Patent Application
20230260616
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.
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.
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.
The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which:
Referring initially to
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A method for manufacturing a communication system 10 that remotely controls a computerized device 16 requires mounting a plurality of diverse electronic components on the computer 14. This includes installing a message center 32 on a base structure of the computer 14 for transmitting and receiving interactively validated communications between the user 12 of the system 10 and the computer 14. Also, it is necessary to establish a protocol unit 26 on the computer 14 for receiving clinical information 28 that defines the predetermined procedure of a protocol for operating the device 16. Functionally, the protocol unit 26 is established to govern implementation of interactive communications between the user 12 and the computerized device 16.
The manufacture of a system 10 for the present invention further requires locating the controller 22 on the computer 14 where it can be electronically connected between the protocol unit 26 and the message center 32. In this combination, the controller 22 operates the computerized device 16 in accordance with the predetermined procedure established for the protocol unit 26. Specifically, for the present invention, this results in implementing the validated and confirmed content in the first communication 18 and the second communication 20 as they are received and transmitted between the message center 32 and the user 12.
An important aspect of the system 10 for the present invention is how communications are passed between the user 12 and the computer 14. For this purpose, the interface unit 34 on the computer 14 is a transceiver having a receiver for receiving instructions from the user 12 that are presented in the transmission of the first communication 18. Specifically, the first communication 18 will include instructions from the user 12 to the computer 14 for a specified operation of the computer-controlled device 16. In response to the first communication 18 from the user 12, a request is transmitted by the computer 14 from the message center 32 hack to the user 12 for an operational confirmation of the instructions sent from the user 12. Together with this request, the computer 14 will also provide a first prearranged signal for validating a subsequent identification of the user 12.
In response to the first communication, the transmitter of the transceiver in the interface unit 34 is used for initiating the second communication 20 between the computer 14 and the user 12. Specifically, the second communication 20 includes an advisory statement from the computer 14 for the user 12 regarding the operational status of the computerized system 10. This second communication 20 will also include a request for reconfirming the response from the user 12 together with a second prearranged signal for identifying the user 12. The user 12 then responds with the requested reconfirmation and an order to execute the instructions.
While the particular User/Device Communication System as herein shown and disclosed in detail is fully capable of obtaining the objects and providing the advantages herein before stated, it is to be understood that it is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended to the details of construction or design herein shown other than as described in the appended claims.
