Infusion site for improved mixing of fluids

• US 8,715,217 B2
• Filed: 10/31/2007
• Issued: 05/06/2014
• 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): Zalukaeva, Tatyana
• Assistant Examiner(s): Mensh, Andrew J
• Application Number:
  US12/674,110
• Publication Number:
  US 20100168643A1
• Time in Patent Office: 2,379 Days
• Field of Search: 604/6.07, 604/6.09, 604/6.16, 604/539, 962/09
• US Class Current: 604/6.16
• 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 blood line for extracorporeal blood or plasma treatment comprising:

a first line portion intended to be connected to an outlet of a filter, the first line portion having a first line passage section,

a second line portion intended to be connected to a patient'"'"'s vascular access,

an infusion site acting between the first line portion and the second line portion, and intended to inject into the blood line a solution reestablishing blood or plasma ion balance, 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, wherein a longitudinal axis of the first main channel of the infusion site is perpendicular to a longitudinal axis of the second main channel of the infusion site,

means for the formation of a turbulence area located downstream from and in fluid communication with the first main channel, located upstream from and in fluid communication with the second main channel, the means for formation of a turbulence comprising a first fluid passage defining a reduction in a passage section and whose smallest passage section is smaller than the first passage section and smaller than the second passage section, wherein the first fluid passage of the turbulence area formation means defines a constant narrowing of internal circular section, thus resulting in a conical internal surface of revolution whose symmetry axis is a longitudinal axis of the first passage means,

a secondary channel comprising an inlet for letting in a solution, reestablishing ion balance and an outlet in fluid communication with at least one of three elements chosen among the first main channel, the means for the formation of a turbulence area and the second main channel, wherein

the turbulence area formation means include a second fluid passage downstream from the first fluid passage defining an increase in fluid passage section in a sense of fluid passage,

the largest fluid passage section of the second fluid passage is smaller than said first passage section and smaller than said second passage section, and

a ratio between a diameter of the smallest passage section of the first fluid passage and a diameter of the first line passage section is less than about 30%.

2. The blood line according to claim 1, wherein the turbulence area formation means comprise a secondary inlet and the outlet of the secondary channel of the infusion site is connected to said secondary inlet.

3. The line according to claim 1, wherein the first main channel includes a secondary inlet and the outlet of the secondary channel of the site is connected to said secondary inlet.

4. The line according to claim 3, wherein the outlet of the secondary channel of the site is connected to said secondary inlet straight downstream from the turbulence area formation means.

5. The line according to claim 1, wherein the second main channel comprises a secondary inlet and the outlet of the secondary channel of the site is connected to said secondary inlet.

6. The line according to claim 5, wherein the outlet of the secondary channel of the site is connected to said secondary inlet straight upward from the turbulence area formation means.

7. The blood line according to claim 1, wherein the number of Reynolds for a blood passage in the smallest circular section of the conical internal surface varies from 350 to 3,000.

8. The blood line according to claim 7, wherein the number of Reynolds for a blood passage in the smallest circular section of the conical surface varies from 500 to 2,000.

9. The blood line according to claim 8, wherein the increase in fluid passage section of the second fluid passage defines a shoulder perpendicular to the axis of the second fluid passage.

10. The line according to claim 1, wherein the first fluid passage of the turbulence area formation means includes at least one partial separation whose longitudinal plane is perpendicular to the longitudinal axis of the first fluid passage.

11. The line according to claim 1, wherein the turbulence area formation means include at least two partial separations, each longitudinal plane thereof being perpendicular to the longitudinal axis of the first fluid passage and distributed according to a symmetry point located on said longitudinal axis.

12. The line according to claim 11, wherein the secondary channel for letting in the ion reestablishing solution in the site is integrated into one of the partial separations, and wherein the axis of the secondary channel is perpendicular to the longitudinal axis of the first fluid passage.

13. The blood line according to claim 1, wherein the turbulence area formation means are an elbow-shaped pipe.

14. The blood line according to claim 7, wherein the outlet of the secondary channel of the infusion site is connected to a secondary inlet of the turbulence area formation means, this secondary inlet being placed on the second fluid passage.

15. The blood line according to claim 1, wherein a longitudinal axis of the secondary channel of the infusion site for letting in a solution reestablishing ion balance is parallel to a longitudinal axis of the second main channel of the infusion site.

16. The line according to claim 1, wherein the longitudinal axis of the secondary channel of the site is perpendicular to the longitudinal axis of the second main channel of the site.

18. The line according to claim 1, wherein the longitudinal axis of the first main channel of the site is parallel with the longitudinal axis of the second main channel of the site.

19. The blood line according to claim 1, wherein the respective axes of the first and of the second main channel of the infusion site and of the secondary channel of the infusion site are coplanar.

20. The blood line according to claim 1, wherein a longitudinal axis of an end of the first line portion connected to the infusion site is coaxial with a longitudinal axis of the first main channel of the infusion site.

21. The blood line according to claim 1, wherein a longitudinal axis of an end of the second line portion connected to the infusion site is coaxial with a longitudinal axis of the second main channel of the infusion site.

22. The blood line according to claim 1, wherein the secondary channel of the infusion site is connected to a bag or to a syringe containing liquid for reestablishing ion balance.

23. The blood line according to claim 1, comprising a bubble trap acting on the first line portion of the blood line upstream from the infusion site.

24. The blood line according to claim 1, wherein the infusion site is made as one piece.

25. The blood line according to claim 1, wherein the infusion site is made of rigid or semi-rigid plastic material.

26. A set of lines intended to be attached to a blood or plasma filter, comprising:

an arterial line having a connector intended to be connected to a first compartment of a filter,

a pre-infusion channel for a local anticoagulation substance attached to the arterial line,

a venous blood line according to claim 1, wherein an inlet of a first line portion is intended to be connected to an outlet of the filter and an outlet of a second blood portion line is intended to be connected to a patient'"'"'s vascular access.

27. The set of lines according to claim 26 comprising:

a container of local anticoagulation substance connected to the pre-infusion channel,

a container of solution reestablishing ion balance connected to a secondary channel of an infusion site.

28. A blood or plasma treatment device by way of extracorporeal circulation comprising:

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

an arterial line connected to a first compartment of the filter,

a pre-infusion channel for a local anticoagulation substance attached to the arterial line, wherein the blood or plasma treatment device comprises a venous blood line getting out of the first compartment of the filter according to claim 1.

29. The blood treatment device according to claim 28, comprising:

a container of local anticoagulation substance connected to the pre-infusion channel,

a container of solution reestablishing ion balance connected to a secondary channel of an infusion site.

30. The blood treatment device according to claim 28, comprising an air detector acting on the venous line downstream from an infusion site.

31. The blood treatment device according to claim 30, comprising an air separator on the venous line, upstream from the air detector.

32. The blood line according to claim 1, wherein the first fluid passage of the turbulence area formation means defines a continuous section narrowing in a sense of fluid passage and presents a smallest outlet section smaller than an inlet section of the first fluid passage, the first passage section of the first main channel is larger than the inlet section of the first fluid passage and wherein the turbulence area formation means include a second fluid passage downstream from the first fluid passage defining an increase in fluid passage section in the sense of fluid passage, a largest fluid passage section of the second fluid passage being smaller than said first passage section of the first main channel and smaller than said second passage section of the second main channel, the secondary channel having a third passage section smaller than said first passage section of the first main channel and smaller than said second passage section of the second main channel, the secondary channel having a secondary inlet directly communicating with the second fluid passage of the turbulence area formation means, the secondary inlet having a section smaller than the third passage section of the secondary inlet.

33. The blood line according to claim 32, wherein the first main channel, the second main channel, the secondary channel and the turbulence area formation means are integral to each other and made into a single piece.

34. The blood line according to claim 32, wherein the secondary inlet section is smaller than the smallest outlet section of the first fluid passage of the turbulence area formation means.

35. The blood line according to claim 1, wherein the ratio is between about 30% and about 25%.

36. The blood line according to claim 1, wherein the ratio is less than about 29%.

37. The blood line according to claim 1, wherein the ratio is less than about 28%.

38. The blood line according to claim 1, wherein

the second line portion is connected to the second main channel and abuts the second fluid passage section, the second line portion having a second line passage section, and

the largest fluid passage section of the second fluid passage is larger than said second line passage section.

39. The blood line according to claim 1, wherein

the second line portion has a second line passage section,

the second line portion is connected to the second main channel and abuts the second fluid passage section, and

the largest fluid passage section of the second fluid passage is larger than said second line passage section.

17. A blood line for extracorporeal blood or plasma treatment comprising:

a first line portion intended to be connected to an outlet of a filter, the first line portion having a first line passage section,

a second line portion intended to be connected to a patient'"'"'s vascular access,

an infusion site acting between the first line portion and the second line portion, and intended to inject into the blood line a solution reestablishing blood or plasma ion balance, 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,

means for the formation of a turbulence area located downstream from and in fluid communication with the first main channel, located upstream from and in fluid communication with the second main channel, the means for formation of a turbulence comprising a first fluid passage defining a reduction in a passage section and whose smallest passage section is smaller than the first passage section and smaller than the second passage section, wherein the first fluid passage of the turbulence area formation means defines a constant narrowing of internal circular section, thus resulting in a conical internal surface of revolution whose symmetry axis is a longitudinal axis of the first passage means,

a secondary channel comprising an inlet for letting in a solution, reestablishing ion balance and an outlet in fluid communication with at least one of three elements chosen among the first main channel, the means for the formation of a turbulence area and the second main channel, a longitudinal axis of the secondary channel of the infusion site for letting in a solution reestablishing ion balance is parallel to a longitudinal axis of the second main channel of the infusion site, wherein

the turbulence area formation means include a second fluid passage downstream from the first fluid passage defining an increase in fluid passage section in a sense of fluid passage,

the largest fluid passage section of the second fluid passage is smaller than said first passage section and smaller than said second passage section, and

a ratio between a diameter of the smallest passage section of the first fluid passage and a diameter of the first line passage section is less than about 30%.

40. The blood line according to claim 17, wherein a longitudinal axis of the first main channel of the infusion site is perpendicular to a longitudinal axis of the second main channel of the infusion site.