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Researchers Submit Patent Application, "Methods for Secure Communication and Pairing of a Medical Infusion Device and a Remote Controller for Such...

May 13, 2014



Researchers Submit Patent Application, "Methods for Secure Communication and Pairing of a Medical Infusion Device and a Remote Controller for Such Medical Device", for Approval

By a News Reporter-Staff News Editor at Life Science Weekly -- From Washington, D.C., NewsRx journalists report that a patent application by the inventors BRUKALO, Krzysztof Z. (Chambersburg, PA); EBNER, Manfred (Oberursel, DE); GETZ, Steven (Malvern, PA); HOHL, David (Milpitas, CA); POHLMAN, David (Malvern, PA); HENDRIXSON, Charles (West Chester, PA); QUINLAN, John (Spring City, PA), filed on September 30, 2013, was made available online on May 1, 2014 (see also Animas Corporation).

The patent's assignee is Animas Corporation.

News editors obtained the following quote from the background information supplied by the inventors: "External infusion devices (e.g., infusion pumps) may be used for delivering medication to users, such as insulin to diabetics. Portable external infusion devices may be attached to a user's belt, for example, or placed in a user's pocket. In external infusion devices delivering insulin, for example, the insulin may be delivered via a cannula, inserted in subcutaneous tissue of the user.

"Some conventional external infusion pumps may communicate remotely with another controlling device, such as a remote controller that is physically separated from the external infusion pump, for altering one or more functional settings of the external infusion pump. One example of such device is shown and described in U.S. Pat. No. 6,554,798. Another example is shown and described in US Patent Application Publication Nos. 2005/0022274 and 2005/0215982. Other conventional infusion pumps may include a remote controller with a blood glucose measurement device. One example of such device is shown and described in US Patent Application Publication No. 2004/0068230.

"Since most remote controllers and infusion pumps are designed to communicate via radio frequency (RF) communications, there is a growing concern among device manufacturers, users, and government regulators that RF transmissions are susceptible to interception and/or manipulation. Under certain circumstances, it has been suggested that a corrupted or malicious signal might be sent to an infusion device. Although no such instances outside of a laboratory are known to applicants, such an inaccurate or deliberately false signal to the infusion device might cause or be intended to cause a change in the delivery of medication that is harmful to the patient."

As a supplement to the background information on this patent application, NewsRx correspondents also obtained the inventors' summary information for this patent application: "By utilization of various technical features described herein, the coupling or pairing of a plurality of medical devices to respective remote controllers is convenient and potentially safer for the user, and instances of incorrect device pairing are believed to be reduced. These technical features are believed to be heretofore unrecognized in the conventional system. Specifically, in one embodiment, a disease management system is provided that includes a medical device and a remote controller. The medical device includes a display for the device and having medical device identification information. The remote controller includes a controller display and remote controller identification information, in which the medical device display is configured to display the controller identification information and the controller display is configured to display the medical device's identification information when the controller and medical device are linked to each other.

"In a further embodiment, a method to verify a wireless connection between a medical device and a remote controller is provided. The method can be achieved by: connecting a remote controller with a medical device via a wireless link; providing identification information specific to the medical device to the remote controller; providing identification information specific to the remote controller on the medical device; and confirming that the medical device identification is with the remote controller and that remote controller identification information is on the medical device.

"In yet a further embodiment, a method of operating a diabetes management system is provided in which the system includes a medical device and at least a remote controller. The method can be achieved by: exchanging identification information of the remote controller to the medical device and identification information of the medical device to the remote controller; and permitting control of the medical device by the remote controller upon acceptance of the remote controller's identification information in the medical device and acceptance of the medical device's identification information in the remote controller.

"In another embodiment of the invention the remote controller and infusion pump each employ radio frequency identification (RFID) tags with a unique code. The use of RFID tags may permit a faster, simpler method of pairing by placing the remote controller and infusion pump in close proximity to one another, allowing for the information stored on the RFID tags to complete the pairing process.

"In yet another embodiment of the invention, potentially corrupted or inaccurate signals that instruct the pump to deliver medication outside of a normal usage pattern, that might be harmful to the patient, or is otherwise outside of parameters pre-set into the infusion device's microcontroller and associated memory can be 'confirmed' by requiring the user to place the remote in close proximity to the infusion device. The exchange of information on the RFID tags can allow for verification that the dosing information received via RF communication from the remote controller is accurate and intended, or may allow the user to cancel and unintended or inaccurately programmed delivery.

BRIEF DESCRIPTION OF THE DRAWINGS

"The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain features of the invention, in which:

"FIG. 1 illustrates an exemplary operational configuration of one embodiment of the present invention.

"FIG. 2 is a perspective view of a remote controller shown in FIG. 1;

"FIG. 3 is a perspective view of the remote controller shown in FIG. 1;

"FIG. 4 is a perspective view of a test strip for use with the remote controller shown in FIGS. 2 and 3;

"FIG. 5 is a simplified schematic view of the remote controller and the medical device exhibiting wireless communication;

"FIG. 6 is a flow chart illustrating screens for pairing a remote controller and medical device that may be displayed on the remote controller, in one exemplary embodiment;

"FIG. 7 is a flow chart illustrating screens for pairing a remote controller and medical device that may be displayed on the medical device in one exemplary embodiment;

"FIG. 8 illustrates notifications that may be displayed on the remote controller during the pairing process of a remote controller and medical device in one exemplary embodiment;

"FIGS. 9A and 9B illustrate meter home screens that may be displayed on the remote controller in one exemplary embodiment;

"FIG. 10 illustrates a medical device home screen that may be displayed on the remote controller in one exemplary embodiment;

"FIG. 11 illustrates a medical device home screen that may be displayed on the medical device in one exemplary embodiment;

"FIG. 12 illustrates a medical device setup screen that may be displayed on the medical device in one exemplary embodiment;

"FIG. 13 illustrates RF communication setup and test screens that may be displayed on the remote controller in one exemplary embodiment;

"FIG. 14 illustrates RF communication setup screens that may be displayed on the remote controller in one exemplary embodiment;

"FIG. 15 illustrates RF communication setup screens that may be displayed on the medical device in one exemplary embodiment;

"FIGS. 16A and 16B illustrate bolus calculator setup screens that may be displayed on the remote controller in one exemplary embodiment;

"FIG. 16B illustrates a series of display screens that can be used to provide various reports on glucose and insulin analysis;

"FIG. 17 illustrates RF communication on/off setup screens that may be displayed on the remote controller in one exemplary embodiment;

"FIG. 18 illustrates screens for turning RF communication on that may be displayed on the remote controller in one exemplary embodiment;

"FIG. 19 is a flow chart illustrating screens for unpairing a remote controller and medical device that may be displayed on the remote controller in one exemplary embodiment;

"FIG. 20 illustrates notification screens that may be displayed on the remote controller during unpairing of a remote controller and medical device in one exemplary embodiment;

"FIG. 21 is a flow chart illustrating screens for a new pairing of a remote controller and medical device that may be displayed on the remote controller in one exemplary embodiment;

"FIG. 22 is a flow chart illustrating screens for a new pairing of a remote controller and medical device that may be displayed on the medical device in one exemplary embodiment;

"FIG. 23 is a schematic flow chart that illustrates a method of establishing an acceptable time window for blood glucose results measured by a remote controller and relied upon in bolus calculations in one exemplary embodiment;

"FIG. 24 is a flow chart illustrating screens for calculating and delivering a bolus, that may be displayed on the remote controller in one exemplary embodiment;

"FIG. 25 illustrates a series of medical device and remote controller status screens that may be displayed on the remote controller in one exemplary embodiment;

"FIG. 26A illustrates a series of logbook and notification screens that may be displayed on the remote controller in one exemplary embodiment;

"FIG. 26B illustrates a series of logbook and notification screens and screen displaying historical information that may be displayed in one exemplary embodiment;

"FIG. 27 illustrates a series of medical device history screens that may be displayed on the remote controller in one exemplary embodiment;

"FIG. 28 illustrates a series of warning and notification screens that may be displayed on the remote controller, as used in the exemplary embodiments; and,

"FIG. 29 illustrates a series of medical device warning screens that are similar in layout, and may be displayed simultaneously on both the remote controller and medical device, as used in the exemplary embodiments.

"FIG. 30 depicts an exemplary RFID for use in accordance with the illustrative embodiments.

"FIG. 31 shows an illustrative screen display on a remote controller that can occur during the pairing process of the exemplary embodiments.

"FIG. 32 shows another illustrative screen display on a remote controller that can occur during the pairing process of the exemplary embodiments.

"FIG. 33 Depicts an illustrative remote controller and infusion device transferring information from an RFID tag on the infusion device to the remote control device, as employed in various exemplary embodiments.

"FIG. 34 schematically depicts an illustrative remote controller and infusion device transferring information from an RFID tag on the infusion device to the remote control device and the circuit employed therein, as employed in various exemplary embodiments.

"FIG. 35 schematically depicts an illustrative remote controller and infusion device transferring information from an RFID tag on the infusion device to the remote control device and the circuits employed by both devices, illustrative of various exemplary embodiments."

For additional information on this patent application, see: BRUKALO, Krzysztof Z.; EBNER, Manfred; GETZ, Steven; HOHL, David; POHLMAN, David; HENDRIXSON, Charles; QUINLAN, John. Methods for Secure Communication and Pairing of a Medical Infusion Device and a Remote Controller for Such Medical Device. Filed September 30, 2013 and posted May 1, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=2191&p=44&f=G&l=50&d=PG01&S1=20140424.PD.&OS=PD/20140424&RS=PD/20140424

Keywords for this news article include: Proinsulin, Transferrin, Beta-Globulins, Blood Proteins, Peptide Hormones, Animas Corporation, Acute-Phase Proteins, Iron-Binding Proteins.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014, NewsRx LLC


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Source: Life Science Weekly


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