Drug pump systems and methods

• US 5,935,099 A
• Filed: 01/10/1997
• Issued: 08/10/1999
• Est. Priority Date: 09/09/1992
• Status: Expired due to Term

• Current Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Original Assignee: Sims Deltec, Inc.
• Inventors: Blomquist, Michael L., Peterson, Thomas L.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US08/782,486
• Time in Patent Office: 942 Days
• Field of Search: 604/65, 604/67, 417/18
• US Class Current: 604/65
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• 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: F04B 2203/0208 Power
• CPC Class Codes: F04B 2205/05 Pressure after the pump outlet
• CPC Class Codes: F04B 2205/10 Inlet temperature
• CPC Class Codes: F04B 2205/503 of gas in a liquid flow, e.g. gas bubbles
• CPC Class Codes: F04B 2207/041 of flow
• CPC Class Codes: F04B 2207/042 of pressure
• CPC Class Codes: F04B 2207/043 of time
• CPC Class Codes: F04B 2207/701 Sound
• CPC Class Codes: F04B 43/082 the tubular flexible member being pressed against a wall by a number of elements, each having an alternating movement in a direction perpendicular to the axes of the tubular member and each having its own driving mechanism
• CPC Class Codes: F04B 49/065 and making use of computers
• CPC Class Codes: F04B 51/00 Testing machines, pumps, or pumping installations
• CPC Class Codes: G09B 19/003 Repetitive work cycles; Sequence of movements
• CPC Class Codes: G09B 5/02 with visual presentation of the material to be studied, e.g. using film strip
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection

Abstract

A menu driven reprogrammable drug pump is provided with a memory, such as flash memory, a display, a keyboard, and a communications port to allow a generic pump to be programmed with a desired pump application (therapy) program and patient specific settings. Programming and data transfer with another pump or a computer to and from the patient pump is by the communications port that allows local and/or remote communications with the pump. Flash memory stores the pump application program during use. Patient safety is provided by a cassette identification system, an occlusion detection system, and a latch/lock detection system. Automated testing of the pump is by a closed loop testing system.

Claims

1. A drug pump for dispensing fluid to a patient comprising:

a pump mechanism for pumping fluid;

a processor electrically connected to the pump mechanism;

a flash memory electrically connected to the processor for storing pump application information for control and operation of the pump mechanism;

a communication port electrically connected to the processor to permit transfer of pump application information to the flash memory from an exterior of the pump;

a communications cable sensor associated with the communications port, the communications cable sensor electrically connected with the processor, the communications cable sensor sending a signal to the processor indicative of the presence of a cable plugged into the communication port;

a reprogrammable memory electrically connected to the processor and separate from the flash memory for storing patient specific settings;

a keyboard electrically connected to the processor usable to enter the patient specific settings; and

a display electrically connected to the processor.

2. The drug pump of claim 1, further comprising a boot program stored within the flash memory to permit the initialization and loading of pump application information to the drug pump via the communications port.

3. The drug pump of claim 1, further comprising:

a pump program stored within the flash memory to control operation of the pump mechanism; and

a plurality of patient specific settings stored in the reprogrammable memory, the pump application program accessing the patient specific settings to control operation of the pump mechanism.

4. The drug pump of claim 3, further comprising a plurality of pump application programs stored within the flash memory.

5. The drug pump of claim 4, wherein one of the pump application programs is a closed loop testing application program for closed loop testing of the pumping mechanism.

6. The drug pump of claim 4, wherein one of the pump application programs is a master application program for pump to pump communication.

7. The drug pump of claim 6, wherein one of the pump application programs is a closed loop testing application program for closed loop testing of the pumping mechanism and further comprising:

a cassette identification sensor electrically connected to the processor for identifying a predetermined cassette mounted to the pump mechanism;

an occlusion sensor electrically connected to the processor for detecting an occlusion in a tubing of a cassette mounted to pump mechanism;

a latch for latching a cassette to the pump mechanism;

a lock for locking the latch in the latched state;

a latch sensor electrically connected to the processor for sensing when the latch is in the latched state; and

a lock sensor electrically connected to the processor for sensing when the lock is in the locked state.

8. The drug pump of claim 1, further comprising a cassette identification sensor electrically connected to the processor for identifying a predetermined cassette mounted to the pump mechanism.

9. The drug pump of claim 1, further comprising an occlusion sensor electrically connected to the processor for detecting an occlusion in a tubing of a cassette mounted to pump mechanism.

10. The drug pump of claim 1, further comprising:

a latch for latching a cassette to the pump mechanism;

a lock for locking the latch in the latched state;

a latch sensor electrically connected to the processor for sensing when the latch is in the latched state; and

a lock sensor electrically connected to the processor for sensing when the lock is in the locked state.

11. The drug pump of claim 1, further comprising a cassette mounted to the pump mechanism, the cassette including a tubing, and a pressure plate, the tubing positioned between the pressure plate and the pump mechanism.

12. The drug pump of claim 11, further comprising a fluid reservoir connected to the tubing for fluid communication.

13. The drug pump of claim 1, further comprising a cable and a digital simultaneous voice and data modem connected to the communications port by the cable.

14. The drug pump of claim 1, further comprising autolock program means for automatically locking access to the processor following a reprogramming operation of the drug pump.

15. The drug pump of claim 1 wherein the drug pump has a stop mode and a start mode, further wherein the processor has a first state wherein the processor is responsive to a predetermined key stroke and a second state wherein the processor is unresponsive to the predetermined key stroke, the drug pump further comprising circuitry configured to automatically change the processor from the first state to the second state when the drug pump changes from the stop mode to the start mode.

16. A drug pump for dispensing fluid to a patient, the drug pump comprising:

a pump mechanism;

an external communication port;

a processor being in electrical communication with the pump mechanism and in electrical communication with the external communication port, the processor being programmed to communicate with an external processor via the external communications port; and

a sensor in electrical communication with the processor, the sensor configured to detect when a communication cable is connected to the external communication port and to send an electrical signal to the processor in response to detection of the communication cable.

17. The drug pump of claim 16 wherein the processor and the external communication port are configured to provide data communication according to the RS232 standard.

18. The drug pump of claim 17 wherein the external processor is in a remote drug pump.

19. The drug pump of claim 17 wherein the external processor is in a computer.

20. The drug pump of claim 16 further wherein the signal generated by the sensor is an interrupt signal that interrupts operation of the processor.

21. A drug pump for dispensing fluid to a patient, the pump system comprising:

a pump mechanism for pumping fluid;

a microprocessor configured to control the pump;

an external communications port electronically connected to the microprocessor;

a sensor in electrical communication with the microprocessor, the sensor configured to detect when a communication cable is connected to the external communication port and to send an electrical signal to the microprocessor in response to detection of the communication cable;

memory internal to the pump and electronically connected to the microprocessor, the memory storing a boot program and a plurality of application programs, one of the application programs being a predetermined application program; and

wherein the boot program is configured to launch the predetermined application program and the application programs are configured to control operation of the pump.

22. The drug pump of claim 21 wherein each application program implements a fluid delivery algorithm, the fluid delivery algorithm controlling the amount of fluid that is delivered and the time the fluid is delivered.

23. A method of operating a pump wherein the pump includes a microprocessor and memory in electrical communication with the microprocessor, the memory storing a boot program and a plurality of application programs, one of the application programs being a predetermined pump application program, another one of the application programs being a communication program, the pump further including an external communications port, and a cable sensor both in electrical communication with the microprocessor, the method comprising the steps of:

applying power to the microprocessor and the memory;

executing the boot program;

launching the predetermined pump application program;

executing the predetermined pump application program, wherein the predetermined pump application program controls operation of the pump;

sensing with the cable sensor whether a cable is connected to the external communications port; and

if the cable is sensed, launching and executing the communication program, wherein the microprocessor communicates with an external device through the cable.

24. A drug pump for dispensing fluid to a patient, the pump comprising:

a pump mechanism;

a control system electrically connected to the pump mechanism, the control system including a processor and a keyboard, the keyboard being electrically connected to the processor, the processor being programmed to respond to predetermined keystrokes, the processor being further programmed with a plurality of access locks; and

wherein each access lock, when activated, prevents the processor from responding to a set of predetermined keystrokes;

wherein the pump has a first state in which the pump mechanism does not dispense fluid to the patient and second state in which the pump mechanism does dispense fluid to the patient, one of the access locks being a predetermined access lock, the processor being further configured to automatically activate the predetermined access lock when the pump changes from the first state to the second state.

25. The drug pump of claim 24 wherein each set of predetermined key strokes corresponds to a unique function.

26. A method of operating a drug pump comprising the steps of:

a) unlocking an access lock of a processor of a drug pump;

b) reprogramming a memory of the drug pump connected to the processor after the access lock is unlocked; and

c) after step b), automatically relocking the access lock.

27. A drug pump for dispensing fluid to a patient, the drug pump comprising:

a pump mechanism, the pump mechanism including a motor and a motor controller;

at least one sensor;

a serial communication device electrically connected to a communication port;

a processor; and

a data bus, the data bus providing electrical communication between the processor and the motor controller, the at least one sensor, and the serial communication device, wherein the at least one sensor is an external communication sensor, the external communication sensor configured to generate a signal when a communication cable is connected to the communication port.

28. The drug pump of claim 27 wherein the at least one sensor is an air detector configured to generate a signal when air is detected in the fluid being dispensed to the patient.

29. The drug pump of claim 28 wherein the at least one sensor is a temperature sensor configured to generate a signal indicative of the ambient air temperature.

30. The drug pump of claim 29 wherein the at least one sensor is a motor position sensor configured to generate a signal indicating the position of the motor.

31. A drug pump for dispensing fluid to a patient, the drug pump comprising:

a control module, a cassette, the cassette including a pressure plate including two hooks at one end and a loop at an opposite end, a fluid reservoir and a fluid line in fluid communication with the reservoir, the pressure plate having indicia, the control module having two pins and a latch to attach the hooks and the loop, respectively, of the pressure plate to the control module, the fluid line positioned between the pressure plate and the control module;

a pump mechanism on the control module configured to pump fluid from the reservoir and through the fluid line, the pump mechanism engaging the fluid line against the pressure plate;

an occlusion detector on the control module configured to detect a pressure level in the fluid line;

a latch sensor on the control module and configured to detect the latch in the latched state;

a cassette identification sensor on the control module and configured to detect the indicia on the pressure plate; and

a processor within the control module electrically connected to the pump mechanism, the occlusion detector, the latch sensor, and the cassette identification sensor, the processor configured to disable the pump mechanism upon detection of, a pressure level in the fluid line above or below a predetermined operating range, a failure to detect the latch in the latched state, or a failure to detect the indicia.

32. The drug pump of claim 31, further comprising a lock for locking the cassette to the control module, and a lock sensor configured to detect the lock, the processor configured to disable the pump mechanism upon a failure to detect the lock.

33. A method of operating a drug pump comprising the steps of:

a) selecting a pump operating program from a plurality of different pump operating programs stored on the drug pump;

b) inputting patient specific settings to the drug pump;

c) pumping fluid to a patient with the drug pump;

d) linking the drug pump to a remote caregiver drug pump over a modem connection; and

e) inputting a further patient specific setting to the drug pump from the caregiver drug pump over the modem connection.

34. The method of claim 33, further comprising the steps of:

a) connecting the drug pump to a personal computer and to a fluid analyzer including a flow rate accuracy testing mechanism and a pressure testing mechanism;

b) operating the drug pump through control signals sent from the personal computer; and

c) collecting fluid at the fluid analyzer from the drug pump.

35. The method of claim 33, further comprising the steps of:

a) sending status report data from the drug pump to the caregiver drug pump before step e); and

b) sending status report data from the drug pump to the caregiver drug pump after step e).