Systems and methods for monitoring an injection procedure

• US 9,180,260 B2
• Filed: 08/30/2013
• Issued: 11/10/2015
• 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
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US14/015,676
• Publication Number:
  US 20150065956A1
• Time in Patent Office: 802 Days
• US Class Current: 1/1
• 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;

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

an optical sensor configured to generate a signal relating to whether the connector is in the open state or the closed state, wherein the optical sensor comprises a sensor housing, an emitter, and a detector, and the sensor housing is removably attachable to an exterior surface of the connector, and wherein the sensor housing comprises a flexible substrate configured to at least partially wrap around the connector and an adhesive layer to removably attach the sensor housing to the exterior surface of the connector.

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 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 5, 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 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 5, 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 of the optical sensor 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 1, 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 1, wherein the first end is removably attachable to a complementary mating connector of the injection device.

12. The sensor assembly of claim 1, wherein the sensor comprises a memory storing a first light intensity threshold indicative of a blocked optical path, a second light intensity threshold indicative of an unblocked optical path, or both.

13. The sensor assembly of claim 1, wherein the optical sensor comprises a pulse oximetry sensor.

14. A sensor assembly, comprising:

a connector comprising;

a first end removably attachable to an injection device;

a second end removably attachable to tubing configured to deliver a fluid from the injection device to a patient such that the connector, when attached, is between the tubing and the injection device;

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

a valve assembly extending into the lumen 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 bandage-type sensor coupled to an exterior surface of the connector and positioned to detect whether the connector is in the open state or the closed state.

15. The sensor assembly of claim 14, wherein the bandage-type sensor comprises an adhesive layer configured to removably attach the bandage-type sensor to the exterior surface of the connector.

16. The sensor assembly of claim 14, wherein the valve assembly comprises:

a valve stem movable relative to a housing of the connector into an open position and an closed position, wherein the 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 biasing the valve stem toward the closed position, wherein the valve stem is movable into the open position when the injection device delivers the fluid to the connector at a pressure above a predetermined threshold;

wherein the bandage-type sensor is configured to generate a signal relating to a position of the valve stem.

17. The sensor assembly of claim 16, wherein the connector is a pressure-activated luer check valve.

18. The sensor assembly of claim 16, wherein the bandage-type sensor is configured to generate a signal relating to the position of the valve stem.

19. The sensor assembly of claim 18, wherein the valve stem is opaque, and wherein the housing of the connector is at least partially transparent.

20. The sensor assembly of claim 18, wherein the bandage-type sensor comprises an emitter and a detector, and wherein an optical path of the bandage-type sensor is substantially perpendicular to movement of the valve stem.

21. The sensor assembly of claim 20, wherein a sensor housing of the bandage-type sensor 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 of the bandage-type 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.

22. The sensor assembly of claim 20, wherein a sensor housing of the bandage-type sensor 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 of the bandage-type sensor 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.

23. The sensor assembly of claim 20, wherein the bandage-type sensor comprises a memory storing a first light intensity threshold indicative of a blocked optical path, a second light intensity threshold indicative of an unblocked optical path, or both.

24. 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

an optical sensor configured to generate a signal relating to whether the connector is in the open state or the closed state, wherein the optical sensor comprises a sensor housing, an emitter, and a detector, and the sensor housing is removably attachable to an exterior surface of the connector, and wherein the optical sensor comprises a bandage-type pulse oximetry sensor, and wherein the bandage-type pulse oximetry sensor is configured to be wrapped around the exterior surface of the connector.

25. The sensor assembly of claim 24, 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.

26. The sensor assembly of claim 25, wherein the connector is a pressure-activated luer check valve.

27. The sensor assembly of claim 25, wherein the bandage-type pulse oximetry sensor is configured to generate a signal relating to the position of the valve stem.

28. The sensor assembly of claim 27, wherein the valve stem is opaque, and wherein the housing of the connector is at least partially transparent.

29. The sensor assembly of claim 27, wherein an optical path of the bandage-type pulse oximetry sensor is substantially perpendicular to movement of the valve stem.

30. The sensor assembly of claim 29, 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 of the bandage-type pulse oximetry 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.

31. The sensor assembly of claim 29, 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 of the bandage-type pulse oximetry sensor 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.

32. The sensor assembly of claim 24, wherein the sensor housing comprises an alignment feature configured to mate with a complementary alignment feature of the connector.

33. The sensor assembly of claim 24, wherein the sensor assembly is removably coupled to the tubing and the injection device.

34. The sensor assembly of claim 24, wherein the first end is removably attachable to a complementary mating connector of the injection device.

35. The sensor assembly of claim 24, wherein the bandage-type pulse oximetry sensor comprises a memory storing a first light intensity threshold indicative of a blocked optical path, a second light intensity threshold indicative of an unblocked optical path, or both.