System and Method for Delivery of Regional Citrate Anticoagulation to Extracorporeal Blood Circuits
First Claim
1. A system for regional citrate anticoagulation in an extracorporeal blood circuit including an arterial blood line arranged to be connected to a vascular access for withdrawing blood from a patient and a venous blood line arranged to be connected to the vascular access for returning blood to the patient, the system comprising:
- a hemofilter in fluid communication with the arterial and venous blood lines;
a first pre-filter infusion line connected to the arterial blood line upstream from the hemofilter for infusing a first pre-filter infusion solution comprising a citrate anticoagulant-containing solution into blood in the arterial blood line;
a second pre-filter infusion line connected to the arterial blood line upstream from the hemofilter for infusing a second pre-filter infusion solution comprising a first bicarbonate-containing solution into blood in the arterial blood line;
a post-filter infusion line connected to the venous blood line downstream from the hemofilter for infusing a post-filter infusion solution comprising a second bicarbonate-containing solution into blood in the venous blood line; and
an additional infusion line connected to the venous blood line downstream from a connection of the post-filter infusion line for infusing an additional infusion solution comprising a calcium- and magnesium-containing solution into blood in the venous blood line.
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Accused Products
Abstract
The present invention includes a comprehensive replacement fluid system and method for the delivery of regional citrate anticoagulation (RCA) to extracorporeal blood circuits, wherein the system may include an online clearance monitor (OCM) and a circuit effluent online sensor system (OSS) for the continuous determination of patient plasma content of ultrafilterable solutes.
132 Citations
89 Claims
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1. A system for regional citrate anticoagulation in an extracorporeal blood circuit including an arterial blood line arranged to be connected to a vascular access for withdrawing blood from a patient and a venous blood line arranged to be connected to the vascular access for returning blood to the patient, the system comprising:
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a hemofilter in fluid communication with the arterial and venous blood lines;
a first pre-filter infusion line connected to the arterial blood line upstream from the hemofilter for infusing a first pre-filter infusion solution comprising a citrate anticoagulant-containing solution into blood in the arterial blood line;
a second pre-filter infusion line connected to the arterial blood line upstream from the hemofilter for infusing a second pre-filter infusion solution comprising a first bicarbonate-containing solution into blood in the arterial blood line;
a post-filter infusion line connected to the venous blood line downstream from the hemofilter for infusing a post-filter infusion solution comprising a second bicarbonate-containing solution into blood in the venous blood line; and
an additional infusion line connected to the venous blood line downstream from a connection of the post-filter infusion line for infusing an additional infusion solution comprising a calcium- and magnesium-containing solution into blood in the venous blood line. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A method for regional citrate anticoagulation in an extracorporeal blood circuit including an arterial blood line arranged to be connected to a vascular access for withdrawing blood from a patient and a venous blood line arranged to be connected to the vascular access for returning blood to the patient, the method comprising:
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providing a hemofilter in fluid communication with the arterial and venous blood lines;
infusing a first pre-filter infusion solution comprising a citrate anticoagulant-containing solution into blood in the arterial blood line upstream from the hemofilter;
infusing a second pre-filter infusion solution comprising a first bicarbonate-containing solution into blood in the arterial blood line upstream from the hemofilter;
infusing a post-filter infusion solution comprising a second bicarbonate-containing solution into blood in the venous blood line downstream from the hemofilter; and
infusing an additional infusion solution comprising a calcium- and magnesium-containing solution into blood in the venous blood line downstream from a connection of the post-filter infusion solution. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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33. A system for regional citrate anticoagulation in an extracorporeal blood circuit including an arterial blood line arranged to be connected to a vascular access for withdrawing blood from a patient and a venous blood line arranged to be connected to the vascular access for returning blood to the patient, the system comprising:
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a hemofilter in fluid communication with the arterial and venous blood lines;
a pre-filter infusion line connected to the arterial blood line upstream from the hemofilter for infusing a pre-filter infusion solution comprising a citrate anticoagulant-containing solution into blood in the arterial blood line;
a post-filter infusion line connected to the venous blood line downstream from the hemofilter for infusing a post-filter infusion solution comprising a bicarbonate-containing solution into blood in the venous blood line; and
an additional infusion line connected to the venous blood line downstream from the post-dilution connection for infusing an additional infusion solution comprising a calcium- and magnesium-containing solution into blood in the venous blood line, wherein at least one of the pre-filter infusion solution and the additional infusion solution contain dextrose at a pH of about 2-2.5.
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34. A system for regional citrate anticoagulation in an extracorporeal blood circuit including an arterial blood line arranged to be connected to a vascular access for withdrawing blood from a patient and a venous blood line arranged to be connected to the vascular access for returning blood to the patient, the system comprising:
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a hemofilter in fluid communication with the arterial and venous blood lines;
a pre-filter infusion line connected to the arterial blood line upstream from the hemofilter for infusing a pre-filter infusion solution comprising a citrate anticoagulant-containing solution into blood in the arterial blood line; and
a post-filter infusion line connected to the venous blood line downstream from the hemofilter for infusing a post-filter infusion solution comprising a bicarbonate-, calcium-, and magnesium-containing solution into blood in the venous blood line, wherein at least one of the pre-filter infusion solution and the post-filter infusion solution contain dextrose at a pH of about 2-2.5.
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35. A system for regional citrate anticoagulation in an extracorporeal blood circuit including an arterial blood line arranged to be connected to a vascular access for withdrawing blood from a patient and a venous blood line arranged to be connected to the vascular access catheter for returning blood to the patient, the system comprising:
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a hemofilter in fluid communication with the arterial and venous blood lines; and
a pre-filter infusion line connected to the arterial blood line upstream from the hemofilter for infusing a pre-filter infusion solution comprising a citrate anticoagulant-, calcium-, magnesium- and dextrose-containing solution into blood in the arterial blood line, the pre-filter infusion solution containing dextrose at a pH of about 2-2.5.
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36. A system for regional citrate anticoagulation and online replacement fluid generation in an extracorporeal blood circuit including an arterial blood line arranged to be connected to a vascular access for withdrawing blood from a patient and a venous blood line arranged to be connected to the vascular access for returning blood to the patient, the system comprising:
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a hemofilter in fluid communication with the arterial and venous blood lines;
a pre-filter infusion line connected to the arterial blood line upstream from the hemofilter for infusing a pre-filter infusion solution comprising a citrate anticoagulant-containing solution into blood in the arterial blood line;
a volumetric balancing chamber operably connected to the hemofilter, the arterial blood line, and the venous blood line for providing balancing of a filter effluent fluid with infusions into the blood circuit of replacement fluids generated online from concentrates; and
a post-filter infusion line connected to the venous blood line downstream from the hemofilter for infusing a post-filter infusion solution comprising calcium- and magnesium-containing solution into blood in the venous blood line, wherein at least one of the pre-filter infusion solution and the post-filter infusion solution contain dextrose at a pH of about 2-2.5. - View Dependent Claims (37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49)
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50. A method for regional citrate anticoagulation and online replacement fluid generation in an extracorporeal blood circuit including an arterial blood line arranged to be connected to a vascular access for withdrawing blood from a patient and a venous blood line arranged to be connected to the vascular access for returning blood to the patient, the method comprising:
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providing a hemofilter in fluid communication with the arterial and venous blood lines;
infusing a pre-filter infusion solution comprising a citrate anticoagulant-containing solution into blood in the arterial blood line upstream from the hemofilter;
providing replacement fluids to the circuit from acid and base concentrates; and
infusing a post-filter infusion solution comprising a calcium- and magnesium-containing solution into blood into the venous blood line downstream from the hemofilter, wherein at least one of the pre-filter infusion solution and the post-filter infusion solution contain dextrose at a pH of about 2-2.5. - View Dependent Claims (51, 52, 53, 54, 55, 56)
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57. A system for regional citrate anticoagulation in an extracorporeal blood circuit including an arterial blood line arranged to be connected to a vascular access for withdrawing blood from a patient and a venous blood line arranged to be connected to the vascular access for returning blood to the patient, the system comprising:
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a hemofilter in fluid communication with the arterial and venous blood lines;
a pre-filter infusion line connected to the arterial blood line upstream from the hemofilter for infusing a pre-filter infusion solution comprising a citrate anticoagulant-containing solution into blood in the arterial blood line;
a single concentrate chamber for generating a replacement fluid for the circuit; and
a post-filter infusion line connected to the venous blood line downstream from the hemofilter for infusing a post-filter solution comprising a calcium- and magnesium-containing solution into blood in the venous blood line, wherein at least one of the pre-filter infusion solution and the post-filter infusion solution contain dextrose at a pH of about 2-2.5.
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- 58. A concentrated acid citrate anticoagulant solution for regional citrate anticoagulation in an extracorporeal blood circuit, the solution comprising about 200 mmol/L sodium chloride, and about 140 mmol/L total citrate comprising about 120 mmol/L trisodium (basic) citrate and about 20 mmol/L citric acid.
- 62. A concentrated basic citrate anticoagulant solution for regional citrate anticoagulation in an extracorporeal blood circuit, the solution comprising about 140 mmol/L sodium bicarbonate, and about 140 mmol/L total citrate comprising about 140 mmol/L trisodium (basic) citrate.
- 66. A pre-filter replacement solution for regional citrate anticoagulation in an extracorporeal blood circuit, the solution comprising about 135-150 mmol/L sodium, about 0-4 mmol/L potassium, about 4-16.67 mmol/L basic citrate, about 0-35 mmol/L bicarbonate, about 0-10 mmol/L acid citrate, about 85-130 mmol/L chloride, about 0-4.0 mmol/L calcium, about 0-2.0 mmol/L magnesium, about 0.0-6.0 mmol/L phosphate, and about 0-100.0 mmol/L dextrose, wherein the dextrose is provided in a concentrated form and pH-adjusted to about 2-2.5 in a separate chamber.
- 68. A post-filter replacement solution for an extracorporeal circuit, the solution comprising about 120-150 mmol/L sodium, about 0-4 mmol/L potassium, about 20-60 mmol/L bicarbonate, about 85-120 mmol/L chloride, about 0-4 mmol/L calcium, about 0-2.0 mmol/L magnesium, about 0-3 mmol/L phosphate, and about 0-25.0 mmol/L dextrose, wherein the dextrose is provided in a concentrated form and pH-adjusted to about 2-2.5 in a separate chamber.
- 75. A formulation including at least one of solute concentrates and solute powders for generating a replacement solution for an extracorporeal blood circuit, the generated replacement solution comprising about 120-150 mmol/L sodium, about 2-4.0 mmol/L potassium, about 80-130 mmol/L chloride, about 20-40 mmol/L bicarbonate, about 0-3 mmol/L calcium, about 0-1.5 mmol/L magnesium, about 0-1.5 mmol/L phosphate, about 0-4 mmol/L acetic/lactic acid, and about 0-11 mmol/L dextrose.
- 85. An infusion solution for an extracorporeal blood circuit, the solution comprising about 10-1000 mmol/L calcium, about 0-500 mmol/L magnesium, about 0-2000 mmol/L sodium, about 28-5000 mmol/L chloride, about 0-10 mmol/L hydrochloric acid, about 0-50 mmol/L phosphate, and about 0-1000 mmol/L dextrose, wherein the dextrose is provided in a concentrated form and pH-adjusted to about 2-2.5.
Specification