USER DEVICE COMMUNICATION DEVICE

A system for controlling the operations of a computerized device requires a sequence of two-way communications between a user and a computer. These communications both validate and control the operation of the device. A first communication from the user to the computer provides instructions that typically include changes for an operation of the device. In response, the computer requests user validation and identification. A second communication from the computer to the user then provides an operational status report of the system and a request for operational confirmation from the user, together with revalidation of user identification. An operation of the communication system is accomplished by selectively using audio, visual, and tactile signals from the user, interactively with vibrations, light variations, visual presentations and sound sequences from the device.

FIELD OF THE INVENTION

The present invention pertains to systems and methods for controlling computerized devices. More particularly, the present invention pertains to communication techniques and procedures for controlling the operation of devices, such as an infusion pump, which must function in accordance with a predetermined clinical protocol for regulatory compliance. The present invention is particularly, but not exclusively useful as a communication system for employing a combination of aural, visual and tactile means to execute and validate the instructions needed for controlling a computerized device.

BACKGROUND OF THE INVENTION

The use of medical devices that are to be operated and controlled by an end-user, without the supervision of trained medical personnel, raises several issues that are not otherwise particularly relevant. An underlying premise here is that the user is both competent and capable of properly operating the device. Although this may initially be a valid presumption, for any of several reasons this may change.

A particular concern for self-operated medical devices is that their operation must comply with regulatory requirements, and they must somehow be properly monitored. Specifically, when a medical protocol has been prescribed, it is essential that the device be operated in appropriate compliance with the protocol. For instance, when the medical device is an infusion pump, and infusions are to be performed in accordance with a prescribed protocol, deviations from the protocol are unacceptable. The situation can become even more problematical when an unqualified caregiver becomes involved.

To safeguard against a potentially dangerous operation of a self-operated Medical device, it is important for any temporal and/or dosage changes to a medical infusion protocol be made in compliance with the protocol's requirements. Moreover, it is also important that any changes be made by the user himself/herself or by trained personnel who are authorized to make the appropriate change.

With the above in mind, it is an object of the present invention to provide a communication system for operating a computer-controlled medical device that provides for two-way communications between the user and the computer controlling an operation of the device. Another object of the present invention is to establish two-way communication between a medical device and the user of the device, whereby the computer's operation is dependent on the validated confirmation of instructions from an appropriately identified user. Still another object of the present invention is to provide a self-controlled medical device which can only be operated by an identified user with regulatory compliance in accordance with a prescribed medical protocol. Yet another object of the present invention is to provide a communication system for operating a computer-controlled medical device that is easy to use, is simple to manufacture and is competitively cost effective.

SUMMARY OF THE INVENTION

A communication system for operating a computer-controlled device in accordance with real time, updated instructions from a user requires a computer that is directly connected with the device. An interface unit which is adapted for communication applications with the user is also mounted on the computer. Specifically, the communication applications provided by the interface unit allow for various combinations of audio, visual, and tactile modes of signal transmissions between a live, animate entity (i.e. a human user) and an inanimate entity (i.e. a computer).

Included in the interface unit on the computer is a transceiver with a receiver for receiving instructions from the user in the transmission of a first communication. Specifically, the first communication will include instructions from the user to the computer, for a specified operation of the computer-controlled device. In response to the first communication from the user, a request is transmitted by the computer back to the user for an operational confirmation of the instructions that are received from the user. Together with this request, the computer will provide a first prearranged signal for validating a subsequent identification of the user.

In response to the first communication, the transmitter of the transceiver in the interface unit on the computer is used for initiating a second communication between the computer and the user. Specifically, the second communication includes an advisory statement from the computer to the user regarding the operational status of the computerized system. It also includes a request for reconfirming the response from the user together with a second prearranged signal for identifying the user. The user then responds with the requested reconfirmation and an order to execute the instructions.

As envisioned for the present invention, the first communication is accomplished by the user in a manner selected from the group consisting of audio, visual, and tactile signals from the user. A response and the second communication are accomplished by the computer in a manner selected from the group consisting of vibrations, light variations, visual presentations, and sound sequences. As will be appreciated by a person of ordinary skill, there are many modes of signal transmissions that may be adapted for use with communication applications of the present invention. The important characteristic of communications between the user and the computer is that they are conversational in the sense that cross verifications, validations, confirmations, and identifications that are unique to the user and the computer are employed for controlling an operation of the device.

For a preferred embodiment of the present invention, the computer-controlled device is an infusion pump. Accordingly, instructions from the user in the first communication will typically include time, dosage and real time updates for medication changes that are compliant with a protocol that has been clinically incorporated for use in the computer. Stated differently, the execution and functional control of the computer-controlled device by the computer must comply with the protocol. To support a flexible functionality of the protocol, a monitor can be connected to the user for collecting data that is pertinent to a physical characteristic or the user (e.g., blood glucose levels). This data can then be used for compliant execution and control of the protocol by the computer. However, in the event an anomaly is detected by the monitor, the computer-controlled device executes an alarm message indicating that the collected data is noncompliant with the protocol. The alarm message is transmitted immediately to both the user, and to designated clinical personnel.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring initially toFIG.1a communication system for remotely controlling the operation of a device is shown and is generally designated10. As shown, the system10involves a user12that remotely interacts directly with a computer14, via a plurality of different modes of communication. The intended purpose of this communication is to provide instructions for the operation of a device16which is controlled by the computer14. In a preferred embodiment of the system10, the device16will be an infusion pump which is adapted for use by the user12for medical purposes.

As shown inFIG.1, the communication between the user12and the computer14is essentially a bifurcated conversation that includes a first communication18and a subsequent, follow-up, second communication20. Generally, in the first communication18, the user12provides instructions to the computer14for an updated operation of the device16(i.e., a change order). The second communication20is then undertaken for the purposes of: i) confirming the operational instructions; ii) validating the identity of the user12; iii) providing the user12with an advisory statement regarding the operational status of the system10; and iv) verifying the operational efficacy of the intended result. The user12then sends the order to execute the instructions for an operation of the device16.

FIG.2shows that the computer14includes a controller22which is connected to a pumping mechanism24in the device16. Specifically, as intended for the system10, the controller22will control the pumping mechanism24of the device16in accordance with operational parameters provided by a protocol unit26. Input for the protocol unit26includes clinical information28that is pertinent to the medical condition of the user12. This clinical information28may also include updated information, in real time, that is collected by a monitor30that may be affecting the medical condition of the user12.

FIG.2also shows that the computer14includes a message center32which interconnects the controller22with an interface unit34. For purposes of the present invention, the interface unit34is a transceiver of a type well known in the pertinent art that includes both a receiver and a transmitter. As shown, the interface unit34establishes the communications link between the computer14and the user12for both the first communication18and the second communication20.

A method for manufacturing a communication system10that remotely controls a computerized device16requires mounting a plurality of diverse electronic components on the computer14. This includes installing a message center32on a base structure of the computer14for transmitting and receiving interactively validated communications between the user12of the system10and the computer14. Also, it is necessary to establish a protocol unit26on the computer14for receiving clinical information28that defines the predetermined procedure of a protocol for operating the device16. Functionally, the protocol unit26is established to govern implementation of interactive communications between the user12and the computerized device16.

The manufacture of a system10for the present invention further requires locating the controller22on the computer14where it can be electronically connected between the protocol unit26and the message center32. In this combination, the controller22operates the computerized device16in accordance with the predetermined procedure established for the protocol unit26. Specifically, for the present invention, this results in implementing the validated and confirmed content in the first communication18and the second communication20as they are received and transmitted between the message center32and the user12.

An important aspect of the system10for the present invention is how communications are passed between the user12and the computer14. For this purpose, the interface unit34on the computer14is a transceiver having a receiver for receiving instructions from the user12that are presented in the transmission of the first communication18. Specifically, the first communication18will include instructions from the user12to the computer14for a specified operation of the computer-controlled device16. In response to the first communication18from the user12, a request is transmitted by the computer14from the message center32hack to the user12for an operational confirmation of the instructions sent from the user12. Together with this request, the computer14will also provide a first prearranged signal for validating a subsequent identification of the user12.

In response to the first communication, the transmitter of the transceiver in the interface unit34is used for initiating the second communication20between the computer14and the user12. Specifically, the second communication20includes an advisory statement from the computer14for the user12regarding the operational status of the computerized system10. This second communication20will also include a request for reconfirming the response from the user12together with a second prearranged signal for identifying the user12. The user12then responds with the requested reconfirmation and an order to execute the instructions.

FIG.3illustrates the temporal context for an exchange of the general contents in both the first communication18and the second communication20. In this exchange, it is to be appreciated that the user12will initiate the first communication18, while it is the computer14that initiates the second communication20. Moreover, unlike the instructional function of the first communication18, the second communication20provides an advisory statement that is based on an evaluation of requirements from the protocol unit26regarding the operational efficacy of instructions contained in the first communication18.

FIG.4illustrates the various modes for transmitting signals between the user12and the computer14. In a preferred embodiment of the system10the user12, who is an animate entity, will typically employ audio, visual, and/or tactile signals for his/her communication to the computer14. On the other hand, the computer14, which is an inanimate entity, will typically employ vibrations, light variations, visual presentations and/or sound sequences from the device16for its communication with the user12.