(a) 1 umbilical cord blood collection bag (comprising a collection bag and three satellite bags);
(b) 1 clear plastic self-adhesive bag;
(c) 1 placenta carrier;
(d) 1 zip-lock placenta collection bag;
(e) 2 standard chucks (blue pads);
(f) 3 povidone-iodine swabs;
(g) 2 alcohol prep pads;
(h) 2 sterile gauze pads;
(i) 2 plastic umbilical cord clamps;
(j) 1 set of non-sterile vinyl gloves;
(k) 1 slide clip; and
(l) 1 sterile C-section adaptor with extension tubing and 16-gauge needle.

The umbilical cord blood collection bag (a) comprises four chambers. The main chamber is large enough to hold all of the blood from the umbilical cord and placenta of a normal, non-twin birth. The collection bag additionally comprises three smaller chambers, approximately 10 cubic centimeters in volume, that are physically separate from the main chamber, but remain connected to the main chamber by plastic tubing. Blood collected into the main chamber may be aliquoted into the three smaller chambers during collection. After collection of blood, the blood collection bags are placed in a plastic self-adhesive bag (Biohazard) which is loosely placed inside the plastic cooler box.

The placenta carrier is a 1.5 liter plastic screw-top canister made of high-density polyethylene. The canister was obtained on a special-order basis from Exakt-Pak (Oklahoma City, Okla.). The canister has an O-ring that improves the seal between lid and canister body. The canister containing the bagged placenta is placed into a cardboard receiver in the bottom of the insulating container for shipping. The canister is sturdy enough to withstand the changes in pressure inherent in air transport.

The kit also includes a maternal blood collection kit, which contains:

- a) two 7mL lavender-top tubes containing 50 μl of an EDTA solution;
- b) two 7mL red-top tubes containing no solution;
- c) 4 bar code labels for the lavender- and red-capped tubes;
- d) 1 Vacutainer Safety-Lok Blood Collection Set (23 gauge) and yellow tube receiver; and
- e) 2 sterile alcohol prep pads.

The maternal blood collection kit is contained in a plastic tray glued into a cavity in the underside of the insulating container lid. The components listed above are positioned in a block of shaped foam within the plastic tray. The plastic tray further includes a set of instructions for performing the timing of maternal blood collection and labeling of the tubes.

The kit further comprises two Saf-T-Pak STP-317 15-30 C temperature controlling composition (refrigerant) bricks that help maintain the contents of the kit at a consistent temperature during shipping. The refrigerant bricks are designed to maintain temperature between 15-30° C. Each refrigerant brick is labeled with instructions not to freeze or microwave the block, and to precondition the blocks between 15-23° C. prior to shipping. The refrigerant bricks were obtained from Saf-T-Pak, Inc. As shipped to the user, the refrigerant bricks are positioned vertically against the two smaller inside faces of the insulating container.

The kit contains three color-coded sets of instructions. The first set, coded blue, provide users an overview of the cold/placental blood collection process, collection record forms, and reminders. The second set, coded green and labeled “Collection Step 1,” instructs the user on the process of collecting maternal blood. The third set, coded red and labeled “Collection Step 2,” instructs the user on umbilical cord/placental blood collection.

Finally, the kit contains the appropriate labels and bar codes for the maternal blood, placenta, and umbilical cord/placental blood, and a shipping label.

6.2 Effect of Configuration of Refrigerants During Shipping

A study was undertaken to determine the effect of different configurations of kit contents and temperature controlling composition (refrigerant) packs on the internal temperature of an insulating shipping container, and on the temperature of various non-refrigerant kit contents, during a simulated 48 hours shipping time. The study used an insulating container having an R value of about 6.5 with an interior volume of about 6 liters. Kit contents tested included a maternal blood collection kit comprising four glass vials and a needle in a flat plastic tray, a plastic bag, and a blood bag. The plastic bag and blood bag were filled with material simulating a placenta and cord blood. For hot weather simulations, the refrigerant-containing kits contained Koolit PCM^2626-xpacks as the refrigerant. For cold weather simulations, the refrigerant-containing kits contained Koolit PCM^1616-xpacks. The following configurations of contents and refrigerant were tested:

I. Kit contents layered between two refrigerant packs on the bottom of the interior of the insulating container and two refrigerant packs on top of the kit contents;

II. Kit contents layered between two refrigerant packs on the bottom of the interior of the insulating container and four refrigerant packs on top of the kit contents;

III. Kit contents placed in insulating container with no refrigerants;

IV. Kit contents placed in the insulating container and covered with two refrigerant packs;

V. Maternal blood collection materials, in tray, taped to the underside of the insulating container lid; other kit contents placed in the insulating container and covered with two refrigerant packs;

VI. Maternal blood collection materials, in tray, taped to the underside of the insulating container lid; two refrigerant packs are placed on the bottom of the interior of the insulating container, other kit contents are placed on these two refrigerant packs, and covered with two additional refrigerant packs;

VII. Maternal blood collection materials, in tray, placed in a cavity formed in the underside of the insulating container lid; two refrigerant packs placed on the bottom of the interior of the insulating container, other kit contents placed on these two refrigerant packs, and covered with two additional refrigerant packs; and

VIII. Maternal blood collection materials, in tray, placed in a cavity formed in the underside of the insulating container lid; other kit contents placed in the insulating container and covered with two refrigerant packs.

For each of the above configurations, thermocouples were attached to the tray containing the maternal blood collection components, the bag containing the simulated placenta, the bag containing the simulated blood; and one was set to record the ambient internal temperature of the insulating container. In each case, the lid of the insulating container was taped shut and the temperature, as detected by the thermocouples, recorded over 48 hours. For each of the configurations above, the kit contents were stabilized at 22° C.±3° C. prior to taping the lid shut.

During the 48 hours of the studies, temperature spikes were used to simulate varying temperature conditions during shipping. In one set of experiments simulating shipping during summer or hot-weather conditions using the above configurations, the temperature exterior to the sealed kit was maintained at 22° C. for seven hours; brought to 44° C. over the course of two hours; held at 44° C. for two hours; brought to 30° C. over the course of two hours; maintained at 30° C. for 12 hours; brought to 44° C. over the course of two hours; held at 44° C. for two hours; brought to 30° C. over the course of two hours; and maintained at 30° C. for the remainder of the 48 hours of the experiment.

In another set of experiments simulating shipping during winter or cold-weather conditions using the above configurations, the temperature exterior to the sealed kit was maintained at 18° C. for sic hours; brought to −20° C. over the course of two hours; maintained at −20° C. for two hours; brought to 10° C. over two hours; held at 10° C. for twelve hours; brought to −20° C. over the course of two hours; maintained at −20° C. for two hours; brought to 10° C. over two hours; and held at 10° C. for the remainder of the 48 hours.

For both sets of simulations, configurations I and II performed the best. In simulated hot weather shipping conditions, internal temperatures recorded by any thermocouple never rose above 27° C. Similarly, in simulated cold weather shipping conditions, internal temperatures recorded by any thermocouple never fell below 13° C. Other configurations allowed for more variation in internal or kit component temperature, but, with the exception of configuration II, such temperatures never exceeded 34° C. or fell below 4° C.

6.3 Effect of Different Refrigerants on Internal Temperature

The objective of this test is to perform thermal qualification testing for cord blood stem cell collection kit's shipping container. A total of six EPS shipping containers (TL-1187) were tested. The product load was the same for all six containers. Three containers were packed each with 2-Phase Pack refrigerants and the other three containers were packed each with Two Koolit PCM^1616-brefrigerants from Cold Chain Technologies. Blood and placenta containers were filled with a phantom gel to simulate collected tissue. Shippers were tested for 48 hours utilizing ISTA7D external ambient guideline profile.

Test Results Overview: Test results indicated that the EPS shipping containers packed with the Koolit PCM1616-b refrigerants provided better thermal protection to the product load based on the recorded product temperatures during the 48-hour test. The results are recapped below.

TABLE 1


Results of simulated cold-weather challenge using different refrigerants.
Recorded Product Temperatures under Winter Challenge

		Lowest Product	Average Product
Test #		Temperature	Temperature
1796	Refrigerant Used	(Centigrade)	(Centigrade)

1b	Koolit PCM	5.9	14.5
2a	Koolit PCM	6.1	14.5
2b	Koolit PCM	6.0	14.6
1a	Phase Pack	−1.8	10.6
1c	Phase Pack	−1.0	10.6
2c	Phase Pack	−1.8	10.7

1a and 1b: 75% phantom gel.
2a and 1c: 80% phantom gel.
2b and 2c: 85% phantom gel.

The present invention is not to be limited in scope by the specific embodiments described herein. Indeed, various modifications of the invention in addition to those described will become apparent to those skilled in the art from the foregoing description and accompanying figures. Such modifications are intended to fall within the scope of the appended claims.

Various publications, patents and patent applications are cited herein, the disclosures of which are incorporated by reference in their entireties.

Claims

1-28. (canceled)

29. A bag for the collection of umbilical cord and placental blood, comprising a collection bag and a plurality of satellite bags, each of which is smaller in volume than said collection bag.

30. The bag ofclaim 29, wherein said collection bag has the capacity to hold about 250 ml of blood.

31. The bag ofclaim 29, wherein each of said satellite bags is joined to said collection bag by plastic tubing.

32. The bag ofclaim 29, wherein said collection bag has a capacity to hold about 250 ml to about 300 ml of liquid.

33. The bag ofclaim 29, wherein said bag is large enough to collect all blood from a single placenta and umbilical cord.

34. The bag ofclaim 29, wherein said satellite bags have a volume of about 50 ml.

35. The bag ofclaim 29, wherein said bag comprises an anticoagulant.

36. The bag ofclaim 34, wherein said anticoagulant is heparin.

37. The bag ofclaim 29, wherein said collection bag and said plurality of satellite bags are joined such that liquid in the collection bag flows directly into one of said plurality of satellite bags.

38. The bag ofclaim 29, wherein said collection bag is joined to said plurality of satellite bags only by tubing.