Infusion site for improved mixing of fluids

• US 10,456,517 B2
• Filed: 08/18/2017
• Issued: 10/29/2019
• Est. Priority Date: 09/05/2007
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Frugier, Alain, Pouchoulin, Dominique
• Primary Examiner(s): Mensh, Andrew J
• Application Number:
  US15/680,336
• Publication Number:
  US 20170340800A1
• Time in Patent Office: 802 Days
• Field of Search: 422 44, 604 607, 604 609, 604 616, 96209
• CPC Class Codes: A61M 1/024 Means for controlling the quantity of transfused blood, e.g. by weighing the container and automatic stopping of the transfusion after reaching a determined amount
• 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 1/3413 Diafiltration
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3431 upstream of the filter
• 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 1/3458 having electrolytes not present in the dialysate
• CPC Class Codes: A61M 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 1/3672 Means preventing coagulation
• CPC Class Codes: A61M 1/3675 Deactivation
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2202/0021 removed from and reintroduced into the body, e.g. after treatment
• CPC Class Codes: A61M 2202/0042 filtrate, i.e. the fluid passing through the filter
• CPC Class Codes: A61M 2206/16 Rotating swirling helical flow, e.g. by tangential inflows
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable

Abstract

The invention relates to a blood line (108) comprising an infusion site (145) intended to inject into the line a solution comprising: —a first main channel (200) having a first passage section, —a second main channel (220) having a second passage section, —means for the formation (210) of a turbulence area located downstream from the first main channel, located upstream from the second main channel, these formation means comprising a first fluid passage means (224) defining a reduction (225) in the passage section and whose smallest passage section is smaller than the first passage section and smaller than the second fluid passage section, —a secondary channel (230) comprising an inlet (231) for letting in the solution and an outlet (232) in fluid communication with the first main channel or the means for the formation of a turbulence area or the second main channel.

Claims

1. A method of anticoagulating blood treated during extracorporeal circulation in an extracorporeal circulation blood or plasma treatment device, the extracorporeal circulation blood or plasma treatment device comprising:

a filter having a first compartment and a second compartment separated by a semipermeable membrane;

an arterial line in fluid communication with the first compartment of the filter;

a pre-infusion channel for a local anticoagulation substance in fluid communication with the arterial line;

a container of a local anticoagulation substance in fluid communication with the pre-infusion channel;

a venous blood line in fluid communication with the first compartment of the filter, the venous blood line comprising;

a first line portion in fluid communication with an outlet of the filter,

a second line portion in fluid communication with a patient'"'"'s vascular access,

an infusion site between the first line portion and the second line portion for injecting into the blood line a solution reestablishing blood or plasma ion balance, the infusion site comprising;

a first main channel in fluid communication with the first line portion and having a first passage section,

a second main channel in fluid communication with the second line portion and having a second passage section, and

a turbulence area downstream from and in fluid communication with the first main channel, and upstream from and in fluid communication with the second main channel, the turbulence area comprising a first fluid passage defining a reduction in passage section having a smallest passage section smaller than the first passage section and smaller than the second passage section, and

a secondary channel comprising an inlet for the solution reestablishing blood or plasma ion balance and an outlet in fluid communication with at least one of the first main channel, the turbulence area and the second main channel; and

a container of solution reestablishing blood or plasma ion balance in fluid communication with the secondary channel of the infusion site via a post-infusion line;

the method comprising;

a) flowing blood or plasma through the arterial line,

b) infusing the local anticoagulation substance through the pre-infusion channel into the arterial line,

c) filtering blood through the filter,

d) flowing the filtered blood through the first line portion of the venous blood line,

e) flowing the filtered blood in the turbulence area of the infusion site to cause a turbulence in blood flow,

f) infusing the solution for reestablishing ion balance through the secondary channel of the infusion site, and

g) flowing the filtered blood mixed with the solution for reestablishing blood or plasma ion balance through the second portion of the blood line, wherein step f) is carried out directly before, during or directly after step e).

2. The method of claim 1, wherein the post-infusion line is internally mounted into the secondary channel, an outer surface of the post-infusion line portion being sealingly connected to an inner surface of a post-infusion passage section of the infusion site.

3. The method of claim 1, wherein the first line portion is internally mounted into the first main channel of the infusion site and the second line portion is internally mounted into the second main channel of the infusion site.

4. The method of claim 1, wherein causing turbulence in blood flow includes switching from a laminar blood flow to a turbulent blood flow in the infusion site.

5. The method of claim 4, further including increasing the Reynolds number to switch from the laminar blood flow to the turbulent blood flow.

6. The method of claim 1, wherein causing turbulence in blood flow includes causing the blood flow to generate multiple whirlpools.

7. The method of claim 1, wherein at least one of the local anticoagulation substance includes citrate or the solution reestablishing blood or plasma ion balance includes calcium.

8. The method of claim 1, wherein the solution reestablishing blood or plasma ion balance is not perturbed before arrival in the at least one of the first main channel, the turbulence area or the second main channel.

9. The method of claim 1, comprising injecting the solution reestablishing blood or plasma ion balance using a pipe having a constant circular section, the constant circular section of the pipe being smaller than any of the sections of the first main channel and the second main channel.

10. The method of claim 1, wherein the turbulence area includes a second fluid passage downstream from the first fluid passage and defining an increase in fluid passage section, and wherein the largest fluid passage section of the second fluid passage is smaller than said first passage section and smaller than said second passage section.

11. The method of claim 10, wherein the increase in fluid passage section of the second fluid passage defines a shoulder perpendicular to the longitudinal axis of the second fluid passage.

12. The method of claim 1, wherein the first fluid passage of the turbulence area defines a continuous section narrowing fluid passage.

13. The method of claim 1, wherein the first fluid passage of the turbulence area has a constantly narrowing internal circular section, resulting in a conical internal surface having a symmetrical axis which is the longitudinal axis of the first passage.

14. The method of claim 13, wherein the Reynolds number for blood flow in the smallest circular section of the conical internal surface varies from 350 to 3,000.

15. The method of claim 13, wherein the Reynolds number for blood flow in the smallest circular section of the conical internal surface varies from 500 to 2,000.

16. The method of claim 13, wherein a ratio between the largest circular section of the conical internal surface and the smallest circular section of the conical internal surface is less than 3.6:

1.

17. The method of claim 13, wherein the diameter of the smallest circular section of the conical internal surface is equal to or less than 1.2 mm.

18. The method of claim 1, wherein the diameter of an outlet of the secondary channel of the infusion site is equal to or less than 0.8 mm.

19. The method of claim 1, wherein a ratio between a diameter of the smallest passage section of the first fluid passage and a diameter of the first passage section is less than about 30%.

20. The method of claim 1, wherein the inlet of the secondary channel of the infusion site is tapered.

21. The method of claim 1, wherein the secondary channel section interposed between the inlet and the outlet has a constant circular section.

22. The method of claim 1, wherein the container of solution reestablishing blood or plasma ion balance is a bag or a syringe.

23. The method of claim 1, wherein the treatment device includes a bubble trap located along the venous blood line upstream from the infusion site.

24. The method of claim 1, wherein the treatment device includes an air detector operating with the venous blood line downstream from the infusion site.