Self-contained pack assembly for an extracorporeal blood circuit

• US 6,811,749 B2
• Filed: 09/28/2001
• Issued: 11/02/2004
• Est. Priority Date: 02/10/1999
• Status: Expired due to Fees

• Current Assignee: Terumo Cardiovascular Systems Corporation (Terumo Corporation)
• Original Assignee: Terumo Cardiovascular Systems Corporation (Terumo Corporation)
• Inventors: Lindsay, Erin J.
• Primary Examiner(s): Bianco, Patricia
• Application Number:
  US09/964,416
• Publication Number:
  US 20020009386A1
• Time in Patent Office: 1,131 Days
• Field of Search: 604/4.01, 604/5-1-, 604/6-1-, 604/6.06, 604/6.09, 604/6.11, 604/6.13, 604/6.14, 604/6.15, 604/6.16, 604/257, 604/259, 604/262, 604/317, 422/44-48, 422/61, 422/63, 422/99, 422/101-104, 600/19, 261/DIG.28, 210/252-262, 128/DIG.3, 603/25
• US Class Current: 422/45
• CPC Class Codes: A61M 1/1698 Blood oxygenators with or without heat-exchangers intracorporal A61M1/1678; manufacturing of membranes therefor B01D67/00; semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi-permeable membranes characterised by their material B01D71/00
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3666 Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
• CPC Class Codes: A61M 2209/082 Mounting brackets, arm supports for equipment
• CPC Class Codes: Y10S 261/28 Blood oxygenators

Abstract

A self-contained pack assembly includes all of the disposable components of an extracorporeal support circuit for cardiac bypass surgery. The pack assembly comprises a blood reservoir, a blood oxygenator, and a carrier for vertically mounting the blood reservoir and blood oxygenator. Trays may be releasably attached to the carrier to serve as containers for coiled tubing used in the support circuit.

Claims

1. A pack assembly for use in an extracorporeal blood circuit, comprising:

(a) a carrier adapted to mount a blood reservoir and a blood oxygenator, said carrier including a mounting element, and said carrier being adapted for mounting on a support;

(b) a blood reservoir releasably attached to the mounting element; and

(c) a blood oxygenator releasably attached to the mounting element;

wherein said carrier is adapted to independently and separately mount said blood reservoir and said blood oxygenator such that when used in an extracorporeal blood circuit one of said blood reservoir and said blood oxygenator may be removed from said carrier without removing another of said blood reservoir and said blood oxygenator.

2. A pack assembly according to claim 1, further comprising:

(d) a mounting bracket releasably engaged with the carrier.

3. A pack assembly according to claim 2, further comprising:

(e) a hinge associated with the mounting bracket; and

(f) at least one panel attached to the hinge, the panel including clips or pegs for supporting a blood reservoir.

4. A pack assembly according to claim 3, wherein two panels are attached to the hinge.

5. A pack assembly according to claim 2, further comprising:

(e) a vertical support structure; and

(f) a clamp attaching the mounting bracket to the vertical support structure.

6. A pack assembly according to claim 2, wherein the mounting bracket is adapted to releasably engage the carrier without removing the barrier pouch so as to maintain the pack assembly in said sterile condition after mounting said pack assembly on said mounting bracket.

7. A pack assembly according to claim 2, wherein the mounting bracket includes a slotted track capable of slidingly engaging and releasing the carrier.

8. A pack assembly according to claim 1, further comprising:

(d) at least one tray releasably attached to the carrier, the blood reservoir or the blood oxygenator.

9. A pack assembly according to claim 8, wherein two trays are releasably attached to the carrier, the blood reservoir or the blood oxygenator.

10. A pack assembly according to claim 8, wherein the tray is separated into individual compartments.

11. A pack assembly according to claim 8, further comprising:

(e) a prime line comprising a priming tube and at least one bag spike attached to the reservoir, at least a portion of the prime line being disposed within one of the trays.

12. A pack assembly according to claim 8, further comprising:

(e) an A-V loop comprising a venous line and an arterial line, at least a portion of the A-V loop being disposed within one of the trays.

13. A pack assembly according to claim 8, further comprising:

(e) a suction line attached to the reservoir, at least a portion of the suction line being disposed within one of the trays.

14. A pack assembly according to claim 8, further comprising:

(e) a pump loop comprising a pump inlet line attached to the reservoir, a pump header attached to the pump inlet line, and a pump outlet line attached to the pump header and the oxygenator, the pump header and at least a portion of the pump inlet line and pump outlet lines being disposed within one of the trays.

15. A pack assembly according to claim 1, further comprising:

(d) a barrier pouch enclosing the carrier, the blood reservoir and the blood oxygenator so as to maintain the pack assembly in a sterile condition prior to use.

16. A pack assembly according to claim 1, wherein the mounting element has a top surface and a bottom surface, the blood reservoir is supported and retained on the top surface of the mounting element, and the blood oxygenator is attached to the bottom surface of the mounting element.

17. A pack assembly according to claim 1, wherein the blood oxygenator includes an attachment disk projecting from its surface on a stem, and the lower surface of the mounting element has a channel for slidingly engaging and releasing the attachment disk.

18. A pack assembly according to claim 1, wherein said blood reservoir comprises a cardiotomy reservoir and said pack assembly further comprises a flexible venous blood reservoir mounted on said carrier.

19. A pack assembly for use in an extracorporeal blood circuit, comprising:

(a) a backbone adapted to mount a blood reservoir and a blood oxygenator on said backbone;

(b) a blood reservoir secured to said backbone; and

(c) a blood oxygenator releasably secured to said backbone;

wherein said backbone is adapted to independently and separately mount said blood reservoir and said blood oxygenator such that when used in an extracorporeal blood circuit said blood oxygenator may be removed from said backbone without removing said blood reservoir from said backbone.

20. A pack assembly according to claim 19, further comprising:

(d) a barrier container enclosing at least the carrier, the blood reservoir and the blood oxygenator so as to maintain the pack assembly in a sterile condition prior to use.

21. A pack assembly according to claim 20, further comprising:

(e) a prime line comprising a priming tube and at least one bag spike attached to the reservoir.

22. A pack assembly according to claim 20, further comprising:

(e) an A-V loop comprising a venous line and an arterial line.

23. A pack assembly according to claim 20, further comprising:

(e) a suction line attached to the reservoir.

24. A pack assembly according to claim 20, further comprising:

(e) a pump loop comprising a pump inlet line attached to the reservoir, a pump header attached to the pump inlet line, and a pump outlet line attached to the pump header and the oxygenator.

25. A method for arranging an extracorporeal blood circuit comprising:

providing a pack assembly including a blood reservoir, a blood oxygenator, and at least one tray including a plurality of tubing assemblies;

mounting the pack assembly for use;

selecting any one of said plurality of tubing assemblies from said at least one tray; and

deploying said selected one of said plurality of tubing assemblies for use.

26. A method according to claim 25, further comprising providing a pack assembly including a flexible venous blood reservoir, the blood reservoir being removable from the pack assembly so as to expose the flexible venous blood reservoir for use.

27. A method according to claim 25, further comprising selecting another one of said plurality of tubing assemblies from said at least one tray and deploying said selected another one of said plurality of tubing assemblies for use.

28. A method of using an extracorporeal blood circuit, comprising:

providing a carrier adapted to mount a blood reservoir and a blood oxygenator, a blood reservoir attached to the carrier, and a blood oxygenator attached to the carrier;

selecting one of said blood reservoir and said blood oxygenator;

removing said selected one of said blood reservoir and said blood oxygenator without removing the other of said blood reservoir and said blood oxygenator; and

thereafter, replacing said selecting one of said blood reservoir and said blood oxygenator.

29. The method of claim 28, wherein said blood reservoir is releasably attached to the carrier.

30. The method of claim 28, wherein said oxygenator is releasably attached to the carrier.