Blood processing systems using a peristaltic pump module with valve and sensing station for operating a peristaltic pump tube cassette

• US 5,482,440 A
• Filed: 12/22/1993
• Issued: 01/09/1996
• Est. Priority Date: 12/22/1993
• Status: Expired due to Term

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Baxter International Inc.
• Inventors: Dennehey, T. Michael, Williamson, Warren P., Brown, Richard I.
• Primary Examiner(s): Bertsch, Richard A.
• Assistant Examiner(s): Korytnyk, Peter G.
• Application Number:
  US08/173,520
• Time in Patent Office: 748 Days
• Field of Search: 417/474-476, 417/477 R, 417/477 A, 417/477.1, 417/477.2, 417/63, 604/4, 604/5, 604/6, 604/153, 604/154
• US Class Current: 417/63
• CPC Class Codes: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/303 having a reservoir for treated blood to be returned
• CPC Class Codes: A61M 1/3603 in the same direction
• CPC Class Codes: A61M 1/362227 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362261 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 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 1/3696 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
• CPC Class Codes: F02B 2075/025 two
• CPC Class Codes: F04B 2205/05 Pressure after the pump outlet
• CPC Class Codes: F04B 43/1253 by using two or more rollers as squeezing elements, the rollers moving on an arc of a circle during squeezing
• CPC Class Codes: F04B 43/1292 Pumps specially adapted for several tubular flexible members

Abstract

A blood processing assembly includes a separation element for separating blood from a source into a first component and a second component. The assembly also includes a fluid path that conveys blood between the source and the separation element. The fluid path includes one or more in-line cassettes that serve in association with peristaltic pumps to centralize pumping and valving functions of the system. The cassettes also serve to segregate the flow paths of the blood components from each other.

Claims

1. A blood processing assembly comprising

a separation element for separating blood from a source into a first component and a second component,

a fluid path for conveying blood between the source and the separation element, the fluid path including an in-line cassette comprising

a housing having an interior wall that divides the housing into a first interior area and a second interior area,

first and second pump ports on the housing,

a flexible tubing loop that extends between the first and second pump ports outside the housing for engagement with an external peristaltic pumping element,

a liquid port on the housing attachable to a length of tubing that extends outside the housing interior and forms a part of the associated fluid path,

liquid passages formed within the first interior area and communicating with the liquid port, the first pump port, and the second pump port, and

valve means formed within the second interior area responsive to the application of external force for controlling liquid flow through the liquid passages and, thus, through the associated fluid path,

a sensing chamber formed within the second interior area and communicating with at least one liquid passage in the first interior area,

a first generally rigid wall that overlies the first interior area and externally seals the liquid passages, and

a second generally flexible wall that overlies the second interior area and externally seals the valve means and the sensing chamber, the second wall flexing in response to external forces applied to control fluid passage through the valve means, the second wall also flexing to transmit information regarding liquid pressure present within the at least one liquid passage to an external sensing element.

2. An assembly according to claim 1

wherein the separation element comprises a chamber in which blood is separated in response to centrifugal force.

3. An assembly according to claim 1 wherein the assembly forms a sterile blood flow path essentially closed to communication with the atmosphere.

4. An assembly according to claim 1 and further including

third and fourth pump ports on the housing, and

a second flexible tubing loop that extends between the third and fourth pump ports outside the housing for engagement with an external peristaltic pumping element.

5. An assembly according to claim 4

wherein the flexible tubing loops are spaced apart for engagement with separate, spaced apart peristaltic pumping elements.

6. A blood processing assembly comprising

a separation element for separating blood from a source into a first component and a second component,

a first fluid path for conveying blood from the source to the separation element,

a second fluid path for conveying the first component from the separation element,

a third fluid path for conveying the second component from the separation element,

the first, second, and third fluid paths including, respectively, first, second, and third flow cassettes, each cassette comprising

a housing having an interior,

first and second pump ports on the housing,

a flexible tubing loop that extends between the first and second pump ports outside the housing for engagement with an external peristaltic pumping element,

a liquid port on the housing attachable to a length of tubing that extends outside the housing interior and forms a part of the associated fluid path,

liquid passages formed within the housing interior and communicating with the liquid port, the first pump port, and the second pump port, and

valve means formed within the housing interior responsive to the application of external force for controlling liquid flow through the liquid passages and, thus, through the associated fluid path.

7. An assembly according to claim 6

wherein at least one of the cassettes includes a sensing chamber formed within the housing interior along at least one liquid passage and including means for transmitting information regarding liquid pressure present within the one liquid passage to an external sensing element.

8. An assembly according to claim 6

wherein the second cassette conveys the first component from the separation element through the second fluid path in a way that bypasses the first fluid path, thereby isolating the first component from the source blood, and

wherein the third cassette conveys the second component from the separation element through the third fluid path in a way that bypasses the first and second fluid paths, thereby isolating the second component from the first component and the source blood.

9. An assembly according to claim 6

wherein the separation element comprises a chamber in which blood is separated in response to centrifugal force.

10. An assembly according to claim 6

wherein the assembly comprises a closed sterile blood flow path.

11. A blood processing system comprising

a liquid flow cassette comprising

a housing having an interior wall that divides the housing into a first interior area and a second interior area,

first and second pump ports on the housing,

a flexible tubing loop that extends between the first and second pump ports outside the housing,

a liquid conveying port on the housing, liquid passages formed within the first interior area and communicating with the liquid conveying port, the first pump port, and the second pump port,

valve means formed within the second interior area for controlling liquid flow through the liquid passages,

a first generally rigid wall that overlies the first interior area and externally seals the liquid paths, and

a second generally flexible wall that overlies the second interior area and externally seals the valve means, the second wall flexing in response to external forces applied to control fluid passage through the valve means,

a processing apparatus including an operating station for the cassette that comprises

a gripping element for engaging the generally rigid cassette wall to hold the cassette in a desired orientation on the station,

a peristaltic pumping element arranged with respect to the gripping element to engage the flexible tubing loop when the cassette is in the desired orientation on the station to pump fluid through the liquid passages, and

a valve actuating element arranged with respect to the pumping element to register with the cassette valve means and apply external force to the generally flexible cassette wall when the cassette is in the desired orientation on the station to control liquid flow in the cassette passages.

12. A system according to claim 11

wherein the cassette includes a sensing chamber formed within the second interior area and communicating with least one liquid passage,

wherein the generally flexible wall overlies and externally seals the sensing chamber, the generally flexible wall flexing to transmit liquid pressure present within the one liquid passage, and

wherein the operating station for the cassette includes a sensing element arranged with respect to the pumping station to register with sensing chamber and sense liquid pressure transmitted by the generally flexible cassette wall when the cassette is in the desired orientation on the station.

13. A system according to claim 11

wherein the processing apparatus includes an element for separating blood components that communicates with tubing attached to the liquid port of the cassette.

14. A system according to claim 11

wherein the liquid flow cassette further includes third and fourth pump ports on the housing communicating with the liquid passages and a second flexible tubing loop that extends between the third and fourth pump ports outside the housing, and

wherein the processing apparatus further includes a second peristaltic pumping element arranged with respect to the gripping element to engage the second flexible tubing loop when the cassette is in the desired orientation on the station to pump fluid through the liquid passages.

15. A system according to claim 14

wherein the flexible tubing loops are mutually spaced apart on the housing, and

wherein the peristaltic pumping elements comprise oppositely spaced pump rotors that each engage one of the flexible tubing loops.

16. A blood processing assembly comprising

a separation element for separating blood from a source into components, and

a fluid path for conveying blood between the source and the separation element, the fluid path including an in-line cassette comprising

a housing having an interior wall that divides the housing into a first interior area and a second interior area,

first and second pump ports on the housing,

a flexible tubing loop that extends between the first and second pump ports outside the housing for engagement with an external peristaltic pumping element,

a liquid conveying port on the housing,

liquid passages formed within the first interior area and communicating with the liquid conveying port, the first pump port, and the second pump port,

valve means formed within the second interior area for controlling liquid flow through the liquid passages,

a first generally rigid wall that overlies the first interior area and externally seals the liquid paths, and

a second generally flexible wall that overlies the second interior area and externally seals the valve means, the second wall flexing in response to external forces applied to control fluid passage through the valve means.

17. An assembly according to claim 16

wherein the separation element comprises a chamber in which blood is separated in response to centrifugal force.

18. An assembly according to claim 16

wherein the assembly forms a sterile blood flow path essentially closed to communication with the atmosphere.

19. An assembly according to claim 16 and further including

third and fourth pump ports on the housing, and

a second flexible tubing loop that extends between the third and fourth pump ports outside the housing for engagement with an external peristaltic pumping element.

20. An assembly according to claim 19

wherein the flexible tubing loops are spaced apart for engagement with separate, spaced apart peristaltic pumping elements.