Differential pressure based flow sensor assembly for medication delivery monitoring and method of using the same

• US 9,272,089 B2
• Filed: 03/25/2013
• Issued: 03/01/2016
• Est. Priority Date: 12/17/2007
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: Hospira Incorporated (Pfizer Inc.)
• Inventors: Barclay, Brian, Choudhury, Hrishikesh, Johnson, Tom, Walsworth, Frank, Jacobson, James D, Brumund, Ryan R, Cho, Steven T, Fathallah, Marwan A, Keely, Patrick B, Khair, Mohammad M, Lowery, Michael G, Ziegler, John S
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): HAYMAN, IMANI N
• Application Number:
  US13/850,126
• Publication Number:
  US 20130218133A1
• Time in Patent Office: 1,072 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/16886 for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: G01F 1/42 Orifices or nozzles

Abstract

A differential pressure based flow sensor assembly and method of using the same to determine the rate of fluid flow in a fluid system. The sensor assembly comprises a disposable portion and a reusable portion. A flow restricting element is positioned along a fluid flow passage between an inlet and an outlet. The disposable portion further has an upstream fluid pressure membrane and a downstream fluid pressure membrane. The reusable portion has an upstream fluid pressure sensor and a downstream fluid pressure sensor. The upstream fluid pressure sensor senses the upstream fluid pressure at a location within the fluid flow passage between the inlet and the flow restricting element. The downstream fluid pressure sensor senses the downstream fluid pressure at a location within the fluid flow passage between the flow restricting element and the outlet. The process utilizes output of the sensors to calculate the flow rate of the fluid.

Claims

1. A differential pressure based flow sensor assembly to determine a flow rate of a fluid system comprising:

a disposable portion having;

a sealed disposable body defining a fluid flow passage forming an inlet and an outlet;

a flow restricting element positioned along the fluid flow passage between the inlet and the outlet, wherein the flow restricting element includes an orifice that defines a fluid flow path;

an impermeable fluid pressure membrane comprising;

an upstream fluid pressure membrane at a location in the fluid flow passage between the inlet and the flow restricting element; and

a downstream fluid pressure membrane at a location in the fluid flow passage between the flow restricting element and the outlet; and

a reusable portion including a housing removably coupled to the disposable portion and comprising;

an upstream fluid pressure sensor to sense an upstream fluid pressure at an upstream location in the fluid flow passage between the inlet and the flow restricting element, the upstream fluid pressure sensor being positioned and adapted to interact with the upstream fluid pressure membrane to determine the fluid pressure at the upstream fluid pressure membrane; and

a downstream fluid pressure sensor to sense a downstream fluid pressure at a downstream location in the fluid flow passage between the flow restricting element and the outlet, the downstream fluid pressure sensor being positioned and adapted to interact with the downstream fluid pressure membrane to determine the fluid pressure at the downstream fluid pressure membrane;

wherein the flow restricting element is a separate component secured within the disposable body between the upstream fluid pressure membrane and the downstream fluid pressure membrane.

2. The differential pressure based flow sensor assembly of claim 1, wherein the upstream fluid pressure membrane and the downstream fluid pressure membrane comprise an elastomeric material.

3. The differential pressure based flow sensor assembly of claim 1, wherein the orifice defines a non-capillary fluid flow path.

5. A method of determining a fluid flow rate in a fluid flow system comprising:

providing a differential pressure based flow sensor assembly according to claim 1;

directing a fluid through the fluid flow passage; and

calculating the fluid flow rate based on a pressure difference between an output of the upstream fluid pressure sensor and an output of the downstream fluid pressure sensor.

6. The method of determining a fluid flow in a fluid flow system of claim 5, further comprising deriving a fluid volume delivered over time based upon the calculating of the fluid flow rate.

7. A fluid delivery system for delivering medication from a first source to a patient including measuring a flow rate of the fluid, the system comprising:

an infusion pump that selectively varies a rate of flow of the first medication from the first source through a fluid line;

a differential pressure based flow sensor assembly according to claim 1 and adapted to determine the flow rate of the first medication within the fluid line; and

a processor adapted to control the infusion pump by varying the rate of flow of the first medication based on information provided by the differential pressure based flow sensor assembly, the processor further being adapted to determine the amount of the first medication provided to the patient.

8. The system of claim 7 further comprising:

a user input device in communication with the processor, the user input device being adapted allow a user to provide information regarding the first medication.

9. The system of claim 8, wherein the processor is adapted to compare information about the first medication received from the user input device to patient treatment information for the patient.

10. The system of claim 9, wherein the processor is adapted to update the patient treatment information for the patient based on information provided by the user input device and the differential pressure based flow sensor assembly.

11. The system of claim 7, wherein the fluid line is adapted to deliver the first medication from a reservoir to the patient, the fluid line further having a fitting adapted to deliver a second medication from a second source.

12. The system of claim 11, wherein the processor is adapted to determine the push rate of the second medication from the second source based on information provided by the differential pressure based flow sensor assembly, and wherein the second source is a syringe.

13. The system of claim 12, wherein the processor is adapted to compare the push rate of the second medication to patient treatment information for the patient.

14. A method of delivering medication to a patient comprising:

providing a differential pressure based flow sensor assembly according to claim 1 to determine a flow rate of a first medication within a fluid line;

sensing the flow rate of a first medication with the flow sensor assembly;

controlling an infusion pump that selectively varies the flow rate of the first medication, wherein the controlling is based upon information the flow sensor assembly provides a processor; and

determining an amount of the first medication delivered to the patient, wherein the determining is based upon information the flow sensor assembly provides the processor.

15. The method of claim 14 further comprising:

delivering the first medication to the patient through a fluid line from a first source, the fluid line further having a fitting adapted to receive a second medication from a second source;

delivering a second medication to the patient from the second source via the fitting; and

determining an amount of the second medication delivered to the patient, wherein the determining is based upon information the flow sensor assembly provides the processor; and

calculating the delivery rate of the second medication, wherein the calculating is based upon information the flow sensor assembly provides the processor.

16. The method of claim 15 further comprising:

sending information about the first medication or the second medication to the processor;

accessing patient specific treatment information with the processor;

comparing the information about the first medication or the second medication with patient specific information;

alerting a caregiver if either the first medication or the second medication is not located on the patient specific treatment information.

17. The method of claim 16 further comprising:

updating the patient specific treatment information to show the amount of the first medication and the second medication delivered to the patient.

18. The method of claim 16 further comprising:

generating guidelines for delivery of the second medication;

delivering a second medication to the patient from the second source via the fitting;

calculating the delivery rate of the second medication, wherein the calculating is based upon information the flow sensor assembly provides the processor

alerting a caregiver if the delivery rate of the second medication does not generally conform to the generated guidelines for delivery of the second medication.

19. The method of claim 18 further comprising:

delivering a second medication to the patient from the second source via the fitting;

determining an amount of the second medication delivered to the patient, wherein the determining is based upon information the flow sensor assembly provides the processor; and

alerting a caregiver if the amount of the second medication delivered to the patient does not generally conform to the patient specific treatment information.

4. A fluid-tight disposable assembly for removably dry coupling to a reusable portion of a differential pressure based fluid flow sensor assembly, the disposable assembly comprising:

a sealed disposable body defining a fluid flow passage forming an inlet and an outlet;

a flow restricting element positioned along the fluid flow passage between the inlet and the outlet, wherein the flow restricting element includes an orifice that defines a fluid flow path;

an impermeable fluid pressure membrane comprising;

an impermeable upstream fluid pressure membrane sealing an upstream fluid chamber at a location in the fluid flow passage between the inlet and the flow restricting element; and

an impermeable downstream fluid pressure membrane sealing a downstream fluid chamber at a location in the fluid flow passage between the flow restricting element and the outlet;

wherein the flow restricting element is a separate component secured within the body between the upstream fluid pressure membrane and the downstream fluid pressure membrane.