System and method for delivery of regional citrate anticoagulation to extracorporeal blood circuits

• US 8,945,036 B2
• Filed: 02/14/2012
• Issued: 02/03/2015
• Est. Priority Date: 02/22/2006
• Status: Expired due to Fees

• Current Assignee: Henry Ford Health System
• Original Assignee: Henry Ford Health System
• Inventors: Szamosfalvi, Balazs, Frinak, Stanley, Yee, Jerry
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US13/372,860
• Publication Number:
  US 20120150090A1
• Time in Patent Office: 1,085 Days
• Field of Search: 210/645, 210/646, 210/739, 210/741, 604/4.01, 604/5.01, 604/5.04, 604/6.09, 604/6.11, 604/6.06, 604/6.07
• US Class Current: 604/6.07
• CPC Class Codes: A61M 1/3406 Physical characteristics of the filtrate, e.g. urea
• CPC Class Codes: A61M 1/3413 Diafiltration
• 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 1/3441 Substitution rate control as a function of the ultrafiltration rate
• CPC Class Codes: A61M 1/3455 Substitution fluids
• CPC Class Codes: A61M 1/3458 having electrolytes not present in the dialysate
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/3658 Indicating the amount of purified blood recirculating in the fistula or shunt
• CPC Class Codes: A61M 1/3672 Means preventing coagulation
• CPC Class Codes: A61M 1/3675 Deactivation
• CPC Class Codes: A61M 2202/0486 Glucose
• CPC Class Codes: A61M 2205/3306 Optical measuring means

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.

Claims

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;

an effluent fluid line in fluid communication with the hemofilter for carrying effluent fluid away from the hemofilter;

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;

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; and

at least one arterial hematocrit sensor operably connected to the arterial blood line upstream from the second pre-filter infusion line for providing circuit plasma flow in real time for controlling at least one of hemofilter single pass citrate extraction and an infusion rate of the additional infusion solution.

2. The system of claim 1, further comprising a second hematocrit sensor operably connected to the blood circuit downstream from the second pre-filter infusion line and upstream from the additional infusion line.

3. The system of claim 1, further comprising a second arterial hematocrit sensor operably connected to the arterial blood line downstream from the second pre-filter infusion line and upstream from the hemofilter.

4. The system of claim 3, wherein the first and second arterial hematocrit sensors determine a degree of hemodilution with the second pre-filter infusion solution infusing at a known rate, and allow calculation of delivered blood flow in the arterial blood line upstream from the hemofilter in an automated manner for at least one of continuously adjusting dosing of the first pre-filter infusion solution to achieve a desired citrate to plasma flow ratio and controlling hemofilter single pass citrate extraction and the infusion rate of the additional infusion solution.

5. The system of claim 3, further comprising a first venous hematocrit sensor operably connected to the venous blood line downstream from the hemofilter and upstream from the post-filter infusion line, and a second venous hematocrit sensor operably connected to the venous blood line downstream from the post-filter infusion line and upstream from the additional infusion line.

6. The system of claim 5, wherein the first and second venous hematocrit sensors determine a degree of hemodilution with the post-filter infusion solution infusing at a known rate, and allow calculation of delivered blood flow in the venous blood line downstream from the hemofilter in an automated manner for at least one of continuously adjusting dosing of the first pre-filter infusion solution to achieve a desired citrate to plasma flow ratio and controlling hemofilter single pass citrate extraction and the infusion rate of the additional infusion solution.

7. The system of claim 5, wherein a programmed change in a flow of at least one of the second pre-filter infusion solution, the post-filter infusion solution, and the filter effluent fluid results in a programmed change in venous blood line hematocrit, wherein the programmed change in venous blood line hematocrit is detected by at least one of the first and second venous hematocrit sensors, the subsequent change in arterial blood line hematocrit due to blood access recirculation is detected by at least one of the first and second arterial hematocrit sensors, and blood access recirculation is calculated from the detected hematocrit changes in an automated manner.

8. The system of claim 1, further comprising a secondary extracorporeal blood treatment device operably connected downstream from the first pre-filter infusion line and upstream from the additional infusion line.

9. The system of claim 1, wherein at least one of the second pre-filter infusion solution and the post-filter infusion solution has a bicarbonate concentration of about 20-60 mmol/L.

10. The system of claim 1, wherein the first pre-filter infusion solution comprises a basic citrate to acid citrate ratio of about 2:

1 to 8;

1.

11. The system of claim 1, wherein the second pre-filter infusion solution and the post-filter infusion solution are essentially free of calcium and magnesium.

12. The system of claim 1, further comprising a control program for coordinating and monitoring the operation of the system, the control program monitoring plasma flow online to calculate an infusion rate of the first pre-filter infusion solution and the second pre-filter and post-filter infusion solutions necessary to keep the hemofilter single pass citrate extraction above about 66%.

13. The system of claim 1, further comprising a solute sensor operably connected to the effluent fluid line for measuring a solute concentration in the filter effluent fluid.

14. 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:

providing a hemofilter in fluid communication with the arterial and venous blood lines;

providing an effluent fluid line in communication with the hemofilter for carrying a filter effluent fluid away from the hemofilter;

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;

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; and

sensing hematocrit on the arterial blood line upstream from the second pre-filter infusion line to provide circuit plasma flow in real time for controlling at least one of hemofilter single pass citrate extraction and an infusion rate of the additional infusion solution.

15. The method of claim 14, further comprising sensing hematocrit on the arterial blood line downstream from the first pre-filter infusion line and both upstream and downstream from the second pre-filter infusion line to determine a degree of hemodilution with the second pre-filter infusion, and calculating delivered blood flow to the hemofilter for at least one of continuously adjusting dosing of the first pre-filter infusion solution to achieve a desired citrate to plasma flow ratio and controlling the hemofilter single pass citrate extraction and the infusion rate of the additional infusion solution.

16. The method of claim 14, further comprising sensing hematocrit on the venous blood line upstream from the additional infusion line and both upstream and downstream from the post-filter infusion line to determine a degree of hemodilution with the post-filter infusion, and calculating delivered blood flow to the hemofilter for at least one of continuously adjusting dosing of the first pre-filter infusion solution to achieve a desired citrate to plasma flow ratio and controlling the hemofilter single pass citrate extraction and the infusion rate of the additional infusion solution.

17. The method of claim 14, further comprising sensing hematocrit on the venous blood line upstream from the additional infusion line, wherein a programmed change in a flow of at least one of the second pre-filter infusion solution, the post-filter infusion solution, and the filter effluent fluid results in a programmed change in venous blood line hematocrit, further comprising detecting the programmed change in venous blood line hematocrit, detecting the subsequent change in arterial blood line hematocrit due to blood access recirculation, and calculating blood access recirculation from the detected hematocrit changes in an automated manner.

18. The method of claim 14, further comprising providing a secondary extracorporeal blood treatment device operably connected downstream from the pre-filter infusion line and upstream from the additional infusion line.

19. The method of claim 14, further comprising sensing a solute concentration in the filter effluent fluid within the effluent fluid line.

20. The method of claim 14, further comprising monitoring plasma flow online to calculate an infusion rate of the first pre-filter infusion solution and the second pre-filter and post-filter infusion solutions necessary to keep the hemofilter single pass citrate extraction above about 66%.