Fluid flow control apparatus

• US 5,372,709 A
• Filed: 06/01/1993
• Issued: 12/13/1994
• Est. Priority Date: 12/13/1988
• Status: Expired due to Fees

• Current Assignee: Bio-Flo Limited
• Original Assignee: Bio-Flo Limited
• Inventors: Hood, Robert G.
• Primary Examiner(s): Drodge, Joseph W.
• Application Number:
  US08/070,635
• Time in Patent Office: 560 Days
• Field of Search: 210/90, 210/97, 210/102, 210/134, 210/137, 210/143, 210/321.65, 210/416.1, 210/646, 210/929, 210/96.2, 210/321.71, 138/43, 138/45, 138/46, 138/119, 251/4, 251/6, 251/7, 251/9, 417/26, 417/28, 417/474, 417/476, 417/477, 417/475, 422/100, 422/101, 422/103, 422/105, 422/112, 422/45, 422/48, 604/25, 604/31, 604/34, 604/65, 604/67, 604/250, 604/4-6
• US Class Current: 210/90
• 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 1/306 Pressure control, e.g. using substantially rigid closed or gas buffered or elastic reservoirs
• CPC Class Codes: A61M 1/309 with trans-membrane pressure [TMP] increasing substantially continuously during arterial phase
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/362263 Details of incorporated filters
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/3663 Flow rate transducers; Flow integrators
• 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: Y10S 210/929 Hemoultrafiltrate volume measurement or control processes

Abstract

A fluid control apparatus for use in separation and filtration having a removable sterilizable and disposable element which is engagable with a fixed element in the apparatus. When the two elements are engaged, the flow of fluid around a fluid circuit is controlled to optimize separation. The elements contain various conduits and inlet and outlet ports that function to deliver fluid to and from separation and filtration systems such as life support systems.

Claims

1. Fluid flow control apparatus operable for use with a fluid handling system having a fluid handling inlet and a fluid handling outlet, said apparatus comprising:

a. a fixed portion;

b. a removable portion removably engageable with said fixed portion and removable for separate sterilizing or replacement, said removable portion including;

1) a main inlet port for receiving fluid to be fed through said fluid handling system,

2) a main outlet port for discharging fluid which has been fed through said fluid handling system,

3) outlet conduit means located downstream of said main inlet port for connecting said control apparatus to said fluid handling inlet,

4) inlet conduit means located upstream of said main outlet port for connecting said control apparatus to said fluid handling outlet, and

5) a deformable fluid conduit connected between one of said main inlet and outlet ports and one of said outlet and inlet conduit means;

c. fluid flow restriction means for restricting flow in said deformable conduit, said flow restriction means including a first element and a second element arranged for compressing said deformable conduit therebetween when said removable portion is engaged with said fixed portion, said flow restriction means being operable to selectively set a pressure in said deformable conduit and said fluid handling system;

d. means for connecting a pump means between one of said main inlet and outlet ports and one of said outlet and inlet conduit means for pumping fluid through said control apparatus and said fluid handling system;

e. fluid pathways, including said deformable fluid conduit, extending between said main inlet and outlet ports and said outlet and inlet conduit means for permitting fluid to flow between said inlet and said outlet ports when said removable portion is coupled to said fluid handling system and said pump means; and

f. a fluid monitoring system, said fluid monitoring system comprising;

1) a first sampling conduit disposed in said removable portion communicating with said main inlet port, said first sampling conduit having a first sampling outlet port,

2) a first sampling inlet port in said fixed portion, said first sampling inlet port being arranged for sealably registering with said first sampling outlet port when said removable portion is engaged with said fixed portion,

3) a second sampling conduit, said second sampling conduit being located in said fixed portion, and having opposite ends, said first sampling inlet port defining an inlet at one end of said second sampling conduit,

4) at least one aperture in said fixed portion communicating with said second sampling conduit for receiving a sensor for measuring a fluid parameter, and

5) a second sampling outlet port in said fixed portion at the other end of said second sampling conduit.

2. Fluid flow control apparatus operable for use with a fluid handling system having a fluid handling inlet and a fluid handling outlet, said apparatus comprising:

a. a fixed portion;

b. a removable portion removably engageable with said fixed portion and removable for separate sterilizing or replacement, said removable portion including;

1) a main inlet port,

2) a main outlet port,

3) a first outlet conduit located downstream of said main inlet port for directing fluid flow to said fluid handling system,

4) a first inlet conduit located upstream of said main outlet port for receiving fluid flow from said fluid handling system,

5) a second outlet conduit operable for connecting said control apparatus to a pump inlet of a pump means for pumping fluid through said control apparatus and said fluid handling system,

6) a second inlet conduit operable for connecting said control apparatus to a pump outlet of said pump means leading to said fluid handling system, and

7) a deformable fluid conduit connected between one of said main inlet and outlet ports and one of said first outlet and inlet conduits;

c. fluid flow restriction means for restricting flow in said deformable conduit, said flow restriction means including a first element and a second element arranged for compressing said deformable conduit therebetween when said removable portion is engaged with said fixed portion, said flow restriction means being operable to selectively set a pressure in said deformable conduit and said fluid handling system;

d. fluid pathways, including said deformable fluid conduit, extending between said main inlet and outlet ports and said first and second outlet and inlet conduits for permitting fluid to flow between said inlet and said outlet ports; and

e. a fluid monitoring system, said fluid monitoring system comprising;

1) a first sampling conduit disposed in said removable portion communicating with said main inlet port, said first sampling conduit having a first sampling outlet port,

2) a first sampling inlet port in said fixed portion, said first sampling inlet port being arranged for sealably registering with said first sampling outlet port when said removable portion is engaged with said fixed portion,

3) a second sampling conduit, said second sampling conduit being located in said fixed portion, and having opposite ends, said first sampling inlet port defining an inlet at one end of said second sampling conduit,

4) at least one aperture in said fixed portion communicating with said second sampling conduit for receiving a sensor for measuring a fluid parameter, and

5) a second sampling outlet port in said fixed portion at the other end of said second sampling conduit.

3. Fluid control apparatus as claimed in claim 2 wherein:

a. said deformable conduit is a flexible conduit.

4. Fluid control apparatus as claimed in claim 2 wherein:

a. said removable portion is constructed of moulded plastic; and

b. said deformable conduit is an integral moulded part of said removable portion.

5. Fluid control apparatus as claimed in claim 2 wherein:

a. the fixed portion defines a recess for slideably receiving said removable portion.

6. Fluid control apparatus as claimed in claim 2 wherein:

a. the removable portion is constructed for engagement with said fixed portion by a fastener.

7. Fluid control apparatus as claimed in claim 2 wherein:

a. said fluid flow control apparatus is coupled to one of a separation and filtration system.

8. Fluid control apparatus as claimed in claim 7 wherein said fluid flow control apparatus is coupled to a life support system.

9. Fluid control apparatus as claimed in claim 2 wherein:

each of

a. said fluid flow control apparatus is coupled to a separation system; and

b. the separation system is a dialysis system for detoxifying blood.

10. Fluid control apparatus as claimed in claim 2 wherein:

a. said removable portion is made of medical grade stainless steel.

11. Fluid control apparatus as claimed in claim 2 wherein:

a. said removable portion is made of sterilisable plastic.

12. Fluid control apparatus as claimed in claim 2 wherein:

a. the removable portion and the fluid handling system are combinable into a single integral structure which is removably coupled to the fixed portion.

13. Fluid flow control apparatus operable as claimed in claim 2 operable for use in a dialysis system for receiving blood to be treated, where said removable portion is coupled to said pump means and to a separation element and said fluid flow restriction means is arranged to set a level of back pressure required for dialysis, said apparatus further comprising:

a. monitoring means coupled to said removable portion for receiving a sample of blood being passed to said dialysis system for analyzing at least one parameter of said blood;

b. purge means coupled to the removable portion of said flow control apparatus for being coupled to a supply of purge fluid after said blood has been treated to purge said monitoring means of blood; and

c. control means coupled to said fluid flow restriction means, to said pump means and to said purge means setting a blood flow rate and pressure of blood in said dialysis system.

14. Fluid flow control apparatus as claimed in claim 2 wherein said apparatus is coupled to a filtration device as the fluid handling system, said device including filter means connected between said first inlet and outlet conduits, said filter means having a filter inlet for receiving an inlet fluid to be filtered and a filter outlet for receiving concentrate from said filter means, said apparatus further comprising:

a. first transmembrane pressure monitoring means associated with said filter inlet for measuring the transmembrane inlet pressure of said filter means;

b. second transmembrane pressure monitoring means associated with said filter outlet for measuring the transmembrane outlet pressure of said filter means;

c. means for comparing the inlet and outlet pressures measured; and

d. flow control means coupled to said first and second pressure monitoring means for providing a comparison signal corresponding to the transmembrane pressures sensed by said first and second monitoring means, and in response to said signal, controlling the flow of fluid through said filter means to optimize control of the transmembrane pressures and filtration.

15. Fluid flow control apparatus as claimed in claim 14 wherein:

a. the flow control means is a pressure switch located in communication with said filter inlet.

16. Fluid flow control apparatus as claimed in claim 14 wherein:

a. the flow control means is a pressure switch located in communication with said filter outlet.

17. Fluid flow control apparatus as claimed in any one of claims 14 to 16 wherein:

a. the pressure monitoring means are each disposed in a bleed line connected to said filter inlet and outlet so that the fluid flows past the respective monitoring means.

18. Fluid flow control apparatus as claimed in claim 17, further comprising:

a. first and second solenoid valves coupled to the first and second pressure monitoring means, respectively, said valves having valve outputs which are combined into a single valve output conduit, said valves being actuatable to open said valve output conduit to permit purging of fluid from said bleed line.

19. Fluid flow control apparatus as claimed in any one of claims 14 to 16 wherein:

a. the pressure monitoring means are each diaphragm pressure sensors so that there is no contact between the fluid being treated and the respective pressure monitoring means.

20. Fluid flow control apparatus as claimed in claim 14 wherein:

a. said apparatus is coupled to a blood separation system including said filtration device and said filtration device includes a filtrate outlet for receiving filtrate from said filter means;

b. said pump means includes

1) a first pump disposed at said filter inlet,

2) a second pump disposed at said filter outlet,

3) a third pump disposed at the filtrate outlet, the filtrate outlet being adapted to be connected to a reservoir of an anticoagulant substance and said filtrate outlet being further adapted to be connected to a plasma collection unit; and

the device being effective to separate plasma from blood donated by a patient, whereby in use, a first value of transmembrane pressure is used to actuate the first and third pumps to separate plasma and to store the separated plasma in a collection unit and a second value of transmembrane pressure is used to stop the first and third pumps and to actuate the second pump to return the blood to the patient.

21. Fluid control apparatus operable for use with a fluid handling system having a fluid handling inlet and a fluid handling outlet, said apparatus comprising:

a. a fixed portion;

b. a removable portion removably and slidably engageable with said fixed portion and removable for separate sterilizing or replacement, said removable portion including;

1) a main inlet port,

2) a main outlet port,

3) a first outlet conduit for directing fluid flow to said fluid handling system,

4) a first inlet conduit for receiving fluid flow from said fluid handling system,

5) a second outlet conduit for connecting said control apparatus to a pump inlet of a pump means for pumping fluid through said control apparatus and said fluid handling system,

6) a second inlet conduit for connecting said control apparatus to a pump outlet of said pump means, said pump outlet leading to said control apparatus and said fluid handling system, and

7) a deformable fluid conduit connected between one of said main inlet and outlet ports and one of said first outlet and inlet conduits;

c. fluid flow restriction means for restricting flow in said deformable conduit, said flow restriction means including a first element and a second element arranged for compressing said deformable conduit therebetween when said removable portion is engaged with said fixed portion, said flow restriction means being operable to set a pressure in said deformable conduit and said fluid handling system; and

d. fluid pathways, including said deformable fluid conduit, extending between said main inlet and outlet ports and said first and second outlet and inlet conduits for permitting fluid to flow between said inlet and said outlet ports;

wherein the fixed portion consists of two separate parts including;

1) a first guide part defining a recess for slideably receiving the removable portion, and

2) a second flow restriction valve control part being defined by said first element disposed in opposing relation to said second element with the deformable conduit disposed therebetween when the fixed and removable portions are engaged and

said second element is mounted on said removable portion.

22. Fluid control apparatus as claimed in claim 21 further comprising:

a fluid monitoring system said fluid monitoring system comprising;

1) a first sampling conduit disposed in said removable portion communicating with said main inlet port, said first sampling conduit having a first sampling outlet port,

2) a first sampling inlet port in said first guide part, said first sampling inlet port being arranged for sealably registering with said first sampling outlet port when said removable portion is engaged with said fixed portion,

3) a second sampling conduit, said second sampling conduit being located in said first guide part, and having opposite ends, said first sampling inlet port defining an inlet at one end of said second sampling conduit,

4) at least one aperture in said first guide part communicating with said second sampling conduit and operable for receiving a sensor for measuring a fluid parameter, and

5) a second sampling outlet port in said first guide part at the other end of said second sampling conduit.

23. Fluid control apparatus as claimed in claim 22 wherein:

said at least one apertures comprises a plurality of apertures and provided; and

one of said sensors is removably coupled to each of said apertures in said first guide part is removably couplable to a sensor for sensing one of various fluid parameters.

24. Fluid control apparatus as claimed in claim 22, further comprising:

a. an openable and closable outlet purge port;

b. purge conduit means connecting said second sampling outlet port to said outlet purge port; and

c. purge valve means communicating with said outlet purge port for selectively opening and closing said outlet purge port to permit purging of fluid in said second sampling conduit through said outlet purge port when said outlet purge port is open.

25. Fluid control apparatus as claimed in claim 24 further comprising:

a. a second sampling inlet port in said removable portion for sealingly registering with said second sampling outlet port when said removable portion is engaged with said fixed portion;

b. said purge conduit means includes a purge conduit in said removable portion connected between said outlet purge port and said second sampling inlet port; and

c. said second sampling outlet port is disposed downstream of said purge valve means relative to the direction of said purging.

26. Fluid control apparatus as claimed in claim 22 or 25, wherein:

a. said sampling ports are aseptic ports.

27. Fluid flow control apparatus operable for use with a fluid handling system having a fluid handling inlet and a fluid handling outlet, said apparatus comprising:

a. a fixed portion;

b. a removable and separable portion removably engageable with said fixed portion and removable to a location spaced from said fixed portion for separate sterilizing or replacement, said removable portion including;

1) a main inlet port for receiving fluid to be fed through said fluid handling system,

2) a main outlet port for discharging fluid which has been fed through said fluid handling system,

3) outlet conduit means located downstream of said main inlet port for connecting said control apparatus to said fluid handling inlet,

4) inlet conduit means located upstream of said main outlet port for connecting said control apparatus to said fluid handling outlet, and

5) a deformable fluid conduit connected between one of said main inlet and outlet ports and one of said outlet and inlet conduit means;

c. fluid flow restriction means for restricting flow in said deformable conduit, said flow restriction means including a first element comprising an adjustable cam means mounted on said fixed portion and a second element comprising a roller mounted on said removable portion and about which said deformable conduit is arranged, said elements being arranged for compressing said deformable conduit therebetween when said removable portion is engaged with said fixed portion, said flow restriction means being operable to selectively set a pressure in said deformable conduit and said fluid handling system;

d. means for connecting a pump means between one of said main inlet and outlet ports and one of said outlet and inlet conduit means for pumping fluid through said control apparatus and said fluid handling system; and

e. fluid pathways, including said deformable fluid conduit, extending between said main inlet and outlet ports and said outlet and inlet conduit means for permitting fluid to flow between said inlet and said outlet ports when said removable portion is coupled to said fluid handling system and said pump means.