Confined air tube and methods for handling air in closed...

Surgery – Blood drawn and replaced or treated and returned to body

Reexamination Certificate

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Details

C604S006090, C604S006150, C604S406000, C604S262000

Reexamination Certificate

active

06267745

ABSTRACT:

FIELD OF THE INVENTION
The invention generally relates to the blood collection systems and methods.
BACKGROUND OF THE INVENTION
FIG. 1
shows a representative prior art closed, multiple blood bag system
10
. The system
10
includes a primary bag
12
and transfer bag
14
, which are made, e.g., from medical grade plasticized polyvinyl chloride plastic. An outlet port
16
in the primary bag
12
communicates with an inlet port
18
in the transfer bag
14
through an integrally attached length of flexible transfer tubing
20
, which is also made from medical grade plasticized polyvinyl chloride plastic. An inlet port
22
in the primary bag
12
communicates with a phlebotomy needle
24
through an integrally attached length of tubing
26
. The primary bag
12
contains a suitable liquid anticoagulant
28
. A frangible cannula
46
normally blocks liquid flow in the transfer tubing
20
from the primary bag
12
to the transfer bag
14
. The system
10
therefore has a “wet” region (i.e., the primary bag
12
filled with liquid anticoagulant
28
) and a “dry” (liquid free) region (i.e., the transfer bag
14
and the transfer tubing
20
downstream of the frangible cannula
46
.
The system
10
is, before use, closed to communication with the atmosphere. The system
10
is heat sterilized in this closed condition, e.g., using steam. During heat sterilization, the walls of the dry transfer bag
14
and the dry transfer tubing
20
are prone to collapse and sticking together. To prevent this from occurring, conventional practice injects a volume of air or helium into the transfer bag
14
and tubing
20
prior to sterilization. This added step in manufacturing requires additional equipment and increases the labor cost. Furthermore, when the system is ultimately used to process blood, additional steps are often required to transfer or otherwise vent the residual air from the system
10
. These air-handling steps can complicate and add to the cost of using the system
10
.
SUMMARY OF THE INVENTION
The invention provides a confined air tube, which is intended to be placed into in-line communication with transfer tubing of a blood processing system. The air tube is confined in an air reservoir, into which the air tube extends a certain distance. The confined air tube provides an incremental volume of air, the magnitude of which depends upon the physical dimensions of the air tube. During heat sterilization, the incremental air volume keeps the transfer tubing from collapsing and sticking together. The presence of the confined air tube obviates the need to inject additional helium or air into the blood processing system during manufacture.
Another aspect of the invention incorporates the confined air tube in a blood processing system, to simplify blood processing techniques. In one mode, the confined air tube accommodates conveyance of a blood component into an associated transfer container. In an other mode, air can be vented from the transfer container into the air reservoir, so that the blood component can undergo further processing or be stored in an air-vented environment within the transfer container.
Other features and advantages of the invention will be pointed out in, or will be apparent from, the drawings, specification and claims that follow.


REFERENCES:
patent: 3058799 (1962-10-01), Rowles, Jr.
patent: 4786286 (1988-11-01), Cerny et al.
patent: 4790815 (1988-12-01), Balteau et al.
patent: 5128048 (1992-07-01), Stewart et al.
patent: 5167656 (1992-12-01), Lynn
patent: 5269946 (1993-12-01), Goldhaber et al.
patent: 5283033 (1994-02-01), Dodrill
patent: 5445629 (1995-08-01), Debrauwere et al.
patent: 5451321 (1995-09-01), Matkovich
patent: 5472621 (1995-12-01), Matkovich
patent: 5514106 (1996-05-01), D'Silva
patent: 5601730 (1997-02-01), Page et al.
patent: 5695489 (1997-12-01), Japuntich
patent: 5928214 (1999-07-01), Rubinstein et al.
patent: 5941866 (1999-08-01), Niedospial, Jr.

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