Apparatus for removing water from blood

• US 4,713,171 A
• Filed: 01/27/1984
• Issued: 12/15/1987
• Est. Priority Date: 01/28/1983
• Status: Expired due to Term

• Current Assignee: Fresenius AG (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius AG (Fresenius SE & Co. KGaA)
• Inventors: Polaschegg, Hans-Dietrich
• Primary Examiner(s): Richman, Barry S.
• Assistant Examiner(s): Delahunty, C. M.
• Application Number:
  US06/574,492
• Time in Patent Office: 1,418 Days
• Field of Search: 210/40, 210/321.1-321.3, 210/929, 210/433.2, 210/109, 210/110, 210/257.2, 604/4, 604/5, 604/6, 604/27, 604/28, 604/29, 604/30, 604/31, 128/DIG. 3, 422/45, 422/48, 422/44
• US Class Current: 210/110
• 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• CPC Class Codes: A61M 1/302 having a reservoir for withdrawn untreated blood
• CPC Class Codes: A61M 1/3444 in which the collected ultra-filtrate expels an equal volume of substitution fluid from a reservoir
• CPC Class Codes: A61M 1/3606 Arrangements for blood-volume reduction of extra-corporeal circuits
• CPC Class Codes: A61M 1/36222 Details related to the interface between cassette and machine
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/362264 the filter being a blood filter
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/3643 Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3646 Expelling the residual body fluid after use, e.g. back to the body
• CPC Class Codes: A61M 1/3647 with recirculation of the priming solution
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/37 Haemodialysis, haemofiltration or diafiltration
• CPC Class Codes: A61M 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/43 using vacuum at the blood pump, e.g. to accelerate filling
• CPC Class Codes: A61M 60/853 the valve being formed by a flexible tube element which is clamped for restricting the flow
• CPC Class Codes: Y10S 210/929 Hemoultrafiltrate volume measurement or control processes

Abstract

Apparatus for removing water from blood, advantageously by the single-needle method, in which by means of an air-operated bellows pump blood is sucked into an expandable pump chamber and thereafter water is forced into a hemofilter and collected in an ultrafiltrate measuring chamber to which a collecting bag is connected. The inlet and the outlet of the ultrafiltrate measuring chamber to which a collecting bag is connected. The inlet and the outlet of the ultrafiltrate measuring chamber can be opened and closed by clamps controlled in opposite phase and the amount of ultrafiltrate collected in the ultrafiltrate measuring chamber can be controlled and determined. The ultrafiltrate measuring chamber is divided by a hose-like wall into two chamber portions, one chamber portion receiving filtrate and the other chamber portion being adapted in a preferred embodiment to receive infusion solution. Thus, the infusion solution can be proportioned and supplied to the patient in volume equivalent manner.

Claims

1. In an apparatus for removing water from blood including an extracorporeal circulation circuit, said extracorporeal circulation circuit having a blood inlet side and a blood outlet side, a supply line on the blood inlet side and having an upstream end and a downstream end, an offtake line on the blood outlet side and having an upstream end and a downstream end, and a filter having a filtrate side and a blood side, said filter being connected to said downstream end of said supply line and said upstream end of said offtake line, said upstream end of said supply line and said downstream end of said offtake line being connected to at least one blood connection, said supply line including therein a blood pump, a first clamp disposed upstream of said blood pump and a second clamp disposed downstream of said blood pump, said offtake line further including therein a third clamp, the improvement comprising:

a filtrate connection (38) on said filtrate side connected to said filter (32);

an inlet tube (54) connected to said filtrate connection (38);

means for limiting the volume of water removed from blood in the circuit in one machine cycle to a predetermined volume V₂, said limiting means comprising an ultrafiltrate measuring chamber (56), said ultrafiltrate measuring chamber having an inlet connection coupled to said inlet tube (54) and an outlet connection, said ultrafiltrate measuring chamber (56) being coupled at its inlet connection through said inlet tube (54) to said filtrate connection and having a restricted maximum intake volume V₂ ;

an inlet tube (70) coupled to said outlet connection;

a fourth clamp (58) on said inlet tube (54) and a fifth clamp (74) on said outlet tube (70); and

control means (126) coupled to said first clamp, to said second clamp, to said third clamp, to said fourth clamp and to said fifth clamp, said control means (126) being operative to open and close said first clamp and said second clamp in opposition to one another, to open and close said third clamp in synchronism with said second clamp, to open and close said fourth clamp in synchronism with said second clamp, and to open and close said fifth clamp in synchronism with said third clamp, said control means being presettable to actuate said clamps (46, 48, 50, 58,

     74) during a treatment to specify total amounts of fluid to be withdrawn from a patient through said ultrafiltrate measuring chamber;

and wherein said blood pump includes a pump chamber (20) in said extracorporeal circulation circuit, the maximum intake volume V₁ of the pump chamber (20) and the maximum intake volume V₂ of the ultrafiltrate measuring chamber (56) are in a ratio of between 5;

1 and 2;

1, thereby controlling the ratio of the amount of blood pumped in a machine cycle to the amount of water removed in a machine cycle.

2. Apparatus according to claim 1 wherein said inlet tube (54) further comprises a vent tube (60) sealed with a hydrophobic microporous bacteria blocking membrane (62).

3. Apparatus according to claim 1 further comprising an air separator (42) disposed downstream of the filter (32), said air separator (42) being vented via a hydrophobic microporous bacteria-blocking membrane (136).

4. Apparatus according to claim 1, further including a throttle means downstream of said third clamp (50), and wherein said control means (126) is constructed and arranged to set said throttle means (52) to establish a predetermined excess pressure in the extracorporeal circulation circuit between the first clamp (46) and the throttling means (52).

5. The apparatus according to claim 1 wherein said ratio of the maximum intake volume V₁ and the maximum intake volume V₂ is 3:

1.

6. Apparatus according to claim 1, further comprising a collecting bag (72) coupled to said outlet tube (70) from said ultrafiltrate measuring chamber.

7. Apparatus according to claim 6, including a subsystem comprising a cassette (158) detachably connectable to said at least one blood connection and to at least said collecting bag wherein said cassette has positioned and arranged therein at least the filter (32) and the filtrate measuring chamber (56), and wherein ends of said supply line, said offtake line and said outlet tube are positioned and arranged to provide fluid coupling from the cassette (158).

8. Apparatus according to claim 6, wherein said ultrafiltrate measuring chamber (56) is divided by an elastic wall (68) into a first chamber portion (64) in flow connection with said filter (32) and said collecting bag (72) and a second chamber portion (66).

9. Apparatus according to claim 8, wherein the elastic wall (68) is made in hose-form and its inner volume can be increased at least by a factor of 5 by expansion of the wall.

10. Apparatus according to claim 6, further including an air separator chamber (42) in said offtake line (40), a throttling means (142) in said offtake line (40) between said filter (32) and said air separator (42) and an infusion bag (146) in fluid communication with said air separator (42) and wherein said control means (126) is coupled to said throttling means (52) to constrict said offtake line (40) in a controlled manner.

11. Apparatus according to claim 10, wherein said infusion bag is coupled to an outer chamber portion (66) of said ultrafiltrate measuring chamber (56) via a first flexible tube (144) and wherein said outer chamber portion (66) is also coupled to said air separator (42) via a second flexible tube (150), said apparatus further including a sixth clamp (148) connected to selectively block and unblock said first flexible tube (144) and a seventh clamp (154) connected to selectively block and unblock said second flexible tube (150) and wherein said control means 126 is constructed and arranged to open and close said sixth clamp (148) synchronously with said first and fifth clamps (46 and 74) and said control means (126) is constructed and arranged to open and close said seventh clamp in opposite phase to said sixth clamp 150.

12. Apparatus according to claim 11, including a subsystem comprising a cassette (158) detachably connectable to said at least one blood connection and to at least said collecting bag, wherein said cassette has positioned and arranged therein at least the filter (32), the filtrate measuring chamber (56) and the air separator (42) and wherein ends of said supply line, said offtake line and said outlet tube are positioned and arranged to provide fluid coupling from the cassette (158), and wherein the cassette (158) further has positioned and arranged therein means for coupling said air separator (42) with said infusion bag, said coupling means projecting from the cassette (158).

13. Apparatus according to claim 1, wherein said pump chamber (20) has a means defining an inner pump chamber portion (22) formed therein, said means defining a pump chamber portion being positioned and arranged in said supply line of said extracorporeal circulation circuit so that blood can be supplied into the pump chamber portion (22) and expelled therefrom in discrete amounts controlled by maximum maximum intake volume V₁ of said pump chamber (20). and wherein said control means (126) specifies total amount of fluid withdrawn from a patient by actuating said clamps a specified number of times.

14. Apparatus according to claim 13, wherein said blood pump includes an air-driven bellows pump (28), operatively connected to said pump chamber (20) to supply an actuating fluid thereto, said bellows pump having a working volume which is greater than the maximum intake volume of the pump chamber (20).

15. Apparatus according to claim 14, wherein the working volume of said bellows pump (28) is more than 20% greater than the maximum intake volume of said pump chamber 20.

16. Apparatus according to claim 13, wherein said bellows pump (20) is pressure controlled.

17. Apparatus according to claim 16, further including a pressure sensor (120) positioned and arranged to measure pressure of said bellows pump and wherein said bellows pump (28) can be switched and monitored under the control of said pressure sensor (120).

18. Apparatus according to claim 16, further including a vacuum valve (122) and an excess pressure valve (124) positioned and arranged to regulate pressure in said bellows pump and wherein said bellows pump (28) can be set to a predetermined partial vacuum or excess pressure by said vacuum valve (122) and said excess pressure valve (124).

19. Apparatus according to claim 18, wherein said bellows pump (28), said pressure sensor (120), said vacuum valve (122) and said excess pressure valve (124) are connected to said control means (126) for automatic control of said extracorporeal circulation circuit.

20. In an apparatus for removing water from blood including an arteriovenous extracorporeal circulation circuit, said extracorporeal circulation circuit having a blood inlet side and a blood outlet side, a supply line on the blood inlet side and having an upstream end and a downstream end, and offtake line on the blood outlet side and having an upstream end and a downstream end, and a filter which is connected to said downstream end of said supply line and said upstream end of said offtake line, said upstream end of said supply line and said downstream end of said offtake line being connected to at least one blood connection, said supply line including a therein a blood pump, a first valve means disposed upstream of said blood pump and a second valve means disposed downstream of said blood pump, said offtake line further including therein a third valve means, said filter (32) having a filtrate side and a filtrate connection (38), the improvement comprising:

means for limiting the volume of water removed from blood in the circuit in one machine cycle to a predetermined volume V₂, said limiting means including an ultrafiltrate measuring chamber (56), said ultrafiltrate measuring chamber (56) having an outlet conduit (70) and an inlet conduit (54) and being coupled through said inlet conduit (54) to said filtrate connection, said ultrafiltrate measuring chamber (56) having a restricted maximum intake volume V₂ ;

a fourth valve means (58) in said inlet conduit (54) and a fifth valve means (74) in said outlet conduit (70);

control means (126) coupled to said first valve means, to said second valve means, to said third valve means, to said fourth valve means and to said fifth valve means, said control means (126) being operative to open and close said first valve means and said second valve means in opposition to one another, to open and close said third valve means in synchronism with said second valve means, to open and close said fourth valve means in synchronism with said second valve means, and to open and close said fifth valve means in synchronism with said third valve means, said control means being presettable to actuate said valve means (46, 48, 50, 58,

     74) during a treatment to specify total amounts of fluid to be withdrawn from a patient through said ultrafiltrate measuring chamber;

an air separator chamber (42) in said offtake line (40);

a throttling means (142) in said offtake line (40) between said filter 32 and said air separator (42);

an infusion bag (146) in fluid communication with said air separator (42);

wherein said control means (126) is coupled to said throttling means (52) to constrict said offtake line (40) in a controlled manner, and wherein said blood pump includes a pump chamber (20) in said supply line of said extracorporeal circulation circuit and the maximum intake volume V₁ of the pump chamber (20) and the maximum intake volume V₂ of the ultrafiltrate measuring chamber (56) are in a ratio of between 5;

1 and 2;

1, thereby controlling the ratio of the amount of blood pumped in a machine cycle to the amount of water removed in a machine cycle.

21. Apparatus according to claim 20, wherein said infusion bag is coupled to an outer chamber portion (66) of said ultrafiltrate measuring chamber (56) via a first flexible tube (144) and wherein said outer chamber portion (66) is also coupled to said air separator (42) via a second flexible tube (150) said apparatus further including a sixth valve means (148) connected to selectively block and unblock said first flexible tube (144) and a seventh valve means (154) connected to selectively block and unblock said second flexible tube (150) and wherein said control means 126 is constructed and arranged to open and close said sixth valve means (148) synchronously with said first and fifth valve means (46 and 74) and said control means (126) is constructed and arranged to open and close said seventh valve means in opposite phase to said sixth valve means (150).

22. The apparatus according to claim 20 wherein said ratio of the maximum intake volume V₁ and the maximum intake volume V₂ is 3:

1.