Plasmapheresis assembly

• US 3,945,380 A
• Filed: 08/21/1974
• Issued: 03/23/1976
• Est. Priority Date: 08/21/1974
• Status: Expired due to Term

• Current Assignee: Cutter Laboratories, Inc. (Bayer AG)
• Original Assignee: Cutter Laboratories, Inc. (Bayer AG)
• Inventors: Tuseth, Robert D., Kristoff, Basil L., Dabney, William C., Hink, John H.
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US05/499,297
• Time in Patent Office: 580 Days
• Field of Search: 128/214 R, 128/214 A, 128/214 B, 128/214 C, 128/214 D, 128/214.2, 128/274, 128/213, 251/342, 137/608, 137/610
• US Class Current: 604/410
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• 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 5/150366 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 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components
• CPC Class Codes: A61M 1/0218 with filters
• CPC Class Codes: A61M 2202/0413 Blood
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: Y10T 137/87788 With valve or movable deflector at junction

Abstract

The plasmapheresis assembly includes a novel Y connector valving structure to replace conventional tube clamps. This valving structure eliminates dead spaces for blood to collect and clot and provides a fluid tight seal during heat sterilization without causing deformation of the tubing for the assembly. Possible erroneous connection of assembly components with resultant contamination is eliminated by the use of unique mating connectors in place of spikes or needle connectors. These mating connectors are employed in a simple and efficient blood bag construction to provide substantially rigid access ports to facilitate rapid manual manipulation of the blood bags.

Claims

1. A medical assembly for biological, pharmaceutical or similar fluids comprising at least one fluid container means, at least one connector means having at least first, second and third angularly disposed fluid conducting branches, said fluid conducting branches being joined at one end at a common juncture to provide connecting fluid flow paths through said branches, said connector means including internal valve means operable at said common juncture to selectively close one of said branches to all fluid flow and to open a fluid flow path between the remaining two branches, said valve means operating to completely close the end of said closed branch at the common juncture to prevent fluid from collecting in the entrance to said closed branch at said juncture and being operable to close a selected branch by movement of the valve means from the end of one of said branches through the common juncture and into the end of the selected branch to be closed, and a fluid conduit connecting said container means to one of the branches of said connector means.

2. The medical assembly of claim 1 wherein said connecttor means is formed to provide fluid conduits through said branches thereof, said valve means being formed by a ball valve movable within said connector means between the ends of the branches

at said common juncture, said ball valve being of sufficient diameter to seal said fluid conduits.

3. The medical assembly of claim 2 wherein said connector means includes a unitary body defining said fluid conducting branches, said unitary body being formed of flexible plastic material to facilitate movement of said ball valve by externally compressing said body.

4. The medical assembly of claim 3 wherein said body is formed of plastic material of sufficient transparency to permit visual determination of the position of said ball valve from the exterior of said body.

5. The medical assembly of claim 3 wherein said connector means is formed to provide tubular fluid conduits through the branches thereof, and flexible fluid conducting tubes are connected to each branch of said body, each said branch terminating in a connecting hub for receiving the end of one of said flexible tubes, each said connecting hub having a tubular inner surface of a diameter greater than the diameter of the tubular fluid conduit through the remainder of the branch.

6. The medical assembly of claim 5 wherein the diameter of the inner surface of each said hub is substantially equal to the outer diameter of the tube received thereby and the diameter of the fluid conduit through the remainder of each branch is substantially equal to the inner diameter of said tube.

7. The medical assembly of claim 1 which includes first and second fluid container means and first and second connector means, both said first and second connector means having first, second and third fluid conducting branches joined at one end at a common juncture, a first flexible tube joining said first container means to one branch of said first connector means, a second flexible tube joining said second container means to one branch of said second connector means, and a third flexible tube joining second branches of said first and second connector means.

8. The medical assembly of claim 7 which includes an administration set having an outlet tube, a fourth flexible tube being connected to a third branch of said second connector means, and joining means to connect said outlet tube with said fourth flexible tube.

9. The medical assembly of claim 8 wherein said joining means includes a first connector section on the end of said fourth flexible tube and a second connector section on the end of said outlet tube, said first and second connector sections being formed of substantially rigid material and being shaped to mate.

10. The medical assembly of claim 8 wherein each said fluid container means includes a container body of flexible, thin material defining an interior fluid fluid chamber, first and second access port means projecting outwardly from said container body, each said access port means including a connector section means formed of substantially rigid material and shaped to cooperate with a mating connector section means to form a fluid connection, the connector section means of said first access port means differing in structure from the connector section means of said second access port means.

11. The medical assembly of claim 10 wherein said administration set includes inlet means, said inlet means including mating connector section means formed to mate with the connector section means of only one access port means for each said fluid container means.

12. The medical assembly of claim 10 wherein said first access port means projects from said container body for a distance greater than said second access port means projects.

13. The medical assembly of claim 7 wherein only said first connector means includes said internal valve means.

14. The medical assembly of claim 13 which includes an administration set having an outlet tube, a fourth flexible tube being connected to a third branch of said second connector means, and joining means to connect said outlet tube with said fourth flexible tube.

15. The medical assembly of claim 7 wherein both said first and second connector means include internal valve means formed by a ball valve movable within the respective first and second connector means between the ends of the branches thereof at said common juncture, each said ball valve being of sufficient diameter to seal the fluid conduits of the respective connector means.

16. A medical assembly for biological, pharmaceutical or similar fluids comprising at least one fluid container means, at least one connector means having at least first, second and third angularly disposed fluid conducting branches joined at one end at a common juncture to provide connecting fluid conduits through said branches, said connector means including internal valve means operable at said common juncture to selectively close one of said branches to fluid flow and to open a fluid flow path between the remaining two branches, said valve means operating to completely close the end of said closed branch at the common juncture to prevent fluid from collecting in the entrance to said closed branch at said juncture and including a ball valve of sufficient diameter to seal said fluid conduits movable within said connector means between the entrance ends of said branches at the common juncture and stop means provided in at least two of said branches to limit the movement of said ball valve into the fluid conduits through said branches, said stop means in each branch being positioned inwardly from the entrance end of said branch at the common juncture for a distance substantially no greater than the diameter of said ball valve, and a fluid conduit connecting said container means to one of the branches of said connector means.

17. A medical assembly for biological, pharmaceutical or similar fluids comprising at least one container means including a container body of flexible, thin material defining an interior fluid chamber, first and second access port means projecting outwardly from said container body, each said access port means including a connector section means formed of substantially rigid material and shaped to cooperate with a mating connector section means to form a fluid connection, the connector section means of one of said access port means differing in structure from the connector section means of the remaining access port means to require unlike mating connector section means for the connector section means of said first and second access port means, at least one connector means having at least first, second and third angularly diposed fluid conducting branches, said fluid conducting branches being joined at one end at a common juncture to provide connecting fluid flow paths through said branches, said connector means including internal valve means operable at said common juncture to selectively close one of said branches to fluid flow and to open a fluid flow path between the remaining two branches, and a fluid conduit connecting said container means to one of the branches of said connector means.

18. A connector valve for joining tubing in a medical assembly comprising a connector body having a plurality of elongated angularly disposed, fluid conducting branches, each branch being joined at one end to a common juncture to provide connecting fluid conduits through said branches, and internal valve means operable at said common juncture to selectively close one of said branches to fluid flow, said valve means operating to completely close the end of said closed branch at the common juncture to prevent fluid from collecting in the entrance to the closed branch at the juncture while permitting fluid to flow in the remaining branches, said valve means including a ball valve movable within said connector body between the ends of the branches thereof at said common juncture, said ball valve being of sufficient diameter to seal said fluid conduits and stop means to limit the movement of said ball valve into the fluid conduits through said branches, the stop means being positioned within a branch inwardly from the end of said branch at the common juncture for a distance substantially no greater than the diameter of said ball valve, said connector body being formed of flexible material to facilitate movement of said ball valve by external compression of said flexible connector body.

19. The connector valve of claim 18 wherein tubular fluid conduits are formed through each of said fluid conducting branches, the outer ends of each branch terminating in an enlarged connecting hub for receiving the end of a tube, each said connecting hub having a tubular inner surface of a diameter greater than the diameter of the tubular fluid conduit through the remainder of the branch but substantially equal to the outer diameter of the tube received thereby, the diameter of the tubular fluid conduit through the remainder of the branch being substantially equal to the inner diameter of said tube.

20. The connector valve of claim 18 wherein said connector body is formed of plastic material of sufficient transparency to permit visual determination of the position of said ball valve from the exterior of said connector body.

21. A medical assembly for biological, pharmaceutical or similar fluids comprising first and second connector means each having first, second and third angularly disposed fluid conducting branches joined at one end to a common juncture to provide connecting fluid flow paths through said branches, said first connector means including internal valve means operable at said common juncture to selectively close one of said branches to fluid flow and to open a fluid flow path between the remaining two branches, first and second fluid container means each including a container body of flexible, thin material defining an interior fluid chamber, first and second access port means projecting outwardly from said container body, each such access port means including a connector section means formed of substantially rigid material and shaped to cooperate with a mating connector section means to form a fluid connection, the connector section means of said first access port means differing in structure from the connector section means of said second access port means to require unlike mating connector section means for the connector section means of said first and second access port means, a first fluid conduit joining said first container means to one branch of said first connector means, a second fluid conduit joining said second container means to one branch of said second connector means, a third fluid conduit joining second branches of said first and second connector means, and an administration set including inlet means, said inlet means including mating connector section means formed to mate with the connector section means of only one access port means for each said fluid container means and outlet means connected to a third branch of said second connector means.

22. The medical assembly of claim 21 wherein said first access port means projects from said container body for a distance greater than said second access port means projects.