Precision variable flow rate infusion system and method

• US 10,709,839 B2
• Filed: 02/24/2016
• Issued: 07/14/2020
• 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
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Ulsh, Dung T
• Application Number:
  US15/052,727
• Publication Number:
  US 20160256625A1
• Time in Patent Office: 1,602 Days
• 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 driven by a constant pressure pump from a reservoir having an initial outflow rate to a known and adjustable flow rate less than the initial outflow rate for infusion to a patient, the liquid having a maximum dosage flow rate, comprising:

a first flexible flow rate tubing having a known length from a proximal end to a distal end and a pre-defined flow rate generally established by a consistent internal diameter along the length to create a known flow rate for the liquid passing therethrough, the known flow rate not exceeding the maximum dosage flow rate for the liquid; 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 at least one 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 flow rate scale visually indicating variable flow rates from the maximum dosage flow rate to the zero flow rate, the adjustable flow rate controller inlet coupled to the first flexible flow rate tubing to receive the liquid at the known flow rate established by the first flexible flow rate tubing;

wherein the pre-defined flow rate and the maximum adjuster flow rate cooperatively combining to be equal to or less than the 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 a maximum delivery flow rate of liquid from the reservoir through the system, and the adjustable flow rate controller permitting precision flow rate control from an off flow rate to about the maximum delivery flow rate permitted by the combination of the pre-defined flow rate and the maximum adjuster flow;

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

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 the 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 first flexible flow rate tubing creates the known flow rate for the liquid having a viscosity greater than saline.

4. The precision variable flow rate infusion system of claim 1, wherein the known flow rate provided to the inlet of the adjustable flow rate controller by the first flexible flow rate tubing limits the adjustable flow rate controller to an adjustable range at or below the maximum dosage flow rate.

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 at least one 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.

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 internal 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 at least one internal fluid pathway from the inlet to the outlet from the closed pathway to the 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 disposed along the at least first flexible flow rate tubing between the reservoir and the patient.

11. 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.

12. The precision variable flow rate infusion system of claim 11, 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.

13. 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.

14. 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.

15. 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.

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

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

18. 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.

38. The precision variable flow rate infusion system of claim 1, further including a flared lure inlet.

19. A precision variable flow rate infusion system for delivering a liquid having a maximum dosage flow rate driven by a constant pressure pump from a reservoir having an initial outflow rate to a known and adjustable flow rate less than the initial outflow rate for infusion 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 at least one 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 flow rate scale visually indicating variable flow rates from the maximum dosage flow rate to the zero flow rate;

a first flexible flow rate tubing having a known first length from a first proximal end to a first distal end and a first pre-defined flow rate generally established by a consistent first internal diameter along the first length to create a first known flow rate for the liquid passing therethrough, 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 known second length from a second proximal end to a second distal end and a second pre-defined flow rate generally established by a consistent second internal diameter along the second length to create a second known flow rate for the liquid passing therethrough, the second flexible flow rate tubing disposed between the outlet of the adjustable flow rate controller and the patient, the first known flow rate and the second known flow rate combining to provide a third known flow rate not exceeding the known maximum dosage flow rate for the liquid;

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 the 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 a maximum delivery flow rate of liquid from the reservoir through the system, and the adjustable flow rate controller permitting precision flow rate control from an off flow rate to about the maximum delivery flow rate permitted by the combination of the first pre-defined flow rate, the second pre-defined flow rate and the maximum adjuster flow;

wherein the variable flow rate infusion system is pre-calibrated with sterile gas correlated to an intended liquid to provide the 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.

20. The precision variable flow rate infusion system of claim 19, wherein the first pre-defined flow rate and the second pre-defined flow rate are selected to combine as the maximum dosage flow rate for the liquid from the reservoir, the maximum adjuster flow rate being an unrestrained flow rate.

21. The precision variable flow rate infusion system of claim 19, wherein the first flexible flow rate tubing and the second flexible flow rate tubing determine the maximum delivery flow rate of liquid from the reservoir to a patient.

22. The precision variable flow rate infusion system of claim 19, wherein the known first pre- defined flow rate provided to the inlet of the adjustable flow rate controller by the first flexible flow rate tubing limits the adjustable flow rate controller to an adjustable range at or below the maximum dosage flow rate.

23. The precision variable flow rate infusion system of claim 19, wherein the fluid pathway modifier is provided by the inlet and the outlet rotating relative to each other to modify the at least one 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.

24. The precision variable flow rate infusion system of claim 23, 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.

25. The precision variable flow rate infusion system of claim 23, 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 internal channel as between the inlet and the outlet varying as the inlet and the outlet are rotated relative to each other.

26. The precision variable flow rate infusion system of claim 19, 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 at least one internal fluid pathway from the inlet to the outlet from the closed pathway to the maximum flow pathway with a plurality of different flow rate pathways there between.

27. The precision variable flow rate infusion system of claim 19, 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.

28. The precision variable flow rate infusion system of claim 19, 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.

29. The precision variable flow rate infusion system of claim 19, 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.

30. The precision variable flow rate infusion system of claim 19, 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.

31. The precision variable flow rate infusion system of claim 19, 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.

32. The precision variable flow rate infusion system of claim 19, further including an inlet luer structured and arranged to receive a syringe as the reservoir.

33. The precision variable flow rate infusion system of claim 19, further including an inlet luer structured and arranged to be received by a specific pump system.

34. The precision flow rate infusion system of claim 19, further including an outlet luer structured and arranged to receive a specific needle set.

35. The precision flow rate infusion system of claim 19, wherein the outlet is bonded to a needle.

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

37. The precision variable flow rate infusion system of claim 19, wherein the system the known flow rate and adjustable flow rate for the liquid having a viscosity greater than saline.

39. The precision variable flow rate infusion system of claim 19, further including a flared lure inlet.