Patent Application
20230256166
The present invention pertains to systems and methods which provide a user with the remote capability of requesting a specific operation of an infusion pump, without requiring tactile contact with the pump. More particularly, the present invention pertains to a computer application that is incorporated into an infusion pump for this purpose. The invention is particularly, but not exclusively, useful as a computer application that responds to voice activated instructions from a user for operating an infusion pump in compliance with a predetermined, clinically prescribed protocol.
A major concern for the administration of prescription medications is that the medication must be properly used in accordance with clinical and regulatory requirements. For long term treatment protocols, such as insulin injections, the administration of the protocol typically involves user participation. It is not uncommon, however, that a third-party caregiver becomes involved. If so, their involvement can complicate matters in several ways. This, of course, is to be avoided.
By way of example, consider an insulin delivery protocol wherein it may be desirable, or necessary, to deviate from a same delivery schedule. Specifically, this will typically be the case when there are activity changes in the user's daily routine. The situation becomes even more problematical when the user is incapacitated or is otherwise incapable of self-administering a desired change in the delivery protocol. In these scenarios, the reliance on a medically uncertified caregiver to administer a change in the delivery protocol may be unwise, and possibly illegal.
To overcome the difficulties and inconveniences note above, it is necessary for the user to somehow maintain his/her personal responsibility for affecting changes in a drug delivery protocol. Thus, when a user is physically unable to affect changes in a drug delivery protocol, the only option may be to do so verbally with a voice-activated insulin delivery pump.
For the reasons set forth above, it is an object of the present invention to provide a system and method for verbally instructing a computerized pump with an initiate message to execute specific changes in a preprogrammed medication delivery protocol. A further object of the present invention is to provide the computerized pump with the capability of analyzing the initiate message and providing the user with an indication of how to properly proceed. Still another object of the present invention is to have the user electronically verify the initiate message, with the consequence that the pump is either activated to perform the change order, or the pump informs the user there can be no activation due to operational/protocol noncompliance. Yet another object of the present invention is to provide a system and method for verbally instructing a computerized pump to execute an initiate message for a preprogrammed medication delivery protocol that is simple to use, easy to manufacture and comparatively cost effective.
A system for activating an infusion pump includes a remote interaction device which is operated by a user to activate the infusion pump. The system also includes a computer which is mounted on the infusion pump and is connected for two-way communication with the interaction device. Typically, the computer is pre-programmed with a protocol that is determined in accordance with the prescription of a licensed clinical person, namely a physician.
An activating switch is provided on the remote interaction device for sending an initiate message from the user to the computer. In this initiate message, the user states his/her intentions for activating the infusion pump. Normally these intentions refer to temporary deviations from the pre-programmed protocol in the computer. Preferably, the initiate message is voice activated.
Upon its receipt of the initiate message, the computer validates the message. This validation is based on a computer evaluation of the operational status metrics compiled by the computer for the infusion pump. More specifically, the evaluation is made by analyzing requirements presented in the initiate message, with consideration given to the operational capabilities of the infusion pump identified by the status metrics, and clinical considerations established by the protocol.
For an operation of the present invention, an indicator is mounted on the infusion pump and connected with the computer. The purpose of the indicator is to identify an appropriate action to be followed by the user for an operation of the infusion pump. Specifically, this appropriate action is based on the computer evaluation, and it is manifested by the computer as an indicating signal to the user. As envisioned for the present invention, the indicating signal can be either audible tones, vibrations, and lights, or a combination of these.
Upon receipt of an indicating signal, the user can respond in any of several ways. Thus, a response button for activating the infusion pump can be operated in several modes. For one, the user can respond via a voice communication between the interactive device and the infusion pump. On the other hand, a physical response button can be provided on the infusion pump for operation by the user. In any event, the response action will typically include a choice between i) activating the pump in accordance with the initiate message, revising the initiate message, and iii) accepting a default with no further action. When a tactile response is to be made, a physical response button on the infusion pump may be either a capacitive button, an accelerometer to register taps and shakes, or a biometric reader.
A methodology for an operation of the present invention requires three essential components. One is a portable interaction device which can be operated by a user to activate an infusion pump. Another is the infusion pump itself. And a computer which is mounted on the infusion pump and is preprogrammed for infusing a fluid medicament from the infusion pump to the user. To implement this methodology, a two-way communication system is provided between the interaction device and the infusion pump. As envisioned for the present invention, this communication between the user and the computer on the infusion pump will typically proceed according to the following scenario.
First, the computer will receive an initiate message from the user wherein the user presents his/her intentions for activating the infusion pump. Upon receipt of the initiate message, the computer evaluates the operational status metrics that are pertinent to an operation of an infusion pump. This evaluation is then used by the computer for validating an operation of the infusion pump. Further, validation is accomplished by evaluating the status metrics of the infusion pump with consideration given to the user's intentions expressed in the initiate message. An indicating signal is then presented at the infusion pump which will support a response signal by the user for an appropriate action from the infusion pump.
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
With reference to
The sole function of the interactive device 12 is to initiate an activation of the infusion pump 14. As shown in
In
Once the initiate message 26 has been evaluated and validated the indicating signal 30 can be created on the indicator 31 in any of several modes. For instance, the indicating signal 30 may be audible tones, vibrations, lights, or a combination thereof.
The response option 32 provided by the indicating signal 30 will typically include a choice between several courses of action for the user; see block 34 of
While the particular Portable Infusion Pump with Remote Activator 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.
