Drug identification and security apparatus for infusion and pumping systems

• US 5,445,621 A
• Filed: 11/09/1993
• Issued: 08/29/1995
• Est. Priority Date: 12/20/1991
• Status: Expired due to Term

• Current Assignee: Hospira Incorporated (Pfizer Inc.)
• Original Assignee: Abbott Laboratories
• Inventors: Chamness, Leland D., Burnside, Robert R., Johnson, Noel L., Huang, J. Terry, Poli, Robert G., Thomas, V. Stanton
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/149,248
• Time in Patent Office: 658 Days
• Field of Search: 604/67, 604/83, 604/110, 604/131, 604/151-155, 604/246, 128/DIG. 12
• US Class Current: 604/246
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements

Abstract

A drug identification and security apparatus usable in conjunction with an electronic drug delivery system having at least one drug channel therein, the apparatus providing a first interlock mechanism between a locking member of the apparatus and the drug delivery system to lock the upper and lower doors of the drug channel and to disengage the drug delivery system and prevent removal of a drug container/cassette assembly when the locking member is in a locked position. A second interlock mechanism is interposed between a bar code reading device usable with the drug delivery apparatus and a sensor provided on the drug delivery system, the sensor assuring the placement of a cassette assembly in a drug channel with a scanner activating a switch to enable the scanner to read identifying indicia provided on a drug container of a cassette assembly installed in the drug channel, and both cassette sensor and scanner switch must be activated to enable a scan of a drug container installed in the drug channel, to enable the drug delivery system to deliver the drug in the container through the drug channel to the patient receiving a drug dosage in a controlled amount and at a controlled delivery rate.

Claims

1. An electronic drug delivery system comprising at least one pump mechanism having upper and lower doors, a pump cassette assembly disposable in said pump mechanism, said upper and lower doors to open to enable installation of the cassette assembly therein, and a drug identification and security apparatus usable with said drug delivery system, said apparatus including:

a pivotable structure operatively disposed between the upper and lower doors to effect conjoint opening and closing thereof;

a latching portion provided in the pivotable structure;

a pivotable locking bale, movable between a lock position in which the upper and lower doors are closed and the bale engages the latching portion of the pivotable structure to hold the doors closed, and an unlock position, in which the bale disengages the latching portion of the pivotable structure to enable opening of the doors;

an interrupt mechanism electronically connected to the pump mechanism and interposed between the locking bale and the pump mechanism to selectively interrupt operation of the pump mechanism when the bale moved from the lock to the unlock position; and

a key lock associated with the pivotable bale to move said bale between said lock and unlock positions.

2. An electronic drug delivery system as claimed in claim 1 wherein the interrupt mechanism includes a normally open micro-switch connected to the drug delivery system which is closed when the locking bale engages the micro-switch in an unlock position for the locking bale to operate the system and normally open when the locking bale engages the pivotable structure in a lock position of the bale to interrupt the system.

3. An electronic drug delivery system as claimed in claim 1, wherein the upper door of the pump mechanism comprises an enclosing hood for the drug container, said upper door and hood having disposed at a conjoint forward portion thereof an open drug identification window.

4. An electronic drug delivery system as claimed in claim 3 wherein the apparatus includes a reading device electronically connected to the system for reading identifying indicia on the drug container installed in the pump mechanism;

and an interlock interposed between the reading device and the pump mechanism to initiate a scan of the drug container installed in the pump mechanism, the interlock including;

a cassette presence sensor provided in the pump mechanism to engage a cassette assembly held in the closed door of the mechanism;

a sensor disposed in the reading device and a sensing device fixedly mounted in the pump mechanism adjacent the drug identification window thereof, a drug container of a cassette assembly mounted in the pump mechanism, and having identifying indicia provided thereon, said indicia displayed in said drug identification window, and controlling means structure in the system to receive inputs from the sensors, initiate the reading, and receive information from the reading device, whereby engagement of the sensor in the reading device with the sensing device in the pump mechanism activates the reading device to read the identifying indicia on the drug container and transmit information coded thereon to the drug delivery system, when the cassette presence sensor is activated in conjunction therewith.

5. An electronic drug delivery system as claimed in claim 4 wherein the reading device is a bar code reader and the identifying indicia provided on the drug container is a specific bar code identifier for the drug within the container.

6. A drug delivery system, said system comprising a plurality of drug delivery channels, each of which comprises a pump mechanism having upper and lower doors, a pump cassette assembly disposable in each of said pump mechanisms, said upper and lower doors to open to enable installation of a pump cassette assembly therein, and a drug identification and security apparatus usable with said drug delivery system, said apparatus including:

a pivotable structure operatively disposed between the upper and lower doors to effect conjoint opening and closing thereof;

a latching portion provided in the pivotable structure;

a pivotable locking bale, movable between a lock position in which the upper and lower doors are closed and the bale engages the latching portion of the pivotable structure to hold the doors closed and an unlock position, in which the bale disengages from the latching portion of the pivotable structure to enable opening of the doors;

an interrupt mechanism electronically connected to the pumping mechanism and interposed between the locking bale and the drug delivery apparatus to selectively interrupt operation of the pump mechanism when the bale moves from, the lock to the unlock position; and

a key lock associated with the pivotable bale to move said bale between said lock and unlock positions.

7. An electronic drug delivery system as claimed in claim 6 wherein the interrupt mechanism includes a normally open micro-switch connected to the drug delivery system, which is closed when the locking bale engages the micro-switch in an unlock position for the locking bale to operate the system and normally open when the locking bale engages the pivotable structure in a lock position of the bale to interrupt the system.

8. An electronic drug delivery system as claimed in claim 6, wherein the upper door of the pump mechanism comprises an enclosing hood for the drug vial, said upper door and hood having disposed at a conjoint forward portion thereof an open drug identification window.

9. An electronic drug delivery system as claimed in claim 8 wherein the system includes a reading device electronically connected to the system for reading identifying indicia provided on the drug container installed in the pump mechanism, said apparatus including an interlock mechanism interposed between the reading device and each drug channel to assure the placement of the cassette assembly including the drug container in the appropriate drug channel at the drug identification window, the interlock including:

a cassette presence sensor provided in each pump mechanism to engage a cassette assembly held in the closed door of the mechanism;

a sensor disposed in the reading device, and a sensing device fixedly mounted in each drug channel adjacent the drug identification window thereof, a drug container of a cassette assembly mounted in each drug channel of the drug delivery system, and having identifying indicia provided thereon, said indicia displayed in said window, and controlling means structure in the system to receive inputs from the sensors, initiate the reading, and receive information from the reading device, whereby engagement of the sensor in the reading device with the sensing device in the drug channel activates the reading device to read the identifying indicia on the drug container and transmit information coded thereon to the drug delivery system, when the cassette presence sensor is activated in conjunction therewith.

10. An electronic drug delivery system as claimed in claim 9 wherein the reading device is a bar code reader and the identifying indicia provided on the drug container is a specific bar code identifier for the drug within the container.

11. A electronic drug delivery system, said system comprising at least one pump mechanism having a pump cassette assembly therein, a drug container provided in the cassette assembly, said container having identifying indicia thereon, said drug identification and security apparatus including:

a reading device interconnected with the system, said reading device having sensors for reading an identifying indicia provided on the drug container, said system including a controlling means to interact with the reading device and its sensors;

and an interlock interposed between the reading device and the pump mechanism including a cassette presence sensor in the mechanism, an activating magnet on the reading device and a switch fixedly mounted on the mechanism, said sensor to be activated by the presence of a cassette in the mechanism and said switch to be activated by the proximity of the magnet on the reading device, to enable the apparatus to read the identifying indicia on the drug container.

12. An electronic drug delivery system comprising at least one pump mechanism having a pump cassette assembly therein, and a drug container provided in the cassette assembly, and a security apparatus including:

upper and lower doors of the pump mechanism, said upper and lower doors selectively held closed and opened by a pivotal structure interconnected therewith, said open doors to permit installation and removal of a drug container within the pump mechanism disposed in the system, a latching portion provided on the pivotal structure, a locking bale pivotally mounted on the pump mechanism for engagement with the latching portion of the pivotal structure and movable between a lock position in engagement with the latching portion of the pivotal structure and an unlock position disengaged with respect to said latching portion; and

a normally open position sensor electronically connected to the system which is disengaged to electronically interrupt the drug delivery system when the locking bale moves out of engagement with the sensor and into engagement with the latching portion of the pivotal structure in a lock position therefor.

13. An electronic drug delivery system, said system including a security apparatus comprising:

a cassette assembly holding compartment having pivotal upper and lower outer doors to open and close said compartment;

a door operating structure for selectivally preventing and enabling opening of said upper and lower doors, said door operating structure including an over-center apparatus engaging the lower door;

a connecting link between the upper door and the over-center apparatus of the lower door;

a latching member pivotally mounted on said compartment;

biasing means for biasing the latching member into latching engagement with said connecting link; and

a cam arrangement interconnected to said latching member and operable against the bias of the latching member to disengage said member from said connecting link, whereby disengagement of the latching member from the connecting link by the cam arrangement selectively prevents and enables opening of said upper and lower doors by the movement of the door operating structure through the link connected to the upper door, and said over-center apparatus includes further biasing means operable to retain the lower door closed against lateral forces directed at the lower door only.

14. An electronic drug delivery system as claimed in claim 13 wherein a switch is interposed between a frame member of the cassette holding compartment and the latching member, said switch normally open to electronically interrupt the electronic drug delivery system when the latching member is biased into latching engagement with said connecting link, and said switch engaged by the latching member when the latching member is disengaged from the connecting link so as to electronically operate the electronic drug delivery system.

15. An electronic drug delivery system as claimed in claim 14 wherein said electronic drug delivery system includes a microprocessor and a first input from the switch to the microprocessor will electronically disable the microprocessor when the latching member associated with the door operating structure is biased into latching engagement with said connecting link and a second input from the switch to the microprocessor will electronically activate the microprocessor when the latching member is disengaged from the connecting link.

16. An electronic drug delivery system as claimed in claim 13 wherein said apparatus includes a reading device interconnected to the system to read identifying indicia provided on a drug container associated with a cassette assembly installed in the cassette holding compartment of the drug delivery system and an interlock switch disposed in said compartment and interconnected between the reading device and the system which prevents the reading device from reading the identifying indicia provided on the drug container unless the cassette assembly is inserted in the cassette holding compartment and the upper and lower doors of said cassette holding compartment are closed.

17. An electronic drug delivery system as claimed in claim 16 wherein the interlock includes a cassette presence sensor which is activated when the cassette assembly is inserted in the cassette holding compartment and the upper and lower outer doors of the compartment are closed to hold the cassette assembly in an operating position within the compartment, an open window between the upper and lower doors of the compartment to admit a reading device associated with the system, a switch disposed in the lower door of the compartment adjacent the window, and a device sensor disposed in the reading device, whereby the cassette presence sensor and the door switch are cooperatively interactive when a cassette is held in the compartment in an operating position of the electronic drug delivery system, controlling means structure in the system to receive inputs from the sensors, initiate the reading, and receive information from the reading device, and activation of the cassette presence sensor enables activation of the door switch by the device sensor to enable reading of the indicia on the drug container received in the cassette assembly holding compartment.

18. An electronic drug delivery system as claimed in claim 13 wherein the over-center apparatus is mounted on a frame of of said compartment and includes a pivotal over-center member carrying an elongated cam track on one side thereof, said cam track receiving a cam follower of the lower door, said cam follower mounted on the lower door to traverse the cam track between an open and closed position of the lower door.

19. An electronic drug delivery system as claimed in claim 18 wherein a lower end of the cam track provided on the over-center member is open and a flat stainless steel spring is mounted on a flat outer face of the over-center member, said stainless steel spring bent to close at an outer end of the cam track to hold the cam follower of the lower door within the cam track and movable away from the over-center member to permit the cam follower to be released therefrom to permit the lower door to fully pivot around a lower pivot point thereof.

20. An electronic drug delivery system as claimed in claim 19 wherein the over-center apparatus includes a slidable link pivotally mounted to the over-center member at one end and a cam track engaging a fixedly mounted point on the frame of the said compartment at an opposite end.

21. An electronic drug delivery system as claimed in claim 20 wherein the slidable link includes a tension spring mounted between the fixed mounted point and a second point generally located at a mid-portion of the link, the spring operative to assist in driving the over-center member around a central pivot point thereof to a over-center position in which the lower door of the cassette holding compartment is fully closed.

22. An electronic drug delivery system as claimed in claim 21 wherein the connecting link is a generally S-shaped link which has a bottom end pivotally connected to the over-center member and an upper end pivotally mounted to the upper door of the cassette holding compartment, whereby pivoting of the upper door to an open position pivots the upper connecting point upward to translate the S-shaped link upward and pivot the over-center member about its central pivot point and selectively prevents and enables opening of the lower door.

23. An electronic drug delivery system as claimed in claim 22 wherein the S-shaped link includes an upper leg portion having a latch receiving notch therein.

24. An electronic drug delivery system as claimed in claim 23 wherein the latching member comprises a latching bale rotatably mounted in opposite side walls of said compartment, the latching bale including a closed lower portion engaging a pin about which the bale rotates, a mid leg portion, an upper hook portion and a biasing spring which in a latching position of the latching bale biases said hook portion into the latching notch of the S-shaped member of the door operating structure.

25. An electronic drug delivery system as claimed in claim 24 wherein a key lock includes an associated cam, said cam engaging the latching bale and movable to a first position which enables the latching bale to engage the latching notch of said S-shaped member of the door operating structure in a locking position which holds the upper and lower door closed, said cam movable to a second position to move the latching bale out of engagement with the notch of the S-shaped link to enable said upper and lower doors to be opened.

26. An electronic drug delivery system including drug identification and security apparatus comprising:

a cassette holding compartment having pivotal upper and lower outer doors to open and close said compartment;

a door operating structure for simultaneously opening and closing said upper and lower doors, said door operating structure including an over-center apparatus engaging the lower door;

a connecting link between the upper door and the over-center apparatus;

a latching member pivotally mounted on said compartment;

biasing means for biasing the latching member into latching engagement with said connecting link;

a cam arrangement interconnected to said latching member and operable against the bias of latching member to disengage said member from said connecting link;

a cassette presence sensor disposed in the cassette holding compartment and operative when a cassette assembly is installed in the cassette holding compartment and the upper and lower doors are closed to hold the cassette assembly within the cassette holding compartment;

a scanning window disposed in the compartment between the upper and lower doors to provide access to scanning indicia disposed on a drug container of the cassette assembly;

a scanner electronically connected to the electronic drug delivery system and operative to read the identifying indicia provided on the drug container installed in the cassette holding compartment;

a switch disposed in the lower door of the cassette holding compartment and adjacent the scanning window of the compartment;

a sensor disposed on the scanner so as to be placed in close proximity to the switch on the lower door of the cassette holding compartment when the scanner is disposed adjacent the scanning window of the compartment; and

controlling means structure in the system to receive inputs from the sensors, initiate the reading, and receive information from the reading device, whereby the cam arrangement moves the latching member out of engagement with the connecting link enabling said upper and lower doors to be opened by the movement of the door operating structure through the connecting link, and said over-center apparatus includes further biasing means operable to retain the lower door closing against lateral force is directed at the lower door only and, when the upper and lower doors are closed, the scanner sensor is operative to read the identifying indicia provided on the drug container in the cassette assembly holding compartment when the cassette sensor switch in the compartment is activated therewith.

27. An electronic drug delivery system including drug identification and security apparatus comprising:

a cassette holding compartment having pivotal upper and lower outer doors to open and close said compartment;

a scanning window disposed in said cassette holding compartment at a conjoint forward position of said closed upper and lower doors;

a cassette presence sensor provided in said compartment and operative when a cassette assembly is installed in said compartment and the upper and lower doors are closed;

a switch disposed in one of the doors of the compartment and adjacent the scanning window thereof;

a scanning device electronically connected to the drug delivery system and operable to be inserted into the scanning window of the cassette holding compartment;

a sensor so positioned on the scanning device as to be brought in close proximity to the switch on the cassette holding compartment when the scanning device is inserted into the scanning window of the compartment; and

controlling means structure in the system to receive inputs from the sensors, initiate the reading, and receive information from the reading device, whereby activation of the cassette presence sensor will enable activation of the switch provided in the scanning window to enable the scanning device to read identifying indicia provided on a drug container of a cassette assembly, said drug container disposed at the scanning window of the cassette holding compartment.

28. An electronic drug delivery system including drug identification and security apparatus comprising:

a holding compartment having open and closed positions;

an operating structure opening and closing said compartment;

a container presence sensor disposed in the holding compartment and operative when a drug container is installed in the holding compartment and the compartment is closed to hold the drug container therein;

a scanner access to provide access to identifying indicia disposed on a drug container installed in the compartment;

a scanning device electronically connected to the electronic drug delivery system and operative to read the identifying indicia provided on the drug container installed in the compartment;

a switch disposed adjacent the scanner access of the compartment;

a sensor disposed on the scanning device so as to be placed in close proximity to the switch on the holding compartment when the scanning device is inserted into the scanner access of the compartment and controlling means structure in the system to receive inputs from the sensors, initiate the reading, and receive information from the reading device;

whereby, when the compartment is closed the scanner sensor is activated by said controlling means structure in the system to read the identifying indicia provided on the container in the holding compartment when the container presence sensor in the compartment is activated therewith, in a time sequence which prevents the scanner from operating on a drug container not installed in the compartment.

29. An electronic drug delivery system including a drug identification and security apparatus comprising:

a holding compartment;

a scanner access disposed in said holding compartment;

a container presence sensor provided in said compartment and operative when a drug container is installed in said compartment;

a switch disposed on said compartment;

a scanning device electronically connected to the drug delivery system and operable to be inserted into the scanner access of the holding compartment;

a scanning sensor so positioned on the scanning device as to be brought in close proximity to the switch on the holding compartment when the scanner is inserted into the scanner access; and

controlling means structure in the system to receive inputs from the sensors, initiate the reading, and receive information from the reading device whereby activation of the container presence sensor will enable activation of the switch provided on the scanning device to enable the scanner to read identifying indicia provided on the drug container and disposed at the scanner access of the holding compartment.

30. An electronic drug delivery system including a drug identification and security apparatus comprising:

a holding compartment;

a scanner access disposed in said holding compartment;

a container presence sensor provided in said compartment and operative when a drug container is installed in said compartment;

a scanning device electronically connected to the drug delivery system; and

controlling means structure in the system to receive inputs from the sensors, initiate the reading, and receive information from the reading device;

whereby activation of the container presence sensor will enable scanner access to enable the scanning device to read identifying indicia provided on the drug container and disposed at the scanner access of the holding compartment.