Velico Medical, Inc.

Sisters of Providence in Oregon

Hemcon Medical Technologies, Inc.

Lisa A Buckley

Robert R Andrews

Clair Strohl

Herman E Snyder

Evan P Ordway

William J Merritt

Jihae Sohn

Mark A Popovsky

Qiyong Peter Liu

Scott Alan Prahl

Steven L Jacques

Simon J McCarthy

Kyle D Erickson

Eric K Meyer

Richard Meehan

Clinton B Pepper

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.

Method for providing dried plasma

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 COor other pH adjustment; and when reconstituted, has reduced complement activation (C5A, C3A).

Blood plasma product

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.

Apparatus and methods for making, storing, and administering freeze-dried materials such as freeze-dried plasma

Levels of psoralen concentration in a biological detection target are determined so that an appropriate UVA light dose of PUVA therapy can be delivered to a biological treatment target. The appropriate therapy is determined by the product of the UVA light dose and psoralen concentration level. After determination of a baseline optical autofluoresence signal from the detection target, a first dosage of psoralen (preferably 8-methoxypsoralen �8-MOP!) is administered. Thereafter, the detection target is irradiated under the same conditions as the pre-psoralen irradiation. Then, the optical return from the psoralen-treated detection target is analyzed. A computer (86) compares the pre-psoralen optical return and psoralen-treated optical return to calculate a real time determination of the concentration level of psoralen in the treatment target. Then, then knowing the precise psoralen concentration level, a UV dosage level required to achieve the desired PUVA therapy can be precisely determined and applied to the treatment target. In some embodiments, the detection target is the treatment target and in vivo real time psoralen concentration is determined. Various forms of applicators (52, 452, 552, 652, 752) are provided for differing types of targets. Each applicator is mounted on an optical fiber bundle (54). In some embodiments, the same optical fiber bundle (54) is employed to transmit the irradiation and optical return signals in the psoralen concentration determination, as well as to transmit the UVA for the PUVA therapy.

Method and apparatus for determination of psoralen concentrations in

Levels of psoralen concentration in a biological detection target are determined so that an appropriate UVA light dose of PUVA therapy can be delivered to a biological treatment target. The appropriate therapy is determined by the product of the UVA light dose and psoralen concentration level. After determination of a baseline optical autofluoresence signal from the detection target, a first dosage of psoralen (preferably 8-methoxypsoralen [8-MOP]) is administered. Thereafter, the detection target is irradiated under the same conditions as the pre-psoralen irradiation. Then, the optical return from the psoralen-treated detection target is analyzed. A computer (86) compares the pre-psoralen optical return and psoralen-treated optical return to calculate a real time determination of the concentration level of psoralen in the treatment target. Then, then knowing the precise psoralen concentration level, a UV dosage level required to achieve the desired PUVA therapy can be precisely determined and applied to the treatment target. In some embodiments, the detection target is the treatment target and in vivo real time psoralen concentration is determined. Various forms of applicators (52, 452, 552, 652, 752) are provided for differing types of targets. Each applicator is mounted on an optical fiber bundle (54). In some embodiments, the same optical fiber bundle (54) is employed to transmit the irradiation and optical return signals in the psoralen concentration determination, as well as to transmit the UVA for the PUVA therapy.

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Portland, OR, United States of America

Lisa A Buckley