VALVE ARRANGEMENT FOR USE IN AN EXTRACORPOREAL BLOOD CIRCUIT AND METHOD

• US 20130110028A1
• Filed: 05/16/2011
• Published: 05/02/2013
• Est. Priority Date: 05/18/2010
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius SE & Co. KGaA)
• Inventors: Herrenbauer, Michael, Wehmeyer, Wolfgang, Bachmann, Angelika
• Granted Patent: US 9,913,939 B2
• Time in Patent Office: Days
• US Class Current: 604/6.1
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• 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 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/3607 Regulation parameters
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• 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 1/3644 Mode of operation
• 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 1/3649 using dialysate as priming or rinsing liquid
• CPC Class Codes: A61M 1/365 through membranes, e.g. by inverted trans-membrane pressure [TMP]
• CPC Class Codes: A61M 2039/0018 designed for flushing a line, e.g. by a by-pass
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405

Abstract

The present invention relates to a valve arrangement for use in an extracorporeal blood circuit having at least one arterial blood line and at least one venous blood line, the valve arrangement having at least one first valve arranged in the arterial blood line, a second valve arranged in the venous blood line, a fourth valve arranged in a first arteriovenous connection line between the arterial blood line of the circuit and the venous blood line of the circuit, and a fifth valve arranged in a second arteriovenous connection line between the arterial blood line and the venous blood line; and/or a third valve arranged for establishing a fluid connection in a blood line between the arterial blood line and the venous blood line of the circuit; and/or a sixth valve arranged between a blood treatment device and an air venting device of the circuit.

Claims

1-33. -33. (canceled)

34. A system having a valve arrangement for use in an extracorporeal blood circuit comprising at least one arterial blood line and at least one venous blood line, wherein the valve arrangement comprises at least:

a first valve which is arranged in the arterial blood line, a second valve which is arranged in the venous blood line, a fourth valve which is arranged in a first arteriovenous connection line between the arterial blood line of the extracorporeal blood circuit and the venous blood line of the extracorporeal blood circuit, and a fifth valve which is arranged in a second arteriovenous connection line between the arterial blood line and the venous blood line; and

/or

a third valve which is arranged for establishing a fluid connection in a blood line between the arterial blood line and the venous blood line of the extracorporeal blood circuit; and

/or

a sixth valve which is arranged between a blood treatment device and an air venting device of the extracorporeal blood circuit.

35. The system according to claim 34, comprising the first valve, the second valve, the third valve, the fourth valve and the fifth valve.

36. The system according to claim 34, comprising the sixth valve.

37. The system according to claim 34, further comprising a ventilation valve for establishing a connection between an interior of the extracorporeal blood circuit and an exterior thereof.

38. The system according to claim 37, wherein some or all of the valves of the group comprising the first, the second, the third, the fourth, the fifth and the sixth valve as well as the ventilation valve are active or controlled valves.

39. The system according to claim 34, configured and provided for being used with a non-occluding pump for conveying the fluid to be treated.

40. The system according to claim 37, further comprising a device for controlling or regulating the valve function of all or some of the valves of the group comprising the first, the second, the third, the fourth, the fifth and the sixth valve as well as the ventilation valve.

41. The system according to claim 34, wherein at least the first, the second, the fourth and the fifth valve are present in a common support material.

42. The system according to claim 34, wherein at least the third valve is a phantom valve.

43. The system according to claim 34, further comprising sensors for detecting an optical density, an arterial or venous pressure and/or air inclusions.

44. The system according to claim 34, further comprising a device for controlling or regulating a flow difference between the flow of the blood pump and the flow of the dialysate pump, wherein the flow difference is generated by a system for operating a blood pump and/or a dialysate pump.

45. The system according to claim 34, wherein at least two or more valves are designed or embodied as a segment of a rotational element such as to be switchable by rotation of the rotational element.

46. The system of claim 34, wherein the system is configured as a blood tubing set.

47. The system of claim 34, wherein the system is configured as a blood cassette.

48. The system of claim 34, wherein the system is configured as a treatment apparatus for treating medical fluids, wherein the system further comprises at least one controlling device and actuators that are provided and configured for controlling or regulating the valve arrangement.

49. The system according to claim 48, wherein the system is configured as an apparatus for extracorporeal blood treatment.

50. A method for handling an extracorporeal blood circuit, comprising the step of using the system according to claim 34.

51. The method according to claim 50, further comprising the step of connecting the arterial blood line with the venous blood line for establishing a fluid communication there by opening the third valve,

wherein said step of said step of connecting the arterial blood line with the venous blood line short-circuits the arterial blood line and the venous blood line of the extracorporeal blood circuit.

52. The method according to claim 50, said method being for filling the extracorporeal blood circuit or parts thereof using an occluding blood pump, said method further comprising at least one step selected from the group consisting of:

a) connecting the extracorporeal blood circuit with an occluding blood pump;

b) connecting a dialysate circuit with a dialysate pump;

c) filling the dialysate circuit with fluid;

d) conveying a flow by use of the blood pump in a direction opposite to the usual flow direction of an extracorporeal blood treatment;

e) conveying a flow by use of the dialysate pump, which is larger than the flow conveyed or generated by utilization of the blood pump, across the membrane of a filter of a blood treatment apparatus while the first valve and the second valve are open;

f) opening a ventilation valve;

g) stopping the dialysate pump or setting a neutral balance in a balancing system and closing the ventilation valve;

h) circulating the fluid within the extracorporeal blood circuit in the usual flow direction by use of the blood pump while the first and the second valve are still open; and

i) removing air from the extracorporeal blood circuit by use of an air separation chamber by setting a positive balance in the balancing system while the ventilation valve is open.

53. The method according to claim 52, further comprising the step of:

j) determining the flows of the dialysate pump and the blood pump such that venting a blood line between a filter of a blood treatment apparatus and the air separation chamber, the arterial blood line as well as the venous blood line is achieved also.

54. The method according to claim 52, comprising the further step of:

k) performing the method steps g) to i) according to claim 52 for several times.

55. The method according to claim 50, said method being for filling the extracorporeal blood circuit or parts thereof using a non-occluding blood pump, said method further comprising at least one step selected from the group consisting of:

a) short-circuiting patient connectors;

b) introducing fluid from a dialysate circuit into the extracorporeal blood circuit by setting a positive balance;

c) stopping the blood pump;

d) closing a sixth valve, opening the first and the second valves as well as the ventilation valve;

e) closing the third, the fourth and the fifth valve, as far as they are present;

f) pressing fluid out of the dialysate compartment across the membrane of the filter onto the blood side of the filter;

g) closing the first and the second valve and opening the sixth valve after having detected a fluid level in the air separation chamber;

h) stopping the dialysate pump and/or setting the balancing system to a neutral balance;

i) closing the ventilation valve;

j) circulating the fluid within the extracorporeal blood circuit by use of the blood pump while the first and the second valve and the sixth valve are open;

k) setting a positive balance in the balancing system with the flow rate of a dialysate being greater than zero;

l) opening the ventilation valve; and

m) stopping the blood pump.

56. The method according to claim 55, comprising the further step of:

n) performing the method steps h) to m) according to claim 55 for several times.

57. The method according to claim 34, said method being for flushing the extracorporeal blood circuit or parts thereof while no flow disturbance is present in one of the blood lines, said method further comprising at least one step selected from the group consisting of:

a) conveying a flow by use of the blood pump in a direction opposite to the usual flow direction while the arterial and the venous blood line are connected with the vascular access of the patient;

b) conveying fluid by use of the dialysate pump with a flow out of the dialysate circuit, wherein the flow is larger than a flow conveyed by use of the blood pump, across the membrane of a filter of a blood treatment apparatus into the extracorporeal blood circuit;

c) opening the first, the second and the sixth valve while the third, the fourth and the fifth valve as well as the ventilation valve are or remain being closed;

d) determining, by use of sensors, when or that fluid displaces or has sufficiently displaced blood out of certain parts of the extracorporeal blood circuit;

e) controlling or regulating a blood return process according to the amount of the flow difference between the flow of the blood pump and the flow of the dialysate pump or by switching the first and the second valve;

f) stopping the non-occluding blood pump; and

g) switching the first and the second valve in order to prompt the blood return to the patient via a selected one of the blood lines.

62. A non-transitory computer-readable storage medium with an executable program stored thereon, wherein the program instructs a programmable computer system to execute the steps of the method according to claim 50.