Device and method for effecting application of a therapeutic agent

• US 4,676,776 A
• Filed: 01/18/1985
• Issued: 06/30/1987
• Est. Priority Date: 01/18/1985
• Status: Expired due to Term

• Current Assignee: Medex Incorporated (Smiths Group International Holdings Ltd.)
• Original Assignee: Intelligent Medicine, Inc. (Peninsula Holdings Group Ltd.)
• Inventors: Howson, David C.
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): Shay, David
• Application Number:
  US06/692,895
• Time in Patent Office: 893 Days
• Field of Search: 604/48-53, 604/65-67, 604/80, 604/93, 604/95, 604/119, 604/121, 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: Y10S 128/12 Pressure infusion
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

Device and method are disclosed for effecting application of a therapeutic agent. A removable programmable element is used to control operation of a delivery unit, which unit delivers the therapeutic agent to the patient. The programmable element is programmed, while removed from the delivery unit, by a computer that is operationally independent of the delivery unit to insure the integrity of subsequent delivery of the therapeutic agent to the patient by the delivery unit. The delivery unit requires no microprocessor and can include a plurality of channels for effecting independent delivery of therapeutic agents in each channel under the control of the programmable element. The programmable element is programmed with respect to available protocol information, including patient history, needs and tolerances, as well as therapeutic agent parameters, to thereby establish a flow profile that is customized for a particular patient during each moment of each day. Patient demand for therapeutic agents can also be accommodated with safeguards being included to assure proper dispensing of the demanded agents.

Claims

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

delivery means adapted to deliver a preselected therapeutic agent to a patient and having a controllable element for controlling therapeutic agent flow from said delivery means; and

electronic means for controlling said controllable element and including a pre-programmed removable logic cartridge means providing sole operative memory for said device with said logic cartridge means being substantially operationally non-volatile to thereby provide programmable means in a format capable of implementing complex flow profiles of substantial duration for said delivery means when said programmable means is operatively positioned at said device.

2. The device of claim 1 wherein said delivery means includes a syringe, and wherein said controllable element includes a driver for driving said syringe.

3. The device of claim 1 wherein said delivery means has a plurality of channels for separately conveying therapeutic agent therethrough, wherein said controllable element includes a controllable unit each of which is associated with a different one of said channels, and wherein said programmable means is pre-programmed to effect a separate flow profile for each of said channels.

4. 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 means providing sole operative memory for said drive means with said logic cartridge means being substantially operationally non-volatile to thereby provide programmable means in a format capable of implementing complex flow profiles of substantial duration to control operation of said drive means when said programmable logic cartridge is programmed and operatively positioned; and

computer means for 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.

5. The device of claim 4 wherein said programmable logic cartridge is selected from one of a programmable read-only-memory, an erasable programmable read-only-memory, an electrically erasable read-only-memory, an electrically alterable read-only-programmable memory, a non-volatile random access memory, and a programmable logic array.

6. The device of claim 4 wherein said computer means is a general-purpose computer.

7. The device of claim 4 wherein said device has a plurality of channels for separately delivering therapeutic agent to a patient, and wherein said drive means includes a driver associated with each of said channels, with each of said drivers being controlled by said programmable logic cartridge, and with said programmable logic cartridge being programmed by said computer to effect a separate flow profile for each of said channels.

8. 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 a controllable element for controlling the flow of said therapeutic agent from said delivery means, and said application means also including electronic means for controlling said controllable element with said electronic means including a removable logic cartridge means providing sole operative memory for said application means with said logic cartridge means being substantially operationally non-volatile to thereby provide programmable means in a format capable of implementing complex flow profiles of substantial duration 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 programming a then selected flow profile into said programmable means while said programmable means is removed from said application means to thereby enhance the integrity of said then selected flow profile during subsequent use while operatively positioned at said application means.

9. The device of claim 8 wherein said application means includes a syringe, and wherein said controllable element includes a driver for driving said syringe.

10. The device of claim 8 wherein said logic cartridge is a read-only-memory type device.

11. The device of claim 8 wherein said logic cartridge is one of a programmable read-only-memory, an erasable programmable read-only-memory, an electrically erasable programmable read-only-memory, an electrically alterable progranable read-only-memory, a non-volatile random access memory and a programmable logic array.

12. The device of claim 8 wherein said programming means is a general-purpose computer.

13. The device of claim 12 wherein said device includes program means connected with said computer to provide data-base and assistive programs so that said computer is responsive to patient and drug information, as well as protocol and unit definition information when programming said programmable means.

14. The device of claim 8 wherein said programmable means is programmed by said programming means to cause said flow through said delivery means to deliver said therapeutic agent by one of a time-based and an event-synchronized flow profile.

15. The device of claim 14 wherein said therapeutic agent is one of physical matter and energy, and wherein said flow profile controls delivery of said selected therapeutic agent.

16. The device of claim 8 wherein said delivery means includes channel means defining a plurality of channels for separately delivering therapeutic agent, wherein said controllable element includes a plurality of controllable units each of which is associated with a different one of said channels, wherein said programable means controls each of said controllable units, and wherein said programming means programs said programmable means so that each of said units operates independently of one another whereby independent flow profiles are established for each of said channels.

17. The device of claim 8 wherein said application means includes a controller and memory means connected with said controller for recording the history of therapeutic agent flow from said device.

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

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

controlling operation of said delivery means through electronic means that includes a removable logic cartridge that provides sole operative memory for said application means with said logic cartridge being substantially operationally non-volatile to thereby provide a programmable element in a format capable of implementing complex profiles of substantial duration so that so programmable element, when operatively positioned, establishes the flow profile of said delivery means; and

pre-programming said programmable element while removed from said application means.

19. The method of claim 18 wherein said method includes providing a syringe and a driver for driving said syringe in order to deliver therapeutic agent to said patient.

20. The method of claim 18 wherein said method includes programming said logic cartridge while removed from said delivery means by use of a general-purpose computer.

21. The method of claim 18 wherein said method includes providing a delivery means having a plurality of channels through which therapeutic agents are separately conveyed for delivery to a patient and separately controlling the flow of therapeutic agent through each of channels by said programmable element by pre-programming said programmable element to establish a separate flow profile for each of said channels.

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

determining the parameters of flow for a preselected therapeutic agent with respect to a predetermined patient;

programming a logic cartridge that provides sole operative memory for said application of said therapeutic agent with said logic cartridge being substantially operationally non-volatile to thereby provided a programmable element in a format capable of implementing complex profiles of substantial duration so that said programmable element establishes a flow profile according to the determined parameters of flow for said preselected therapeutic agent; and

using said programmable element to control flow of said predetermined therapeutic agent to said patient.

23. The method of claim 22 wherein said method includes determining the parameters of flow for a plurality of preselected therapeutic agents with respect to a predetermined patient, programming said programmable element with a flow profile according to the determined parameters of flow for each of said preselected therapeutic agents, and using said programmable element to separately control flow of said preselected therapeutic agents to said patient.

24. The method of claim 22 wherein said method includes using a computer to determine said flow parameters.

25. The method of claim 24 wherein user needs and patient history are utilized in said computer to determine said parameters.

26. The method of claim 25 wherein said flow profile is established based upon the toxic threshold of said patient at preselected times of the day to thereby enhance the effectiveness of therapeutic agent delivery to said patient.