INFUSION APPARATUS

• US 20100280430A1
• Filed: 10/04/2007
• Published: 11/04/2010
• Est. Priority Date: 10/04/2007
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Sakota, Ranko, Franzoni, Giuseppe, Caleffi, Luca
• Granted Patent: US 8,728,020 B2
• Time in Patent Office: Days
• US Class Current: 604/5.01
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3434 with pre-dilution and post-dilution
• CPC Class Codes: A61M 1/3437 downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 2005/1402 Priming
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: A61M 5/1684 by detecting the amount of infusate remaining, e.g. signalling end of infusion
• CPC Class Codes: A61M 5/16845 by weight
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/36 with means for eliminating or preventing injection or infusion of air into body dialysis systems, blood oxygenators A61M1/14; haemofiltration equipment A61M1/34; automatic tube cut-off A61M39/281

Abstract

In an infusion apparatus, an infusion line (4) connects a container (2) of an infusion fluid to an extracorporeal blood circuit (23). A first valve (6) closes the infusion line downstream of an infusion pump (5). An expansion chamber (9), provided with a pressure sensor (10), is arranged between the infusion pump and the first valve. A second valve (8) closes a vent line (7) of the expansion chamber. The processor closes the first valve when the container is emptied. After replacement with a new and full container, the processor restarts the pump and selectively opens the first valve or the second valve according to the increase in pressure measured in the expansion chamber.

Claims

1-38. -38. (canceled)

39. An infusion apparatus comprising:

at least a batch container containing an infusion fluid;

an infusion line having a first end which is connected to the batch container and a second end which supplies the infusion fluid;

an infusion pump operating on the infusion line for circulation of the infusion fluid from the first end to the second end;

a first valve designed to close the infusion line between the pump and the second end;

a vent line having a first end which is connected to an intermediate tract of the infusion line and a second discharge end, the intermediate tract being arranged between the infusion pump and the first valve;

a second valve designed to close the vent line.

40. The apparatus of claim 39, comprising a gas-liquid separator arranged in the intermediate tract.

41. The apparatus of claim 39, comprising:

a first sensor for emitting a first signal indicating the quantity of liquid in the intermediate tract;

control means which are programmed to receive the first signal and for commanding the first valve and/or the second valve on the basis of the first signal received.

42. The apparatus of claim 41, wherein the first sensor comprises a first pressure sensor for emitting a first pressure signal indicating a pressure in the intermediate tract.

43. The apparatus of claim 39, wherein the control means are programmed to perform a first sequence of stages which comprises:

closing the first valve and/or the second valve;

activating the infusion pump; and

opening the first valve and/or the second valve on the basis of the first signal received.

44. The apparatus of claim 39, wherein the control means are programmed to perform a second sequence of stages which comprises:

closing the first valve and the second valve;

activating the infusion pump;

determining at least a value of pressure change in the intermediate tract; and

opening the first valve or the second valve on the basis of the pressure change value.

45. The apparatus of claim 44, wherein the second sequence of stages comprises a stage of selectively opening the first valve or the second valve according to whether the pressure change value is greater or, respectively, lower than a reference value.

46. The apparatus of claim 44, wherein the pressure change value in the intermediate tract is determined during a predetermined change of another parameter while the pump is activated.

47. The apparatus of claim 46, wherein the another parameter is chosen from a group of parameters comprising the time, volume/weight of fluid displaced by the pump, displacement of a mobile element of the pump, and a weight of the batch container of the infusion fluid.

48. The apparatus of claim 46, wherein the pressure change value is placed in relation with or normalised with respect to the other parameter.

49. The apparatus of claim 44, wherein the second sequence of stages comprises a stage of comparing the pressure change value with a reference value, the stage of opening the first valve or the second valve being performed as a result of the comparison.

50. The apparatus of claim 39, wherein the control means are programmed to perform a third sequence of stages which comprises:

closing the first valve and the second valve, activating the infusion pump, determining at least a volume/weight value of the fluid pumped by the infusion pump, comparing the volume/weight value of the pumped fluid to at least a reference value, and opening the first valve or the second valve according to a result of the comparison.

51. The apparatus of claim 50, wherein the third sequence of stages comprises a stage of selectively opening the first valve or the second valve according to whether the volume/weight value of pumped fluid is lower or, respectively, higher than a reference value.

52. The apparatus of claim 50, wherein the volume/weight value of the fluid pumped in the intermediate tract is determined in relation to a predetermined change in another parameter while the pump is in an activated stage.

53. The apparatus of claim 52, wherein the other parameter is chosen from a group of parameters comprising time, pressure change in the intermediate tract, and volume/weight of the batch container of the infusion fluid.

54. The apparatus of claim 52, wherein the value of the volume/weight of pumped fluid is set in relation to or normalised with respect to the other parameter.

55. The apparatus of claim 50, wherein the third sequence of stages comprises a stage of comparing the volume/weight value of the pumped fluid with a reference value, the stage of opening the first valve or the second valve being performed according to the comparison.

56. The apparatus of claim 39, wherein the control means are programmed to perform a fourth sequence of stages which comprises:

closing the first valve and the second valve, activating the infusion pump, determining at least a relation between a pressure variation in the intermediate tract and a volume/weight of fluid pumped by the infusion pump, comparing the value of the relation to at least a reference value, and opening the first valve or the second valve according to a result of the comparison.

57. The apparatus of claim 39, wherein the control means are programmed to perform a fifth sequence of stages which comprises:

closing the first valve and the second valve, activating the infusion pump, acquiring at least a pressure valve in the intermediate tract, comparing the pressure value to at least a reference value, and opening the first valve or the second valve according to a result of the comparison.

58. The apparatus of claim 39, wherein the control means are programmed to perform stages as follow:

closing the first valve and the second valve;

activating the infusion pump when the first valve and the second valve are closed;

measuring at least a pressure value in the intermediate tract when the infusion pump is or has been activated;

comparing the measured pressure value with a threshold value; and

opening at least one of the first valve and the second valve if the measured pressure value exceeds the threshold value.

59. The apparatus of claim 39, wherein the second end of the vent line is connected to an element selected from a group of elements comprising:

the batch container of the infusion fluid, an initial tract of the infusion line comprised between the batch container and the infusion pump, a hydrophobic filter connected to the atmosphere, an aspiration device, a fluid transport line connected to a fluid chamber of a blood treatment device having a semi-permeable membrane which separates the fluid chamber from a blood chamber, and a used fluid discharge line of a hemo(dia)filtration apparatus.

60. The apparatus of claim 40, wherein the gas-liquid separator comprises an expansion chamber.

61. The apparatus of claim 40, wherein the first end of the vent line is connected with or engaged to a top of the gas-liquid separator.

62. The apparatus of claim 40, wherein the pressure sensor is associated to the gas-liquid separator.

63. The apparatus of claim 39, wherein the second end of the infusion line is connected to an extracorporeal blood circuit of an apparatus for extracorporeal blood treatment.

64. The apparatus of claim 39, comprising a weight sensor which emits a signal indicating a weight of the batch container, the control means being programmed to perform following stages:

opening the first valve, closing the second valve, activating the pump with the first valve open and the second valve closed, acquiring at least a weight value of the batch container, comparing the weight value with a reference weight value, and signalling a faulty situation and/or stopping the pump and/or closing the first valve according to a result of the comparison.

65. The apparatus of claim 64, wherein the reference weight value comprises a weight value of the batch container acquired previously with an aim of assessing whether the weight of the batch container is no longer decreasing, or a predefined value indicating the weight of the empty fluid batch container.

66. The apparatus of claim 39, wherein the control means are programmed to perform a sixth sequence of stages which comprises:

closing the first valve, closing the second valve, activating the pump with the first valve closed and the second valve closed, acquiring at least a pressure value in the intermediate tract while the pump is or has been activated, acquiring at least a value of the pressure change in the intermediate tract, and selectively opening the first valve or the second valve when the pressure value exceeds a threshold value, the selection being performed according to the pressure change value.

67. The apparatus of claim 39, wherein the infusion pump is a volumetric pump.

68. The apparatus of claim 39, wherein the infusion pump is an occlusive pump.

69. The apparatus of claim 39, wherein the pump is predisposed along the infusion line downstream of the batch container.

70. The apparatus of claim 39, comprising a second pressure sensor for emitting a second signal indicating the pressure in an initial tract of infusion line comprised between the batch container and the pump.

71. The apparatus of claim 70, wherein the control means are programmed to perform a seventh sequence of stages which comprises:

acquiring at least a pressure value in the initial tract supplied by the second pressure sensor, comparing the pressure value in the initial tract with a reference value, and signalling a faulty situation and/or stopping the pump and/or closing the first valve according to the comparison.

72. A method for controlling an infusion apparatus comprising stages of:

providing an infusion line having a first end for receiving an infusion fluid and a second end for supplying the infusion fluid;

connecting the infusion line to a pump for circulation of infusion fluid from the first end to the second end;

connecting a first valve to the infusion line between the pump and the second end for closing the line;

connecting a first end of a vent line to an intermediate tract of the infusion line arranged between the pump and the first valve, the vent line having a second discharge end;

connecting a second valve to the vent line for closing the vent line;

providing a first sensor for emitting a first signal of at least a first parameter indicating a liquid level in the intermediate tract;

closing the first valve and/or the second valve;

connecting at least a batch container containing an infusion fluid to the first end of the infusion line;

activating the pump with the first valve closed and/or the second valve closed;

acquiring at least a value of the first parameter in the intermediate tract following the activation of the pump;

comparing the value of the first parameter with a reference value; and

opening the first valve or the second valve according to a result of the comparison.

73. The method of claim 72, wherein the first sensor comprises a pressure sensor.

74. The method of claim 72, comprising stages of:

determining at least a value of the change of the first parameter in the intermediate tract during a predetermined change of another parameter;

comparing the change of the first parameter with a reference value; and

opening the first valve or the second valve according to a result of the comparison.

75. The method of claim 74, wherein the other parameter is chosen from a group of parameters comprising time, volume/weight of fluid pumped by the infusion pump, displacement of a mobile element of the infusion pump, and a weight of the batch container of the infusion fluid.

76. The method of claim 72, comprising stages of:

a) closing the first valve;

b) closing the second valve;

c) activating the pump with the first valve closed and the second valve closed;

d) acquiring at least a value of the first parameter in the intermediate tract while the pump is operating;

e) acquiring at least a value of the change of the first parameter in the intermediate tract;

f) selectively opening the first valve or the second valve when the value of the first parameter reaches a threshold value, the selection being performed according to the value of the change of the first parameter.