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: 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 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: 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: The present invention includes an ease-of-use system that allows the spray drying disposable device to fit (e.g., align) in both spray drying apparatus and the spray drying finishing apparatus to safely operate the system. The system includes locating arrangements between the spray drying disposable and the spray drying apparatus and/or spray drying finishing apparatus, a first retainer and second retainer, a shorter disposable device that allows for effective spray drying of plasma, a feedback indicators of correct installment, redundant indicators of correct installment, easily accessible operator controls and emergency shut offs.

Abstract: An alignment system that allows a spray drying disposable to align in both spray drying apparatus and finishing apparatus. The first instance is a locating arrangement wherein a locator is disposed on the spray drying apparatus and/or finishing apparatus and another locator is on the spray drying head of the disposable such that the locators allow for alignment of the disposable with the spray drying apparatus or finishing apparatus. A second instance of an alignment element includes a guide that is offset as positioned on the spray drying head of the disposable. Yet a third instance of the alignment arrangement relates to the gas exhaust port. In a fourth instance, the alignment system includes a positioning arrangement to reversibly attach the outer wall of the disposable to the finishing apparatus. In a fifth and sixth instance, a retaining device that retains the spray drying head in the spray drying apparatus and/or finishing apparatus.

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 spray drying plasma methodology that includes pretreating a donated liquid plasma unit, drying the liquid plasma using a spray drying apparatus with the spray drying disposable device that results in a disposable having the dried plasma, finishing the disposable using the finishing apparatus that is designed to seal and separate the disposable, and transform the disposable into a dried plasma unit. The methods of the present invention include storing the dried plasma unit and, when ready for use, reconstituting the dried plasma unit with reconstitution solution to obtain a plasma unit ready for transfusion into a recipient.

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: 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: 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: A method for repairing an abnormality in the wall of a body lumen, the method comprising: isolating the abnormality in the wall of the body lumen from flow in the body lumen; positioning flowable forming material adjacent to the abnormality in the wall of the body lumen; and transforming the flowable forming material into a substantially stationary state so as to repair the abnormality in the wall of the body lumen. Apparatus for repairing an abnormality in the wall of a body lumen, the apparatus comprising: a supply of flowable forming material; zone isolation apparatus for isolating the abnormality in the wall of the body lumen from flow in the body lumen; and positioning apparatus for positioning the flowable forming material adjacent to the abnormality in the wall of the body lumen so as to repair the abnormality in the wall of the body lumen.

Abstract: Apparatus and method for repairing an abnormality in the wall of a body lumen, the method comprising isolating the abnormality in the wall of the body lumen from flow in the body lumen; positioning flowable forming material adjacent to the abnormality in the wall of the body lumen; and transforming the flowable forming material into a substantially stationary state so as to repair the abnormality in the wall of the body lumen, and the apparatus comprising a supply of flowable forming material; zone isolation apparatus for isolating the abnormality in the wall of the body lumen from flow in the body lumen; and positioning apparatus for positioning the flowable forming material adjacent to the abnormality in the wall of the body lumen so as to repair the abnormality in the wall of the body lumen.

Abstract: A method for repairing an abnormality in the wall of a body lumen, the method comprising: isolating the abnormality in the wall of the body lumen from flow in the body lumen; positioning flowable forming material adjacent to the abnormality in the wall of the body lumen; and transforming the flowable forming material into a substantially stationary state so as to repair the abnormality in the wall of the body lumen. Apparatus for repairing an abnormality in the wall of a body lumen, the apparatus comprising: a supply of flowable forming material; zone isolation apparatus for isolating the abnormality in the wall of the body lumen from flow in the body lumen; and positioning apparatus for positioning the flowable forming material adjacent to the abnormality in the wall of the body lumen so as to repair the abnormality in the wall of the body lumen.

Abstract: A system and method of marking percutaneous myocardial revascularization channels in a human heart and introducing into the channels a therapeutic or diagnostic agent by inserting a catheter system into the left ventricle of a heart, applying tissue ablative energy through the catheter to create a channel into the heart wall, introducing an imaging medium to the heart wall proximate the channel for marking the position of that channel for imaging, and introducing in or proximate the channel a therapeutic or diagnostic agent.

Abstract: A myocardial revascularization system that includes a laser energy source (e.g., a semiconductor laser), an outer guide member providing access to a patient's heart, and an optical fiber. The optical fiber is coupled to receive laser energy pulses from the source, is slidably located within the guide member, and is extendible from the distal end of the guide member. A drive motor is connected to the fiber to automatically move the distal end of the optical fiber with respect to the distal end of the guide member. A controller controls the drive motor to automatically move the fiber in synchronism with firing of the laser energy, and automatically calibrates the position of the distal end of the fiber with respect to the distal end of the catheter. The fiber has, at its tip, an enlargened portion with a front surface coated with a heat absorbing material that is nonmetallic and is partially transparent to the pulses. The outer guide member is 7 French or smaller and has a deflectable distal end.

Abstract: A myocardial revascularization system that includes a laser energy source (e.g., a semiconductor laser), an outer guide member providing access to a patient's heart, and an optical fiber. The optical fiber is coupled to receive laser energy pulses from the source, is slidably located within the guide member, and is extendible from the distal end of the guide member. A drive motor is connected to the fiber to automatically move the distal end of the optical fiber with respect to the distal end of the guide member. A controller controls the drive motor to automatically move the fiber in synchronism with firing of the laser energy, and automatically calibrates the position of the distal end of the fiber with respect to the distal end of the catheter. The fiber has, at its tip, an enlargened portion with a front surface coated with a heat absorbing material that is nonmetallic and is partially transparent to the pulses. The outer guide member is 7 French or smaller and has a deflectable distal end.

Abstract: An energy delivery system for performing myocardial revascularization on a heart of a patient including an energy pulse source that produces energy pulses sufficient to create channels in a wall of a heart, and an energy pulse delivery system connected to receive the energy pulses and deliver the energy pulses to desired locations for channels in the wall of the heart. Also disclosed are a sensor that senses a cyclical event related to the contraction and expansion of the beating heart; a controller responsive to the sensor for automatically firing the energy pulse system to provide energy to strike the beating heart only within a safe time period during a heart beat cycle; RF electrical or laser energy pulses; a temperature sensor to avoid damage caused by overheating adjacent heart tissue; a thermal conductivity cooling system; and programmably adjusting duty cycle, duration and amplitude of energy pulses.