acidic substance (SDSAS) and an amino acid, prior to or contemporaneously with spray drying of the plasma that results in greater recovery and greater long-term stabilization of the dried plasma proteins as compared to spray dried plasma that has not be subject to the formulation method of the present invention, as well as compositions related to plasma dried by the methods of the present invention.

Abstract: The inventive device and methods described herein address the introduction of a safe and effective freeze-dried biological product, and particularly a plasma product, to a subject in need thereof. The present invention relates to a multifunctional, staged closure device, which also is described as a lyophilization container for plasma (LCP). The device and methods described herein address how to reproducibly achieve a low moisture and substantially oxygen-free atmosphere within a finally hermetically sealed biocompatible low aspect plastic vessel within a standard shelf-stoppering freeze dryer. The present inventive device and methods provide a freeze-dried plasma product that is fully traceable, preserves the constituent plasma activity, is readily prepared in a sterile fashion, is stable, ensures ease of storage and permits rapid reconstitution and delivery to a patient.

Abstract: A flexible container receives a liquid material, which is freeze-dried in situ within the flexible container. A gas permeable material that is separate from the flexible container provides gas transport for sublimation during drying and lyophilization. The gas permeable portion of the system can be isolated and removed from the flexible container post-lyophilzation The freeze-dried material is stored in the flexible container until administration is necessary. The flexible container receives a reconstituting liquid for mixing with the freeze-dried material, and conveys the reconstituted freeze-dried material from the flexible container for administration to an individual.

Abstract: A flexible container receives a liquid material, which is freeze-dried in situ within the flexible container. A gas permeable material that is separate from the flexible container provides gas transport for sublimation during drying and lyophilization. The gas permeable portion of the system can be isolated and removed from the flexible container post-lyophilzation The freeze-dried material is stored in the flexible container until administration is necessary. The flexible container receives a reconstituting liquid for mixing with the freeze-dried material, and conveys the reconstituted freeze-dried material from the flexible container for administration to an individual.

Abstract: A method for preparing and a system containing freeze-dried plasma that will be reconstituted. Ascorbic acid is incorporated into the freeze-dried plasma prior to the plasma being reconstituted.

Abstract: A flexible container receives a liquid material, which is freeze-dried in situ within the flexible container. A gas permeable material that is separate from the flexible container provides gas transport for sublimation during drying and lyophilization. The gas permeable portion of the system can be isolated and removed from the flexible container post-lyophilzation The freeze-dried material is stored in the flexible container until administration is necessary. The flexible container receives a reconstituting liquid for mixing with the freeze-dried material, and conveys the reconstituted freeze-dried material from the flexible container for administration to an individual.

Abstract: A vessel receives a liquid material, which is freeze-dried in situ within the vessel. A gas permeable material carried by the vessel provides gas transport for sublimation during drying. After freeze drying, an oxygen-free inert gas is introduced into the vessel through the gas permeable material, to occupy the interior of the vessel with the freeze-dried material. The gas permeable material is covered, to trap the oxygen-free inert gas within the vessel with the freeze-dried material. The freeze-dried material is stored in the entrapped oxygen-free inert gas within the vessel for a storage period. The vessel receives a reconstituting liquid for mixing with the freeze-dried material, and conveys the reconstituted freeze-dried material from the vessel for administration to an individual.

Abstract: A bioprosthetic valve graft comprises a valve frame and valve flaps, the latter acting to open or close a valve aperture to directionally control fluid flow through the bioprosthesis. The bioprosthetic valve graft comprises method for suturelessly attaching a biomaterial suturelessly bonded to the A method for securing a biomaterial to a valve frame includes positioning a flexible valve frame defining an open area on a first major surface of a biomaterial sheet having a peripheral edge, wherein positioning serves to approximate the valve frame and the peripheral edge of the biomaterial sheet to form an at least first bonding locus; and suturelessly bonding the biomaterial to the valve frame at the at least first bonding locus. The method avoids the disadvantages associated with conventional sutures and substantially reduces medical complications in implantations.

Abstract: A bioprosthetic stent graft is disclosed, having a stent frame and a biomaterial sheath suturelessly bonded to the stent frame. Sutureless bonding avoids sutures and substantially reducing medical complications in implantation of the stent graft. A device and method for manufacturing the stent graft further is disclosed. A mandrel is employed for shaping the stent graft, and means for irradiating the biomaterial effects sutureless bonding.

Abstract: A bioprosthetic valve graft comprises a valve frame and valve flaps, the latter acting to open or close a valve aperture to directionally control fluid flow through the bioprosthesis. The bioprosthetic valve graft comprises a biomaterial suturelessly bonded to the valve frame, avoiding sutures and substantially reducing medical complications in implantations.

Abstract: A bioprosthetic valve graft comprises a valve frame and valve flaps, the latter acting to open or close a valve aperture to directionally control fluid flow through the bioprosthesis. The bioprosthetic valve graft comprises method for suturelessly attaching a biomaterial suturelessly bonded to the A method for securing a biomaterial to a valve frame includes positioning a flexible valve frame defining an open area on a first major surface of a biomaterial sheet having a peripheral edge, wherein positioning serves to approximate the valve frame and the peripheral edge of the biomaterial sheet to form an at least first bonding locus: and suturelessly bonding the biomaterial to the valve frame at the at least first bonding locus. The method avoids the disadvantages associated with conventional sutures and substantially reduces medical complications in implantations.

Abstract: A bioprosthetic stent graft is disclosed, having a stent frame and a biomaterial sheath suturelessly bonded to the stent frame. Sutureless bonding avoids sutures and substantially reducing medical complications in implantation of the stent graft.