Cord blood and placenta collection kit

• US 7,147,626 B2
• Filed: 09/20/2005
• Issued: 12/12/2006
• Est. Priority Date: 09/23/2004
• Status: Active Grant

• Current Assignee: Celularity, Inc.
• Original Assignee: Celgene Corporation (Bristol-Myers Squibb Company)
• Inventors: Goodman, Chris B., Feingold, Barnett Dov, Robinson, Wayne Malcolm
• Primary Examiner(s): Stephens, Jacqueline F.
• Application Number:
  US11/230,760
• Publication Number:
  US 20060060494A1
• Time in Patent Office: 448 Days
• Field of Search: 604/408, 604/317, 606/119, 606/120, 435/2, 435/1.1, 435/372, 435/284.1, 435/307.1, 424/529, 424/93.1, 424/93.7
• US Class Current: 604/317
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 5/150038 for blood from umbilical cord
• CPC Class Codes: A61B 5/150045 for blood from vagina, placenta, colon or mouth
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150366 Blood collection bags, e.g. connected to the patient by a catheter comprising means for removing a small sample of collected blood from the bag collection bags as such A61J1/05, A61M1/0209
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150824 by visual feedback

Abstract

The present invention provides an improved kit for the collection of umbilical cord blood and placental blood, and collection of the placenta from which such blood is obtained. The kit improves upon existing kits in that it provides for improved user convenience, provides for the collection of the placenta itself, and better maintains the internal temperature of the container in which the collected blood and placenta are shipped to a blood bank or registry. The invention further provides a method of collecting umbilical cord and placental blood, and the placenta from which such blood is obtained, comprising using the kit described herein.

Claims

1. A kit comprising (a) a container for the collection of placental or umbilical cord blood;

(b) a container for the collection of said placenta;

(c) a temperature-controlling composition;

(d) materials sufficient for the collection of maternal blood;

(e) instructions, wherein said instructions comprise a first set of instructions for the collection of maternal blood and a second set of instructions for the collection of umbilical cord and placental blood, wherein said first and second set of instructions are differently coded; and

(f) an insulating container of sufficient capacity to contain (1) items (a)–

(e) prior to use, (2) items (a)–

(d) after said collection of placental and umbilical cord blood, and (3) said placenta.

2. The kit of claim 1, wherein said container for the collection of blood is a blood bag.

3. The kit of claim 2, wherein said blood bag comprises a plurality of bags.

4. The kit of claim 3, wherein said blood bag comprises a collection bag and three satellite bags that are each smaller than said collection bag.

5. The kit of claim 1, wherein said materials for the collection of maternal blood comprises a plurality of vials and a needle suitable for the collection of blood.

6. The kit of claim 5, wherein at least one of said plurality of vials comprises EDTA, and at least one of said plurality of vials does not contain EDTA.

7. The kit of claim 6, wherein said materials for the collection of maternal blood comprise a plurality of vials containing EDTA and a plurality of vials not containing EDTA.

8. The kit of claim 5, wherein said materials for the collection of maternal blood are contained within a first container separate from the remaining contents of the kit.

9. The kit of claim 8, wherein said first container fits into a cavity in the lid of said insulating container.

10. The kit of claim 8, wherein said first container additionally comprises color-coded instructions for the use of said materials for the collection of maternal blood.

11. The kit of claim 1, wherein said insulating container (f) has an R value of between about 5 and about 8.

12. The kit of claim 11, wherein said insulating container has an R value of about 6.5.

13. The kit of claim 11, wherein the internal volume of said insulating container is between 4 and 8 liters.

14. The kit of claim 13, wherein the volume of said insulating container is about 6 liters.

15. The kit of claim 11, wherein said insulating container comprises a lid having a central cavity suitable for receiving a first container that comprises a plurality of kit contents.

16. The kit of claim 1, wherein said temperature controlling composition is a temperature controlling composition that resists temperature spikes.

17. The kit of claim 1, wherein said temperature controlling composition is a temperature controlling composition that resists temperature drops.

18. The kit of claim 17, wherein said temperature controlling composition is in brick or pack form.

19. The kit of claim 1, wherein said temperature controlling composition is a temperature controlling composition that resists both temperature spikes and temperature drops.

20. The kit of claim 19, wherein said temperature controlling composition is in brick or pack form.

21. The kit of claim 20, which contains two temperature controlling composition packs.

22. The kit of claim 1, wherein said kit comprises a plurality of temperature controlling composition bricks or temperature controlling composition packs.

23. The kit of claim 22, wherein said kit is designed to contain two temperature controlling composition packs in a vertical configuration on opposite sides of the interior of said insulating container.

24. The kit of claim 22, where said temperature controlling composition is a plurality of Saf-T-Pak STP-317 15–

30C refrigerant bricks.

25. The kit of claim 1 which comprises two temperature controlling composition packs, wherein at least one of said instructions instructs the user to place at least one pack under said umbilical cord blood and said placenta, and at least one pack on top of said umbilical cord blood and said placenta, prior to shipping.

26. The kit of claim 1 which comprises a sufficient volume of temperature controlling composition to maintain the interior of said insulating container between 15°

C. and 37°

C. during shipping of said kit to a cord blood bank or cord blood registry.

27. The kit of claim 1 which comprises a sufficient volume of temperature controlling composition to maintain the interior of said insulating container between 15°

C. and 37°

C. during at least 12 hours of shipping of said kit to a cord blood bank or cord blood registry.

28. A method for the collection of umbilical cord blood or placental blood, and of a placenta, comprising using a kit which comprises (a) a container for the collection of said placental blood or umbilical cord blood;

(b) a container for the collection of said placenta;

(c) a temperature controlling composition;

(d) materials sufficient for the collection of maternal blood;

(e) instructions, wherein said instructions comprise a first set of instructions for the collection of maternal blood and a second set of instructions for the collection of umbilical cord and placental blood, wherein said first and second set of instructions are differently coded; and

(f) an insulating container of sufficient capacity to contain (1) items (a)–

(e) prior to use, (2) items (a)–

(d) after said collection of said placental blood or umbilical cord blood, and (3) said placenta.