Selectively Controlling fluid flow through a fluid pathway

Patent metadata

Field	Value
Publication number	US-10293107-B2
Application number	US-201213529876-A
Country	US
Kind code	B2
Filing date	Jun 21, 2012
Priority date	Jun 22, 2011
Publication date	May 21, 2019
Grant date	May 21, 2019

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.

First claim

What is claimed is:

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;
a fluid flow sensor disposed between the fluid inlet and the fluid outlet for measuring a specific value of how much fluid has been delivered from the manually administrable fluid source into the fluid inlet;
a flow state controller to selectively cause the fluid flow stop to transition between the first state and the second state automatically in response to the fluid source information being detected by the identification sensor, wherein the flow state controller causes the fluid flow stop to transition from the second state to the first state when a predetermined volume of fluid has been delivered as measured by the fluid flow sensor;
a housing including a reusable sub-housing and a disposable sub-housing, the disposable sub-housing enveloping at least a portion of each of the fluid inlet, the fluid outlet, and the fluid flow stop, wherein the fluid inlet and the fluid outlet are configured relative to the disposable sub-housing such that they are available for external connections, wherein the disposable sub-housing is operatively coupled to the reusable 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; and
a memory within the disposable sub-housing storing a characteristic of a fluid flow path between the fluid inlet and the fluid outlet, a number of fluid inlets, a number of flow control valves, and an arrangement of the flow control valves.

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

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 of claim 2 , wherein the flow state controller uses a rules engine that utilizes flow control input data to determine whether to transition the fluid flow stop between the states, wherein the flow control input data is 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 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.

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

7. The apparatus of claim 5 , further comprising: a communications module configured to transmit at least one of the flow control input data, rules engine output data, and data characterizing the manually administrable fluid source to a remote data processing apparatus and receive the at least one of the flow control input data, the rules engine output data, and the data characterizing the manually administrable fluid source from the remote data processing apparatus.

8. The apparatus of claim 5 , further comprising: an interface to provide at least one of audio and visual feedback to a user characterizing one or more of the fluid source information, a volume of fluid administration from the manually administrable fluid source, rules engine information, and rules engine output.

9. The apparatus of claim 8 , wherein the interface provides an indication to the user when the fluid flow stop is in the first state.

10. The apparatus of claim 8 , wherein the interface provides an indication to the user of one or more of the rules used by the rules engine causing a fluid flow stop state transition.

11. The apparatus of claim 8 , wherein the interface provides an indication to the user without a fluid flow stop state transition.

12. The apparatus of claim 8 , wherein the interface displays medication administration information associated with the fluid.

13. The apparatus of claim 8 , wherein the memory stores medication administration information.

14. The apparatus of claim 13 , further comprising: a communications module configured to transmit the medication administration information to a remote data source and receive the medication administration information from the remote data source.

15. The apparatus of claim 8 , wherein the interface is adjacent to the fluid inlet.

16. The apparatus of claim 8 , wherein the interface is remote from the fluid inlet.

17. 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 composition detected by the fluid composition sensor.

18. 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 state of the fluid flow stop.

19. 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.

20. The apparatus of claim 1 , wherein the fluid source information is a code or an identifier used to reference a secondary data set that is characteristic of the fluid contained in the manually administrable fluid source.

21. The apparatus of claim 20 , wherein the memory stores the secondary data set.

22. The apparatus of claim 20 , further comprising: a remote data store coupled to the flow state controller by at least one network storing the secondary data set.

23. The apparatus of claim 22 , wherein the remote data store forms part of at least one of a medical device and a medical information system.

24. The apparatus of cl

Assignees

• Prince Stephen Michael
• Bochenko Walter John
• Crisi Medical Systems Inc

Inventors

• Prince Stephen Michael
• Bochenko Walter John

Classifications

• Y10T137/0324

  With control of flow by a condition or characteristic of a fluid · CPC title

• A61M2205/6009

  for matching patient with his treatment, e.g. to improve transfusion security · CPC title

• A61M2205/3561

  local, e.g. within room or hospital · CPC title

• A61M5/16881 Primary

  Regulating valves (on-off valves, e.g. clamps A61M39/28) · CPC title

• Y10T137/7722

  Line condition change responsive valves · CPC title