SYSTEMS AND METHODS FOR MONITORING AN INJECTION PROCEDURE

• US 20150065956A1
• Filed: 08/30/2013
• Published: 03/05/2015
• Est. Priority Date: 08/30/2013
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Huang, Qiaojian, Li, Youzhi, Hayman, Sarah, Manning, Keith
• Granted Patent: US 9,180,260 B2
• Time in Patent Office: Days
• US Class Current: 604/111
• CPC Class Codes: A61M 2039/242 designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: A61M 5/16813 by controlling the degree of opening of the flow line
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: F16K 15/063 the valve being loaded by a spring
• CPC Class Codes: F16K 31/1221 one side of the piston being spring-loaded
• CPC Class Codes: F16K 37/0075 For recording or indicating the functioning of a valve in combination with test equipment

Abstract

An indicator dilution system includes a catheter configured to deliver an indicator to a patient, an injection device configured to deliver the indicator to the catheter, and a connector coupling the injection device to the catheter. The system also includes one or more sensors configured to acquire measurements from components of the system, which may be used to determine the start and end time of the injection of the indicator to the patient. For example, the one or more sensors may be configured to acquire signals relating to a state of the connector, which may be used to determine whether the connector is in an open state to enable flow of the indicator or in a closed state to reduce flow of the indicator.

Claims

1. A sensor assembly comprising:

a connector comprising;

a first end configured to be coupled to an injection device configured to inject a fluid;

a second end configured to be coupled to tubing configured to deliver the fluid to a patient such that the connector, when coupled, is between the tubing and the injection device;

a lumen extending from the first end to the second end; and

a valve assembly configured to enable flow of the fluid through the lumen when the connector is in an open state and to reduce flow of the fluid through the lumen when the connector is in a closed state; and

a sensor disposed proximate to the connector and configured to generate a signal relating to whether the connector is in the open state or the closed state.

2. The sensor assembly of claim 1, wherein the valve assembly comprises:

a valve stem configured to move relative to a housing of the connector into an open position and an closed position, wherein connector is in the closed state when the valve stem is in the closed position and is in the open state when the valve stem is in the open position; and

a biasing member coupled to the valve stem and configured to bias the valve stem in the closed position, wherein the valve stem is configured to move to the open position when the injection device delivers the fluid to the connector at a pressure above a predetermined threshold.

3. The sensor assembly of claim 2, wherein the connector is a pressure-activated luer check valve.

4. The sensor assembly of claim 2, wherein the sensor is an optical sensor, and wherein the optical sensor is configured to generate a signal relating to the position of the valve stem.

5. The sensor assembly of claim 4, wherein an optical path of the optical sensor is substantially perpendicular to movement of the valve stem.

6. The sensor assembly of claim 4, wherein the valve stem is opaque, and wherein the housing of the connector is at least partially transparent.

7. The sensor assembly of claim 4, wherein the optical sensor comprises an emitter and a detector disposed in a sensor housing, and wherein the sensor housing is configured to position the emitter and the detector about the connector such that the valve stem blocks at least a portion of an optical path of the optical sensor when the valve stem is in the closed position and does not block the optical path when the valve stem is in the open position.

8. The sensor assembly of claim 4, wherein the optical sensor comprises an emitter and a detector disposed in a sensor housing, and wherein the sensor housing is configured to position the emitter and the detector about the connector such that the valve stem blocks at least a portion of the optical path when the valve stem is in the open position and does not block the optical path when the valve stem is in the closed position.

9. The sensor assembly of claim 8, wherein the sensor housing comprises an alignment feature configured to mate with a complementary alignment feature of the connector.

10. The sensor assembly of claim 1, wherein the sensor assembly is removably coupled to the tubing and the injection device.

11. The sensor assembly of claim 2, wherein the valve stem is metal, and wherein the sensor comprises a coil, and wherein movement of the valve stem induces a current in the coil of the sensor.

12. A system comprising:

a connector configured to interface between an injection device configured to inject a fluid and a catheter configured to deliver the fluid to a patient, wherein the connector comprises;

a lumen extending from a first end of the connector to a second end of the connector; and

a valve assembly configured to enable flow of the fluid through the lumen when the connector is in an open state and to reduce flow of the fluid through the lumen when the connector is in a closed state;

a sensor disposed proximate to the connector and configured to generate a signal relating to the state of the connector; and

a monitor comprising a processor configured to receive the signal from the sensor and to determine a start time and an end time of an injection procedure based at least in part upon the signal, wherein the start time of the injection is based at least in part upon a determination that the connector is in the open state and the end time of the injection is based at least in part upon a determination that the connector is in the closed state.

13. The system of claim 12, wherein the valve assembly comprises:

a valve stem configured to move relative to a housing of the connector into an open position and an closed position, wherein connector is in the closed state when the valve stem is in the closed position and is in the open state when the valve stem is in the open position; and

a biasing member coupled to the valve stem and configured to bias the valve stem in the closed position; and

wherein the valve stem is configured to move to the open position when the injection device delivers the fluid to the connector at a pressure above a predetermined threshold.

14. The system of claim 13, wherein the sensor is an optical sensor, and wherein the optical sensor is configured to generate a signal relating to the position of the valve stem.

15. The system of claim 13, wherein the sensor comprises a sensor body configured to surround at least a portion of the connector corresponding to the valve assembly.

16. The system of claim 15, wherein the sensor comprises an emitter and a detector, and wherein the sensor body is configured to position the emitter and the detector about the connector such that at least a portion of an optical path of the sensor is interrupted by the valve stem when the valve stem is in the closed position and the optical path is not interrupted by the valve stem when the valve stem is in the open position.

17. The system of claim 13, wherein the processor is configured to determine the start time of the injection based at least in part upon a determination that the valve stem moved from the closed position to the open position.

18. A method comprising:

using a processor to;

receive two or more signals from a sensor indicative of a state of a valve assembly, wherein the state of the valve assembly comprises an open state or a closed state;

determine whether the valve assembly is in the open or closed state based at least in part upon the received signals;

determine a start time of an injection procedure based at least in part upon the determination that the valve assembly is in the open state; and

determine an end time of the injection procedure based at least in part upon the determination that the open state of the valve assembly is followed by the closed state.

19. The method of claim 19, wherein determining the start time of the injection procedure comprises using the processor to:

receive a baseline signal from the sensor prior to the injection procedure;

determine that the valve assembly is in the closed position based at least in part upon the baseline signal; and

determine that the valve assembly is in the open position based at least in part upon a second signal from the sensor, wherein the second signal is received after the baseline signal.

20. The method of claim 19, comprising determining an indicator dilution using the start time and the end time.