Selectively Controlling Fluid Flow Through a Fluid Pathway

• US 20120325330A1
• Filed: 06/21/2012
• Published: 12/27/2012
• Est. Priority Date: 06/22/2011
• Status: Active Grant

• Current Assignee: CRISI Medical Systems, Inc. (Becton, Dickinson & Co)
• Original Assignee: CRISI Medical Systems, Inc. (Becton, Dickinson & Co)
• Inventors: Prince, Stephen M., Bochenko, Walter John
• Granted Patent: US 10,293,107 B2
• Time in Patent Office: Days
• US Class Current: 137/2
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/6009 for matching patient with his treatment, e.g. to improve transfusion security
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28
• CPC Class Codes: Y10T 137/0324 With control of flow by a condition or characteristic of a fluid
• CPC Class Codes: Y10T 137/7722 Line condition change responsive valves

Abstract

Systems and methods for controlling fluid delivery via a manually administrable medication container to a patient through a fluid delivery pathway are provided. The systems and methods described herein incorporate rules-based clinical decision support logic to drive a flow control valve within a flow pathway to determine whether the IV fluid connected to the input port is consistent with medical orders, accepted delivery protocols, and/or specific patient and patient histories. Related apparatus, systems, methods and articles are also described.

Claims

1. An apparatus comprising:

a fluid inlet configured to couple to an outlet of a manually administrable fluid source having fluid source information encoded thereon;

a fluid outlet configured to deliver fluid from the manually administrable fluid source to a fluid line leading to a patient;

a fluid flow stop disposed between the fluid inlet and the fluid outlet that prevents fluid flow in a first state and permits fluid flow in a second state;

an identification sensor to detect the fluid source information when the manually administrable fluid source is being coupled or is coupled to the fluid inlet; and

a flow state controller to selectively cause the fluid flow stop to transition between the first state and the second state based on the fluid source information detected by the identification sensor.

2. The apparatus as in claim 1, wherein the flow state controller uses a plurality of rules to determine whether to transition the current state of the fluid flow stop to the other state.

3. The apparatus as in claim 2, wherein the flow state controller polls at least one remote data source to obtain at least a portion of the rules.

4. The apparatus as in claim 2, wherein the rules are utilized by a rules engine that takes into account the fluid source information and flow control input data selected from a group consisting of:

fluid information, patient-specific information, medical order information, clinical guideline information, environmental factors, flow control valve status, and historical information.

5. The apparatus as in claim 4, wherein the flow state controller comprises the rule engine and the rules engine is programmable.

6. The apparatus as in claim 1, further comprising:

a fluid composition sensor to characterize composition of the fluid when the manually administrable fluid source is coupled to the fluid inlet; and

wherein the flow state controller further selectively causes the fluid flow stop to transition between the first state and the second state based on the fluid composition detected by the fluid composition sensor.

7. The apparatus as in claim 1, wherein the flow state controller transmits data characterizing the fluid source information detected by the identification sensor to a remote rules engine that sends a signal indicating whether to change the current state of the fluid flow stop.

8. The apparatus of claim 1, wherein the fluid is medication and the fluid source information characterizes one or more of a group consisting of:

medication type, medication concentration, medication volume, medication expiration date, a dosage form of the medication, dose instructions for the medication, administration instructions for a specific patient, medication formulation, medication manufacturer information, a re-packager of the medication, a distributor of the medication, medication package form, medication package size, medication package serial number, medication lot number, blood type, an NDC code (National Drug Code), a segment of an NDC code identifying a corresponding medication product, a segment of an NDC code identifying a corresponding medication package, a unique identifier code, a human readable alphanumeric string, and a machine readable code.

9. The apparatus of claim 1, wherein the fluid source information is a code or identifier used to reference a secondary data set that is characteristic of the fluid contained therein.

10. The apparatus of claim 9, further comprising:

memory storing the secondary data set.

11. The apparatus of claim 9, further comprising:

a remote data store coupled to the flow state controller by at least one network storing the secondary data set.

12. The apparatus of claim 11, wherein the remote data store forms part of a medical device and/or a medical information system.

13. The apparatus of claim 1, wherein the transition between states is automatically initiated and executed by the flow state controller without user intervention.

14. The apparatus of claim 13, wherein the transition between states is automatically initiated and executed by the flow state controller as a result of coupling the fluid source outlet to the fluid inlet.

15. The apparatus of claim 1, further comprising:

an interface to provide audio and/or visual feedback to a user characterizing one or more of the fluid source information, volume of fluid administration, rules engine information, and rules engine output.

16. The apparatus of claim 15, wherein the interface provides an indication to the user when the fluid flow stop is in the first state.

17. The apparatus of claim 15, wherein the interface provides an indication to the user of one or more rules used by a rules engine causing a fluid flow stop state transition.

18. The apparatus of claim 15, wherein the interface provides an indication to the user without a fluid flow stop state transition.

19. The apparatus of claim 15, wherein the interface displays medication administration information associated with the fluid.

20. The apparatus of claim 15, further comprising:

memory storing the medication administration information.

21. The apparatus of claim 20, further comprising:

a communications module to transmit and/or receive the medication administration information to or from a remote data source.

22. The apparatus of claim 15, wherein the interface is adjacent to the fluid inlet.

23. The apparatus of claim 15, wherein the interface is remote from the fluid inlet.

24. The apparatus of claim 1, further comprising:

a manual override element, which when activated by a user, causes the flow state controller to cause the fluid flow stop to transition from the first state to the second state.

25. The apparatus of claim 1, further comprising:

a communications module to transmit and/or receive flow control input data, rules engine output data and/or data characterizing the fluid source to or from a remote data processing apparatus.

26. The apparatus of claim 1, wherein there are a plurality of fluid inlets, each configured to couple to an outlet of one of a plurality of manually administrable fluid sources each having fluid source information thereon.

27. The apparatus of claim 26, wherein there are a plurality of fluid flow stops, each fluid flow stop being coupled to the flow state controller to selectively prevent fluid flow in at least one of the plurality of fluid inlets.

28. The apparatus of claim 1, wherein the fluid flow stop is maintained in the first state until it is determined, by using the fluid source information, to transition the fluid flow stop to the second state.

29. The apparatus of claim 1, wherein the fluid flow stop is maintained in the second state until it is determined, by using the fluid source information, to transition the fluid flow stop to the first state.

30. The apparatus of claim 1, wherein the flow state controller receives data characterizing the patient that is used, in combination with the fluid flow source information, to determine whether to transition the current state of the fluid flow stop.

31. The apparatus of claim 30, wherein the data characterizing the patient comprises at least one medication order, the at least one medication order being used to confirm whether the fluid in the fluid source matches one or more parameters specified by the at least one medication order.

32. The apparatus of claim 30, wherein the data characterizing the patient comprises a patient identifier and the flow state controller polls at least one remote data store using the patient identifier to obtain reference information for the rules engine to determine whether to transition the current state of the fluid flow stop.

33. The apparatus of claim 1, further comprising:

a fluid flow sensor measuring how much fluid has been delivered from the fluid source into the fluid inlet.

34. The apparatus of claim 33, wherein the flow state controller causes the fluid flow stop to transition from the second state to the first state when a predetermined volume has been delivered as measured by the fluid flow sensor.

35. The apparatus of claim 34, further comprising:

an interface providing audio and/or visual feedback indicating how much fluid has been delivered as measured by the fluid flow sensor.

36. The apparatus of claim 33, wherein the flow state controller causes the fluid flow stop to transition from the second state to the first state when a first predetermined volume has been delivered as measured by the fluid flow sensor, and after a pre-determined span of time, causes the fluid flow stop to transition from the first state to the second state.

37. The apparatus of claim 2, wherein the rules engine utilizes flow control input data selected from a group consisting of:

fluid information, patient-specific information, medical order information, clinical guideline information, environmental factors, flow control valve status, and historical information.

38. The apparatus of claim 1, wherein the identification sensor detects the fluid source information using one or more technologies selected from a group consisting of:

optical, magnetic, mechanical, conductive, switchable, infrared, switchable RFID, and proximity sensors.

39. An apparatus as in claim 1, comprising a reusable sub-housing and a disposable sub-housing, the reusable sub-housing being operatively coupled to the disposable sub-housing, wherein the reusable sub-housing is intended for use by a plurality of patients and the disposable sub-housing is intended for use by a single patient.

40. An apparatus as in claim 39, wherein at least the fluid inlet, fluid outlet, flow channel, and fluid flow stop are disposed within the disposable sub-housing.

41. An apparatus as in claim 39, wherein the disposable sub-housing is part of a kit including a sterile pouch enveloping the disposable sub-housing.

42. An apparatus as in claim 39, further comprising:

memory within the disposable sub-housing for storing data that can include flow stop configuration information, flow sensor calibration information, a serial number and/or a unique identification number.

43. The apparatus of claim 1 further comprising:

a housing enveloping at least a portion of each of the fluid inlet, the fluid outlet, the fluid flow stop, the identification sensor, and the flow state controller.

44. The apparatus as in claim 1, wherein the housing has a shape and size allowing a user to hold the housing in a first hand while activating the manually injectable medication container in a second hand.

45. The apparatus of claim 43, further comprising:

a self-contained power source within the housing powering the fluid flow stop, the identification sensor, and the flow state controller.

46. The apparatus of claim 45, wherein the fluid line is an IV fluid line and the housing is suspended on the IV fluid line.

47. The apparatus of claim 1, wherein the manually administrable fluid source is selected from a group consisting of:

syringes, IV bags, disposable medication cartridges, disposable medication pouches, and IV tubing.

48. A method comprising:

detecting, by an identification sensor of a fluid delivery device, fluid source information of a manually administrable fluid source, the fluid delivery device comprising;

a fluid inlet configured to couple to an outlet of the manually administrable fluid source having fluid source information encoded thereon;

a fluid outlet configured to deliver fluid from the manually administrable fluid source to a fluid line leading to a patient;

a fluid flow stop disposed between the fluid inlet and the fluid outlet that prevents fluid flow in a first state and permits fluid flow in a second state;

wherein the identification sensor detects the fluid source information when the manually administrable fluid source is being coupled or is coupled to the fluid inlet; and

a flow state controller to selectively cause the fluid flow stop to transition between the first state and the second state based on the fluid source information detected by the identification sensor;

determining, by using the detected fluid source information, whether to transition the current state of the fluid flow stop to the other state; and

causing, by the flow state controller, the fluid flow stop to transition to the other state if it is determined that the fluid flow stop should transition to the other state;

or

maintaining the current state of the fluid flow stop if it is not determined that fluid flow stop should transition to the other state.

49. An apparatus comprising:

a fluid inlet configured to couple to an outlet of a manually administrable fluid source having fluid source information encoded thereon;

a fluid outlet configured to deliver fluid from the manually administrable fluid source to a fluid line leading to a patient;

a fluid flow stop disposed between the fluid inlet and the fluid outlet that prevents fluid flow in a first state and permits fluid flow in a second state;

an identification sensor to detect the fluid source information when the manually administrable fluid source is being coupled or is coupled to the fluid inlet;

memory storing rules; and

a flow state controller to selectively cause the fluid flow stop to transition between the first state and the second state based on the rules as applied to the fluid source information detected by the identification sensor.

50. An apparatus comprising:

a fluid inlet configured to couple to an outlet of a manually administrable fluid source having fluid source information encoded thereon;

a fluid outlet configured to deliver fluid from the manually administrable fluid source to a fluid line leading to a patient;

a fluid flow stop disposed between the fluid inlet and the fluid outlet that prevents fluid flow in a first state and permits fluid flow in a second state;

an identification sensor to detect the fluid source information when the manually administrable fluid source is being coupled or is coupled to the fluid inlet;

a communications module to transmit and/or receive data to and from at least one remote system storing rules and/or reference information and executing at least one rule; and

a flow state controller to poll, via the communications module, the at least one remote system with the fluid source information, and based on a response from the at least one remote system, selectively cause the fluid flow stop to transition between the first state and the second state.