Distributed medication delivery system and method having autonomous delivery devices

• US 9,089,642 B2
• Filed: 06/20/2012
• Issued: 07/28/2015
• Est. Priority Date: 06/20/2011
• Status: Active Grant

• Current Assignee: Richard H. Salzar, William H. Murphy Jr
• Original Assignee: Renaudia Medical, LLC
• Inventors: Murphy, William H., Salzar, Richard H.
• Primary Examiner(s): Mendez, Manuel
• Assistant Examiner(s): KOO, BENJAMIN K
• Application Number:
  US13/528,758
• Publication Number:
  US 20120323212A1
• Time in Patent Office: 1,133 Days
• Field of Search: 604 65- 67, 604/131, 604/151, 604/890.1, 604/891.1, 604/93.01, 604/95.01, 128/DIG.12, 128/DIG.13
• US Class Current: 1/1
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• CPC Class Codes: A61M 5/1408 in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• CPC Class Codes: A61M 5/14228 with linear peristaltic action, i.e. comprising at least three pressurising members or a helical member
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: F04C 2270/0421 Controlled or regulated
• CPC Class Codes: G06F 3/0488 using a touch-screen or digitiser, e.g. input of commands through traced gestures
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16H 70/20 relating to practices or guidelines

Abstract

A pump operations module having a base function includes only base function programming in the module itself but is configured to receive advanced delivery programs in a buffer for execution autonomously. An advanced interface module (AIM) is used to prepare advanced delivery programs and upload them to one or more delivery modules as well as monitor the performance of those modules. However, the advanced interface module does not control the execution of those advanced delivery programs by the pump operations modules. The AIM includes a touch screen and access to drug libraries. The AIM will generate graphical slide controls on the touch screen with the minimum and maximum values on the touch screen for the user to create an advanced delivery program for upload, to greatly lessen the risk of errors. Support for PK applications is provided.

Claims

1. A system for the delivery of medication, the system comprising:

a medical delivery operations module comprising a delivery mechanism having a base function of medication delivery at a selectable delivery rate and a selectable delivery volume, the medical delivery operations module further comprising a user interface, a buffer memory, a communications system, an operations module processor, and a base function control program stored in a non-volatile memory that is configured, when accessed and executed, to program the operations module processor to control the operation of the delivery mechanism to perform its base function wherein the operation module processor is connected to the user interface to receive program instructions to set delivery rate and delivery volume at fixed values;

wherein the communications system is configured to receive an advanced medication delivery program from a source outside the medical delivery operations module and store the advanced medication delivery program in the buffer memory, wherein the advanced medication delivery program has a plurality of different values for at least one of the delivery rate and the delivery volume that vary with time; and

wherein the base function control program also programs the operations module processor to access the buffer memory and when an advanced medication delivery program has been completely loaded into the buffer memory and a “

start”

instruction is received from the user interface, to execute the advanced medication delivery program under which the operations module processor automatically varies at least one of the rate of delivery and volume of delivery values in accordance with the advanced delivery program, and wherein the operations module processor is programmed to execute the advanced delivery program residing in the buffer memory autonomously without being under real time control of, or dependent on, any remote processor or data source, including a processor at the source from which the advanced delivery program came, or the user interface, except that the user interface is usable to start and stop the operations module processor in running the advanced delivery program, but neither the user interface nor any other control or data device can be used to change the advanced program.

2. The medication delivery system of claim 1 wherein the advanced medication delivery program stored in the buffer memory comprises a sequence of varying base function operations that may be performed one at a time, with the operations module processor being programmed to access the buffer memory to retrieve a base function operation after an earlier one has been executed.

3. The medication delivery system of claim 1 further comprising an advanced interface module (“

AIM”

) configured to create advanced medication delivery programs, the AIM comprising;

an input device;

a display;

a medication delivery library containing delivery parameters and acceptable values for medications;

an AIM processor configured to prepare an advanced medication delivery program including varying base functions; and

an AIM communication device to communicate an advanced medication delivery program to the communications system of the medical delivery operations module.

4. The medication delivery system of claim 3 wherein the display of the AIM includes a graphical touch screen, wherein the AIM processor is further programmed to display an acceptable range of values for a selected medication on the touch screen and accept a touch of a user to select a particular value in the range, wherein that selected particular value is incorporated into an advanced medication delivery program.

5. The medication delivery system of claim 4 wherein the graphical touch screen displays slide controls for parameters related to an accessed delivery parameter from the medication library, and receives movement of a cursor within the slide control to select a value for the medication.

6. The system of claim 4 wherein the displayed range of values on the AIM for a selected medication includes absolute numbers at each end of the range plus a percentage value for the selected particular value in the range.

7. The system of claim 4 wherein the AIM display comprises a patient population switch that enables the display of drugs for that population as well as the limits for each drug specifically designed for the selected population.

8. The medication delivery system of claim 3 wherein the medical delivery operations module is located in a housing and the advanced interface module is located in a second housing that is separate from the housing of the medication delivery operations module.

9. The medication delivery system of claim 3 wherein the medical delivery operations module is located in a housing and the advanced interface module is located in the same housing.

10. The medication delivery system of claim 3 wherein:

the delivery mechanism of the operations module comprises an infusion pump configured to deliver medication by pumping, wherein the base function of the pump operations module is delivery rate and volume-to-be-infused (“

VTBI”

); and

wherein the advanced interface module processor is programmed to prepare an advanced pumping program for the infusion pump comprising a sequence of varying at least one of delivery rate and/or VTBI values.

11. The system of claim 3 wherein the medical delivery operations module processor is further programmed to control the systems operations of the medical delivery operations module, to monitor those operations, and to display error notices on the delivery operations module user interface independent of the AIM.

12. The system of claim 3 wherein an AIM is programmed to communicate advanced medication delivery programs to a plurality of medical delivery operations modules with which it is simultaneously connected.

13. The system of claim 1 wherein the medical delivery operations module does not include the capability to generate an advanced medication delivery program.

14. The system of claim 1 wherein the advanced delivery program comprises delay starts and a series of rate and volume-to-be-infused commands.

15. The system of claim 1 wherein the medical delivery operations module processor is further programmed by the base function control program to provide medication delivery data through the communications system to a PK simulation while the delivery mechanism is under manual user interface control, to use the drug rate delivery information to continue to track and predict the drug concentration even though it is not controlling that rate.

16. The system of claim 1 wherein the advanced delivery program may be overridden at the user interface by pressing the stop key, at which time the user interface may be used to program at least one of the delivery rate and delivery volume for manual operation of the delivery mechanism, and the user interface includes a continue key that the user may press to return the delivery mechanism to operation under the advanced delivery program.

17. A system for the delivery of medication, the system comprising:

a medical delivery operations module comprising a delivery mechanism having a base function of medication delivery at a selectable delivery rate and a selectable delivery volume, the medical delivery operations module further comprising a user interface, a buffer memory, a communications system, an operations module processor, and a base function control program stored in a non-volatile memory that is configured, when accessed and executed, to program the operations module processor to control the operation of the delivery mechanism to perform its base function wherein the operation module processor is connected to the user interface to receive program instructions to set delivery rate and delivery volume at fixed values, and further to control the systems operations of the medical delivery operations module, to monitor those operations, and to display error notices on the delivery operations module user interface;

wherein the communications system is configured to receive an advanced medication delivery program from a source outside the medical delivery operations module and store the advanced medication delivery program in the buffer memory, wherein the advanced medication delivery program has a plurality of different values for at least one of the delivery rate and the delivery volume that vary with time; and

wherein the base function control program also programs the operations module processor to access the buffer memory and when the advanced medication delivery program has been completely loaded into the buffer memory and a “

start”

instruction is received from the user interface, to execute the advanced medication delivery program under which the operations module processor automatically varies at least one of the rate of delivery and volume of delivery values in accordance with the advanced delivery program, and wherein the operations module processor is programmed to execute the advanced delivery program residing in the buffer memory autonomously without being under real time control of, or dependent on, any remote processor or data source, including a processor at the source from which the advanced delivery program came, or the user interface, except that the user interface is usable to start and stop the operations module processor in running the advanced delivery program, but neither the user interface nor any other control or data device can be used to change the advanced program;

wherein the advanced delivery program may be overridden at the user interface by pressing a stop key, at which time the user interface may be used to program at least one of the delivery rate and delivery volume for manual operation of the delivery mechanism, and the user interface includes a continue key that the user may press to return the delivery mechanism to operation under the advanced delivery program.

18. The system for the delivery of medication of claim 17, wherein the medical delivery operations module processor is further programmed by the base function control program to provide medication delivery data through the communications system to a PK simulation while the delivery mechanism is under manual user interface control, to use the drug rate delivery information to continue to track and predict the drug concentration even though it is not controlling that rate.

19. The system for the delivery of medication of claim 18, wherein the medical delivery operations module does not include the capability to generate an advanced medication delivery program.

20. The system for the delivery of medication of claim 17, further comprising an advanced interface module (“

AIM”

) configured to create advanced medication delivery programs, the AIM comprising;

an input device;

an AIM display;

a medication delivery library containing delivery parameters and acceptable values for medications;

an AIM processor configured to prepare the advanced medication delivery program including varying base functions; and

an AIM communication device to communicate the advanced medication delivery program to the communications system of the medical delivery operations module;

wherein the AIM display comprising a graphical touch screen, wherein the AIM processor is further programmed to display an acceptable range of values for a selected medication on the touch screen and accept a touch of a user to select a particular value in the range, wherein that selected particular value is incorporated into the advanced medication delivery program.