PRECISION VARIABLE FLOW RATE INFUSION SYSTEM AND METHOD

• US 20160256625A1
• Filed: 02/24/2016
• Published: 09/08/2016
• Est. Priority Date: 03/04/2015
• Status: Active Grant

• Current Assignee: KORU Medical Systems, Inc.
• Original Assignee: Repro-Med Systems Incorporated
• Inventors: SEALFON, Andrew, Gheshmi, Siavash
• Granted Patent: US 10,709,839 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 5/141 with capillaries for restricting fluid flow
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/16813 by controlling the degree of opening of the flow line
• CPC Class Codes: A61M 5/16877 Adjusting flow; Devices for setting a flow rate
• CPC Class Codes: A61M 5/16886 for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: A61M 5/178 Syringes

Abstract

Provided is a precision variable flow rate infusion system and method for delivering a liquid from a reservoir having an initial potential outflow rate to a patient. The system includes at least a first flexible flow rate tubing having a pre-defined flow rate selected at a maximum dosage flow rate for the liquid from the reservoir, the pre-defined flow rate being less than the initial potential outflow rate of the reservoir. Also provided is an adjustable flow rate controller having an inlet and an outlet, at least one internal fluid pathway there between and a fluid pathway modifier structured and arranged to modify the internal fluid pathway from the inlet to the outlet from a closed pathway to a maximum flow pathway with a plurality of different flow rate pathways there between. Moreover, the at least first flexible flow rate tubing and adjustable flow rate controller determine the maximum flow rate of liquid from the reservoir to a patient and the adjustable flow rate controller permits precision flow rate control from an off flow rate to about the maximum flow rate permitted. Associated methods of providing, calibrating and using the precision variable flow rate infusion system are also provided.

Claims

1. A precision variable flow rate infusion system for delivering a liquid from a reservoir having an initial potential outflow rate to a patient, comprising:

at least a first flexible flow rate tubing having a pre-defined flow rate; and

an adjustable flow rate controller having an inlet and an outlet, at least one internal fluid pathway there between and a fluid pathway modifier structured and arranged to modify the internal fluid pathway from the inlet to the outlet from a closed pathway to a maximum flow pathway with a plurality of different flow rate pathways there between providing from a maximum adjuster flow rate to a zero flow rate;

wherein the pre-defined flow rate and the maximum adjuster flow rate cooperatively combining to be equal to or less than a maximum dosage flow rate for the liquid from the reservoir;

wherein the combination of the pre-defined flow rate and the maximum adjuster flow rate determine the maximum flow rate of liquid from the reservoir to a patient, and the adjustable flow rate controller permitting precision flow rate control from an off flow rate to about the maximum flow rate permitted by the combination of the pre-defined flow rate and the maximum adjuster flow rate.

2. The precision variable flow rate infusion system of claim 1, wherein the pre-defined flow rate of the first flexible flow rate tubing is selected at a maximum dosage flow rate for the liquid from the reservoir, the maximum adjuster flow rate being an unrestrained flow rate.

3. The precision variable flow rate infusion system of claim 1, wherein the at least first flexible flow rate tubing determines the maximum flow rate of liquid from the reservoir to a patient.

4. The precision variable flow rate infusion system of claim 1, wherein the pre-defined flow rate of the first flexible flow rate tubing is less than the initial potential outflow rate of the reservoir.

5. The precision variable flow rate infusion system of claim 1, wherein the fluid pathway modifier is provided by the inlet and the outlet rotating relative to each other to modify the internal pathway from the inlet to the outlet from a closed pathway to a maximum flow pathway with a plurality of different flow rate pathways there between.

6. The precision variable flow rate infusion system of claim 5, wherein the adjustable flow rate controller provides the plurality of different flow rate pathways by disposing differently sized orifices between the inlet and the outlet.

7. The precision variable flow rate infusion system of claim 5, wherein the adjustable flow rate controller provides an internal channel having a length and at least one characteristic that is varied along the length, the length of the channel as between the inlet and the outlet varying as the inlet and the outlet are rotated relative to each other.

8. The precision variable flow rate infusion system of claim 1, wherein the fluid pathway modifier is provided by a plurality of differently sized internal channels, a selector structured and arranged to select and deselect one or more of the differently sized internal channels to modify the internal pathway from the inlet to the outlet from a closed pathway to a maximum flow pathway with a plurality of different flow rate pathways there between.

9. The precision variable flow rate infusion system of claim 1, wherein the adjustable flow rate controller has a pre-defined flow direction, the adjustable flow rate controller incorporated to provide a flow direction opposite to the pre-defined flow direction.

10. The precision variable flow rate infusion system of claim 1, wherein the adjustable flow rate controller is pre-calibrated with sterile gas correlated to an intended liquid to provide a flow rate scale tuned for each assembly of the at least first flexible flow rate tubing and adjustable flow rate controller.

11. The precision variable flow rate infusion system of claim 1, wherein the adjustable flow rate controller is disposed along the at least first flexible flow rate tubing between the reservoir and the patient.

12. The precision variable flow rate infusion system of claim 1, further including a second flexible tubing, the first flexible flow rate tubing disposed between the reservoir and the inlet of the adjustable flow rate controller and the second flexible tubing disposed between the outlet of the adjustable flow rate controller and the patient.

13. The precision variable flow rate infusion system of claim 12, wherein the second flexible tubing is a second flexible flow rate tubing having a pre-defined flow rate equal to or less than the pre-defined flow rate of the first flexible flow rate tubing.

14. The precision variable flow rate infusion system of claim 1, wherein the pre-determined flow rate of the first flexible flow rate tubing is selected from the group consisting of:

about 30 mL/hr, about 45 mL/hr, about 60 mL/hr, about 120 mL/hr, about 180 mL/hr, about 420 mL/hr, about 600 mL/hr, about 900 mL/hr, about 1200 mL/hr, and about 2400 mL/hr.

15. The precision variable flow rate infusion system of claim 1, further including an inlet luer structured and arranged to receive a syringe as the reservoir.

16. The precision variable flow rate infusion system of claim 1, further including an inlet luer structured and arranged to be received by a specific pump system.

17. The precision flow rate infusion system of claim 1, further including an outlet luer structured and arranged to receive a specific needle set.

18. The precision flow rate infusion system of claim 1, wherein the outlet is bonded to a needle.

19. The precision variable flow rate infusion system of claim 1, wherein the adjustable flow rate controller may be permanently fixed to a selected flow rate pathway.

20. A precision variable flow rate infusion system for delivering a liquid from a reservoir having an initial potential outflow rate to a patient, comprising:

an adjustable flow rate controller having an inlet and an outlet, at least one internal fluid pathway there between and a fluid pathway modifier structured and arranged to modify the internal fluid pathway from the inlet to the outlet from a closed pathway to a maximum flow pathway with a plurality of different flow rate pathways there between providing from a maximum adjuster flow rate to a zero flow rate;

a first flexible flow rate tubing having a first pre-defined flow rate, the first flexible flow rate tubing disposed between the reservoir and the inlet of the adjustable flow rate controller; and

a second flexible flow rate tubing having a second pre-defined flow rate, the second flexible flow rate tubing disposed between the outlet of the adjustable flow rate controller and the patient;

wherein the first pre-defined flow rate and the second pre-defined flow rate and the maximum adjuster flow rate cooperatively combine to be equal to or less than a maximum dosage flow rate for the liquid from the reservoir; and

wherein the combination of first pre-defined flow rate and the second pre-defined flow rate and the maximum adjuster flow rate determine the maximum flow rate of liquid from the reservoir to a patient, and the adjustable flow rate controller permitting precision flow rate control from an off flow rate to about the maximum flow rate permitted by the combination of the first pre-defined flow rate, the second pre-defined flow rate and the maximum adjuster flow rate.

21. The precision variable flow rate infusion system of claim 20, wherein the first pre-defined flow rate and the second pre-defined flow rate are selected to combine as a maximum dosage flow rate for the liquid from the reservoir, the maximum adjuster flow rate being an unrestrained flow rate.

22. The precision variable flow rate infusion system of claim 20, wherein the first flexible flow rate tubing and the second flexible flow rate tubing determine the maximum flow rate of liquid from the reservoir to a patient.

23. The precision variable flow rate infusion system of claim 20, wherein the first pre-defined flow rate and the second pre-defined flow rate and the maximum adjuster flow rate cooperatively combine for a flow rate that is less than the initial potential outflow rate of the reservoir.

24. The precision variable flow rate infusion system of claim 20, wherein the fluid pathway modifier is provided by the inlet and the outlet rotating relative to each other to modify the internal pathway from the inlet to the outlet from a closed pathway to a maximum flow pathway with a plurality of different flow rate pathways there between.

25. The precision variable flow rate infusion system of claim 24, wherein the adjustable flow rate controller provides the plurality of different flow rate pathways by disposing differently sized orifices between the inlet and the outlet.

26. The precision variable flow rate infusion system of claim 24, wherein the adjustable flow rate controller provides an internal channel having a length and at least one characteristic that is varied along the length, the length of the channel as between the inlet and the outlet varying as the inlet and the outlet are rotated relative to each other.

27. The precision variable flow rate infusion system of claim 20, wherein the fluid pathway modifier is provided by a plurality of differently sized internal channels, a selector structured and arranged to select and deselect one or more of the differently sized internal channels to modify the internal pathway from the inlet to the outlet from a closed pathway to a maximum flow pathway with a plurality of different flow rate pathways there between.

28. The precision variable flow rate infusion system of claim 20, wherein the adjustable flow rate controller has a pre-defined flow direction, the adjustable flow rate controller incorporated to provide a flow direction opposite to the pre-defined flow direction.

29. The precision variable flow rate infusion system of claim 20, wherein the adjustable flow rate controller is pre-calibrated with sterile gas correlated to an intended liquid to provide a flow rate scale tuned for each assembly of the first flexible flow rate tubing, the second flexible flow rate tubing and the adjustable flow rate controller.

30. The precision variable flow rate infusion system of claim 20, wherein the first pre-defined flow rate of the first flexible flow rate tubing is equal to or greater than the second pre-defined flow rate of the second flexible flow rate tubing.

31. The precision variable flow rate infusion system of claim 20, wherein the second pre-defined flow rate of the second flexible flow rate tubing is equal to or greater than the first pre-defined flow rate of the first flexible flow rate tubing.

32. The precision variable flow rate infusion system of claim 20, wherein the first pre-determined flow rate of the first flexible flow rate tubing is selected from the group consisting of:

about 30 mL/hr, about 45 mL/hr, about 60 mL/hr, about 120 mL/hr, about 180 mL/hr, about 420 mL/hr, about 600 mL/hr, about 900 mL/hr, about 1200 mL/hr, and about 2400 mL/hr.

33. The precision variable flow rate infusion system of claim 20, wherein the second pre-determined flow rate of the second flexible flow rate tubing is selected from the group consisting of:

about 30 mL/hr, about 45 mL/hr, about 60 mL/hr, about 120 mL/hr, about 180 mL/hr, about 420 mL/hr, about 600 mL/hr, about 900 mL/hr, about 1200 mL/hr, and about 2400 mL/hr.

34. The precision variable flow rate infusion system of claim 20, further including an inlet luer structured and arranged to receive a syringe as the reservoir.

35. The precision variable flow rate infusion system of claim 20, further including an inlet luer structured and arranged to be received by a specific pump system.

36. The precision flow rate infusion system of claim 20, further including an outlet luer structured and arranged to receive a specific needle set.

37. The precision flow rate infusion system of claim 20, wherein the outlet is bonded to a needle.

38. The precision variable flow rate infusion system of claim 20, wherein the adjustable flow rate controller may be permanently fixed to a selected flow rate pathway.

39. A method for providing a precision variable flow rate infusion system for delivering a liquid from a reservoir having an initial potential outflow rate to a patient at a flow rate equal to or less than a maximum dosage flow rate for the liquid, comprising:

providing an adjustable flow rate controller having an inlet and an outlet, at least one internal fluid pathway there between and a fluid pathway modifier structured and arranged to modify the internal fluid pathway from the inlet to the outlet from a closed pathway to a maximum flow pathway with a plurality of different flow rate pathways there between providing from a maximum adjuster flow rate to a zero flow rate;

providing a first flexible flow rate tubing having a first pre-defined flow rate, the first flexible flow rate tubing disposed between the reservoir and the inlet of the adjustable flow rate controller; and

providing a second flexible flow rate tubing having a second pre-defined flow rate, the second flexible flow rate tubing disposed between the outlet of the adjustable flow rate controller and the patient;

wherein the first pre-defined flow rate and the second pre-defined flow rate and the maximum adjuster flow rate cooperatively combine to be equal to or less than a maximum dosage flow rate for the liquid from the reservoir; and

wherein the combination of first pre-defined flow rate and the second pre-defined flow rate and the maximum adjuster flow rate determine the maximum flow rate of liquid from the reservoir to a patient, and the adjustable flow rate controller permitting precision flow rate control from an off flow rate to about the maximum flow rate permitted by the combination of the first pre-defined flow rate, the second pre-defined flow rate and the maximum adjuster flow rate.

40. The method of claim 39, wherein the first pre-defined flow rate and the second pre-defined flow rate are selected to combine as a maximum dosage flow rate for the liquid from the reservoir, the maximum adjuster flow rate being an unrestrained flow rate.

41. The method of claim 39, wherein the first flexible flow rate tubing and the second flexible flow rate tubing determine the maximum flow rate of liquid from the reservoir to a patient.

42. The method of claim 39, wherein the first pre-defined flow rate and the second pre-defined flow rate and the maximum adjuster flow rate cooperatively combine for a flow rate that is less than the initial potential outflow rate of the reservoir.

43. The method of claim 39, wherein the fluid pathway modifier is provided by the inlet and the outlet rotating relative to each other to modify the internal pathway from the inlet to the outlet from a closed pathway to a maximum flow pathway with a plurality of different flow rate pathways there between.

44. The method of claim 43, wherein the adjustable flow rate controller provides the plurality of different flow rate pathways by disposing differently sized orifices between the inlet and the outlet.

45. The method of claim 43, wherein the adjustable flow rate controller provides an internal channel having a length and at least one characteristic that is varied along the length, the length of the channel as between the inlet and the outlet varying as the inlet and the outlet are rotated relative to each other.

46. The method of claim 39, wherein the fluid pathway modifier is provided by a plurality of differently sized internal channels, a selector structured and arranged to select and deselect one or more of the differently sized internal channels to modify the internal pathway from the inlet to the outlet from a closed pathway to a maximum flow pathway with a plurality of different flow rate pathways there between.

47. The method of claim 39, wherein the adjustable flow rate controller has a pre-defined flow direction, the adjustable flow rate controller disposed between the first flexible flow rate tubing and the second flexible flow rate tubing to provide a flow direction through the adjustable flow rate controller opposite to the pre-defined flow direction.

48. The method of claim 39, further including pre-calibrating the adjustable flow rate controller with sterile gas correlated to an intended liquid to provide a flow rate scale tuned for each assembly of the first flexible flow rate tubing, the second flexible flow rate tubing and the adjustable flow rate controller.

49. The method of claim 39, wherein the first pre-defined flow rate of the first flexible flow rate tubing is equal to or greater than the second pre-defined flow rate of the second flexible flow rate tubing.

50. The method of claim 39, wherein the second pre-defined flow rate of the second flexible flow rate tubing is equal to or greater than the first pre-defined flow rate of the first flexible flow rate tubing.

51. The method of claim 39, wherein the first pre-determined flow rate of the first flexible flow rate tubing is selected from the group consisting of:

about 30 mL/hr, about 45 mL/hr, about 60 mL/hr, about 120 mL/hr, about 180 mL/hr, about 420 mL/hr, about 600 mL/hr, about 900 mL/hr, about 1200 mL/hr, and about 2400 mL/hr.

52. The method of claim 39, wherein the second pre-determined flow rate of the second flexible flow rate tubing is selected from the group consisting of:

about 30 mL/hr, about 45 mL/hr, about 60 mL/hr, about 120 mL/hr, about 180 mL/hr, about 420 mL/hr, about 600 mL/hr, about 900 mL/hr, about 1200 mL/hr, and about 2400 mL/hr.

53. The method of claim 39, wherein the first flexible flow rate tubing further includes an inlet luer structured and arranged to receive a syringe as the reservoir.

54. The method of claim 39, wherein the first flexible flow rate tubing further includes an inlet luer structured and arranged to be received by a specific pump system.

55. The method of claim 39, wherein an outlet luer structured and arranged to receive a specific needle set.

56. The method of claim 39, wherein the outlet is bonded to a needle.

57. The method of claim 39, wherein the adjustable flow rate controller may be permanently fixed to a selected flow rate pathway.