Claims for Patent: 5,140,993

Summary for Patent: 5,140,993

Title:	Device for collecting a breath sample
Abstract:	In accordance with illustrative embodiments of the present invention as disclosed herein, a breath sample collecting device includes a flexible plastic bag having a mouthpiece and inlet valve assembly connected adjacent one end of the bag, and a sample transfer assembly connected adjacent the other end of the bag. The transfer assembly has a sleeve attached to a neck on the bag, such sleeve having an inner end wall which mounts a hollow needle having a sharp tip on its outer end in a manner such that the tip is within the bore of the sleeve to prevent accidental stick injuries. A rubber boot which closes the tip, and an elastomer stopper on an associated transfer device, are selectively pierced by the needle tip in response to compressive force to permit transfer of a breath sample from the bag to such associated device.
Inventor(s):	Opekun, Jr.; Antone R. (Pearland, TX), Klein; Peter D. (Houston, TX)
Assignee:	Baylor College of Medicine (Houston, TX)
Application Number:	07/813,646
Patent Claims:	1. A device for use in collecting a breath sample, comprising: a flexible bag made of a medical grade, impervious plastic; inlet means adjacent one end of the bag by which it can be insufflated by a patient, said inlet means including a mouthpiece providing an inlet passage, and valve means for opening and closing said inlet passage; and outlet means adjacent the opposite end of said bag for safely transferring at least a portion of said sample to an external container, said outlet means including a sleeve member having a bore and an inner end wall, and a needle assembly mounted on said inner end wall, a needle of said assembly having a bore and a tip and extending outward into the bore of said sleeve member in a manner such that its tip is positioned within said bore of the sleeve member means on said needle for covering said tip and for closing the bore of said needle, said tip being arranged to pierce said covering means and a wall of an associated external transfer means to thereby communicate the interior of said bag with said associated external transfer means. 2. The device of claim 1 further including a flexible neck having a bore and having its inner end joined to said bag, an inner portion of said sleeve member being received in the bore of said neck, and means for clamping said neck on said sleeve member to prevent fluid leakage therebetween. 3. The device of claim 1 wherein said valve means includes a one-way check valve element which permits flow only into the interior of said bag. 4. The device of claim 3 further including neck means on said bag having a bore in communication with the said interior of said bag; and adapter means for coupling said neck means to said valve means. 5. The device of claim 4 wherein said adapter means comprises a sleeve having an internal bore surface that tapers outwardly, said valve means including a body with an external flange that slides into said sleeve and fits tightly within said internal bore surface. 6. The device of claim 5 wherein said adapter means comprises a sleeve having an internal bore surface that tapers outwardly, said valve means including a body with an external flange that slides into said sleeve and fits tightly within said internal bore surface. 7. The device of claim 1 wherein said valve means includes a valve element that can be moved manually between open and closed positions. 8. The device of claim 7 further including neck means on said bag having a bore in communication with the said interior of said bag; and adapter means for coupling said neck means to said valve means.