Safety enhanced device and method for effecting application of a therapeutic agent

• US 5,088,981 A
• Filed: 07/31/1987
• Issued: 02/18/1992
• Est. Priority Date: 01/18/1985
• Status: Expired due to Term

• Current Assignee: Medex Incorporated (Smiths Group International Holdings Ltd.)
• Original Assignee: Ivion Corporation
• Inventors: Smith, Andrew D., Howson, David C., Simonelli, Richard A.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Lacyk, John P.
• Application Number:
  US07/080,405
• Time in Patent Office: 1,663 Days
• Field of Search: 604/31, 604/48-53, 604/65-67, 604/80, 604/90, 604/93, 604/95, 604/119, 604/12, 604/154, 604/246, 128/DIG. 12, 128/DIG. 13
• US Class Current: 604/31
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

Safety enhanced device and method are disclosed for effecting application of a therapeutic agent. A removable and operationally non-volatile programmable element is used to control operation of a therapeutic agent delivery unit. A computer, operationally independent of the delivery unit, is utilized to establish coded information for programming of the programmable element while removed from the delivery unit. Operation of the delivery unit according to the program then established for the programmable element is simulated at the computer prior to actual programming of the programmable element to insure the integrity of subsequent delivery of the therapeutic agent to a patient by the delivery unit. The programmable element effects independent delivery of therapeutic agents in each of a plurality of channels under the control of the programmable element. The programmable element is programmed to establish a flow profile that is customized for a particular patient during each minute of each day, and patient demand for therapeutic agents can also be accommodated with safeguards being included to assure proper dispensing.

Claims

1. A device for effecting application of a therapeutic agent to a patient, said device comprising:

application means including delivery means adapted to deliver a preselected therapeutic agent to a patient with said delivery means having flow control means for controlling the flow of said therapeutic agent from said delivery means, and said application means also including electronic control means for controlling said flow control means with said electronic control means including removable programmable means for establishing a flow profile for said delivery means when said programmable means is programmed and operatively positioned at said application means; and

programming means operationally independent of said application means for establishing a then selected flow profile program and programming said program into said programmable means while said programmable means is removed from said application means, said programming means also simulating operation of said delivery means according to said then selected flow profile program.

2. The device of claim 1 wherein said programmable means is an operationally non-volatile cartridge movable between said application means and said programming means, and wherein said programming means is a general-purpose computer.

3. The device of claim 2 wherein said computer includes database means to provide information so that said computer is responsive to at least patient information, drug information, and delivery unit operating instructions when establishing and simulating said program.

4. The device of claim 1 wherein said programming means includes means to store a series of instructions available to said electronic control means for operation of said flow control means, and wherein said progamming means utilizes said series of instructions along with said program for simulation purposes.

5. The decive of claim 1 wherein said programming means simulates operation of said delivery means prior to programming said program into said programmable means.

6. The device of claim 5 wherein said programming means also calculates proposed delivery of therapeutic agent according to said then selected profile, calculates delivery according to said simulated operation of said delivery means, and compares the calculated results to provide a cross-check function for enhancing safety of operation of said application means.

7. The device of claim 1 wherein said program established by said programming means is coded information when programmed into said programmable means, and wherein said coded information into said progammable means includes patient ID information to further enhance seccuity and safety of subsequent delivery of therapeutic agent by said application means.

8. The device of claim 1 wherein said application means includes refillable reservoir means for containing said therapeutic agent to be delivered by said delivery means, and wherein said device also includes means for preparation of a refill schedule for said reservoir means.

9. The device of claim 1 wherein said programming means also causes printing of at least one of a report of said simulation, a report of therapeutic agent administration, and therapeutic agent administration, and therapeutic agent information carrying labels.

10. The device of claim 1 wherein said delivery means includes channel means defining a plurality of channel for seprately delivering therapeutic agent, wherein said flow control means includes a plurality of controllable units each of which is associated with a different one of said channels, wherein said programmable means controls each of said controllable units, wherein said programming means programs said programmable means so that each of said units operates independently of one another whereby independent flow profile are established for each of said channels, and wherein said programming means simulates operation of each of said controllable units to thereby substantially assure safety of delivery from all of said channels.

11. The device of claim 10 wherein said programming means also provides calculated results of flow profile with respect to each of said channels and calculated results of simulated operation with respect to each of said channels, and providing a cross-check between said calculated results to thereby further assure safety of delivery from all of said channels.

12. A device for effecting application of a therapeutic agent to a patient, said device comprising:

drive means for controlling delivery of a preselected therapeutic agent to a patient;

electronic means including a removable programmable logic cartridge that is substantially operationally non-volatile for being programmed with a flow profile to control operation of said drive means when said programmable logic cartridge is programmed and operatively positioned; and

computer means for establishing a program of a then selected flow profile and receiving said removable programmable logic cartridge and programming the same with a then selected flow profile based upon predetermined parameters of patient need and therapeutic agent capabilities, said computer means also simulating operation of said drive means according to said program prior to programming of said programmable logic cartridge by said computer means to establish simulated operation results and cross-checking said simulated operation results with said then selected flow profile to thereby enhance safety of delivery of therapeutic agent to a patient.

13. The device of claim 12 wherein said computer means includes database means connected with said computer to provide information thereto so that said computer is responsive to at least patient information, durg information, and delivery unit operation instructions when establishing and simulating said program, and wherein said computer means causes printing of at least one of reports and labels for use in association with delivery of therapeutic agent from said device.

14. The device of claim 12 wherein said device has a plurality of channels for separately delivering therapeutic agent to a patient, wherein said drive means includes a separate driver associated with each of said channels with operation of each of said drivers being controlled by said programmable logic cartridge, wherein said programmable logic cartridge is programmed by said computer means to effect a separate flow profile for each of said channels, and wherein said computer means simulates operation of each of said controllable units to establish simulated operation results and provides cross-checking of said simulated operation results with said then selected flow profile with respect to each of said channels to thereby enhance safety of delivery from all of said channels.

15. In a system for effecting application of a therapeutic agent with known therapeutic properties to a patient utilizing therapeutic agent application means, wherein the improvement comprises:

control means for controlling operation of said application means, and a programming system for programming said control means, said programming system including program establishing means for establishing a desired program and means for cross-checking said desired program with said therapeutic properties and said patient history to thereby enhance saftey of delivery of the therapeutic agent to the patient.

16. The programming system of claim 15 wherein said desired program establishing means includes a computer for establishing said desired program therein, and for simulating operation of said control means according to said desired program.

17. The programming system of claim 16 wherein said computer also calculates the resullts of operation according to said desired program and according to said simulating operation and compares said calculated results to one another to further assure safe operation of said application means.

18. A method for effecting application of a therapeutic agent to a patient, said method comprising:

establishing parameters for safe application of said therapeutic agent to a patient;

providing delivery means adapted to deliver said therapeutic agent to a patient;

controlling operation of said delivery means through electronic control means that includes a removable programming element which, when operatively positioned, controls the flow of said therapeutic agent from said delivery means;

establishing a flow profile program through computer means and simulating operation of said delivery means through said computer means utilizing said flow profile program; and

programmming said programmable element with said flow profile program through said computer means only if said simulation of operation of said delivery means through said computer means indicates that delivery of said therapeutic agent according to said flow profile program can be effected within said parameters.

19. The method of claim 18 wherein said method also includes calculating the results of fluid delivery using said established flow profile, calculating the results of fluid delivery adccording to said simulated operation of said delivery means, comparing the calculated results to determine difference therebetween, and utilizing any such differences greater than predetermined difference to further prevent programming of the programmable element.

20. The methods of claim 19 wherein said programmable element is an operatively non-volatile logic cartridge, and wherein said method includes programming said programmable logic cartrige while removed from said delivery means by use of a general-purpose computer.

21. The method of claim 20 wherein said method includes providing a delivery means having a plurality of channels through which therapeutic agent are separately conveyed for delivery to a patient, establishing a program for separately controlling the flow of therapeutic agent through each of channels by said programmable element, simulating operation through each of said channels according to said established program, and programming said programmable element to establish said separate flow profile for each of said channels only if simulation of said operation through all of said channels indicates that said flow through all of said channels can be safely effected.

22. The method of claim 21 wherein said method includes calculating the results of fluid delivery using said selected flow profile for each of plurality of channels, calculating the results of fluid delivery arising from said simulating operation, comparing the calculated results to determine therefrom differences indicative of unsafe flow through any said plurality of channels, and preventing programming of said programmable element if any said unsafe flow indication is determined.

23. A method for effecting application of a therapeutic agent to a patient, said method comprising:

selecting a desired flow profile for a preselected therapeutic agent with respect to a predetermined patient;

simulating a preselected operation of delivery of said therapeutic agent to a patient utilizing said selected profile;

calculating the results of fluid delivery using said selected flow profile and fluid delivery due to said simulated operation and comparing the same to determined differences therebetween;

determining from said simulation operation and said determined comparison differences whether said selected flow profile can be utilized to safely deliver therapeutic agent to a patient using said selected profile;

programming a logic cartridge that is operationally non-volatile to thereby provide said flow profile only if it has been determined that said selected profile can be safely utilized; and

using said programmed logic cartridge to control flow of said predetermined therapeutic agent to said patient.

25. The method of claim 23 wherein said method includes printing an expected drug administration report and therapeutic agent information labels after programming of said logic cartridge to facilitate said use of said programmed logic cartridge.

24. A method for effecting application of a therapeutic agent to a patient, said method comprising:

establishing parameters for the safe application of said agent to said patient;

simulating a preselected operation of delivery of said therapeutic agent to a patient utilizing said selected profile;

calculating the results of fluid delivery using said selected flow profile and fluid delivery due to said simulated operation and comparing the same to determined differences therebetween;

determining from said simulation operation and said determined comparison differences whether said selected flow profile can be utilized within said parameters to deliver therapeutic agent to a patient using said selected profile;

programming a logic cartridge that is operationally non-volatile to thereby provide said flow profile only if it has been determined that said selected profile can be safely utilized; and

using said programmed logic cartridge to control flow of said predetermined therapeutic agent to said patient.