FLUID DELIVERY SYSTEM WITH SPIKED CASSETTE

• US 20090012448A1
• Filed: 07/05/2007
• Published: 01/08/2009
• Est. Priority Date: 07/05/2007
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Childers, Robert W., Reitz, Douglas, Roger, Rodolfo, Kopychev, Andrey, Steck, John E., Lee, Patrick
• Granted Patent: US 8,496,609 B2
• Time in Patent Office: Days
• US Class Current: 604/29
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/152 Details related to the interface between cassette and machine
• CPC Class Codes: A61M 1/153 the cassette being adapted for heating or cooling the treating fluid, e.g. the dialysate or the treating gas
• CPC Class Codes: A61M 1/154 with sensing means or components thereof
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/1561 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/1565 Details of valves
• CPC Class Codes: A61M 1/159 specially adapted for peritoneal dialysis
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1621 Constructional aspects thereof 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 2039/1027 Quick-acting type connectors
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 39/165 Shrouds or protectors for aseptically enclosing the connector
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/1626 Needle protectors therefor in combination with syringes A61M5/3202; protectors for sharps A61B50/3001
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A fluid dispensing machine, such as a peritoneal dialysis or hemodialysis machine, includes a dispenser or cassette that pumps a medical fluid for dialysis or other treatments for patients. The machine includes and uses an autoconnect device for connecting containers of liquid, such as bags of dialysis fluid or medication fluids, to the machine, while maintaining the sterility of the connection. The autoconnect device removes the cap from the fluid bag and pierces a sealing membrane on tubing from the bag. This makes it easier for patients to receive treatment, especially home treatment. The cassettes preferably have tubing ports with integral spikes for piercing the membrane on tubing from bags of liquids. The ports may be staggered for sequential engagement with the spikes. Other embodiments are useful for dispensing other liquids from other types of dispensing or pumping machines.

Claims

1. A dialysis cassette, comprising:

a frame;

at least one pump chamber within the frame;

first and second flexible membranes joined to opposite sides of the frame;

a plurality of valves for routing liquid within the cassette; and

a plurality of ports communicating with the valves, each port comprising an integral spike, the ports configured for connection with sources of dialysis fluid.

2. The dialysis cassette of claim 1, wherein each port comprises a shroud, the spike recessed within the shroud.

3. The dialysis cassette of claim 1, wherein the ports and spikes are oriented at about ninety degrees to a longitudinal axis of the cassette.

4. The dialysis cassette of claim 1, wherein the cassette is suitable for peritoneal dialysis or hemodialysis.

5. The dialysis cassette of claim 1, further comprising an line-heater.

6. The dialysis cassette of claim 1, wherein the ports and spikes protrude in sequentially greater distances from the cassette.

7. The dialysis cassette of claim 1, wherein the spikes protrude different distances from the cassette, the distances differing sequentially by about ⅛

inch to about ½

inch.

8. The dialysis cassette of claim 1, further comprising a dialysis machine or an autoconnect machine configured for interfacing with the dialysis cassette.

9. A dialysis cassette, comprising:

a frame;

at least one pump chamber within the frame;

first and second flexible membranes joined to opposite sides of the frame;

a plurality of valves for routing liquid within the cassette; and

a plurality of ports arranged in a row and communicating with the valves, each port comprising an integral spike, the ports configured for connection with a source of dialysis fluid, the spikes protruding in sequentially greater distances from the cassette, the distances from about ⅛

inch to about ½

inch.

10. The dialysis cassette of claim 9, wherein the ports also protrude different distances from the cassette, the distances differing from each other by about ⅛

inch to about ½

inch.

11. The dialysis cassette of claim 9, wherein the integral spike comprises three diameters along a length of the spike.

12. The dialysis cassette of claim 9, wherein the ports and spikes are oriented at about ninety degrees to a longitudinal axis of the cassette.

13. The dialysis cassette of claim 9, wherein the cassette further comprises a drain port and separate ports for flow of fluid to and from a patient, and optionally, wherein the ports to and from the patient are adjacent.

14. A dialysis cassette, comprising:

a rigid frame;

at least one pump chamber within the frame;

a plurality of valves for routing liquid within the cassette;

a plurality of ports communicating with the valves, the ports configured for connection to tubing; and

first and second flexible membranes joined to opposite sides of the frame, wherein the membranes are configured to cover the at least one pump chamber and the valves and not to cover the ports.

15. The dialysis cassette of claim 14, wherein the ports comprise an integral recessed spike.

16. The dialysis cassette of claim 14, wherein the ports comprise an integral recessed spike, the spike having three sequential diameters.

17. The dialysis cassette of claim 14, wherein the ports comprise an integral recessed spike, the spike having three sequential diameters, a first diameter, a second diameter adjacent the first diameter and larger than the first diameter, and a third diameter adjacent the second diameter and larger than the second diameter.

18. The dialysis cassette of claim 14, wherein the cassette further comprises adjacent ports for routing dialysis fluid to and from a patient.

19. The dialysis cassette of claim 14, wherein the ports are perpendicular to a longitudinal axis of the cassette.

20. A dialysis cassette, comprising:

a rigid frame;

at least one pump chamber within the frame;

a plurality of valves for routing liquid within the cassette;

a plurality of ports communicating with the valves, the ports perpendicular to a longitudinal axis of the frame, the ports also configured for connection to tubing; and

first and second flexible membranes joined to opposite sides of the frame, wherein the membranes are configured to cover the at least one pump chamber and the valves and not to cover the ports.

21. The dialysis cassette of claim 20, wherein the ports each comprise an outer shroud and an integral recessed spike.

22. The dialysis cassette of claim 20, wherein the cassette further comprises a drain port and separate ports for flow of fluid to and from a patient, and optionally, wherein the ports to and from the patient are adjacent.

23. The dialysis cassette of claim 20, further comprising ports for at least one of pH meter, a conductivity meter, and a temperature element.

24. The dialysis cassette of claim 20, further comprising a heater.

25. The dialysis cassette of claim 20, wherein the ports protrude different distances from the cassette, the distances differing from each other by about ⅛

inch to about ½

inch.

26. A method for connecting fluid containers, the method comprising:

placing a connector from a fluid container into an autoconnect machine;

placing a tubing cap from tubing from one of the fluid containers into a pocket of one of a plurality of fingers of the autoconnect machine, causing the finger to move or rotate in a direction toward a dispensing cassette on a different side of the fingers;

translating the tubing and the tubing cap a distance in a direction toward the cassette, wherein translating rotates the plurality of fingers and causes only the finger into which the tubing cap was placed to capture a port cap from a port of the cassette, the cassette comprising at least one pump chamber and a plurality of ports in a row and a plurality of port caps, each port comprising an integral internal spike, wherein the spikes protrude from the cassette different distances, the distances differing by about ⅛

inch to about ½

inch;

translating the tubing in a direction away from the cassette, removing the tubing cap from the tubing and leaving the tubing cap from the tubing in the pocket;

rotating the fingers away from the cassette and in a direction to remove the port cap from the port of the cassette; and

translating the tubing toward the cassette and causing a spike in the port of the cassette to pierce a sealing membrane in the tubing, wherein the method is suitable for fluid containers for peritoneal dialysis or hemodialysis.

27. The method of claim 26, wherein the fluid is selected from the group consisting of dialysis fluid, blood, a blood substitute, nutritional fluids, fluids containing a medication, and saline.

28. The method of claim 26, wherein a seal is formed between a stepped portion of the spike and the tubing just before the spike pierces the sealing membrane.

29. The method of claim 26, wherein a seal is formed between a stepped portion of the spike and an entrance to the tubing after the spike pierces the sealing membrane.

30. The method of claim 26, wherein a plurality of fluid containers with tubing and tubing caps are placed onto the autoconnect machine, and wherein the third step of translating the tubing toward the cassette causes sequential piercing of membranes of the plurality of tubing by the staggered spikes.

31. The method of claim 26, wherein the tubing is placed onto separate positions within the autoconnect machine and wherein the tubing or the bag has a unique identifier, and further comprising reading the unique identifier with a bar code reader, a camera, or an RFID reader, and further comprising instructing a user of the autoconnect device in which position to place the tubing.

32. The method of claim 26, further comprising sensing a property of the fluid with at least one of a pH meter, a conductivity meter, and a temperature element.