IP Library › Granted Patent US 11,400,213
Granted Patent B2
US 11,400,213 · App. 16/865,764 · Granted Aug 2, 2022

Precision variable flow rate infusion system and method

Inventors: Andrew I. Sealfon (Monroe, NY); Siavash Gheshmi (Chester, NY)
Assignee: REPRO-MED SYSTEMS, INC.
A61M5/16877A61M5/141A61M5/142A61M5/1413A61M5/16813A61M5/16886A61M5/178
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Quick Facts
Patent No.
US 11,400,213
App. No.
16/865,764
Granted
Aug 2, 2022
Kind
B2
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 (32)

1. A method for providing 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 patient at an adjustable 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 at least one internal fluid pathway from the inlet to the outlet from a closed pathway providing a zero flow rate to a maximum flow pathway providing a maximum adjuster flow rate with a plurality of different flow rate pathways therebetween, a flow rate scale visually indicating variable flow rates from the maximum dosage flow rate of the liquid to the zero flow rate of the liquid;

providing a first flexible flow rate tubing having a length from a proximal end to a distal end and a first 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 first flexible flow rate tubing disposed between the reservoir and the inlet of the adjustable flow rate controller;

providing a second flexible flow rate tubing having a 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 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 the 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 the 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 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.

2. The method of claim 1 , wherein the first pre-defined flow rate and the second pre-defined flow rate are selected to combine and provide the maximum dosage flow rate for the liquid from the reservoir, the maximum adjuster flow rate being an unrestrained flow rate that does not substantially affect the maximum dosage flow rate for the liquid as provided by the first pre-defined flow rate and the second pre-defined flow rate.

3. The method of claim 1 , wherein the 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 for the liquid.

4. The method 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 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.

5. The method 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 the closed pathway to the maximum flow pathway with a plurality of different flow rate pathways there between.

6. The method of claim 1 , 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.

7. The method of claim 1 , 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.

8. The method of claim 1 , 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.

9. The method of claim 1 , 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.

10. The method of claim 1 , 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.

11. The method of claim 1 , 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.

12. A method for providing 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 patient at an adjustable flow rate equal to or less than a maximum dosage flow rate for the liquid, comprising:

providing a first flexible flow rate tubing having a 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

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 at least one internal fluid pathway from the inlet to the outlet from a closed pathway providing a zero flow rate to a maximum flow pathway providing a maximum adjuster flow rate with a plurality of different flow rate pathways therebetween, a flow rate scale visually indicating variable flow rates from the maximum dosage flow rate of the liquid to the zero flow rate of the liquid, 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 the 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 rate.

13. The method of claim 12 , 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 adjustable flow rate controller.

14. The method of claim 12 , 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 that does not substantially affect the maximum dosage flow rate for the liquid as provided by the first flexible flow rate tubing.

15. The method of claim 12 , 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.

16. The method of claim 12 , 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 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.

17. The method of claim 12 , 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 the closed pathway to the maximum flow pathway with a plurality of different flow rate pathways there between.

18. The method of claim 12 , 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.

19. The method of claim 12 , 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 and adjustable flow rate controller.

20. The method of claim 12 , wherein the adjustable flow rate controller is disposed along the first flexible flow rate tubing between the reservoir and the patient.

21. The method of claim 12 , 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.

22. The method of claim 21 , 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.

23. The method of claim 12 , 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.

Assignments (1)
CHANGE OF NAME Recorded May 2, 2023
From: REPRO MED SYSTEMS, INC.
To: KORU MEDICAL SYSTEMS, INC.
Reel/Frame 063511/0071 →
Continuity (3)
Division 15052727 · Feb 24, 2016
Provisional Application 62128501 · Mar 4, 2015
Related Publication 20200261646A1 · Aug 20, 2020